Ashmont Holdings Limited v Nature Vet Pty Limited and American Home Products Corporation
[2001] APO 43
•5 September 2001
OFFICIAL NOTICE
DECISION OF A DELEGATE OF THE COMMISSIONER OF PATENTS
Petty Patent : No. 711820 in the name of ASHMONT HOLDINGS LIMITED
Title: Anthelmintic Formulations
Action: Application under section 69 for an extension of term of the petty patent and section 28 notices by NATURE VET PTY LIMITED and AMERICAN HOME PRODUCTS CORPORATION.
Decision: Issued .
Abstract
It was found that all the claims of the petty patent lack novelty and inventive step in light of the Virbac document, except for where the claims define pastes in which the solvent is ethyl lactate or N-methyl-2 pyrrolidone. It was also found that the term "and the like" in the claims lacks fair basis.
Section 24(1)(b) constitutes an exception to novelty under certain limited circumstances where there has been unauthorised disclosure and was discussed at the hearing in connection with the Virbac document. However, it was found that the relevant application was filed too late for section 24(1)(b) to be relied upon. In the event of this finding, the patentee indicated that it is possible that an application under section 223 may be made for an extension of time for filing the application. It was noted that if an application under section 223 were made and subsequently allowed, the issue of unauthorised disclosure would need to be re-visited by inviting submissions from the parties. At that same time evidence/submissions would be considered on the issue of whether the patentee is entitled to the grant of the petty patent. This is connected to the allegations of unauthorised disclosure and could itself render the petty patent invalid.
The patentee was allowed 60 days in which to file relevant amendments or to file a section 223 application. All other considerations were deferred until one of these options is pursued.
PATENTS ACT 1990
DECISION OF A DELEGATE OF THE COMMISSIONER OF PATENTS
Re:Petty Patent No. 711820 by ASHMONT HOLDINGS LIMITED, application under section 69 for an extension of term of the petty patent and notices under section 28 by NATURE VET PTY LIMITED AND AMERICAN HOME PRODUCTS CORPORATION
BACKGROUND
Petty patent 711820 was filed as application 44648/99 on 20 August 1999, in the name of Ashmont Holdings Limited (Ashmont). This application is a divisional of standard application 35604/97 (707949), which claims priority from New Zealand applications 299094 and 299387 with an earliest priority date of 30 July 1996. The petty patent was sealed on 21 October 1999.
On 29 August 2000, Ashmont filed an application under section 69 for an extension of term of the petty patent. Nature Vet Pty Limited (Nature Vet) and American Home Products Corporation (AHPC) both filed notices under section 28 ("matters affecting validity of petty patents") on 21 September 2000, accompanied by declarations and exhibits in support. AHPC were granted an extension of time under section 223 until 22 September 2000 to file a further declaration, properly witnessed. Ashmont filed evidence in response to both section 28 notices on 21 December 2000.
The matter was heard in Canberra on 22 May 2001. Ashmont was represented by Dr Annabelle Bennett SC, instructed by Mr Martin Earley of Pipers, Melbourne. Nature Vet was represented by Ms Katrina Howard of counsel, instructed by Mr John O'Connor of Spruson & Ferguson, Sydney and AHPC was represented by Mr Denis Tuffery of Baldwin Shelston Waters, Sydney.
THE EVIDENCE
In support of their section 28 notice, Nature Vet filed declarations by John Ray Biffin, with exhibits JRB-1 to JRB-8, and Gregory Cox, with exhibits GC-1 and GC-2. Mr Biffin states that he is a veterinarian, specialising in horses and is Research Director of Nature Vet. Mr Cox declares he is employed by Spruson & Ferguson as a librarian. Nature Vet also filed several other documents with the section 28 notice. Many of these are copies of documents forming the exhibits to Mr Biffin's declaration. However, in addition, copies of the following documents were filed: AU 552403 (80711/82); AU 691990 (39087/95); GB 2252730; US 4310519; abstract of AU 487329 (84106/75); abridgement page and claims of AU 604759 (79534/87) and judgements of the High Court of New Zealand and the Court of Appeal of New Zealand in regard to New Zealand patent 237086.
