Intellectual Property Office of New Zealand - Patents Decisions
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Intellectual Property Office of New Zealand - Trade MarksLast Updated: 14 October 2008
P15/2004
IN THE INTELLECTUAL
PROPERTY OFFICE OF
NEW
ZEALAND
IN THE MATTER of the Patents Act 1953
AND
IN THE MATTER Letters Patent No 286896 in the name of WYETH HOLDINGS CORPORATION
Patentee
AND
IN THE MATTER of an application for revocation under section 42 by COLIN MANSON HARVEY
Applicant
Hearing: 17 and 18 May 2004
C Elliott and T Jackson for the patentee
P Dengate Thrush and N Bannister
for the applicant
Decision
BACKGROUND
Patent application 286896 was filed in New Zealand on 29 June 1996, claiming priority from a United States patent application dated 30 June 1995. The patent was sealed on 15 September 1998.
Application for revocation was filed on 29 June 1999, grounds (a), (b), (c), (d), (e) - both limbs, (f) and (g) of section 21(1) being pleaded by the applicant.
All grounds pleaded were denied by the patentee.
Grounds (a), (b), (c), (d), (e) - second limb and (g) were not pursued at the hearing.
LOCUS STANDI
The patentee admits that the applicant is a person interested. I accept that the applicant has locus standi.
PRIORITY DATES
The patentee states that the applicant has given no basis for its assertion that the claims are not entitled to the earlier priority date of 30 June 1995. This is true. I have studied the claims and the priority document. The three question test in Mond Nickel Co Ltd’s Application [1956] RPC 189 at 194 is satisfied:
It is my decision that the claims are entitled to the date of 30 June 1995 as their priority date.
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.
The amendment proposals, which are unconditionally proposed, are the amendment of claim 1 of the specification at acceptance, together with consequential amendment of the remaining claims.
The amendment proposals for claim 1 are as follows (deletions being shown struck through and additions being shown underlined):
A macrolide vaccine composition for parenteral
administration which comprises on a weight to volume basis about 0.05% to 2.5%
of a macrolide compound
or mixture thereof; about 0.1% to 10%
6% of a water soluble organic solvent; about 1% to 8% of a dispersing
agent; about 10% to 50% of an adjuvant; at least one antigen; and saline
or water or a mixture thereof.
The applicant does not object to the amendment proposals, and neither do I. The amendments to the claims in their entirety are clearly disclaimer, the scope of the claimed invention being reduced. The proposals do not result in the specification as amended claiming or describing matter not in substance disclosed in the specification before the amendment, and each claim of the specification as amended falls wholly within the scope of a claim of the specification before the amendment. The amendments meet the requirements of section 40(1).
I find that the amendments are allowable and are to be made. I note that suitably amended pages for insertion in the specification have already been supplied.
EVIDENCE
The applicant’s evidence consisted of affidavits of :
The patentee’s evidence consisted of statutory declarations by:
The applicant’s evidence in reply consisted of affidavits of:
NATURE OF THE INVENTION
The invention relates to stable compositions for parenteral administration, a method for their use, and a process for their preparation.
The opening paragraph describes the field of invention:
The present invention relates to vaccine compositions which are stable and to the use of said vaccine compositions for the treatment and control of helminthiasis and infection by acarids and arthropod endo- and ectoparasites in warm-blooded animals, and to a process for the preparation of the vaccine compositions.
Macrolide compounds including macrocyclic lactones such as LL-F28249α-λ compounds, 23-oxo or 23-imino derivatives of LL-F28249α-λ compounds, milbemycin compounds such as milbemycin D, and milbemycin oxime, avermectin compounds such as abamectin, ivermectin and doramectin, and mixtures thereof are useful for the prevention and control of helminthiasis and infection by acarids and arthropod endo- and ectoparasites in warm-blooded animals. Subcutaneous injection of aqueous compositions is one of the preferred methods for administering those compounds.
Vaccines are used to protect warm-blooded animals from a variety of diseases and are also administered by subcutaneous injection. However, a vaccine composition containing both a macrolide compound and antigens is not known. The primary reason for the lack of such a combination is due to the fact that aqueous injectable compositions of macrolide compounds contain dispersing agents which are known to interact with proteins and affect the permeability of the outer membrane of bacterial cells. Such interaction can denature or otherwise disrupt proteins such as antigens.
