Roussel-Uclaf v Shell Internationale Research Maatschappij B.V

[1995] APO 3

official notice

decision of a delegate of the commissioner of patents

Application       :    No. 561371 in the name of ROUSSEL-UCLAF

Title:    Methods of treating sheep infested with parasites

Action:    Opposition by Shell Internationale Research Maatschappij B.V. under Section 59 of the Patents Act 1952

Decision:    Issued          .

Abstract:    Claims are not entitled to take as their priority date the date of filing of either the basic application or the parent.  As a consequence all claims lack novelty and are obvious.  Some minor S. 40 problems.  Applicant given the opportunity to amend.

patents act 1990

decision of a delegate of the commissioner of patents

Re:Patent Application No. 561371 by ROUSSEL-UCLAF and Opposition thereto by SHELL INTERNATIONALE RESEARCH MAATSCHAPPIJ B.V. under Section 59 of the Patents Act 1952.

background

Patent application 561371 by Roussel-Uclaf was filed on 6 August 1984 as a further application under Section 51(1) of the Patents Act 1952 in respect of an invention disclosed in the complete specification of application 65207/80 (543379). The parent application (65207/80) was filed on 9 December 1980 as a Convention application, and was based on French application 79-30203 which was filed in France on 10 December 1979.

Application 561371 was advertised accepted on 7 May 1987. On 7 August 1987 Shell Internationale Research Maatschappij B.V. (Shell) filed a Notice of Opposition under the provisions of Section 59 of the Patents Act 1952. The grounds of opposition were those set out in Section 59(c) to (i). At the hearing the only grounds argued were novelty, obviousness and Section 40. There were also extensive submissions concerning the priority dates of the claims.

The serving of evidence-in-support was completed on 26 March 1991.  On 11 January 1993 the applicant advised that it would not be relying on formal evidence-in-answer.  The opponent subsequently requested that the hearing be postponed.  I heard the matter in Canberra on 12 September 1994.  Roussel-Uclaf was represented at the hearing by Mr Robert Kelson, patent attorney of Callinan Lawrie, and Shell was represented by Dr Annabelle Bennett of counsel assisted by Mr John O'Connor, patent attorney of Spruson & Ferguson.

As acceptance of the application was advertised before commencement of the Patents Act 1990, the provisions of Section 234(3) and Regulation 23.3 of this Act apply.

specification

The specification indicates the invention is a method of controlling parasites on sheep by the "pour on" method, whereby one or more compounds falling within a specified formula (formula (1)) are administered to a sheep.  The compounds falling within formula (1) are known generically as synthetic pyrethroids.  The description at page 5 lines 1-5 refers to the invention being:

"especially a method of treating a sheep, infested with parasites wherein, in order to rid the whole body of the animal of parasites, there is administered to one part of the body of the animal to be treated, and, preferably, to a part of the back of the animal, an effective amount of a composition containing, as active principle (sic), at least one compound corresponding to the formula (1) in an appropriate vehicle."

Preferable compounds for use in the method are then described.

The specification admits, at page 7, that the compounds of formula (1) are known and that they have pesticidal properties.  However it states that administration by the "pour on" method was not suggested in the prior art.

At page 9 lines 13-22 the specification indicates that the term "appropriate vehicle" means:

"a vehicle which is capable of permitting migration of the active principle (sic) relative to the skin of the animal."

and indicates examples of such vehicles.  The vehicle can also contain a dispersing product.

The specification ends with 25 claims all of which are directed to methods.  Claim 1 is for:

"A method of controlling parasites on sheep which comprises administering to sheep by the "pour on" method (as herein defined) at least one compound of Formula(1), A-CO2-B (1)....."

Claims 2 and 3 read as follows:

"2.  A method of treating a sheep, infested with parasites wherein, in order to rid the whole of the body of the said animal of its parasites, there is administered to one part of the body of the said animal to be treated and, preferably, to a part of the back of the said animal, an effective amount of a composition containing, as active principle (sic), at least one compound corresponding to the Formula (1), as defined in Claim 1, in an appropriate vehicle (as herein defined) enabling the said animal to be treated.

3.   A method of treating or preventing an infestation by parasites of a sheep which comprises applying to a portion of the surface of the body of the said animal an effective amount of a composition comprising at least one compound of Formula 1 as defined in Claim 1 in association with said vehicle selected from oils, alcohols, esters of monocarboxylic acids, esters of dicarboxylic acids and esters of aliphatic acids."

The remaining claims are dependent claims with additional qualifications.  Claim 25 is an omnibus claim.

evidence

In support of the opposition Shell filed a number of declarations and accompanying exhibits.  However all but the principal declaration, by Peter James Noble, either refer only to various documents supporting the opposition or establish the publication dates of certain documents.