AHPC filed a declaration by James Steven Rowe, with his curriculum vitae annexed as exhibit JSR-1, and a declaration by Charles William Tansey with annexed copy of AU 39087/95 as exhibit CWT-1. Mr Rowe has qualifications in pharmacy with experience in formulation of pharmaceuticals and is presently Scientific Director of the company Technical Consultancy Services Pty Ltd. Mr Tansey is the patent attorney representing AHPC.
In response to both section 28 notices, Ashmont filed declarations by Colin Manson Harvey, with exhibits CMH-1 to CMH-5 and by Michael Ffloyd Forster with exhibits MFF-1 to MFF-3. Mr Harvey states he is the founder and Managing Director of Ancare New Zealand Limited and also a Director of Ancare Australia Pty Ltd. Mr Harvey also declares that he has worked in the veterinary pharmaceutical industry in Australia and New Zealand for over thirty years. I note that Mr Harvey is named as the sole inventor for petty patent 711820. Mr Forster states that he is an employee of Ancare Australia Pty Limited and has 15 years experience in the field of veterinary pharmaceutical formulation.
THE SPECIFICATION
I note that the specification has been amended following a Federal Court Order dated 21 February 2001, the amendments relating to some minor typographical errors. This decision is based on the amended specification.
The specification is entitled "Anthelmintic Formulations" and is related to animal worming compositions. In the background to the invention it is pointed out that the macrolide anthelmintics, such as the avermectins, have been the drugs of choice in recent years for the treatment of internal parasites of sheep, cattle and other farm animals. These compounds have become known as endecticides due to their ability to control both internal and external parasites. However, it is said that these macrolide anthelmintics need to be administered as solutions since they are poorly absorbed by the animal in their solid form. Dr Rowe also confirms this in his declaration. The specification states that it has been the practice to formulate the avermectins by dissolving in solvents for administration.
The specification then goes on to point out that some types of parasites, particularly trematodes, are not controlled by the macrolide endecticides. In sheep, such trematodes include Liver Fluke (Fasciola hepatica) and Tapeworm (Monezia spp.). Page 2 lines 19 to 22 states "Previous methods of incorporating anthelmintics that have activity against trematodes have relied on suspending a compound like praziquantel that controls Monezia spp. in an anthelmintic solution. It is more desirable to have dual formulations as solutions as this allows wider application as injectables or drenches."
It is also stated on page 2 of the specification that an object of the invention is "to provide a composition containing an effective amount of praziquantel and at least one of the active anthelmintics of the macrolide group or a least one that provides the public with a useful choice". Page 19 also indicates that it is advantageous to combine two or more anthelmintics with different activity in one composition to obtain a broad spectrum activity.
The bottom of page 2 to the top of page 4 of the specification describes the invention. One aspect of the invention is said to comprise a veterinary composition containing:
a) an effective amount of praziquantel;
b)an effective amount of at least one macrolide anthelmintic selected from the group comprising the avermectins and the milbemycins; and
c) a suitable organic solvent capable of dissolving a) and b);
wherein the composition is suitable for administration to warm-blooded non-human animals.
It is said that the solvent is preferably an ester or ester-like compound and that certain esters and similar compounds have the benefit of dissolving both praziquantel and the avermectins and milbemycins without being toxic to animals. Most preferably the solvent is selected from the group consisting of glycerol formal, ethyl lactate, benzyl alcohol and N-methyl-2-pyrrolidone and the like.
It is stated on page 3 that the composition can also be a paste containing:
a) a solution of an effective amount of praziquantel, an effective amount of at least one macrolide anthelmintic selected from the group comprising the avermectins and the milbemycins, and a suitable organic solvent; and
b) a thickener.
The thickener is said preferably to be "a solid carrier onto which the solution is absorbed and is selected from the group comprising oat meal flour, methocel and xanthan gum". The suitable solvents are not specified but I read this to mean the ester or ester-like compounds which would dissolve both active components.
Pages 4 to 11 give examples of the formulations of the invention. Examples 1 to 3 show drenches for administration to sheep, cattle and goats, example 5 is a drench for all farm animals, example 6 is an injectable for all farm animals and example 7 is either an injectable or drench for administration to all farm animals. Only example 4 shows an oral paste, for administration to horses and companion animals. The ingredients of example 4 are as follows:
| Ingredient Abamectin | %w/v 0.400 |
It can be seen that example 4 contains praziquantel, an avermectin (abamectin), 2 organic solvents (glycerol formal and benzyl alcohol) and a thickener (oat meal flour). This formulation was tested for stability and the results given on page 13 show it to be stable over a six-month period at 30°C and 40°C. However, I note that no test results are given for the administration of the formulation of example 4 to animals. The manufacturing steps show that the abamectin is dissolved in the glycerol formal, polyethylene glycol 400 and benzyl alcohol. This is then added to a powder containing the praziquantel and oat meal flour, before adding the remainder of the ingredients.
