Coopers Animal Health Australia Ltd. v. Western Stock Distributors Pty. Ltd.

[1986] APO 15

In the Matter of the Patents Act 1952

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In the Matter of the Extension of Term of Petty Patent No. 541447 in the Name of COOPERS ANIMAL HEALTH AUSTRALIA LTD.

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In the Matter of Notice under Section 68B(3) by WESTERN STOCK DISTRIBUTORS PTY. LTD.

REASONS FOR DECISION BY A SUPERVISING EXAMINER OF PATENTS:
Decision
         On 31 January, 1986 I issued a decision in which I granted an extension of the term of petty patent No. 541447 and I indicated reasons for my decision would issue later.  What follows are those reasons.
Background
         Petty patent specification No. 541447 was lodged on 17 September, 1984 in the name of WELLCOME AUSTRALIA LTD. (WELLCOME) and it was sealed on 31 January, 1985.  This petty patent is a further application under S.51 based on original application No. 546672 (91851/82) which is also a further application based on application No. 529748 (77004/81).  The latter application was initially accompanied by provisional specification No. PE6592 which was lodged on 21 November, 1980.
         An assignment of the petty patent to COOPERS ANIMAL HEALTH AUSTRALIA LTD. (COOPERS) was registered on 6 March, 1985.
         A notice in accordance with sub‑section 68B(3) was filed on 11 September, 1985 by WESTERN STOCK DISTRIBUTORS PTY. LTD. (WESTERN) and on 4 October, 1985 the patentee made an application in accordance with sub‑section

68B(1) for an extension of the term of the petty patent.  Consequently both the patentee and the informant were represented at a hearing in respect of the above matters on 15 November, 1985.
         At the hearing the patentee was represented by Mr. W.M. Gummow Q.C. instructed by Dr. M. Horner, patent attorney of Griffith, Hassel & Frazer, and assisted by Mr. M. Cooper and Mr. M. Lindsey of COOPERS.
         WESTERN was represented by Mr. R. Wray, patent attorney of Wray & Associates.
Specification
         The invention relates to a pour‑on formulation, particularly for use on merino sheep.
         The pour‑on method of application is well established for cattle.  This method involves the application of a concentrated parasiticidal formulation to the head or back of the animal to give protection over the whole animal.  Attempts to produce a corresponding pour‑on for sheep met with disappointing results for a large number of established parasiticides.  However the pyrethroids proved to be surprisingly effective in controlling sheep ectoparasites when applied by the pour‑on method.
         The  invention is then described in similar terms to those found in the claim.  In the claim the term "localised application" means that the pyrethroid is only applied to a minor portion (relative to the area of infestation) of the skin or fleece of the sheep, generally as a line or spot on the sheep's back.  For example, it is not necessary to totally immerse the sheep in the formulation to control lice which infest the entire surface of the sheep.  The formulation may be applied to a full‑woolled or sheared sheep.  The specification continues as follows:

"Diethylene glycol mono‑n‑butyl ether (i.e. 2‑(2‑butoxy‑

ethoxy)‑ethanol) has been found to be particularly useful.  It has minimal adverse effect on the skin in terms of the mild epidermal shedding seen with other solvents in some sheep.  It also exhibits good spreading over the skin and fleece of the sheep."

For convenience I will refer to the above compound as DGBE.
         The specific examples describe the effectiveness of several known insecticides as pour‑on formulations for controlling sheep lice as well as similarly describing the evaluation of a variety of pyrethroids in the control of lice and keds on merino sheep.  Testing of formulations of deltamethrin in a variety of solvents including DGBE containing solvents is described.  Several specific formulations which include deltamethrin as the pyrethroid are also described.
         The claim defining the invention reads as follows:

"A pour‑on formulation for localised application, which comprises a pyrethroid of the formula

OCH ‑ O ‑ M

R1

X5

X1

whereinM is ‑ CO ‑ CH ‑‑ CH ‑ CH = C

X2

C

CH3  CH3

X1

‑ CO ‑ CH ‑‑ CH ‑ CH ‑ C

X2

CX3   X4

CH3   CH3  or

‑ CO ‑ CH ‑ R2

CH

CH3    CH3

and wherein X1 to X4 are independently selected from halo,

C1‑C4 alkyl, halogen‑substituted C1‑C4 phenyl;

X5 is ‑H or halo;

R1 is ‑H or cyano; and

R2 is halogen‑substituted phenyl;

in admixture with a topically acceptable carrier comprising at least 50 wt % of diethylene glycol mono‑butyl ether."

Notice and Statement of Facts
         The notice filed on behalf of the informant under S.68B(3) gave notice of the following facts:

"(a)the use of the invention the subject of the claim of the petty patent at a field day held at the Eurella Station, Mitchell, Queensland on the 16th September, 1980 as reported in the "Queensland Country Life" issue of the 25th September, 1980.  A photocopy of the relevant part of the newspaper is enclosed together with a copy of a letter dated 16th August, 1985 from the Managing Editor of "Queensland Country Life".