Mr Noble has worked in the field of research and development of animal health ectoparasites and has had commercial experience in the animal health business.  He has annexed 4 exhibits, PJN-1, PJN-2, PJN-3 and PJN-4, to his declaration.

I shall refer specifically to the declarations later in this decision.  However the main points of Mr Noble's declaration are:

.Exhibit PJN-1 summarizes what was known and used commercially in Australia in the field of insecticides prior to December 1979 (para 10).

.Prior to December 1979 it would have been reasonable to expect synthetic pyrethroids could be adapted to localised methods of application including "pour on" application (para 41).

.A person skilled in the art would not have been surprised to find that synthetic pyrethroids would perform well against a range of animal pests including sheep lice (para 45).

.Shell evaluated certain synthetic pyrethroids as "pour on" treatments for controlling sheep lice in July 1977 (para 50).

.It was common general knowledge prior to December 1979 in Australia that ectoparasites could be controlled by the "pour on" method and that synthetic pyrethroids could be used to control such parasites (para 53).

.By August 1984 several "pour on" formulations containing synthetic pyrethroids were available in Australia and were used for the control of ectoparasites on sheep (paras 59 and 73).

.It would have been a matter of routine to a pesticide formulator in Australia in 1979 to choose a suitable solvent system for use in a "pour on" formulation containing a synthetic pyrethroid (para 63).

.Liquids which penetrate the skin of an animal are different from liquids which spread over the skin.  The range of solvents specified in the opposed application do not both penetrate and spread on the hides of warm-blooded animals in the same way (para 64).

.An agricultural chemist skilled in pesticide formulations in Australia prior to December 1979 would have considered and tried a "pour on" formulation.  In 1984 this chemist would have selected as first choice a "pour on" formulation (para 65).

.It was common general knowledge in Australia prior to 1979 to include a dispersing agent in a pesticide formulation (para 72).

Roussel-Uclaf did not file any evidence-in-answer.

submissions

Dr Bennett's submissions on behalf of Shell were based on the contention that the claims of the opposed application were not fairly based on the French basic application.  Therefore the claims were not entitled to the priority date of 10 December 1979 but, in her view, their earliest priority date was August 1984.  In this event the invention as claimed lacked novelty in the light of the prior art, and Dr Bennett submitted that, in any event, the invention was obvious.

Fair Basis

In Dr Bennett's submission the invention in the French basic involved the putting together of known compounds (synthetic pyrethroids) and a known method ("pour on") to get a product that enters the general circulation of an animal.  The compounds were selected so that they passed through the cutaneous barrier and an appropriate vehicle was used to enable the composition to pass through that barrier.

However the opposed application was, in Dr Bennett's view, directed to an entirely different invention in that a compound was selected which kept its activity on migration relative to the skin.  The same compounds would not be chosen for internal use as for external use, and the Noble declaration was uncontradicted evidence that liquids which penetrate the skin of an animal are different from liquids which spread over the skin.  Therefore, relying on the decision of the Full Court of the Federal Court in Coopers Animal Health Australia Ltd v Western Stock DistributorsPty Ltd and Others 11 IPR 20, she concluded that, since a choice had to be made, if the addressee of the divisional was directed differently in that choice to the addressee of the basic, then the inventions in the divisional and the basic were not the same. Hence the claims of the divisional were not fairly based on the basic application and therefore were not entitled to its priority date. Alternatively Dr Bennett argued that, in considering fair basis, the Mond Nickel Rules (in Mond Nickel Company Ltd.'s Application (1956) RPC 189 at page 194) were clearly not satisfied.

Dr Bennett also argued that the divisional could not take the filing date of the parent as its priority date since the concept of using as an appropriate vehicle one which permits migration of the active agent relative to the skin was not introduced until the statement of amendments filed on 3 August 1984.  She pointed out that claim 1 of the divisional imposed no limitation on the vehicle, if any, used and therefore was not fairly based on the disclosure within the specification.

In response Mr Kelson for Roussel-Uclaf contended that the invention was sufficiently described in the priority document and hence the application in suit was entitled to the earliest priority date.  He submitted that the changes between the French basic and the divisional did not bring something new into the combination.

Mr Kelson relied on the decision of the Full Court of the Federal Court in CCOM Pty Ltd & Anor v Jiejing Pty Ltd & Ors (1994) AIPC 91-079 to support his arguments on fair basis. He referred to the part of the decision of Buckley LJ in Stauffer Chemical Co's Application [1977] RPC 33, which was cited with approval in CCOM, at page 38449, to support his contention that there was no departure in the divisional from the concept of the invention in the French basic and hence there was no lack of fair basis.