Thus, the specification discloses that esters and ester-like compounds are preferable solvents since they dissolve both anthelmintic compounds. However, the specification does not disclose any further information on how to choose the solvent other than stating that the particular solvents glycerol formal, ethyl lactate, benzyl alcohol and N-methyl-2-pyrrolidone and the like are "more preferable".
The use of the words "and the like" leads to some ambiguity. I believe that these words can be interpreted in two ways, that either the solvents come from within a class of solvents including those named or that they have a similar function, namely that they dissolve both anthelmintics. However, I must discount the first option since it is not apparent to me that the named solvents come from a particular class, rather they seem to be very structurally different solvents. Hence, I can resolve the ambiguity and will proceed on the basis that the solvents are those which dissolve both the abamectin and the praziquantel. This is discussed more fully later for fair basis.
The specification ends with three claims, numbered 1, 2 and 5, as follows:
A viscous oral anthelmintic paste suitable for oral administration to horses containing an effective amount of abamectin, an effective amount of praziquantel and a paste like carrier including an organic solvent selected from the group consisting of glycerol formal, ethyl lactate, benzyl alcohol and N-methyl-2-pyrrolidone and the like, and a solid carrier.
A viscous oral anthelmintic paste suitable for oral administration to horses according to claim 1 wherein the organic solvent is glycerol formal together with PolyEthylene Glycol, and where the solid carrier is selected from the group comprising oat meal flour, methocel, and xanthan gum.
A viscous oral anthelmintic paste suitable for oral administration to horses according to claim 2 and containing in addition DiEthylene Glycol Palmito Stearate, and Sorbitol Solution.
Thus, from reading the specification as a whole, I believe that the invention lies in providing dual formulations of praziquantel with a macrolide anthelmintic, such as abamectin, to provide broader protection for the animal against parasites. This is achieved by combining both of these components with a suitable organic solvent. As can be seen, the petty patent is only claiming one aspect of the invention disclosed in the specification, namely a horse paste in which the composition of the two anthelmintics and solvent are absorbed onto a solid carrier. I note that, although the descriptions of the petty patent and the parent application (AU 707949) are identical, the parent application claims more broadly and includes solutions not just pastes.
DECISION
Section 40 issues
The section 28 notice filed by Nature Vet states that the claims are not clear, succinct or fairly based on the matter described in the specification. Ms Howard did not make submissions on the section 40 issues at the hearing but referred me back to the section 28 notice in that regard. I note that none of the declarants addressed these matters. Mr Tuffery submitted that claim 1, as defined, is not limited to the situation where both the abamectin and praziquantel are dissolved in the organic solvent. Although the wording of the claim is somewhat vague, I believe that in light of the specification as a whole, the claim should be interpreted as including only those solvents which dissolve both active components.
With regard to the section 40 issues identified in the section 28 notice, I note that while the drafting of the claims might not be ideal, the parties have been able to interpret the claims. Thus, I do not find any lack of clarity. However, I do have some concern about the term "and the like" as discussed above. Although I have been able to resolve the ambiguity and construe the claim, it is not apparent what other solvents would be included. The defined solvents come from very diverse structural groups and there are no directions given in the specification how to select other solvents which would perform the same function. I do not believe that there has been sufficient disclosure for the skilled addressee to be able to determine which other solvents to choose. I note that Dr Bennett conceded that the patentee's invention was concerned with the solvent system. If this is the case, I consider that it would take more than routine trial and error to find other solvents falling within the group of like solvents. As a result, I believe that the section 40 grounds have only been made out in regard to the term "and the like" which is not fairly based. For the rest of the decision I will construe the claims as if they had been amended to remove the term "and the like"
Novelty and Inventive step
The test for determining whether an invention lacks novelty is the " reverse infringement test" as stated by Aiken J in Meyers Taylor Pty Ltd v Vicarr Industries Ltd, (1977) CLR 228 at 235:
"The basic test for anticipation or want of novelty is the same as that for infringement and generally one can properly ask oneself whether the alleged anticipation would, if the patent were valid, constitute an infringement."
