FEDERAL COURT OF AUSTRALIA Boehringer Ingelheim International v Commissioner of Patents [2000] FCA 1918 PATENTS – extension of patent – meaning of "pharmaceutical substance per se" WORDS AND PHRASES - "pharmaceutical substance per se" Patents Act 1990 (Cth) s 70(2)(a) BOEHRINGER INGELHEIM INTERNATIONAL Gmbh v THE COMMISSIONER OF PATENTS NO V 181 of 2000 HEEREY J 22 DECEMBER 2000 MELBOURNE IN THE FEDERAL COURT OF AUSTRALIA VICTORIA DISTRICT REGISTRY V 181 OF 2000 BETWEEN: BOEHRINGER INGELHEIM INTERNATIONAL GmbH APPLICANT AND: THE COMMISSIONER OF PATENTS RESPONDENT JUDGE: HEEREY J DATE OF ORDER: 22 DECEMBER 2000 WHERE MADE: MELBOURNE THE COURT ORDERS THAT: 1. The application is dismissed. 2. The applicant pay the respondent's costs, including reserved costs. 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 V 181 OF 2000 BETWEEN: BOEHRINGER INGELHEIM INTERNATIONAL GmbH APPLICANT AND: THE COMMISSIONER OF PATENTS RESPONDENT JUDGE: HEEREY J DATE: 22 DECEMBER 200 PLACE: MELBOURNE REASONS FOR JUDGMENT 1 The applicant seeks review under the Administrative Decisions (Judicial Review) Act 1977 (Cth) ("the AD(JR) Act") of a delegate of the Commissioner of Patents to refuse an extension of time under s 70 of the Patents Act 1990 (Cth) ("the 1990 Act") for its patent no 531074 ("the Patent"). The critical issue is whether the delegate misconstrued s 70(2)(a) in finding that "one or more pharmaceutical substances per se"did not "fall within the scope of the claim or claims" of the specification of the Patent. 2 The Patent was granted on 17 November 1983 with a priority date of 4 July 1979. It relates to compositions for the treatment of nasal hypersecretion (runny nose), containers adapted for nasal administration and containing compositions for such treatment and methods of treating the condition. 3 Claim 1 of the Patent is as follows: "1. A container comprising an aerosol or spray composition for nasal administration which composition comprises as active ingredient a quaternary tropane alkaloid derivative with atropine-like activity [hereafter "the Substance"], the container being provided with a nozzle adapted for nasal administration of the composition." 4 Claims 2 and 3 are for a container where the composition comprises or contains specified substances, being more particular forms of the Substance. Claim 4 is for a container claimed in any one of the preceding claims having a metering device. Claim 5 is for the container of claim 4 wherein the metering device is adapted to deliver specified quantities of the Substance. Claims 6 to 9 are directed to methods of treatment of nasal hypersecretion comprising the nasal administration of an effective amount of a pharmaceutical composition comprising as active ingredient the Substance or particular forms or quantities of the Substance. Claims 10 to 12 are omnibus claims. Claim 13 is for a method of treatment as claimed in claim 6 with reference to any one of the Examples. Claims 14 to 16 are directed to an aerosol or spray composition as claimed in claim 1 when used in the container of claim 1. 5 Section 70, relevantly for present purposes, provides: "70 (1) The patentee of a standard patent may apply to the Commissioner for an extension of the term of the patent if the requirements set out in subsections (2), (3) and (4) are satisfied. (2) Either or both of the following conditions must be satisfied: (a) one or more pharmaceutical substances per se must in substance be disclosed in the complete specification of the patent and in substance fall within the scope of the claim or claims of that specification; (b) one or more pharmaceutical substances when produced by a process that involves the use of recombinant DNA technology, must in substance be disclosed in the complete specification of the patent and in substance fall within the scope of the claim or claims of that specification. (3) Both of the following conditions must be satisfied in relation to at least one of those pharmaceutical substances: (a) goods containing, or consisting of, the substance must be included in the Australian Register of Therapeutic Goods; (b) the period beginning on the date of the patent and ending on the first regulatory approval date for the substance must be at least 5 years. (4) … (5) … (6) …" 6 Basic to the applicant's case is the submission that the words "per se" confer no special or different meaning on the expression "pharmaceutical substance". In other words, there is no difference between "pharmaceutical substance per se" and "pharmaceutical substance". It being common ground that the Substance is a "pharmaceutical substance" it follows, so the applicant says, that the condition of s 72(2)(a) is met. 7 At the outset, it can be observed that words are usually inserted in legislation for good purpose. The Latin words "per se" have an accepted meaning as an expression in English, namely "by or in itself", "intrinsically" or "essentially" (Macquarie, New Shorter Oxford). It would be surprising if the expression as used in s 70(2)(a) added nothing and had no work to do. But, as counsel for the Commissioner submitted, the history of the legislation shows that this is not the case. 8 Under Part IX of the Patents Act 1952 (Cth) ("the 1952 Act") a patentee could seek an extension of up to ten years if it could be shown that the patentee had been "inadequately remunerated". Section 93 directed the court to have regard to the nature and merits of the invention, the profits made by the patentee and all the circumstances of the case. In practice patentees produced substantial accounting evidence endeavouring to show great expenditure on research and development and only modest sales. 