Intellectual Property Office of New Zealand - Patents Decisions
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Last Updated: 7 October 2014
IN THE INTELLECTUAL PROPERTY OFFICE OF NEW
ZEALAND
[2014] NZIPOPAT 20
IN THE MATTER of the Patents Act 1953
AND
IN THE MATTER of Letters Patent No 556537 in the name of Norbrook Laboratories Limited
Patentee
AND
IN THE MATTER of an application for revocation of said patent under section 42 by Merial Limited
Applicant for Revocation
Hearing: 5 June
2014
A Brown QC and M Caine for the Patentee
Dr J Landells and M
Caulfield for the Applicant for Revocation
DECISION OF AN ASSISTANT
COMMISSIONER OF PATENTS
Locus standi
The onus of proof
At any time within 12 months after the sealing of a patent, any person
interested who did not oppose the grant of the patent may apply
to the
Commissioner for an order revoking the patent on any one or more of the grounds
upon which the grant of the patent could have
been opposed
provided that the Commissioner shall not make an order for the unconditional
revocation of a patent under this section unless the
circumstances are such as
would have justified him in refusing to grant the patent in proceedings under
section
21.
[10] [Opposition proceedings] are designed to clear the Register of patents which are manifestly untenable. They are not intended to provide a method of disposing of truly contentious cases - General Electric Co (Coxs) Patents [1977] RPC 421 at 437. If there is a conflict of credible evidence, the Commissioner should not refuse the grant of a patent unless the conflict is clearly resolved in favour of the party opposing the grant [General Electric Co’s Applications [1964] RPC 413 (CA) at 453; Beecham Group Ltd v Bristol-Myers Co (No 2) [1979] NZCA 64; 1979 NZLR 629 (SC)]. At the examination stage, the application should be allowed to proceed unless on no reasonable view can it be regarded as meeting the requirements of the Act.
[11] The onus on the opponent has been explained by reference to the interests of justice and the concern that, except in a clear case, the applicant should not be denied the opportunity of propounding the patent in revocation proceedings. The following passage from the judgment of Buckley LJ in Dunlop Holdings Ltd’s Application 1979] RPC 523 at 544-545 is often quoted:
It is a peculiar feature of opposition proceedings that, if opposition fails, the opponents are not at the end of the road; they still have an opportunity, at a later date, to defeat the objective of the applicants in a revocation action under section 32 [New Zealand section 41] of the Act in High Court proceedings, with all the features of pleadings, discovery, oral evidence including cross-examination, appertaining to a High Court action. It has been frequently said that opposition proceedings are a device for weeding out patent applications which obviously could not survive a revocation action. This peculiar feature of opposition proceedings may, it seems to me, have a bearing upon the degree of certitude which the Comptroller should feel in opposition proceedings, but it remains true that the standard of proof is the civil standard and not the criminal standard.
...
lf on the assessment of all the evidence adduced, regarded in the light of the civil standard of proof, the tribunal were to reach the conclusion that, if the application for a patent were dismissed, there would be a real risk that an injustice might be done by depriving the applicant of any opportunity to protect his right to the patent in a full scale revocation action in the High Court, it seems to me at least arguable that special weight should be given to that consideration by the tribunal hearing the opposition proceedings in considering what degree of certainty it should have in relation to the alleged grounds of opposition. It is for the tribunal hearing the opposition proceedings to determine, on the balance of probabilities, what degree of risk of that kind there is. I would think that that would be one of the circumstances that it would be proper for the tribunal to take into account in considering whether, on the balance of probabilities, the opponents had succeeded in making out their case.
[12] More succinctly, Buckley LJ said in General Electric Co’s Applications:
It seems to me that the test can be stated, perhaps more simply, in these terms: ls it clear on the evidence before the Comptroller that, if the issues of obviousness (assuming that to be the ground relied on) were fought out in a full scale revocation action, the claims would be held bad for obviousness? If the answer is affirmative, then it is right that the patent should be killed in its infancy. If the answer is negative, the patentee should not be deprived of his patent without the protection of a full scale action. In other words, section 33, like section 14, is designed to clear the register of patents which are manifestly untenable. It is not intended to provide a method of disposing of truly contentious cases.
[14] I propose to approach the appeal on the basis which appealed to Barker J in Beecham Group Ltd v Bristol-Myers Co (No 2):
I shall ask myself the questions in respect of each ground of opposition; is
the claim to the patent in suit “manifestly untenable”?
Is there a
prima facie case for the grant of the patent? Does the justice of the case
require the applicant to be permitted to resist
the claim for invalidity in
properly constituted revocation proceedings? All these tests, although
differently stated really amount
to the same thing.
... whilst the overall onus to prove obviousness or anticipation in
opposition proceedings rests on the opponent, that onus may shift,
if on a
consideration of the documents alone and without the necessity for
cross-examination to resolve any conflict, the opponent
makes out a prima facie
case, on the balance of probabilities. In that event, the applicant may then
bear the onus to rebut this
conclusion. ....
... look at the evidence filed on behalf of the applicants and the opponents
in order to see (1) whether the opponents’ evidence
read by itself clearly
establishes the opponents’ case, and, if so, (2) whether the
applicants’ evidence in reply raises
any bone fide conflict of fact or
expert opinion on a question the answer to which the opponents’ case
depends.
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.
Here, the examiner expressly recognised that it was a close case - that is,
it was, on his analysis, finely balanced. His observation
is an implicit
acknowledgement of the division within the extensive body of expert evidence
lodged before the commissioner. That
evidence was directed towards the nature of
the skilled addressee, the body of knowledge which he would possess and the way
in which
such a skilled man would approach problems. Self-evidently, that
conflict could not be resolved without a contested hearing, where
the evidence
was tested through the orthodox means of cross-examination, unless of course the
collective weight of one view was so
patently wrong that it should be dismissed
at a preliminary stage. There was no basis upon which the examiner could reach
such a
definitive conclusion, and so he was wrong to call it a close
case.
Evidence
Damian SLIZYS, Melbourne, Victoria, Australia, a New Zealand Patent Attorney and a Partner of FB Rice & Co, declared on 16 January 2013.
Marilyn DOMNEY, Wellington, New Zealand, a Business Information Specialist employed by Wellington City Libraries, declared on 30 March 2011 (Domney 1).
Marilyn DOMNEY, declared on 12 September 2012 (Domney 2).
Stephen W PAGE, Newtown, New South Wales, Australia, a consultant specialising in the area of livestock pharmacology and, in particular, consulting on the use of veterinary medicines in livestock animals, such as sheep, beef and dairy cattle, goats, and horses and in companion species such as dogs and cats, declared on 8 February 2013 (Page 1).
Marilyn DOMNEY, declared and signed but undated (Domney 3).
Ian Stanley PASCARL, Melbourne, Victoria, Australia, a Partner of Davies Collison Cave Law and Davies Collison Cave, declared on 2 August 2013.
