Astra Lakemedel Aktiebolag v Commissioner of Patents [1995] FCA 79

CATCHWORDS INTELLECTUAL PROPERTY - patents - extension of patent in respect of pharmaceutical substance - whether patent for method or process may be so extended. Patents Act 1952 ss 67, 68, 230, 233 Patents Act 1990 Ch 6; Pt 3; ss 69-79; sub-ss 70(1), 75(2); para.75(2)(b); Schedule 1 Patents Amendment Act 1989 T.A. Blanco White, Patents for Inventions (5th Ed.) Lahore et al., Patents, Designs and Trade Marks Law Ricketson, The Law of Intellectual Property, 1984 Terrell on The Law of Patents (13th Ed) Adhesive Dry Mounting Company Ltd. v. Trapp & Co. (1910) 27 R.P.C. 341 Catnic Components Ltd. v. Hill & Smith Ltd. [1982] 99 R.P.C. 183 National Research Development Corporation v. Commissioner of Patents (1959) 102 C.L.R. 252 C. Van der Lely NY v. Ruston's Engineering Co. Ltd. [1985] 102 R.P.C. 461 Virbac (Australia) Pty. Ltd. v. Merck Patent GmbH (1994) A.I.P.C. 91-094 The Wellcome Foundation Limited v. The Commissioner of Patents (1980) 145 C.L.R. 520 ASTRA LAKEMEDEL AKTIEBOLAG V. COMMISSIONER OF PATENTS VG194 OF 1994 LEE J. PERTH (HEARD IN MELBOURNE) 28 FEBRUARY 1995

IN THE FEDERAL COURT) OF AUSTRALIA ) VICTORIA ) DISTRICT REGISTRY ) GENERAL DIVISION ) NO. VG 194 OF 1994 B E T W E E N: ASTRA LAKEMEDEL AKTIEBOLAG Applicant and COMMISSIONER OF PATENTS Respondent MINUTE OF ORDER JUDGE MAKING ORDER: LEE J. DATE OF ORDER: 28 FEBRUARY 1995 WHERE MADE: PERTH (HEARD IN MELBOURNE) THE COURT ORDERS THAT:

1. The decision of the respondent be set aside. 2. The application be remitted to the respondent for determination in accordance with law. 3. The respondent pay the applicant's costs of the appeal. Note: Settlement and entry of orders is dealt with in Order 36 of the Federal Court Rules.