GB-A-2030043 describes injectable compositions which comprise tetramisole or its levorotatory isomer and a vaccine. However, that application does not disclose a combination vaccine which includes a complex macrolide compound. Further, that application does not describe the use of a dispersing agent, an important component in the aqueous macrolide injectable compositions.
It is therefore an object of the present invention to provide stable vaccine compositions comprising macrolide compounds and antigens. It is also an object to provide stable compositions of macrolide compounds in the absence of an antigen.
It is also an object of the present invention to provide a stable vaccine composition for use in preventing or controlling helminthiasis, infection by acarid and arthropod endo- and ectoparasites and bacterial and viral disease in warm-blooded animals.
It is a further object of the present invention to provide a process for the preparation of stable vaccine compositions.
These and other objects and features of the present invention will become more apparent from the detailed description thereof set forth below.
The main claim is claim 1 which, as it is proposed to be amended, reads:
A vaccine composition for parenteral administration which comprises on a weight to volume basis about 0.05% to 2.5% of a macrolide compound or mixture thereof; about 0.1% to 6% of a water soluble organic solvent; about 1% to 8% of a dispersing agent; about 10% to 50% of an adjuvant; at least one antigen; and saline or water or a mixture thereof.
All other claims depend from this claim.
THE LAW
The applicant 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 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 (Decisions of the Commissioner, P18/2002, 6 August 2002) regarding any conflict of fact or expert opinion that is largely to be resolved by giving the patentee in revocation proceedings 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 (Decisions of the Commissioner, P2/2001, 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.
OBTAINING – section 21(1)(a)
This ground was not pursued at the hearing. However, since evidence was provided, I will consider the ground briefly in the public interest.
Section 21(1)(a) states:
That the applicant for the patent, or the person described in the application as the true and first inventor, obtained the invention or any part thereof from him, or from a person of whom he is the personal representative
The patentee pointed out that a patent is only to be revoked if the Commissioner cannot reasonably come to a decision in favour of the patentee. In support I was directed to Stuart’s Application 9 RPC 452 at 452, which particularly refers to the high burden of proof in obtaining cases:
Sir E CLARKE, SG I think that the Law Officer is only entitled to stop the issue of a patent, having examined all the evidence given on one side or the other, if he is so clearly of the opinion that the Opponent has made out his case that he would, if a jury were to find in favour of the Applicant, refuse to accept it and overrule the decision on the ground that it was perverse and contrary to the obvious weight and effect of the evidence. That is the proposition which I keep before my mind.
Aston, QC – It practically comes down to this, that if there is reasonable doubt upon the evidence which is given, the Law Officer will give the Patentee the benefit of that doubt and let it be decided elsewhere.
The SOLICITOR-GENERAL – Yes.
In Eric Graham King v Robert Blundel Norgate (Decisions of the Commissioner, P21/1992, 22 December 1992) it is stated at page 11:
To succeed on the ground of obtaining, an opponent must show that some other person (or persons) was (were) the true and first inventor(s), and that the invention subject of an application for protection under challenge, was obtained from that person(s) in contravention of the rights of the opponent. As is established by the case law, this places the burden of proof upon the opponent to establish firstly that some other person than that named by the applicant is the true and first inventor, and secondly that there was some relationship between the parties which gave rise to the act of obtaining.
The decision shows that the burden of proof is on the applicant in revocation proceedings to establish firstly that some other person than the person named by the patentee (in revocation proceedings) is the true and first inventor, and secondly that there was some relationship between the parties which gave rise to the act of obtaining. A two part test is prescribed:
The applicant claimed to have been the first inventor. The evidence provided was unpublished New Zealand provisional patent application 270863 filed on 3 April 1995. This specification is said to relate to a stable injectable composition comprising a non-aqueous anthelmintic and an immunising agent in combination with known excipients and or adjuvants for use in warm-blooded animals. The specification particularly describes oil based formulations. Any water-soluble organic solvent or dispersing agent exemplified is well in excess of the proportions described for the patentee’s composition. The patentee’s composition is not described in this document so the document does not show that some other person was the true and first inventor of the patentee’s claimed invention.
Since the first question is answered in the affirmative, the second question is unnecessary. If, however, one searches for an answer to the second question there is no relationship between the parties shown that could give rise to any act of obtaining.
The ground is not made out.
PRIOR PUBLICATION – section 21(1)(b)
This ground was not pursued at the hearing. However I will consider the
ground briefly in the public interest.
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.