Craig BUNT, Christchurch, New Zealand, a Senior Lecturer in Animal Science at Lincoln University, New Zealand, declared on 27 September 2013 (Bunt 1).
Craig BUNT, a Statutory Declaration filed in Australian opposition proceedings in relation to Australian Patent Application No 2006207326 and included as Annexure CB-10 to Bunt 1 above (Bunt 2).
Stephen W PAGE, declared on 3 March 2014 (Page 2).
John Simon LANDELLS, a registered New Zealand Patent Attorney and
Senior Associate of FB Rice & Co, declared on 4 March 2014.
Nature
of the invention
Anthelmintic Compositions
Field of the Invention
This invention relates to a composition displaying efficacy against infections of Fasciola hepatica, Ostertagia ostertagi and Cooperia oncophora in susceptible ruminants, especially cattle.
Background of the Invention
Infections of Fasciola hepatica, Ostertagia ostertagi and Cooperia oncophora in livestock are problematic, and in particular first season grazing cattle can be susceptible in contaminated pastures. Injection solutions containing ivermectin and clorsulon are known in the industry for use in treating beef and non-lactating cattle.
Clorsulon is a compound belonging to the benzenesulphonamide (benzenesulfonamide -USA) family which is recommended for control of adult liver flukes (Fasciola hepatica and Fasqiola gigantica) in cattle as suspensions for oral use or in injectable formulations for subcutaneous administrations. The oral recommended level is 7 mg/kg body weight (bw) and the subcutaneous level 2mg/kg bw. Currently, there is no known topical formulation, and this is likely to be due to foreseeable difficulties in achieving adequate penetration of the skin by clorsulon.
An objective of the invention is to provide a topical formulation which is effective against the aforesaid infections, preferably presented as a pour-on formulation. A further object of the invention is provide a composition comprising at least one effective agent derived from Streptomyces avermitilis, i.e. a macrocylic lactone or chemically modified or synthetic derivative thereof together with another anthelmintic of the sulphonamide type. Another objective of the invention is to provide a composition suitable for the treatment of immature Fasciola hepatica.
With this objective in mind, a study was conducted to determine the feasibility of producing a topical formulation containing known agents already recognised in the field in other delivery forms, e.g. injections, as offering efficacy against infections of Fasciola hepatica (Adult), Ostertagia ostertagi (Adult) and Cooperia oncophora (Adult) in cattle.
The new formulation under consideration for the purposes of this study would include at least one anthelmintic compound of the disulphonamide type, e.g. clorsulon, a member of the benzenesulphonamide family (CAS.No. 60200-06-84; Amino-6-(trichloroethenyl)-1,3-benzene-disulfonamide), and an avermectin suitable for the treatment of immature Fasciola hepatica e.g. ivermectin, a mixture of semi-synthetic macrocyclic lactones (CAS.No. 70288-86-7; “22, 23-dihydro-C076B” a mixture of 80% ivermectin component B1a (5-O-demethyl-22,23-dihydroavermectin A1a) and 20% ivermectin component B1b (5-O-demethyl-35-de(l-methylpropyl)-22,23-dihydro-35-(1-methylethyl)avermectin A1a)).
This study followed an authorised protocol in accordance with recognised industry practice, at an accredited animal facility of Norbrook Laboratories Limited, Research Division, upon healthy male calves of European bovine stock.
During the study each animal was infected with 500 metacercariae of Fasciola hepatica, 10000 Ostertagia ostertagi larvae and 10000 Cooperia oncophora larvae. At 79 days following the administration of Fasciola hepatica and 32 days following administration of Ostertagia ostertagi and Cooperia oncophora the animals were treated with a pour-on formulation newly developed by Norbrook Laboratories Limited, comprising ivermectin and clorsulon. Approximately 3 weeks following treatment all animals were slaughtered and livers, abomasums and small intestines removed. These organs were processed to allow enumeration of helminths contained in each.
The calves used in the study were all healthy at selection and throughout the study period. The tested pour-on product was well tolerated in cattle and no adverse reactions to treatment were observed during the course of the study.
Enumeration of Fasciola hepatica, Ostertagia ostertagi and Cooperia oncophora burdens after slaughter and comparison to those of the untreated control group confirmed an efficacy of > 90% for each parasite and therefore it can be concluded that the tested pour~on product is effective in the treatment of adult FascioIa hepatica, adult Ostertagia ostertagi and adult Cooperia oncophora infections in cattle.
The efficacy of the tested pour-on product, in this instance comprising ivermectin and clorsulon, against induced infections of adult Fasciola hepatica, adult Ostertagia oslertagi and adult Cooperia oncophora cattle following topical administration at a nominal dose rate of 500 µg ivermectin and 5mg clorsulon per kg bodyweight was recognised.
Summary of the invention
Accordingly, the present invention provides a hitherto unavailable topical formulation comprising as active ingredients, at least one effective agent derived from Streptomyces avermitilis, i.e. a macrocylic lactone e.g. an avermectin or chemically modified or synthetic derivative thereof, e.g. ivermectin, together with another anthelmintic of the sulphonamide type, e.g. clorsulon, in a carrier that facilitates topical administration and delivery of the active ingredients transdermally. The carrier comprises alcoholic solvents, with optional excipients and formulation aids, which may comprise a polymeric species such as PVP or a poloxamer. In preferred form, a pour-on formulation is provided containing clorsulon and ivermectin. The alcoholic solvents comprise at least 30% (v/v) of ethanol, together with isopropanol to make the formulation up to 100%.
An embodiment of such a formulation of this invention is:
ivermectin 0.5% (w/v) Clorsulon 5.0% (w/v)
Ethanol 30% v/v PEG200 10% v/v
Crodamol Cap 20% v/v IPA (isopropanol) to 100% v/v
Brilliant Blue Dye 0.01 %(w/v) Denatonium Benzoate 0.001 %(w/v)
The nominal dose rate thereof is 500 µg ivermectin and 5mg clorsulon per kg bodyweight.
The invention also provides a topical anthelmintic formulation including, as active ingredients, a therapeutically effective amount of at least one anthelmintic agent derived from Streptomyces avermitilis, with a therapeutically effective amount of at least one other anthelmintic of the sulphonamide type, in an alcoholic solvent-based carrier suitable for topical administration and delivery of the active ingredients transdermally, said carrier including at least 30% (v/v) of ethanol together with isopropanol quantity sufficient to 100%.
Preferably the formulation is presented as a pour-on.
Preferably the formulation includes an avermectin. In a further preferred form the formulation includes ivermectin. In a highly preferred form both.
Preferably the anthelmintic of the sulphonamide type is clorsulon. A highly preferred form of the formulation includes clorsulon and ivermectin.
Preferably the formulation has an efficacy such that, when applied to the skin of an animal infected by F. hepatica, at least 90% of the mature F. hepatica are killed.
Preferably the therapeutically effective amount for cattle of clorsulon is at least 5% (w/v). Preferably the dosage rate is controlled to provide about 500µg ivermectin and 5mg/kg of clorsulon.
Preferably the carrier includes a polymeric species.