Mr Kelson also submitted that the approach taken by the Federal Court in CCOM to determine priority from a provisional application to a complete was applicable to the determination of priority of a divisional from a foreign basic application.  The Court recognised that in going from a provisional to a complete, greater definition of the invention as a result of further experimentation may be necessary.  In this regard he referred to the passage from the Coopers case (supra) which was cited at page 38450 of CCOM.  In Mr Kelson's submission the change in wording from the basic to the parent to the divisional reflected different theories about the operation of the formulation but did not change the nature of the formulation itself.  It was not necessary to describe the mechanism of action of the active ingredient in detail, but enough detail had to be provided to enable the appropriate addressee to perform the invention.

Mr Kelson stressed that if Roussel-Uclaf was wrong, and the claims of the divisional were not entitled to the earliest priority date, they could be amended to be so entitled.  Dr Bennett however contended that no amendment was possible.

Novelty

While Dr Bennett contended the application in suit was entitled only to the priority date of August 1984, she submitted that the invention was not novel even at the earliest priority date.  By August 1984 the claims were clearly anticipated, and Mr Kelson conceded that by this time several pour ons containing synthetic pyrethroids were on the market in Australia.

In Dr Bennett's view the essential integers of the invention were the use of synthetic pyrethroids in a "pour on" technique, and hence any published prior art document disclosing those integers was an anticipation by reverse infringement according to the Nicaro test (Nicaro Holdings Pty Ltd and Others v Martin Engineering Co and Another 16IPR 545), following Meyers TaylorPty Ltd v Vicarr Industries Ltd (1977) 137 CLR 228.

Dr Bennett directed my attention in particular to 3 exhibits annexed to Mr O'Connor's declaration of 4 August 1989 in support of her submissions.  Exhibit JDOC-6 is a copy of Australian patent 499291 in the name of The Wellcome Foundation Limited (Wellcome).  Exhibit JDOC-52 to Mr O'Connor's declaration of 4 December 1990 shows that this patent became OPI in Australia on 11 November 1976.  This patent is directed to a method of repelling insects in domestic mammals by localised applications one of which is a "pour on" application.  Dr Bennett submitted that this patent was a direct anticipation by reverse infringement when the particular insects are regarded as mechanical equivalents of the parasites of the application in suit.

Exhibit JDOC-8 is another Australian patent to Wellcome, no. 512901, which the evidence shows was published on 28 June 1979.  Dr Bennett submitted that this was also a direct anticipation since it was directed to a method of controlling parasites, specifically acarine ectoparasites, in mammals using various methods of application including the "pour on" method.

Dr Bennett also referred me to Exhibit JDOC-11, which is a copy of Australian patent application 33670/78 also to Wellcome, and which was published on 6 September 1979.  She contended that this was also a direct anticipation since it disclosed the application of a synthetic pyrethroid by the "pour on" method to treat sheep lice.

On the question of novelty Mr Kelson again referred me to the CCOM decision (supra) at page 38453 and its adoption of the principles in Nicaro and Myers Taylor (supra).  However he pointed out that, to constitute anticipation, there must be clear and unmistakeable directions to do something and not merely a signpost.  In his view the citations raised by Dr Bennett did not anticipate the invention according to this test.

In particular Mr Kelson considered that JDOC-6 taught a repellant effect with respect to diptera and the medium was not specified.  Although an example of a "pour on" was given, there was no evidence that it was actually tested.  He submitted that JDOC-11 did not teach the invention since it was directed to a potentiation effect between pyrethroids and carbamates.  Regarding JDOC-8, Mr Kelson pointed out that the present application was the subject of considerable discussion with respect to the parent case, and he referred me to the first page of a letter from Callinan and Associates to the Commissioner dated 11 January 1985, which is part of Exhibit JDOC-3.

If the priority date was 1984, Dr Bennett referred me to all of the Exhibits after JDOC-12 annexed to Mr O'Connor's declaration of 4 August 1989.  She indicated that Shell relied on each article individually as an anticipation.  In particular Dr Bennett referred to Exhibit JDOC-13, a copy of Australian patent application 50931/79 to Shell, published on 27 March 1980, and Exhibit JDOC-28, a copy of GB patent 206547 to Roussel-Uclaf, which was OPI at the Australian Patent Office on 4 September 1981.

While Mr Kelson conceded that the novelty of the claims in suit may be a problem if they took as their priority date August 1984, he warned against extrapolation of information contained in some of the documents put in as evidence by the opponent.  In particular he referred to Exhibit JDOC-48, an article from the March/April 1981 edition of Wool Technology and Sheep Breeding which was published in Australia on 5 June 1981.  The passage in column 3 at page 19 reads as follows:

"Pour-on formulations for the control of lice and warble fly on cattle have been available for several years.  To date no pour-on product has been successfully developed and marketed for external parasite control on sheep in Australia."

In Mr Kelson's submission this illustrated that extrapolation from one type of pour on to another was not permissible.