New Zealand Patent Specification 197796
This document was available at the Intellectual Property Office of New Zealand (the office) before 22 April 1985, the date of sealing the patent in suit. The document teaches a stabilised aqueous formulation of a water-insoluble macrolide, ivermectin. There is no antigen in the composition as in the patent in suit so there is no teaching of how a combined formulation may be made. The aqueous formulation requires a surface-active agent, and one or both of a co-solvent and a substrate. The composition is said to contain 4 to 25% w/v of dispersing agent, with 8%, 12% and 8% being taught by the three examples in the specification. This is to be compared with the range of 1% to 8% which is present in the composition of the claims of the patent in suit.
The document discloses the presence of from 10 to 40% w/v of co-solvent in the final composition with the three examples utilising 20%, 25% and 20%. In the present patent the organic solvent is present between about 0.1% and 6%. Benzyl alcohol is not defined in the document as being a co-solvent.
The document teaches the need for both co-solvent and substrate to achieve a stable and commercially viable composition of ivermectin with surface-active agent. A substrate is not required in patent in suit in order to produce a stable formulation. Although benzyl alcohol could be considered as either a substrate or a co-solvent, the co-solvent and substrate are specifically defined in the document, and benzyl alcohol is only defined as being a substrate. Thus, when it is present in a formulation, it is only there as a substrate and there has to be a co-solvent present. The examples in the document contain both a co-solvent and a substrate.
The document also discloses the optional use of an adjuvant, but no range is given for this component and the examples do not include an adjuvant. The present invention claims the presence of 10 to 50% of adjuvant in the formulation.
Thus the document teaches away from the patentee’s claimed invention in several respects and does not prior publish the invention as it is proposed to be claimed.
United Kingdom Patent Specification 2030043
This document was available at the office from 25 June 1980. This specification discloses a composition containing levamisole, which is an anthelmintic. However, levamisole is not a macrolide anthelmintic, and, unlike macrolide anthelmintics, is water-soluble. There is also a clostridial vaccine present.
There is no reference to the use of a dispersing agent, it not being necessary as levamisole is water-soluble.
The problem to be overcome in the case of a combination of tetramisole and vaccine was the prevention of hydrolysis of the tetramisole, and this was achieved using an acidic aqueous composition.
Thus the document does not teach how to combine in a stable composition water-insoluble macrolide and water-soluble antigen or that this is possible.
This citation does not prior publish the invention as it is proposed to be claimed.
New Zealand Patent Specification 286752/299093
This document was not available at the office until 24 November 1997. Thus, it is not eligible to be considered under prior publication. Notwithstanding this, the document discloses a stable injectable composition comprising a non-aqueous macrolide and an antigen in combination with carriers that also acts as an adjuvant for use in warm-blooded animals. The specification particularly describes oil based formulations. Any water-soluble organic solvent and dispersing agent exemplified are well in excess of the proportions described for the patentee’s composition.
This citation could not prior publish the invention as it is proposed to be claimed even if it had been eligible for consideration.
I find that the ground of prior publication is not made out.
PRIOR CLAIMING – section 21(1)(c)
This ground was not pursued at the hearing. However I will consider the ground briefly in the public interest.
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 286752/299093
This document was not available at the office until 24 November 1997. It has a filing date of 5 June 1997, and claims priority from two provisional patent applications dated 5 June 1996 and 30 July 1996. The specification claims a stable injectable composition comprising a non-aqueous macrolide and an antigen in combination with carriers that also acts as an adjuvant for use in warm-blooded animals. The specification particularly describes oil based formulations. Any water-soluble organic solvent and dispersing agent exemplified are well in excess of the proportions described for the patentee’s composition.
None of the claims of the present patent are coterminous with the claims of the cited specification. In addition, since I have also found that the present claims are entitled to the priority date of 30 June 1995, which is before any date to which the cited document’s claims are entitled, the cited document could not prior claim the patentee’s claimed invention
The ground is not made out.
PRIOR USE - section 21(1)(d)
This ground was not pursued at the hearing. However I will consider the ground briefly in the public interest.
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 an opponent (the applicant in revocation proceedings) 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.
The patentee pointed to High Court Rule 725Z1 as to the particulars that must be shown for the opponent (applicant in revocation proceedings) to succeed on a claim to prior use.
