Intellectual Property Office of New Zealand - Patents Decisions
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Last Updated: 14 October 2008
P19/2003
IN THE INTELLECTUAL
PROPERTY OFFICE
OF
NEW ZEALAND
IN THE MATTER of the Patents Act 1953
AND
IN THE MATTER of an application for Letters Patent No 286752/299093 in the name of ASHMONT HOLDINGS LIMITED
Applicant
AND
IN THE MATTER of opposition to said application under section 21 by FORT DODGE NEW ZEALAND LIMITED
Opponent
Hearing: 31 July and 1 August 2003
P C Dengate Thrush assisted by E Body for the Applicant
C L Elliott assisted by T G Jackson for the Opponent
Decision
BACKGROUND
Patent application 286752/299093 was filed on 5 June 1997, claiming priority from provisional application 286752 filed on 5 June 1996 and from provisional application 299093 filed on 30 July 1996.
The notice of acceptance issued on 15 October 1997, acceptance being published in Patent Office Journal 1422 of 24 November 1997.
Notice of opposition was filed on 23 March 1998.
A notice of opposition and statement of case were filed on 23 October 1998.
A further amended notice of opposition was filed on 17 December 1998 to accompany the statement of case filed 23 October 1998.
A counterstatement was filed on 10 May 1999.
A first amended notice of opposition and first amended statement of case were filed on 11 October 1999.
A first amended counterstatement was filed on 15 February 2000.
A second amended notice of opposition and second amended statement of case were filed on 9 November 2000.
A second amended counterstatement was filed on 14 May 2001. Amendment proposals were made unconditionally and amended claims pages were included. The examining section of the Intellectual Property Office of New Zealand (“the office”) did not accept that the amendments met the requirements of section 40(1) and this was reported back to the applicant. The amendment proposals are considered in this decision.
A third amended notice of opposition and third amended statement of case were filed on 18 March 2002, the grounds pleaded being grounds (b), (e) - both limbs, (f) and (g) of section 21(1). Ground (d), pleaded earlier in the proceedings, was not pursued following amendment proposals for the claims.
All grounds pleaded are denied by the applicant.
LOCUS STANDI
The applicant accepted that the opponent has the necessary locus standi for this opposition. I accept that the opponent, a company involved in the manufacture and distribution of animal remedies in New Zealand including combinations of parasiticides and vaccines, has locus standi.
AMENDMENT PROPOSALS
Section 40(1) relates to amendment of a specification after acceptance:
After the acceptance of a complete specification, no amendment thereof shall be effected except by way of disclaimer, correction, or explanation, and no amendment thereof shall be allowed, except for the purpose of correcting an obvious mistake, the effect of which would be that the specification as amended would claim or describe matter not in substance disclosed in the specification before the amendment, or that any claim of the specification as amended would not fall wholly within the scope of a claim of the specification before the amendment.
Claim 1 at acceptance read:
A stable injectable composition comprising a non-aqueous parasitic agent in a therapeutically effective amount, chosen from the macrolide group of compounds comprising avermectin, ivermectin, doramectin, abamectin, milbemycin and moxidectin, and an antigen in combination with a liquid carrier that also acts as an adjuvant for use with warm blooded animals.
Claim 1 is unconditionally proposed to be amended to read (with additions shown underlined and deletions shown struckthrough):
A stable injectable composition suitable for the treatment of warm blooded animals comprising
(a) a parasitic macrolide compound present non-aqueous
parasitic agent in a therapeutically effective amount, chosen from the
macrolide group of compounds comprising milbemycins including moxidectin, and
avermectins including avermectin, ivermectin,
doramectin, and abamectin, milbemycin and
moxidectin and
(b) an antigen;
in combination with a non-aqueous liquid carrier that also acts as an adjuvant for use with said warm blooded animals, the liquid carrier comprising one or more oils selected from the group of vegetables or mineral oils and purified derivatives thereof.
The proposals change the macrolides from those in original claim 1. One proposal is to change “avermectin” and “milbemycin” to include all the family of macrolides covered by the terms “avermectins” and “milbemycins”, with ivermectin, doramectin, abamectin and moxidectin being specifically named. In addition, the “liquid carrier” is proposed to comprise an “non-aqueous liquid carrier” as defined in the proposed new claim 1. It is proposed that the parasitic agent, now to be a “parasitic macrolide compound”, is no longer to be described as “non aqueous”.
The opponents stated its views on amendment of the specification at the opposition stage.
The opponent said the opposed specification contains a number of false statements, quoting in support the High Court decision in Novartis v Ancare (HC Auckland. CP 480/97, 19 June 1998, Morris J, unreported) at pages 71-72:
In the statement of claim the plaintiffs allege there were a number of false statements in the specifications which had led to the obtaining of the patent. Only one has been pursued. At p 4 second para. the specifications state:
“Praziquantel ... The surprising discovery that the efficacy of praziquantel can be enhanced in domesticated animals by simultaneous administration with other anthelmintics (as listed above) has been exploited in the present invention which offers improved efficacy in the control of cestodes together with simultaneous control of nematode infestations.”
The plaintiffs claim this passage is in effect a promise of synergy i.e. synergy between the praziquantel and the other active through the enhanced efficacy of the praziquantel.
Let me say immediately I interpret the passage as alleged by the plaintiffs. There can be no other conclusion if the words used are given their commonly understood and accepted meaning in this industry. This meaning is not restricted or curtailed in any way by other material in the specifications. The evidence clearly does not support a synergy. In fact it is denied by the defendant it is a synergy. There was therefore a false suggestion in the specifications.
A false suggestion on its own is not however sufficient to set aside a grant. The plaintiff must also prove the patent was granted on the basis of the false suggestion.
The opponent submitted that if the specification is false and not capable of substantiation the inference must be that the specification is insufficient as the categorical statements cannot be achieved following the instruction in the specification. As stated in Cyanamid v Ancare (High Court Auckland, CP 480/97, 19 June 1998, Morris J, unreported) paragraph 38:
I have real doubts whether the evidence I have heard justifies claiming a drench of the formulation described in the specifications prevents or controls t-ovis in sheep. The material produced to me makes reference to tests involving lambs. There is reference to the effectiveness of a combination of praziquantel chemotherapy and vaccine for the control of t-ovis in sheep but certainly no substantial reference to the prevention of sheep measles in sheep. I understood from Mr Harvey he regarded the terms ‘prevent and control’ as literally synonymous - by controlling lambs you control the illness in sheep. I consider I am entitled, on the material before me, to conclude there is in fact no true evidence to justify or substantiate claim 19 insofar as it refers to sheep measles and this is the true reason the application to delete it has been made.
The opponent disputed that the amendments proposed to the application should be allowed and said that, in the context of this opposition, the onus is on the applicant to show that the amendment request should be allowed. The onus is a heavy one as stated by Justice Graham in Chevron Research Companies Patent [1970] RPC 580 at 586:
... it is essential that those seeking amendment should realise that they have a heavy onus to discharge and can only expect to do so if they have full evidence to prove their case and put the whole story before the court.
The opponent drew again on Justice Graham in Chevron at 584:
In all these cases of amendment the interests of the public must be carefully watched, because from the very nature of the proceedings there is danger that something which originally was not likely to be held to be an infringement for one reason or another may be made so by the amendment, and this is of course particularly the case where a claim is enlarged.
The public interest is an overriding factor in the determination of amendment applications after acceptance, this irrespective of the individual parties’ actions. The Commissioner’s role is to protect the public from the grant of an improper monopoly.
The opponent submitted the change in focus of the specification has been marked and material parts still make no sense. Rowe (paragraph 7) points to the confusion surrounding the word “non-aqueous” as it is applied to the antiparasitic agent/antiparasitic macrolide compound:
I note that even the deponents on behalf of the applicant differ as to what the term “non-aqueous” means (see elsewhere in this decision).
In Holtite v Jost [1979] RPC 81 at 91 Lord Diplock stated:
The policy of the section is clear. A major purpose of a patent specification is to define the scope of the invention claimed . . . so as to give public notice of the limits of the monopoly claimed. An amendment, if allowed, is retrospective to the date of filing the complete specification.
The opponent said that if the formulations can be made stable (which they dispute) the applicant will need to add matter to explain how. They submit this would be in breach of the requirements of section 40 of the Patents Act 1953 in that the new claims would inevitably claim matter not in substance disclosed in the specification before amendment.
The opponent said the Commissioner has a discretion whether or not to allow amendments as in Terrell on the Law of Patents, 14th edition, paragraph 7.22:
The Court’s discretion is generally exercised taking into account two factors, the effect of the amendment on the validity or intelligibility of the patent and the conduct of the patentee.
The opponent submitted that any amendments to cure insufficiency would result in claims that are invalid, not being not fairly based on the description. They should be refused as a matter of discretion. While fair basis is not a ground of opposition, the issue of validity as it affects discretion is not so restricted.
My decision on allowability of the amendments
I agree with the examining section of the office that the amendments to change “milbemycin” to “milbemycins including” and “avermectin” to “avermectins including” is not allowable as broadening the scope of the claimed invention.
Harvey (paragraph 21), Grayson (paragraph 12) and Booker (paragraph 9) state that the term “avermectin” refers to the avermectin class of compounds including ivermectin, doramectin, abamectin and the like. I do not agree with these statements. It seems to me that “avermectin” refers to the compound “avermectin” and “milbemycin” to the compound “milbemycin”. What are defined in Harvey, Grayson and Booker are the group of compounds covered by terms like “the avermectins” and “the avermectin group of compounds” which relate to avermectin and avermectin-like compounds and the similar group of milbemycin and milbemycin-like compounds covered by terms like “the milbemycins”. The amendments are unsatisfactory as widening the scope of the claims.
Should the office view be wrong and there would be little or no change in the scope of the invention claimed by changing “milbemycin” to “milbemycins including” and “avermectin” to “avermectins including” then any difference due to the gloss introduced by the change of wording is unacceptable and the amendment is still unsatisfactory. However I fully accept that the office view is correct.
The proposed deletion of the qualification “non-aqueous” applied to the term “parasitic agent” is unsatisfactory. The qualification is criticised by the opponent as it appears to be unclear. This is discussed later in this decision. I do not believe the correct course is to delete the term. What is needed is clarification of the exact meaning of the term in relation to the antiparasitic agent before any amendment proposal can be properly considered.
The remaining amendments proposed appear satisfactory.
The word “parasitic” should be “parasiticidal” or “antiparasitic” in claim 1.
PRIORITY DATES
The opponent argued this in depth in submissions. The only ground to which the actual priority date would have any relevance, the ground of prior claiming, was not pursued by the opponent. This ground was omitted from the third amended notice of opposition and third amended statement of case.
Where the priority date is not an issue in opposition proceedings it is common that no determination is made as to priority date. On this understanding the applicant did not have any prepared submissions on the issue of priority dates.
I did say at the hearing that I needed to decide the matter of priority date in order to consider the ground of prior claiming in the public interest. The applicant was obliged to formulate argument at the hearing.
The opponent noted the onus is on the applicant to show that the claims of the complete specification are entitled to the priority date of the provisional specifications as held in Stauffer Chemical Company [1977] RPC 33 at 55. The applicant was put to proof by the opponent, but the applicant has not provided proof.
The relevant guidelines for fair basis of a complete specification on a priority document are those given by Lloyd Jacob J in Mond Nickel Co Ltd’s Application [1956] RPC 189 at 194:
These rules can be given a broadened interpretation. In the report of the decision in Mond Nickel, when the issue was before the Superintending Examiner he stated:
a mere broadening of the protection claimed in a complete specification, while not departing from an invention described in clear terms in the corresponding provisional specification, should not result in a finding that the claim is not “fairly based” on the provisional specification.
This was not adversely commented on by Lloyd-Jacob J who supported the decision of the Superintending Examiner on appeal to the Patent Appeal Tribunal. In the Mond Nickel case the invention related to reduction of the amount of magnesium required to be added to molten cast iron to produce cast iron with what were said to be remarkable mechanical properties. The amount of added magnesium could be reduced if the sulphur content of the molten cast iron was lowered to a certain limit before magnesium addition. The Superintending Examiner agreed with the opponent that the limit of the reduced sulphur content stated and claimed in the complete specification was higher than one might expect from perusal of the provisional specification. The claimed invention was wider than that described in the provisional specification with respect to the lowered sulphur content limit. Against this background the Superintending Examiner decided that a mere broadening of the protection sought should not result in the finding that the claimed invention was not fairly based on a narrower provisional specification.
The opponent said that priority document, New Zealand patent application 299093, having a filing date of 30 July 1996, requires the use of a wetting agent, a solubilising agent and an adjuvant with avermectin or milbemycin parasiticides in conjunction with immunising agents. The solubilising agent can be the adjuvant. As I see it, no claim of the complete specification is so restricted. It is my finding that no claim is entitled to the priority date of this document.
Priority document New Zealand patent application 286572, with a filing date of 5 June 1996, requires the use of a wetting agent in the case of mainly water based formulations and in the case of oil based formulations. An oil soluble solvent is also used in the case of oil based formulations. The document does not state that the liquid carrier also acts as an adjuvant, however it is my understanding that adjuvant effects of oils likely to be used in such formulations are known. Again, no claim of the complete specification is solely restricted to wetting agents in either mainly water based formulations or in oil based formulations, and additionally having an oil soluble solvent present in oil based formulations. Again, it is my finding that no claim is entitled to the priority date of this document.
The wetting agent, particularly, is an essential feature of the invention claimed. It is my opinion that the extensions of the claimed invention to include formulations which exclude wetting agents, and oil soluble solvents, are not developments along the same lines of thought, as held in Stauffer (above) at 54.
I do not think the broadening fits within that envisaged in Mond Nickel, above, which related to the complete specification having an extended range for a particular parameter, the reduced sulphur content, compared to what one might have expected from perusal of the provisional specification. In the present case the widening results from the omission of essential integers.
The answers to questions 1, 2 and 3 from Mond Nickel are “No”, “Yes” and “Yes” respectively.
I find that the claims are entitled to the date of 5 June 1997 as their priority date.
In addition it is my opinion that my comments under the grounds of opposition in this decision also apply in the main to the provisional specifications 299093 and 286752.
EVIDENCE
The opponent’s evidence:
The applicant’s evidence:
The opponent’s evidence in reply:
The opponent drew attention to deponent Cobb’s extensive qualifications and experience in the veterinary formulation field. The applicant questioned the relevance of deponent Cobb’s experience, having worked early in her professional life on chickens in Australia, then in product development, product registration, technical service and research management in vaccine development in Australia and the United States where she is currently Vice President, Pharmaceutical Research and Development of the opponent company in the United States. The applicant pointed to lack of experience of the relevant art in New Zealand. The opponent pointed to the extensive experience of deponent Cobb in her very detailed curriculum vitae and to several places in the this curriculum vitae where she has shown a knowledge and experience directly relevant to the art in New Zealand. She has been involved very much in development work on veterinary remedies, especially for New Zealand and for other countries. It seems to me that deponent Cobb is very well qualified to give evidence on the state of the relevant art in New Zealand at the priority date of the claimed invention.
Deponent Rowe is a pharmacy graduate of New South Wales, Australia, with many years experience of pharmaceutical development in the United Kingdom and Australia.
The opponent questioned the qualifications of deponent Harvey to give expert evidence on the art in New Zealand. Although he is the inventor of the application in suit he has not declared any technical qualifications needed to give expert evidence. The applicant referred to him as a pharmacologist in submissions at the hearing, however Mr Harvey has not declared such a qualification. There is no evidence before me as to what academic qualifications and experience deponent Harvey has.
As to deponent Grayson, he was said in submissions to be “an experienced veterinary formulation chemist - the subject of this patent”. He deposes that he is experienced in chemistry and microbiology including the area of veterinary formulation chemistry. However I note from his qualifications and experience attached as FWG-1 to his declaration that he does not include any reference to veterinary formulation work in his detailed curriculum vitae.
In the case of deponent Booker he does not provide a separate curriculum vitae. He deposes that he has twelve years experience in the development and manufacture of veterinary vaccines, especially clostridial vaccines, apparently in the roles of Production Supervisor, Production Manager and Operations Manager for Mannings Division of Merck, Sharp & Dohme (New Zealand) Ltd and Arthur Webster (New Zealand) Pty Ltd. In addition he states he has seven years experience in development and manufacture of veterinary pharmaceutical as Operations Manager for Stockguard Laboratories (New Zealand) Ltd. His experience appears to be in production and operations management roles. He does not identify how veterinary formulation development duties fitted into these managerial roles.
I will consider the evidence of all deponents on its merits.
NATURE OF THE INVENTION
The invention relates to an injectable composition.
The opening paragraphs
describe the background to the invention:
TECHNICAL FIELD OF THE INVENTION
This invention relates to novel compositions of avermectin and milbemycin endecticides with an immunising agent and in particular it relates to a stable injectable composition for use with warm-blooded animals, in particular ruminants.
The use of a combination of an [sic] parasitic agent and immunising agent as a single injectable formulation offers advantages both in time and cost saving to the farmer.
BACKGROUND
New Zealand Patent Nos. 191413 and 193807 of ICI Tasman Limited disclose water based formulations of D,L-tetramisole and clostridial vaccine in the treatment of helminthiasis and clostridial diseases in warm-blooded animals. Both D,L-tetramisole and the clostridial vaccine are water soluble hence a combination of the two is straight forward. What was surprising was that the clostridial vaccine remained effective at a pH lower than 6.0 and that the combination improved the immune response in ruminants, though not in other animals.