Infringement of a claim occurs where "each and every one of the essential integers" of that claim have been taken, Rodi and Wienenberger AG v Henry Showell Ltd, (1969) RPC 367 at 391.
A more recent statement in relation to novelty is given in Nicaro Holdings Pty Ltd v Martin Engineering Co (1990) 91 ALR 513 at 517:
"It is well accepted that the prior art must disclose all features of the invention embodied in the patent in suit and must do so in clear, unequivocal and unmistakable terms. The prior art must enable the notionally skilled addressee at once to perceive and understand and be able practically to apply the discovery without the necessity of making further experiments. What ever is essential to the invention must be read out of or gleaned from the prior publications"
The law on inventive step, as given in sections 7(2) and 7(3), makes it clear that obviousness is assessed against the common general knowledge alone or common general knowledge in combination with a document. Such a document must be publicly available and must reasonably be expected to have been ascertained, understood and regarded as relevant.
The legal test for obviousness is given in Wellcome Foundation Ltd v VR Laboratories (Aust) Pty Ltd (1981) 148 CLR 262 at 286
"What is important is that the patent itself should involve an inventive step, whether or not it is consciously taken by the patentee and whether or not it appeared obvious to the patentee himself. The test is whether the hypothetical addressee faced with the same problem would have taken as a matter of routine whatever steps might have led from the prior art to the invention, whether they are the steps of the inventor or not."
AU 691990 (Virbac)
The closest prior art document is Virbac. This document has a publication date of 6 June 1996, which is before the earliest priority date of the present petty patent (30 July 1996). It is directed to equine anthelmintic formulations and discloses formulations comprising praziquantel in combination with an avermectin or milbemycin. Page 2 describes how it has been discovered that this combination shows a surprising synergy in the treatment of horse tapeworms. Example 1 of AU 691990 is a formulation for a horse paste as follows:
| Ingredient Abamectin | %w/v 0.4g |
As can be seen, this has exactly the same components as example 4 of petty patent AU 711820. The only difference seems to be in the amount of abamectin, which is given as 0.4g per 1 litre in Virbac but 0.4 g per 100ml in the petty patent. However, example 3 of Virbac is a horse paste the same as example 1 but with 4g abamectin per litre, so is exactly the same formulation as example 4 of the petty patent. It can be seen that the processes for preparing the formulations in the two specifications are also the same. Example 6 of the Virbac document is an oral drench for horses but contains xanthan gum.
Thus, the Virbac specification discloses and exemplifies all the features of the present claims. It describes a viscous oral anthelmintic paste suitable for administration to horses. This formulation contains an effective amount of both abamectin and praziquantel. Virbac points out that the combination of praziquantel and abamectin exhibits higher synergistic activity when formulated as a paste for horses. The instructions for making that paste include the same steps using the same ingredients. It contains a paste like carrier, which includes an organic solvent, with the combination of glycerol formal, polyethylene glycol and benzyl alcohol being specifically exemplified in example 1. The formulation also contains a solid carrier, with both oat meal flour and xanthan gum being exemplified. The additional components defined in claim 5 of the petty patent, diethylene glycol palmito stearate and sorbitol solution, are also disclosed.
However, although Dr Bennett acknowledged that these features are disclosed, she argued that the Virbac patent "does not teach the solvents of the invention of the petty patent. It does not teach how to choose the solvents or what they are meant to achieve." Dr Bennett submitted that Virbac was a "mere disclosure" and referred me to Bristol-Myers Squibb Company v FH Faulding & Co Ltd (2000) 46 IPR 553-600. At 574 the Full Court observed:
"In the case of a paper anticipation, the reverse infringement test cannot be applied literally"
and at 576 their Honours came to the view that :
"The question is still, what does the prior publication teach? Each of the reports taught, no doubt, some useful things relating to the administration of taxol. But none of them taught the method of the claims."
Thus I need to consider whether the Virbac patent teaches the invention claimed in the petty patent, as proposed by Ms Howard, or if it is a mere disclosure of a formulation falling within the scope of the claims.
