o CATCHWORDS PATENTS - Validity of petty patent for sheep lousicide - Petty patent preceded by provisional specification, complete specification and amended complete specification - Appropriate priority date - Whether claim of ,.cty patent is fairly based on any earlier specification ~ Novelty - Significance of priority date - Whether invention disclosed by patent for pour-on formulation for the control of other insects - Disclosure in trials of respondent's product - Obviousness - Opinion evidence as to obviousness of various alleged inventive steps - Evidence of people concerned with the question at the time - History of development of product - Utility - Description of active ingredient of formulation includes pyrethroids which are not useful - Lack of specification of appropriate dose - Failure to specify whole of solvent formula. JURISDICTION ~ Revocation of patent - Whether Federal Court of Australia has power to order revocation. Patents Act 1952 ss.6, 6A, 35, 36, 39, 40, 45, 45A, 46, 51, 68A, 68B, 100, 103, 104, 105, 146, 148. Trade Practices Act 1974 ss.52, 53. Federal Court of Australia Act 1976 ss.21, 22, 23, 32. yorastes meee er ee wm Foamy ame oe eee eres ee pee pe eo ee en ere aan ~s a" + a e asia a aN Bailey v_ Robertson [1878] 3 AC 1055, Tate v Haskins (1935) 53 CLR 594, Stoner v Todd [1876] 4 Ch D 58, Dunlop v Cooper . (1908) 7 CLR 146, F Hoffman - La Roche & Co A G v Commissioner of Patents (1969) 123 CLR 529, Re Mond Nickel Company Ltd's Application [1956] RPC 189, Imperial Chemical Industries Ltd's Application [1960] RPC 223, H PM Industries Pty Limited v Gerard Industries Pty Limited (1957) 98 CLR 424, Harwood v Fu, Great Northern Railway Company (1865) 11 HLC 654, Meyers , Taylor Pty Limited v Vicarr Industries Pty Limited (1977) 13 ps Sto aoe Cr a ALR 605, Hill v Evans (1862) 31 LJ Ch 457, Martin and Biro fF . Swan Ltd v_H Millwood Ltd [1956] RPC 125, General Tire Rubber . Company v The Firestone Tyre and Rubber Company Limited [1972] ro RPC 457, Olin Corporation v_ Super Cartridge Co Pty Ltd (1977) a 51 ALJR 525, Griffin v Isaacs (1942) 12 AOJP 739, Windsurfing % International Inc v Petit [1984] 2 NSWLR 196, Beecham Group fr Limited's (Amoxycillin) Application [1980] RPC 261, Tetra : Molectric Ltd v Japan Imports Ltd [1976] RPC 547, Minnesota : Mining and Manufacturing Company v Beiersdorf (Australia) ia Limited (1980) 144 CLR 253, American Cyanamid Company v Berk ' Pharmaceuticals Limited [1976] RPC 231, Interlego AG v Toltoys |. - Pty Ltd (1973) 130 CLR 461, Norton and Gregory Ltd v Jacobs fe (1937) 54 RPC 271, Minerals Separation North America b- Corporation v Noranda Mines Ltd (1952) 69 RPC 81, Needham v Johnson & Co (1884) 1 RPC 49, Electric Musical Industries Ltd v_Lissen Ltd (1938) 56 RPC 23, Welch Perrin & Co Pty Ltd v Worrel (1961) 106 CLR 588 referred to. any tty Se Bean aren meade eke aE ans 3 > NSW G.189 of 1985 COOPERS ANIMAL HEALTH AUSTRALIA LIMITED v_ WESTERN STOCK DISTRIBUTORS PTY LIMITED & ORS is Wilcox J Sydney 22 August 1986 a ae tort nelaes s reer ie . . - 3 - ee . ~ ws IN THE FEDERAL COURT OF AUSTRALIA NEW SOUTH WALES DISTRICT REGISTRY GENERAL DIVISION AND wee ws we wv BETWEEN: BETWEEN : AND: No. G.189 of 1985 COOPERS ANIMAL HEALTH AUSTRALIA LIMITED Applicant WESTERN STOCK DISTRIBUTORS PTY LIMITED First Respondent AUSTRALIAN STOCK DEVELOPMENTS LIMITED Second Respondent CETHANA NOMINEES PTY LIMITED Third Respondent WESTERN STOCK DISTRIBUTORS PTY LIMITED First Cross-Claimant COOPERS ANIMAL HEALTH AUSTRALIA LIMITED Cross-Respondent ame ere $ ' AND BETWEEN: AUSTRALIAN STOCK DEVELOPMENTS LIMITED and CETHANA NOMINEES PTY ' LIMITED Second Cross-Claimant AND: COOPERS ANIMAL HEALTH AUSTRALIA LIMITED Cross—Respondent CORAM: WILCOX J PLACE: SYDNEY DATE: 22 AUGUST 1986 MINUTES OF ORDER THE COURT ORDERS THAT: 1. The Application be dismissed. 2. It be declared that petty patent no.541447 is invalid. 3. Leave be reserved to the respondent, if so advised and upon not less than seven (7) days' notice to the applicant, to apply to the Court for an order pursuant to s.103 of the Patents Act 1952 for the revocation of the said petty patent. wae Saleen ceelll=-teerinca mnie tates teeta inet Renan aa it Note: The applicant pay to the respondents their costs of these proceedings. Settlement and entry of orders is dealt with in Order 36 of the Federal Court Rules. areola oe ve ! IN THE FEDERAL COURT OF AUSTRALIA ) ) NEW SOUTH WALES DISTRICT REGISTRY ) ) ) GENERAL DIVISION BETWEEN : AND: AND BETWEEN: ° AND: No. G.189 of 1985 COOPERS ANIMAL HEALTH AUSTRALIA LIMITED Applicant WESTERN STOCK DISTRIBUTORS PTY LIMITED First Respondent AUSTRALIAN STOCK DEVELOPMENTS LIMITED Second Respondent CETHANA NOMINEES PTY LIMITED Third Respondent WESTERN STOCK DISTRIBUTORS PTY LIMITED First Cross-Claimant COOPERS ANIMAL HEALTH AUSTRALIA LIMITED Cross-—Respondent a meres ee Qe ee epee ee te ee ey AND BETWEEN: AUSTRALIAN STOCK DEVELOPMENTS LIMITED and CETHANA NOMINEES PTY LIMITED Second Cross-Claimant AND: COOPERS ANIMAL HEALTH AUSTRALIA LIMITED Cross-Respondent CORAM : WILCOX J PLACE: SYDNEY DATE: 22 AUGUST 1986 . REASONS FOR JUDGMENT The population of Australia includes some 140 million sheep and, no doubt, an even greater number of biting lice (Damalinia ovis). The propensity of the latter to infest the former represents a continuing problem for graziers. The biting lice feed off the cells of the skin surrounding the emerging wool fibre, thereby directly damaging the fleece. They also cause indirect wool damage by causing the sheep to rub against other objects in an attempt to reduce irritation. Severe infestations may so debilitate a sheep as to affect meat production. Control measures are essential and represent a considerable cost to the grazing industry. sere Sey fey « frahaiat ener tecacarnenrcmammeaPeaptan tance pI eee ap en eee A my OEY ' opoace est cpsee , 1 As I shall elaborate, the currently favoured method of control of lice is by the "pour-on" method, that is the \ application of a small quantity of an insecticide in solution to the back of the sheep. This case arises out of competition ' for the sale of "pour-on" sheep lousicides. The proceedings Coopers Animal Health Australia Limited, the applicant in ti.ese proceedings, is a member of the international Wellcome group of companies. Since February l 1981 it has marketed a pour-on lousicide for sheep known as "Clout" which consists of an active ingredient known as decamethrin or deltamethrin -~ one of the group of chemicals known as pyrethroids -- in a solution of xylene and cyclohexanone with a marking dye. Since late 1982 Coopers has ' also marketed "Clout S", comprising the same active ingredient dissolved in water. . In February 1983 Western Stock Distributors Pty Limited, a Perth based company and the first respondent herein, commenced to market a rival "pour-on" formulation known as "Spurt". At all material times "Spurt" has comprised, as the active ingredient, cypermethrin, which is also a pyrethroid, in a solution of diethylene glycol mono-butyl ether -- referred to in evidence by the abbreviation "DGBE" -- with a marking dye. Since that time we re we eee — ny 'ta eeenebaieaiaieLinte- catered ae ge re po ry tee re ee ee is aati: A a cr ee t "Spurt" and "Clout"/"Clout S" have been in active competition for what is, apparently, a lucrative market. When the proceedings commenced, on 23 July 1985, "Spurt" continued to be distributed by Western Stock Distributors. However, by two agreements dated respectively 6 September 1985 and 24 December 1985 Cethana Nominees Pty Limited, the third respondent, purchased the business and assets of Western Stock Distributors and since 6 January 1986 that company has been the manufacturer and distributor of "Spurt". Cethana Nominees holds its assets in the capacity of trustee of a Unit Trust, the only issued unit of which is held by Australian Stock Developments Limited, the second respondent. On 17 September 1984 Wellcome Australia Limited made application, pursuant to ss.35'' and 36 of the Patents Act 1952, for the grant to it of a petty patent for an invention which it described shortly as "pour-on formulation". The claim defined the invention as "a pour-on formulation for localised application, which comprises a pyrethroid of the formula" as (specified symbolically) "in admixture with a topically acceptable carrier comprising at least 50 wt % of diethylene glycol mono-butyl ether". The petty patent was published and sealed on 31 January 1985. Section 68A of the Patents Act provides that, subject to certain exceptions, the term of a petty patent shall consist of a period of 12 months commencing on the date of the sealing of the patent but s.68B provides for an extension of the term for a further period of six sor ogs + PTT een ne - ° 4, > te ee ee nee eemenns coreemeee ae nee > + a wet wet eee eee me ee ener et re ee eee ee aot e . we 7 soo - . T f oe ie years. In fact, and despite various objections == including that of Western Stock Distributors -- an extension was granted as from 31 January 1986. The petty patent has been assigned" to the applicant, who is currently registered as proprietor. Upon the pleadings there are numerous issues between the parties. The Statement of Claim alleges that the petty patent is in full force and effect and that the respondents have infringed the petty patent. It alleges that the first respondent published various advertisements which falsely represented, amongst other things, that it was at liberty to make and sell ""Spurt" and that any person was at liberty to purchase and to use the product. The representations in those advertisements are said to constitute misleading or deceptive conduct, or conduct likely to mislead or to deceive, within the meaning of s.52 of the Trade Practices Act 1974 and to be false or misleading statements contravening s.53(g) of that Act. By its Further Amended Statement of Claim, filed on 22 April 1986, the applicant alleges that similar misrepresentations were made by the second respondent in a prospectus issued on 11 March 1986, being misleading or deceptive conduct, and that both the second and third respondents have contravened s.53(g) in connection with the marketing of "Spurt". The three respondents do not deny that they published the matter complained of; they contest the implications said to be conveyed. But, in a practical sense, these issues have fallen by the wayside. The respondents now " vs foe op ? , weg ete pee ne oe ee ana ee pee —. concede that ""Spurt" falls within the claim of the petty patent and that, if the petty patent is valid, the applicant is entitled to the relief it seeks: in broad terms, various injunctions and declarations, damages -- or an account of profits --and the delivery up to the applicant for destruction of all material in the possession or control of the respondents the exercise, use or sale of which would be an infringement of the patent. The respondents deny the validity of the petty patent. They resist the relief claimed by the applicant and they cross-claim for an order of revocation of the petty patent. For its part, the applicant does not dispute that, if the patent is invalid, this relief ought to be granted. Thus the only issue is validity, upon which the respondents bear the onus of proof. They have raised three major issues: lack of novelty, obviousness and inutility. Questions arise as to the appropriate priority date for consideration of the first two of these matters. The Wellcome research At one stage biting lice were controlled by the use . of organochlorines, such as DDT and dieldrin. The organochlorine operated systemically, that is it was absorbed into the bloodstream of the animal and was then distributed to all parts of the skin surface, killing the lice. However, in wne- oe we = + epee wen wt Se ere the mid-1960s the use of organochlorine insecticides on sheep was banned. There was concern about the build up of chemical residues in the tissues of the sheep and the risk which such residues posed to consumers of the meat. Thereafter graziers had to rely upon organophosphorus compounds. But the only available products depended upon application being made to the whole of the body of the sheep. The most common techniques were dipping, showering and jetting. Bach technique involved substantial disadvantages. Dips rapidly became polluted, what has been described as a "bacterial suup", so that the dips often caused the outbreak of infections; the more especially when -- as was desirable for maximum effectiveness -- the sheep were dipped immediately after shearing. At that time many sheep bear cuts or abrasions. Showering and jetting were slow and costly, requiring large volumes of insecticide wash to achieve adequate penetration of the fleece. Alternatively, the wash may be recycled, causing the same problem of possible infection. All three techniques are labour intensive operations. All three involve total saturation of the sheep, exposing it to a risk of death through chill in cold weather. The pour-on technique has been used in the control of lice on cattle since the late 1960s; although these lice were of a different species, the sucking louse not the biting louse. The technique involves the control of an ectoparasite infesting the whole of the body of the host animal by the application of the insecticidal formulation only to a small nT) var '* ' cet ee re en er ne eee mere ropes ae Sideista' diitedeeteaetalanearalouatcanamedsedtedeiit adie tate vw Pad ay nt nce pee wee part of that body. An ectoparasite is, of course, a parasite which derives its nourishment from the skin of an animal. Ectoparasites include Damalinia ovis but also other species of insects. In 1969-1970 Bayer launched "Tiguron", a pour-on formulation containing the organophosphorus compound fenthion. The success of this product substantially affected the sales of Cooper cattle sprays, in