These aqueous formulations commonly used an adjuvant such as alum or alum hydroxide to enhance the effect of the antigen. Such adjuvants are usually included in the formulations as an aqueous suspensions [sic]. The vaccines can then be readily mixed with water based anthelmintic formulations.
Since the use of D,L-tetramisole and more particularly the L-isomer levamisole, there have been a number of other potent antiparasitic macrocyclic lactone compounds such as the avermectins, ivermectin, doramectin, abamectin, milbemycin, moxidectin used in the treatment of diseases in warm blooded animals. These later parasiticides are insoluble in water which creates difficulties in formulating stable injectable compositions. However, the compounds have the advantage that they are active against internal and external parasites in domestic animals.
Formulations are therefore based on co-solvent systems or aqueous solvent systems utilising a water-soluble solvent with one or more wetting agents. Water soluble solvents mix readily with traditional aqueous adjuvant systems to form combinations of anthelmintics and vaccines. This is not the case with oil based (non-aqueous) systems.
OBJECT
It is an object of the invention to provide an improved injectable composition combining a parasitic agent and an antigen or at least one that provides the public with a useful choice.
STATEMENT OF THE INVENTION
It has been surprisingly discovered that non-aqueous anthelmintics can be combined with an antigen using a liquid such as an oil adjuvant and carrier to give a stable formulation that can be safely injected into warm blooded animals including cattle and sheep.
In one aspect the invention comprises a stable injectable composition comprising a non-aqueous parasitic agent in a therapeutically effect [sic] amount and an antigen in combination with a liquid carrier that also acts as an adjuvant for use with warm blooded animals.
Preferably the non-aqueous parasitic agent is a macrolide compound selected from the group comprising avermectin, ivermectin, doramectin, abamectin, milbemycin and moxidectin, present from 0.05 to 10%w/v. More preferably the non-aqueous parasitic agent is chosen from the group comprising abamectin, ivermectin, moxidectin and doramectin.
The examples of formulations in the specification, representing the preferred embodiments, use abamectin, ivermectin or doramectin
Claim 1 is the main claim with the remaining claims, claims 2 to 10, depending from this claim.
Claim 1 as at acceptance reads:
A stable injectable composition comprising a non-aqueous parasitic agent in a therapeutically effective amount, chosen from the macrolide group of compounds comprising avermectin, ivermectin, doramectin, abamectin, milbemycin and moxidectin, and an antigen in combination with a liquid carrier that also acts as an adjuvant for use with warm blooded animals.
Claim 1 as it was proposed to be amended reads:
A stable injectable composition suitable for the treatment of warm blooded animals comprising
(a) a parasitic macrolide compound present in a therapeutically effective amount, chosen from the macrolide group of compounds comprising milbemycins including moxidectin, and avermectins including ivermectin, doramectin and abamectin; and
(b) an antigen;
in combination with a non-aqueous liquid carrier that also acts as an adjuvant for use with said warm blooded animals, the liquid carrier comprising one or more oils selected from the group of vegetable or mineral oils and purified derivatives thereof.
THE LAW
The opponent submitted the approach to claim construction is a purposive one as held in Catnic Components Ltd & Anr v Hill & Smith Ltd [1982] RPC 183 at 243:
A patent specification should be given a purposive construction rather than a purely literal one derived from applying to it the kind of meticulous verbal analysis in which lawyers are too often tempted by their training to indulge.
The opponent submitted that there is no rule of benevolent construction. In the recent United Kingdom Court of Appeal decision in BASF AG v Smithkline Beecham Plc [2003] EWCA Civ 872 unreported, Aldous LJ stated at para 102:
The current, 15th, edition of Terrell on The Law of Patents at paragraph 6.42 illustrates the pre-1977 judicial approach by what Lindley LJ said in Needham and Kite v Johnson and Co (1884) 1 RPC 49, 58:
“I do not like the expression 'benevolent interpretation'. I do not believe in it. The question is whether a given construction is the true construction; but, of course, if any patent is capable of more constructions than one, the general rule would be applied that you would put upon it that construction which makes it a valid patent rather than a construction which renders it invalid.”
Even this approach leans towards the patentee, in a way which Jessel MR, despite the reasons which emerge very clearly from the passage I have cited, did not. The editors state the modern position, by contrast, as follows:
"The court does not resolve doubt in favour of the patentee, as this is not part of the purposive approach to construction [ fn. Assidoman Multipack v Mead [1995] RPC 321,332]. To do so would appear to be in conflict with the Protocol insofar as it requires there to be certainty for third parties."
The applicant said that in construing specifications considerable aid can be found in the principles recently enunciated by Fisher J in Lucas v Peterson (Auckland High Court decision CP6/69, 9 May 2003):
(a) The interpretation of a patent specification is a question of law for the Court to determine but that expert evidence can be received as to the meaning of technical terms and concepts found within it.
(b) The specification is to be construed objectively through the eyes of a skilled but unimaginative addressee. The test is what an addressee skilled in the particular art in question would understand from the document as a whole.
(c) The patent is to be given a purposive construction. Not appropriate is the kind of meticulous verbal analysis to which lawyers can sometimes be attracted.
(d) The Court is to have regard to the surrounding circumstances as they existed at the priority date, this including matters of common general knowledge at that time.
(e) It is to be assumed that redundancy was not intended. Consequently separate effect should be given to each word and phrase unless no sensible additional meaning can be ascertained from them.
(f) The specification is to be interpreted as a whole. Since it is the claims that define the scope of the monopoly, they will normally be the starting point but ambiguity in words or expressions can, in appropriate cases, be resolved by reference to the context of the document as a whole. Importantly, for this purpose the document includes the drawings.
(g) The complete specification is broadly divisible into the description or consistory clauses (s 10(1) and (3)(a)) of the Patents Act, the best method of performing the invention (s 10(3)(b)), and the claims (s 10(3)(c) and (4)).
(h) The description or consistory clauses must identify and describe the essence of the invention in terms which reveal the inventive step or steps. The question is what the skilled addressee would understand as the essential and novel features of the invention.
(i) The superlative “best” when referring to the best method (s 10(3)(b)) implies that more than one embodiment will be possible for any given invention. Passages in the specification introduced by the word “preferably”, or “in a preferred form”, or “in one embodiment of the invention”, or words to similar effect, may tend to indicate that what is being described is merely optional and therefore not an essential part of the invention itself.
(j) It may also be necessary to distinguish between consistory clauses and embodiments for another reason. When referring to the body of the specification for the purpose of clarifying ambiguous expressions in a claim, consistory clauses may be exhaustive as to the intended scope of the expression. Embodiments, on the other hand, might help to show the broadness of a claim but presumably never its narrowness.
(k) Notwithstanding those technicalities, the overriding requirement will always be to view the specification purposively through the eyes of the technically skilled addressee and not those of a lawyer conducting a line by line analysis of a debenture or will.
The applicant stated that the onus in opposition proceedings is clearly on the opponent. The Commissioner needs to be satisfied beyond doubt that the letters patent applied for ought not to be sealed. The applicant drew on Tetra Pak Tebel BV’s Application 328267 (Assistant Commissioner Hazlewood, 6 August 2002) regarding any conflict of fact or expert opinion that is largely to be resolved by giving the applicant the benefit of the doubt. The relevant passage appears on the fifth page of the decision:
On any conflict of fact and expert opinion, the applicant drew attention to General Electric Company’s Application [1964] RPC 413 (approved in Beecham Group Limited v Bristol Myers Company (No2) [1979] NZLR 629 at 634) where Lord Diplock said:
The right principle is that if on the face of the written evidence filed there appears to be a bona fide conflict of fact or credible expert opinion upon a question on the answer to which the existence or non-existence of the ground for refusal specified ..... depends, the [Commissioner] should not exercise his jurisdiction to refuse the grant unless, after cross-examination of the witness if he thinks fit to order it, the conflict is clearly resolved in favour of the party opposing the grant.
The applicant also drew attention to Rural Pacific Marketing Pty Ltd’s Application 277456 (Assistant Commissioner Hazlewood, 8 January 2001) at page 7:
Consequently the burden of proof in opposition cases is high, and the onus lies with the opponent. Any invention claimed in an application must be manifestly untenable for the application to be prevented from proceeding to grant at the opposition stage.
As I see it, the decision in BASF (above) refers to doubt as to what construction may be placed on any particular wording. In such a case an applicant cannot be given the benefit of the doubt, ie a “benevolent interpretation”. On the other hand, the benefit of any doubt as to whether or not a ground has been made out must be given to the applicant.
Speaking specifically about the ground of obviousness, the opponent said the ground is available and the use of the word “clearly” qualifying obviousness does not mean success on this ground should be unattainable.
PRIOR PUBLICATION – section 21(1)(b)
Section 21(1)(b) states:
That the invention, so far as claimed in any claim of the complete specification, has been published in New Zealand before the priority date of the claim —
(i) In any specification filed in pursuance of an application for a patent made in New Zealand and dated within 50 years next before the date of filing of the applicant’s complete specification:
(ii) In any other document (not being a document of any class described in subsection (1) of section 59 of this Act)
The usual test for prior publication is that set forth in the judgment of the English Court of Appeal by Sachs LJ in The General Tire & Rubber Company v The Firestone Tyre and Rubber Company Limited and Others [1972] RPC 457 at 485 to 486:
If the prior inventor’s publication contains a clear description of, or clear instructions to do or make, something that would infringe the patentee’s claim if carried out after the grant of the patentee’s patent, the patentee’s claim will have been shown to lack the necessary novelty, that is to say, it will have been anticipated. The prior inventor, however, and the patentee may have approached the same device from different starting points and may for this reason, or it may be for other reasons, have so described their devices that it cannot be immediately discerned from a reading of the language which they have respectively used that they have discovered in truth the same device; but if carrying out the directions contained in the prior inventor’s publication will inevitably result in something being made or done which, if the patentee’s patent were valid, would constitute an infringement of the patentee’s claim, this circumstance demonstrates that the patentee’s claim has in fact been anticipated.
If, on the other hand, the prior publication contains a direction which is capable of being carried out in a manner which would infringe the patentee’s claim, but would be at least as likely to be carried out in a way which would not do so, the patentee’s claim will not have been anticipated, although it may fail on the ground of obviousness. To anticipate the patentee’s claim the prior publication must contain clear and unmistakeable directions to do what the patentee claims to have invented ... A signpost, however clear, upon the road to the patentee’s invention will not suffice. The prior inventor must be clearly shown to have planted his flag at the precise destination before the patentee.
This dictum has been applied and followed by the Court of Appeal of New Zealand in Beecham Group Limited’s (New Zealand/Amoxycillin) Application [1982] FSR 181.
Claim 1 as at acceptance includes:
a stable injectable composition comprising
(a) a non-aqueous parasitic agent in a therapeutically effective amount, chosen from the macrolide group of compounds comprising avermectin, ivermectin, doramectin, abamectin, milbemycin and moxidectin; and
(b) an antigen;
in combination with a liquid carrier that also acts as an adjuvant for use with warm blooded animals.
Claim 1 as it was proposed to be amended includes:
a stable injectable composition suitable for the treatment of warm blooded animals comprising
(a) a parasitic macrolide compound present in a therapeutically effective amount, chosen from the macrolide group of compounds comprising milbemycins including moxidectin, and avermectins including ivermectin, doramectin and abamectin; and
(b) an antigen;
in combination with a non-aqueous liquid carrier that also acts as an adjuvant for use with the warm blooded animals, the liquid carrier comprising one or more oils selected from the group of vegetable or mineral oils and purified derivatives thereof.
New Zealand Patent Specification 224597/224862
This document was available at the office from 25 February 1992. The specification describes a vaccine comprising a polypeptide antigen in combination with pharmaceutically acceptable adjuvants, carriers or diluents therefor. Included as adjuvants are Freund’s complete adjuvant and Freund’s incomplete adjuvant (page 13). Both of the Freund’s adjuvants are water-in-oil emulsions of antigens. The specification says the antigen can be administered in conjunction with other therapeutic agents such as anthelmintics, for example levamisole (page 13). There is no mention of the addition of an anthelmintic from the milbemycin and avermectin groups of compounds, however the opponent submitted the skilled reader would have been aware of such anthelmintics at the time.
The test in the General Tire case is not satisfied. This document does not prior publish the applicant’s claimed invention.
I find that the ground of prior publication is not made out.
PRIOR CLAIMING – section 21(1)(c)
Section 21(1)(c) states:
That the invention, so far as claimed in any claim of the complete specification is claimed in any claim of a complete specification published on or after the priority date of the applicant’s claim and filed in pursuance of an application for a patent in New Zealand, being a claim of which the priority date is earlier than that of the applicant’s claim
New Zealand Patent Specification 286896
The date of filing of the complete specification of NZ 286896 is 27 June 1996 based on an application in the United States of America dated 30 June 1995. I have found that the claims of the present application are entitled to the date of 5 June 1997 as their priority date. However, the claims of NZ 286896 relate to a water soluble composition so the invention claimed therein is different from that of the present application which requires an oil carrier to be present.
The ground of prior claiming is not made out.
PRIOR USE - section 21(1)(d)
Section 21(1)(d) states:
That the invention, so far as claimed in any claim of the complete specification, was used in New Zealand before the priority date of that claim
The Office Practice Note, published in Patent Office Journal No 1287 in July 1986, page 714, sets out what the opponent must do to prove this ground:
To succeed on this ground, an opponent must first establish that the alleged instance(s) of prior use was (were) not secret use(s) of the invention, as claimed. See the decision of the House of Lords in Bristol-Myers (Johnson’s) Application [1975] RPC 127, at 157, for a discussion on what constitutes public use, as opposed to secret use. The opponent must also establish, by evidence,
(a) what was used
(b) where it was used
(c) by whom it was used
(d) the date it was used
(e) where apparatus still extant may be inspected.
This ground was not pursued by the opponent.
This ground is not made out.
OBVIOUSNESS - section 21(1)(e)
Section 21(1)(e) reads:
That the invention, so far as claimed in any claim of the complete specification is obvious and clearly does not involve any inventive step having regard to matter published as mentioned in paragraph (b) of this subsection, or having regard to what was used in New Zealand before the priority date of the applicant’s claim
The Act requires that the invention must be shown to be clearly obvious, otherwise the applicant should be given the benefit of any doubt. The word “clearly” is discussed in Beecham Group Ltd v Bristol Myers Company (No 2) [1980] 1 NZLR 192 at 230 where Barker J states:
The word “clearly” in s 21(1)(e) is not found in s 41(1)(f) which provides, as a ground for revocation by the court of a patent in proceedings to that end:
That the invention, so far as it is claimed in any claim of the complete specification, is obvious and does not involve any inventive step having regard to what was known or used before the priority date of the claim in New Zealand.
The insertion of the word “clearly” in the opposition section indicates a higher onus on an opponent in opposition proceedings who alleges that there is no inventive step, the omission of the word in the revocation section indicates that the onus there is not quite so high.
The ground of obviousness has two limbs, one being based on prior publication, the other being based on prior use. The Office Practice Note No 33 published in Patent Office Journal No 1367 of April 1993, page 492, explained this as follows:
This ground has two separate distinct limbs, (a) obviousness and clear lack of inventive step, having regard to what has been published in New Zealand, before the priority date of a claim under attack, and (b) obviousness and clear lack of inventive step, having regard to what has been used in New Zealand, before the priority date of a claim under attack. It is not permissible to combine the two separate limbs. Note the use of the disjunctive “or” in the [section of the Act].
Only the first limb was pursued at the hearing.
Both the opponent and the applicant pointed out that the usual test for obviousness was that set out by Oliver J in Windsurfing International Inc v Tabur Marine (Great Britain) Ltd [1985] RPC 59 at 73, and followed in New Zealand by Tompkins J in Smale v North Sails Ltd [1991] 3 NZLR 19 at 42 and Gault J in Ancare v Cyanamid [2000] 3 NZLR 299 at 309:
There are, we think, four steps which require to be taken in answering the jury question. The first is to identify the inventive concept embodied in the patent in suit. Thereafter, the court has to assume the mantle of the normally skilled but unimaginative addressee in the art at the priority date and to impute to him what was, at that date, common general knowledge in the art in question. The third step is to identify what, if any, differences exist between the matter cited as being ‘known or used’ and the alleged invention. Finally the court has to ask itself whether, viewed without any knowledge of the alleged invention, those differences constitute steps which would have been obvious to the skilled man or whether they require any degree of invention.
The approach can be summarised as:
The opponent pointed out that the test for obviousness was recently
stated by the
New Zealand Court of Appeal in Ancare v Cyanamid [2001]
RPC 335 at 346:
The test for obviousness postulated a person (or, where appropriate, a team), who was skilled in the field but not inventive and was invested with the common general knowledge available in the field at the priority date, being presented with the prior knowledge or prior use relied on. Prior documents might be looked at together if that was what the skilled person or team would have done. The test was to ask whether the alleged inventive step would have been obvious to that person or team and would have been recognised, without bringing to bear any inventiveness, as something that could have been done or was at least worth trying. That was a question of fact. The element of inventiveness necessary to resist attack was not high, but if any embodiment within the scope of the claim was obvious the claim was invalid.
The opponent submitted that prior certainty of success was not required and that it was enough if the skilled addressee considered it “worth a try” toward a definite end. The uninventive skilled addressee must consider it “worth a try” in order to solve a recognised problem or meet a recognised need. In support the opponent drew on the United Kingdom Court of Appeal decision of Johns-Manville Corporation’s Patent [1967] RPC 479 at 494 where Diplock LJ stated:
I think that “would be” puts it too high if it postulates prior certainty of success before actual testing ..; it is enough that the person versed in the art would assess the likelihood of success as sufficient to warrant actual trial.