The applicant did not provide any evidence necessary to prove the ground. The applicant asserted, without establishing this by evidence, that farmers would combine two injectable products. Deponents for the patentee expressed surprise at this and pointed to the foolhardiness such actions. The patentee also expressed the view that to mix such formulations was illegal. The patentee submitted that farmers and veterinarians are aware of the need to use only licensed animal remedies in food producing animals and that vaccines particularly are made to strict specifications and they should not be tampered with prior to administration.
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 patentee (in revocation proceedings) 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. Only the first limb is being pursued at this, the hearing, stage. 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].
The patentee drew attention to the usual practice of calling expert witnesses to give their opinions on whether or not the inventive step would have been obvious to the skilled person having regard to the state of the art at the priority date. Reliance was placed on Molnlycke AB and Anor v Procter & Gamble Ltd and Ors [1994] RPC 49 at 113:
In applying the statutory criterion [of obviousness] and making these findings the court will almost invariably require the assistance of expert evidence. The primary evidence will be that of properly qualified expert witnesses who will say whether or not in their opinions the relevant step would have been obvious to a skilled man having regard to the state of the art. All other evidence is secondary to that primary evidence.
From the same case, at 115, the burden of proof is upon the person attacking the validity of the patent to show that no inventive step was involved:
The burden of proof is upon the person attacking the validity of the patent to show that no inventive step was involved. It is therefore for him to make out the case of obviousness and prove it by appropriate expert evidence. Accordingly in any given case it will be for that person to marshal and prove those aspects of the state of the art which he alleges make the relevant step obvious
From the same case, at 114, it is seen that whether or not the invention is obvious is a question of fact:
The question to be answered ... is a question of fact. In some cases it may be a very complex question; in others the question may involve no complexity although it may still be difficult to answer with confidence. In the present case the technology is reasonably straightforward, and the inventive step claimed involved an idea for the application of that technology in relation to a particular product. It exemplifies a case where, despite the fact that no doubt large sums of money are at stake, the resolution of the question of fact is obscured, not assisted, by an over-elaboration of the evidence or a failure to recognise that the relevant question is the primary question.
The patentee pointed out that hindsight is to be avoided, and quoted the United Kingdom Court of Appeal in Hickman v Andrews [1983] RPC 147 at 193 with its quote from Lord Diplock in Technograph Printed Circuits Ltd v Mills and Rockley (Electronics) Ltd [1972] RPC 346 at 362:
Once an invention has been made it is generally possible to postulate a combination of steps by which the inventor might have arrived at the invention that he claims in his specification if he started from something that was already known. But it is only because the invention has been made and has proved successful that it is possible to postulate from what starting point and by what particular combination of steps the inventor could have arrived at his invention. It may be that taken in isolation none of the steps which it is now possible to postulate, appears to call for any inventive ingenuity. It is improbable that this reconstruction a posteriori represents the mental process by which the inventor in fact arrived at his invention, but, even if it were, inventive ingenuity lay in perceiving that the final result which it was the object of the inventor to achieve was attainable from the particular starting point and in his selection of the particular combination of steps which would lead to the result.
Both parties 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.
Both parties pointed out that the test for obviousness was also stated by the New Zealand Court of Appeal in Ancare v Cyanamid [2001] RPC 335 at 346:
That aside, the test is well established. It postulates a person (or, where appropriate, a team), skilled in the field but not inventive, invested with the common general knowledge available in the field at the priority date, presented with the prior knowledge or prior use relied upon. Prior documents may be looked at together if that is what the skilled person or team would do. It asks whether to that person or team the alleged inventive step would be obvious and would be recognised, without bringing to bear any inventiveness, as something that could be done or is at least worth trying. That is a question of fact. If any embodiment within the scope of the claim is obvious the claim is invalid.
The approach from Windsurfing can be summarised as:
Step 1:
The inventive concept of the present invention is a stable vaccine composition for parenteral administration which comprises at least one macrolide and at least one antigen. The composition comprises, on a weight to volume basis, about 0.05% to 2.5% of a macrolide compound or mixture of macrolides; about 0.1% to 6% of a water soluble organic solvent; about 1% to 8% of a dispersing agent; about 10% to 50% of an adjuvant; at least one antigen; and saline or water or a mixture thereof.