Obviousness

In Dr Bennett's submission the use of known products (synthetic pyrethroids) with known properties (control of parasites) in a known method (pour-on) did not constitute a new combination and hence the invention was obvious.  She pointed out that it was not enough to put together two things which had not been done before, but, following Winnerand Another v Ammar Holdings Pty Ltd 25 IPR 273, there must be some "new working" to constitute an invention.

Dr Bennett pointed out the Noble declaration provided evidence of the common general knowledge of the art in Australia prior to December 1979 and that there was no rebuttal of this evidence.  For example the Noble declaration was evidence it was common general knowledge prior to December 1979 that ectoparasites could be controlled in livestock by "pour on" methods and that synthetic pyrethroids could be used to control ectoparasites.  In Dr Bennett's submission, and relying on the Noble declaration, each claim was obvious at the earliest priority date and the claims were obvious to all by August 1984.

In response Mr Kelson pointed out that the onus was on the opponent to establish the common general knowledge at the relevant date.  In his view the opponent had not done this sufficiently to show that the hypothetical unskilled, unimaginative technician would be lead from that knowledge to the claimed invention.  He cautioned against using hindsight to draw conclusions.

Mr Kelson submitted that, while the "pour on" method and its advantages were known, no pyrethroid had been used in a "pour on" in Australia by December 1979.  Since pyrethroids were known to be not systemic, in his view a person skilled in the art would be dissuaded from trying to use the "pour on" method for pyrethroids.  To support his argument Mr Kelson again referred to Exhibit JDOC-48, which indicated that no pour ons had been successfully developed for external parasites on sheep in Australia.
Mr Kelson did concede that, as stated in paragraph 59 of the Noble declaration, by August 1984 there were several "pour on" formulations containing synthetic pyrethroids on the market in Australia.

decision

In order to resolve the issues in this opposition I must first determine the priority date of the claims of the application in suit.  Mr Kelson contended that the claims are entitled to the earliest priority date, which is the date of filing of the French basic (10 December 1979).  However Dr Bennett argued that the earliest possible priority date is 3 August 1984, the date of filing the amendments to the parent.  Both parties agreed that the ascertainment of the correct priority date involved a consideration of fair basing.

Fair Basis

There have been several recent Court decisions where the issue of fair basis has arisen.  Both parties referred me to the CCOM decision (supra) where the Federal Court considered whether there was "a real and reasonably clear disclosure" in a provisional specification of the matter claimed in a petty patent claim (see, for example, page 38452), or whether the claim was "plainly foreshadowed" in the disclosure (page 38450).  I would agree with Mr Kelson that the approach adopted in CCOM is applicable to the present situation in determining priority from a foreign basic application.

In order to determine whether the claims of the divisional are fairly based on the basic application, I must compare the claims of the divisional with the disclosure in the basic, as required by the statute.  The French basic (Exhibit JDOC-1) at page 1 indicates the invention relates to compositions for controlling parasites in warm-blooded animals.  The compositions contain at least one of a class of synthetic pyrethroids, which class includes the compounds of formula (1) of the divisional.  The basic application acknowledges, at page 7, that the compounds are known and that they have pesticidal, including acaricidal, properties.  At pages 7-8 it indicates it has been discovered that the "pour on" method of administration of the compositions produces excellent results, and admits that method is known.  The following passage then appears at page 8:

"It is known that this method consists in painting a small surface, preferably the dorsal spine of the body of the animal, with a solution containing an active product, in order to make the active product enter the general circulation of the animal's body and thus achieve an effect on the whole body of the animal.

However, this method is not general, and can only be used for chemical compounds capable of passing through the cutaneous barrier and entering the general circulation, whilst keeping their activity...."

The description at page 10 indicates the compositions can be applied to all warm-blooded animals, including sheep, and that they can be used to combat both internal and external parasites.  It continues:

"The vehicle enabling the active substance to pass through the cutaneous barrier refers particularly to solutions, preferably oily solutions, containing a dispersing agent, such as dimethylformamide, dimethylsulphoxide or dimethylacetamide or other agents known in the pharmaceutical industry for facilitating penetration of the cutaneous barrier..."

Claim 1 is directed to compositions and is couched in similar terms to the description at pages 1-5.  It ends with the statement corresponding to the description at page 5 that the compositions are "in an appropriate vehicle enabling the composition to pass through the cutaneous barrier."  Claims 2-9 further characterise the active agent, claims 10 and 11 refer to the vehicle, claim 12 is directed to pharmaceutical compositions and claim 13 refers to the use of the compositions for controlling parasites.

Turning now to the claims of the application in suit, I note they are all directed to methods of treating sheep to control parasites by the "pour on" method using compounds of formula (1).  While claims 2 and 3 do not specifically refer to the "pour on" method, I believe this method is implicit in the wording of the claims, especially in view of the description in the specification spanning pages 7 and 8.  Thus far there seems to me to be a disclosure in the French basic of the matter claimed.

