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. ... 71. An application for an extension of the term of a patent lapses if the applicant does not, within the prescribed period, give the Commissioner: (a) a marketing approval certificate in respect of the pharmaceutical substance to which the application relates; and (b) a proposed claim or claims. 72. Where: (a) a patentee asks the Secretary to the Department of Community Services and Health, in writing, for the issue of a marketing approval certificate in respect of a pharmaceutical substance; and (b) the Secretary to the Department of Community Services and Health has approved the marketing of that substance, or a product containing that substance, in Australia; the Secretary must immediately give a marketing approval certificate in the approved form to the patentee in respect of that substance. ... 74. The Minister, the Secretary to the Department of Community Services and Health or a person interested may, within the prescribed period and in accordance with the regulations, oppose the grant of an extension of the term of a patent on either one or both of the following grounds, but on no other ground: (a) that the application for the extension, the marketing approval certificate, or the proposed claim or claims, is or are not in accordance with this Act; (b) that the proposed claim or claims claim matter other than the pharmaceutical substance or substances to which the application relates. 75.(1) The Commissioner may determine an application for an extension of the term of a patent even though the term of the patent has expired. (2) Where the time for opposing the grant of an extension of the term of a patent has expired, the Commissioner must, if satisfied that: (a) the application for the extension, the marketing approval certificate and the proposed claim or claims are in accordance with this Act; and (b) the proposed claim or claims do not claim matter other than the pharmaceutical substance or substances to which the application relates; grant an extension of the term of the patent for a period of 4 years in relation to the proposed claim or claims, but if not satisfied, the Commissioner must, subject to subsection (3), refuse to grant an extension of the term of the patent. (3) The patentee may, within such period as the Commissioner allows, amend the proposed claim or claims. (4) If, after amendments are made under subsection (3), the Commissioner is satisfied as to the matters referred to in subsection (2), the Commissioner must grant an extension of the term of the patent for a period of 4 years in relation to the proposed claim or claims, but if the Commissioner is not so satisfied the Commissioner must refuse to grant an extension of the term of the patent. ... 76. Where the term of a patent has been extended, proceedings for infringement of the patent cannot be instituted in respect of an act done more than 2 years after the day on which the term of the patent expired unless the act constitutes sale, offering for sale, or distribution for a purpose other than obtaining marketing approval, of the pharmaceutical substance of substances concerned." The term "pharmaceutical substance" is defined in Schedule 1 of the Act as follows: "'pharmaceutical substance' means a substance (including a mixture or compound of substances) for therapeutic use whose application (or one of whose applications) involves: (a) a chemical interaction, or physico-chemical interaction, with a human physiological system; or (b) action on an infectious agent, or on a toxin or other poison, in a human body; but does not include a substance that is solely for use in in vitro diagnosis or in vitro testing;" The term "therapeutic use" is also defined in Schedule 1: "'therapeutic use' means use for the purpose of: (a) preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in persons; or (b) influencing, inhibiting or modifying a physiological process in persons; or (c) testing the susceptibility of persons to a disease or ailment;" Pursuant to s.71 of the Act Astra filed with the Commissioner proposed claims for the extended patent and a Marketing Approval Certificate in respect of a pharmaceutical substance described as "Foscarnet Sodium" said to be the generic name of a trisodium salt of phosphonoformic acid. The Certificate also stated that the proprietary name of products containing the substance was "Foscavir". The proposed claims, which numbered 1-30, repeated, as proposed claims 1-18, Claims 1-16 of the patent specification, with minor variations. Proposed claims 19-30 claimed protection for the use of phosphonoformic acid or a salt thereof "when used for" inhibiting the replication of a virus or the growth of virus-transformed cells. The Examiner of Patents responded to the application, inter alia, by stating that proposed claims 19-30 were not allowable "because they (were) directed to methods". In fact, the form of proposed claims 19-30 resembled the form of Claims 39-42 of the patent specification and, like those Claims, made no direct reference to a method unlike Claims 17-38 of the specification. Astra submitted revised proposed claims which deleted five claims but repeated as proposed claims 18-25 the claims that had been formerly proposed claims 19-26. The Commissioner responded by advising Astra that proposed claims 18-25 were not allowable "because they (were) directed to methods". In December 1993 Astra lodged a new set of proposed claims which, after amendment on 18 April 1994, read as follows: "1. A pharmaceutical preparation including as the pharmaceutically active substance phosphonoformic acid or a physiologically acceptable salt thereof when used for inhibiting the replication of virus in man. 2. A pharmaceutical preparation including as the pharmaceutically active substance phosphonoformic acid or a physiologically acceptable salt thereof when used for inhibiting the replication of influenza virus in man. 3. A pharmaceutical preparation including as the pharmaceutically active substance phosphonoformic acid or a physiologically acceptable salt thereof