Step 2:
The documents raised, in addition to those raised under Prior publication above, are:
CAB Abstracts and BIOSIS Abstracts of an article by Umehara et al in Revista Brasileria de Parasitologie Veterinaria (1993) Vol 2 No 2 141-144
These were said by the applicant to be available at Victoria University of Wellington Library before the earliest priority date. These abstracts disclose the concurrent but separate administration of a macrolide, doramectin, and a foot and mouth disease vaccine. However, the macrolide and the vaccine are administered separately but at the same time. The patentee alleges the full Umehara document states that they are applied to opposite sides of the animal’s neck. The applicant states that the abstracts show that a combined composition is obvious and would be obvious to achieve. There is nothing in the documents teaching how macrolide and antigen can be mixed to make a stable composition. The simultaneous administration of two actives, especially if carried out at different sides of the neck of the animal, cannot be said to be the administration of a combination of the two actives with all the possibilities of interactions and interferences that such a combination could entail. The documents, in fact, point to the market need for such a combination, but do not suggest how this may be formulated or that such a formulation is possible.
US patent specification 5262400; US patent 4199569 (equivalent to NZ Patent Specification 188460); and US patent 4310519 (equivalent to NZ Patent Specification 183847)
These documents were said to be available at the office from 7 January 1994, 23 May 1980 and March 1992, respectively.
These documents refer to novel avermectins or C-076 derivatives. The use of these compounds and the formulation of compositions containing them are only referred to very generally. The documents are not discussed in the applicant’s evidence.
Chapter 7 of Campbell “Ivermectin and Abamectin” (1989)
This document was available at AgResearch Library from 19 January 1990 and at other libraries in New Zealand. This document refers broadly to ivermectin formulations including modes of administration. There is no disclosure of a combination formulation with a macrolide anthelmintic or with any other active.
NZ Patent Specification 186851 and NZ Patent Specification 186852
These documents were available at the office from 14 December 1984 and 28 September 1984, respectively. These documents refer to novel macrolide compounds. Any use of these compounds and the formulation of compositions containing them are only referred to in general terms. Again, there is no disclosure of a combination formulation with a macrolide anthelmintic or with any other active.
NZ Patent Specification 248486
This document was available at the office from 26 July 1996. The document was not publicly available in New Zealand at the priority date of the claims and cannot be considered.
US patent 4606918
This document was available at the office from 7 January 1994 and refers to
compositions with antigens alone in a multiphase system.
There is no
combination of macrolide and antigen and the document is not referred to in
evidence.
.
US patent 4292307
This document was available at the office from 24 November 1981 and discloses clostridial vaccine formulations with a sorbent and a solvent. There is no reference to combination with anthelmintic, and specifically no reference to macrolide anthelmintic.
US Patent Specification 3579633
This document was available at the office from 24 July 1986. The document relates to a vaccine formulation containing antigenic material from at least two pathogenic clostridium species. There is present a mineral oil and emulsifiers. The document does not disclose the presence of any anthelmintic, particularly any water-insoluble macrolide anthelmintic. The document is not referred to in the applicant’s evidence.
GB patent specification 1171125
This document was available at the office from 14 October 1986 and relates to an injectable formulation with antigen in an oily medium. The document does not disclose any anthelmintic. The document is only referred to in Grayson 2 in discussing the effects of dispersing agents in formulations.
Step 3:
The difference from the prior art is a formulation that provides a stable and commercially viable composition containing macrolide and antigen in one composition. There is a combination of water-insoluble macrolide and antigen, and a low proportion of dispersing agent and water-soluble organic solvent and high proportion of adjuvant. Such a formulation is not what one would expect from the prior art cited.
Step 4:
The evidence shows that at the priority date of the claims there was a long felt want that had existed over a number of years for a stable combination of macrolide and antigen enabling these two types of agent to be applied at one time in a single composition. This long felt want had not been satisfied until the composition of the present patent appeared. The evidence shows that the applicant was unsuccessful in its attempts to make such a composition. The composition of the patent has been shown in evidence to be commercially successful.
The macrolide is not water-soluble, but when dissolved in an organic solvent and ‘wetted’ with a dispersing agent it forms part of a stable veterinary formulation. The vaccine component is combined with a substantial amount of adjuvant and suspended in the macrolide solution. The composition is said to be highly effective in controlling both internal and external parasites of all kinds. It is also said to protect livestock from many common infectious diseases. With just one injection a farmer can protect animals from a large number of pests and diseases.