However, as Dr Bennett pointed out and as Mr Kelson conceded, there were some changes between the French basic and the divisional.  In considering claim 1 there seem to me to be 3 main points of departure from the basic application:

1)It is restricted to sheep

2)The parasites are on the sheep

3)It does not require a vehicle.

In relation to difference (1), it is possible that sheep could be regarded as a more specific form of the warm-blooded animals of the basic and, especially in view of the disclosure at page 10 of the basic, would lead by a process of selection to the limitation in claim 1.  However there is only a single reference to sheep in the basic and that is in the general context of all warm-blooded animals.  I note that all the examples in the basic refer to the treatment of calves, cattle or cows.  Therefore I am inclined to think that the limitation to sheep represents a departure from the idea of the invention disclosed in the basic.  This conclusion is also supported by the reasons given later in this decision under the consideration of novelty.  Hence I believe the restriction to sheep could result in a lack of fair basis of the claims.

In relation to differences (2) and (3), Dr Bennett submitted that these lead to an entirely different invention from that disclosed in the basic.  Mr Kelson considered they merely represented further definition of the invention or related to the operation of the formulation rather than to the formulation itself.  In my view the invention disclosed in the French basic is quite clear.  It relates to a composition in which the active agent is applied in a pour on method with a vehicle which enables the composition to pass through the cutaneous barrier.  I do not believe that such a disclosure plainly foreshadows the use of the active agent without any vehicle whatsoever, and I would agree with Dr Bennett that there is no " real and reasonably clear disclosure" of claim 1.  Hence claim 1 is not fairly based on the disclosure in the French basic.

While considering claim 1, there are two section 40 matters raised by Dr Bennett that I should determine.  The first concerns the reference to the "pour on" method "as herein defined".  I agree with Dr Bennett that there is no clear definition in the specification of such a method, and hence there is a clarity problem with the claim.  There is some description at pages 7-8 of this method, but this description is not clearly tied to the "definition" required in claim 1.

The second matter concerns the internal fair basis of the claim in view of the fact that it does not require the presence of a vehicle.  While I do not think the specification is clear as to whether a vehicle is essential, the description of the pour on method at page 7 refers to the use of "a solution containing active compounds".  Also the fact that the method is a pour on means that the formulation must be a liquid, and there is no evidence before me to establish that all the compounds of Formula (1) are liquids.  Therefore I am inclined to think this means the compounds cannot be used without a vehicle, and hence claim 1 is not fairly based on the disclosure within the specification.

Turning now to claim 2, this claim does include the presence of a vehicle.  The vehicle is defined at page 9 as "a vehicle which is capable of permitting migration of the active principle (sic) relative to the skin of the animal".  The specification gives no indication of what such "migration" encompasses.  Does it include penetration of the cutaneous barrier?  Mr Noble highlights the problems of the term "migration relative to the skin" at paragraph 64 of his declaration.  He states that the specified solvents "do not both penetrate and spread on the hides of warm-blooded animals in the same way" and, in his opinion, "liquids which penetrate the skin of an animal are different from liquids which spread over the skin or through the hair or fleece of an animal".

The French basic is very specific in its reference to a vehicle which enables the composition to pass through the cutaneous barrier.  I do not think this reasonably foreshadows a vehicle which permits any type of migration whatsoever.  I do not agree with Mr Kelson that the "migration" is a result of "further experimentation" as described in the Coopers case (supra at page 29). The generality of expression seems to me to be in the specification under consideration rather than in the French basic. Therefore I believe claim 2 is also not fairly based on the disclosure in the French basic.
I have referred above to my difficulty in the interpretation of the term "migration".  I believe this results in claim 2 lacking clarity.  Some further description of what the term "migration" encompasses would seem to be necessary to avoid any ambiguity in the interpretation of claim 2.

Claim 3 is essentially the same as claim 2 except that the vehicle is specified.  I note in passing that there is a clarity problem in this claim in its reference to "said vehicle", which has no antecedent either in the claim itself or in claim 1.

From a reading of the whole specification it seems to me that the vehicle of claim 3 is the "appropriate vehicle" of claim 2, that is, one which permits migration of the active agent relative to the skin of the animal.  Hence, for the same reasons as for claim 2, claim 3 is not fairly based on the French basic.

I note that some of the vehicles stated in claim 3, namely oils, are specifically mentioned in the French basic.  However the basic clearly states at page 10:

"The vehicle enabling the active substance to pass through the cutaneous barrier refers particularly to solutions, preferably oily solutions, containing a dispersing agent, such as dimethylformamide, dimethyl sulphoxide or dimethylacetamide or other agents known in the pharmaceutical industry for facilitating penetration of the cutaneous barrier...."