when used for inhibiting the replication of herpes viruses in man. 4. A pharmaceutical preparation including as the pharmaceutically active substance phosphonoformic acid or a physiologically acceptable salt thereof when used for inhibiting the growth of virus-transformed cells in man. 5. A pharmaceutical preparation including as the pharmaceutically active substance trisodium phosphonoformate when used for inhibiting the replication of virus in man. 6. A pharmaceutical preparation including as the pharmaceutically active substance trisodium phosphonoformate when used for inhibiting the replication of influenza virus in man. 7. A pharmaceutical preparation including as the pharmaceutically active substance trisodium phosphonoformate when used for inhibiting the replication of herpes viruses in man. 8. A pharmaceutical preparation including as the pharmaceutically active substance trisodium phosphonoformate when used for inhibiting the growth of virus-transformed cells in man." It may be seen that in their final form the proposed claims followed, in part, Claims 1-16 of the patent specification but did not specify, or limit, the carrier to be used in the admixture. A hearing was held before a delegate of the Commissioner on 13 April 1994 to deal with objections to the application raised by the Commissioner. After that hearing the delegate found, inter alia, that the proposed claims did not claim a pharmaceutical substance which in substance fell within the scope of the Claims of the patent specification. The delegate found, in effect, that the only pharmaceutical substances to be found within the scope of the Claims of the specification were the pharmaceutical preparations defined by Claims 1-16. The delegate found that Claims 17-42 did not define the invention other than by claims to methods and did not specify pharmaceutical substances to be used in those methods other than the substances defined in Claims 1-16. Astra contended that Claims 39-42 of the specification had sufficient scope to include the pharmaceutical preparations the subject of proposed claims 1-8, being pharmaceutical preparations not limited to the use of "carriers" other than water and organic solvents. Claims 39-42 of the specification make no sense if read as the definition of an invention of a process to apply phosphonoformic acid, or a salt thereof, directly to animals including man, to inhibit virus infections. Such a claim would not be fairly based on the matter described in the specification as a description of the invention. No such method is described in the specification. The description of the invention in the specification is directed to defining pharmaceutical preparations which include the antiviral agent and may be used to administer the antiviral agent to animals including man for the purpose of inhibiting viral infections. The pharmaceutical preparations set out in Claims 1-16 of the specification form part of the method of administration of the antiviral agent set out in Claims 17-38 of the specification. The balance of Claims 17-38 and Claims 39-42 have no useful meaning unless they refer to the use of the pharmaceutical preparations described in the specification not limited to the preparations dealt with in Claims 1-16. Such a meaning for those Claims is supplied by the use of a purposive construction. It is appropriate to apply such a construction to the Claims of the patent specification if that appears to be the intention of the specification when read as a whole, having regard to the fact that the specification is directed to a skilled reader. (See: Catnic Components Ltd. v. Hill & Smith Ltd. [1982] 99 R.P.C. 183 per Lord Diplock at 243; C. Van der Lely NY v. Ruston's Engineering Co. Ltd. [1985] R.P.C. 461 per Neill L.J. at 502-503; T.A. Blanco White, Patents for Inventions (5th Ed.) (London: Stevens & Sons. Limited, 1983) paras.2-103 - 2-104.) I am satisfied that the intention of Claims 17-38, where reference is made to a method of treating virus infections by a therapeutically effective amount of phosphonoformic acid, and of Claims 39-42, where the words "the use of phosphonoformic acid, or a physiologically acceptable salt thereof", are used in respect of the inhibition of replication of a virus or growth of virus-transformed cells, is to include the pharmaceutical preparations described in the specification not limited to the pharmaceutical preparations referred to in Claims 1-16. Relying upon that construction claims 1-8 of the proposed claims may be read as referring to all pharmaceutical preparations identified in Claims 17-42 of the specification as preparations to be used in a process of administering the antiviral agent to treat viral infections and inhibit replication of the virus and the growth of virus-transformed cells. The delegate found that the proper construction of ss.70 and 75 of the Act did not allow extension of the term of a patent for "methods involving the use of substances" and that proposed claims in support of an application for the grant of an extension of the term of a patent "can only be founded on claims to substances; they cannot be founded upon method- or process- type claims in the specification;". It is obvious that the pharmaceutical preparations referred to in the patent specification are within the meaning of the term "pharmaceutical substance" as defined in the Act. The delegate noted that there was no dispute that the requirements of s.70 of the Act were met in so far as the pharmaceutical substance was, in substance, disclosed in the complete specification of the patent. However, the delegate found that other than for the substances claimed in Claims 1-16 of the specification, the application for extension of the patent did not meet the additional requirement of s.70, namely, that the pharmaceutical substance, in substance, fall within the scope of the Claims of the patent specification. Claims 1-16 of the specification define the invention as, and claim protection for, "a pharmaceutical preparation". Claims 17-38 of the specification define the invention as a "method to treat