consequence of which the company developed, and launched in 1971, a pour-on formulation containing the organophosphorus compound famphur in a solution of xylene and cyclohexanone. The company called this product "Warbex". Other chemical companies followed with other organophosphorus formulations. The common feature of all these products is that they were applied locally. They depended upon skin penetration and systemic activity. As was stated in affidavit evidence by Mr S Harvey Langford, a veterinary surgeon who was from 1964-1976 responsible for the development of new animal health products by Coopers: "This approach to lice control in cattle superseded previous methods of treatment such as dipping, hand spraying and spray-race application of insecticides. Thus, by the early 1970s the pour-on method of application was the generally accepted method for the treatment of cattle lice." Mr Langford said that the success of pour-on techniques for the control of lice in cattle "stimulated similar interest in lice control for sheep within the Company". Tests were carried out by persons within the Wellcome group -- in Australia, in the United Kingdom and in same oe Ie er ere, te New Zealand -- concerning the effectiveness of various organophosphorus compounds in a pour-on solution. But the results were disappointing. The group did, for a short period, market in New Zealand a pour-on formulation called "Bash", containing famphur. It was thought that an organophosphate might be more successful in New Zealand, where British breeds predominate, than in Australia, where most sheep are merinos. The merino fleece is heavier and more greasy than that of British breeds. However, even on British ~.eeds, the product proved ineffective and was withdrawn. Mr Langford left Coopers in July 1976. His evidence is that, to that time, "there had been no real progress towards developing an effective sheep pour-on which could work on sheep as a replacement for dipping in the control of lice «+. we were no further forward than we had been when work on the problem started in 1970/71 despite six years of continuous research effort in Australia and overseas". At that time Mr Langford "saw no prospect of marketing a successful sheep pour-on which would work against lice on Australian sheep". However, enter the pyrethroids: a group of chemicals developed from the pyrethins, chemicals derived from the chrysanthemum flower. Pyrethrins have long been known as potent insecticides. The problem is that they are light unstable, that is they break down quickly when exposed to daylight, so that they are unsuitable to be used as the active 10. ingredient in a formulation to be applied to sheep. But, during the 1960s and early 1970s, a group of English researchers succeeded in developing from the pyrethrins a series of synthetic compounds with insecticidal qualities, of which some were light stable. They were called pyrethroids. This success was described by one of the witnesses for the respondents, Professor George Crank, Associate Professor in Organic Chemistry at the University of New South Wales, as "the most outstanding event in insecticidal developments in the last 20 years". The pyrethroids became progressively available during the early to mid 1970s. One of them, permethrin, was used by Mr Langford in 1974 in a field trial of the control of buffalo fly on cattle but neither it nor any other pyrethroid was tried by Coopers, during Mr Langford's time, in a pour-on formulation for the control of lice on sheep. Nonetheless the potential of the new chemicals was soon appreciated. In August 1977 Mr Peter Kieran, a veterinary surgeon, became Veterinary Development Manager of Wellcome Australia. Mr Kieran had read about the pyrethroids in the technical Literature. He knew that they were broad spectrum insecticides, suitable not only for agricultural and botanical use but also for veterinary use. He thought that they had "significant potential in the animal sector". One Wellcome test, in September-December 1976, after the departure of Mr Langford and before the appointment of Mr Kieran, had ete ben alii mes or a oer ll. shown that permethrin was marginally more effective against sheep lice than certain organophosphates but the test was inconclusive. After Mr Kieran's appointment the testing program became concentrated on pyrethroids. The actual tests were carried out by Mr Robert Townsend, a scientist with a background in the control of parasites on livestock, working under the supervision of Mr Kieran. These men were supported by a team of analytical and formulating chemists led by Mr Michael Maguire, a qualified pharmacist. The nature of the tests is relevant to the issue of obviousness, so it is desirable to summarize them. The first tests carried out after Mr Kieran's appointment were in the period November 1977 to January 1978. They were described in the relevant research report as being "to evaluate permethrin and decamethrin in the control of Damalinia ovis on sheep, when applied by the pour-on method. Concurrently, the potentiation of an OP formulation (famphur) by the prior administration of carbon tetrachloride was investigated". The results showed that there was little difference between the famphur potentiated with carbon tetrachloride and famphur alone. In each case the results were only moderately satisfactory. Permethrin was effective only at a dosage of 250 mg per kilogram of sheep body weight; decamethrin at much smaller figures. Decamethrin eliminated lice on short woolled sheep at 10 mg per kilogram and on all sheep at 50 mg per kilogram. All.formulations employed the ""Warbex" solvents: xylene and cyclohexanone. te rn, nen ae rope - - 7 Tay ae Na ee 12. Between July and September 1978 tests were carried out to determine the optimum dose of a formulation of decamethrin, formulated as a pour-on in the "Warbex" solvent system. Mr Townsend found that the chemical was effective at a dosage as low as 5 mg per kilogram. The next step taken by the researchers was to investigate alternative solvents. A series of tests performed in the period December 1978 to February 1979 tried decamethrin in four different solutions: one of which was DGBE with propylene glycol and another the "Warbex" system. Newly shorn sheep being unavailable, the formulations were applied to sheep with eight weeks' wool. The results proved unsatisfactory. Mr Townsend commented that "the wool length of the treated animals biased the trial against all the formulations used". He thought that "the wool length of merino sheep when treated with decamethrin pour-on -may have a critical effect on the efficacy of the insecticide". Over-lapping this last series of tests was another using decamethrin in each of the same four solutions but applied to newly shorn sheep. Although DGBE was reported by Mr Townsend as "the best solvent amongst those selected for study", it was found that, when used in conjunction with propylene glycol, it did not adequately penetrate the wool. 13. ""Warbex" solvent was found more effective. The researchers at this stage prepared what they called "a preliminary specification of requirements for a decamethrin sheep-lice pour-on": that it be effective, dyed for visual aid, packable in plastic, non-flammable and cheap. This list was then expanded to include other features -- including good initial wetting of the skin and good spreadability on the skin -- in what was described as "an ideal specification". In August~Sep.smber 1979 Mr Townsend tested decamethrin in two alternative solutions, applied to newly shorn sheep some of which were affected by mycotic dermatitis. (Mycotic dermatitis is a skin condition which causes an encrustation in the fleece. It was thought that it may affect the efficacy of a pour-on treatment.) The two solutions tried were the "Warbex" system and a DGBE formulation. The point of the exercise was to compare the results upon sheep affected by mycotic dermatitis with those of unaffected animals. Mr Kieran said in evidence that, by that time, the research team had "firmed up" that decamethrin was the active agent which they were wanting and that xylene and DGBE were the most likely solvents. In the result, it was found that mycotic dermatitis did reduce the efficacy of the treatment but. that "there was no significant difference between the efficacies of the xylene and the DGBE based formulations". | naheeaiannneht annaenenee Senne ae 14. During the same two months further tests were carried out to identify the minimum dose of decamethrin which was needed to eradicate the sheep biting louse from newly shorn sheep. The solvents used were the "Warbex" system and DGBE with isopropyl myristate. The latter solvent, often referred to as IPM, is a solvent well known for its non-irritant properties and, for that reason, widely used in cosmetics and baby oils. The tests involved a total of 84 sheep, 24 sub-groups each containing 3 animals and an untreated control group of 12 sheep. A different formulation was administered to each sub-group, the dosages ranging from 1 mg per kilogram to 5 mg per kilogram for each of the two solvent systems. The results were excellent. Total eradication was achieved upon all sheep treated with decamethrin in the "Warbex" solution. There was almost total eradication of lice on the sheep to which had been applied decamethrin dissolved in DGBE and IPM. The results of these tests contrast with that of another test, undertaken at about the same time, in which the organophosphorus compound cyanofenphos, in "Warbex" solution, proved almost totally ineffective. In order that Wellcome might obtain registration of any new pour-on formulation under the various State statutes dealing with pesticides it was necessary that the formulation be approved by the non-statutory committee, called the Technical Committee on Veterinary Drugs ("TCVD"),which advises power ere ores ae wr nye tear ne = cree = en ae vee + . . SLs er ee oor te eer 15. & the Commonwealth and State governments upon new products. This committee habitually reguires trials of new formulations under a variety of circumstances of use. One of the trials carried out in the period September-October 1979 was to evaluate the safety of decamethrin, dissolved alternatively in xylene and DGBE based solutions, both when applied at elevated dosages and when applied concurrently with a number of standard veterinary products, such as might be administered to sheep immediately after shearing. The elevated doses produced some temporary adverse reactions in some sheep, reactions being more frequent in the case of the xylene based solutions than for DGBE. There was in no case a problem caused by the concurrent administration of other products. During this same period, that is the last half of 1979, by arrangement with numerous graziers, Mr Townsend carried out extensive field trials using sheep upon properties in all States of mainland Australia. The purpose of these trials was to demonstrate the efficacy of decamethrin in the field under a variety of conditions. The trials used both the "Warbex " solvent and_a solution based upon DGBE with IPM. The results were summarised in the report of the trials prepared by Mr Townsend, Mr Kieran and two others: "In this series of field trials the safety and efficacy of decamethrin when applied as a pour-on off shears treatment for the control of biting lice and ked has been clearly demonstrated. 16. The universal acceptance of the pour-on treatment during these trials and the high level of grazier interest point to the need, evident in major sheep grazing areas, for a product which can safely and conveniently be used off shears for the control of the common external parasites of the sheep." In his affidavit in these proceedings Mr Townsend elaborated: "A consistent level of control was achieved with the 10 g/l pour-on formulation of Deltamethrin with either Formulation 1 or Formulation 2, when used as an 'off-shears' treatment. Further, during the course of the said field trials, I noted no adverse affects suffered by sheep following the treatment with the Deltamethrin-based formulations, apart from one Corriedale ewe in Trial 6, which showed a mild reaction following treatment. I did occasionally observe minor irritation to damaged skin where the Deltamethrin based formulations were applied over fresh shearing cuts, active fly strikes or skin left completely bare following a break in the wool. However apart from this, the said treatment appeared to affect the sheep no differently to treatments made on sound skin." In March 1980, and upon the strength of these trials, Wellcome applied for TCVD approval of both the formulations which had been the subject of the field trials. Approval was granted in September 1980. In the meantime, in June 1980, Wellcome conducted further tests of possible solvents. There was a continuing concern about skin irritation. Also, it had been noticed in the field trials that some discoloration of the wool occurred when the xylene based formulation was used. The researchers were anxious to identify the reason for this effect. The most - 4, cacy ocr ep - Sr 17. important finding from these tests was that, whilst DGBE used in conjunction with IPM caused a skin reaction, there was no reaction when DGBE was used alone. In summary -- in a report which also included some additional tests commenced on 1 November 1980 -- Mr Townsend stated "deltamethrin proved effective in a wide range of solvent formulations and also in an aqueous suspension formulation". The launching of "Ciout" By January 1980 a Wellcome project team was considering marketing arrangements for the new decamethrin pour-on formulation; although no decision had been made as to the solvent system. Neither had a trade name been chosen. Discussions were being held with various regulatory authorities. There was considerable interest in the new