I have discussed above that I believe that the invention of the petty patent lies in providing dual formulations of praziquantel and abamectin and that this is achieved by combining both of these components in a suitable organic solvent. The Virbac patent is also concerned with providing dual formulations of these two components and appears to have arrived at the same solution to the problem. Neither patent discusses the importance of the solvent or how to select the solvent. However, I believe that the Virbac patent clearly directs the reader to prepare such formulations and describes the way in which they could be prepared. As such, the present situation can be distinguished from that in Bristol-Myers (supra).
Thus, I consider that all the essential integers of the claims of the petty patent are disclosed in Virbac and that Virbac teaches the invention claimed in the petty patent. As a result, I find that all three claims of the petty patent lack novelty as they are anticipated by the disclosure in Virbac in so far as the solvent is benzyl lactate or glycerol formal.
Clearly, the features defined in the claims of the petty patent but not specifically disclosed in Virbac are the solvents ethyl lactate and N-methyl-2-pyrrolidone defined in claim 1and the solid carrier methocel defined in claim 2. In regard to inventive step, Virbac is a relevant document and I need to consider if the person skilled in the art would have taken as a matter of routine whatever steps might have led from Virbac to the invention claimed in relation to those missing features.
The evidence from Rowe and Biffin indicates that methocel is a well-known thickening agent for pharmaceutical and veterinary use. The patentee does not show that there was any special inducement to choose methocel over any other thickener or that there were any special advantages conferred by its use. It seems to me that methocel is a mere technical equivalent to the other thickeners disclosed. As a result I must find that the claims lack inventive step compared with Virbac with regard to the thickener methocel.
In regard to the solvent, the specification at page 2 tells how it has been practice to formulate the macrolide anthelmintics as solutions since they are poorly absorbed in solid form. This is acknowledged by Rowe in his declaration and also by Harvey and Forster, although Harvey states that this is not disclosed in any publication that he is aware. On the other hand, praziquantel is poorly soluble in water but well absorbed following oral administration of solid forms of the drug. It has historically been formulated as a suspension according to both the specification of the petty patent and to Rowe. Virbac also discloses the insolubility of praziquantel in water.
Rowe declares that if asked to formulate a formulation containing both a macrolide (such as abamectin) and praziquantel, he would consult text books and reference books to determine the properties of these compounds. He also states "the selection of suitable solvents to dissolve any particular product would not normally involve any great difficulty as the characteristics of solvents and their suitability for use in therapeutic formulations is widely known." Further on he notes his belief that there was nothing surprising in the choice of any of the particular solvents as they are "known solvents along with a number of others that could perform the desired function."
Ms Howard also brought to my attention the decision in Coopers Animal Health Australia Ltd v Western Stock Distributors Pty Ltd (1986) 6 IPR 545. The facts are somewhat analogous to the present case. In Coopers, the petty patent claimed a pour-on formulation for control of lice in sheep comprising a pyrethroid in admixture with a topically acceptable carrier comprising at least 50 wt per cent DGBE. The main issue in this case (and the appeal to the Full Bench of the Federal Court) was concerned with fair basis of the petty patent on a provisional application but the Court also considered the issue of inventive step. Wilcox J. found that the selection of DGBE as the solvent did not involve an inventive step. This was based on expert evidence, which established that the skilled worker would have considered DGBE worth trying.
However, in the present case Dr Bennett submitted that the invention lay in the choice of solvent system. The solvents defined in the claims come from very different structural groups of compounds and neither of the declarants asserts that he would have actually chosen these particular solvents. Harvey, at paragraph 13, lists the properties required by solvent system in addition to dissolving both actives. These include that the solvent must not chemically affect the active agent, it must not be toxic to the animal, it should be palatable and the solution needs to be stable. At paragraph 14 he states that "a prohibitively large number of possible permutations must be sorted through to arrive at a solvent system having the properties listed above."
Thus, I am not convinced in this case that the hypothetical addressee would necessarily be led to try the particular solvents ethyl lactate and N-methyl-2-pyrrolidone rather than any other. It seems to me that it has not been proved that the choice of these solvents is an obvious selection and as a result, I must find that the ground of lack of inventive step has not been made out where the solvent is ethyl lactate or N-methyl-2-pyrrolidone.
In conclusion, I have found that the invention as claimed lacks novelty and inventive step in the light of the Virbac disclosure, except for pastes in which the solvent is ethyl lactate or N-methyl-2-pyrrolidone which are both novel and inventive.