(b)the statutory  declarations filed as Evidence in Support by all the Opponents in respect of the Opposition to Australian Patent Application No. 529748 from which Petty Patent No. 541447 was divided.

(c)the admission by the Applicant now known as Coopers Animal Health Australia Limited in the statutory declarations filed as the Applicant's Evidence in Answer in the Opposition to Patent Application No. 529748 to the effect that the invention the subject of Patent Application No. 529748 and hence the invention the subject of the petty patent was used in a number of field trials conducted prior to the priority date of the claim of the petty patent."

Evidence
         Prior to the hearing the attorney representing the patentee lodged a letter in response to this statement of facts which included an unsworn affidavit made by Robert Bruce Townsend accompanied by one exhibit and an unsworn affidavit made by Ian Hamilton Pitman.  At the hearing Mr. Gummow lodged sworn copies of both affidavits.
         Mr. Townsend is one of the inventors of the petty patent and in his affidavit he describes the development of a sheep pour‑on formulation which used the same solvent system as that which was used on cattle.  This product is sold under the trade mark CLOUT.  During the pre‑marketing trial work and after the launch of CLOUT it became apparent that a skin reaction was sometimes occurring on the sheep and this reaction was found to be due to the solvent system used.  A number of solvent systems were tested and Mr. Townsend concluded that DGBE was a unique solvent for a pour‑on formulation intended for application to the back of sheep.
         The exhibit lodged with the affidavit is a copy of a paper entitled "Effects of a pour‑on insecticidal formulation on sheep skin" which was published in the Australian Veterinary Journal in 1984 and which was co‑
authored by Dr. Pitman.
         Dr. Pitman is the Dean at the School of Pharmaceuticals at the Victorian College of Pharmacy Ltd.  In his affidavit Dr. Pitman describes the state of knowledge in Australia in November 1980 concerning sheep skin and the effects of solvents thereon.
Preliminary Submissions
Mr. Wray submitted as a preliminary matter that petty patent No. 541447 had been improperly granted because a Dreyfus situation (44 RPC 291) existed between it and its grandparent application No. 529748. He argued that the lodgement of the petty patent was an attempt to get around the S.59 oppositions which had been raised against this application.
         Mr. Gummow submitted that the granting of the petty patent did not amount to double patenting because application No. 529748 was yet to be sealed.
         I agree with this submission.  In the Dreyfus case the Solicitor‑
General decided that "it was not intended to allow one man to have two grants for the same invention" and in the present situation the fact is that only  petty patent No. 541447 has been granted to COOPERS.
Paragraph (b)
         It is convenient to consider the documents described in paragraph (b) of the statement of facts first.
         Mr. Townsend in his affidavit in this matter states:

"My conclusion from my results was that DGBE is a unique solvent for a pour‑on formulation intended for application to the back of sheep, in particular merino sheep.  DGBE combines the necessary solvent properties and most other required criteria with minimal skin reaction."