product, both within government organizations and in the grazing community. There was, apparently, no attempt by Wellcome, at that stage, to keep the new product a secret. In a memorandum dated 11 June 1980 the Victorian State Manager of Wellcome, Mr Neil Jones, said that the Victorian field force, consisting of himself and two others, "have been quietly talking about it for months". With a touch of hyperbole he said: "Everybody's dog and cat in Victoria is aware that Cooper have a pour-on dip about to enter the market". a Fre nr er eee eee oe ra ae eae * Ten te ge Dye rep ees worries 18. Coopers embarked upon a series of public demonstrations at country field days. One of these demonstrations was held at "Eurella" Station, at Mitchell, Queensland on 16 September 1980. Mr Bob Smith, a Cooper representative, informed the assembled company that the new product was called "Clout", that the active agent was decamethrin and that the solvent was xylene based and the same as that used in "Warbex". Mr Smith demonstrated the method of application and yave information about dose sizes and cost. At least 150 persons attended the field day, and the demonstration and the information given by Mr Smith was extensively publicised by radio and in the press, including in "Queensland Country Life". This publication then enjoyed a circulation through newsagents of over 34,000 and a direct subscription list of over 9,000 persons, including numerous organizations involved in animal husbandry. - At about the same time there were other public demonstrations of "Clout". It is clear that many people were aware, prior to 21 November 1980 -- a date the significance of which will shortly emerge -~ of the imminent release of "Clout" and of the nature of its formulation. This _ expectation co-incided with that of the company, 'as is evidenced by a letter dated 17 October 1980 from the Western Australian Regional Sales Manager of Coopers to an inquirer stating that, subject to "certain problems (unrelated to 19. product performance) being overcome", "the product will be released in the near future ie early 1981". The letter identified the product as one "Suitable for backline treatment of sheep to control lice". As already mentioned, "Clout" was in fact launched in February 1981. It was soon followed by "Clout S". According to Mr Kieran, "Clout S" now outsells "Clout". The deveivpment of "Spurt" The Managing Director of Western Stock Distributors, Mr P C Dainton, gave evidence that as early as 1978-1979 his company realised the potential of synthetic pyrethroids as a pour-on lousicide for sheep and endeavoured to obtain a light stable pyrethroid. He was aware of the sale of "Bash", as a pour-on, in New Zealand. He said that pour-ons "were hot news in Western Australia" and were being sought by farmers, but that -- despite inquiries of numerous possible chemical distributors -- his company was unable to get supplies of a suitable pyrethroid. He realised that there was a substantial available market and, after "Clout" was launched, the company "pulled out all stops" to develop and launch a rival product as quickly as possible. Western Stock Distributors approached Shell Chemicals, seeking cypermethrin. There was discussion with Shell, apparently about some joint enterprise, in which Western Stock Distributors suggested a formulation containing oa - SOT Rare ace oye oo oe te 20. cypermethrin and neatsfoot oil. Shell supplied some cypermethrin and Western Stock Distributors arranged some tests. In all 149 different formulations were tried; but those formulations were all based upon either xylene or cyclohexanone, in conjunction with one or more of three emollients: jlanoline, neatsfoot oil or white oil C. The emollients were intended to reduce what Mr Dainton referred to as "the corrosive action" of the basic formulation. By this - he meant a reduction of the wool wax in the fleece. DGBE was not: tried. Mr Dainton, who is not a scientist and whose company relied for research upon outside consultants rather than upon its own staff, said that he had never heard of DGBE until October or November 1981 when, in response to an enquiry for cypermethrin, he received from Robert Young & Co a quantity of cypermethrin dissolved in DGBE. He tested this formulation with neatsfoot oil, which he regarded as a useful spreading agent, but he eventually decided to abandon neatsfoot oil because Shell advised that the tendency of neatsfoot oil to solidify might cause difficulties when the product was stored under very cold conditions. In the event, Western Stock Distributors decided to go ahead with the marketing of "Spurt", containing only cypermethrin, DGBE and a marker dye. After various field trials during 1982 the product was approved by TCVD and was released onto the market in February 1983. There is no evidence before me as to how it came about that Robert Young & Co selected DGBE as an appropriate solvent for cypermethrin. wee 21. The patent applications On 21 November 1980 Wellcome Australia lodged at the Patent Office a provisional specification for an invention entitled "Control of Sheep Lice". The specification commenced: "The present invention relates to a method of controlling the sheep biting louse (Damalinia ovis) particularly on merino sheep. There has been a need to control sheep lice particularly on merino sheep -- which have hitherto proved resistant to treatment. Attempts have been made to treat lice infested sheep with a large variety of known insecticides by various routes, including pour-on treatments, subcutaneous injection, and by oral dosage. Hitherto, none of the treatments had any significant effect on the lice populations. The present invention is based on the unexpected discovery that pyrethroids are surprisingly effective in controlling and eradicating lice even on long-woolled merino sheep. Thus, the present invention provides a method of controlling sheep lice, which comprises the application of a pyrethroid onto a localised region of the skin or fleece of a sheep. The localised application is preferably carried out as a pour-on treatment by pouring a liquid formulation comprising the pyrethroid along the back of the sheep. Surprisingly, it is not necessary to totally immerse the sheep in the formulation so that the treatment of large numbers of sheep is facilitated. The pyrethroid is preferably selected from the group of light stable pyrethroids, for example premethrin, decamethrin, cypermethrin, and cyhalothrin. Decamethrin is preferred and has the following formula."- ete en epee ee eee eo . ' " t seater, omenpes epee menee maps ome re . * % eri. one me ot oP we eye = op 22. There followed a chemical formula stated symbolically. The specification proceeded: "Suitably, the formulation contains from 1 to 500, preferably 10 to 250 mg/ml of the pyrethroid. Moreover, the pyrethroid is preferably applied to the sheep in an application of from 1 to 500, preferably 1.5 to 250 mg/kg body weight. The pyrethroid is preferably applied in the form of a pour-on formulation. The formulation may comprise one or more organic solvents, such as xylene, cyclohexanone, or a glycol ether." The specification went on to refer to various classes of suitable glycols and glycol ethers. Those classes include DGBE which was, however, directly referred to only ina comment that: "the inclusion of 2, 6 ditert-butyl 4 cresol (BHT) has a useful stabilising effect on the active ingredients in formulations" based on DGBE. However, the provisional specification did not insist upon the use of a glycol or glycol ether solvent. It stated that, alternatively, "the formulation may be an aqueous formulation containing the pyrethroid in the form of a suspension and comprising suitable surfactants to stabilise the suspension and prevent undue run-off from the back of the sheep". The provisional specification referred to tests comparing the performance of organophosphates, and some other chemicals, with that of decamethrin and permethrin. The cited tests of decamethrin and permethrin -~ which were, of course, amongst those carried out after Mr Kieran's arrival at Wellcome -~ were all tests employing a xylene, cyclohexanone aoe peas wer ye tit cee ee Ff es 1 9 sarge en TTT pote ee se pe va FP ee a eae ah 23. and corn oil solvent system; the "Warbex" formula. There was no reference to any test in which DGBE was used. The statement of "Suitable formulations" at the end of the provisional patent was: "In general, a suitable solvent system contains 0 to 100% by weight xylene, 0 to 100% by weight cyclohexanone, and up to 20% by weight corn oil". No reference was made to DGBE, although two of the five examples of suitable formulations included DGBE, one as the sole solvent and one with cyclohexanone. On 30 October 1981 a complete specification was lodged with the Patent Office. The applicant was Wellcome Australia, the actual inventors being identified as Mr Kieran and Mr Townsend. The title of the invention was broader than that for the provisional specification, being "Control of Sheep Ectoparasites". The complete specification followed the provisional specification in referring to a "method" invention, as was explained in the opening section of the Gocument: "The present invention relates to a method of controlling sheep ectoparasites including keds, lice, flies, mites and ticks. The invention has special application to the control of the sheep-biting louse (Damalinia ovis) and keds (Melophagus ovinus) particularly on merino sheep. Traditionally, sheep have been treated for the control of ectoparasites by dipping or ~ spraying the whole external surface of the sheep. However, this is an inconvenient and time-consuming operation. Attempts have been made to treat infested sheep, particularly lice-infested sheep, with a large variety of known insecticides by various more 'convenient eetannetanren 24. routes, including pour-on treatments, subcutaneous injection, and by oral dosage. Hitherto, none of the treatments had any significant effect on the control of the lice populations. In particular, merino sheep which have very dense wool have not responded to such treatments. The present invention is based on the unexpected discovery that localised applications of pyrethroids are surprisingly effective in controlling and eradicating lice, keds, blow flies and other ectoparasites. It is particularly surprising that such localised application is effective even on long-woolled merino sheep. Thus, the present invention provides a method of controlling sheep ectoparasites which comprises the application onto a localised region of the skin or fleece of a sheep of a pyrethroid of the formula" There followed a formula stated symbolically. The specification went on: "By 'localised application' is meant that the pyrethroid is only applied to a minor portion of the skin or fleece of the sheep, generally as a line or spot on the sheep's back. It has been surprisingly discovered that, notwithstanding the presence of a sometimes dense coating of wool, the pyrethroid appears to act over the entire surface of the sheep. It is believed as a hypothesis that the pyrethroid is transmitted over the surface of the sheep by diffusion through the wool grease. The pyrethroid is generally applied as a liquid formulation, a paste or as a solid powder. Surprisingly, it has been found that it is not necessary that the pyrethroid be dissolved to be effective. The localised application is preferably carried out as a pour-on treatment by pouring a liquid formulation comprising the pyrethroid along the back of the sheep (i.e. a so-called 'packline' application). Surprisingly, it is not necessary to totally immerse the sheep in the formulation so that the treatment of large numbers of sheep is facilitated. a 7 . roy we ye wees mer eres gyn te were nes ge mone 25. Alternatively, the application may be carried out by means of a localised spray or aerosol, usually along the sheep's back as it passes through a sheep race. The aerosol might comprise the pyrethroid dissolved in a liquid carbon dioxide propellant." DGBE was mentioned as having been found to be "particularly useful" because "found to have minimal adverse effect on the skin in terms of a mild epidermal shedding seen with other solvents in some sheep". But it was also said that the formulation may be an aqueous formulation containing the pyrethroid in the form of a suspension or emulsion with surfactants. Reference was made to the tests of decamethrin with the alternative xylene and DGBE based solutions which have already been mentioned. Consistently with the description of the invention in the body of the specification the various claims defining the invention -- 14 in all -- were method claims. Claim 1 was for "a method of controlling sheep ectoparasites which comprises the application onto a localised region of the skin or fleece of a sheep of the formula" stated symbolically. Claim 2 referred to "a method according to claim 1 wherein the pyrethroid is selected from" various specified compounds, including cypermethrin and decamethrin. The remaining claims were for methods according to claim 1 or claim 2 with additional qualifications added. Claim 12 was for "a method according to any preceding claim wherein the sheep is infested 'ae en poe een ra me ae . . 