Other Documents
AU 552403 (Sankyo)
This document, published on 2 September 1982, relates to synergistic anthelmintic compositions for administration to animals. These compositions comprise a macrolide anthelmintic, such as abamectin, and another anthelmintic which may be an isoquinoline compound such as praziquantel. Although the specification mentions that other materials may be present in the formulations, I do not believe that there is any disclosure of the solvents and solid carriers as presently claimed. Thus, claims 1,2 and 5 are both novel and inventive in the light of Sankyo.
GB 2252730 (Ancare)
This document, published on 19 August 1992, discloses anthelmintic compositions comprising praziquantel and an avermectin. These formulations are intended for treatment of domestic animals such as cattle, sheep and goats. Although some of the examples contain xanthan gum, there is no disclosure of the specific organic solvents presently claimed. I believe that the claims of the petty patent are both novel and inventive in the light of this document.
Equimax
At the hearing Ms Howard referred to the product Equimax. Ms Howard alleges prior use by this product if the petty patent were shown not to be entitled to claim priority from the New Zealand basic documents. Equimax is an oral paste for horses marketed by Virbac. The product details for Equimax (exhibit MFF-3 to the Forster declaration) show that this was first registered on 8 November 1996 and that it contains both abamectin and praziquantel. Harvey also indicates in his declaration that Equimax is an abamectin/praziquantel horse wormer which is marketed by Virbac in Australia. However, apart from this, there is nothing before me to show what components are included in the Equimax product or any evidence concerning this alleged prior use. I thus find that the ground of prior use has not been made out.
Conclusion on novelty and inventive step
From the discussion outlined above, I have found that all the claims lack novelty and inventive step in the light of the Virbac disclosure alone, except for where the claims define pastes in which the solvent is ethyl lactate or N-methyl-2-pyrrolidone.
Section 24(1)(b)
Section 24(1)(b) of the Patents Act provides that any information made publicly available without the consent of the nominated person is to be disregarded for the purposes of novelty and inventive step so long as an application for the invention is made within the prescribed period. Regulation 2.3(2) outlines the prescribed period in this case, being 12 months from the date the information became publicly available. It appears that the intention of this regulation is that there are no special provisions for Convention applications. Regulation 2.3(2) is different to the situations given in regulation 2.3(1) which do include reference to the making of a basic application in the case of disclosure at a recognised exhibition, publication by a learned society and working of the invention for the purposes of reasonable trial.
Thus, section 24(1)(b) constitutes an exception to novelty under certain limited circumstances and was brought to my attention at the hearing in connection with the Virbac disclosure. The issue was raised in the declarations in response by the patentee's declarants, Mr Harvey and Mr Forster. Mr Harvey is named as the inventor of the petty patent and indicates that he is the founder and Managing Director of Ancare New Zealand Limited (Ancare) and Director of Ancare Australia Pty Ltd. He is also a director of Ashmont. Mr Forster is named as an inventor of the Virbac application and states that he was an employee of Virbac in August 1994 but is now an employee of Ancare. According to Mr Harvey, Ancare is the exclusive licensee of all technology held by Ashmont, including 73 patents and patent applications. Virbac (Australia) Pty Ltd (Virbac) was Ancare's distributor in Australia from 1987 until November 1999.
Both Harvey and Forster declare that they worked together on a project to develop an anthelmintic horse worming paste from 1993. This joint project, involving both Virbac and Ancare, was code-named Speedwell. In his declaration, Forster comments that the Speedwell project "was truly a joint effort". He acknowledges that he contributed to the paste formulation while it was Harvey who developed the solvent system. He declares that he believed that he was "one of the true and first inventors of the formulation included in the Virbac patent as examples 1 to 8". Harvey also notes his surprise that he was not contacted by Virbac prior to the filing of their patent application in Australia.
To me this indicates that Harvey is acknowledging that the contribution he made to the invention, namely the solvent system, is disclosed in Virbac. He even states "in fact my solvent system was published without my consent" referring to the Virbac disclosure. This is confirmed by Forster. Furthermore, even the test results given in the petty patent are using Speedwell Mineral drench for Sheep, apparently named after the joint project.