Preferably in use the formulation provides at least 2µg of a benzenesulphonamide per ml of blood plasma.
A highly preferred formulation for use on cattle, presented as a pour-on includes:
Ivermectin 0.5% (w/v) Clorsulon 5.0% (w/v)
Ethanol 30% v/v PEG200 10% v/v
Crodamol Cap 20% v/v IPA (isopropanol) to 100% v/v
Brilliant Blue Dye 0.0l%(w/v) Denatonium Benzoate 0.001 %(w/v)
Preferably the formulation includes at least one excipient and/or formulation
aid.
Ivermectin 0.5% (w/v) Clorsulon 5.0% (w/v)
Ethanol 30% v/v PEG200 10% v/v
Crodamol Cap 20% v/v IPA (isopropanol) to 100% v/v
Brilliant Blue Dye 0.0l%(w/v) Denatonium Benzoate 0.001 %(w/v
Priority date
2.2 The Opponent alleges that none of the claims are entitled to a priority date of 21 January 2005 and puts the Applicant to proof that they are so entitled.
2.3 The Opponent submits that the specification at page 2, lines 20 to 26 and 28 to 32 of the priority document does not provide priority basis for the features of claim 1 of the patent as granted. In particular, the only disclosure of the percentage ethanol and isopropanol is in the context of the specific embodiment at the bottom of page 2 of the priority document, which discloses that:
"An embodiment of such a formulation of this invention is:
Ivermectin 0.5% (w/v) Clorsulon 5.0% (w/v)
Ethanol 30% (v/v) PEG200 10% (v/v)
Crodamol Cap 20 % (v/v) IPA(isopropanol) to 100 % v/v
Brilliant Blue Dye 0.01% (w/v) Denatonium Benzoate 0.001% (w/v)"
2.4 Thus, aside from this particular embodiment, there is no disclosure that the formulations of the patent in general contain 30 % ethanol (v/v). In other words, the "30 % ethanol" feature is not disclosed anywhere other than in combination with the above-specified components, in the defined amounts.
2.5 Moreover, claim 1 refers to an alcoholic solvent based carrier comprising "at least 30% ethanol", whereas the priority document only discloses a specific embodiment containing 30% (v/v) ethanol, i.e. there is no disclosure anywhere in the priority document of formulations containing greater than 30 % ethanol.
[Emphasis added by Applicant for Revocation]
It seems to me that there is a three-fold investigation which is called for.
Firstly one has to enquire whether the alleged invention as claimed can be
said to have been broadly described in the provisional
specification, and
only if an affirmative answer is given to that question does one proceed to the
second question, which is: Is there anything in the provisional specification
which is inconsistent with the alleged invention as claimed? If it is found,
upon examination, that the invention as characterised in the claim includes
something which is inconsistent with
that which is described in the provisional
specification, as at present advised I should think that it would be right to
conclude
that that claim could not have been fairly based upon the disclosure;
but, assuming that those two burdens are satisfactorily surmounted,
there is, I
think, a third matter for enquiry: Does the claim include as a characteristic
of the invention a feature as to which the provisional specification is wholly
silent? It is with those approaches which I have indicated that I have to
consider the submissions which have been made to me in the present
case.
[Emphasis added]
Accordingly, the present invention provides a hitherto unavailable topical formulation comprising as active ingredients, at least one effective agent derived from Streptomyces avermitilis, i.e. a macrocylic lactone e.g. an avermectin or chemically modified or synthetic derivative thereof, e.g. ivermectin, together with another anthelmintic of the sulphonamide type, e.g. clorsulon, in a carrier that facilitates topical administration and delivery of the active ingredients transdermally. A carrier that is useful for this purpose comprises alcoholic solvents with optional excipients and formulation aids. In preferred form, pour-on formulation is provided containing clorsulon and ivermectin.
An embodiment of such a formulation of this invention is:
Ivermectin 0.5% (w/v) Clorsulon 5.0% (w/v)
Ethanol 30% v/v PEG200 10% v/v
Crodamol Cap 20% v/v IPA (isopropanol) to 100% v/v
Brilliant Blue Dye 0.01% (w/v) Denatonium Benzoate 0.001% (w/v)
The second amended Application for Revocation
and first amended Statement of Case
In support of this request it is submitted that the prior art documents of
lvomec-F and lvomec Pour-On were extensively relied upon
as ”published
documents" in the evidence filed by the Opponent, for example at paragraphs 28,
29, 34 and 35, of the First Page
New Zealand Declaration dated 8 February 2013,
extensively addressed in the Patentee's evidence in support, for example at
paragraphs
34 to 45 in the Second Bunt New Zealand Declaration dated 27
September 2013, and again extensively relied upon as published prior
art in the
Opponent's evidence in reply, for example the Second Page New Zealand
Declaration dated 3 March 2014 and the Landells
Declaration dated 4 March 2014
(including Exhibits JSL-1 to JSL-4). Further, the written submissions filed by
the Opponent, which
were made available to the attorneys and counsel for the
Patentee earlier in the week before the hearing, clearly relied upon these
prior
published documents as "published" documents under the first limb of the Section
21(e) ground. It is also pointed out that
the attorneys for the Patentee have
been fully aware of these two prior art documents as published documents in the
counterpart Australian
opposition. It is therefore submitted that the Patentee
has been able to fully address these two documents, and it would be in the
public interest not to restrict the Assistant Commissioner in the consideration
of the evidence under both limbs of Section 21(e).
(1) In any proceedings before the Commissioner, if he thinks fit,—
(a) any document filed in the proceedings for the amendment of which no express provision is made in the Act or these regulations may be amended during the course of the proceedings:
(b) any irregularity in procedure may be rectified.
(2) Any approval given by the Commissioner under this section may be on such terms as he may direct, including, if he thinks fit, the payment of a fee not exceeding $50.
... The issues must be adequately defined by the Statement and
Counter-statement, and not left to be made clear by the declarations
filed at a
later stage. ...
Additions and alterations to the opponent’s case, not needing amendment to the notice of opposition, should be made the subject of a supplementary statement of case. There is an old-established practice of taking such altered or additional grounds into consideration without amendment of the statement, where they are adequately raised by the evidence, but this is wrong—the parties ought not to raise matters not pleaded. Leave to raise new matter at the hearing is apt to be refused, if the hearing will be adjourned in consequence.
[Emphasis added]
It is of the utmost importance that documents required by the Rules to be
filed in cases such as the present [i.e. opposition proceedings]
should be as
clear and as explicit as is reasonably possible and that no submission or
argument should be presented or considered
which is inconsistent with their
plain meaning. The strong aversion shared by the Patent Office and parties to
adjournments of fixed
hearings, with its accompaniment of delay, expense and
wasted effort, should not be permitted to excuse non-observance of the essential
requirements that the issues to be debated should be adequately and formally
defined.