IN THE FEDERAL COURT) OF AUSTRALIA ) VICTORIA ) DISTRICT REGISTRY ) GENERAL DIVISION ) NO. VG 194 OF 1994 B E T W E E N: ASTRA LAKEMEDEL AKTIEBOLAG Applicant and COMMISSIONER OF PATENTS Respondent CORAM: LEE J. PLACE: PERTH (HEARD IN MELBOURNE) DATE : 28 FEBRUARY 1995 REASONS FOR JUDGMENT This is an "appeal" under s.78 of the Patents Act 1990 ("the Act") against a decision of the Commissioner of Patents ("the Commissioner") refusing to grant to the applicant ("Astra") an extension of the term of a standard patent ("the patent"). The Commissioner is the respondent to the appeal and the appeal is heard in the original jurisdiction of the Court. Astra applied for the patent on 27 June 1977. A complete specification was lodged on that day but amended on several occasions thereafter. The patent was granted on 29 January 1981. Pursuant to ss.67 and 68 of the Patents Act 1952 ("the 1952 Act"), the term of the patent was sixteen years from the date on which the complete specification was lodged and, therefore, the patent expired on or about 27 June 1993. Under s.70 of the Act an application to extend a patent had to be made not later than twelve months before the end of the term of the patent. Astra applied for an extension of the patent on or about 19 June 1992. The application was not opposed. By s.230 of the Act, the 1952 Act was repealed from 30 April 1991, the date of commencement of the Act, but pursuant to s.233 of the Act, the Act applied to a standard patent granted under the 1952 Act as if the patent had been granted under the Act. Prior to 1989 the period of a standard patent could be extended on the petition of a patentee on one of two grounds, namely: 1. that the patentee had not been adequately remunerated by the patent; or 2. that by reason of hostilities between Australia and a foreign state the patentee had suffered loss or damage as patentee including loss of opportunity of dealing in, or developing the invention. The history of these provisions and like provisions under United Kingdom law is discussed in Ricketson, The Law of Intellectual Property at 995; Lahore et al., Patents, Designs and Trade Marks Law, 1.8.006 et seq.; Terrell on The Law of Patents (13th Ed.) para.11.01-11.03. On 15 December 1989 the 1952 Act was amended by the Patents Amendment Act 1989 which repealed the provisions relating to extension of patents and substituted an entitlement in a patentee to obtain an extension of a patent for a limited period in respect of a "pharmaceutical substance", if the patent specification disclosed that substance and the Commissioner was satisfied that the application complied with statutory requirements. Those provisions were repeated, in substance, in Ch.6 Pt.3 of the Act (ss.69-79). The issues in this appeal involve construction of the Claims of the complete specification and construction of the Act. According to the complete specification, the short description of the invention to which the patent applied, was "Method For Combating Virus Infections". The full description of the invention, including the best known method of performing it, stated that the invention related to pharmaceutical compositions and a method for selectively combating virus infections such as influenza and herpes infections in animals including man. In the specification Astra stated that research it had undertaken had led to discovery of the property of phosphonoformic acid, and salts thereof, when administered to animals including man, to combat virus infections in general, and influenza and herpes virus infections in particular. The specification suggested that the invention could be used in the treatment of infections caused by a broad range of viruses and for inhibiting the growth of cancers and tumors caused by viruses. It was stated that no chemotherapeutic antiviral agent had been found that was capable of delivering antiviral effects with acceptable side effects. A particular undesired effect of existing agents was their inability to discriminate between the virus to be attacked and components of the host cells that had been infiltrated by the virus. The essence of the invention for which the patent was obtained was the discovery of the property of phosphonoformic acid to selectively inhibit viral functions, with negligible inhibiting effect on functions of the host cells, and the selection of a practical method to make use of that property. The invention so described met the criteria for patentability under the 1952 Act according to the principles outlined in National Research Development Corporation v. Commissioner of Patents (1959) 102 C.L.R. 252. Furthermore, by granting the patent the Commissioner was satisfied that para.155(1)(b) of the 1952 Act presented no bar to the grant of the patent. (See: Ricketson, p.915, para.48.23.) The specification described in detail various pharmaceutical preparations in which phosphonoformic acid, or a salt thereof, could be administered: including solutions for injection; liquids for oral application; nasal sprays and nasal drops; ointments, jellies, creams; tablets, capsules, elixirs, syrups, and effervescent powders. At the time of application for the patent phosphonoformic acid was not a novel compound. It was used in solution with common organic solvents, and water, for application to plants to regulate their growth. Forty-two Claims were used to define the invention set out in the specification. The grant of the patent indicates that it was accepted by the Commissioner that the Claims were fairly based upon the material preceding the Claims in the specification. Claims 1-16 defined the invention in the terms of pharmaceutical preparations suitable for combating virus infections in animals including man, being an admixture in which an effective amount of phosophonoformic acid, or a physiologically acceptable salt thereof, was the active ingredient and a substance physiologically acceptable to animals including man "other than water or an organic solvent...or any other form of carrier conventionally used for the preparation of plant growth regulating formulations" was the carrier. Claims 17-38 defined the invention by reference to a method for the selective treatment of antivirus infections by administering a pharmaceutical preparation described in Claims 1-16, or "a therapeutically effective amount of phosphonoformic acid or a physiologically acceptable salt thereof." Claims 39-42 read as follows: "39. The use of phosphonoformic acid or a physiologically acceptable salt thereof for inhibiting the replication of virus in animals and man. 40. The use of phosphonoformic acid or a physiologically acceptable salt thereof for inhibiting the replication of influenza virus in animals and man. 41. The use of phosphonoformic acid or a physiologically acceptable salt thereof for inhibiting the replication of herpes viruses in animals and man. 42. The use of phosphonoformic acid or a physiologically acceptable salt thereof for inhibiting the growth of virus-transformed cells in animals and man." It is to be noted that Claims 39-42 did not refer to a pharmaceutical preparation suitable for combating virus infections or to a method for the selective treatment of such infections. In the general description of the invention under the heading "Pharmaceutical Compositions" admixtures of therapeutically effective amounts of phosphonoformic acid with carriers, which included water and organic solvents, were described. The general description of the invention did not outline a method for the use of the acid, or a salt thereof, in the treatment of viral infections, or for inhibiting replication of a virus or the growth of virus-transformed cells other than by the use of admixtures. It appears that the latter part of Claims 17-38, and Claims 39-42, are said to be fairly based on the description of the invention set out in the specification in that the context in which the Claims appear limits the scope of the Claims to use of phosphonoformic acid, or a physiologically acceptable salt thereof, in the manner, and in the pharmaceutical preparations described in the specification. I will return to the question of construction of the Claims later in the reasons. The relevant provisions of the Act relating to the extension of a patent are as follows: "70.(1) Where: (a) a pharmaceutical substance is in substance disclosed in the complete specification of a standard patent and in substance falls within the scope of the claim or claims of that complete specification; and (b) the patentee has requested the issue of a marketing approval certificate in respect of that substance; the patentee may, by notice in writing in the approved form given to the Commissioner not later than 12 months before the end of the term of the patent, apply for an extension of the term of the patent in respect of that substance and any other pharmaceutical substance which is in substance disclosed in the specification and in substance falls within the scope of the claim or claims of the specification.