In the present case, therefore, the opponent submitted the relevant question to ask is whether the skilled person would have considered that combining injectable compositions containing a water insoluble macrolide and a water soluble vaccine would be “obvious to try” or “worth trying”. The opponent drew also on the Australian Federal Court decision in W R Grace v Asahi Kogyo [1993] FCA 84; (1993) 25 IPR 481 at 494 where it was seen as obvious that a skilled addressee would consider a new plastic as worth trying:
His Honour’s conclusion plainly was that the hypothetical skilled addressee having read these articles, would consider VLDPE worth trying.
The skilled person must have a definite object in view and, as stated by the United Kingdom Court of Appeal in Hickman v Andrews [1983] RPC 147 at 189, this can be an improvement of a product already on the market:
There is another preliminary question and that is what the expert is supposed to be doing. It cannot be that he is to look to the whole store of his imaginary knowledge and see if it is obvious to turn something therein to better account. He must I think have some definite object in view, and in the instant case, for example, he would be seeking to make a workbench which would be an improvement on those already on the market.
The skilled addressee may reasonably be expected to seek advice and assistance from experts in the field to recognise that a combination was worth trying, as per Buckley J in the United Kingdom Court of Appeal in Tetra Molectric v Japan Imports [1976] RPC 547 at 583:
... one must, I think, first consider whether in the state of knowledge to be attributed to him [the skilled person] he should have been put on the track of a solution, and secondly whether from his own unassisted knowledge, or with the assistance of such technical advice as it would be reasonable for him to seek and obtain in the circumstances, he would recognise that the combination would be worth trying.
The opponent said the skilled addressee will be armed with the common general knowledge as at the priority date of the application.
The opponent submitted that the ground of obviousness is available and the
use of the word “clearly” qualifying obviousness
does not mean
success on this ground should be unattainable.
The opponent relied on the
following published documents and uses:
The applicant objected to the documents as there was no declaration that the documents were found as the result of a diligent search, to meet High Court rules on admissibility of evidence. I had much assistance from the parties on this matter. It is not usual in opposition proceedings before the Commissioner to require evidence that the search conducted for prior art was diligent.
It seems to me that none of the documents are from an obscure source. None of the documents are provided in order to make an obscure technical point. They are documentary evidence of well accepted matters, matters which have been acknowledged by the applicant in the provisional and complete specifications and in Harvey and Booker.
I will consider the foregoing documents on their merits and I admit them.
The opponent discussed its position on obviousness.
The opponent submitted in the third statement of case (paragraphs 24-27), that macrolides and oils, whether in oil, oil-based or oil containing compositions, are well known. The alleged properties of an oil or liquid carrier including oil as an adjuvant in enhancing the macrolide effect and improving the effect of the antigen are well known. US patent 5262400 discloses certain of the exemplified macrolides used in the specification, that they can be administered by injection and can be dissolved in an inert liquid carrier that can include inter alia vegetable oils, such as sesame oil. Cobb I (paragraphs 24-28) deposes that macrolides and oils are well known. In Harvey (paragraph 18) the applicant admits that the use of oily components was known for macrolides as a means of extending their activity. Cobb I (paragraphs 24-28) reads:
“oil solutions can be used to prolong plasma concentrations of doramectin”.
Harvey (paragraph 18) states:
18. Likewise the use of oily components was known for Macrolides as a means of extending their activity. This knowhow had recently been introduced by my company at the time.
In the third statement of case (paragraphs 28-32) the opponent said that it is known to use oils to extend the effects of macrolides. The Wicks and Campbell documents refer to oil prolonging plasma concentrations of doramectin; to higher initial levels of macrolide activity or longer duration of the active being obtained by manipulation of the formulation including use of emulsifying agents to carry the macrolide in the plasma of the blood; and to non-aqueous injectable formulations of ivermectin showing a slow absorption process. This was supported by Cobb I (paragraphs 26-27, quoted above) for the opponent and by Harvey (paragraph 18, quoted above) for the applicant - “Likewise the use of oily components was known for Macrolides as a means of extending their activity.”
The third statement of case (paragraphs 28-32) states:
“Oil solutions can be used to prolong plasma concentrations of doramectin.”
The third statement of case (paragraphs 33-45) states that vaccines plus oils are well known. This is supported by Cobb I (paragraphs 29-34) and Harvey (paragraph 17). The third statement of case (paragraphs 33-45) reads:
Cobb I (paragraphs 29-34) reads:
Harvey (paragraph 17) reads:
17. While the use of oils was well understood for the formulation of vaccines this technology was not widely used in veterinary medicine largely because they often caused severe reactions. The main types of vaccine were aqueous based with the use of alum or aluminum hydroxide as adjuvant. This adjuvant absorbed the toxoids and prolonged their affect [sic] in stimulating immunity.
The opponent’s comments on Harvey (paragraph 17) are to be found in Cobb II (paragraph 39):
“These
preparations have been shown to be stable and do not cause injury when
injected...”.
and, also on page 8:
“The formulations have a shelf life of approximately two years.”
I refer to my comments above on the “have been shown to be stable” issue and note there is nothing in the Application to show that “injury” was a problem or that this had in fact been overcome and, if so, how this is achieved. There is definitely nothing in the Application to support a two year shelf life.
The opponent said that the simple reading of Coopers’ application, NZ patent 224597/224862, with a skilled person’s knowledge of anthelmintics available at the earliest priority date makes the formulation as claimed by the applicant clearly lacking an inventive step (third statement of case, paragraph 43, above). Example 1 of NZ patent 224597/224862 (page 16) describes the use of an incomplete oil adjuvant (antigen in a water-in-oil emulsion) for parenteral administration of the protective antigen to control T.ovis in sheep.
The opponent said the Cydectin Eweguard® product available in New Zealand before 5 June 1995 teaches a combination formulation of macrolide and antigen (third statement of case, paragraphs 22-23):
NZ 286752 (provisional) - a non-aqueous anthelmintic, a wetting agent, known excipients, and known adjuvants (page 2 line 20-24);
NZ 299043 [sic] (provisional) - a non-aqueous anthelmintic, a wetting agent, known excipients, and known adjuvants (page 2 line 20-24).
The disclosure of Cydectin Eweguard® in the IVS manual is therefore evidence of the availability and use of this product before the earliest priority date (5 June 1997) available to NZ 256752 [sic].
The opponent said the combination of Waksman (mineral oil has a depot function and disseminates antigen following parenteral administration resulting in long persistence and slow release) and Wicks (oils, particularly sesame oil, are typical and useful carriers for macrolides and oils solutions can be used to prolong plasma concentrations of the avermectin doramectin) teach the invention by simple combination of the teachings, demonstrating the lack of inventive step (third statement of case, paragraphs 46-47). The third statement of case (paragraphs 46-47 reads:
The opponent pointed out that the priority documents (NZ 286752 and NZ 299093) admit the adjuvant effect is known, the third statement of case (paragraph 48) stating:
Both documents NZ 286752 and NZ 299093 have paragraphs at their pages 2 stating:
It has been surprisingly discovered that non-aqueous anthelmintics can be combined with an immuni[z/s]ing agent in the presence of a wetting agent and known excipients and adjuvants to give a stable formulation that can be safely injected into warm blooded animals including cattle and sheep.
The opponent submitted the complete specification does not admit that the adjuvant effect of oils is known in its corresponding statement of the invention:
It has been surprisingly discovered that non-aqueous anthelmintics can be combined with an antigen using a liquid such as an oil as an adjuvant and carrier to give a stable formulation that can be safely injected into warm blooded animals including cattle and sheep.
As stated above, evidence for both the opponent and applicant show that the adjuvant effect is known, in Cobb I (paragraphs 20-21) and Harvey (paragraph 17, above). Cobb I (paragraphs 20-21) reads:
“Surprisingly, the oil also acts as an adjuvant in the composition, enhancing the activity of the vaccine and extending the parasiticide activity of the anthelmintic.”
Harvey (paragraph 17, above) admits the adjuvant effect is known.
Harvey (paragraph 17, above), as part of its admission that the adjuvant effect is known, also admits that oil adjuvants can cause severe reactions.
The opponent stated the third statement of case (paragraphs 49-51) indicates that combinations were the obvious thing to do:
The opponent said the third statement of case (paragraphs 52-53) points out the interrelationship with the sufficiency of the disclosure:
The opponent submitted that Harvey (paragraph 14) admits that the prior art as discussed by the opponent and which discloses the use of oils for macrolides and the use of oils and adjuvants is known:
14. Ramune Cobb discusses a wide range of prior art, which discloses the use of oils for macrolides and also the use of oils and adjuvant. Not one of these publications despite their wide ranging nature discusses the use of these two concepts together let alone putting forward formulations which resemble the invention of the present application. This further reinforces the novelty of this combination of ideas into a useful invention.
In response, for the opponent, Cobb II (paragraph 37) states:
The opponent submitted that Harvey (paragraph 19) also admits that there was an obvious need to combine a vaccine and macrolide and pointed to the commercial success of the opponent’s Eweguard product (the subject of NZ patent 286896). Harvey (paragraph 19) reads:
19. The commercial success of a combination of a vaccine and macrolide had been clearly shown by the introduction of the Eweguard combination by Cyanamid in response to the obvious need to combine two jobs. As identified and detailed in the evidence filed in the NZ 286896 matter.
The opponent discussed the alleged inventive concept.
The opponent submitted that the inventive concept appears to be the formulation of a stable combination of a macrolide and a vaccine in a non-aqueous carrier. Harvey (paragraph 5), in agreeing with the statement in Cobb I (paragraph 12), states:
5. I(n) paragraph 12 Ramune Cobb identifies the heart of the invention.
Cobb II (paragraph 12) states:
The opponent pointed out that in Harvey (paragraph 12) there is an attempt to keep the options open by referring to a “concept” in broad terms:
12. I do not consider Ramune Cobb’s comments are supported by any practical attempt to follow the formulations outlined. They seem to be based only on opinion. It is not the purpose of the patent specification to list all details and to provide each and every variation possible. To do so would make patents extremely large and difficult to read. Rather it is necessary only to provide sufficient details of the concept. The proper disclosure of the formulations is all that is required in this instance to show the validity of this novel concept.
Cobb II (paragraph 35) comments on the “concept” as follows:
The opponent pointed out that Harvey (paragraphs 17-18, above) agreed that oils are well understood (and used) for vaccine formulation (but that oils are not widely used for veterinary formulations because of problems, it being said that they often cause severe reactions) and pointed out that Harvey says that oils are known to be used with macrolides as a means of extending their activity.
The opponent pointed to the obvious need or want for a combination drench/vaccine such as Eweguard. In support it drew on Cobb I (paragraph 39) and Harvey (paragraphs 15 and 19). Cobb I (paragraph 39) states:
Harvey (paragraphs 15 and 19) reads:
15. In addition I refer to the affidavits presented in support of NZ 286896. These clearly indicate the market demand for a product which included vaccines in combination with a macrocyclic lactone. In addition the affidavits of Gliddon and Ramune Cobb indicate that Cyanamid experienced difficulties achieving a formulation which satisfied the demand. One has to ask why if the invention claimed in this patent application was so obvious they had not arrived at it as a solution to the problem themselves. This is especially the case if as Ramune Cobb suggests that the advantages of the formulation were so clear. The only reason I can think of is that the invention the subject of the application represents an advance in the field of the formulation technology.
19. The commercial success of a combination of a vaccine and macrolide had been clearly shown by the introduction of the Eweguard combination by Cyanamid in response to the obvious need to combine two jobs. As identified and detailed in the evidence filed in the NZ 286896 matter.
The opponent submitted that, having acknowledged that all of the elements of the invention are known and acknowledged that the broad principle is known, all that is left are the formulation differences that could impart stability and effectiveness. The opponent said that the only difference between the marketed Eweguard (a combination of the macrolide moxidectin and clostridial antigens) are in the formulation details. Eweguard can therefore be regarded as the starting point for assessment of inventive step. The only difference between Eweguard and the applicant’s claimed invention is that the macrolide in the opposed specification is in an oil carrier whilst the macrolide in Eweguard is an aqueous formulation.
Thus, as I see it, the applicant has claimed as an invention the problem and the long felt need or want, that is the stable admixture of an anthelmintic (oil soluble, water insoluble) and an antigen (water soluble, oil insoluble) using an oil based liquid which may be entirely oil, but could include water. The examples, such as they are, appear to include water. How one gets the stable mixture is not stated. The applicant is claiming any method of obtaining a stable mixture.
As an alternative, the opponent submitted that the starting point for assessment of inventive step can be the macrolide in oil formulation that was marketed by Mr Harvey and others. The opponent said it was clear from Harvey (exhibit CMH 2) that Mr Harvey has simply added a market clostridial vaccine to his marketed Genesis LA (abamectin/oil) together with a wetting agent. The opponent said this was the most obvious combination to try.
The opponent said that macrolides are soluble in oils and easily formulated therein and this would be an obvious route to take. The opposed specification therefore lacks any inventive step over the acknowledged prior art.
The opponent also said that if how to make the invention stable was not clearly obvious the applicant has failed to disclose and describe the way of doing it so that the invention claimed is different from the prior art. The opponent submitted that the applicant is on the horns of a dilemma, the invention being both obvious and insufficient.
The opponent said that the scope of claims 1-5 allows for oil only compositions as well as oil compositions that include water. The opponent believes both options are equally and clearly obvious.
The combination of Waksman (mineral oil has a depot function and disseminates antigen following parenteral administration resulting in long persistence and slow release; see above for discussion) and Wicks (oils, particularly sesame oil, are typical and useful carriers for macrolides and oils solutions can be used to prolong plasma concentrations of the avermectin doramectin) teaches the invention by simple combination of the teachings, demonstrating the lack of inventive step. Cobb I (paragraphs 37-38) refers to this. Harvey (paragraphs 17-18 (above)) accepts that oil and anthelmintic and oil and vaccine are known. Cobb I (paragraphs 37-38) reads:
The opponent by way of Cobb II (paragraph 42) comments on Harvey (paragraph 18, above) as follows:
The opponent said that anthelmintic together with vaccine and oil is clearly obvious if not merely collocation.
The opponent said that when the applicant asked Grayson Laboratories to perform trials in order to develop a stable emulsion, the combination of Formulation 2 of the specification, combining a macrolide in oil with a vaccine was the first thing that the formulators did and without prompting. Harvey (exhibit CMH-2) shows that he asked Grayson Laboratories to perform trials in order to develop a stable emulsion with Abamectin LA (apparently a mixture of abamectin, benzyl alcohol and sesame oil) and water using emulsifying agents.
After several trials what was described as a good stable emulsion was formed with 10% Span (an emulsifying agent). Trials were then performed with vaccine in place of water. The trials formulations separated reasonably quickly. The mixture had to be stirred to enable proper packaging. The Laboratories sent their best sample to Mr Harvey saying that the product should be shaken well before use.
The opponent pointed out that to try and achieve the applicant’s product they did what was obvious, they mixed macrolide in oil with vaccine and an emulsifying agent. The trails were run by laboratory staff using routine steps. The staff were utilising the skills of the normally skilled but unimaginative addressee in the art, there was no inventive work done.
It is my understanding of the present specification that it contains the promise that mere admixture will produce the desired result, perhaps with the help of routine laboratory skills. The specification indicates that emulsifying agent and/or cosolvent (I take benzyl alcohol to be a cosolvent) would be useful. Exhibit CMH-2 appears to show this promise is not fulfilled.
The opponent pointed out that those who conducted the trials are not acknowledged as inventors in the application and this, to the opponent, further indicates that the invention was routine laboratory work for those skilled in the art of such formulations. The first thing these workers did to try and achieve a stable mixture, the obvious thing to try, was to mix the oil/macrolide with the vaccine and add an emulsifying agent, all obvious steps for the skilled but unimaginative addressee. In the end the result was unstable, the invention had not been achieved. The mixture even had to be shaken for packaging purposes. In addition, the applicant was advised to shake the product before use.
There were no physical and chemical stability tests carried out according to the report (CMH-2). When mixing the vaccine into the abamectin and oil and cosolvent the mixture had to be stirred vigorously indicating difficulty with separation, and the product had to be packaged while stirring.
The opponent also pointed out that the work was done before any priority date to which the claims may be entitled. I note from this that even though the efforts by Grayson Laboratories appeared unsuccessful the specifications produced later do not acknowledge and deal with such substantial difficulties.
I note also that Formulation 2 of the Harvey exhibit trials appears to be Formulation 2 of the specification where it is said, at page 8 of the specification, to meet the promises of the invention. However there is no mention of the difficulties with the Formulation in the specification.
The opponent submitted it was therefore obvious to try the combination of anthelmintic and vaccine and emulsifier, the opponent noting the presence of the emulsifier leading to the inference that water was also present.
If all that was required was to make the composition stable is within obvious technical adjustment then, the opponent submitted, there is nothing inventive and the invention is clearly obvious. As stated in Cobb II (paragraphs 40 – 43):
In Booker (paragraph 6) the combination was said to be obvious to try since he indicates that the formulations “would be of a routine character”:
6. I, and I believe others skilled in the art, would consider the instructions contained within the specification are sufficient to permit the formulations to be duplicated, although the omission of some information would necessitate some experimentation. The experimentation involved however would be of a routine character and would be well within the ability of a person familiar with the technology. The issue of the amount of vaccine being unclear is not important, since the volume can be easily calculated from the other information provided. It is correct that it is not specifically stated whether the vaccine is in water or some other carrier, however, each of the formulations 1-5 contains a surface active agent of the type commonly used in the preparation of water-in-oil emulsions and so it can be concluded that the vaccine component is water based.