Obviousness: Ground (e) This ground has two separate and 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 paragraph. It should be noted that
the term
“common general knowledge" is not mentioned in the section, and is
consequently not a ground of opposition. What is,
or is not, common general
knowledge is a matter for the evidence stages of the pleadings. See Benz
Ltd’s Application [1958] R.P.C. 78 at 79.
...
[Emphasis in original]
[Emphasis added]
Prior publication – section 21(1)(b)
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):
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 claims 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.
The test for prior publication is the “reverse infringement”
test. That is to say, the test is to consider the document
relied upon as
constituting prior publication, and to determine whether that clearly (a)
describes something that would infringe
the claim, or (b) instructs something to
be done or made which would infringe the claim, or (c) gives directions, the
carrying out
of which would inevitably result in infringement of the patent
applied for. The test is described by Sachs LJ (delivering the judgment
of the
Court) in General Tire & Rubber Company v The
Firestone Tyre and Rubber Company Limited and Others [1972] RPC 457 at
485-486, in these terms ...
The invention relates to a veterinary composition and in particular one that
enables the incorporation of both hydrophilic and lipophilic
drugs. In a first
aspect the invention relates to a stable composition including at least one
hydrophilic active and medium chain
mono- and di-glycerides. Preferably the
composition additionally includes at least one lipophilic active. Preferably the
composition
additionally includes at least one of a surfactant, solvent and a
carrier. Preferably the hydrophilic is selected from the group
including
clorsulon, closantel, vaccine solution, sodium selenate, vitamin B12, and other
hydrophilic anthelmintics and mineral salts.
More preferably the lipophilic
active is selected from the group including macrocyclic lactones, including
avermectins and milbemycins.
More preferably the organic solvent is selected from the group including
benzyl alcohol, polyethylene glycol (PEG), propylene glycol,
alcohol including
isopropyl, amyl and benzyl, 2-pyrollidone, N-methyl pyrollidone, tetraglycol,
dimethyl sulphoxide, xylene, petroleum
distillate, aromatic hydrocarbons,
dipropylene glycol methyl ether, diethylene glycol monobutyl ether, dioxolans,
glycerol formal,
glycofurol, dimethylacetamide, N-(B-hydroxyethyl)-lactamide,
ethyl lactate, glycerin, 1,3-Butylene glycol and other pharmaceutically
acceptable excipients. Most preferably said organic solvent may be benzyl
alcohol.
I have undertaken the comparison requested In Annexure CB-9 and it is clear that the Razzak patent does not disclose all the features of the claims of the Australian patent. The Razzak patent does not disclose:
(a) a topical formulation comprising a combination of at least one anthelmintic derived from Streptomyces avermitillis, with at least one anthelmintic of the sulphonamide type.
(b) neither does It disclose a topical formulation comprising ethanol and isopropyl [sec] as the alcoholic solvents either alone or in combination; or
(c) in the proportions of at least 30% (v/v) ethanol together with an isopropanol quantity sufficient to 100%.
Obviousness – section 21(1)(e)
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), or having regard to
what was used in New Zealand before the
priority date of the applicant's
claim:
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 ... 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 word ‘obvious’ in [united Kingdom] section 3 is I believe
directed to whether or not an advance is technically or
practically obvious and
not to whether it is commercially obvious. Although the law is encapsulated in
section 3 of the [United Kingdom]
Patents Act 1977, the law on obviousness goes
back many hundreds of years. The basis of the law is that the public are
entitled to
manufacture that which has been published, in the sense of made
available to the public, with obvious modifications. By ‘obvious
modifications’ are meant that which technically or practically would be
obvious to the unimaginative skilled addressee in the
art. Such a skilled man
should be assured that his actions will not be covered by any monopoly granted
to another if he does that
which is part of the state of the art with
modifications which are workshop alterations or otherwise technically or
practically obvious
alterations. He does not and should not have to look further
and consider whether the step he is taking is obvious or not for commercial
reasons. The prize for a good commercial decision or idea is a head start on the
competition and not a monopoly for twenty years.
(b) Identify the relevant common general knowledge of that person;
The notional “normally skilled but unimaginative
addressee”
The issue of obviousness is to be judged from the viewpoint of a notional addressee. This, wraith-like legal creature who stalks the Reports of Patent Cases just as the “reasonable man” does the treatises at tort, is required to have numerous attributes:
(i) He is presumed to be a skilled technician, knowledgeable in the relevant literature, including patent specifications, but incapable of a “scintilla of invention" (see Technograph Printed Circuits Ltd v Mills & Rockley (Electronics) Ltd [I972] RPC 346, 355, per Lord Reid:
“To whom must the invention be obvious? It is not disputed that the hypothetical addressee is a skilled technician who is well acquainted with workshop technique and who has carefully read the relevant literature. He is supposed to have an unlimited capacity to assimilate the contents of, it may be scores of specifications but to be incapable of a scintilla of invention. When dealing with obviousness, unlike novelty, it is permissible to make a ‘mosaic’ out of the relevant documents, but it must be a mosaic which can be put together by an unimaginative man with no inventive capacity."
(ii) The notional addressee need not be an individual but may be a research team such as the teams employed by both the parties in this case. See Olin Mathieson Chemical Corporation v Biorex Laboratories Ltd [l970] RPC l57, l84, where Graham J said:
“At this stage it is most important to appreciate that the papers above referred to are only a very small part of the relevant prior art. It seems probable, as stated above, that they, together with a very large mass of other material, would certainly be produced and would be brought to the notice of a properly qualified and instructed research organisation engaged on the problem in question . . .”
(iii) lt is to be presumed that the notional addressee would seek advice on aspects with which he is not personally familiar. See Tetra Molectric Ltd v Japan Imports Ltd [1976] RPC 547, 583, per Buckley LJ in the Court of Appeal:
“He [referring to the notional skilled person] would not probably be himself expert in the techniques of piezo-electricity; but, having been put on the track, he should, l think, reasonably be expected to seek advice and assistance from an expert or experts in that field. lf he had done so, the evidence of the defendants’ experts, in my opinion, establishes that he would have been advised that the suggestion was definitely worth trying.“
(iv) It is presumed that the notional addressee believes what he finds in the documentation to be true. See May & Baker Ltd v Boots Pure Drug Co Ltd (1950) 67 RPC 23, 36, per Lord Normand:
‘lf it is sometimes convenient to say that the specification should be
read as it would be read by a qualified addressee, it
is as well to remember
that that is not a completely accurate statement, and that the addressee
postulated must be assumed to read
it with the will to believe what he finds set
down in it.”
I return to what I understand to be the crucial question. The problem, as
defined in the specification by the description of the object
of the patent, is
to minimise stretch or distortion in the luff area. The question, therefore, is
whether a skilled addressee, knowledgeable
in the art of sail design and
construction, aware of all the developments that had previously taken place,
considering the problem
at the priority date, 16 May 1983, would have found the
solution contained in the patent to be obvious. ...
