FEDERAL COURT OF AUSTRALIA Prejay Holdings Ltd v Commissioner of Patents [2002] FCA 881 PATENTS – extension of term of standard patent – claim for method of use of pharmaceutical substance – whether pharmaceutical substance per se in substance falls within the scope of the claim WORDS AND PHRASES – "fall within the scope of the claim" Patents Act 1990 (Cth) ss 70, 117 Boehringer Ingelheim International GmbH v Commissioner of Patents [2000] FCA 1918 followed Boehringer Ingelheim International GmbH v Commissioner of Patents (2001) 112 FCR 595 applied Bristol-Myers Squibb Company v FH Faulding & Co Limited (2000) 97 FCR 524 at [86] discussed Rescare Ltd v Anaesthetic Supplies Pty Ltd (1992) 25 IPR 119 at 154 mentioned Anaesthetic Supplies Pty Ltd v Rescare Ltd (1994) 50 FCR 1 at 24 mentioned Distiller Co Ltd's Application (1953) 70 RPC 221 at 223 mentioned Lahore, Patents, Designs and Trade Marks Law at [18,285] mentioned PREJAY HOLDINGS LTD and WOCO INVESTMENTS LTD v THE COMMISSIONER OF PATENTS NO V 365 OF 2001 HEEREY J 16 JULY 2002 MELBOURNE IN THE FEDERAL COURT OF AUSTRALIA VICTORIA DISTRICT REGISTRY V 365 OF 2001 BETWEEN: PREJAY HOLDINGS LTD and WOCO INVESTMENTS LTD APPLICANTS AND: THE COMMISSIONER OF PATENTS RESPONDENT JUDGE: HEEREY J DATE OF ORDER: 16 JULY 2002 WHERE MADE: MELBOURNE THE COURT ORDERS THAT: 1. The application is dismissed. 2. The applicants pay the respondent's costs to be taxed, 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 365 OF 2001 BETWEEN: PREJAY HOLDINGS LTD and WOCO INVESTMENTS LTD APPLICANTS AND: THE COMMISSIONER OF PATENTS RESPONDENT JUDGE: HEEREY J DATE: 16 JULY 2002 PLACE: MELBOURNE REASONS FOR JUDGMENT 1 The applicants seek an order under the Administrative Decisions (Judicial Review) Act 1977 (Cth) for review of a decision of Dr Gillian Jenkins, a delegate of the Commissioner of Patents, refusing to accept an application under s 70 of the Patents Act 1990 (Cth) (the Act) for an extension of the term of a standard patent, Australian Patent no 520834 (the Patent). 2 Relevantly for present purposes s 70 provides (emphasis added) : "70 Applications for extension of patent (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) The term of the patent must not have been previously extended under this Division. (5) … (6) …" 3 The delegate found that all requirements were satisfied except for the one emphasised which is the second limb of s 70(2)(a). 4 The Patent was granted on 28 July 1989 and its twenty year term expires on 1 August 2004. 5 The Patent is for an invention comprising a method of treating menopausal or post-menopausal disorders in women by administering a combination of progestogen and estrogen hormones. The Patent has 24 claims, all of which are method claims. The claim with which the present proceeding is concerned is claim 14 which is as follows: "A method of hormonally treating menopausal or post-menopausal disorders in a womAn, comprising administering to said woman continuously and uninterruptedly both progestogen and estrogen in daily dosage units of progestogen equivalent to laevo-norgestrel dosages of from about 0.025mg to 0.05mg and of estrogen equivalent to estradiol dosages of about 0.5mg to 1.0mg." 6 "Pharmaceutical substance" is defined in sch 1 of the Act to mean "… 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 physio-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." "Therapeutic use" is defined in sch 1 to mean "… use for the purpose: (a) preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in persons; or (b) influencing, inhibiting or modifying a physiological process n persons; or (c) testing the susceptibilityo if persons to a disease or ailment." Delegate's decision 7 The delegate identified as the relevant pharmaceutical substance the product marketed as PREMIA 2.5 CONTINUOUS (Premia) which is a combination of 2.5 mg medroxyprogesterone acetate and 0.625 mg oestrogen-conjugate. This product is listed on the Australian Register of Therapeutic Goods (ARTG) and is a tablet comprising a combined dosage of the two hormones. It was accepted by the delegate that this product is disclosed in the specification of the Patent. The delegate was further satisfied that Premia per se was in substance disclosed in the specification. Although the invention was directed to the use of Premia, the delegate accepted that there was disclosure in the specification of that pharmaceutical substance by itself. 8 However the delegate, applying my decision in Boehringer Ingelheim International GmbH v Commissioner of Patents [2000] FCA 1918, held that Premia in substance did not fall within the scope of the claim. The delegate considered that the effect of Boehringer was that s 70(2)(a) is only available to extend the term of a patent when there is at least one claim to a pharmaceutical substance by itself, and unqualified by process or method components. The intent of the legislation was only to provide an extension of term for a patent in certain circumstances and such an extension was not available in relation to method claims. The Boehringer case 9 Boehringer concerned a patent the relevant claim of which was: "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, the container being provided with a nozzle adapted for nasal administration of the composition." After reviewing the relevant history of the legislation I said (at [13]): "[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. 