I agree with Dr Bennett that a reading of the French basic would not "lead readily, or by process of selection" (per Fox J in the Coopers case at page 29) to what is set out in claim 3. Therefore claim 3, even in its reference to "oils" is not fairly based on the French basic.

The remainder of the claims are all dependent claims and hence none of them are fairly based.  Therefore I conclude that the claims cannot take as their priority date 10 December 1979.

I must now consider whether the claims of the divisional can take the filing date of the parent (9 December 1980) as their priority date.  I note first of all that the parent refers to the treatment of warm-blooded animals and is not restricted to sheep.  For the same reasons as I have mentioned above in regard to the French basic, there seems to me to be a departure in the claims of the divisional from the invention disclosed in the parent.  The restriction to sheep may result in a lack of fair basis of the claims of the divisional.

It seems to me that the parent (Exhibit JDOC-2) as filed corresponds to the French basic except in the following:

a)It is directed to methods of treatment of warm-blooded animals infested with parasites rather than to compositions for such treatment

b)The function of the vehicle is not stated i.e. there is no requirement that the vehicle enables the active substance to pass through the cutaneous barrier

c)The exemplified vehicles are broader in scope and correspond to those in the divisional.

In my view the invention disclosed in the parent as filed concerns the treatment of warm-blooded animals infested with parasites by the "pour on" method using synthetic pyrethroids in an appropriate vehicle.  I do not believe this method plainly foreshadows a method of treatment where no vehicle is used and hence claim 1 of the divisional is not fairly based on the parent.  Since the function of the vehicle has not been explained in the parent, and there is no evidence on this point, I find it hard to decide whether the parent as filed provides a real and reasonably clear disclosure of a method of treatment wherein the active agent is administered in a vehicle which permits migration relative to the skin, as required by claims 2 and 3.

I find some guidance in the Coopers case (supra).  There the issue concerned the fair basis of a petty patent claim on the disclosure of a provisional.  This case also related to a pour on formulation for controlling sheep lice using a synthetic pyrethroid in a carrier.  The CCOM decision (supra) refers to it at page 38452 as follows:

"There the claim in the petty patent for the formulation including DGBE as a carrier could not be regarded as a more specific application of what was claimed in the provisional specification; rather it was the result of further experimentation and was properly regarded as involving an inventive step beyond the disclosure in the provisional specification.  Whilst some generality of expression in the provisional specification was acceptable, nevertheless a reading or study of it would not lead by a process of selection to that which was later claimed."

The situation seems to be similar in the present case and hence I am inclined to agree with Dr Bennett that the requirement for the vehicle to permit migration relative to the skin brings something new into the combination and is not, as Mr Kelson submitted, merely "greater definition, as a result of further experimentation" (Coopers case (supra) at page 27). Therefore claims 2 and 3, and hence all the claims of the divisional, are not fairly based on the parent as filed.

As Dr Bennett pointed out, and as shown in Exhibit JDOC-3, amendment of the parent to bring in the concept of migration relative to the skin was first proposed in the statement of amendments filed on 3 August 1984.  Therefore I conclude that claims 2 and 3 of the divisional, and claims dependent thereon, take as their earliest priority date 3 August 1984.  Since claim 1 does not require a vehicle, I conclude that its priority date is the date of filing of the divisional, namely 6 August 1984.  Alternatively if the claims of the divisional cannot depend on the parent because of the limitation to sheep, all claims of the divisional must take 6 August 1984 as their priority date.

Novelty

Both parties agreed the test for novelty is the so-called "reverse infringement" test as set out in the Myers Taylor case (supra) at page 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..."

The invention is claimed as a combination and hence, to constitute an anticipation, a prior document must disclose all the essential integers of that combination:

"to establish infringement of a combination patent the patentee must show that the defendant has taken each and every one of the essential integers of the plaintiff's claim; if on its true construction the claim is for a particular combination of integers and the alleged infringer omits one of them, the infringer escapes liability...."

per Gummow J in Nicaro v Martin (supra).

Therefore I must first determine the essential features of the combination.  In Dr Bennett's view this was the use of a known synthetic pyrethroid in a pour on method.  However Mr Kelson seemed to regard this as too general, indicating that the invention lay in a method of controlling parasites in sheep using the pour on method by the administration of a compound of the formula (1) specified in claim 1.  There is no dispute between the parties, and I agree, that the combination must include as essential features at least the administration of certain synthetic pyrethroids by the pour on method.  These features are present in all the claims although, as I have mentioned above, the pour on method is implicit in claims 2 and 3 rather than being explicitly stated.

I am inclined to agree with Mr Kelson that the combination claimed is not limited to these two essential features.  It seems to me that all the claims are directed to the control of parasites, and the description in the specification confirms this.  I do agree, however, with Dr Bennett that the particular parasite is unimportant, and this is supported by the specification at page 9 where reference is made, at lines 8-9, to the invention enabling "parasites to be combated".  Therefore, as Dr Bennett submitted, the particular parasite is an inessential feature and different parasites could be regarded as mechanical equivalents.