In the present situation the Virbac application was published on 6 June 1996 so an application for the invention should have been made by 6 June 1997 for the provisions of section 24(1)(b) to apply. As noted above, my interpretation of this is to an application made in Australia and excludes the New Zealand basic documents. The parent application was filed on 25 July 1997 and, as noted above, this specification is identical to that of the petty patent apart from the claims. Thus, it seems that the application was filed too late for section 24(1)(b) to be relied upon. However, Dr Bennett indicated that if I were to make a finding of lack of novelty based on the Virbac application, her client would be considering making an application under section 223 for an extension of time to file the relevant application for the invention. I note that no section 223 application has yet been made and I cannot comment on the likelihood of such a request being granted.
However, these allegations by Harvey and Forster raise the issue of entitlement on the present petty patent. In her submissions at the hearing, Ms Howard made the point that there was some doubt about this entitlement if Ashmont did not correctly derive title to the invention from all the inventors. If this is true, prime facie the petty patent must be found to be invalid as this is not a matter which is capable of being rectified by amendment [see Stack v Brisbane City Council 47 IPR 525 and Stack v Davies Shephard [2001] FCA 502 (4 May 2001]. Dr Bennett asserted at the hearing that she had not been given sufficient notice to prepare submissions on entitlement so I am unable to make any determination on this matter without asking for further submissions from the parties on this issue.
Manner of manufacture
At the hearing, both Ms Howard and Mr Tuffery submitted that the claims do not define a manner of manufacture within the meaning of section 18(1)(a) since the claims (a) define a mere collocation of known integers and (b) define a new use of a know material. However, I do not believe that this ground has been made out. The claims define compositions for use in treating internal parasites in horses and the specification describes these compositions as achieving a new and improved result. Although the specification does not indicate that there is synergy between the components of the compositions, I believe that the compositions show an obvious advantage compared to the prior art compositions and that it can be seen from the evidence that they do exhibit synergy. As to the submission that this is a new use of a known material, I consider that this is really an inventive step argument, which has been adequately considered above.
CONCLUSION
I have found above that the term "and the like" in the claims lacks fair basis. I have also found that all the claims of the petty patent lack novelty and inventive step in light of the Virbac document. Because of the section 24(1)(b) issue, Dr Bennett indicated to me that it is possible that the patentee may make an application under section 223 for filing the relevant application. If such an application were to be filed, it would need to justify the reasons for the error and explain why the patentee had not sought the extension sooner. Further, although the extension required would be less than 3 months, the notifiers would be given an opportunity to object to the extension noting the provisions of regulation 22.22.
I would also note that if an application under section 223 is made and subsequently allowed, the issue of unauthorised disclosure will need to be re-visited. Accordingly, if a section 223 application is allowed, I will give further directions to allow the parties to file relevant evidence and submissions on the unauthorised disclosure issue.
Of course, relevant to the issue of unauthorised disclosure is the concession from the patentee that Forster and Harvey worked together on the project to develop an anthelmintic worming paste. This concession raises a very serious question of entitlement as Forster was not a named inventor in the current patent. An adverse finding on entitlement here could invalidate the petty patent in toto [see Stack v Brisbane City Council (supra) and Stack v Davies Shephard (supra)]. I will therefore also be providing directions to the parties to provide evidence/submissions on the issue of entitlement at the same time as submissions on the unauthorised disclosure issue.
I note that the grounds of lack of novelty and inventive step have not been made out where the claims relate to pastes comprising the solvents ethyl lactate and N-methyl-2-pyrrolidine. A section 223 application, and subsequent reconsideration of the unauthorised disclosure issue, would not be necessary to overcome the novelty/inventive step issues if the claims were to be restricted to such solvents. Further, the issue of entitlement does not arise in respect to those solvents as it cannot be inferred from the unauthorised disclosure argument and was not raised by the opponent. In any case, the solvent system was admitted as being the contribution of Harvey.
I allow the patentee 60 days in which to file relevant amendments to overcome the problems I have noted above (or to file a section 223 application). I defer further consideration of the case until one or other of the options above has been pursued.
COSTS
Since this is only a partial decision, I will reserve a finding on costs until the final decision is issued.
Gillian Jenkins
Delegate of the Commissioner of Patents
Patent attorneys for the patentee: Pipers, Melbourne
Patent attorneys for Nature Vet: Spruson & Ferguson, Sydney;
Patent attorneys for AHPC: Baldwin Shelston Waters, Sydney
0
4
0