9 Part IX applied to all patents, irrespective of subject matter. However extension applications were frequently brought in the case of pharmaceutical patents because regulatory approval requirements often meant that the product could not enter the marketplace until a substantial part of the patent protection period had already passed. 10 The first particularised legislative treatment of pharmaceutical patents came in 1989. By the Patents Amendment Act 1989 (Cth) a new s 90 was inserted in the 1952 Act. The new s 90(1) provided: "90. (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 accordance with the prescribed form given to the Commissioner note 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." 11 When the 1990 Act was introduced, Part IX of the 1952 Act, as amended in 1989, was in substance re-enacted. 12 By the Patents (World Trade Organization Amendments) Act 1994 (Cth) Div 2 of Pt 3 of Ch 6 of the 1990 Act, containing the extension provisions in ss 70 to 79, was repealed. Section 70 and related sections in their present form were introduced by the Intellectual Property Laws Amendment Act 1998 (Cth). For the first time, provision was made for the extension of not just of a "pharmaceutical patent", but a "pharmaceutical patent per se". 13 The 1990 Act in its present form manifests a policy which draws a distinction between, on the one hand, a pharmaceutical substance that is the subject of a patent claim and, on the other hand, a pharmaceutical substance that forms part of a method or process claim. The specific exception to the latter (an exception which proves the rule) is the provision for recombinant DNA technology in s 70(2)(b). 14 Broadly speaking, a claim in relation to a pharmaceutical substance can be made in three ways (i) a new and inventive product alone; (ii) an old or known product prepared by a new and inventive process; (iii) an old or known product used in a new and inventive mode of treatment. 15 What is clear in s 70 is that only the first type of claim to a pharmaceutical product is to be subject to extension rights. So far as a new process is concerned, it is only when the new process answers the particular description in s 70(2)(b) (recombinant DNA process) that it can be the subject of an extension. As counsel for the Commissioner submitted, the policy to be deduced in the light of the legislative history is that Parliament has decided that what is intended to be fostered is primary research and development in inventive substances, not the way they are made or the way they are used, with the sole (and important) exception of recombinant DNA techniques, this being an area particularly worthy of assistance for research and development. 16 In the light of this history, the relevance of the expression "per se" becomes clear. Section 70(2)(a) is only to make extension rights available when the claim is for a pharmaceutical substance as such, as opposed to a substance forming part of a method or process. 17 Reference was made at the hearing to the Patent Office Manual of Practice and Procedure. This work is used as an internal guide to the administration of the 1990 Act and is also made available to the patent attorney and legal professions. 18 Relevantly for present purposes the Manual states: "25.2.2 Pharmaceutical Substance per se Except for substances produced by a process involving the use of recombinant DNA technology, an extension of term is only available in respect of a pharmaceutical substance per se being within the scope of a claim of the patent. The explanatory memorandum to the Intellectual Property Laws Bill of 1997 noted that, except for substances produced by a process involving the use of recombinant DNA technology, claims to pharmaceutical substances per se would usually be restricted to new and inventive substances. The memorandum also mentioned a number of specific instances where an extension would not be available: 'Patents that claim pharmaceutical substances when produced by a particular process (product by process claims) will not be eligible unless that process involves the use of recombinant DNA technology. Claims which limit the use of a known substance to a particular environment, for example claims to pharmaceutical substances when used in a new and inventive method of treatment, are not considered to be claims to pharmaceutical substances per se.' This distinction is specifically evident as between the reference in the Act to 'pharmaceutical substances per se', and to 'pharmaceutical substances when produced by a process that involves the use of recombinant DNA technology'. The use of the word 'per se' requires the claim to the substance to be unqualified by process, temporal, or environmental, components. Thus, in order that the term of a patent be extended, the patent must contain one or more claims in the form: a) A substance of formula **** b) Substance X mixed with substance Y Examples of claims that