Cobb gives what I find to be a convincing and detailed background to the inventive process by which the formulation was developed. The patentee points out that evidence from one of the inventors of the circumstances in which the invention was made is highly relevant: SKM v Wagner-Spraytech and Ors [1982] RPC 497 at 505 and 508. At 505 is the following:
This represents the first step in Mr Gratwick’s argument and he draws attention to the following passage from the judgment of Farwell J in Howaldt v Cordrup Ltd (1937) 54 RPC 133:
After all, in any case of this kind, if I may use a homely adage, the proof of the pudding is in the eating, and, when I find that the person who has made the invention, himself being a person skilled in the art (emphasis added) has had to take time and make experiments before he arrived at the solution, that it is a solution which has apparently been sought for many years by various persons and has not been arrived at ... then I think in the light of that evidence that prima facie view which one might take of this matter must be displaced and I ought to come to the conclusion ... that on the whole there is sufficient here to support the patent.
The patentee says that the use of a water-insoluble macrolide indicates that higher levels of dispersing agent would be needed to solubilise it. The presence of the vaccine component of the formulation, on the other hand, indicated that dispersing agents should be avoided or minimised because of their denaturing or disrupting the antigens of the vaccine component. Lowering the dispersing agent was a problem as at lower levels of dispersing agent the macrolide would tend to come out of solution, with associated problems of administration. The patentee says that the present composition enables the macrolide component to be solubilised in water and the vaccine composition to be stable in the presence of a dispersing agent. In addition, the present composition can be stored for prolonged periods without loss of antigen and macrolide potency.
The patentee says the reason for the stabilising effects is not completely understood, however the patentee has produced a successful formulation in spite of the foregoing conflicts presented by the combination of water-insoluble macrolide and water-soluble antigen. As far as I can see, none of the prior art suggests that the patentee’s invention is an obvious answer to the problem. The obvious answer, the mere combination of the two separate component formulations did not work. The addition of solvents and dispersing agents in the amounts taught by the prior art did not work. This is evidenced by the patentee, by the applicant in their unsuccessful attempts to create a combination formulation in this way, and by the non-availability of such a product on the market at the priority date of the present claims.
Whilst an amount of dispersing agent below 8% is required of the patentee’s formulation, the patentee points out that this is not the sole crucial element. The formulation, to be successful, requires a combination of other components with relatively narrow percentage ranges. For example, the organic solvent has to be low, ie 0.1 to 6%. This low level of organic solvent is said to be particularly surprising since, ordinarily, lower amounts of dispersing agents would require the use of larger amounts of organic solvents to keep the macrolide in solution. The patentee says that the lower levels of dispersing agent in relation to macrolide component was in itself counterintuitive.
The patentee referred to the question posed in the CIPA Guide, 4th edition, at paragraph 3.09:
... those seeking to invalidate a patent on the ground of alleged obviousness should have a credible answer to the question: if obvious, why was it not done before?
and from Lucas v Gaedor [1978] RPC 297:
The question of obviousness is probably best tested, if this be possible, by the guidance given by contemporaneous events... If an invention has resulted in the solution of a problem which has been troubling industry for years and achieves immediate success upon its introduction, then the suggestion after the event that the step was obvious inevitable rings a little hollow.
and from Samuel Parkes v Cocker Bros (1929) 46 RPC 241:
When it has been found that the problem had awaited solution for many years and that the device is in fact novel and superior to what had gone before and has been widely used and indeed in preference to alternative devices, it is practically impossible to say that there is not present that scintilla of invention necessary to support the patent.
This is especially pertinent since the document relied upon as the closest prior art, NZ 197796 has a filing date in 1981 and the patent in suit a filing date in 1996, 15 years later.
Harvey 1 states that the present invention is identical to the formulation in NZ 197796 without the vaccine and the inclusion of a substrate. Clearly, Harvey 1 is wrong on this, and particularly bearing in mind the construction that is to be put on the contents of publications. In spite of the assertions that the invention is obvious Harvey 1 shows that workers at Grayson Laboratories were unable to produce, for Harvey, a stable combination of macrolide and vaccine and certainly did not produce any formulation that is the same as in the patent in suit. Harvey 1’s appraisal of the patent in suit appears to me to be largely based on hindsight. Harvey 1 does not give any convincing evidence for me to conclude that the invention claimed in the patent in suit is obvious and clearly lacking an inventive step.
Grayson 1 does not appear to show that the invention would be obvious. It appears to view the invention as mere admixture and the component parts and their amounts in the formulation as being obvious to use. In the final paragraph it says that the invention is a combination formulation including a macrolide and a vaccine that is a simple mixture of available products, an obvious thing to do, and then adjust the pH to between 6 and 7, the optimal pH for the antigen. It does not give any convincing evidence in support for me to conclude that the invention is as it is described and claimed is obvious and clearly lacking an inventive step.