10 I also (at [18]) quoted the following passage from the Patent Office Manual of Practice and Procedure (emphasis in original): "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 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)." 11 Subsequently to the delegate's decision now under review, my judgment in Boehringer was affirmed by the Full Court on appeal: (2001) 112 FCR 595, 52 IPR 529. Their Honours concluded (at [37]) that my decision was correct, substantially for the reasons I gave. For present purposes there is an important observation of the Full Court, which needs to be read in the light of an argument put by counsel for the Commissioner. Their Honours noted (at [35]) counsel's submission that the words "in substance fall within the scope of the claim or claims" of the specification referred to the elements that make up the claim or claims. If one essential integer is removed from a patent claim, the effect is to broaden the claim. The use of the pharmaceutical substance itself would not be an infringement: it would be necessary for the infringer also to replicate the additional elements of any claim that was said to be infringed. It followed that the pharmaceutical substance, standing alone, did not "in substance fall within the scope of" any claim of the specification. 12 Their Honours (at [42]) applied that reasoning in the following way: "The appellant's best point is that in ordinary usage a necessary integer of a whole would be regarded as falling within the scope of that whole. However, in the context of s 70(2)(a), we think that falling within the scope of a claim in a patent specification means included among the things claimed. Here, the substance, in itself, is not a thing claimed in the patent sense." Is Boehringer distinguishable? 13 Senior counsel for the applicants stated that special leave to appeal to the High Court is being sought in Boehringer and the formal submission was made that the decision was wrong. Needless to say however, it is binding on me unless distinguishable. 14 Senior counsel argued that Boehringer was distinguishable because the present claim 14, unlike the claim in Boehringer, does not have a physical component such as the container with nozzle. I do not accept this argument. In both Boehringer and the present case the claims included integers other than the pharmaceutical substance itself. The fact that in Boehringer the other integer was a particular physical device and in the present case the other integer is a particular method of use is to my mind a distinction without a difference. 15 A further ground argued was that Premia was not an "old or known product". 16 Counsel for the Commissioner referred in some detail to correspondence in the Patent Office file at the time of grant which, he said, showed that the combination of claim 14 was in fact an old or known product. I do not think it is necessary to pursue this line of argument. Whether or not the combination, or the more precisely defined form of it constituted by Premia, is or is not an old or known product is not to the point. The fact remains that claim 14 is a method claim and mere use of the substance otherwise than in accordance with the specified method would not infringe. The reasoning in Boehringer was applicable and was correctly applied by the delegate. The s 117 argument 17 Senior counsel for the applicants advanced a submission based on s 117 of the Act. This argument was not put to the delegate. Section 117 is as follows: "117 Infringement by supply of products (1) If the use of a product by a person would infringe a patent, the supply of that product by one person to another is an infringement of the patent by the supplier unless the supplier is the patentee or licensee of the patent. (2) A reference in subsection (1) to the use of a product by a person is a reference to: (a) if the product is capable of only one reasonable use, having regard to its nature or design – that use; or (b) if the product is not a staple commercial product – any use of the product, if the supplier had reason to believe that the person would put it to that use; or (c) in any case – the use of the product in accordance with any instructions for the use of the product, or any inducement to use the product, given to the person by the supplier or contained in an advertisement published by or with the authority of the supplier." 18 Senior counsel argued that the "scope" of a claim is to be tested by enquiring what would infringe the claim. In determining what infringes a claim it is necessary to take into account the effect of s 117. The expression "in substance" has the effect that one must look at the scope of the claim as a matter of substance, not merely as a matter of form. In the present case the pharmaceutical substance (Premia) has only one reasonable use. This use both satisfies the test for pharmaceutical substance and falls within the scope of claim 14. 19 Hence, so the argument goes, the supply of Premia from one person to another is an infringement of claim 14. But the therapeutic use of Premia necessarily involves supply from one person to another and hence infringes claim 14. Therefore the pharmaceutical substance, Premia, in substance falls within the scope of claim 14. 