The opponent stated again, that it should be noted that the Grayson Laboratories formulator mentioned in Harvey (exhibit CMH-2) is not listed as an inventor. Only Mr. Harvey is. The opponent said this either means that the Declaration as to Inventorship is false or there is nothing inventive in putting the composition together (and making it stable - if this has been achieved, the opponent disputing that a stable composition has been shown to have been made).
The opponent said that if there was something inventive about preparing the formulation then the actual formulator at Grayson Laboratories must be an inventor since Mr. Harvey did not do this. He simply instructed the Grayson Laboratories employee to add Genesis (Abamectin LA) to a market vaccine with a wetting agent. The result was exactly Formulation 2 of the patent application. This simply and plainly lacks an inventive step deserving of a patent monopoly.
The opponent said that as at the priority date of the application it was known and/or would have been obvious to combine anthelmintic plus a vaccine plus oil. However, this also means that the invention claimed is a mere collocation, which is ground of opposition 21(1)(f).
Alternatively, said the opponent, it would be equally obvious to combine these three parts, anthelmintic plus a vaccine plus oil, along with an emulsifier. This also means that the invention claimed is a mere collocation, ground 21(1)(f).
The opponent drew on the Court of Appeal, in Ancare New Zealand Limited’s Patent [2001] RPC 335 approved Hallen v Brabantia [1991] RPC 195, when it stated at 352 paragraph 63:
If it is obvious to do something for one purpose, it does not become inventive to do it for another.
Again, following the dicta of the Court in Ancare and in Hallen v Brabantia, the opponent said the method as claimed does not constitute an invention within the meaning of the Patents Act 1953.
The opponent referred to Gadd & Mason v Mayor of Manchester (1892) 9 RPC 516 at 524 wherein Lindley L J expressed the law according to the two following propositions:
1. A patent for the mere new use of a known contrivance, without any additional ingenuity in overcoming fresh difficulties, is bad, and cannot be supported. If the new use involves no ingenuity, but is in manner and purpose analogous to the old use, although not quite the same, there is no invention, no manner of new manufacture within the meaning of the Statute of James.
2. On the other hand, a patent for a new use of a known contrivance is good, and can be supported if the new use involves practical difficulties which the patentee has been the first to see and overcome by some ingenuity of his own. An improved thing produced by a new and ingenious application of a known contrivance to an old thing, is a manner of new manufacture within the meaning of the statute.
The opponent said in so far as the claims of the application, as proposed to be amended (and as accepted), include the use of known or obvious features, particular reference is made to the known actives and the use of an oil-based carrier system to carry those actives. Likewise, the use of adjuvants for this purpose was well known. Finally, while stability is referred to in the abstract no particulars are given as to how it might possibly be achieved.
The opponent submitted the composition as now claimed (and as accepted) includes compositions in manner and purpose analogous to the old use as defined in the prior art and in particular in Wicks and Waksman.
Thus, the opponent submitted that the claims of the application as proposed, and as accepted, include compositions not being a “manner of new manufacture” and therefore not meeting the definition of invention under the Patents Act 1953.
The opponent submitted the claims as accepted and as proposed to be amended are too broad. They include matter not constituting an “invention”, following the reasoning of Lord Hoffmann in Biogen Inc v Medeva Plc (HL) [1996] UKHL 18; [1997] RPC 1 at 50-52. One early quote from those pages being:
It is not whether the claimed invention could deliver the goods, but whether the claims cover other ways in which they might be delivered: ways which owe nothing to the teaching of the patent or any principle which it disclosed.
The opponent is of the view that there is no invention disclosed, the invention merely claiming the obvious starting point for research into how such a composition might be found.
There is no dispute between the deponents Cobb and Harvey that combination of one active (macrolide) in oil carrier with other active (antigen) in oil carrier is known. Thus to combine the two is mere collocation, all the components perform as expected and continue to perform their known functions.
The opponent stated that if Booker (paragraph 6, above) is correct and a skilled person could in fact make the formulation stable then the applicant has failed to disclose how this can be done. According to Booker (paragraph 6, above) it can only be routine and thus obvious (“I, and I believe others skilled in the art, would consider the instructions contained within the specification are sufficient to permit the formulations to be duplicated, although the omission of some information would necessitate some experimentation. The experimentation involved however would be of a routine character and would be well within the ability of a person familiar with the technology.”).
The opponent said that if, as the applicant asserts, the crucial part of the invention is stability then the applicant has to explain how and why it is achieved. Failing to do so shows that the alleged invention is totally lacking in inventive step. The crucial difference is between identifying the need to do it as opposed to showing how to do it.
The opponent submitted that the “so-called” invention claimed is bad. It over- reaches and is speculative. It takes a lot out of the public domain but offers little or nothing in return.
The opponent did not to pursue the ground of obviousness on the limb of prior use.
The applicant noted that evidence has not been given on four documents: Product registration of Cydectin Eweguard® and Vetdectin Eweguard®; the article by Bomford in Parasitology Today 5 (1989) 41-46; US patent 3579633; and US patent 4292307.
The applicant said the inventive step was considered in its review of the specification in written submissions.
It appears that water soluble macrolides and water soluble vaccines have been known to have been combined into formulations using cosolvents and wetting agents. The more recently used avermectin anthelmintics are not water soluble and this insolubility creates difficulties in formulating stable injectable solutions. Cosolvent systems or aqueous solvent systems using one or more wetting agents do not work with oil-based systems. The essence of the invention is, then, a water-insoluble anthelmintic mixed with one or more antigens in an oil-based system, wherein the oil acts as an adjuvant and a carrier giving a stable formulation for safe injection.
The applicant then discussed the common general knowledge that would be known to the appropriately skilled addressee and it quoted, as follows, from the United Kingdom Court of Appeal in Richardson-Vicks Inc’s Application [1977] RPC 888 at 895:
It is therefore clear that the relevant person must have skill in the art with which the invention described in the patent is concerned. In some cases the patent may include within it information derived from or utilising more than one aspect of science or technology and in such cases the notionally skilled addressee, the person skilled in the art, will consist of a combination of scientists or technicians having those skills (citation omitted). Each case will depend upon the description in the patent, but there is no basis in law or logic for including within the concept of ‘a person skilled in the art’, somebody who is not a person directly involved in producing the product described in the patent or in carrying out the process of production.
The applicant submitted that the skilled addressee in the present case is a scientist or group of scientists including the skills of a pharmacist or pharmacologist, and a veterinary formulation expert. The opponent says that deponent Cobb is such a person. Deponent Cobb has veterinary qualifications and work experience on treatment of animal diseases in Australia and the United States. I see that her United States employer has seen no barrier in relocating her from Australia where her qualifications and her experience were initially gained to senior positions in its company in the United States. The opponent has pointed out, from her curriculum vitae attached to Cobb I, her past and current experience in working on animal remedies for New Zealand and other countries. As far as I can see she is, and accept she is, a skilled addressee.
On the other hand the applicant and inventor in the present case, Mr Harvey, does not assert any qualification. The opponent pointed out that the only qualification Mr Harvey has given in support of his knowing what was the common general knowledge in the art in New Zealand at the appropriate date was his being a resident of New Zealand. The attorney for the applicant stated at the hearing that Mr Harvey was a pharmacologist, although how he became so qualified and what level of qualification or experience he achieved is not stated in his declaration. Mr Harvey himself has not claimed he has such qualifications.
I accept that Mr Harvey is a skilled addressee.
The applicant referred to Leader Products Pty Ltd v Allflex International Ltd [1987] APO 16; (1987) 9 IPR 649 as to how an overseas expert should be viewed. This case involved the relative state of the art of ear tags in New Zealand and Australia. As stated at page 655:
Common general knowledge
It is convenient to consider, which, if any, of the prior art specifications form part of common general knowledge before turning to the question of whether the claimed invention has been anticipated or is obvious.
Mr Callinan submitted that Mr Wassilieff’s conclusions as to what was common general knowledge in Australia was inadmissible because Mr Wassilieff was a resident of New Zealand at the relevant time. Mr Hinde, on the other hand, submitted that there was no difference between the common general knowledge in Australian and New Zealand because the simplicity of the technology involved meant the common general knowledge in the art was the international.
In his declaration Mr Wassilieff does not declare that the common general knowledge in the field of ear tags is the same in Australia as it is in New Zealand, neither does he specifically declare that he was aware of what was common general knowledge in Australia at the relevant time . Therefore I am satisfied that there is no evidence before me which establishes that any of the prior art documents described in Mr Wassilieff’s declaration form any art of the common general knowledge in Australia.
There was a submission in the proceedings that, because the technology was simple, the state of the art was international. However, the evidence from Mr Wassilieff was not accepted because of the absence of a statement in his declaration that the state of the art would be the same in New Zealand and Australia, and because he did not declare that he was aware of what was the common general knowledge in Australia at the relevant date.
The decision does not appear to be applicable in the present case. I believe the technology to be international. It is the subject of articles in international journals and internationally available textbooks and patent specifications. Deponent Cobb has shown she has worked in Australia and the United States on animal remedies of the type the present technology is a part, and she has been involved and is involved in developing animal remedies for several countries including New Zealand. The circumstances are different from those in Leader v Allflex and I accept, again, that she is qualified to give evidence on the common general knowledge in New Zealand at the relevant date.
The applicant referred to Novagen Research Pty Ltd’s Application 252051 (Assistant Commissioner Popplewell, 5 April 2002) where the expertise of overseas witnesses to give evidence was questioned, the view of the Assistant Commissioner appears to be summarised in the statement:
but there can be no doubt that the patentee’s witnesses are skilled scientists who, with the exception of Morris, a physical chemist, have all worked in the area of natural remedies and would have a good understanding of the “common general knowledge” at the relevant time.
It is my view that deponent Cobb is in the same situation as the skilled
scientists (except Morris) in the quote from Novagen. She is a skilled
scientist working in the field of animal remedies for several countries
including New Zealand and would, I believe,
have a very good understanding of
the “common general knowledge” in
New Zealand at the relevant
date.
In Rural Pacific Marketing Pty Ltd’s Application 277456 (Assistant Commissioner Hazlewood, 8 January 2001), referred to by the applicant, the evidence “of three experts” was rejected as inappropriate and unhelpful. Two of these “experts” were not qualified as engineers, neither educationally nor vocationally, and merely stated that in their opinions the engineering involved in the new product would have been obvious to an engineer, opinions they were clearly not qualified to give. In the case of the third deponent who was an engineer he merely gave the same opinion as the other two. He did not use his engineering skill to show in what way the engineering involved was obvious.
The situation from Rural Pacific Marketing does not apply to deponent
Cobb who, I believe, is qualified to comment on the “common general
knowledge” in
New Zealand at the relevant date and give reasoned
evidence.
The applicant referred to Genencor International Inc’s Applications 208612 and 224536 (Assistant Commissioner Popplewell, 6 August 2001). The Assistant Commissioner found some merit in the applicant’s criticism of the ability of “highly qualified overseas academics” to say what would have been the level of common general knowledge of the notional skilled addressee in New Zealand at the relevant date. In that case he was particularly concerned that the earliest of the opponent’s evidence was given more than ten years after the relevant date and it seemed to the Assistant Commissioner that it would be difficult for anyone however highly qualified to avoid an element of hindsight. His comments, although they were referring to highly qualified overseas academics, were made with reference to any person giving evidence. The Assistant Commissioner did however consider all the evidence on its merits. He did not dismiss the evidence.
The situation in Genencor does not apply here. Deponent Cobb has been active in development of animal remedies in an area of technology that has an internationally understood “common general knowledge” for a number of years and is still active in relevant development work. Her knowledge and work is directly relevant to New Zealand, as shown in her curriculum vitae. I consider her evidence as very relevant.
The applicant submitted that one of the consequences of deponent Cobb’s lack of experience in New Zealand is an inability to accurately characterise the “common general knowledge in the art in question”. General Tire (above), at 482, was quoted by the applicant:
The common general knowledge imputed to such an addressee must, of course, be carefully distinguished from what in patent law is regarded as public knowledge. This distinction is well explained in Halsbury’s Laws of England, Vol. 29, para. 63. As regards patent specifications it is the somewhat artificial (see per Lord Reid in the Technograph case [1971] F.S.R. 188 at 193) concept of patent law that each and every specification, of the last 50 years, however unlikely to be looked at and in whatever language written, is part of the relevant public knowledge if it is resting anywhere in the shelves of the Patent Office. On the other hand, common general knowledge is a different concept derived from a commonsense approach to the practical question of what would in fact be known to an appropriately skilled addressee - the sort of man, good at his job, that could be found in real life. ... it is clear that individual patent specifications and their contents do not form part of the relevant common general knowledge, though there may be specifications which are so well known amongst those versed in the art that upon evidence of that state of affairs they form part of such knowledge, and also that there may occasionally be particular industries (such as that of colour photography) in which the evidence may show that all specifications form part of the relevant knowledge.
The documents introduced into these proceedings by the opponent appear to me to have been selected for relevance. I believe they are relevant and to the point. The technology is internationally understood. No obscure references have been introduced. The references include patent specifications, textbooks and articles in international journals directed to the technology of the claims. The documents indicate the common general knowledge of the art. They do not evidence obscure points. They evidence the well known oils and other vehicles use in veterinary formulations, they evidence to types of wetting agents and solvents used in the art. They reference the use of anthelmintics and antigens separately and together with aqueous systems and oils. They reference well known adjuvant effects of oils on macrolides and antigens. All this knowledge appears to be understood by the applicant and admitted in the specification in suit and its associated provisional specifications, and in the depositions in support of the applicant (not to mention the depositions in support of the opponent). I do not find that the documents fall within the criticism in the quotation above from General Tire.
The applicant quotes further from the same decision, at 497:
... whoever seeks revocation of a patent to show that the alleged inventive step was obvious to a normally skilled addressee in the art. On the way to that end there are a number of preliminary questions to be resolved. These include the common general knowledge to be imputed to that addressee; whether what had to be done to achieve the step was truly a matter of inventive experiment or merely a matter of trial and error which forms part of the normal industrial function of such an addressee; what documents he would find in the course of such researches as he would be expected to make; and how he would regard those documents in the light of common general knowledge. Then finally one has to consider whether the step is properly described as a new combination of images or merely as a collocation of old ones.
In my opinion the opponent has fulfilled these requirements, as noted above. The common general knowledge is generally understood by both parties, I believe. No remote issue is being raised by the opponent.
Another quote follows from the same decision, at 499-500 :
As regards diligent search, a phrase which we were given to understand originates from Lord Reith in Technograph (supra), we take this as apt to describe what research groups employed by large-scale concerns, such as those in the Technograph case and in the instant case, ought to know. Such researches, however, can involve not only heavy expenditure but also questions of priorities in the use of available manpower. What extent of search is appropriate in a given case and what would be its probable results are questions of fact.
It appears to me that the search is adequate. The documents cited are not excessive in number nor obscure. Again, the points drawn from them are agreed by the parties as representing the art. I will consider all documents on their merits.
There were two other quotes introduced on this matter by the applicant. One is from British Acoustic Films Ltd v Nettlefold (1936) 53 RPC 221 at 250:
In my judgment it is not sufficient to prove common general knowledge that a particular disclosure is made in an article, or series of articles, in a scientific journal, no matter how wide the circulation of that journal may be, in the absence of any evidence that the disclosure is accepted generally by those who are engaged in the art to which the disclosure relates. A piece of particular knowledge as disclosed in a scientific paper does not become common general knowledge merely because it is widely read, and still less because it is widely circulated. Such a piece of knowledge only becomes general knowledge when it is generally known and accepted without question by the bulk of those who are engaged in the particular art; in other words, when it becomes part of their common stock of knowledge relating to the art.
As already stated, the knowledge contained in the documents is agreed upon by the parties in one way or another, by way of specification content and declarations. Deponent Cobb is more than sufficiently experienced in my view to say what the state of the art is in New Zealand. I note that the British Acoustic Films decision was published in 1936 when the scientific world was much different from what it is at the present time. Since this decision research in all fields, and particularly the present field, that of animal remedies, has become much more international. Companies involved in this type of research are now international, multinational, transnational. The speed of communication is instantaneous. Learned journals are internationally regarded. International travel to attend conferences, conduct business, share research, experience and knowledge is commonplace. The art in the technology of animal remedies in Australia, Europe, America and New Zealand are interlinked and in my view would be in all aspects virtually the same. The experience of deponent Cobb, particularly, shows this to be so.
The other quote is from British Ore Concentration Syndicate Ltd v Merrell Separation Ltd (1909) 26 RPC 124 at 133:
It is often difficult for a Court to ascertain the degree of knowledge with which it ought thus to arm itself for its task of judging between the inventor and the public, because under the pressure of litigation documents, which would otherwise have remained utterly unknown to members of the particular trade or profession, are ransacked out and put before the Court as though they were part of the general knowledge of the public on the subject. In my opinion the Court in arriving at the state of knowledge which it ought to hypothesise in the public, and which therefore it should itself use in judging of inventions, should reject documents of this kind. It has to arrive as closely as it can at the mental attitude of a well instructed representative of the class to whom the specification is addressed, and no more.
The quote recognises that documents haven’t to be obscure and difficult to find, and that the skilled person is a well instructed representative of the class. The documents cited are not numerous so there is no great pressure of litigation literature. It does not appear to me that the documents cited would have remained utterly unknown and that they have been ransacked out. The relevant contents have been agreed to as being part of the common general knowledge by the applicant.
I note from the quote from British Ore that the contest (the opposition proceedings), if contest it is, is between the applicant and the public. I understand from this that any opponent is assisting this contest.