The judge of obviousness is a notional addressee. This person is a skilled
technician in the art in question, knowledgeable in the
relevant literature
(including patent specifications and such material as would be discovered on
making a diligent search), but unimaginative
and with no inventive capacity;
Technograph Printed Circuits Ltd v Mills & Rockley (Electronics)
Ltd [1972] RPC 346, 355 per Lord Reid; Beecham Group Ltd v.
Bristol Myers Co (No.2) [1980] 192. Where the subject matter covers more
than one discipline, the notional addressee need not be an individual but may be
a research team. In this case such a team would include a toxicologist, chemist
and formulator. The Court must consider the whole
field of research and the
whole field of documents reasonably discoverable or generally known; Dow
Chemical Co. (Mildners’) Patent [1975] RPC 165.
... the test [for obviousness] 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. These propositions are helpfully expanded upon in the recent English
cases
which are still applicable though under the 1977 Act; see the
Windsurfing International case, Hallen Co v Brabantia (UK)
Ltd [1991] RPC 195 at p 211, and Molnlycke AB v Procter &
Gamble Ltd [1994] RPC 49 112
A point of contention is whether, if the skilled person were led to undertake a series of ‘trial and error’ tests which would give the result, the required inventive step would be absent. In Hickman v Andrews [1983] RPC 147 at p189, Goff LJ said:
There is another preliminary question and that is what the expert is supposed to be doing. It cannot be that he is to look at 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.
In Beecham Group Ltd's (Amoxycillin) Application [1980] RPC 261 at pp290-291 Buckley LJ said that it must be shown that the notional addressee would consider it worthwhile to try the step or process ‘in order to solve some recognised problem or meet some recognised need’. It should not be assumed that the uninventive expert will be engaged in attempting to discover something inventive. Similarly, the Court in Hallen Co (supra) said that the skilled man must be supposed to have tried everything that appeared to him to have a prospect of valuable results.
[Emphasis added by Mr Brown]
Fisher J identified all the relevant principles, albeit that he did not
specifically invoke the "worth a try" test, the utility of
which may well be
moot. It seems to add little to the technique of ascertaining obviousness.
Anything may be worth a try, depending
on acceptable cost for potential benefit,
but inventiveness may lie in deciding what to try. The crucial test is the
statutory expression
examined in terms of the orthodoxy of
Windsurfing.
The question of obviousness must be considered on the facts of each case. The court must consider the weight to be attached to any particular factor in the light of all the relevant circumstances. These may include such matters as the motive to find a solution to the problem the patent addressees, the number and extent of the possible avenues of research, the effort involved in pursuing them and the expectation of success.
[Emphasis added by Mr Brown]
Slight reflection suggests, we think, that there is usually an element of
'obviousness to try' in any research endeavor, that it is
not undertaken with
complete blindness but rather with some semblance of a chance of success, and
that patentability determinations
based on that as the test would not only be
contrary to statute but result in a marked deterioration of the entire patent
system
as an incentive to invest in those efforts and attempts which go by the
name of ‘research’.
The High Court also held in Astra (at [50]–[53]) that obviousness was to be determined by asking whether a hypothetical non-inventive skilled addressee, equipped with the common general knowledge as at the priority date, would have taken steps towards the invention “as a matter of routine” in the expectation that they might well produce the invention or some other useful result (endorsing statements in Wellcome Foundation Ltd v V.R. Laboratories (Aust) Pty Ltd (1981) 148 CLR 262 (Wellcome) at 286 and Olin Mathieson Chemical Corporation v Biorex Laboratories Limited [1970] RPC 157 (Olin) at 187-188). The High Court has therefore insisted on the two elements: (1) being led as a matter of routine to the desired result; and (2) having a reasonable expectation of achieving that result.
[Emphasis added]
... The claim is for a combination, the interaction between the integers of
which is the essential requirement for the presence of
an inventive step. It is
the selection of the integers out of "perhaps many possibilities" which must be
shown by Alphapharm to be
obvious, bearing in mind that the selection of the
integers in which the invention lies can be expected to be a process necessarily
involving rejection of other possible integers. ...
In In re O'Farrell [98], Judge Rich also said:
“The admonition that 'obvious to try' is not the standard under §103 has been directed mainly at two kinds of error. In some cases, what would have been 'obvious to try' would have been to vary all parameters or try each of numerous possible choices until one possibly arrived at a successful result, where the prior art gave either no indication of which parameters were critical or no direction as to which of many possible choices is likely to be successful. ... In others, what was 'obvious to try' was to explore a new technology or general approach that seemed to be a promising field of experimentation, where the prior art gave only general guidance as to the particular form of the claimed invention or how to achieve it."
The reasoning in these and other United States authorities
[99]
should be accepted in preference to the path apparently taken in the English
decisions, particularly after the 1977 UK Act, upon
which Alphapharm relied. The
United States decisions reflect an approach to the subject closer to that
adopted in Minnesota Mining and Wellcome Foundation.
That way of approaching the matter has an affinity with the reformulation of the "Cripps question" by Graham J in Olin Mathieson Chemical Corporation v Biorex Laboratories Ltd [57]. This Court had been referred to Olin in the argument in Wellcome Foundation [58]. Graham J had posed the question [59]:
"Would the notional research group at the relevant date, in all the circumstances, which include a knowledge of all the relevant prior art and of the facts of the nature and success of chlorpromazine, directly be led as a matter of course to try the -CF3 substitution in the '2' position in place of the -C1 atom in chlorpromazine or in any other body which, apart from the -CF3 substitution, has the other characteristics of the formula of claim 1, in the expectation that it might well produce a useful alternative to or better drug than chlorpromazine or a body useful for any other purpose?" (emphasis added)
That approach should be accepted.
The notional skilled
addressee(s) in the present case
The common general
knowledge
... It seems to me that another passage in the [General Tire and Rubber Company v Firestone Tyre & Rubber Company Limited 1972 RPC 457 at 43 sets] out the rationale for treating data as common general knowledge:
“As regards patent specifications it is the somewhat artificial 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 common-sense 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.”
This emphasises the difference between pleaded prior art and common general
knowledge. The court is trying to determine in a common
sense way how the
average skilled but non-inventive technician would have reacted to the pleaded
prior art if it had been put before
him in his work place or laboratory. The
common general knowledge is the technical background of the notional man in the
art against
which the prior art must be considered. This is not limited to
material he has memorised and has at the front of his mind. In includes
all that
material in the field he is working in which he knows exists, which he would
refer to as a matter of course if he cannot
remember it and which he understands
is generally regarded as sufficiently reliable to use as a foundation for
further work or to
help understand the pleaded prior art. This does not mean
that everything on the shelf which is capable of being referred to without
difficulty is common general knowledge nor does it mean that every word in a
common text book is either. In the case of standard
textbooks, it is likely that
all or most of the main text will be common general knowledge. In many cases
common general knowledge
will include or be reflected in readily available trade
literature which a man in the art would be expected to have at his elbow
and
regard as basic reliable information. ...