I consider that this special property of formulations containing DGBE is adequately described in the petty patent specification despite Mr. Wray's submission to the contrary.  From this description I conclude that the use of DGBE in a pyrethroid formulation contributes to the working of the formulation.
         From my perusal of the many statutory declarations and exhibits which were filed as evidence‑in‑support of the S.59 oppositions to application No. 529748 I consider that there is no evidence which suggests that it was common general knowledge to use DGBE in a topically acceptable carrier in a pyrethroid composition.  Therefore the only documents which I consider relevant to S.100(1)(g) are those which disclose the use of this particular solvent.  Only three documents describe a pyrethroid formulation containing DGBE and they are provisional specification No. PE6592, application No. 529748 and patent No. 517397 and of these I only need consider the last two documents.
         Mr. Wray submitted that it was not clear from the available evidence at what date the special properties of formulations containing DGBE had been discovered.  Whereas Mr. Gummow's submission was that these formulations were first described in provisional specification No. PE6592.  He also directed my attention to exhibit PJK‑4 which is attached to the statutory declaration made by Peter John Kieran and which formed part of WELLCOME'S evidence‑in‑answer to the S.59 oppositions.
         I consider that exhibit PJK‑4 indicates that WELLCOME investigated pyrethroid formulations containing DGBE in 1979.  Provisional specification No. PE6592 was subsequently lodged which included a description of pyrethroid formulations based on DGBE which are stabilised by BHT.  However there is no description which corresponds to the description of the properties of DGBE‑
containing formulations which I have quoted in the summary of the present specification.  The specifications of applications Nos. 546672 and 529748 (i.e. the parent and grandparent of the petty patent respectively) contain a description of the properties of DGBE‑containing formulations in similar terms to the present.  All of these specifications disclose pyrethroid compositions which contain DGBE and include examples wherein decamethrin, also known as deltamethrin, is the pyrethroid and in which DGBE comprisess at least "50 wt %" of the carrier.
         I consider that both petty patent No. 541447 and its parent application No. 546672 comply with the requirements of S.51(1).  It then follows from the preceding description of the disclosures contained in the parent and grandparent that the priority date of the claim of the present petty patent is either the date of lodgement of application No. 529748 or the date of lodgement of provisional specification No. PE6592.  In that case application No. 529748 is no longer relevant in respect of S.100(1)(g).
         With respect to patent No. 517397 Mr. Wray noted in his submissions that amendments had been proposed to the specification during prosecution to include a description of DGBE‑containing formulations.  This amendment to the description was proposed on 27 May 1981 and the amended specification was published when the application was advertised accepted on 30 July, 1981.  The accepted specification describes subject matter which lies within the scope of the claim of the present petty patent. 
         Thus I have to decide whether this subject matter was first disclosed in application No. 517397 or in provisional specification No. PE6592.  Fortunately this is an easy matter to decide because the words of the proposed amendment correspond to some of the words in the provisional specification.  For example BHT is described as a useful stabilising agent for DGBE‑containing formulations in both documents.  Also the specific examples added by the proposed amendment contain the same components in the same proportions as some of those in the provisional specification.  These same embodiments are also described in the petty patent specification.  Therefore I consider that patent No. 517397 does not prior publish nor render not novel the petty patent. Thus I am satisfied that paragraph (b) of the statement of facts does not make out any of the grounds set out in paragraphs 100(1)(b) to (g) of the Act in relation to petty patent No. 541447.
Paragraph (a)
         Paragraph (a) of the statement of facts refers to the issue of "Queensland Country Life" which was published on 25 September, 1980 and it also refers to a letter from the paper's Managing Editor.  A copy of the relevant part of the newspaper was lodged with the statement of facts.
         The newspaper reported on a field day which was held at Euralla Station on 16 September, 1980 where a representative of COOPERS demonstrated a lice control product named CLOUT.  According to the report the representative said that CLOUT contained a pyrethroid as an active ingredient and that it contained a scourable red dye for easy identification.  The method of application was also demonstrated by applying CLOUT to the sheep's back with a drench gun.  I consider that the Managing Editor's letter adds nothing of substance to the report in the newspaper.
         I consider that this report contains insufficient detail to prior publish or render not novel the presently claimed formulation.
However Mr. Wray submitted that the above report demonstrated that the patentee had used the invention before the priority date of the claim. He argued that a field day was a normal commercial situation and as such fell within the scope of the word "used" as accepted by the Court of Appeal in Wheatley's Application ((1985) RPC 91 at page 94). Mr. Wray also asserted that in order to establish prior use of the invention it was not necessary to show that the public found out the components of the formulation at the field day (Cullen v. Wellsbach Light Company of Australasia Ltd. 4 CLR 990).
         Mr. Gummow replied by pointing to the paragraphs in Mr. Townsend's affidavit which read as follows:

"A DGBE‑containing formulation was developed by Wellcome Australia Limited, though never sold.  The reason for this was that a water‑based suspension formulation ("CLOUT‑S") was later developed by Wellcome Australia Limited which was also non‑reactive.  This had marketing benefits in being a non‑solvent formulation.

.....

The pour‑on sold under the trademark CLOUT contains and always has contained a solvent system comprising a mixture of xylene, corn oil and cyclohexanone (i.e. the "WARBEX" system).  At no time has a pour‑on containing DGBE ever been sold or demonstrated to the public by Wellcome Australia Limited or Coopers Animal Health Australia Limited under the CLOUT trademark or any other trademark.  No DGBE‑containing pour‑on has ever been developed by us for the marketplace."