I again note that in my view deponent Cobb appears very well qualified to state what is the common general knowledge in New Zealand.
The British Ore decision was published 1909, and as I mentioned above in my comments on the British Acoustic Films decision, the technological and scientific world has changed much since then.
The applicant criticised particularly the Waksman article as not being part of the common general knowledge of the New Zealand veterinary formulation industry. In this resect I note that the claimed compositions in suit are not restricted to veterinary compositions. The compositions of claims 1-7 are said to be suitable for warm-blooded animals and hence include compositions suitable for humans. In addition, claims 8-10, before examination by the office, included the treatment of humans. This was by way of reference to the treatment of warm-blooded animals, which include humans. This treatment of humans was excluded from the claims following objection by the office, presumably as a result of that objection.
The Waksman document discloses that the adjuvant effect of oils on antigens has been known for decades. My reading of the article is that it discusses the use of adjuvants in some degree of depth and not in passing as the applicant suggests. It is to be noted that the applicant has also agreed in its evidence that the adjuvant effect was known at the relevant date. As I see it, the Waksman article forms part of the state of the art in New Zealand, and at least it merely confirms the declarations for the opponent and for the applicant where they assert that the adjuvant effects are known.
Both provisional specifications under “Background” state that adjuvants are known. The complete specification, as pointed out by the opponent, does not mention that oils are known adjuvants (although at page 9 line 7 there is a reference to “adjuvant mineral oils”). Instead, the reference to the adjuvant effect is located at the end of the descriptive part of the specification. It appears on page 8 at lines 11-13 as:
Surprisingly, the oil also acts as an adjuvant in the composition, enhancing the activity of the vaccine and extending the parasiticide activity of the anthelmintic.
Depending on the point to be made, the applicant can, apparently, argue that the adjuvant effect is an expected effect, or an essential integer of the claimed composition or an additional bonus.
Paragraph 222 of the applicant’s submissions admits that each of the documents explores the role of oil as an adjuvant in relation to vaccines and macrolides. The roles are known and accepted by the parties. As I see it, there can be no surprise that such effects could be expected to occur or that they do occur.
My conclusions on obviousness
It was obvious to combine an anthelmintic in oil with an antigen in aqueous system as a starting point to try to obtain a safe, effective, combined animal treatment. That the oil would act as an adjuvant for the anthelmintic and for the antigen was to be expected from the prior art. This is the basic claimed invention.
The first step is mere admixture. It would be obvious to try and improve on the results of this mere admixture by adding cosolvents and emulsifying agents, separately and together, as aids to better achieve the stable solution, stable that is in terms of an emulsion phase which did not separate out into two phases or stable in terms of throwing out of the mixture one or both actives (or any other ingredient for that matter) as deposits. All is obvious so far.
If it is the applicant’s claim that the invention is the admixture of the known macrolide in oil composition and known antigen composition and which has to be shaken before administration to animals then again there is mere admixture. This is the obvious starting point for research into finding a suitable combination product. There appears to be no technical achievement in terms of problems overcome or unexpected property other than the saving of time and effort which are to be expected. The property of the mixture is the sum of the properties of the individual components. This combination is an obvious step, the delivery of two treatments together. It is obvious to do. In addition, this amounts to mere collocation, and mere collocation is not an invention.
Nowhere in the specification is it suggested that such an agitated two phase system or mixture is the subject of the invention.
It seems to me that the applicant has laid claim to the gateway through which anyone seeking a combined composition must pass, the combination of the aqueous solution of macrolide and the solution in oil of the anthelmintic. This step is obvious as a starting point for search for a stable combined composition.
How one gets the stable composition from these obvious steps, if they do not work (and the skilled addressee is not told they do not work and is not told of any problems) is said to be obvious to the skilled but unimaginative addressee. Thus this step, if it is needed, must be obvious. The use of emulsifying agents and cosolvents to bring aqueous and oil phases into a stable one phase emulsion is known and is obvious to try.
The invention as claimed is in my view obvious.
As far as I can see the invention claimed fits into the “hunting licence” described in Commissioner of Patents v Manson [1966] USSC 48; 383 U.S. 519, 86 S.Ct. 1033:
But a patent is not a hunting licence. It is not a reward for the search, but compensation for its successful conclusion.
In American Home Products v Novartis Pharmaceuticals [2000] EWCA Civ 231; [2001] RPC 159 paragraph 43 it is stated:
The duty of the patentee was to provide a description which enabled the skilled person to perform the invention across the breadth of the claim; it was not to supply the starting point for a search.
The invention claimed in the present application is in my view that starting point for a search for a physically stable emulsion, being a combination of anthelmintic and antigen in an oil-containing medium and being effective and safe for treating warm-blooded animals, the oil providing adjuvant effects.
I think the patent application can be described as “bad”. The applicant has placed himself in a position, where, if a patent is granted for this application, if any person skilled in this art, however much inventiveness that person displays, actually succeeds in producing a successful product by admixing known oil-soluble macrolide and water soluble antigen this product falls within the scope of the monopoly granted.
The invention claimed is obvious with regard to the published documents and the state of the common general knowledge in the art in New Zealand at any date to which the claims would be entitled.
The ground is made out.
INSUFFICIENCY - section 21(1)(g)
Section 21(1)(g) states:
That the complete specification does not sufficiently and fairly describe the invention or the method by which it is to be performed
The opponent pointed to the two limbs of section 21(1)(g) that the specification must satisfy. These are that the specification does not sufficiently and fairly describe the invention or does not sufficiently and fairly describe the method by which the invention is to be performed, section 21(1)(g) stating:
That the complete specification does not sufficiently and fairly describe the invention or the method by which it is to be performed (emphasis added).
Section 21(1)(g) is different from section 41(1)(g) which has one limb:
That the complete specification does not sufficiently and fairly describe the invention and the method by which it is to be performed, or does not disclose the best method of performing it which was known to the applicant for the patent and for which he was entitled to claim protection. (emphasis added)
The opponent was concerned about the boundary between insufficiency and inutility, the former being a ground of opposition or revocation before the Commissioner, the latter being a ground that can only be argued in revocation proceedings before a Court. In support of its understanding of the difference between the two grounds the opponent quoted from Davison CJ in Noton New Zealand Limited v Alister Bevin Limited (1979) 1 NZIPR 236 at 238 on the question of inutility and insufficiency:
If reference is needed to authority on this matter, it can be found in Tetra Molectric Ltd’s Application [1977] RPC 290 at p 297, lines 32-40:
In my view, a dividing line can fairly be drawn thus: If you cannot achieve the promised result because of deficiencies in the information given in the specification, there is insufficiency. But if, following that information and having achieved mechanically that which the specification promises you will achieve by so following it, the end product will not of itself achieve that promise, then that is inutility. I do not pretend that that suggested dividing line is exhaustive, but it will in many cases - and perhaps in the majority of cases in which this question arises in opposition proceedings - point to the right approach in determining which side of the line a particular case falls.
But, in this case, inutility as opposed to insufficiency cannot be raised before the Commissioner. On examining the decision I find that the Assistant Commissioner did, however, indicate quite clearly that he had both requirements of sufficiency in mind when he was deciding the application. He said at p 5 of his decision:
An allegation of insufficiency is an allegation that the addressee of the complete specification will be unable to produce the subject of the principal or broadest claim by following the directions of the specification without further invention on the part of the addressee.
The first portion of that statement where he says, “will be unable to produce the subject of the principal or broadest claim” is a reference to the first leg, namely, the invention. The reference next to “following the directions of the specification without further invention on the part of the addressee” is reference to the method, the second leg of the matter.
So the boundary is discernible.
The opponent said the primary onus is on the applicant to satisfy the necessary formal requirements of the Act, section 10(3)(a) stating:
Every complete specification-
(a) Shall particularly describe the invention and the method by which it is to be performed (emphasis added).
In Commonwealth Scientific & Industrial Research Organisation’s Application 196125 (Commissioner Burton, 9 March 1993) the Commissioner stated at p. 80:
As discussed earlier, it is my view that a sufficient and fair description requires, inter alia, a set of clear claims, fairly based upon the complete specification, for the reason that s.10(4) is always speaking to the applicant (or patentee). Whatever arguments may or may not be mounted on the nature of opposition proceedings (General Electric Company’s Patent [1964] RPC 413), one thing is absolutely clear. Applications with insufficient descriptions and/or claims which are not fairly based, should not proceed to grant.
The opponent said that a specification must be “fair, honest and open” as well as sufficient as in the House of Lords decision in Raleigh v Miller (1948) 65 RPC 141 at 147:
But, having given the matter the best consideration that I can, I have come to the conclusion that the substantial question is whether the specification under review is (to use the words of Baron Alderson so often cited in this case) “fair, honest, open and sufficient”, words that are apt to describe the obligations of the patentee in relation both to the body of the specification and to the claims. With much that was said on behalf of the patentee I am in sympathy. The art of drafting specifications is a difficult one and the Court should not be astute to find a way of defeating a patent. But, when this has been said, it still remains that it is imperative in the public interest that the now statutory prescription should be observed, that the nature of the invention and the manner in which it is to be performed should be sufficiently and fairly described and ascertained, and (equally pertinent to the present case) that the scope of the monopoly claimed should be sufficiently and clearly ascertained. It will in this case, I think, be found that it is from the failure to observe these requirements that much controversy otherwise unnecessary has arisen.
I note from this that the words “fair, honest, open and sufficient”, are words that are apt to describe the obligations of the patentee, and that there is a public interest that statutory provisions should be observed.
The applicant objected to the words “honest, open” as not being in the present Act.
The opponent further pointed out that the words are still used in the British Manual of Office Practice (Patents) under the United Kingdom Act which was to all intents and purposes the same as the New Zealand Patent Act 1953. The relevant paragraph in the manual is paragraph 4,37 which begins:
The highest degree of good faith is called for from the applicant when describing his invention; the description should be clear, precise, fair honest and open.
The opponent also mentioned that an applicant for a patent must act uberrimae fidei in disclosing the invention and referred to the Court of Appeal decision in Vidal Dyes v Levinstein (1912) 29 RPC 245 at 269. The applicant again objected to the introduction of additional requirements to those in the Act.
The opponent pointed out that these words from Raleigh v Miller and Vidal Dyes v Levinstein are also referred to by Blanco White in Patents For Inventions, 4th Ed, at paragraph 4-508:
A specification must be “fair, honest and open” as well as sufficient: an applicant for a patent must act uberrimae fidei in disclosing his invention.
It seems to me that it is permissible to criticise a specification as not being “honest and open”, although I believe in the present case a decision can be reached without recourse to the use of these words.
The opponent stated that though mere width of claim is not a ground for objection it is a fundamental rule of patent law that the consideration that a patentee gives for its monopoly is the disclosure which it makes; and the protection which it gets cannot extend further than which is disclosed. In Eastman Kodak Company’s Application [1970] RPC 548 at 563 it was held:
I return therefore, to the ground of alleged insufficiency. For the opponents, Mr Ford really I think puts his point on insufficiency in this way. Though mere width of claim is in itself no good ground of objection under section 14, it is a fundamental rule of patent law that the consideration which a patentee gives for his monopoly is the disclosure which he makes and the protection which he gets cannot extend further than is necessary to protect that which, in view of his disclosure, he is fairly entitled to cover. In a decision on an application by Abraham Esau and C. Lorenz Aktiengesellschaft (1932) 49 RPC 85, Sir Stafford Cripps, then Solicitor-General, observed at page 87, line 44, that patentees should realise that “it is not the practice of the Patent Office to allow broad and indeterminate claims of a speculative character”, and that, “if they put such claims into their complete specifications, they must expect to find them disallowed unless they are able to give a sufficiently detailed and full description to support them.”
The opponent said that sufficiency thus overlaps with other grounds and, in the scheme of the Act, it is a key ground in terms of ensuring both the letter and the spirit of the Act is complied with.
The opponent said that sufficiency is a pure question of fact, to be determined preferably by the evidence of addressees of the specification. The opponent referred to the House of Lords decision in British Dynamite v Krebs (1896) 13 RPC 190 at 192 and Blanco White, Patents For Inventions, 4th Ed, paragraph 4-505. These were relied on in Noton (above) at 238 – 239:
The question of sufficiency of a complete specification is a question of fact. If authority is needed for that proposition, it may be found in Blanco White on Patents For Inventions, 4th Ed, para 4-505:
Sufficiency of instructions is a pure question of fact, to be determined preferably by the evidence of addressees of the specification.
Reference can also be made on that topic to British Dynamite v Krebs (1896) 13 RPC 190 at 192:
In determining whether the Complete Specification is sufficient, the first thing is to ascertain what the invention is. This is a question of construction, and the construction of the Specification is for the Court, to be determined like the construction of any other written instrument, the Court placing itself in the position of some person acquainted with the surrounding circumstances as to the state of art and manufacture at the time, and making itself acquainted with the technical meaning in art or manufacture which any particular word or words may have. When the nature of the invention is thus ascertained by the Court, as a matter of construction, the Court has then to inquire whether the manner in which the same is to be performed is sufficiently described in the Specification to the comprehension of any workman of ordinary skill in the particular art or manufacture, and this the Court can best do by the evidence of workmen of that description, and by the evidence of what workmen of that description have actually done under the patent.
In the above quote I have used the actual wording from the British Dynamite v Krebs decision rather than the wording quoted in Patents For Inventions.
The opponent said that where the alleged invention comprises an improvement on what exists the skilled person has to be told with sufficient detail how to actually achieve the improvement. The opponent referred to the United Kingdom Court of Appeal decision in Mentor Corporation & anor v Hollister Inc [1993] RPC 7 at 11:
Aldous J made the point well in his judgment in the present case (at page 19B to D):
“Even where patents relate to articles, the inventions disclosed in different specifications can be different in kind. For example, the invention disclosed may relate to an article which will perform a particular function or an article which is cheaper to make than similar articles. In the latter case, it is the very essence of the invention disclosed in the specification that the article can be made more cheaply and therefore to perform the invention, the person skilled in the art must be able to make the article cheaply as described in the specification. In the former case, the person skilled in the art must be able to produce the article which will perform the function, as that is the invention disclosed.”
Following this the opponent said, as it is the very essence of the present invention that the product, the formulation, is stable, it is essential that the addressee is shown that it is stable and is told how it is made stable.
The opponent submitted that the standard of proof needed to support its position is that of “sufficient evidence to satisfy a reasonable tribunal of fact on the balance of probabilities”, or put another way, whether it is “more probable than not”. The opponent referred to Cross on Evidence, NZ Edition, LexisNexis, Chapter 5, Degrees of Proof, paragraphs 5.2 and 5.3. From paragraph 5.2:
When, in a civil case, the party with the legal burden on a particular issue also bears the evidential burden, it is discharged by the adduction of sufficient evidence to satisfy a reasonable tribunal of fact on the balance of probabilities.
And from paragraph 5.3, and quoting Denning J from Miller v Minister of Pensions [1947] 2 All ER 372, 373-374, it is stated:
When speaking of the degree of cogency which evidence must reach in order that it may discharge the legal burden in a civil case, His Lordship said:
That degree is well settled. It must carry a reasonable degree of probability but not so high as is required in a criminal case. If the evidence is such that the tribunal can say: ‘We think it more probable than not’, the burden is discharged, but if the probabilities are equal it is not.
The opponent said that on any question of fact a call has to be made by the tribunal, one way or the other, (whether of primary fact or inference) and there is no concept of a so called “benefit of the doubt” in an evidential sense. Any decision I make has to be based on the balance of probabilities. It is my further understanding from the quotes from Cross on Evidence is that if, after considering the evidence, I have not been able to formulate an opinion then I am not “satisfied” and I cannot then find against the applicant.
The opponent drew on the New Zealand Court of Appeal decision in Beecham Group Limited v Bristol-Myers Company [1981] NZLR 600 at 612 where it is stated:
. . . a patent should not be granted and the public domain not restricted except to the legitimate extent of an invention. To put it tritely, a man should not have a patent for more than he has invented.
The Court of Appeal in Beecham referred, at 612, to the guidance that could be obtained by analogy from the House of Lords decision in Mullard Radio Valve Co. Ltd. v Philco Radio and Television Corporation 53 RPC 323. The Court referred in particular to the passage at 346-347 which held:
A patentee is granted his monopoly in order to protect the invention which in his specification he has communicated to the public. He is not entitled to claim a monopoly more extensive than is necessary to protect that which he himself said is his invention.
The opponent said that this statement clearly links the invention as claimed to the sufficiency of the description that supports it. It is the “invention” that must be sufficiently described. The British Manual of Office Practice (Patents) at paragraph 4,37 also states that:
the description should be sufficient to enable the invention to be carried into effect by the persons to whom the specification is addressed.
The Court in Beecham (above) at 613 also stated that the above passage from Mullard:
sufficiently captures, we think, the legislative policy embodied in s10(3)(c) of the New Zealand Act and also in s21(1)(e) and (g), which are recognised to overlap . . .
The date at which sufficiency of description is to be determined is the date of publication as stated by the United Kingdom Court of Appeal in Standard Brands Incorporated’s Patent (No. 2) [1981] RPC 499 at 530.
The opponent stated that it is clear from the description that the invention to which the application is directed is a stable and efficacious injectable composition. To the extent that section 21(1)(g) requires a complete specification to “sufficiently and fairly describe the invention”, a process which does not include a description of how to make the composition stable and effective must be insufficient.
The opponent’s basic position on this ground is that there is no evidence that the alleged invention does work.