26. with lice" and claim 14 for "a method of controlling sheep lice which comprises the application of a formulation substantially as disclosed in any Example". The complete specification was subsequently amended, on 22 December 1982. Although the title remained the same the description of special application, in the opening paragraph, was confined to lice. The amended specification elaborated the virtues of the pour-on technique and this was reflected in the description of the discovery: "that a class of known insecticides, the pyrethroids, are surprisingly effective in controlling sheep ectoparasites when applied by the pour-on method". However, notwithstanding this emphasis, the description continued to include the possibility of application as a liquid formulation, a paste or as a solid powder or, alternatively, as a localised spray or aerosol. There was no change in the specification of suitable solvents and DGBE continued to be mentioned as being "particularly useful". The claims were considerably expanded in the amended specification, now numbering 39, but all continued to be method claims; the ectoparasites to be controlled now being restricted to sheep lice. Finally, the Petty Patent Specification was lodged on 17 September 1984. In contrast to its predecessors this specification claimed the subject invention as being for a product, not a method. The invention was entitled "Pour-on Mer ome eter ye sm ee ee fe. on ie tare 27. Formulation" and in the opening words of the specification it was stated that the formulation was "particularly for use on merino sheep". Reference was made to the traditional methods of controlling ectoparasites, in words taken from the complete specification, and the specification then proceeded to refer to the pour-on method in these words: "The pour-on method of application is known. In this method, a low volume of a concentrated parasiticidal formulation is applied as a line or spot to the head or back of the animal. This gives protection over the whole animal. The pour-on method is very advantageous to the farmer or grazier since it allows the animai to be treated in a matter of seconds and requires a minimum of labour, thereby keeping costs down. The pour-on method is well established for cattle and a pour-on formulation containing the organophosphorus compound famphur is commercially available under the trade mark 'Warbex'. However, attempts by the applicant over a long period to develop a corresponding pour-on for sheep have hitherto met with disappointing results. As shown in the comparative tests hereafter, a large number of established parasiticides proved ineffective when applied as pour-ons to sheep. This difference in activity is surprising since the previously widely~held view was that the parasiticide worked systemically, i.e. passed through the skin into the bloodstream. If such a mechanism were correct the difference in ' activity between cattle and sheep is difficult to explain. Thus, up to the present no pour-ons had been available for the treatment of sheep (particularly merino sheep), which could be used as a substitute for conventional dipping or showering." The specification then followed the amended specification in describing the nature of the invention by reference to the pour-on method: fe et ee ee pe Stk es — 28. "The present invention is based on the discovery that a class of known insecticides, the pyrethroids, are surprisingly effective in controlling sheep ectoparasites when applied by the pour-on method. ... In particular, the present invention provides an especially advantageous pour-on formulation for localised application, which comprises a pyrethroid of the formula" stated symbolically "in admixture with a topically acceptable carrier comprising at least 50 wt % of" DGBE. Decamethrin was stated to be the "preferred" pyrethroid but the claim made by the Petty Patent was wider; being a claim for "a pour-on formulation for localised application, which comprises a pyrethroid of the formula" stated symbolically "in admixture with a topically acceptable carrier comprising at least 50 wt % of" DGBE. The priority date As the pleadings stood at the commencement of the trial it was common ground between the parties that the relevant date for the purpose of considering the charges of obviousness and lack of novelty was 21 November 1980, the date "upon which the provisional specification was lodged. However, on 23 July 1986, midway through the hearing, the respondents obtained leave to amend their Defences so as to challenge this assumption and to contend in the alternative for various later priority dates. sey mt mar - or 29. Section 51 of the Patents Act permits an applicant for a standard patent, within certain limits of time, to make a further application for a petty patent "in respect of an invention or inventions disclosed in the provisional specification or complete specification lodged in respect of" the standard patent. Section 45A of the Act deals with the priority date of the claim of a petty patent specification. The general rule, provided by s.45A(1), is that the priority date is the date of lodgment of the petty patent specification. However, this rule is subject to any other provision of the Act. In this connection sub-s.(2) provides: "(2) The priority date of the claim of a petty patent specification lodged in respect of a further application for a petty patent made by virtue of section 51, being a claim fairly based on matter disclosed in-- (a) we. (b) where the original application was an application for a standard patent-~the provisional specification or the complete specification lodged in respect of the original application, (C) wee (d) in a case to which paragraph (b) applies-- (i) if a complete specification was lodged in respect of the application referred to in that paragraph--the date that would have been the priority date of the claim if the claim were a claim of that complete specification; and (ii) ..." > cm In ee rer WPF — wes 30. Paragraph (d)(i) takes the reader back to the rules relating to the priority date of a claim for a complete specification provided by s.45. In that connection s.45(2) makes the priority date of a claim for a complete specification received after a provisional specification, and being a claim fairly based on matter disclosed in the provisional specification, the date of lodgment of the provisional specification. 'The effect of these provisions is that, in a case where a provisional specification has been followed by a complete specification and thereafter by a claim for a petty patent, the priority date of the claim for a petty patent is the date of lodgment of the provisional specification. However, this is conditional upon satisfaction of what are stated as two separate conditions: the application for a petty patent must be in respect of an invention disclosed in the provisional specification (s.51(1)) and the claim of the petty patent must be fairly based upon the provisional specification (s.45A(2)). These conditions are in reality two separate statements of the same thing. Either both or neither will be satisfied. The essential condition may be called the "fairly based" requirement. If the requirement is not fulfilled in relation to the provisional specification but is fulfilled in relation to the complete specification -- or any amended complete specification -~ the priority date of the claim of the petty patent will be the date of lodgment of the complete specification or amended complete specification, as the case may be. oo Acree ee peg oe o hres t wey - toa, 31. The selection of the appropriate priority date may be critical to the resolution of an issue of novelty. A patent is not invalid by reason only of the publication or use of the claimed invention in Australia on or after the priority date of the claim or because of the grant of another patent, which claims the same invention, claimed in a claim having the same, or a later, priority date: see s.46. In the present case the applicant contends, and the respondents dispute, that the necessary conditions are fulfilled in respect of the provisional specification, so that the priority date applicable to the claim of the petty patent is the date of lodgment of the provisional specification, 21 November 1980. Alternatively, the applicant argues for -- and again the respondents argue against -- a priority date of 30 October 1981, when the complete specification was lodged, or, as a last resort, 22 December 1982 when the complete specification was amended. As events, which are relevant upon the question of novelty, occurred between 21 November 1980 and 17 September 1984, when the petty patent claim was lodged, it is desirable immediately to consider whether the claim of the petty patent was "fairly based" on any earlier specification. The early historical relationship between provisional specifications and complete specifications was set out by Lord Blackburn in Bailey v_ Robertson [1878] 3 AC 1055 at peers tc ve wef . sae 32. pp.1073-1075. It was brought up to a later date, and translated to the Australian context, by Rich, Dixon, Evatt and McTiernan JJ in Tate v Haskins (1935) 53 CLR 594 at pp.606-610. These histories make plain that it is not necessary that there be total conformity between the provisional and the complete -- or petty patent -- specifications. As the matter was expressed by Jessel MR in Stoner v Todd [1876] 4 Ch D 58 at pp.59-60: "... a provisional specification was never intended to be more than a mode of protecting an inventor until the time for filing the final specification. It was not intended to contain a complete description of the thing so as to enable any workman of ordinary skill to make it, but only to disclose the invention, fairly no doubt, but in its rough state, until the inventor could perfect its details." The point made by Jessel MR is reflected in the language used in the current Australian legislation. Whereas s.40 requires a complete specification, or a petty patent specification, to "fully describe the invention", s.39 merely requires that a provisional specification "shall describe" the invention. However, it was always fundamental that the invention claimed in the complete specification be the same invention as that described in the provisional specification. As Lord Blackburn put the matter in Bailey v_ Robertson at p.1075: "if it is a new and separate invention, and a different one, then you are not protected". See also Dunlop v Cooper (1908) 7 CLR 146 at pp.160-162, 166-169. In that latter case Isaacs J, who dissented on the facts and who favoured a generous attitude to yo ny we et ee era oer ror, 33. discrepancies between the description of the provisional patent and the claim of the complete specification, nonetheless emphasised the necessity for the claim of the complete specification to be comprehended within the terms of the provisional specification. In F Hoffman - La Roche & Co A G v Commissioner of Patents (1969) 123 CLR 529 at pp.538-539 Gibbs J listed three questions, postulated by Lloyd-Jacob J in Re Mond Nickel Company Ltd's Application [1956] RPC 18° at p.194 and Imperial Chemical Industries Ltd's Application [1960] RPC 223 at p.228, as an aid to determination of the question whether a complete specification was fairly based upon a basic (provisional) specification. They were: "(1) Is the alleged invention as claimed broadly (i.e. in a general sense) described in the basic application? (2) Is there anything in the basic application which is inconsistent with the alleged invention as claimed? (3) Does the claim include as a characteristic of the invention a feature as to which the basic application is wholly silent?" I see no problem, from the applicant's point of view, in relation to question (2). However, the other two questions do pose difficulties. As to question (1): the invention claimed by the petty patent is a pour-on formulation comprising a pyrethroid of a particular formula in admixture with not less than 50 wt % of DGBE. The invention described ee een we men ope gmp peTEReN FN aeoRS eS eerEY ee oe ot oy , . eae se an ane oe iy smnenteinelernee ee ee ee ee re ee, Opn ne rte nee + =e 34. in the provisional application is a method of controlling the sheep biting louse, particularly on merino sheep. The claim of the petty patent is narrower than the description in the provisional specification in some respects, which is permissible, but it is wider in other respects, which is not. The invention described in the provisional specification relates specifically to the control of Damalinia ovis on sheep. The petty patent claims a monopoly in the use of a particular composition for any purpose, that is for the control of any ectoparasite on any host. This is not an unimportant distinction. There is evidence that pyrethroids are effective to control some species of ectoparasites other than Damalinia ovis and there is evidence that pour-on formulations are, and have for some years been, used for the control of ectoparasites on cattle, pigs, horses, dogs and goats. Question (3) asks whether the claim of the petty patent includes as a characteristic of the invention a feature as to which the basic application is "wholly silent". One feature of the claim of the petty patent is the inclusion, as an essential integer of the claimed formulation, of not less than 50 wt % of DGBE. It cannot be said that the provisional specification was "wholly silent" on the subject of DGBE; but DGBE was not an essential integer of the invention there described. The provisional specification referred to DGBE only incidentally, in relation to the utility of BHT. Neither wim rr err Rn mere ree eg orp te tree cpp oe a a eeeecn ete oe henemoartoetanad aan a on TS aes ee ad a 7 ars mo meer —- aot Sir eaten? 