virus infections" by the use of a pharmaceutical preparation and claim protection for that method. Claims 39-42 of the specification, as construed above, further define the invention by reference to a method involving the use of a pharmaceutical preparation for inhibiting replication of viruses and growth of virus-transformed cells. As stated earlier, the latter part of Claims 17-38, and Claims 39-42, are not limited by Claim 1 which excludes, inter alia, water and organic solvents as carriers of the antiviral agent in the admixtures described as pharmaceutical preparations. The limitation contained in Claim 1 is not part of the general description of the invention in the patent specification and was introduced as an amendment to the complete specification to avoid claiming as a protected preparation an admixture already covered by an earlier patent. Whilst that limitation may have been relevant to a claim to a pharmaceutical preparation per se, it was not relevant to a claim for protection of a process, in particular the use of a pharmaceutical preparation to administer a known substance to obtain the benefit of a discovered property of that substance, namely, inhibition of viral infections. Properly construed, Claims 39-42 of the patent specification disclose, in substance, a pharmaceutical substance, or substances, in respect of which extension of the term of the patent has been applied for and, therefore, not only in substance are the pharmaceutical substances disclosed in the patent specification, they also fall within the scope of the Claims of the specification. The requirements of s.70, therefore, are satisfied. Pursuant to sub-s.75(2) of the Act the Commissioner must grant an extension of the term of a patent if satisfied that, inter alia, the proposed claims do not claim matter other than the pharmaceutical substance, or substances, to which the application relates. In their final form the proposed claims, when read with the patent specification, define the intended scope of the extended patent as protection of the use of pharmaceutical preparations that include phosphonoformic acid, or a salt thereof, in the treatment of viral infections in man, being preparations described in the specification. The delegate applied the following construction to para.75(2)(b): "The plain meaning of this clause is that the proposed claims can only claim pharmaceutical substances per se; method-type claims are excluded as they would clearly claim matter other than the pharmaceutical substance - viz the steps of the method. Consequently subsection 75(2)(b) requires that the proposed claims must claim substances per se." The pharmaceutical substance to which s.75 applies is that set out in s.70 being the pharmaceutical substance, in substance, disclosed in the patent specification and, in substance, falling within the scope of the Claims of that specification. Sub-section 75(2) of the Act requires the Commissioner to grant an extension of the term of the patent "in relation to the proposed claim or claims" if satisfied that the qualifying conditions set out in the sub-section have been met. In the passage set out above the delegate adopted a construction of para.75(2)(b) which attributed little, or no, meaning to the words "to which the application relates" as used in that paragraph. Those words must be read together with s.70 which describes the entitlement to make application for the extension of a patent and defines the scope of the application. By s.70 a patentee may apply for extension of the term of a patent "in respect of" a pharmaceutical substance disclosed in the patent specification and within the scope of the claims of the specification. A patent, in so far as it is "in respect of" such a pharmaceutical substance is extended. It is not a grant of a new patent for a substance and s.70 does not restrict a patentee's entitlement to apply for extension of a patent to a patent "for a pharmaceutical substance". Therefore, the delegate erred in applying a restricted meaning to para.75(2)(b) by failing to accord to s.70 the full meaning of that section. The delegate placed undue weight on observations made by the High Court in The Wellcome Foundation Limited v. The Commissioner of Patents (1980) 145 C.L.R. 520 at 529 where the Court stated that "there is no distinction between the claim to the process and the claim to the substance when the substance claim is limited to its use in the process". The Court referred with approval to the remarks of Parker J. in Adhesive Dry Mounting Company Ltd. v. Trapp & Co. (1910) 27 R.P.C. 341 at 353. It may be accepted that the proposed claims lodged with the application do not extend beyond the use of described pharmaceutical preparations in processes defined in the Claims of the specification. It may also be accepted that it would not be an infringement of the patent defined in Claims 17-42 to manufacture any of the pharmaceutical preparations used in a process to which those Claims applied but that is not to say that such preparations are incapable of being protected by reliance upon the patent. It would be an infringement of the patent to use such a preparation in the manner described in the Claims and manufacture of a preparation for the purpose of distributing the substance for a use that would infringe the patent would support an injunction to restrain the threatened infringement by restraining manufacture and distribution of the substance. (See: Adhesive Dry Mounting at 353.) But in any event, protection of a substance under a patent claim limited to the use of the substance in a process is not a bar to a right to apply for an extension of the term of the patent under s.70 of the Act, having regard to the meaning given by the Act to the terms "pharmaceutical substance" and "therapeutic use". Section 70 applies to a substance for use for the purpose of, inter alia, inhibiting a physiological process by a chemical interaction with the human physiological system, or by action on an infectious agent in a human body. The definition of pharmaceutical substance is not limited to