Page also says in paragraph 78 of his 10 August 2012 declaration and in a number of paragraphs in his 8 February 2013 declaration including at paragraphs 45, 46 and 47 that the combination of 30% ethanol together with lsopropanol to 100% is a trivial selection of a solvent mixture that a skilled person would derive through routine experimentation. I disagree with this comment. Although selection of an aliphatic alcohol in a solvent system is not unusual, the selection of two aliphatic alcohols as the solvent system for a pour-on formulation is atypical.
[Emphasis added]
The inventive concept
I think the [Windsurfing] test requires some restatement and elaboration. First one must actually conduct the first two operations in the opposite order—mantle first, then concept. For it is only through the eyes of the skilled man that one properly understand what such a man would understand the patentee to have meant and thereby set about identifying the concept.
Next, that first step actually involves two steps, identification of the attributes of the notional “person skilled in the art” (the statutory term) and second identification of the common general knowledge (cgk) of such a person.
What now becomes stage (2), identifying the inventive concept, also needs some elaboration. As I pointed out in Unilever Plc v Chefaro Proprietaries Ltd [1994] R.P.C. 567 at 580:
“It is the inventive concept of the claim in question which must be considered, not some generalised concept to be derived from the specification as a whole. Different claims can, and generally will, have different inventive concepts. The first stage of identification of the concept is likely to be a question of construction: what does the claim mean? It might be thought there is no second stage—the concept is what the claim covers and that is that. But that is too wooden and not what courts, applying Windsurfing stage one, have done. It is too wooden" because if one merely construes the claim one does not distinguish between portions which matter and portions which, although limitations on the ambit of the claim, do not. One is trying to identify the essence of the claim in this exercise.”
... the inventive concept (or solution to the problem as identified in the complete specification) provided by claim 1 is the use of an alcoholic solvent-based carrier comprising ethanol and isopropanol. Claim 1 also recites an additional parameter of "at least 30% v/v ethanol". It is submitted by the Opponent that this additional parameter is an arbitrary selection that does not provide any additional technical property, particularly in view of the evidence of the Opponent and as detailed further below. Consequently, the Opponent submits that the inventive concept does not encompass this additional arbitrary parameter and the inventive concept should be considered (at most) to essentially be a ‘topical anthelmintic formulation comprising a macrocyclic lactone (e.g. ivermectin) and a sulphonamide (clorsulon) in an alcoholic solvent carrier comprising ethanol and isopropanol'.
The inventive concept [of Claim 1] is the provision of a topical anthelmintic formulation effective for the treatment of infections of Fasciola hepatica, Ostertagia ostertagi and Cooperia oncophora in susceptible ruminants, the topical anthelmintic formulation comprising the combination of at least one anthelmintic agent derived from Streptomyces avermitilis, at least one anthelmintic of the sulphonamide type and an alcoholic solvent based carrier comprising at least 30% ethanol and isopropanol sufficient to 100%, the combination allowing the transdermal administration and delivery of the anthelmintic agents to the site of infection.
The inventive concept [of Claim 12] is the provision of a topical pour-on
anthelmintic formulation effective for the treatment of
infections of
Fasciola hepatica, Ostertagia ostertagi and Cooperia
oncophora in cattle, the topical pour-on anthelmintic formulation consisting
of 0.5% (w/v) ivermectin, 5.0% (w/v) clorsulon, 305 vlv ethanol,
10% v/v PEG200,
20% v/v Crodamol Cap, 0.01% (w/v) Brilliant Blue Dye, 0.001% (w/v) denatonium
benzoate and isopropanol to 100 % v/v,
the pour-on formulation allowing the
transdermal administration and delivery of the anthelmintic agents to the site
of infection.
Obviousness with regard to Prior Publication –
(first limb)
D1 European Patent Specification
No WO 0209764
D2 Baynes R E, “In vitro dermal disposition of
abamectin (abamectin B1) in livestock”, Research in Vet Science, 2004,
Vol
76, p 235-242.
D3 Clymer B et al,
“Persistance of the activity of topical ivermectin against biting lice
(Bovicola bovis)”, The Veterinary
Record, 1998, Vol 143, p
193-195.
D4 Page N et al,
“Observations on topical ivermectin in the treatment of otoacariosis,
cheyletillosis, and toxocariosis in cats”,
Can Vet J, 2000, Vol 41, p
773-776.
D5 Rolfe PF and Boray
JC, “Comparative efficiencuy of moxidectin, an ivermectin clorsulon
combination and closantel against
immature paramphistomes in cattle”
Australian Veterinary Journal, 1993, Vol 70 (7)
D6 Sibille P et al,
“Fasciola hepatica: influence of gender and liver biotransformations on
flukicide efficiency of rats infested
and cured with either
clorsulon/ivermectinor triclabedazole”, Experimental Parasitology, 2000,
Vol 24, p 227-236.
D7 Loyacano et al,
“Effects of parenteral administration of doramectin and clorsulon on
control of gastrointestinal nematode
and liver fluke infections and growth
performance in cattle”, JAVMA, 2001, Vol 218, No 9, p
1465-1468.
Objective—To compare effects of an injectable doramectin preparation with those of an injectable ivermectin-clorsulon preparation on control of gastrointestinal nematodes and liver flukes and on growth performance in cattle.
Design—Randomized complete block design.
Animals—60 crossbred calves.
Procedures—Calves (20/treatment group) were treated with doramectin or ivermectin-clorsulon or were not treated. Fecal samples were collected for nematode and Fasciola hepatica egg counts on day 0 and for up to 140 days after treatment. Cattle were weighed before treatment and at 28-day intervals until day 140.
Results—From day 7 through day 49, nematode egg counts for calves treated with doramectin or with ivermectin-clorsulon were significantly lower than those for untreated control calves. As the study progressed beyond day 56, the percentages of cattle with fluke eggs in their feces increased, but differences in regard to these percentages were not detected among the 3 groups. Average daily gain for the doramectin-treated cattle (0.79 kg/d [1.74 lb/d]) was significantly greater than that for the cattle treated with ivermectin-clorsuIon (0.71 kg/d [1.56 lb/d]); values for both groups were significantly greater than that for the control cattle (0.62 kg/d [1.37 lb/d]).
Conclusions and Clinical Relevance—Results suggest that
doramectin had a greater impact on subclinical gastrointestinal tract parasitism
in calves, as demonstrated
by growth performance, than did ivermectin-clorsulon.
In the Gulf Coast region of the United States, spring-born nursing beef calves
may have minimal grazing exposure to F hepatica during the peak fluke
transmission period; therefore, mature fluke burdens may be negligible at the
beginning of the fall season.
(J Am Vet Med Assoc 2001; 218:
1465-1468).
D8
Rehbein S and Visser M, “Efficiency of an injectable ivermectin/clorsulon
combination against Fasciola hepatica in sheep”,
The Veterinary Record,
(1999) 145, 468-469
D9 United
States Patent No 5 773 422
Novel formulations are disclosed for the administration of an avermectin,
based upon the use of N-methylpyrrolidone or 2-pyrrolidone
or mixtures thereof
to dissolve avermectin. Formulations can contain from 0.1 to 40% by weight
dissolved in at least 5% by volume
of N-methylpyrrolidone, 2-pyrrolidone or
mixture thereof. Various formulations are suitable for administration by
intramuscular or
subcutaneous injection, by topical application, stomach
intubation, oral and drench administration.