I also believe that another essential feature of the combination concerns the animal to be treated.  The entire specification and claims refer solely to the treatment of sheep.  There is no suggestion that the method described and claimed can be used to treat any other animal.  Dr Bennett argued that the animal to be treated was an inessential feature and hence any prior art published document which discloses a synthetic pyrethroid used in a pour on method is an anticipation by reverse infringement.  I cannot agree with this contention.  The decision of Willcox J in Coopers Animal Health Australia Ltd v Western Stock Distributors Ltd 6 IPR 545 gives a comprehensive description, at pages 549-554, of the development of pour ons for sheep, and indicates that it was not simply a matter of using the same formulations as had been used for cattle and applying them to sheep.

Mr Kelson also referred me to a passage in JDOC-48 (quoted previously) which tends to support this view.  I note also a passage at pages 2-3 of Australian patent 539105 (Exhibit JDOC-17) which highlights the difficulties of using known paracitides in pour on formulations for sheep.  Therefore I consider that, to constitute anticipation, a prior art document must show the use of a synthetic pyrethroid in a pour on method to combat parasites in sheep.

I have found that all the claims must take as their priority date August 1984 and therefore I can consider any document published in Australia up to that time.  I will consider first the documents to which Dr Bennett made specific reference.

Australian patent 499291 (Exhibit JDOC-6) discloses methods of repelling insects of the order Diptera in domestic animals, including sheep, using a synthetic pyrethroid in
formulations which include pour on formulations.  While this patent prima facie discloses all the essential features of the invention, I would agree with Mr Kelson that the disclosure is merely a signpost to the invention and does not contain clear and unmistakeable directions to carry out the particular invention claimed in the application in suit.  In reaching this conclusion I have had regard to the decision in General Tyre & Rubber Co v Firestone Tyre & Rubber Co Ltd [1972] RPC 457, which was cited with approval in the Nicaro case (supra). The English Court of Appeal, in dealing with anticipation by prior publication, stated at page 485-6:

"If...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 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."

It seems to me that a reading of patent 499291 would not necessarily teach the reader to use a pyrethroid in a pour on formulation to treat sheep.  It would be at least as likely to direct the reader to use a pyrethroid in a formulation other than a pour on (eg a dust or spray) to treat an animal other than sheep (eg cattle).  Hence there is no anticipation.
Australian patent 512901 (Exhibit JDOC-8) concerns a method of controlling acarine parasites in mammals, including a specific exemplification of sheep, using synthetic pyrethroids.  The method of application can include a pour on, but this method is not exemplified or described in any detail, and is merely one of a list of standard methods of application.  I therefore agree with Mr Kelson that this document does not constitute an anticipation but again could be regarded as a "signpost".

Australian application 33670/78 (Exhibit JDOC-11) concerns a method of controlling ectoparasites in mammals, including sheep, using synthetic pyrethroids in formulations, including a specific example of a pour on formulation.  However, as Mr Kelson pointed out, the thrust of the invention concerns a potentiation effect between pyrethroids and carbamates.  Also there is no particular reference to the use of a pour on formulation with sheep.  Therefore again I conclude that this application does not constitute an anticipation.

Australian application 50931/79 (Exhibit JDOC-13) is directed to an animal ear tag and does not refer to any pour on formulations.  While Dr Bennett submitted that the ear tag worked in the same way as a pour on, I do not consider that it would constitute an anticipation by "reverse infringement".

Great Britain patent 2065475 (Exhibit JDOC-28) concerns the control of parasites in warm blooded animals, including sheep, using a synthetic pyrethroid in a pour on method.  While this patent discloses all the essential features of the present invention, I do not think it constitutes a direct anticipation since it merely refers to sheep in the context of "all warm-blooded animals and especially stock animals such as, for example, cattle, sheep or pigs", and all the examples refer to cattle, calves or cows.  In view of what I have mentioned above concerning the difficulties in adapting pour ons for use in sheep, I do not believe this patent contains clear and unmistakeable directions to use the pour on described in sheep.

Exhibit JDOC -15 is a copy of Australian patent application 77004/81 to Wellcome.  It was published on 27 May 1982.  It describes a method of controlling sheep ectoparasites by localised application of a synthetic pyrethroid.  The specification describes "localised application" at page 3 as meaning "the pyrethroid is only applied to a minor portion of the skin or fleece of the sheep, generally a line or spot on the sheep's back."  The description at page 4 indicates that the preferable mode of application is by pour on.  There are also specific examples of the treatment of sheep by the pour on method.  I therefore consider that application 77004/81 constitutes an anticipation since it contains clear and unmistakeable directions to do what Roussel-Uclaf claims to have invented.  More specifically I consider that all the claims are anticipated since the additional features specified in some claims, such as the presence of a vehicle or dispersing agent, are not essential features of the invention.