a substance the manufacture of which is protected by patent. The Act is concerned with extending the application of an existing patent in respect of substances able to be used in a therapeutic manner, to wit curing or alleviating a disease, or inhibiting a physiological process. Such a substance protected by a process claim is a substance within the contemplation of s.70. It was submitted that in Virbac (Australia) Pty. Ltd. v. Merck Patent GmbH (1994) A.I.P.C. 91-094 Burchett J. reached a contrary conclusion. In Virbac it was contended that s.70 of the Act did not contemplate extension of patent protection in respect of a substance per se and only contemplated extension of the patent in respect of a substance to be used for a purpose related to the treatment of human beings. His Honour found that the meaning of s.70 was not so limited. It was not necessary for his Honour to consider whether the proper construction of ss.70 and 75 excluded extension of the term of a patent in respect of a pharmaceutical substance where the protection provided by the patent for that substance was limited to the use of that substance in a therapeutic process, and the comments his Honour made on the construction of s.70 are to be understood in the terms of the question his Honour was called upon to answer. His Honour considered that the expression "pharmaceutical substance for therapeutic use" extended to a substance that was suitable for that purpose and was not limited to a substance suitable for no other use. Where at 38,570 his Honour stated that s.70 and the following sections made it clear that the extension contemplated by the statute related to the substance itself, and not to any method or use claim, his Honour was disallowing a limitation of the application of s.70 to a method or use claim as his Honour made clear in a later sentence on that page: "There is no suggestion in the terms of these sections that, if the substance is in fact a pharmaceutical substance, some limitation is to be placed upon the extension simply because the substance has also uses which would not qualify it as a pharmaceutical substance." No doubt it is the intention of the Act that the term of a patent that is in respect of substances suitable for a therapeutic use is to be extended. But there is nothing in the Act to provide cause to conclude that the benefit of extension of a patent will not apply to a patent that is in respect of pharmaceutical substances in so far as the patent applies to the application of those substances for therapeutic use. In the relevant sections of the Act it is the intention of Parliament that pharmaceutical substances covered by a patent and currently exploited by a patentee will have the benefit of an entitlement to extension of the term of the patent for a period of four years. In doing so, Parliament has recognized the time taken to obtain marketing approval for pharmaceutical substances under legislation which controls the distribution of such substances, and the cost incurred by the patentee in conducting clinical trials and tests over and above the cost of development of the invention the subject of the patent. Of course, approval to market a pharmaceutical substance is directed to the proposed use of the substance for a therapeutic purpose, not to the manufacture of the substance per se. In para.75(2)(b) "matter other than the pharmaceutical substance or substances to which the application relates" is a reference to a claim to protection in respect of a pharmaceutical substance that cannot be said to be disclosed in, or fall within, the claims of the patent specification. That is, the entitlement to an extension of the term of a patent granted by sub-s.75(2) will be limited by that part of the patent that is defined by claims in respect of a pharmaceutical substance. As stated earlier, a patent will be in respect of a pharmaceutical substance if the pharmaceutical substance is referred to in the specification, and in the Claims of the specification, as part of a process protected by the patent. The delegate misdirected himself by concluding that "method-type claims" claimed matter other than a pharmaceutical substance. The proposed claims relate to the use of pharmaceutical substances to treat viral infections in man. The protection applied for, by way of extension of the patent, was in respect of those pharmaceutical substances so used, and was an application that fell within the meaning of ss.70 and 75 of the Act. It follows that the proposed claims accompanying the application for extension of the patent do not claim matter other than the pharmaceutical substances to which the application relates and the requirements of para.75(2)(b) were met. It was also submitted that the delegate erred in finding as follows: "I cannot conclude that the marketing approval has necessarily been given for a pharmaceutical substance falling within the scope of the claims of the patent - that is, involving a carrier which is not disclaimed by claim 1 of the patent." It is apparent that the delegate's conclusion expressed above was dependent upon other determinations made by the delegate now found to have been made erroneously. Indeed, having regard to the meaning to be given to ss.70 and 75 of the Act and the Claims of the specification, it would appear that a certificate in the terms required by s.72 of the Act was requested and obtained. There will be an order that the decision of the Commissioner by his delegate be set aside and that the application be remitted to the Commissioner for determination in accordance with these reasons. The Commissioner must pay Astra's costs of the appeal. I certify that this and the preceding twenty-three (23) pages are a true copy of the Reasons for Judgment of his Honour Justice Lee. Associate: Date: APPEARANCES Counsel for the Applicant: J.McL. Emmerson. Q.C. Solicitors for the Applicant: Minter Ellison Morris Fletcher Counsel for the Respondent: E. Strong Solicitors for the Respondent: Australian Government Solicitor Date of Hearing : 8 and 9 November 1994 Date of Judgment : 28 February 1995