35. was it an essential integer of the invention described in the provisional specification that there be a solvent, for which DGBE would be a suitable choice. The provisional specification expressly rejected the essentiality of a solvent. A further matter which is claimed as an essential integer of the invention claimed for the petty patent is that it be a pour-on formulation. This was not an essential feature of the description of the invention contained in the provisional specification. Certainly, it was said that the pyrethroid is "preferably" applied in the form of a pour-on formulation but that statement itself conveys that this particular method of application was not considered essential. The concept underlying the back-dating of a petty patent claim to an earlier priority date is that the inventor has, in the earlier document, described all the salient features of the invention claimed by the petty patent. There may be a selection from alternatives left open by the provisional specification but there must not be a fresh inventive step -- see Hoffman La Roche at pp.542-543 -- such as is implied by the addition of a new essential integer. As was conceded by counsel for the applicant, once it appears that the petty patent embodies as an essential integer something which was not so regarded -- whether specifically -or ween wees 5 agent el ea ee tne ee een ete pepe ap eee nye Ce ene mye eee 7 IS yt. aa 36. as a member of a class -- in the earlier descriptive document, it must be concluded that the claim of the petty patent is not fairly based upon the earlier description. To put the matter another way, in the words of Lord Blackburn, it is "a new and different invention". Similar comments may be made in respect of the question whether the claim of the petty patent is fairly based upon the matter disclosed in either the original or amended complete specification. The original complete specification was limited to ectoparasites on sheep, the amended specification to sheep lice on sheep: in each case this was consistent with the description of the invention contained in the specification itself. As mentioned, the claim made by the petty patent is much wider, extending -to any ectoparasite on any animal. Moreover, although both the original and the amended specifications refer to DGBE as a "particularly useful" carrier, neither description claims the use of DGBE, or of any other solvent, to be an essential feature of the invention. It is true that claim 25 of the amended specification includes DGBE as a necessary ingredient but the relevant question under s.45A(2) is what "matter", that is what description of the invention, is disclosed by that document. 37. 1 Finally, both the original and the amended complete specification treat the use of a pour-on solution as being merely preferred, not essential to the invention being described. I am of the opinion that the claim of the petty patent is not fairly based upon any of the earlier descriptions so that it has no priority date earlier than the day upon which it was itself lodged, 17 September 1984. The issues of novelty and obviousness are to be evaluated as at that date. Lack of novelty Section 100(1) of the Patents Act prescribes the grounds upon which, inter alia, a petty patent may be revoked. The grounds include: "(g) that the invention, so far as claimed ... in the claim of the petty patent specification ... was not novel in Australia on the priority date of that claim." Section 105 makes every ground on which a patent may be revoked available as a ground of defence in an action for infringement of a patent. The respondents rely upon para.(g) both as a defence to the applicant's claim of infringement and in support of their claim for revocation. weer es en pee ee eo ee ry ay tee LY oo ~ 38. On 31 July 1980 Wellcome United Kingdom made application for an Australian patent which, as amended on 26 May 1981, was described as "Prevention or Control of Infestation by Insects of the Order Diptera". This application was numbered 517397 and published on 30 July 1981. The claims made by the specification were all methods of treating an animal for repelling insects of the Order Diptera (flies) by the application to the animal of a compound having a particular chemical formula. It appears from the evidence of Mr Maguire that this chemical formula is comprehended within the claim of the later petty patent relating to sheep lice. The synthetic pyrethroids, and decamethrin and cypermethrin in particular, fall within it. It follows, according to the argument of the respondents, that the use of a formulation referred to in patent 517397 in order to repel insects of the Order Diptera would be an infringement of the claim made by the subject petty patent, were it in operation at that time. It will be recalled that the claim made by the petty patent was not specific as to any particular ectoparasites to be controlled or in relation to the animals to which it was to be applied. The petty patent does insist that the formulation be of the pour-on type and that it contain not less than 50 wt % of DGBE but these ingredients are both within the claims of patent 517397 and are specifically envisaged in the description of the invention contained in the body of the specification. Indeed one of the examples contained in the specification, example 12, is for- decamethrin in DGBE. ee pee pe cows vee Mee om ee ae boys 39. In H_ PM Industries Pty Limited v Gerard Industries Pty Limited (1957) 98 CLR 424 at p.437, Williams J commented that para.(g) of s.100(1) "appears to accept the law relating to want of novelty as it existed at the date of the Patents Act". The old test, in regard to a submission that a patent lacked novelty because of its similarity to a product previously disclosed, by description or by manufacture, was to reverse the order of time and to ask whether the other product, if produced after che priority date of the subject claimant, would have infringed the monopoly of that claimant: see Harwood v Great Northern Railway Company (1865) 11 HLC 654 at 681. That same test was applied to s.100(1)(g) by Aickin J in Meyers Taylor Pty Limited v Vicarr Industries Pty Limited (1977) 13 ALR 605 at p.611. In that case Aickin J went on to consider whether any prior object, or any object according to a prior document, incorporated all the integers of any one of the claims of the subject patent. In the present case the method claimed by patent 517397 involves the use of a formulation which falls exactly within the description of the product the subject of the petty patent claim. If the order of the patents were reversed, and the petty patent were in force at a time when a person adopted the method described in claim 1 of patent 517397 for combatting flies of the Order Diptera, there would be an Be pe cree ee res poe a eee ain peice - Mook yoan, ee an) eg ee ti - 40. infringement of that patent. It follows that, after the publication on 30 July 1981 of the patent 517397, the invention claimed by the subject petty patent was not new. It would, therefore, be insufficient for the applicant to show that -- contrary to my opinion -- the petty patent was fairly based on either the complete or amended specification. Upon the issue of novelty it is essential for it to show that the petty patent was fairly based upon the provisional specification. Secondly, the respondents rely upon the field trials for "Spurt". These commenced in January 1982 and extended throughout most of the year. The evidence shows that they were conducted upon a non-confidential basis. The fact of the field trials, and the nature of the product being tested, was known to a number of people: principally officers of the Western Australian Department of Agriculture and the graziers whose flocks were used for the trials. "Spurt" comprises cypermethrin, as the active ingredient, in a solution of DGBE with a marker dye. It is common ground -- indeed the basis of the applicant's case -~ that it falls within the claim of the petty patent. It must follow that, at least in relation to a product having the ingredients of "Spurt", the petty patent claims what was not new as at any priority date after January 1982. 41. Other disclosures were urged by the respondents: a patent application by Robert Young & Company Limited (no.81246/82) laid open to inspection on 23 September 1982 and the actual manufacture and sale of "Spurt" as from February 1983. It is not necessary to consider these submissions. It is clear that the invention claimed in the petty patent was not novel as at these dates. In my opinion the objection of lack of novelty must be upheld. The view I have reached about novelty depends directly upon the adoption of a priority date later than that contended for by the applicant, 21 November 1980. By their Defences, as framed at the commencement of the trial, the respondents alleged lack of novelty even as at that date. Their particulars of that allegation repeated their particulars upon the issue of obviousness. Having regard to my conclusion as to the priority date, the question as to novelty at 21 November 1980 is not important. However, depending upon the outcome of other issues, the matter may have some relevance in regard to costs. I therefore express my view that, whatever may be the significance of the matters particularised in relation to obviousness, they do not make out a case of lack of novelty at 21 November 1980. Applying the test of Lord Westbury LC in Hill v_ Evans (1862) 31 LJ Ch 457, which has been approved and applied in numerous Wet ae ey i ee ere ene mas, 42. subsequent cases including by Viscount Simonds in Martin and Biro Swan Ltd v_ H Millwood Ltd [1956] RPC 125 at p.133, in the judgment of the English Court of Appeal in General Tire Rubber Company v_The Firestone Tyre and Rubber Company Limited [1972] RPC 457 at p.493 and by Stephens and Mason JJ in Olin Corporation v_ Super Cartridge Co Pty Ltd (1977) 51 ALJR 525 at p-536, none of the documents referred to in those particulars give, "for the purposes of practical utility", the same information in relation to the product claimed by the petty patent as is given by the petty patent icself. Nor do I think that the disclosure by the applicant of the contents of "Clout" at the demonstration at "Eurella" in September 1980 constituted a prior disclosure of the invention the subject of the petty patent claim. In saying this I do not overlook what was said in Griffin v_ Isaacs (1942) 12 AoJP 739, especially by Dixon J at p.740, about variations "which make no substantial contribution to the working of the thing or involve no ingenuity or inventive step"; and see Windsurfing International Inc v Petit [1984] 2 NSWLR 196 at pp.223-226. But, whether or not it would have been obvious to a skilled worker in the field that the substitution might be made, it seems to me to be important in relation to novelty that the disclosure at "Eurella" was of a product containing a solvent other than DGBE. The evidence shows that variations in solvents are not irrelevant to the practical utility of the pyrethroids for the control of sheep lice. wee eee pee ee ee a oe Sie iia Rotel tected wre ey govrgre- ayes ye more oe 43. Obviousness I turn to the issue to which most of the evidence was directed: whether the case falls within s.100(1)(e) of the Patents Act: "(e) that the invention, so far as claimed ... in the claim of the petty patent specification ... was obvious and did not involve an inventive step having regard to what was known or used in Australia on or before the prioricy date of that claim;" The evidence on this issue was directed to the position at 21 November 1980 but, of course, if my analysis of the question of the appropriate priority date is correct, obviousness has to be determined as at 17 September 1984. Tf the invention was obvious at 21 November 1980 then a fortiori it was obvious at 17 September 1984, by which time had been published not only the applicant's provisional, complete and amended specifications but also the specification relating to combatting the Order Diptera and that of Robert Young & Co. If the invention was not obvious at the earlier date, the question arises whether it had become obvious by the latter date, having regard to that new material. Notwithstanding my conclusion that the appropriate date for determining obviousness is 17 September 1984, I propose to make a finding upon the position as at 21 November 1980. I do so for two reasons. First, as this is such a tee ine ie oecaieresel tad aay 44, major factual issue, it is desirable that I make a finding in case my view on the proper priority date should be held to be erroneous. Secondly, there was no suggestion of a priority date later than 21 November 1980 until well into the hearing of the case. If the respondents are entitled to succeed only because of a finding based upon a later priority date, significant questions as to costs emerge. In Beecham Group Limited's (Amoxycillin) Application (1980; RPC 261 at pp.290-291 Buckley LJ, with whom Browne LJ agreed, spoke of the notion of obviousness in patent law: "Obviousness and inventiveness are antitheses. What is obvious cannot be inventive, and what is inventive cannot be obvious. ... It is clearly established that, for a particular step or process to be obvious for the purpose of either section, it is not necessary to establish that its success is clearly predictable (Johns-Manville Corporation's Patent [1967] R.P.C. 479 at 494 line 10). It will suffice if it is shown that it would appear to anyone skilled in the art but lacking in inventive capacity that to try the step or process would be worthwhile (Technograph Printed Circuits Ltd. v. Mills & Rockley (Electronics) Ltd. [1972] R.P.C. 346, per Lord Reid at 355 line 37 and 356 line 3; Johns Manville, supra, per Diplock L.d. at 493 and 494; Tetra Molectric Ltd. v. Japan Imports Ltd. [1976] R.P.C. 547 at 581 line 41, 583 line 37, 584, line 2). Worthwhile to what end? It must, in my opinion, be shown to be worth trying in order to solve some recognised problem or meet some recognised need. The - uninventive expert (see [1972] R.P.C. page 355, line 5) should not be supposed to be attempting to discover something new, that is, to be striving for inventiveness. Having been shown what was disclosed by the prior art, he must be supposed to be attempting to solve some problem or fulfill some need which has not been resolved or satisfied by the prior vee eae stpT ee te preweece + ae ee T pr ee eee 45. ~ art but which appears to his