D10 European Patent Specification No
WO 0160380
A parasiticidal formulation is provided. This formulation includes a
pyrrolidone solvent, a bridging solvent, and a parasiticidal
agent. One or more
parasiticidal agents may be included in the formulation. Preferably, the
formulation contains both closantel and
ivermectin. Another aspect of the
present invention is a method of making this parasiticidal formulation. This
method includes mixing
a pyrrolidone solvent and a bridging solvent to form a
solvent solution and adding one or more parasiticidal agents to the solvent
solution. A further aspect of the present invention is a method for
administering the parasiticidal formulation of the present invention
to an
animal. This method of administration includes providing the parasiticidal
formulation described above and applying this formulation
to the skin of an
animal, wherein the formulation is absorbed through the animal's skin.
D11 European Patent Specification No EP
0125004
D12 United
States Patent specification No 2003040494
D13 WO
94/26113
D14 WO
0030449
A long-acting antiparasitic formulation suitable for topical application
including: (a) 0.1-50 % w/v an avermectin or milbemycin having
activity against
endo- and/or ectoparasites; (b) 1-50 % v/v a di(C2-4 glycol) mono(C1-4 alkyl)
ether; (c) an optional antioxidant;
and (d) an optional skin acceptable volatile
solvent q.s. v/v.
D15 WO
2004089239
This invention provides for inter alia, topical anthelmintic formulations
which comprise a pharmaceutically active combination consisting
of at least one
macrocyclic compound and at least one compound selected from the group
consisting of praziquantel, morantel and pyrantel,
which are dissolved in a
non-aqueous solvent or solvent mixture and optionally a thickening
agent.
... this document describes anthelmintic formulations comprising an
avermectin (an anthelmintic agent derived from Streptomyces avermitiis)
and a second anthelmintic which can be applied topically using a
solvent/co-solvent mixture as a carrier. The solvent and co-solvent
can be
selected from solvents including the alcohols isopropanol and ethanol. The
alleged invention differs to that described in
this document in that the second
anthelmintic of the combination is not one of the sulphonamide type (clorsulon).
...
D16 United States
patent specification No 20040151744
D17 Australian
patent specification No AU 199742110
D18 Coldman MF
et al, “Enhancement of Percutaneous Absorption by the use of Volatile
Non-volatile Systems as Vehicles”,
J Pharm Sci, 1969, Vol 58, p
1098-1102
D19 Chiu et al,
“Determination of ivermectin residue in animal tissues by high-performance
liquid chromatography-reverse isotope
dilution assay”, J Agric Food Chem,
1985, Vol 33, p 99-102
D20 WO
2005007241
An anti-parasiticidal composition presented as a topical 'pour-on' product
for treating animals infected by parasites which are known
to be susceptible to
salicylanilides, especially closantel, alone or together with at least one other
anti parasitic compound of
the avermectin or milbemycin type and offers enhanced
bioavailability of the salicylanilide by provision of a delivery system
comprising
at least 20%(v/v) of one or more alcohols, and optionally including a
polymeric moiety selected from the group consisting of polyvinylpyrrolidone
(PVP), polyoxypropylene/polyoxyethylene block copolymers (poloxamer), and
polyethylene glycols (PEG), thereby improving the bioavailability
of e.g.
closantel (as assessed with respect to blood plasma levels of
closantel).
... this document describes anthelmintic formulations comprising an
avermectin, and specifically ivermectin, (an anthelmintic agent
derived from
Streptomyces avermititis) and a second anthelmintic which are applied
topically using an alcoholic solvent-based carrier of 30% ethanol and
isopropanol quantity
sufficient to 100%. The alleged invention differs to that
described in this document in that the second anthelmintic of the combination
is
not one of the sulphonamide type (clorsulon). ...
The
differences between the cited published matter and the invention as claimed and
whether these differences constitute steps which
would have been obvious to a
"normally skilled but unimaginative addressee" in the appropriate art, armed
with the “common
general knowledge" in the appropriate art
One of the arguments advanced by Mr Silverleaf was that Raychem’s
patents were an exercise in what has become known amongst
patent lawyers as
parametritis. This is the practice of seeking to repentant the prior art by
limiting claims by reference to a series
of parameters which were not mentioned
in the prior art. Sometimes it includes reference to parameters measured on test
equipment
which did not exist at the time of the prior art. The attraction of
this to a patentee is that it may be impossible to prove now
that the prior art
inevitably exhibited the parameters and therefore it is impossible for an
opponent to prove anticipation. Even
if that is what has happened here, it does
not alter the task of the court. It must decide whether the opponent has proved
anticipation
or some other statutory ground of invalidity. Parametritis may make
the court’s task more difficult, but at the end of the
day the test of
invalidity must be the same, whatever the form of the claims.
... is essentially arbitrary and has little technical significance. The
selection of a group of compositions by reference to such
a parameter does not
involve any inventive step. Although it may not be obvious, in the common use of
that word, to limit a claim
by reference to this particular meaningless and
arbitrary parameter, that has nothing to do with patentability. Patents are not
given
for skill in inventing technically meaningless parameters. Many PTC
compositions having obviously desirable characteristics will
happen to fall
within the limits of these claims. As such they cover what is obvious and would
be invalid for this reason.
... there is nothing in the specification that suggests that the proportions or the ranges of the metals in the alloys are in any way part of the invention, other than the mere reference to them. It is a case of “parameteritis”.
... there is reference in the patent specification and evidence which
supports the fact that the parameters have been carefully chosen,
are part of
the invention and are related to a claimed advantage as part of the combination
of the design.
Clorsulon is a compound belonging to the benzenesulphonamide (benzenesulfonamide -USA) family which is recommended for control of adult liver flukes (Fasciola hepatica and Fasqiola gigantica) in cattle as suspensions for oral use or in injectable formulations for subcutaneous administrations. The oral recommended level is 7 mg/kg body weight (bw) and the subcutaneous level 2mg/kg bw. Currently, there is no known topical formulation, and this is likely to be due to foreseeable difficulties in achieving adequate penetration of the skin by clorsulon.
[Emphasis added]
Accordingly, the present invention provides a hitherto unavailable topical formulation comprising as active ingredients, at least one effective agent derived from Streptomyces avermitilis, i.e. a macrocylic lactone e.g. an avermectin or chemically modified or synthetic derivative thereof, e.g. ivermectin, together with another anthelmintic of the sulphonamide type, e.g. clorsulon, in a carrier that facilitates topical administration and delivery of the active ingredients transdermally. The carrier comprises alcoholic solvents, with optional excipients and formulation aids, which may comprise a polymeric species such as PVP or a poloxamer. In preferred form, a pour-on formulation is provided containing clorsulon and ivermectin. The alcoholic solvents comprise at least 30% (v/v) of ethanol, together with isopropanol to make the formulation up to 100%.