There was no evidence to contradict Mr. Townsend's evidence and in fact Mr. Wray conceded that the product which was demonstrated at the field day was not the same as the formulation which is claimed in the petty patent.
         Thus I consider that the decision in the case of Wheatley's Application is not relevant to what happened at the field day at Euralla Station because any normal commercial activity which took place did not involve the invention which is claimed in the petty patent.
         I also consider that the present situation can be distinguished from that which occurred in the Cullen v. Wellsbach case.  In that case it was clear that the product of the invention was of such a nature that anyone conversant with the subject and applying the common knowledge of the time could, with the aid of the information given by the product itself, have brought about the claimed result.  In the present situation a member of the public may have been able to obtain a sample of CLOUT at the field day.  A subsequent analysis of the formulation's constituents may have revealed that a mixture of xylene, corn oil and cyclohexanone was used as the solvent in the formulation.  However I consider that the knowledge of this solvent mixture would not have lead to the presently claimed formulation.  This is because there is no evidence that it was common general knowledge to use DGBE in a topically acceptable carrier in a pyrethroid composition.
         Therefore I am satisfied that the formulation claimed in the petty patent was not prior used by the demonstration at the field day at Euralla Station.  It follows that I am satisfied that paragraph (a) of the statement of facts does not make out any of the grounds set out in paragraphs 100(1)(b) to (g) of the Act in relation to petty patent No. 541447.
Paragraph (c)
         Paragraph (c) of the statement of facts refers to the admission by WELLCOME in the statutory declarations filed as evidence‑in‑answer to the S.59 oppositions to application No. 529748 that it used the claimed invention in field trials prior to the priority date of the claim of the petty patent.
         It is apparent from the declarations filed as evidence‑in‑answer that field trials were conducted before the priority date and Mr. Wray submitted that it was not clear that these trials had been conducted in a confidential manner.
         Mr. Kieran in his declaration, which forms part of the evidence‑in‑
answer, explains how WELLCOME conducted field trials with CLOUT.  Small scale efficacy trials were conducted in a confidential manner on Bangalla research station, which is operated by WELLCOME.  However it is generally necessary to validate small scale work in field trials to see whether the same results are obtained in practical situations as would be encountered by farmers and graziers.  It is also necessary to provide information relating to safety and efficacy obtained in real life situations to government instrumentalities in order to obtain authorisation to market new products.  Field trials are conducted on properties owned by third parties and the farmers are told that any information given to them is in strict confidence.  WELLCOME also takes all practical steps to hide what it is doing from the public.  Mr. Kieran continues as follows:

"For example, in field tests carried out by Wellcome Australia Limited, it would be our practice to allocate numbers to formulations being tested.  We would not disclose the compositions of formulations unless it were absolutely necessary to do so, for example to alert the property owner to any possible hazards involved or any special precautions or treatments which might be required.  Despite this it is a fact of life that information gleaned from field trials does sometimes leak out to competitors, contrary to our wishes."

I am of the opinion that in order to prove anticipation by prior use by the patentee it is necessary to show that the use was "public use" in the sense of commercial dealing in the claimed formulation.  In arriving at this opinion I rely on the speech of Lord Diplock in the House of Lords in Bristol‑Myers Company (Johnson's) Application 1975 RPC 127 at 157:

"If the inventor, after discovering how to make (a substance), had himself dealt with the substance commercially before applying for a patent for it, he would be disqualified from obtaining a grant; but this was not because of any prior use of it by others, but for the different reason that the invention having been put him to "public use" was no longer a manner of new manufacture within the meaning of the Statute of Monopolies.  For the other mischief against which the Statute was directed was that even monopolies of new manufactures should not extend beyond fourteen years.  If the inventor had already reaped commercial benefit from a de facto monopoly in his discovery owing to his concealment from all other traders of the way in which the new substance could be made, he was not to be permitted to prolong his monopoly for an additional fourteen years.  So "public use" in the sense of commercial dealing in a product claimed as an invention, by any trader even though it were by the inventor himself, rendered invalid any patent for the product claimed ... In the case of use by traders, at any rate, the expression "public use" was not employed to mark the contrast between the public and secret use but to distinguish commercial from experimental use in the course of discovering, perfecting and trying out the invention so as to test its suitability for commercial use ... To sell the product by way of trade, is to "use" it, notwithstanding the seller's ignorance of its identity or his lack of knowledge of its composition or his uncertainty as to how and where further supplies of it could be obtained."

It is apparent from some of the declarations filed as evidence‑in‑
support of the opposition to application No. 529748, that certain individuals appeared to have some knowledge of the field trials of CLOUT.  However it is equally apparent from these declarations that none of the declarants knew of the use of pyrethroid formulations containing DGBE before the present priority date.
         In fact Mr. Townsend in his affidavit in the present matter states that:

"All our work on DGBE‑containing pour‑on formulations has been of a purely experimental nature and has been kept confidential."

Therefore I am satisfied that the field trials of the DGBE‑containing formulation referred to in paragraph (c) of the statement of facts was experimental use in the course of discovering, perfecting and trying out the invention so as to test its suitability for commercial use rather than commercial dealing with the formulation.  It follows that I am satisfied that paragraph (c) of the statement of facts does not make out any of the grounds set out in paragraphs 100(1)(b) to (g) of the Act in relation to petty patent No. 541447.
Summary
         For the reasons given I am not satisfied of the existence in relation to petty patent No. 541447 of any of the grounds set out in paragraphs 100(1)(b) to (g) of the Act.  Consequently on 31 January, 1986 I decided to grant an extension of the term of petty patent No. 541447 under S.68B(5).  I award costs in this matter against the informant WESTERN STOCK DISTRIBUTORS PTY. LTD.

(M. KENDALL)