Case: Boehringer Ingelheim International v Commissioner of Patents (2001) AIPC |P91-670
Outcome: followed
Dr Elliott was cross-examined at some length by Mr Caine. It is unnecessary for present purposes to set out in any great detail the nature of the cross-examination. Put simply, Mr Caine suggested to Dr Elliott that her opinion was idiosyncratic, and failed to reflect the authoritative interpretation that had been accorded to the definition of "pharmaceutical substance" by both Heerey J at first instance ( Boehringer Ingelheim International v Commissioner of Patents (2001) AIPC |P91-670), and by the Full Court in Boehringer . 68 The transcript of Mr Caine's cross-examination sheds considerable light on this issue: "MR CAINE:...Dr Elliott, just to identify it for the transcript, that is a copy of the Boehringer decision at first instance before Heerey J which is document 5 in the briefing documents that you were given for the purpose of preparing your report. Would you be good enough to go to paragraph 18 of that decision where his Honour sets out an extract from the Patent Office Manual of Practice and Procedure?---Yes, I have it. Would you go to the part of paragraph 18 where his Honour extracts from the Manual paragraph 25.2.3 which is headed, "Mixture or Compound of Substances". Do you see in the first paragraph under that sub-heading his Honour - I am sorry, the Patent Office Manual says: The definition of a pharmaceutical substance includes a mixture or compound of substances. Just pausing there, you would accept that that is part of the statutory definition in schedule 1 of the Act, would you not?---It is. Yes, and the Manual goes on to say: 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. And then in the next paragraph the Manual says: 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. Now pausing there, do you recall reading those two paragraphs and taking them on board when you were reading Heerey Js decision for the purpose of your report?---Yes, I did. Did you - the view that you have expressed in your report as I understand it is that the pharmaceutical substance as defined in the Act should be narrowly considered as the active ingredient on its own?---I do. Yes. That is at odds, is it not, with what is set out in those two paragraphs in the Patent Office Manual?---I don't believe so and as far as the active ingredient is the pharmaceutical substance that is going to interact with the body and regardless of what the other components are, that is the product that is going to be exerting its pharmacological effect. I understand that is your view but the view expressed here in the Manual and extracted by his Honour is that it is the active ingredient, my words, together with the carrier or excipient, not the active ingredient alone. Do you see that?---For clarification I would read that saying it is the pharmaceutical substance is the active ingredient in the carrier or excipient so that they go together and that is those components are being put in the body but in fact it will be only the pharmaceutical substance that is having an effect so you can have multiple products with the same active ingredient. Yes. Why then do the words appear at the end of that sentence: Not the active ingredient alone. MS STRONG: I don't think Dr Elliott can really answer that question, your Honour. HIS HONOUR: Sorry, I didn't quite catch what you were saying, Ms Strong. MS STRONG: Well, my learned friend has asked her why there is a particular sentence put into the Patent Office Manual. I doubt that she would know why. HIS HONOUR: It seems to me this is cross-examination as to credit and quite permissible, Ms Strong. MS STRONG: If your Honour pleases. HIS HONOUR: Yes, you can ask the question again. MR CAINE: As a result of that, I will put it again if I can. What I am simply putting to you, Dr Elliott, is I understand that the view you have expressed in the report is that the pharmaceutical substance defined in the Act is to be confined to the active ingredient alone and all I am putting to you is that the Manual, the Australian Patent Office Manual, does not share your view. It says that: For the purposes of the Act the pharmaceutical substance is the combination of the active ingredient together with the carrier or excipient, not the active ingredient alone. Do you accept that your view is at odds with the Manual?---In relation to that specific paragraph? Yes?---The interpretation could be that it is. Yes, and if the Manual expresses the correct test according to law and that will be a matter for his Honour later on, you would accept that your view is at odds with that test?---If that is that particular sentence as opposed to the other guidances that are provided in that extract from the Manual which again clearly are at odds there would appear to be an internal inconsistency within that. Yes." 69 When Dr Elliott's attention was drawn to what the Patent Office Manual of Practice and Procedure ("the Manual") said about the meaning of "pharmaceutical substance", and what both Heerey J and the Full Court had said about that matter, she remained doggedly of the view that her position was correct, and what was said elsewhere was of little consequence. She regarded the Manual as leading to "confusion in terms of understanding what is the active component", and rejected its essential tenor. 