[Emphasis added]
The invention also provides a topical anthelmintic formulation including, as active ingredients, a therapeutically effective amount of at least one anthelmintic agent derived from Streptomyces avermitilis, with a therapeutically effective amount of at least one other anthelmintic of the sulphonamide type, in an alcoholic solvent-based carrier suitable for topical administration and delivery of the active ingredients transdermally, said carrier including at least 30% (v/v) of ethanol together with isopropanol quantity sufficient to 100%.
[Emphasis added]
On the basis of the physicochemical parameters, particularly MW and log K, clorsulon can be defined as a poor candidate for transdermal delivery. Of the parameters mentioned in the table above, the MW and log K parameters are the two of most Importance for the assessment of suitability for transdermal delivery. Therefore, at 21 January 2005, based on this publication a formulator would foresee substantial difficulties achieving penetration of the skin by clorsulon and would be disinclined to select it as a candidate for transdermal delivery.
[Emphasis added]
Therefore, when developing an alternative topical formulation that is capable
of incorporating both a lipophilic drug (e.g. ivermectin)
and a hydrophilic drug
(e.g. clorsulon) in a single formulation, it would be clearly obvious to a
skilled person to modify the formulations
of the Komer paper [Document D9] to
include ethanol and isopropanol, based on their common general knowledge, and
more specifically
in light of the teachings of the Blakely [Document D20], Soll
[Document D15] and/or Lukas [Document D14] papers. Moreover, as mentioned
above
at [265], the “at least 30%" feature in relation to the ethanol component
is already known from the Blakely [Document
D20] paper. In the absence of any
particular technical effect associated with this value being described in the
opposed application,
l consider that the "at least 30%" is an arbitrary choice
of little technical significance to the invention as claimed that does
not
involve any degree of inventiveness as an alternative choice would provide the
same result. Further, l consider that such a solvent
system could be chosen or
predicted by any competent formulation chemist without difficulty.
Obviousness with regard to
Prior Use – section 21(1)(e) second limb
6.1 MERIAL contends 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 what was used in New Zealand before the priority
date of the applicant's claim. The following
instances of prior use and/or
publication of the registration of the products in New Zealand will be relied
upon:
6.2 IVOMEC Plus Injection for Cattle has been a New Zealand-registered veterinary medicine since 16 March 1993 (Reg. No. A006481) and has been used in New Zealand since before the priority date of NZ 556537.
6.2.1`This product is an injectable solution which is sold by MERIAL Limited and is recommended for use in the treatment and control of internal and external parasites of cattle, including adult liver flukes.
6.2.2 According to Section 2 of the MSDS [Material Safety Data Sheet] IVOMEC Plus comprises the following components
|
Name
|
CAS
|
Proportion
|
|
Ivermectin
|
70288-86-7
|
10g/L
|
|
Clorsulon
|
60200-06-8
|
100g/L
|
|
Glycerol Formal
|
5464-28-8
|
400g/L
|
|
Propylene Glycol
|
57-55-6
|
400g/L
|
6.2.3 Thus, the MSDS teaches that the combination of ivermectin and clorsulon can provide a safe, stable and effective broad spectrum anthelmintic product. Additionally, the disclosure of the MSDS teaches that both ivermectin and clorsulon are soluble in alcohols. Accordingly, when formulating an ivermectin and clorsulon combination for pour-on administration it would be obvious for a skilled artisan to employ alcohols which facilitate dermal absorption.
6.3 IVOMEC Pour-on for Cattle and Deer has been a New Zealand-registered veterinary medicine since 5 June 1998 (Reg. No. A005303) and has been used in New Zealand since before the priority date of NZ 556537.
6.3.1 This product is a pour-on which is sold by MERIAL Limited and is recommended for use in the treatment and control of major internal and external parasites of cattle and deer.
6.3.2 According to Section 2 of the MSDS IVOMEC Plus comprises the following components
|
Component
|
Molecular
Formula |
Molecular
Weight |
CAS Number
|
|
Ivermectin Comp B1a
|
C48H74O14
|
875
|
70288-86-7
|
|
Comp. B1b
|
C47H72O14
|
861
|
(Mixture)
|
|
Isopropyl alcohol
|
C3H8O
|
60.09
|
67-63-0
|
|
Inert ingredients
|
Not available
|
Not available
|
Not available
|
6.3.3 Thus, the disclosure of the MSDS teaches that ivermectin can be delivered by pour-on application using an alcoholic solvent-based carrier. Specifically, the MSDS teaches that the alcoholic solvent-based carrier can comprise isopropanol. As discussed above in Section 4, there is a significant advantage in preparing a formulation for a new product that is as familiar as possible to regulatory reviewers. For this reason, there would have been great interest in a formulation of the combination of ivermectin and clorsulon that was as similar as possible to the existing ivermectin pour-on formulation, just as the combination of clorsulon and ivermectin in an injectable formulation is similar to the injectable formulation of ivermectin alone.
6.3.4 Accordingly, the Opponent submits that in developing an ivermectin and clorsulon combination for pour-on administration it would be obvious for a skilled artisan to start with a formulation wherein the carrier system is isopropanol. As discussed in Section 4 and 5.2.5, in the development of a new formulation with high efficacy an optimisation process would be routinely employed. In carrying out such an optimisation process, it would be obvious for a skilled artisan to prepare a number of formulations comprising varying amounts and types of solvents, excipients and additives. It is known that alcohols such as methanol, ethanol and isopropanol, and mixtures thereof, are commonly used for topical applications due to the ability of these solvents to improve dermal absorption. Accordingly, it would be obvious for a skilled artisan to look to combinations of solvents such as ethanol and isopropanol as a carrier system for a topical formulation comprising ivermectin and clorsulon.
6.3.5 As discussed in Section 5.2.5, the Applicant has not shown evidence
demonstrating the optimisation process and appears to have
arbitrarily selected
at least 30% (v/v) ethanol together with isopropanol quantity sufficient to 100%
as the solvent system for the
pour-on formulations. As such, the Opponent
considers that there is no inventive step involved in such an arbitrary
selection and
further considers that the selection of at least 30% (v/v) ethanol
would be obvious to a skilled artisan.
Decision
Costs
|
Item in IPONZ scale of costs |
Cost |
|
Preparing and filing Counterstatement: Receiving and perusing Applicant for Revocation’s evidence: Preparing and filing Patentee’s evidence: Receiving and perusing the Applicant for Revocation’s evidence strictly in reply: Preparation of case for hearing: Attendance at hearing by counsel (1 day): Hearing fee: TOTAL: |
300.00 400.00 800.00 100.00 500.00 810.00 750.00 $3660.00 to the Patentee |
Dated this 22 day of September 2014
_____________________________
K B Popplewell
Assistant
Commissioner of Patents
Davies Collison Cave for the Patentee
FB
Rice for the Applicant for Revocation
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