are not directed to substances per se are: a) Substance X when used … b) Substance X for use … c) Substance X when produced by method Y d) An antiseptic comprising substance X [unless the label 'antiseptic' was clearly non-limiting on the scope of the claim.] e) A method of preparing substance X f) A substance of formula …, where component Y is produced by … g) [A specified quantum] of substance X h) 'Swiss' – style claims referring to substance X i) Use of substance X in the treatment of Y In limited circumstances, a substance could be new and inventive but can only be defined by reference to the process in which it was made (for example, compound X obtainable by process Y) because the chemical structure or composition is undetermined. In such circumstances, a claim which defines the substance by reference to such method steps would be a claim to the substance per se. 25.2.3. Mixture or Compound of Substances The definition of a pharmaceutical substance includes a mixture or compound of substances. In the case of such mixtures or compounds, the test of whether or not a substance is a pharmaceutical substance applies to the mixture or compound as a whole, not to an individual component of the mixture or compound. Thus, a typical ARTG [Australian Register of Therapeutic Goods] registration might refer to an active ingredient in a particular carrier or excipient. In this situation, the pharmaceutical substance is the active ingredient in the carrier or excipient – not the active ingredient alone. Of course, under patent law a patent is not granted for a substance capable of being used as a medicine if it is a mere mixture of known ingredients. Similarly, a collocation of known integers with no working interrelationship is not patentable. Consequently, while the ARTG may contain many entries involving an active substance with different carriers or excipients, separate patents corresponding to the differing ARTG entries are unlikely to have been granted. 25.2.4 'within the scope of the claim' The mere fact that a substance is mentioned in a claim does not mean that the substance is within the scope of the claim. The phrase 'in substance fall within the scope' has been the subject of judicial interpretation in the context of amendments. In The Distillers Co. Ld.'s Application, (1953) 70 RPC 221 at page 223 the test for 'in substance fall within the scope' was stated to be: 'would the amendment make anything an infringement which would not have been an infringement before the amendment?' This was considered by the Commissioner in Astra Lakemedal AG 29 IPR 183, (1994) AIPC ¶91-087, in deciding that a substance was not in substance within the scope of certain claims. On appeal to the Federal Court in Astra Lakemedal AG 31 IPR 1, the Commissioner's decision was overturned, having regard to the words 'to which the application relates' as present in the then s. 70 (and which are not present in the present legislation)." 19 I find this material of assistance. It is not extrinsic material like explanatory memoranda or second reading speeches which might reveal what in fact was the intention behind legislation (although of course the passage in par 25.2.2 quoted from the explanatory memorandum does just that). Rather, it can be used in the same way as counsel's submissions or text books or articles in learned journals. It shows a way in which the language of the statute can be given a workable meaning. The explanation given by the Manual is in my opinion consistent with the language of the legislation considered in the light of its history and evident purpose. All the claims of the Patent are for modes of treatment involving the Substance, not for the Substance in itself. 20 The applicant relied on a number of grounds of review under the AD (JR) Act. The delegate's decision was said to be invalid as an improper exercise of power (s 5(1)(e), to involve an error of law (s 5(1)(b)), and to be otherwise contrary to law (s 5(1)(i)). However all these grounds were in essence variations of the central argument as to the meaning of "pharmaceutical substance per se" and therefore must fail. 21 The applicant also argued that the meaning of "pharmaceutical substance per se" adopted by the delegate was inconsistent with the granting of a number of extensions under the present legislation for other patents. Eight other patents were mentioned. I did not see this as a fruitful line of argument. It would be necessary to consider in detail each of these other patents and the extensions granted. At best for the applicant, this might show that some or all of the extensions were granted on the basis of the construction of s 70(2)(a) for which the applicant now contends. If so, the only conclusion would be that the grant of those extensions was incorrect. 22 The application will be dismissed with costs, including reserved costs. I certify that the preceding twenty-two (22) numbered paragraphs are a true copy of the Reasons for Judgment herein of the Honourable Justice Heerey J. Associate: Dated: 22 December 2000 Counsel for the Applicant: B Hess and L J Duncan Solicitor for the Applicant: Callinan Lawrie Counsel for the Respondent: B N Caine Solicitor for the Respondent: Australian Government Solicitor Date of Hearing: 15 December 2000 Date of Judgment: 22 December 2000