70 In closing submissions, Mr Caine invited me to disregard the opinion expressed by Dr Elliott. He submitted that if her interpretation of "pharmaceutical substance" were correct, it would be impossible to obtain an extension of a patent involving any invented solution, of which only one component was of direct therapeutic use. That would be so even if the product as a whole, including inert compounds designed to achieve stability for the actual substance that exerts a therapeutic effect, had a therapeutic effect in the body (in this case a cytotoxic effect against cancer cells). 71 It is important to note that Mr Macaw expressly declined to adopt Ms Strong's submission that Pharmacia's product was not, relevantly, a "pharmaceutical substance". He confined his submission to contending that the product was not a "pharmaceutical substance per se ", essentially because it encompassed elements of process. 72 Ms Strong also made a number of submissions regarding the timing of Interpharma's application for review. She noted that s 11(4) of the ADJR Act provides this Court with the discretion to refuse to entertain an application for an order of review if "the court is of the opinion that the application was not made within a reasonable time after the decision was made " (emphasis added). She also noted that when forming its opinion, s 11(5) of that Act provides that the Court "shall have regard to the time when the applicant became aware of the making of the decision; and...may have regard to such other matters as it considers relevant." Ms Strong then sought to explain, and to justify, Interpharma's delay. 73 On this point, Ms Strong submitted that there was nothing in the evidence led on behalf of Pharmacia to suggest that it would, in any way, be prejudiced if time were extended to allow the application for review to proceed. She described that evidence as "broadbrush" and speculative. She further submitted that Interpharma had acted reasonably in assuming that the processes by which EBEWE Pharma proposed to manufacture doxorubicin EBEWE and epirubicin EBEWE for the Australian market did not come within the claims specified in the Patent. 85 The meaning of the expression "pharmaceutical substance per se " in s 70(2)(a) has been authoritatively considered by a Full Court of this Court in Boehringer . The facts of that case were set out succinctly by Heerey J, at first instance . 86 As previously indicated, the patent in that case related to compositions for the treatment of nasal hypersecretion (runny nose), containers adapted for nasal administration and containing compositions for such treatments, and methods of treating the condition. Claim 1 of the patent in that case was as follows: "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." 87 His Honour described at [4] the remaining claims in the following terms: "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." 88 Heerey J found it useful to consider the history of s 70 in order to understand why the expression "pharmaceutical substance per se " had been introduced. His Honour observed at [8]-[13]: "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. 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. 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 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." When the 1990 Act was introduced, Part IX of the 1952 Act, as amended in 1989, was in substance re-enacted. 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 ". 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)." 89 Heerey J went on to say at [14]-[16]: "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. 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. 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." 90 His Honour next referred to the Manual, a work used as an internal guide to the administration of the Patents Act , and available to the patent attorney and legal professions. He drew attention, in particular, to the following passages from the Manual: "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 |P91-087, 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)." 91 His Honour said that he found this material to be of assistance, though he recognised that it was not extrinsic material of the normal type. Importantly, he implicitly approved of the examples set out at [25.2.2] as aiding in the interpretation of the expression "pharmaceutical substance per se " considered in the light of the history of the relevant section, and its evident purpose. 92 Not surprisingly, having regard to the nature of the claims relied upon in that case, Heerey J concluded that all of them were for "modes of treatment involving the Substance, not for the Substance in itself". Accordingly, the application to review the Commissioner's refusal to grant the extension was dismissed. 93 On appeal, the Full Court in Boehringer (Wilcox, Whitlam and Gyles JJ) held that the decision at first instance was correct. The Court noted that it had been conceded by counsel for the appellant that a container was fundamental to each of the claims, in the sense that, absent a container as described claim 1, there would be no infringement of the patent. However, it had been submitted that the requirements of s 70(2)(a) were met, and that Heerey J had erroneously interpreted paragraph (a) "as requiring the claim or claims of the patent to exclusively define a pharmaceutical substance per se or to be limited or confined to a pharmaceutical substance per se ". It had been further submitted that the paragraph required "no more than that a pharmaceutical substance... be included in one or more of those claims as an essential feature", and that all the relevant claims in that case had specifically included as an essential feature a pharmaceutical substance per se . The appellant submitted that it did not matter that each claim also included one or more other elements. 