The opponent submitted that if this basic position is wrong and the invention does work, then the applicant has not shown how it can be made to work. As stated in Rowe (paragraph 12):
The opponent said Harvey (paragraph 11) refers to the prototype Genesis Guard-All. However, it is unclear as to whether this formulation is covered by the present patent application. Even with the benefit of the evidence the position is still most unclear. Harvey (paragraph 11) states:
11. The product also has, as stated in the patent, excellent tolerance and activity in animals. I attach as exhibit “CMH-4” a study on the comparison of Genesis Guard-all (the combination covered in this patent) with Genesis Injection in sheep. Exhibit “CMH-5” is also attached which provides vaccine titre responses to the formulation when compared to an oil based clostridial vaccine and a traditional 5 in 1 clostridial vaccine.
The opponent submitted the evidence is misleading in material respects.
The opponent said Harvey (paragraph 11) states that the product has excellent tolerances and activity in animals but never identifies the amounts and particular components of the formulation. Harvey refers to attached exhibit CMH-4. This relates to a prototype combination of abamectin at 1.5% in an oil base combined with a 5-in-1 clostridial toxoid vaccine. There is no direct correlation of this prototype with that which has stability trials reported in exhibit CMH-3. There is no direct correlation with the Formulations, particularly Formulation 5, of the complete specification. There are no further details of the preparation of this prototype. There is no mention of any emulsion stability problems as for the formulation of CMH-2. There are no tests of stability for this product. There are no details as to how the skilled addressee could make this formulation from the teachings of the specification unless mixing of the aqueous and oil phases was sufficient.
The opponent said the conclusion of the report CMH-4 states merely that labour costs will be saved by the combination formulation.
The opponent stated that Harvey (paragraphs 13 and 20) merely says the product was useful. There is no mention that the product possesses the advantages stated at page 8 of the complete specification:
13. I believe the information and trials in the patent application are clear and I believe they would be clear to those skilled in the art. In addition I believe these formulations are useful in their own right and disclose a novel approach to the formulation of macrolide compounds with vaccines which has never previously been identified or suggested.
20. The combination of the use of the oil carrier for the macrolide represents a novel alternative approach of achieving a useful combination macrolide/avermectin product.
The opponent said Harvey (paragraph 18, above) says certain know-how regarding the use of oily components as extending the activity of macrolides had been previously introduced by his firm. What this means is not explained, for example, what specifically was introduced, at what date and by whom.
The opponent said that while deponent Harvey has implied it, there is no evidence that a commercial product Guard-All was ever successfully made. The opponent said it has searched the New Zealand Regulatory database and this registry shows that no such product has been registered for use or sale in New Zealand. The opponent submitted that the applicant has not been able to produce a commercially acceptable product to date.
At most, submitted the opponent, the applicant has conducted unsuccessful trials.
The opponent said that there is no evidence to support assertions by the applicant of excellent tolerances and activity. Cobb II (paragraphs 24 -29 and 42) discusses the Guard-All product:
“Results demonstrate that the efficacy of abamectin when administered with a clostridial injection is the same as when it is administered alone.”
The opponent drew particular attention to the following from the immediately preceding paragraphs: the 28 February 1995 report actually confirmed instability; there is no reference to an assessment of tolerance ... either evaluation of local site reactivity after injection, or any monitoring of systemic effects; the results demonstrate that the efficacy of abamectin when administered with a clostridial injection is the same as when it is administered alone.
As to the Harvey (paragraph 15, above) argument “why, if the invention claimed in this patent application was so obvious they [the opponent] had not arrived at it as a solution to the problems themselves”, in reply the opponent asked “why did Mr Harvey not arrive at the solution himself?” The opponent submitted that Ashmont has not found the solution either since Ashmont does not have a product on the market as of 2003, some seven years after their filing of this application.
It appears to me that the opponent could have been looking for a stable emulsion whereas it appears the present applicant may have settled for a non-miscible composition that needs to be shaken before packaging and administration. And perhaps it is this non-miscible arrangement that is the actual product of the present application.
The opponent noted that Booker (paragraph 3) stated he has read NZ patent 286752 and Cobb I but not Harvey. The opponent would have expected him to have done so and it submitted the fact that he has not read Harvey raises a real question mark about his evidence. The opponent said that the same has to be said about deponent Grayson.
In Booker (paragraph 6, above) the opponent noted that the deponent states
that omission of information would necessitate some experimentation,
of a
routine nature. Booker (paragraph 6, above) also reads water into the
formulations on the basis of surfactant use, even though
there is clearly no
specific disclosure of the use of water.
I note that Booker (paragraph 6,
above) says that the instructions contained within the specification are
sufficient to permit the
formulations to be duplicated although the omission of
some information would necessitate some experimentation. What information
is
missing is not stated. Is this the information necessary to make the
formulation stable, safe and effective, with the oil acting
to enhance the
activity of the vaccine and extend the antiparasitic activity of the
anthelmintic? What kinds of experimentation
is needed? Deponent Booker is
silent on these. I also note that there is no way to exactly reproduce
Formulations 1 to 5 as the
vaccines/antigens are not stated.
From the point of view of Formulation 2 in the specification we can see what is missing. Formulation 2 is the subject of Harvey exhibit CMH-2. The formulators at Grayson Laboratories apparently were unable to make the emulsion stable. Yet this formulation is described in exactly the same way in the specification. There it is said to meet the requirements of safety, efficacy, stability, adjuvancy and shelf life. What is missing from the specification is the information on how to make Formulation 2 stable. I would have thought that, if this is within the skill of the uninventive formulators at Grayson Laboratories, they would have produced a stable formulation to hand over to Mr Harvey. But if the information is not within the capabilities of the skilled addressee and because this information is missing from the specification the specification is insufficient and unfair.
The opponent drew attention to Booker (paragraph 7) which refers to vaccines. The deponent assumes that the specification is referring to the vaccines listed in page 5. Page 5 lists “suitable” antigens from “bacterial and viral pathogens of warm-blooded animals” and more preferred antigens. Again, the specification is silent on what vaccines are used particularly in the Formulations. The skilled addressee is not restricted by the preferments of the applicant and can choose any vaccine. The opponent also said that the assumption that the specification is referring to the vaccines listed at page 5 leaves open the possibility that there may be other components necessary to achieve a stable formulation. Booker (paragraph 7) merely states:
7. By “vaccine” I would assume the specification was referring to a preparation of clostridial antigens listed on page 5 of the specification.
It is my understanding from the complete specification that the vaccines listed at page 5 lines 2 to 7 of the specification include preferments from the broad range of antigens which may be used.
The opponent submitted that Booker (paragraph 8) glosses over what the part B formulations are and the opponent said this is part of the problem. Cobb II (paragraph 6) discusses her problems understanding how the formulations are to be made. Taking for example Formulation 2, it is my understanding of the text that to make the formulation one has to make Part A by combining 1.13 grams of abamectin (or ivermectin), 20.0 grams of benzyl alcohol and adding sesame oil to make the volume 100mls. Then 50.0mls of this mixture (referred to in the Formulation as 1% abamectin) is added to 10 grams of Span 80 and vaccine is added to make the volume up to 100mls. What vaccine to add is not stated and the person following the formulation has to make their own choice. Booker (paragraph 8) states:
8. The specification refers to part A and part B of the formulations. From this I would understand the formulation of part A was made up - the avermectin being dissolved in the benzyl alcohol and then oil being added to volume. Then taking the amount of this formulation indicated and adding to it the emulsifier and the antigens or vaccine. I would understand that the standard methods of mixing the formulation would be effective.
I note it is stated in Booker (paragraph 8) that the standard methods of mixing the formulation would be effective. As seen from Harvey (exhibit CMH-2) they weren’t effective.
Booker (paragraph 5) admits (by implication) that he agrees with some of deponent Cobb’s comments, Booker (paragraph 5) reading in total:
5. I do not agree with some of Ms Cobbs comments.
The opponent asks “Which comments?” It is not clear which part of Cobb I it is that deponent Booker agrees with and which part he disagrees with.
Harvey (paragraphs 8-9) refers to exhibit CMH-2 attached to his declaration where antigen formulation details are given. He refers to these details as being similar to antigen formulation details disclosed in Cyanamid’s NZ patent application 286896 (“Cyanamid” recently changed its name to “Fort Dodge”) at page 14. Harvey (paragraphs 8-9) reads:
8. In Formulation 5 detail is given to the addition rate using specific antigens identified by number. I attach as exhibit CMH-2 the laboratory reports on the preparation of Formulations 2 and 5. In Formulation 5 these [sic] titrated antigens of known activity, the level of which is not material to the scope of understanding of the technology.
9. I refer to a similar table in NZ 286896 (page 14) which is in Cyanamid’s name. This outlines the antigens included in a similar way. However in that case the formulation is a simple combination of macrolide and antigens with an adjuvant in a water based formulation.
As the opponent pointed out, this comparison is erroneous since the data in Harvey’s exhibit is not part of his specification and hence is not made available to the skilled addressee. The information in Cyanamid’s NZ 286896, on the other hand, is disclosed to the skilled addressee. The opponent appears to have given quite full formulation details of examples in its complete specification of NZ 286896 as part of its requirements under section 10(3) to describe the invention, the way it is to be performed and the best way in which it is to be performed for the skilled addressee. The applicant in the case in suit appears to have had the antigen formulation information since 7 September 1995 but has not disclosed it to the public in the complete specification.
I think it is interesting to compare the level of information provided in the specification by the applicant in the present case with that provided by the patentee in the complete specification of NZ patent 286896. At page 13 of NZ 286896 the skilled addressee is told exactly how to make and test examples of compositions according to the claimed invention as follows:
EXAMPLE 1
Preparation of Moxidectin/6 in 1 Vaccine Compositions
The moxidectin/6 in 1 vaccine composition identified as composition number 1 in Table I is prepared by blending TASGEL® (300 mL) with normal saline solution (332.5 mL), adding the appropriate antigen concentrates in the amounts identified below, adding a moxidectin solution (previously prepared by blending a 30%wt/wt moxidectin in benzyl alcohol solution (7.5 mL) with a 17%wt/wt TWEEN®80 solution (300 mL) at about 37oC, and filtering and cooling the resultant solution), adding a 1.3%wt/wt thimerosal solution (7.7 mL), and adjusting the pH to about pH 6.5 with sulphuric acid.
Antigen Concentration Amount (mL)
Cl. Septicum 4.4
Cl. novyi B 1.8
Cl. tetani 1.85
Cl. perfringens D 40.5
Cl. chauvoei 8.75
Cl. pseudotuberculosis 2.5
At page 14 of NZ 286896 there
are composition details for three more examples, these examples being said to be
made by essentially
the same procedure as for Example 1 above. Then follow
the composition details of three control formulations from which is omitted
the
moxidectin. These control formulations are said to be made by essentially the
same procedure as Example 1. Then follow thirteen
pages where tests on sheep
are described in such a way that the skilled addressee can repeat those tests;
results of those tests
are given in table form; conclusions from the results are
drawn; and details of stability tests performed for over 18 months on
two of
the example formulations and one of the control examples are given. All is
described so that the skilled addressee can repeat
all preparations, trials and
tests.
This is to be compared with the applicant’s examples, that for Formulation 5 (being a 5 in 1 vaccine composition) reading:
Formulation 5 (oil based)
Part A w/v%
Abamectin 1.13
Benzyl Alcohol 20.0
Sesame oil to volume
Part B v/v%
Part A 50.0ml
Sorbitan Oleate 10gm
Antigen 1 4.555ml
Antigen 2 0.135ml
Antigen 3 0.870ml
Antigen 4 0.933ml
Antigen 5 4.258ml
Benzyl Alcohol to volume
100%
There are no other preparation details for this example, the antigens are not identified, there are no animal trial details or formulation stability trial details other than:
Dosage rates for these formulations [Formulations 1 to 5] range from 0.5 - 5ml/50Kg bodyweight of the animal.
These preparations have been shown to be stable and do not cause injury when injected to warm blooded animals. The parasitic agent and the antigen retain their activity. The formulations have a shelf life of approximately two years.
The animals and condition being treated are not described. There are no control tests described, with their results. There are no described stability tests on the formulations. In addition, and, as was established at the hearing and as mentioned elsewhere in this decision, the applicant does not disclose to the skilled addressee what is meant by “stable”.
The opponent then raised the non-aqueous aspect of the formulation.
The opponent submitted that, as set out in the third amended statement of case (paragraphs 59 – 60), the specification is insufficient to teach compositions containing a carrier with more than just oil:
The specification is silent as to any need for water. The opponent said it may be possible to read in water as a component because of the use of an emulsifier.
Booker (paragraph 6, above) says water is involved in the compositions claimed. However the opponent said the specification is still silent on this point, and this results in serious uncertainty. The only reference to “aqueous” is by reference to “non-aqueous”. Thus, the opponent said, there is internal inconsistency. Booker (paragraph 6, above) states it is true that water is present in the compositions but he has to infer that it is because, as he says:
each of the formulations 1-5 contains a surface active agent of the type commonly used in the preparation of water-in-oil emulsions so it can be concluded that the vaccine component is water based.
If this interpretation is wrong and the claims 1-5 do not require an emulsifier, then the opponent said there is a conflict with the reference on page 4 of the specification which notes that the antigen is incorporated into the composition by an emulsifier.
The opponent submitted that claims 1 - 5 are thus not fairly based on the specification because the alleged invention requires the presence of an emulsifier. In other words, the specification contains an insufficient or unfair description of how to make a composition without an emulsifier.
I note that the claims 1-5 are not necessarily restricted to compositions containing water and are not restricted to the presence of cosolvent or emulsifying agent. These are introduced into later claims. Thus claims 1-5 include compositions made without water, cosolvent or emulsifier.
In fact in the applicant’s written submission at paragraph 43 it is stated:
There is no description in the specification as to how a stable, safe, effective composition with oil as adjuvant for macrolide and antigen is to be made, especially without emulsifier or cosolvent. This is part of the invention, yet it is left to the skilled but unimaginative addressee to work out because, in the applicant’s view, it requires no inventive capacity.
The opponent acknowledged that fair basis or inutility are not bases for opposition. If claims require an oil-only formulation, then the invention as claimed is clearly insufficiently disclosed because the skilled person is not taught how to prepare the invention without an emulsifier.
The opponent then questioned the enhancements claimed for the invention.
The opponent said in the third amended statement of case (paragraph 62) that reference is made to the alleged enhancement:
The opponent said the documents do not show the enhancement over known effects. It does not say how any such enhancement is achieved.
In the third amended statement of case (paragraphs 63 – 65) reference is made to the adjuvant effect:
CYDECTIN® moxidectin/Clostridium vaccine 10mg/50kg bodyweight
EWEGUARD® moxidectin/Clostridium vaccine 10mg/50kg bodyweight
IVOMEC® ivermectin 10mg/50kg bodyweight
DECTOMAX® doramectin 10mg/50kg bodyweight
The opponent submitted that Harvey (paragraph 7) admits that the vaccines used in the compositions of Formulations 1-4 in the application are “prepared vaccines” as supplied by a major producer. They are commercially available. This information is nowhere in the specification and the skilled reader would not know this. Thus, the opponent submitted, the specification does not teach all the components of the Part B material, or even indicate whether such are primarily water-based or oil-based. The specification does not say it is only those available vaccine formulations without alum, for example, that can be used, especially when one refers to page 8 of the specification where adverse reaction was said to be produced in animals by the combination of oil and alum.
The opponent then raised the issue of stability of formulations.
The opponent pointed out that Harvey (paragraph 5) refers to Cobb I (paragraph 12) as identifying the “heart of invention” when she states:
This is said to be consistent with the actual context of the opposed specification (“Background” and “Statement of Invention” at pages 2 and 3), yet there is nothing in the specification to state how the necessary stability is achieved.
Cobb I (paragraphs 18 – 19 and 45) states:
“These preparations have been shown to be stable and do not cause injury when injected into warm blooded animals. The parasitic agent and the antigen retain their activity. The formulations have a shelf life of approximately two years.”
If all this has been shown and is therefore presumably available for inclusion in the specification, it should have been given for the reader’s information.
In Cobb II (paragraph 39) it is stated:
“These
preparations have been shown to be stable and do not cause injury when
injected...”.
and, also on page 8:
“The formulations have a shelf life of approximately two years.”
I refer to my comments above on the “have been shown to be stable” issue and note there is nothing in the Application to show that “injury” was a problem or that this had in fact been overcome and, if so, how this is achieved. There is definitely nothing in the Application to support a two year shelf life.
And there is nothing to show that this is actually achieved, despite the Harvey declaration. No actual data is given in the specification.
The opponent said that there is no difference between Formulation 2 of the specification and the formulation used in the formulator’s report dated 28 February 1995 (Harvey, exhibit CMH-2). However, the report concludes that the formulation is not stable, stating “these trials separated reasonably quickly into two layers”.
The opponent said that nowhere in the specification or in the evidence are we told how to make a stable formulation. This is simply missing. As stated in Cobb I (paragraph 47):
The opponent said that Harvey (paragraph 12) decides what is a proper standard for a patent disclosure. The opponent said that since he is not a registered attorney or expert in patent law, this is a matter left to the Patent Office. Harvey (paragraph 12) states:
12. I do not consider Ramune Cobb’s comments are supported by any practical attempt to follow the formulations outlined. They seem to be based only on opinion. It is not the purpose of the patent specification to list all details and to provide each and every variation possible. To do so would make patents extremely large and difficult to read. Rather it is necessary only to provide sufficient details of the concept. The proper disclosure of the formulations is all that is required in this instance to show the validity of this novel concept.