I prefer the evidence of the patentee’s experts rather than those of the applicant. The patentee’s experts, particularly Cobb and Glidden, appear to be experienced workers in the present technology. On the papers before me, the experts of the applicant, Harvey and Grayson, appear to be largely managerial in terms of the present technology. The attempts by the applicant to produce a combination macrolide and antigen formulation appears to have been initiated by Harvey asking the Grayson Laboratories to produce a combination based on the long felt want. However the actual experimentation appears to have been the work of two employees of Grayson Laboratories. Although the results were then sent for the attention of Harvey there is no evidence as to what, if any, consideration in any technical sense he gave to them. Thus the only clearly expert evidence is that of the patentee.
The patentee says the applicant is using hindsight to attack the patent. I agree. I agree with the patentee when it says that in the tables produced by the applicant to show how the compositions of the prior art and those of the patent can overlap, the applicant has to take the lowest possible figures for component ranges in the prior art to enable a fit to be made with the upper figures for component ranges in the patent. This indicates quite clearly the hindsight approach of the applicant. I note that the patentee was able to make other valid criticisms of such attempts to show overlapping of ranges which nullified or minimised the value of those attempts.
I have considered all evidence. There is nothing in the evidence of the applicant to show me that the present invention would be merely obvious to, and not require any degree of invention of, the skilled but unimaginative addressee in the art based on the documents cited as published at the priority date of the claims. On the other hand the patentee appears to have overcome difficulties of formulation relating to the production of a stable and effective combination of a water-insoluble macrolide and a water-soluble antigen. The patentee appears also to have had to disregard some expectations prevailing at the priority date as to which ingredients and combinations of ingredients would be useful or which ingredients or combinations needed to be avoided in the formulation of such a composition. These expectations included that a larger amount of dispersing agent would be necessary to solubilise the macrolide anthelmintic; and that lowering the amount of dispersing agent would mean that the organic solvent would need to be increased to compensate for this in order to dissolve the macrolide and prevent its crystallisation from solution. The patentee would also be unaware of interactions or possible interactions between the component parts of any particular formulation, particularly of any effects that would impact on efficacy or stability of the actives.
The applicant drew on the approach referred to in Ashmont Holdings Limited’s Application No 286752/299093 (Decisions of the Commissioner, P19/2003, 16 September 2003) at 24:
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 a try”.
The answer to this question is “yes”. This is agreed by the parties. What is not obvious is the choice of components and their specific proportions necessary to form a stable and commercially effective combined formulation. A stable and commercially effective combined formulation was an unsatisfied long felt want at the priority date. It has not been shown, at least not to my satisfaction, that these components and their specific proportions would have been obvious to the skilled person at the priority date from the cited publications.
The patentee has merely to describe the invention, not explain how it works. The fact that a patentee may not be able to explain how the invention works, or be able to explain the interrelationships between the components and their ranges, is not relevant to the proceedings.
I can only come to the conclusion that obviousness has not been proved . In any event I must give the benefit of any doubt to the patentee (in revocation proceedings), however, there appears to me to be no doubt.
The ground is not 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
The applicant had intended to rely on the understanding that since in its view the invention claimed in the present patent was obvious, then, there was no invention. I have found that the claimed invention is not obvious so that the ground is not made out.
In addition, I have found that the invention claimed is not prior published, not prior claimed, and not prior used. I can see nothing else to show that the invention claimed is not an invention.
The ground is not made out.
NOT SUFFICIENTLY AND FAIRLY DESCRIBED - 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
This ground was not pursued at the hearing. It also is my view from reading the specification that the skilled addressee would be able to follow the instructions of the specification to perform the invention claimed.
The ground is not made out.
DECISION
I find that none of the grounds has been made out. The application for revocation fails. I direct that the new pages supplied be inserted in the specification..
COSTS
Since amendment of the patent has been made, limiting the scope of the claimed invention, I have decided that each party is to meet its own costs.
Dated this 14th day of June 2004
____________________________
A Hazlewood
Assistant Commissioner of
Patents
Baldwin Shelston Waters for the Patentee
Pipers for the Applicant
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URL: http://www.nzlii.org/nz/cases/NZIPOPAT/2004/15.html