20 In my opinion, s 117 does not assist the applicants. It was introduced to clarify the difficulties and uncertainties associated with contributory infringement at common law: Lahore, Patents, Designs and Trade Marks Law (Butterworths) at [18,285]. It is concerned with the liability for infringement of a supplier. "Supply" is defined in sch 1 to include "supply by way of sale, exchange, lease, hire, or hire-purchase". Section 117 makes a supplier of a product liable as an infringer when there is, or would be, as a result of the supply, an infringing use of the product by the person supplied in one of the ways stipulated in subs (2). Section 117 does not extend the "scope" of claim 14 by making a claim for a method of using a particular product into a claim for the product only. 21 The operation of s 117 was discussed by Black CJ and Lehane J in Bristol-Myers Squibb Company v F H Faulding & Co Limited (2000) 97 FCR 524 at [82]-[97]. That case involved petty patents for a method for the treatment of ovarian cancer by the administration of taxol (a naturally occurring substance) in certain quantities over certain periods of time. One issue was whether the respondent had infringed the petty patents by supplying taxol to doctors with instructions for use which corresponded to the method of the patents. Their Honours upheld my finding as to invalidity, but went on to discuss the question of infringement. 22 Their Honours expressed the view that, had the petty patents been valid, infringement would have been made out, notwithstanding what was said in Rescare Ltd v Anaesthetic Supplies Pty Ltd (1992) 25 IPR 119 at 154 (Gummow J) and on appeal Anaesthetic Supplies Pty Ltd v Rescare Ltd (1994) 50 FCR 1 at 24. 23 This conclusion was based on the application of s 117(2)(c), but their Honours made passing reference to par (b) as follows (at [86]): "There is a textual difficulty - which, given our conclusion about par (c), we do not need to resolve – with the suggested application of par (b). The use to which the appellant had reason to believe that the taxol which it supplied would be put was, in part, use in the treatment of patients with cancer and, in part, use in clinical trials involving patients suffering from cancer. It is not clear, we think, that the particular method by which it was expected to be used is properly to be described as the use to which it was to be put. If one were to ask, to what use is a therapeutic drug, prescribed for a patient, put, the answer might be: 'It is to be taken to cure the patient's condition'. It would not, perhaps, be: 'It is to be taken three times daily, before meals.'" 24 In other words, their Honours were saying that par (b) did not apply because "any use of the product", in the sense of "use to cure a cancer patient's condition", would not be an infringing use, given that the patent was for a particular method of use of taxol. Applying that reasoning in the present case, where the applicants' argument was based only on par (a), I think the expression in s 117(1) "the use of a product (which) would infringe a patent" means, in the case of a patent for a method, use of the product by that method. Unless that criterion is satisfied, one does not get to the particular sub-set of infringing use in par (a). The point of subs (2) is that it stipulates particular types of use which will constitute "use" by a person for the purposes of subs (1), thus making supply to that person an infringement. The "use" to which s 117(1) refers must be an infringing use, but not all infringing uses are caught – only those specified in subs (2). 25 If the patent is for a product only, then of course use by a person of the product would be exploitation and thus infringement (see par (a) of the definition of "exploit" in sch 1) and (additionally) if that use was the only use of which the product is reasonably capable, then by virtue of s 117(1) and (2)(a) a supplier to that person would infringe also. 26 Where there is a patent for a method, such as "Substance X when used…", it would usually follow that there is more than one reasonable use of X. If that were not so, one would expect the patent to be only for Substance X per se. 27 The applicants' construction makes s 117 operate not as a clarification or extension of the ways in which infringement may occur but as a substantial extension of the monopoly granted by the patent itself. If one were to accept the applicants' case, where once there was a patent for use of a particular substance in a particular way, there would now be a patent for use of that product in any way, provided only it was therapeutic. And this would occur without any need to establish novelty and all the other criteria of s 18(1) even at the priority date, let alone at the date of extension. It seems axiomatic that extension cannot enlarge the scope of a patent, any more than can amendment under s 102: Distiller Co Ltd's Application (1953) 70 RPC 221 at 223. Orders 28 The application will be dismissed. I see no reason why the usual consequence as to costs should not follow. The Commissioner has been put to expense in resisting what she has successfully contended would be a wrong construction of the Act. There was no other party who could have taken that role. I certify that the preceding twenty-eight (28) numbered paragraphs are a true copy of the Reasons for Judgment herein of the Honourable Justice Heerey. Associate: Dated: 16 July 2002 Counsel for the Applicants: J McL Emmerson QC and A J Ryan Solicitor for the Applicants: Freehills Counsel for the Respondent: G C McGowan Solicitor for the Respondent: Australian Government Solicitor Date of Hearing: 4 July 2002 Date of Judgment: 16 July 2002