uninventive mind to be possibly capable of solution or satisfaction by taking the step or doing the thing under consideration. This, it seems to me, must involve the uninventive but skilled man having a particular problem or need in mind. If on carrying out his test he finds that the new step has the sort of consequence he had hoped but in an unexpectedly high degree, this would or might not mean that the new step was inventive or other than obvious; it might merely mean that a new and obvious step has solved the problem or met the need unexpectedly well. The question would, I think, be one of degree. If, on the other hand, the new step produces some unexpected result productive of an improvement or benefit of an unexpected kind it may well be held to be inventive, the association of the new step with its result not having been obvious." Some addenda are appropriate. First, as Buckley LJ himself pointed out in Tetra Molectric at p.583, there may be occasions upon which the "person skilled in the art" should be regarded as a composite being or team, no one person having the necessary range of knowledge to determine whether it is worthwhile to try a particular step or process. This is relevant to the present case, in which it is agreed that development of an appropriate product would require input from persons skilled in several different disciplines. Secondly, that which is imputed to a person skilled in the art is common general knowledge. This is a different concept from what, in patent law, is called public knowledge. To take the example given by Sachs CJ in General Tire at p.482: "... each and every specification, of the last 50 years, however unlikely to be looked at and in whatever language written, is part of the relevant public knowledge if it is resting anywhere on the shelves of the Patent Office. eyvom™ on Ie TF ober, sat ap een ten pears : lamaiaea -—- ha : 46. On the other hand, common general knowledge is a different concept derived from a commonsense approach to the practical question of what would in fact be known to an appropriately skilled addressee -- the sort of man, good at his job, that could be found in real life". Finally, in Minnesota Mining and Manufacturing Company v Beiersdorf (Australia) Limited (1980) 144 CLR 253 at p.293 Aickin J -- with whom Barwick CJ, Stephen, Mason and Wilson JJ all agreed -~ warned against hindsight: "An allegation of want of inventive step is not made out by saying you may take one or two, or twenty-one or twenty-two, prior publications and then select from them appropriate extracts or pieces of information, which will add up to the invention claimed and so demonstrate that it was obvious. So to proceed is to mistake the nature of an invention and the nature of the objection of obviousness. The question is, is the invention itself obvious, not whether a diligent searcher might find pieces from which there might have been selected the elements which make up the patent. If this were not so, there could never be a valid patent for a new combination of old integers. The proper question is not whether it would have been obvious to the hypothetical addressee who was presented with an ex post facto selection of prior specifications that elements from them could be combined to produce a new product or process. It is rather whether it would have been obvious to a non-inventive skilled worker in the field to select from a possibly very large range of publications the particular combination subsequently chosen by the opponent in the glare of hindsight and also whether it would have been obvious to that worker to select the particular combination of integers from those selected publications. In the case of a combination patent the invention will lie in - the selection of integers, a process which will necessarily involve rejection of other possible integers. The prior existence of publications revealing those integers, as separate items, and other possible integers does not of itself make an alleged invention obvious. It is the selection of the integers out of, perhaps many possibilities, which must be shown to be obvious." 47. In the present case, the applicants for the petty patent described their invention in these terms: "The present invention is based on the discovery that a class of known insecticides, the pyrethroids, are surprisingly effective in controlling sheep ectoparasites when applied by the pour-on method." Nothing was said in that description about DGBE but it is an essential integer of the product the subject of the claim that it include not less that 50 wt % of DGBE. Consequently, it may be said that there are three steps in the claimed invention: (a) that pyrethroids within the specified formula are an effective sheep lousicide; (b) that such pyrethroids may effectively be administered to sheep by the pour-on technique; and (c) that DGBE is an especially suitable solvent for use in a pour-on formulation. The applicant concedes the obviousness of the first step, as at 21 November 1980. In an issues document prepared at the commencement of the hearing counsel for the applicant stated: "The applicant does not assert that as at the priority date the fact that synthetic pyrethroids could be used as a lousicide on sheep by the process of dipping was itself novel or otherwise than within the common general knowledge." The applicant does dispute the obviousness of each of the second and third steps. wy recpescin porte ee eae - : oy . wr, 48. In relation to the second matter, the effectiveness of pour-on insecticides, the applicant concedes that, at 21 November 1980, it was common general knowledge that a pour-on method of application could be used to apply organophosphate insecticides to cattle. But, the applicant says, all attempts -~ by Mr Langford and others -~ to develop an organophosphate sheep pour-on had failed. As at 21 November 1980 there was no assurance that any attempt to develop any type of sheep ~ pour-on would be any more successful. Experts in the field did not even know how' a pouc-on insecticide operated. The assumption had previously been made that pour-on insecticides operated systemically but, by 1980, this assumption was widely rejected. The most commonly accepted theory in 1980 was that the insecticides worked by diffusion, that is by being dissolved in the wool wax and being diffused around the body of the sheep. According to Dr Ian Pitman, Dean of the School of Pharmaceutics at the Victorian College of Pharmacy Ltd, who was called by the applicant, more recent work has discredited this theory, leaving the position that, even at the present time, the mechanism of the dissemination of pour-on insecticides is not known. . The accuracy of these submissions may be accepted. There was certainly no guarantee of success. But in this connection the point made by Buckley LJ in Beecham is important: it is enough that a person skilled in the art would think the process to be worth trying. There was every weer Se om ee coor a Ve wee ap coo pat a cer ey ae af oy 49. reason for a skilled worker, at 21 November 1980, to regard it ; as worthwhile to try pyrethroids in a pour-on formulation. 1 Pyrethroids were known as wide spectrum insecticides which were highly effective against insects. As long ago as 1957 two researchers, McCosker and Osborne, had reported success in ' eradicating sheep lice with a pour-on formulation using dieldrin and aldrin. This report was recalled in subsequent publications on the control of ectoparasites. Numerous patents at about this time referred to the use of pour-on i insecticides on animuls. It is not clear to what extent some ' of these patents were common general knowledge in Australia ro prior to 21 November 1980 but it is sufficient to refer to patent 512901 and patent 517142 both of which were laid open to public inspection in the Australian Patent Office on 28 June 1979. Patent 512901, in the name of Wellcome United Kingdom, related to control of pests of the Order Acarina by the use of pyrethroids -- including decamethrin -- administered, amongst other methods, by the pour-on technique. Sheep are specifically mentioned amongst the host animals in relation to which the invention might be used. Patent 517142, also in the name of Wellcome United Kingdom, related to a method of controlling ectoparasites of the sub-orders Ixodoidea and Sarcoptiformes of mammals and birds by the application of a pyrethroid according to a particular formula. Amongst other techniques, the specification referred to dispensation by a pour-on formulation, inter alia, to sheep. meee wee Tt te te eee toe 50. There is evidence from a number of expert witnesses, on both sides of the case, of the practice of chemical companies -- including Wellcome -- of circulating extracts from patents which are relevant to their work. In addition, abstracts of patents are regularly included in the Chemical Abstracts which are, and then were, published by the American Chemical Society and widely available in Australia. In addition to the documentary material there is a body of expert evidence in relation to the question whether, at the time, the use of a pyrethroid lousicide in a pour-on formulation was an obvious step. I bear in mind the warning about hindsight given by Aickin J but I was particularly impressed with the evidence of Professor Crank, and of Dr James Reynoldson, Senior Lecturer in Pharmacology and Chemotherapy at Murdoch University, each of whom, under cross-examination, gave persuasive reasons for his view that, upon the then state of the literature, the trial of pyrethroids in a pour-on formulation was an obvious step. These witnesses, who were supported by other experts called by the respondents, were not really contradicted. The experts called by the applicant tended rather to emphasize the lack of a predictable result. Moreover, there is evidence from two witnesses who were involved at the relevant time. One of them is Mr Alan Cole, a veterinarian who was for some years employed by the Prod = wee epee wee n woot: Sree. 51. New South Wales Department of Agriculture. For a period of about seven years, spanning November 1980, he represented that Department on TCVD and was thus concerned with the assessment of all new veterinary drugs intended to be used on food producing animals. Referring to publications prior to September 1979, Mr Cole said in evidence, which I accept, that it had by then become obvious to him "that the substitution of such potent insecticides as synthetic pyrethroids for pyrethrins would enable very small dosages of concentrated insecticide to be applied for example as a back line spray or topical local application ... against Damalinia ovis". He referred to the need, obvious to him at the time, for a , pour-on formulation and to the demand for such a product being voiced by some graziers. Mr Cole was aware, at the time, of companies -- other than Wellcome -- which were experimenting with pyrethroid pour-ons. One of those companies was the Commonwealth Industrial Gases Limited ("CIG"). Mr M J McQuillan, Market Development Manager, Agriculture, of that company gave evidence that, immediately after his appointment in July 1979, he identified a potential market for CIG liquid gases in the dispensing of insecticide treatments for pests of sheep. Between July 1979 and August 1980 CIG produced a product named "Banish" which used cypermethrin as the active constituent of a -formulation, sprayed along the backline of a sheep. This product was proved in tests, conducted on a non-confidential basis, in September and October 1980. oe ery However, in relation to this second step in the alleged inventive process it is not really necessary for the respondents to point to the opinions or experience of other parties. The evidence is that, by 21 November 1980, it had become widely known from the "Eurella" demonstration that _ Cooper had developed a pour-on lousicide, using decamethrin in a "Warbex" solvent. If the second step was not common general knowledge before the "Eurella" demonstration, it was thereafter. The third step in the alleged inventive process was the selection of DGBE as a solvent. This, say counsel for the applicant, was the "primary problem". It was not enough to make a random choice. The solvent had to meet certain criteria related to the efficacy and marketability of the product. The task involved was described by counsel for the applicant as requiring "first, an appraisal of the relevant literature to which they as workers in the art had recourse, secondly, an evaluation of the data contained in that literature so far as it bore on the subject in hand and, thirdly, a considered selection of a relatively small number of solvents with which to conduct tests", in order to determine whether they met the selected criteria. Counsel point out that the selection process extended over a lengthy period, that it produced some surprises (for example, with IPM) and that it involved a deal of skill. a ie roms tee ee 53. In their submissions counsel go on to say: "The critical factor which became apparent as a result of testing of the formulations initially chosen was that the skin of sheep exhibited an undue degree of sensitivity and susceptibility to irritation... In view of this sensitivity it was necessary for the inventors to devise tests dissecting the compenents (sic) of the formulation in order to identify whether the primary cause of irritation was the insecticide, the solvent or the dye ... These tests revealed chat the problematic ingredient was in fact the solvent. Further experimentation indicated that glycols and, particularly, DGBE, exhibited uniquely favourable non reactivity." Counsel for the applicant also make reference to the necessity to ascertain whether sensitivity is affected by variations in the breed, age, sex or physical condition of the sheep to whom a formulation is administered or