94 The Full Court regarded these submissions as being tantamount to an argument that the words " per se " made no substantial contribution to, and provided no limitation upon, the statutory provisions of s 70(2)(a). The Court rejected that argument. It referred with approval, at [34] and [37], to the submission of the respondent that the introduction of the words " per se " by the 1998 amendments indicated a clear intention, on the part of the legislature, to limit the operation of s 70 to patents disclosing and claiming a pharmaceutical substance "by or in itself, intrinsically, essentially" ( New Shorter Oxford English Dictionary ), or "taken alone; essentially; without reference to anything else" ( Butterworth's Australian Legal Dictionary ). 95 The Full Court noted that the appellant's argument, if accepted, would have the effect of reading out of s 70(2)(a) the words " per se ". In addition, the Court regarded the second reading speech and the explanatory memorandum as providing no support to the appellant's argument; quite the contrary. The emphasis in those materials was upon the development of new drugs, not drugs in combination with other elements. The explanatory memorandum, in particular, excluded the application of the new provisions to "new processes of making pharmaceutical substances or new methods of using pharmaceutical substances, where the substances themselves are known". 105 As extracted at [88] and [89] of these reasons for judgment, in Boehringer , Heerey J at first instance distinguished a pharmaceutical substance that is the subject of a patent claim from a pharmaceutical substance that forms part of a method or process claim. His Honour said that, broadly speaking, a claim could be made in relation to a pharmaceutical substance in three ways: (a) a new and inventive product alone; (b) an old or known product prepared by a new and inventive process; or (c) an old or known product used in a new and inventive mode of treatment. 106 It is important to note that Heerey J did not distinguish between the "active ingredients" in a compound, and other components of that compound, in the way that Dr Elliott did. Nor did the Full Court. 107 His Honour's approval of the Manual, and its analysis of the concept of a pharmaceutical substance which was generally accepted as correct by the Full Court, cannot be reconciled with Dr Elliott's view that the introduction of any non-active ingredient into a product prevents it from being a pharmaceutical substance. For one thing, her approach would effectively mean that s 70 had almost no function to perform. Almost every pharmaceutical product will consist of a combination of individual substances, some of which may be intrinsically therapeutic (active ingredients), while others serve different, albeit essential, roles. To restrict the capacity to extend a patent to those unlikely cases where every component of the compound is itself therapeutically useful would be to deprive the section of any real utility, and largely defeat the purpose of its enactment. 108 For the reasons already given in the Pharmacia Proceeding, I reject Interpharma's alternative contention that claim 1 does not, by reason of any reference that it makes to process elements, disclose a "pharmaceutical substance per se ". 109 This makes it unnecessary for me to consider whether to grant Interpharma an extension of time within which to bring its application for review under the ADJR Act . It also makes it unnecessary to consider whether, as a matter of discretion, I would refuse relief to Interpharma, under the Judiciary Act , because of the lengthy delay that took place between the time the Commissioner granted the extension, and the institution of the Interpharma Review Proceeding. The simple fact is that, as in the case of Mayne, Interpharma cannot make good its contention that claim 1 does not involve a "pharmaceutical substance per se". For that reason, Interpharma's application must be dismissed, with costs. I certify that the preceding one hundred and nine (109) numbered paragraphs are a true copy of the Reasons for Judgment herein of the Honourable Justice Weinberg. Associate: Dated: 29 March 2006 Matter No VID429 of 2003 Counsel for the Applicants: Mr B. Caine SC with Ms H. Rofe Solicitors for the Applicant: Allens Arthur Robinson Counsel for the Respondents: Mr R.C. Macaw QC with Mr A.J. Ryan Solicitors for the Respondents: Clayton Utz Matter No VID1274 of 2005 Counsel for the Applicant: Ms E. Strong SC Solicitors for the Applicant: Stephens Lawyers Counsel for the First Respondent: No appearance for the First Respondent Counsel for the Second Respondent Mr B. Caine SC with Ms H. Rofe Solicitors for the Second Respondent: Allens Arthur Robinson Dates of Hearing: 7 and 8 February 2006 Date of Judgment: 29 March 2006 AustLII: Copyright Policy | Disclaimers | Privacy Policy | Feedback URL: http://www.austlii.edu.au/au/cases/cth/FCA/2006/305.html