As I see it an applicant has to fulfil its obligations under section 10(3)(a) and (b) to describe the invention and the way it is to be performed and to describe the best way of performing the invention which is known to the applicant (at the time the application is made). I note that the descriptive part of the applicant’s specification is 8 pages long. The corresponding description in NZ patent 286896, discussed and compared in part above, is 28 pages long, and that specification is not in my view extremely large and difficult to read. In NZ 286896 examples, presumably best methods of performing the invention, are described in detail. The description tells the skilled reader exactly how to prepare specific formulations, the tests carried out on animals using these, the results obtained from the tests and the conclusions drawn from these tests. The description gives detailed stability tests carried out on examples. The skilled but unimaginative reader is told how to perform the invention and specifically the details of best methods of performing the invention and how to confirm the promises made about the invention.
There are no such details in the applicant’s specification. There are only what are sketched details of what must be assumed are the best method of performing the invention known to the applicant. The best methods described appear to be generic formulations. There are few preparation details for these Formulations, mainly lists of ingredients. The vaccines used in the Formulations are not identified. The only details of tests are a range of application, being 0.5 - 5ml/50kg bodyweight of the animal. There is no reference to any specific type of animal used for trial purposes, what condition is being treated, and no test results following any treatment other than generalised statements at page 8 (referred to above). There are no details of tests of stability, and even what is meant by “stability”.
At the hearing the applicant said that “stability” was to be determined by the opponent. It was stated that it could even be that “stable” meant that the density remained the same over time. Given that density is mass/volume and the formulations would be held in sealed containment there can be no loss of mass or volume. So, on that basis of density, any formulation will always be stable.
I understand that an applicant does not have to give all details and to provide each and every variation possible as is suggested in Harvey (paragraph 12). However there has to be sufficient instruction for the skilled but unimaginative addressee to be able to repeat the invention and obtain the promises made. I cannot see in the present case that the invention has been described sufficiently and fairly for that addressee.
The applicant said that all that is required is that the novel concept has to be shown. I note that the opponent said it produced its water-based product of an antigen and a macrolide in aqueous system (the subject of NZ patent 286896) because it could not find a way of successfully combining a water-soluble antigen and an oil soluble macrolide. The opponent said that a first step to produce the combined formulation was to mix the antigen in water with the macrolide in oil and try to find a way to obtain a stable formulation. Also obvious to try in such a situation would be the addition of emulsifying agents and/or cosolvents where no stable formulation resulted from mere admixture or to improve the stability of the product resulting from the mere admixture. The opponent failed, but succeeded with an aqueous system. The opponent said the applicant has also failed (based on results from Harvey and based on there being no registered product resulting from the teachings of the present application), and has failed to show how success is to be achieved with the present specification.
What the applicant has done is claimed obvious combinations whilst not disclosing how a stable formulation is produced. The present specification, therefore, does not sufficiently and fairly describe the invention to be achieved so that the skilled but unimaginative addressee can produce that stable combination. The inventive part is not disclosed. It appears that how to reach that “stable” formulation is still not yet known.
Thus, what the applicant is attempting to obtain by the present application is the “hunting licence” of Commissioner of Patents v Manson (above) so that any successful achievement of the goal of the stable combination apparently will fall within the present claims if the application should reach grant. This cannot happen as it is unfair to the public. The public is denied the starting point for research as well as results of that research.
The opponent pointed out that Harvey (exhibit CMH-2) shows that there is a serious problem with settling out of the formulation, into two phases, and Mr Grayson asks if he wishes “to continue trials to improve the emulsion stability”.
The opponent said the patent application is silent as to the means of formulation of antigens in oil, in water and in oil and water. It is my understanding that the skilled but unimaginative reader will be able to make a formulation of antigen in water as this is part of the prior art. It appears from such as Freund’s complete and incomplete adjuvants that antigens in oil and water emulsions are also known.
The opponent submitted that the skilled reader will be unable to make the applicant’s formulation as there is insufficient detail on the antigens, the amounts of antigens, and the other components - what they are to be and in what amounts. There are insufficient details to produce the exact compositions of Formulations 1 to 5. There are no experimental procedural details of making the Formulations. These experimental details are important as the formulation in the report dated 28 February 1995 (CMH-2) was not stable and required much agitation to disperse the phases even for packaging purposes.
The skilled but unimaginative addressee needs to know how to get from the unstable state to a stable one. I note that even the unstable formulation of exhibit CMH-2 contained cosolvent and emulsifier.
It seems to me that the skilled but unimaginative addressee will be able to make a composition containing macrolide in non-aqueous liquid, the avermectin and milbemycin groups of macrolides being soluble in non-aqueous systems. The skilled but unimaginative addressee will be able to make a composition containing an antigen in an aqueous system, antigens being soluble in aqueous systems. The skilled but unimaginative addressee will know to mix the two to see what kind of composition results and will know about emulsifiers and cosolvents. The skilled addressee knows that there is a marketplace need for a combination and this mere admixture is a first step of a search for a combined composition. The skilled addressee will know that oil is an adjuvant for macrolides and antigens.
The applicant said the claimed mixtures succeed. According to the exhibits attached to Harvey they don’t. According to the opponent it did not succeed in making such a stable composition along the lines of the present invention. The opponent only succeeded in making an aqueous combined composition. In the case of the present application, the skilled but unimaginative addressee is not told what else is needed to make the mixtures succeed. Thus the specification simply does not sufficiently and fairly describe the invention. In fact all the applicant appears to have made, from the applicant’s submissions, is an admixture of two immiscible compositions which separate easily and require shaking before packaging and administration.
The opponent submitted that the specification is additionally insufficient as to which adjuvants need to be avoided, such as alum and alum hydroxide. I note the specification uses the wording “such as alum and alum hydroxide”. This wording implies that there are others to be avoided. But the specification does not mention what those others are.
At page 8 of the specification it is stated that compositions containing a
traditional adjuvant such as alum and oil stimulated the
working of the vaccine
to such a level that an adverse reaction was produced in the animal. Again,
alum is the example, but other
adjuvants are implied as having the same effect,
yet these are not identified. The skilled but unimaginative addressee is left
to
work out which adjuvants work, which don’t work, and which adjuvants
might work under some conditions but not others.
As I see it a big burden
is placed on the skilled but unimaginative addressee by the applicant. All this
implies that the specification
is insufficient and unfair.
The opponent submitted the application not only fails to describe what is in the “vaccine” of Part B, but also fails to describe how such are formulated. The reader of the application cannot even repeat the applicant’s examples, since there is no identification of the source or even general type of “vaccine” being used.
The opponent said that Grayson (paragraph 9) makes a bold statement that the “instructions are adequate” but does not explain what the instructions are adequate to achieve. Asks the opponent, “An unstable trial formulation?” The opponent said the statement is so vague as to be meaningless and reference is made to the comments in Cobb II (paragraph 34):
I agree that one cannot even begin to replicate these examples with the limited information offered.
Harvey (paragraph 10) admits Formulation 5 had “physical separation”. Cobb II (paragraphs 21 – 25) points out that the increase in sediment from 10%-15% and then into four layers leads her to conclude that this product (whatever its composition) did not have good stability, in contrast to the statement of Harvey (paragraph 10). Harvey (paragraph 10) states:
10. The products produced by this process have proven to be stable overtime [sic] as outlined in the patent. I attach, by way of example, exhibit CMH-3 a stability study experiment where the abamectin has been stable for a period of three years. There is as one would expect with an antigen/cell containing formulation a small amount of physical separation of the product but it remixes well to the product.
The applicant submitted that the opponent had missed the comment in Harvey (paragraph 10) that “the product remixes well to the product”. It seems to me that at this stage such a statement is insufficient. The applicant needs to say how often one has to remix and how effective the remixing is, especially since the specification has already stated merely how well the claimed composition performs without any supporting composition details and trial and test details and results. I think that if remixing is necessary this should have been discussed fully in the specification.
Cobb II (paragraphs 21-25) states:
The opponent pointed out the conflict between trial data provided in evidence (but which data is not provided in the specification) and what is disclosed in the specification. The evidence shows problems of stability and problems with adjuvant effects. The specification does not deal with such issues, the composition of the specification and the Formulations all being covered by broad statements as behaving according to the invention.
As I see it the specification does not tell the skilled addressee that problems occur and how to overcome them. In this respect, too, the specification is insufficient and unfair. The applicant’s evidence shows instability and does not show how this problem is overcome, or even if the applicant itself knows how it can be overcome.
I note that as far as the efficacy of the adjuvant is concerned the specification says that the antiparasitic agent and the antigen retain their activity in the exemplified Formulations (specification, page 8, line 7) whereas elsewhere on the same page, and apparently reporting on trials, the activity of the antigen is said to be enhanced and the antiparasitic activity of the anthelmintic is said to be extended (specification, page 8, lines 12-13). Thus there appear to be two different effects claimed, and the second is the one promised by the invention. The specification is inconsistent. The invention may work, but how it is to work must require something else which is not disclosed in the specification. The opponent knows this something else is not disclosed in the application. The specification insufficiently and unfairly describes the invention.
The opponent submitted that the something else required to make the invention work is not capable of identification from the specification and the invention cannot be replicated by the skilled reader. I agree.
The opponent submitted that the non-disclosure of the something else to make the invention work is a defect which is material and non-curable by amendment. The opponent drew on the Court of Appeal decision in Cyanamid v Ancare [2000] NZCA 127; [2001] RPC 20 in support. I quote Gault J at paragraph 36 of that decision:
36 In The Procter & Gamble Co. v. Peaudouce (UK) Ltd [1989] 1 F.S.R. 614, at page 615 in the Court of Appeal, Fox L.J., with reference to an application for amendment, said (with the agreement of the other members of the court):
“In fact no question of any amendment or any application for such relief in the alternative was raised until July 31 of this year in consequence of the decision of the court that the patent was ambiguous in its terms. If it had been, any necessary evidence could have been investigated before the judge and the question of whether the amendment was proper could have been determined by the end of July. As it is, if we now give leave to proceed with an application for amendment, the other side are left in the position that probably very extensive further litigation, quite apart from any proceedings in the House of Lords, will then be necessary with the result that this patent, which at the moment is held to be invalid, may be [sic] reason of suspension of any order for revocation pending investigation of the validity of the application to amend, be continued for a further lengthy period.
It is admittedly a matter for the discretion of the court whether to allow the application to be made. Speaking for myself, I am of the opinion this is not an appropriate case to give such leave. I think it is altogether too late and I think that it is unfair to the other party that the possibility of disputes in this litigation should be continued for so lengthy a period as might be necessary, if an application for amendment were to be made. The patentee had ample opportunity to raise the matter in the lengthy litigation which has taken place and which has been on foot now for some five and a half years. Looking at the whole matter, in the exercise of our discretion, I would, for the reasons which I have indicated, refuse the application.”
I agree that amendment at this stage to resolve any problem of insufficiency is not permissible.
The opponent submitted that if the complete specification does not sufficiently describe the invention then the process described in the proposed amendment must be obvious and clearly lacking in inventive step as it is assumed the skilled person will know how this is to be achieved without instruction. As stated by Cobb I (paragraphs 46 – 48):
The opponent referred to Helitune Ltd v Stewart Hughes Ltd [1991] 171 at 205 and Standard Brands (supra) at 532 line 29 - 37. In Helitune Aldous J stated:
Thirdly the defendant pleaded that if the invention was not obvious, then the specification was insufficient as it did not disclose clearly and completely enough the method of calculation, the way to programme the computer, the way to construct the displays, how to mount an accelerometer on the tail rotor hub, or how to apply the invention to anything other than helicopter blades.
As I have held the invention obvious, these allegations do not fall for decision. It is sufficient for me to hold that once the concepts claimed were obvious, then the skilled man could carry out those concepts without using ingenuity despite the fact that the specification contains no details.
In the United Kingdom Court of Appeal decision in Standard Brands it is stated by Buckley LJ:
It may seem an odd evidential situation, in proceedings in which an opponent is alleging obviousness, that the inventor should be saying that what he claims was common general knowledge at the date of the application and that the opponents should be saying the contrary. In the present case this was a consequence of the opponents riding two horses at one time, insufficiency and obviousness. These are horses which are not likely to work harmoniously in the ring together. The rider who attempts to manage both at once may find himself compelled at times to give more attention to one than to the other: indeed the mastery of one may prove fatal to the control of the other.
I think that in the present case, whatever my finding on obviousness, I still need to decide the issue of sufficiency.
All that appears to be described in the specification is the obviousness of combining an aqueous antigen composition and a non-aqueous macrolide composition as a starting point for research to try to achieve a stable effective composition with adjuvant effect on antigen and macrolide.
The separate starting compositions are known. The need for such a combination is known. The adjuvant effects of oils on antigens and macrolides are known. It would not require inventiveness to try cosolvent and emulsifiers separately and together to try to achieve stability or improved stability.
However it has been shown that mere admixture and the use of cosolvents and emulsifiers, strangely enough in the evidence of the applicant, are unsuccessful. The assertion that the invention works is there in the specification. But how the normally skilled but unimaginative addressee proceeds from what is known to the promised composition is unknown.
If it is clear how to proceed, as asserted by the applicant, then the details of how to proceed are not present in the specification for the skilled addressee to assess. There is no evidence of success by way of detailed examples to repeat, trial and test or by way of proven success in the marketplace.
There may therefore be an invention to be made, however at this stage how to achieve that invention, what is present in a composition that meets the promise of the specification, and how one produces this composition, are not described. All the applicant seems to have claimed is a gateway through which the skilled addressee must pass on the way to try to find a successful product, the stable and effective composition.
The applicant took a different view. The applicant referred to the third amended statement of case (paragraph 58) which states that there is nothing in the specification describing how to make a combined product as claimed in claim 1. The paragraph reads:
The applicant pointed to the examples and to its evidence, and said that sufficient information is provided for this purpose.
The applicant turned to the third statement of case (paragraph 59):
The applicant said that it is not true that the combination as a whole is not required to be non-aqueous. The applicant submitted it is the carrier that is defined as being non-aqueous and this is plain from the description that the addition of the vaccine constitutes a water in oil emulsion.
As I see it, the claims and the specification do not mention the use of water in the composition. The use of water has to be deduced from the use of vaccines in the example formulations and possibly from the use of emulsifiers. It seems from the evidence that emulsifiers do not in all cases imply the presence of water and that not all vaccines are necessarily in aqueous solutions. Claims 1-5 do not necessarily include water, especially as the emulsifying agent is not envisaged until claim 6. All examples, the Formulations, in the specification include cosolvent and emulsifying agent. There is no description of how to make a formulation without these and presumably without water. The specification insufficiently and unfairly describes the invention for the skilled but unimaginative addressee.
The complete specification has to be understood by the normally skilled but unimaginative addressee. While such an addressee may be able to reach the conclusion that water may be present based on the use of vaccines in the formulation, this is anything but “plain” as suggested by the applicant. “Plain” to me requires specific reference to the compositions of the invention including water. The specification is not plain if the presence has to be deduced, and deduced from the use of the one word, “vaccine”.
I also note that Booker (paragraph 6), for the applicant, stated:
I note that some vaccines may not include water. It would be understandable to me, then, if the skilled addressee did not deduce that water would be present. At least the skilled addressee would be confused.
I also note that in claim 1 at acceptance the antiparasitic agent is said to be “non-aqueous”. This is proposed to be omitted in amendments proposed for claim 1. It is not clear to me why the antiparasitic agent has to be “non-aqueous” if the overall composition is to include water.
I also note that Harvey (paragraph 4), and, according to Harvey, the skilled person, understand that the term “non-aqueous” is a reference to solubility characteristics:
4. The comments made by Ms Cobb in paragraphs 9 to 14 are directed at the wording of the patent and are clearly often taken out of context. Her comments mainly centre about the use of the word “aqueous” and non-aqueous”. I do not believe a person skilled in the art would fail to understand the terms aqueous and non-aqueous refer to the solubility characteristics.
However Grayson (paragraph 6) is equally clear, on behalf of himself and those skilled in the art, that “non-aqueous” has a different meaning:
6. I disagree with Cobb’s comments that the language employed in the specification is unclear. When taken in context I would understand the phrase “non-aqueous anthelmintic” to be describing the amount of water in the anthelmintic ie anthelmintics which are substantially without water. This is clear to me and I would believe would be clear to those skilled in the art.
The understanding of “non-aqueous” is different among deponents for the applicant, Harvey and Grayson, with each believing their different understandings would be clear to the skilled reader. Obviously the specification is unclear on this point. The specification is insufficient in explaining a requirement of one of the actives, the anthelmintic.
The applicant in written submissions referred to the statement that the exemplifications (Formulations) in the complete specification are merely paper examples. It is clear to me that as they are written they appear to be merely paper examples. The examples are descriptions of general methods of preparation. There are no specific formulations for the skilled but unimaginative addressee to make and evaluate. Generalising from these paper examples to the full scope of the invention claimed does not in my view come within the sound prediction described in Olin Mathieson v Biorex [1970] RPC 157 at 193:
If it possible for the patentee to make a sound prediction and to frame a claim which does not go beyond the limits within which the prediction remains sound, then he is entitled to do so. Of course, in doing so he takes the risk that a defendant may be able to show that his prediction is unsound or that some other bodies falling within the words he has used have no utility or are old or obvious or that some promise he has made in his specification is false in a material respect; but if, when attacked, he survives this risk successfully, then his claim does not go beyond the consideration given by his disclosure, his claim is fairly based on such disclosure in these respects, and is valid.