For similar reasons I consider that Australian patent 539105 to Wellcome (Exhibit JDOC-17), published on 12 April 1984, Australian patent 546672 to Cooper's Animal Health Australia Limited (Exhibit JDOC-18), published on 24 March 1983, and Australian application 91850/82 to Wellcome (Exhibit JDOC-19), published 24 March 1983, all anticipate the present invention since they all describe pour on formulations containing synthetic pyrethroids for treating ectoparasites in sheep.  I note that all of these citations were published before August 1984, the priority date I have concluded all the claims must take.  However none of them were published before 10 December 1979, the date the applicant asserted was the priority date.

Obviousness

The consideration of obviousness under the 1952 Act involves a determination of the common general knowledge in the art in Australia at the priority date of the claims:

"...the question of obviousness involves asking the question whether the invention would have been obvious to a non-inventive worker in the field, equipped with the common general knowledge in that particular field as at the priority date, without regard to documents in existence but not part of such common general knowledge."

per Aickin J in The Wellcome Foundation v VR Laboratories (1981) 55 ALJR at 251.

The specification admits, at page 7, that the synthetic pyrethroids had known pesticidal properties and had been used to control parasites in warm-blooded animals.  Mr Noble's declaration, which contains the only evidence as to the common general knowledge in Australia, refers, at paragraphs 40-45, to synthetic pyrethroids commercially available before December 1979 and their use as insecticides.  At paragraph 53 he indicates it was common general knowledge in Australia prior to December 1979 that synthetic pyrethroid formulations could be used to control ectoparasites.

The specification also admits at page 7 that the "pour on" method was known, and this is again supported by paragraphs 47, 51 and 53 of the Noble declaration.  In particular Mr Noble states in paragraph 53 it was common general knowledge in Australia prior to December 1979 that "ectoparasites could be controlled in livestock by the "pour on" method."

Dr Bennett submitted that the invention was obvious since it merely involved the putting together of known integers with no "new working".  In a combination patent I must consider the combination as a whole to determine obviousness:

"Where questions of inventiveness arise in respect of a combination patent it is the inventiveness of the combination as a whole that must be examined; it is impermissible to determine inventiveness by a piecemeal examination integer by integer..."

per Lockhart J in Elconnex Pty Ltd v Gerard Industries Pty Ltd 25 IPR 173 at page 184.

I do not have to decide whether there was any "new working" between the integers of the combination in 1979.  Rather I must determine whether the invention was obvious by 1984.  Paragraphs 54-59 of the Noble declaration refer to pour on formulations containing synthetic pyrethroids that were commercially available in Australia prior to August 1984.  Some of these were described in standard texts referred to by people skilled in the pesticide art.  Mr Kelson for the applicant did not dispute this evidence.  In my view there can be nothing inventive in using known compounds in a known method to achieve a known result.  Therefore it seems clear to me that the combination, at least as claimed in claim 1, was obvious by 6 August 1984, the priority date I have decided that claim must take.

The remainder of the claims concern the use of a known vehicle or the addition of a known dispersing agent.  Mr Noble states, in paragraph 63 of his declaration that the selection of a suitable solvent would have been "a matter of routine" for a pesticide formulator in Australia in 1979.  At paragraph 72 Mr Noble refers to the inclusion of a dispersing agent in a pour on formulation as being part of the common general knowledge in the art in Australia prior to 1979.  Therefore I conclude that all the claims were obvious by the priority date August 1984.

summary

I have found that none of the claims can take as their priority date the date of filing either of the basic application or of parent application.  Instead they must take as their priority date the date of filing of the divisional (claim 1 at least) or possibly the date of filing of amendments to the parent.  Consequent upon this, all the claims lack novelty and are obvious.

I have also found that claim 1 is not fairly based on the disclosure within the specification in that it does not include the presence of a vehicle.  There are also clarity problems concerning the definition of the pour on method, the meaning of the term "migration relative to the skin", and the reference to a vehicle in claim 3.

In Dr Bennett's view the specification could not be amended to overcome the deficiencies.  Mr Kelson submitted that amendment was possible.  While I am doubtful that the specification can be amended to fully overcome the problems with the priority date, nevertheless I allow the applicant 60 days to propose suitable amendments to try to overcome the deficiencies.

costs

In actions of this kind costs usually follow the event.  I see no reason to depart from that practice in this case.  Therefore I award costs against the applicant, Roussel-Uclaf, and in favour of the opponent, Shell.

Janet Werner
Delegate of the Commissioner of Patents

Patent attorneys for the applicant  :  Callinan Lawrie, Melbourne

Patent attorneys for the opponent   :  Spruson & Ferguson, Sydney