to any difference in the environmental circumstances, especially temperature, under which it is administered. However, I do not think that much may be made of this. It is true that the field trials were devised so as to include a variety of sheep, in a variety of locations, and thereby to ascertain whether there were any relevant differences. Apart from mycotic dermatitis -- which was seen as a special problem and for which special tests were made -- there were no relevant differences. This result would have caused no surprise to the researchers. They expected, and found, some variations in sensitivity as between individual sheep but, so far as the evidence indicates, they never expected to find differences in tc sre pe. - +4 eee pe erne 54. sensitivity based on characteristics such as breed; age, sex or physical condition or related to environmental circumstances. The problem they faced was to select the most suitable solvent for use with sheep generally. The critical question, so far as obviousness is concerned, is whether the selection of DGBE represented an inventive step or whether, as the respondents say, this selection was merely a result of "that type of trial and error which forms part of the normal industrial function" of a skilled worker in the relevant. field: see General Tire at p.497. Put another way, were the known characteristics of DGBE such as to make it, out of the field of possible solvents, a solvent worth trying? The argument on behalf of the applicant on this question focusses on four main matters: that the search for a suitable solvent was hindered by the general ignorance of the manner in which the active ingredient of a pour-on formulation spread to the whole of the body surface of an animal, that there was no prior knowledge of the sensitivity of sheep to DGBE, the complexity of the tests which were undertaken and the time which was occupied by those tests. All of the expert witnesses agree that the method of distribution of the active ingredient of a pour-on formulation is still not known. There appears to be general agreement amongst them that, at the time Mr Kieran and Mr Townsend started their work with pyrethroids, there was substantial ae ene epee were oe ores yc a pe eg ce en re eee ee 55. support for the systemic theory. Mr Kieran, at that time, himself accepted this theory. There is also general agreement amongst the witnesses that, by 1980, the systemic theory had been displaced, in terms of acceptance by concerned experts, by the view that the active ingredient was diffusd through the wool wax. Mr Kieran was aware of, and moved with, the change of opinion. No doubt it is always helpful to a researcher to have the greatest possible knowledge of the manner in which a formulation will actually operate. Sometimes this will be critical to his or her success. But, as this case shows, such information is not always essential. The evidence shows that DGBE was initially selected for testing at a time when Mr Kieran adhered to the systemic theory. He was aware of its percutaneous properties. The results of the tests were encouraging and he persisted with DGBE despite his changing belief as to the manner of dispersal. There was no inconsistency between the new theory and the likely utility of DGBE. DGBE was known by Mr Maguire to have good spreading qualities -on various surfaces, although it had not previously been tested on sheep. In relation to the second matter referred to by counsel for the applicant there is, once again, agreement between the expert witnesses. All accept that, prior to 21 "4 ~ a pre tn pe ete ees er o ff al en reer ee "wom owe ot we eer or nore 56. November 1980, DGBE had been shown to have a low irritation value when applied to the skin of various animals, notably rabbits, but that there was no general knowledge of its effect upon the skin of sheep. There is some difference between the witnesses as to the confidence with which one may extrapolate from irritation tests upon one animal to another; but they all agree, first, that unexpected results may occur -- as, for example, the sensitivity of sheep to IPM -- and that there ought to be actual testing upon the subject animal before any particular compound is selected for use. Having regard to this evidence the nature of the question is important. If the respondents had to show that it was obvious prior to November 1980 that DGBE would be suitable, they would fail on the defence of obviousness. There was no common general knowledge of its actual suitability. But this is not the test. The question is wheher a skilled worker in the field, having regard to common general knowledge, would have thought it worth trying. On this question there is no issue between the expert witnesses. Although they differed as to the confidence with which one could predict success in advance of testing, no expert suggested that DGBE was not obviously worth trying. There is uncontested evidence that DGBE was used for a wide variety of purposes including insecticides and pesticides. It was known to be of low toxicity. Dr Pitman said that, in looking for a ve 57. solvent which was non-irritant to sheep skin, he would choose from the solvents "which had been shown to be non-irritant or less irritant to rabbits and/or human skin". Subject to the question of skin sensitivity, DGBE was known to fulfill alli of the criteria which the research team had stipulated. It appears that not many solvents were available which did fulfill those criteria. Professor Crank said that in November 1980 there wene about six commercially available glycol ethers, of which DGBE was one. He thought that there might have been between five and ten solvents, other than glycol ethers, which were suitable for testing. Both Dr Reynoldson and Mr Townsend said in evidence that decamethrin is soluble in only a few substances, DGBE being one. Perhaps the most cogent evidence of the suitability of DGBE as a candidate for testing was that it was selected for testing so early in the program. In American Cyanamid Company v Berk Pharmaceuticals Limited [1976] RPC 231 at p.257 Whitford J said: "If a thing is obvious you can go straight to it". The converse is not necessarily true but the early selection of DGBE is telling; the more especially because there is no suggestion that the decision to try DGBE resulted from information peculiar to Wellcome or 'from any inventive idea of a member of the research team. Mr Maguire said in evidence that DGBE "was a member of a family of . solvents which, as formulating chemists, we thought were Tort ose wee . tore Or ne yee —_ net see 58. interesting". But some members of the family were toxic. Having regard to its known low toxicity, it is not surprising that DGBE was one of the first three solvents, alternative to "Warbex", to be selected for testing; in the tests of December 1978 ~ March 1979. In its application to newly shorn sheep it proved effective. Thereafter DGBE never looked back. It was included as one alternative in each subsequent test, the main interest being what co-solvent, if any, would be used in conjunction with it. It is possible to deal together with the third and fourth points made by counsel for the applicant: the complexity of the tests and the time which they occupied. Once again there was considerable common ground. All the expert witnesses agreed that a team effort was necessary, involving people with a variety of skills. The testing regime was complex and had to be carefully planned and executed. It was labour-intensive and, no doubt, expensive. But those facts do not necessarily mean that the result must be characterized as inventive; they are equally consistent with patient trial and error. The tests were in fact described in evidence by Professor Crank, which I accept, as "all well established routine procedures which are used in the development of the formulation of any biological active agent whether it is to be applied to an animal or to a human being". . - — Saaenranaaemy 59. So far as the duration of the testing is concerned, it seemg_to me that the facts tell against the submission. The first field test of DGBE commenced in December 1978. By March 1980 the suitability of DGBE was so well established that Wellcome was in a position to apply to TCVD for registration of a formulation using DGBE as a solvent. Given the difficulties, referred to in some reports, in obtaining suitable sheep for experimentation and the time which is necessarily involved in each test, a period of 15 months appears to be a short period for the development of the formulation. Counsel for the applicant place some emphasis upon the fact that, despite the obvious commercial potential of a pour-on sheep lice formulation, no other company developed a product before the release of "Clout". This supports the suggestion, they say, that the necessary steps were not obvious. However, this argument loses much of its force because of evidence from both Mr Dainton and Mr Kieran that the pyrethroids were not generally available as a raw product to persons other than licensees of the manufacturers. [In practice, it seems, only a limited number of companies would have found it easy to obtain the necessary raw material to carry out a testing program. 60. In relation to the question whether the selection of DGBE represented an inventive step it is, I think, inStructive to consider the contemporaneous reaction of the inventors themselves, and their employer. As previously pointed out, neither the provisional specification nor the complete specification -- in either its original or amended form —- claimed the use of DGBE as an essential integer of the alleged invention. The compound received only passing mention. This is so notwithstanding the concession made in this case by counsel for the applicant that all of the invention the subject of the petty patent claim was done before 21 November 1980. It is difficult to resist the inference that the failure of the inventors to emphasise their choice of DGBE in the applications submitted in 1980, 1981 and 1982 reflected their acceptance that there was nothing inventive about that choice. It may not be co-incidental that their insistence, in 1984, upon the significance of DGBE followed the release of "Spurt", using DGBE, upon the market. In my opinion the selection of DGBE aS a solvent did not involve the making of an inventive step. It follows that the defence of obviousness -- even considered as at 21 November 1980 -- succeeds. eRanL nica Reap oe ee ries pire easy 4 wee gee ees oe en ey weet e a eae -< 61. Utility Section 100(1)(h) provides as a ground of objection "that the invention, so far as claimed ... in the claim of the petty patent specification ... is not useful". It is- important to note that the paragraph directs attention to the invention actually claimed rather than to the invention described in the body of the specification. As was said by Barwick CJ and Mason J in Interlego AG v Toltoys Pty Ltd (1973) 130 CLR 461 at p.478, "...ethe settled rule is that in ascertaining the width of a particular claim it is not permissible to vary or qualify the plain and unambiguous meaning of the claim by reference to the body of the specification". If a claim exceeds what is useful, it is invalid. It does not matter that no skilled worker would seek to apply the patent to that wider purpose. Speaking for the English Court of Appeal in Norton and Gregory Ltd v_ Jacobs (1937) 54 RPC 271 at pp.276~277 Lord Greene MR said: "The duty of a patentee is to formulate his claim in such a way as to define with clarity the area of his monopoly; the claim is the solemn operative part of the Specification in which the patentee sets himself to achieve that purpose, and in construing it, it is of great importance not to lose sight of that fact. It is illegitimate to whittle away clear words in a claim by reading into them glosses and limitations extracted from the body of the Specification whose function is in its essence different from that of the claim. Each part of the document must be construed in the light of the function which is peculiarly its own. In the same way it is'in our opinion illegitimate to whittle away the clear words of the claim-~selected, as they must be taken to be, with the peculiar function of the claim mori rl ere ee rete oe TOT wae renee a4 a - ea 62. in mind--by writing into them glosses and limitations based on the fact that a skilled chemist would avoid working. in part of the area which the words in their ordinary meaning are wide enough to include. This does not mean that regard is not to be paid to the fact that the claim as well as the body of the Specification is addressed to persons skilled in the art and must be construed accordingly. But the argument here goes far beyond this and, under the pretence of construing the claim, in reality seeks to reform it." In Minerals Separation North America Corporation . Noranda Mines Ltd (1952) 69 RPC 81 Lord Reid, speaking on behalf of the Judicial Committee of the Privy Council, put the same matter more succinctly at p.95: "It is well settled that, where the scope of a claim includes some method which is useless, the claim cannot be saved by showing that no skilled person would ever try to use that method". By their Defences, as amended during the hearing, the respondents allege that the claim of the petty patent specification is not useful. They say that the claim of the petty patent, which refers merely to "a pyrethroid" of the specified formula, takes in more than is useful. Their first submission is that the evidence of Mr Maguire shows that there are some hundreds of known pyrethroids, that is pyrethroids which have been screened by chemical companies, virtually all of which have a chemical structure falling within the formula specified in the petty patent. Only a minority of these pyrethroids are light stable and only "about ten" have been developed commercially. Even some of the ten are not light eeimae poer ee -a ae, teqiese sort wreenrt _ 63. stable. It follows, say the respondents, that the description of pyrethroids employed by the claim includes numerous pyrethroids which, when exposed to daylight, would break down too quickly to be useful as the active ingredient of a sheep lousicide. Secondly, it is pointed out that the claim of the petty patent does not specify any particular dose of the pyrethroid used in the formulation. Even if it were permissible to read down the general reference to L,-ethroids in the claim by resort to the dosage rates specified in the body of the specification, the utility of the document would not, they say, be much advanced. Mr Kieran said in evidence that "dose is critical" because some isomers of pyrethroids are more active than others. He agreed that, upon the evidence he had, it is likely that, at the minimum concentration of pyrethroid to solvent referred to in the specification (0.1 mg per millilitre) it is likely that some of the isomers or mixtures of isomers of the specified pyrethroids would be ineffective. Except in relation to the particular formulations he had tested, he was not able to say what concentration would be needed for the effectiveness of any particular isomer or mixture of isomers of any particular pyrethroid. He agreed that there were differences in potency between particular pyrethroids; as indeed was shown by some of the tests carried out by Mr Townsend. Mr Kieran said that empirical testing was always necessary to establish the effectiveness of any particular formulation. Be 64. The problem raised by the failure to specify with | particularity the relevant pyrethroids -- and indeed the relevant isomers and mixtures of isomers -- is illustrated by evidence given by Dr Pitman. In cross-examination by counsel for the respondents he was shown the claim of the petty patent and asked to assume a concentration of 0.1 mg per millilitre. When asked whether that would be effective to control or eradicate lice on a sheep, he responded: "Without knowing the active ingredient I cannot give any answer to that at all". Finally, the respondents rely upon the failure of the petty patent claim fully to specify the appropriate solvent. The claim merely calls for "at least" 50 wt % of DGBE. Mr Kieran, one of the claimed inventors, said that 50% was an arbitrary figure. Mr Townsend, the other, said that he had no idea what should be put with it. This would not matter if any other solvent would provide a satisfactory result but the evidence shows that some co-solvents cause an unacceptable degree of skin irritation. Even 100% DGBE may be unsatisfactory. Mr Maguire said that, in the case of decamethrin -~ one of the pyrethroids within the claimed formula -- the use of DGBE creates a problem of stability during storage at high temperatures. Unstabilized, the active ingredient is likely to degrade and to lose effectiveness. Although Mr Maguire earlier said that "DGBE by itself is. fine", this statement was apparently not intended to relate to the use of DGBE with decamethrin. Pt io a aoe eae ayo - ay ee arn ee e , Kr oo oe 65. In response to the respondents' submissions concerning utility, counsel for the applicant drew attention to the statement of Lindley LJ in Needham v Johnson & Co : (1884) 1 RPC 49 at p.58 that "if any patent is capable of more constructions than one, the general rule would be applied that you would put upon it that construction which makes it a valid patent rather than a construction which renders it invalid". They refer also to the speech of Lord Russell of Killowen in Electric Musica, Industries Ltd v_ Lissen-Ltd -(1938) 56 RPC 23 at p.39 affirming that a specification "must be read as a whole and in the light of surrounding circumstances; that it may be gathered from the specification that particular words bear an unusual meaning; and that, if possible, a specification should be construed so as not to lead to a foolish result or one which the patentee could not have contemplated". Here, they say, is a claim with a number of ambiguities which may legitimately be resolved by referring to the body of the specification: "pour-on", "localised application" and "pyrethroid". They draw attention to the comment of Menzies J in Welch Perrin & Co Pty Ltd v Worrel (1961) 106 CLR 588 at p.602 that what was said by Lord Greene MR in Norton and Gregory "does not mean that a specification should be construed in a way that any sensible person would appreciate would lead to unworkability when by construction it could be given a more limited meaning". mor we we ie WV wei ee ee ee ge re ee ee ee se ' a sly 2 fee ras ae ' wr "ne 47 ai 66. The correctness of the particular propositions put by counsel for the applicant may be accepted; but those propositions do not meet the respondents' case on utility. This is, no doubt, some ambiguity about both of the terms "pour-on" and "localised application". Both are defined more precisely in the body of the specification and it would accord with the principle stated by Lord Russell for the reader to resolve those ambiguities by going to the body of the specification. But no reliance is placed by the respondents on any uncertainty in either of these terms. In relation to "pyrethroids", the position is different. This term is defined by the claim itself, by reference to a stated chemical formula but without any other limitation. There is no warrant for further qualifying it by reference to dosage rates or other matters stated in the body of the specification. As Lord Russell went on to say: "The function of the claims is to define clearly and with precision the monopoly claimed, so that others may know the exact boundaries of the area within which they will be trespassers ... The claims must undoubtedly be read as part of the entire document, and not as a separate document; but the forbidden field must be found in the language of the claims and not elsewhere. It is not permissible ... by reference to some language used in the earlier part of the specification to change a claim which by its own language is a claim for one subject-matter into a claim for another and a different subject-matter rp eyes 67. In the present case the applicants for the patent have clearly staked out the forbidden field. It includes the use of any pyrethroid of the specified formula in conjunction with 50 wt % of DGBE. For the reasons advanced by the respondents the claim is so wide as to include formulations which have no practical utility for the desired purpose. That partial inutility brings down the whole claim, under s.100(1)(h) of the Act. Orders I have found that the petty patent is invalid for each of the reasons advanced by the respondents, lack of novelty, obviousness and lack of utility. It follows that the action for infringement fails. The Application must be dismissed. As mentioned, the respondents cross-claim for an order for the revocation of the petty patent. Section 103 of the Patents Act provides that a "prescribed court". may revoke a patent. The term "prescribed court" is defined by s.6 of the Act as meaning the Supreme Court of a State or of one of three specified Territories. Original jurisdiction is conferred upon those courts by s.146 of the Act. Except in relation to the exercise of appellate jurisdiction -- see ss.148(1) and 6A(a) -- this Court is not a "prescribed court". The Court does have jurisdiction under s.32 of the Federal a aa te pee sere Nit ere cee sree re 68. Court of Australia Act 1976 in respect of matters not otherwise within its jurisdiction that are associated with matters in which the jurisdiction of the Court is invoked. This associated jurisdiction, in a proper case, permits the Court to determine a claim for infringement of a patent which is associated with a claim under the Trade Practices Act. The Court has power, under s.23 of its constituting Act, in relation to matters in which it has jurisdiction to make orders of such kind as it thinks appropriate. That power equally applies in cases in which it is exercising the associated jurisdiction. Section 22 commands the Court, in every matter before it, to grant all remedies to which any of the parties appears to be entitled in respect of any legal or equitable claim properly brought forward in the matter so as to achieve, as far as possible, finality and so as to avoid multiplicity of proceedings. Section 21 authorizes the making of binding declarations of right. Notwithstanding these broad provisions, it appears to me doubtful that this Court has power, when exercising its original jurisdiction, to make an order under s.103 for the revocation of a patent. The effect of s.32 is to give to the Court jurisdiction to deal with the controversy between the parties- as to the validity of the patent. Having regard to s.23, it may be accepted that the Court is able to make any order necessary for the resolution of that controversy. This is so notwithstanding that a power to make a particular order Yes Ce cn 2 ap rere = Siena 69. g 3 is not expressly conferred upon the Court but, possibly, subject to there being no implied limitation of power. However, a revocation order does more than resolve an issue between the parties. A court making a revocation order is obliged by s.103 to require the applicant for revocation to serve a copy of the order for revocation upon the Commissioner of Patents and the Commissioner is required to insert a reférence to the order in the Register of Patents kept pursuant to s.20 of the Act (s.104). An order for revocation is, in effect, an order for the rectic.ication of the register; - an order which may have consequences tor persons other than the immediate parties. It seems to me that two questions arise: whether the making of a revocation order can properly be regarded as an order for the resolution of the controversy between the parties so as to be supported by a combination of ss.32 and 23 of the Federal Court of Australia Act and, if so, whether nonetheless the Court is deprived of the power to make such an order by an implication arising out of the fact that the power is conferred expressly upon the Supreme Courts, without mention of this Court. No argument was addressed to any of these matters. I have not reached any final view about them. But, at this moment, I am not satisfied that this Court has power to make an order under s.103. The Court does have power to make a declaration, binding the present parties but no others, in relation to invalidity and I propose to make such a wee acer NI ee, woe EEE EEEAANnER AAT aed aie ~~ oe rc rrcor peer ange wre eo or Tene oe 70. declaration. From the respondents! point of view this may suffice. However, against the possibility that the respondents will wish to press for an order for revocation I _ will reserve leave for them to make an appropriate application. If the position is as I tentatively suggest, the result is unfortunate. Presumably the reason for providing for a revocation order to be made in an infringement suit was the desiie to avoid multiplicity of actions, the re-litigation between the patentee and some other alleged infringer of issues of validity already determined against the patentee in a suit against another alleged infringer. That reason is just as compelling in relation to litigation in this Court respecting the validity of a patent as it is in relation to litigation in any other court. This Court is increasingly being asked to deal, in its original jurisdiction and in conjunction with trade practices cases, with intellectual property claims. tt seems highly desirable to remove any doubt as to the Court's power to deal fully and efficiently with all questions which may arise in such proceedings, including by the making of orders for revocation of patents. Finally, I turn to the question of costs. The applicant submits that, in the event of success by the - respondents by virtue only of a defence raised by the amendments of 23 July 1986, a special order ought to be made; Sian ee anata me eee we weg say tere yt Pa. -4 ' 71. an order which not only denies to the respondents recovery of - the costs incurred by them prior to that date but which also requires them to pay the applicant's costs to that date. I do not doubt that, in the event postulated, some special order would be appropriate; it is not necessary to consider whether it should go so far as is suggested. Nor is it necessary to take the alternative course suggested by counsel, that of putting the matter back in the list for argument regarding costs. In my judgment the respondents are entitled to succeed on an issue -- indeed the main issue -- which was raised in their original Defences: obviousness as at 21 November 1980. No substantial separate evidence was directed to the additional defences raised by the amendments of 23 July 1986. Although the existence of these defences somewhat prolonged the subsequent hearing, these costs were incurred when the parties were at issue on those matters. Under the circumstances there is no reason to depart from the usual rule that costs follow the event. I certify this and the seventy (70) preceding pages to be a true copy of the Reasons for Judgment of his Honour Mr Justice Wilcox. Associate: Yosane. A He Choe — Date: 22 August 1986 _ Se allcaileneek mametemrertaton tty »f St sit ceed ne tiriaereet taal cae! ¢ siesiohiar eecceiaaiied Counsel for the Applicant: Solicitors for the Applicant: Counsel for the Respondents: Solicitors for the Respondenst: Date(s) of hearing: 72. Mr D E Grieve OC with Mr W M Gummow and Mr D K Catterns Messrs Stephen Jacques Stone James Mr T Simos QC with Mr J S Hilton and Mr R McCormack Messrs Corser & Corser 24, 25, 26, 27 and 30 June 1986, 1, 2, 3, 4, 21, 22, 23, 24 and 29 July 1986. et vere om ee a - opoereet Sn ataeaenEAeEEETaet atime'