That case related to chemical compounds of a formula which had useful properties. Based on tests on examples of such compounds it was possible to make a sound prediction that certain changes to the basic chemical formula would not affect those useful properties. Examples of specific compounds within the general formula were included in the specification. In the present case there appear to be no specific examples and no test results the specification. Such examples as there are require emulsifier, cosolvent and, perhaps, water to be present. There does not appear to be any basis for a sound prediction that compositions without these three ingredients would posses the same properties.
The applicant referred to the third amended statement of case (paragraph 60) where the opponent said the definition of “non-aqueous liquid carrier” is not sufficiently clear if it purports to include components other than oil, the opponent saying that there was no reference to the use of any other component than the oil in the liquid carrier. The applicant said that “comprises” can be interpreted in the specification as meaning “made up of, or consisting of” and can be, depending on the evidence, interpreted as exclusionary. In the present circumstance the applicant said that how the word “comprises” is to be interpreted depends on the evidence. As I see it the word has to be understood from reading the specification.
The applicant referred to the third amended statement of case (paragraphs 61 and 62) which it said focused on the lack of description of the enhancements. Paragraphs 61 and 62 argue:
The applicant said it was trite law that a patentee is not required to state advantages and the applicant drew on paragraph 5.13 of Terrell on the Law of Patents (14th Ed) in support. This paragraph from Terrell says that in general it is not necessary for the inventor to state the advantages of the invention. An example was given in the paragraph from Badische Anilin und Soda Fabrik v Levinstein (1887) 4 RPC 449 which related to a specification which described four processes for the production of certain dyes varying in colour from brown to red. All four processes were claimed. Only one shade was said to be of any practical value. It was argued that the patent was bad because there was no description of the relative advantages of each particular shade of colour. Lord Halsbury said:
Upon the principle contended for, each shade must not only be shown, but its excellence or popularity must be distinguished separately by the patentee. This, as it appears to me, reduces the obligation supposed to press upon the patentee to an absurdity.
This is quite true. The specification considered in the decision taught new processes for the manufacture of dyes. If the argument before Lord Halsbury had been accepted, then the applicant in the present case would have to spell out advantages of formulations for each type of antigen and/or macrolide. However it is my understanding that in the present case the properties are part of the essence of the invention (see Mentor above). The invention is said in the specification to be safe, stable, effective, with the oil having an adjuvant effect. These are the advantages I see that the opponent (and the quote from Mentor) is referring to. These are the advantages that the skilled but unimaginative addressee is being taught are to be achieved by the invention. In the specification at page 3 line 14 the oil is an adjuvant; at page 8 lines 11-13 the oil acts as an adjuvant in the composition, enhancing the activity of the vaccine and extending the parasiticide activity of the anthelmintic; in claim 1, as accepted, at line 4 and in claim 1, as it is to be amended, at line 7, the liquid carrier acts as an adjuvant. So as I see it the adjuvant effect is not just an advantage, it is an advantage that is an essence of the invention. The specification has to say how the advantages are to be achieved.
The advantage as being an essence of invention is commented upon in the same edition of Terrell on the Law of Patents at paragraph 5.14 as follows:
5.14 Advantage whole essence of the invention
Where the attainment of a particular advantage constitutes the whole essence of the invention it may be necessary to state this advantage and to confine the claims to apparatus or processes that will achieve it in order to properly to delimit the invention.
In the present case there appear to be several advantages and these appear to be essential integers of the invention and are in the claims to the invention. They are therefore integral parts of the whole essence of the invention. The applicant does not appear to me to be correct in stating in submissions that the specification teaches that the advantages are a single injectable composition dealing with two problems, being the saving of time and the saving of other resources. The advantages are the stable, safe, injectable composition where the adjuvant enhances the activity of the vaccine and extends the parasiticidal effect of the anthelmintic. The specification must show the skilled but unimaginative addressee how to produce such a composition and what is in such a composition.
It seems to me that the “stable” aspect of the invention is an essential but apparently mercurial property. In answer to a query as to how the opponent, or anyone else for that matter, was to test that stability had been achieved the applicant replied that it was for the opponent to decide what stability meant. Thus what the applicant means as “stable” in the specification is for the opponent, or the skilled addressee, to determine. The concept of “stable” appears to be variable too. Hence, as far as I can see, the specification is insufficient and unfair to the skilled addressee in not defining the meaning to be ascribed to “stable”.
There is no description in the specification as to what the skilled but unimaginative addressee is to understand by “stable” There is no definition of the word in the complete specification. The applicant suggested it could be stability of the emulsion, or colour of the mixture, or even density. As I stated elsewhere in this decision, I don’t think density can be a realistic measure of stability in the present technology. It seems to me therefore that the specification is insufficient and unfair with respect to what the skilled but unimaginative reader is to understand by the word “stable” and hence the skilled addressee cannot know what kind of stability is to be achieved and hence cannot know when stability is achieved.
In paragraph 32 of the applicant’s response to the opponent’s submissions the applicant said that Cobb II (paragraph 13) makes an immediate and unexplained correlation between “stability” and “separation”. The applicant said that a separated composition is “stable”, particularly as it can be shaken as part of further processing prior to delivery.
It seems to me that deponent Cobb and the skilled reader have no option but to make “immediate” and “unexplained” correlations between “stability” and “separation”. Firstly it seems to me that “separation” is an obvious measure of “stability” for oil and water emulsions. Secondly the specification does not define “stability”. Thirdly the applicant declined to say what “stability” was at the hearing, saying this was for the opponent to decide. Fourthly, from the last point, the opponent has made a decision.
Even the formulators at Grayson Laboratories appeared to regard “stable” as being a stable emulsion.
Nowhere in the specification does it mention separation of the phases and the need to remix. If the phases do separate prior to delivery does not this amount to the prior art position of separate deliveries of the actives, as exemplified in Umehara (above)?
If it is being suggested in submissions (paragraph 32 of the applicant’s response to the opponent’s submissions) that it is the applicant’s claim that stability refers to the actives retaining their activity over a long period, and the invention is the admixture of the known macrolide in oil composition and known antigen composition which is to be shaken, perhaps vigorously, before delivery, in the sense of administration to animals, then there is mere admixture. Nowhere in the specification is it stated in any terms, clear or otherwise, that this is what the invention is. There appears to be the promise in the specification that the user takes the ready mixed composition and administers it. There is no mention of mixing and shaking of separated phases before administration. There is no mention in the specification that there is a problem with the actives in anthelmintic compositions and antigen compositions retaining their activities over time. The specification is insufficient and unfair if these are understandings that the skilled addressee is expected to draw from the specification.
It is to be noted that this step is obvious, as the first step of research to find a “stable” composition, and the collocation resulting is a mere collocation, possessing as it will merely the sum of the known properties of the component parts.
Further, it seems to me that an animal remedy is a carefully formulated treatment. The fact that the present formulation separates prior to delivery, and separates very quickly according to Harvey exhibit CMH-2, and has to be shaken before administration, indicates that what will actually be delivered to the individual animals of a group of animals being treated is going to be very variable and of variable efficacy. This separated mixture may explain why there is no animal remedy that can be officially registered.
The applicant at paragraph 87 of submissions dismisses the rest of the opponents discussion of insufficiency in its third amended statement of case.
The applicant drew on paragraph 5.06 from Terrell on the Law of Patents, 14th edition, and quoted the extract given therein from Valensi and Another v British Radio Corporation [1973] RPC 337 at 377, where the Court of Appeal held that in assessing insufficiency:
...the hypothetical addressee is not a person of exceptional skill and knowledge and he is not expected to exercise any invention or any prolonged research, enquiry or experiment. He must, however, be prepared to display a reasonable degree of skill and common knowledge of the art in making trials and to correct obvious errors in the specification, if a means of correcting them can be easily found...
I note the quote from Valensi in Terrell continues:
Further, we are of the opinion that it is not only inventive steps that can not be required of the addressee. While the addressee must be taken as a person with a will to make the instructions work, he is not called upon to make a prolonged study of matters which present some initial difficulty: and in particular, if there are actual errors in the specification - if the apparatus really will not work without departing from what is described - then unless both the existence of the error and the way to correct it can be quickly discovered by an addressee of the degree of skill and knowledge which we envisage the description is insufficient.
Based on the first quote above from Valensi the applicant said that it is not appropriate to say that the vaccine composition used in Formulations 1-5 (the examples) is not described. The applicant drew attention to page 5 lines 3 to 8 of the specification in support. To me, what appears at page 5 lines 3 to 8 are the preferred antigens. The statement of invention and the claims cover all antigens. The first two lines of page 5 then state preferred antigens by saying that suitable antigens include antigens derived from bacterial and viral pathogens of warm blooded animals. Beginning at line 2 of page 5 the specification then further limits the preferred antigens to those derived from, and toxins of, clostridial diseases including Clostridium Septicum, Clostridium tetani, Clostridium chauvoei, Clostridium novyi, Clostridium sordelli, and Clostridium haemolytica. From line 5 of page 5 the specification states that other possible antigens include Pasteurella, Pasteurella maltocida and Corynebacterium pseudotuberculosis and viral antigens for Infectious Bovine Rhinotracheitis, Bovine Viral Diarrhoea and Parainfluenza.
There is nothing in the specification specifically linking the preferred antigens to any of Formulations 1-5. The choice is up to the skilled but unimaginative addressee. In any event, from the specification and the generic Formulations 1-5, it appears choice of antigen is not relevant to achieving the promises of the invention.
The applicant said that the Valensi approach was adopted in Tetra Pak Tebel BV’s Application 328267 (Assistant Commissioner Hazlewood, 6 August 2002). The applicant quoted my saying:
The applicant submitted that raising purely hypothetical problems when the practical answer is apparent to the skilled reader from the specification or raising deliberately obtuse constructions of the specification do not render the patent specification insufficient.
In that case it was my understanding that having read the specification and claims in that case I thought the skilled reader would have little difficulty in producing the claimed invention without further invention on the part of the addressee. I then went on the address the specific allegations of the opponent and dismissed them.
In the present case it is my belief that the opponent has raised relevant and real problems with the specification. I have much sympathy for the skilled addressee in the present case. I do not believe the specification teaches the skilled but unimaginative addressee how to perform the invention should it require more that mere mixing of the separate aqueous and oil compositions with or without emulsifier or cosolvent. The opponent has raised many matters of concern in the understanding of the invention in these proceedings. I have not referred to all the concerns in this decision.
Of particular concern to me is that the mixture separates, perhaps very quickly, and has to be shaken before administration and none of this is mentioned in the specification.
I do not believe the opponent has raised purely hypothetical problems and deliberately obtuse constructions and I do not believe the practical answer as to how to make the product which meets the promises of the invention is apparent to the skilled addressee from the specification.
The applicant submitted that the opponent is ignoring the “two in one” advantage specified. I take it that this “two in one” advantage is the combined delivery of two actives in one formulation thus saving time and other resources.
It seems to me that the “two in one” advantage is an area in which it can be argued that there is no invention because the combination is a mere collocation and also that it would be obvious to combine two (or more) actives to save time and other resources.
Where two (or more) actives can be mixed together into one formulation without problem then it is likely that there is no invention because the result is mere admixture, the two actives merely contributing their individual properties to the mixture, and the properties of the mixture is the sum of the individual properties of the actives. There is no surprise in such an admixture. And there is no invention.
When, in mixing two (or more) actives, there are problems to be overcome in making a successful formulation containing the two actives and the applicant overcomes these problems using some ingenuity then there is likely to be invention.
Where there are unexpected benefits gained on admixture, such as synergistic effects, then there is likely to be invention.
The saving of time and other resources mentioned by the applicant, however, are to be expected so there is no invention merely based on these savings.
In the present case there would be no invention in merely mixing the two actives. There was an established need. The mixing is an obvious step. One problem to be overcome would be an expected lack of emulsion stability. This would be expected because water and oil phases do not usually form stable emulsions on mere admixture. A known way to form emulsions of oil and water is to use cosolvents and emulsifying agents separately or together. The use of emulsions and cosolvents for such a purpose would be well known to the skilled but unimaginative addressee.
The tests attached as exhibits to Harvey shows that producing a stable composition on admixture is not straightforward. Yet according to the applicant this part of the invention would be obvious to the skilled but unimaginative addressee. Because this would be within the skills of the unimaginative addressee the applicant has not included these details in the specification. Thus all the invention becomes obvious. This obviousness is one of the “horses” referred to above by Buckley LJ in Standard Brands (above).
The other “horse” is that of insufficiency. In my opinion the opponent has managed both horses successfully in its submissions. If there is an invention but the specification lacks the necessary information for the skilled but unimaginative addressee to perform the invention then the specification is insufficient and unfair. In the present case, assuming the invention is not obvious, the skilled but unimaginative addressee has to find out how to make the combination of a water phase containing antigen and an oil phase containing (oil-soluble) macrolide into a stable composition (taking for the present purposes that “stable” relates to the emulsion stability). Claims 1-5 merely include these two separately known compositions in admixture. The specification does not teach the skilled addressee how to make such simple admixtures into the stable combined composition with the promised properties.
The next step to try and achieve the promised composition is to use additional knowledge which the skilled but unimaginative addressee already possesses. This additional knowledge is the knowledge that cosolvents and/or emulsifiers are useful in trying to achieve a one phase emulsion of oil and water. However even using these there are problems with stability of the emulsion. Thus, stability is difficult to achieve. This has been shown by the evidence of the applicant, being exhibits attached to Harvey.
Without further instruction the skilled but unimaginative addressee cannot produce the promised composition. The specification does not tell. The applicant in evidence says it is obvious to the skilled addressee. But the applicant’s evidence shows it is not achievable. The skilled addressee cannot perform the invention. Hence the specification insufficiently and unfairly describes the invention.
The addressee has to find a stable emulsion, it has to be safe and effective as an animal remedy and the oil has to provide an adjuvant effect that enhances the activity of the vaccine and extends the parasiticidal activity of the anthelmintic. This is where the invention lies, if there is an invention to be found, and this invention is not described for the skilled addressee. I think in the present case, if the invention is not obvious to the skilled but unimaginative addressee and how to make it is not obvious, the specification is insufficient and is not fair.
As noted above, since cosolvents and emulsifiers are known to bring water and oils into emulsion form the specification also appears to be insufficient in not describing how stable formulations can be made without cosolvent which only appears in claim 5 and without emulsifier which only appears in claim 6.
The specification does not state that the invention is the “mixture” of two immiscible liquids which is shaken before administration if this is the alleged invention.
The ground of insufficiency is made out.
NOT AN INVENTION - section 21(1)(f)
Section 21(1)(f) states:
That the subject of any claim of the complete specification is not an invention within the meaning of this Act
As I have found that the invention claimed is obvious there does not appear to be any invention, hence this ground is made out.
The applicant said that this ground has not been pursued by the opponent. The applicant said that the ground fails because of the new role given to oil in formulating these products. The applicant said that no previous formulation uses oil as the carrier in these volumes, enabling both an adjuvant effect on the antigen, and enhancement of the macrolide.
Deponent Cobb has said that there is nothing new in the claims and this includes the volumes of oil. She said there is nothing in the specification that links the volume of oil to adjuvant effects. It is admitted by both parties that the adjuvant effects of oil on anthelmintics and antigens was known to the skilled addressee at the earliest date to which the claims are entitled.
I have also found that, in an alternative to the invention not being obvious, the invention and the method by which it is to be performed is not sufficiently and fairly described in the specification. In the event that there is an invention claimed the skilled reader is not taught what is in the formulation so that it meets the promise of the invention described and does not state how to make this formulation (ie how to perform the invention).
It seems to me that if there is an invention within the scope of the claims it is not identified by any formulation or method of preparation in the specification. The opponent appears to me to have shown that the formulations produced so far have not met the requirements of the invention, that the composition be stable, safe and effective, with the oil acting to enhance the activity of the vaccine and extend the antiparasitic activity of the anthelmintic.
As far as I can see the subject of the claims of the complete specification is not an invention. As I have said above, what is claimed is the “hunting licence” from Commissioner of Patents v Manson.
If it is the applicant’s claim that stability refers to the actives retaining their activity over a long period, and the invention is the admixture of the known macrolide in oil composition and known antigen composition which is to be shaken, perhaps vigorously, before delivery (in the sense of administration to animals), then there is mere admixture, mere collocation. There appears to be no technical achievement in terms of problems overcome or unexpected property found. The composition merely saves time and effort which are to be expected. The property of the mixture is the sum of the properties of the individual components, and I believe this would include the stability of the actives in retaining their activity over a long period. All this is mere collocation, and mere collocation is not an invention. I note that nowhere in the specification is it stated in any terms, clear or otherwise, that this is what the invention is. There appears to be the promise in the specification that the user takes the ready mixed composition and administers it. There is no mention of mixing and shaking of separated phases before administration. In addition, given that at an extreme position a combination could include the separate macrolide and antigen compositions stored in separate containers to be mixed before use, there is even less to be claimed as invention.
Based on the information before me, even though the opponent did not press this ground, I believe that the claims do not relate to an invention.
The ground is made out.
DECISION
I find that the grounds 21(e), (f) and (g) have been made out. I direct that the patent not be sealed. In view of my decision that the patent is not to be sealed amendment proposals considered above under section 40(1) to the extent that they met the requirements of section 40(1) cannot be effected. It is my belief that there are no amendments that can be made to save the application.
COSTS
The opposition has been successful. Pursuant to section 95(1) I award the opponent $6,130.00 based on the schedule of costs in Information to Clients, 17 August 1999, to be paid by the applicant.
Dated this 16th day of September 2003
_____________________________
A Hazlewood
Assistant Commissioner of
Patents
Pipers for the Applicant
Baldwin Shelston Waters for the Opponent
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