HIGH COURT OF AUSTRALIA
FRENCH CJ,
HAYNE, CRENNAN, KIEFEL AND GAGELER JJAPOTEX PTY LTD APPLICANT/APPELLANT
AND
SANOFI-AVENTIS AUSTRALIA PTY LTD & ORS RESPONDENTS
Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd
[2013] HCA 50
4 December 2013
S219/2012 & S1/2013
ORDER
Matter No S1 of 2013
Appeal dismissed with costs.
Matter No S219 of 2012
1.Special leave to appeal on ground 3 of the Draft Notice of Appeal filed on 10 September 2012 granted.
2.Appeal allowed with costs.
3.Set aside the orders of the Full Court of the Federal Court of Australia made on 18 July 2012 and, in their place, order that:
(a)the appeal be allowed in part;
(b)orders 2, 3 and 6 of the Federal Court made on 18 November 2011 be set aside;
(c)order 1 of the Federal Court made on 24 February 2012 be set aside; and
(d)so much of the Amended Application dated 22 September 2009 as made in paragraphs 14 to 22 be dismissed.
4.Remit the matter to the Full Court on the questions of the costs of the appeal to that Court and the costs of the trial (which latter question may, at the discretion of the Full Court, be remitted to the primary judge).
On appeal from the Federal Court of Australia
Representation
D K Catterns QC with N R Murray for the applicant/appellant (instructed by Herbert Smith Freehills)
D F Jackson QC with C Dimitriadis for the respondents (instructed by Jones Day)
Notice: This copy of the Court's Reasons for Judgment is subject to formal revision prior to publication in the Commonwealth Law Reports.
CATCHWORDS
Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd
Intellectual property – Patents – Patent claimed administration of pharmaceutical substance as method of preventing or treating medical condition – Whether method of medical treatment of human body is patentable invention within meaning of s 18(1)(a) of Patents Act 1990 (Cth) – Whether product or process is manner of manufacture within meaning of s 6 of Statute of Monopolies – Whether novel therapeutic use of known substance is patentable invention.
Intellectual property – Patents – Infringement – Construction of claim – Patent claimed use of pharmaceutical substance for preventing or treating medical condition – Whether person who supplies drug and indicates use for treatment of different condition infringes patent under s 117(1) of Patents Act 1990 (Cth).
Words and phrases – "manner of manufacture", "patentable invention".
Patents Act 1990 (Cth), ss 13(1), 18(1)(a), 18(2), 117(1), 119A, 138(3)(b), Sched 1.
Statute of Monopolies 1623 (21 Jac I c 3), s 6.
Therapeutic Goods Act 1989 (Cth), s 16(1).
FRENCH CJ.
Introduction
The primary question in this case is whether methods of medical treatment of human beings, including surgery and the administration of therapeutic drugs, can be the subject of patents. This Court has not had to decide the question until now. For the reasons that follow, in particular so that the law may be logically coherent, the question ought to be answered in the affirmative. The appellant, Apotex Pty Ltd ("Apotex"), which was sued by the respondents for infringement of their patent for a method of using a known drug to prevent or treat psoriasis, therefore fails in its challenge to the validity of the patent.However, for the reasons given by Crennan and Kiefel JJ[1], Apotex's application for special leave to appeal against the finding in the Federal Court that it infringed the patent should be granted and its appeal on that matter allowed.
[1]Reasons of Crennan and Kiefel JJ at [293]–[305].
Factual and procedural history
It is sufficient to outline briefly salient features of the factual and procedural history, which are dealt with in more detail in the judgment of Hayne J[2] and the joint judgment of Crennan and Kiefel JJ[3].
[2]Reasons of Hayne J at [59]–[67].
[3]Reasons of Crennan and Kiefel JJ at [178]–[185], [205]–[214].
The drug Leflunomide, the preparation and composition of which were the subject of an expired Australian patent[4], is used for the treatment of psoriatic and rheumatoid arthritis. A method of using Leflunomide is the subject of a current Australian Patent No 670491 entitled "Pharmaceutical for the treatment of skin disorders" ("the Patent"). The Patent has a priority date of 31 March 1993 and expires on 29 March 2014. It has a single claim:
"A method of preventing or treating a skin disorder, wherein the skin disorder is psoriasis, which comprises administering to a recipient an effective amount of a pharmaceutical composition containing as an active ingredient a compound of the formula I or II".
The formulae are then set out. A compound of the formula I is Leflunomide. The validity of the Patent is in issue in this appeal. Apotex contends that it relates to a method of medical treatment and cannot be a patentable invention under the Patents Act 1990 (Cth) ("1990 Act"). In the alternative, Apotex contends that the claim in the Patent is for a second or subsequent medical use of a previously known product involving the purpose of its use as an element and that on that ground, it does not disclose a patentable invention.
[4]Australian Patent No 529341 claimed a chemical formula of Leflunomide, a process for its preparation, a composition containing the compound as an active ingredient and a method claim. That patent expired in 2004.
The second respondent, Sanofi-Aventis Deutschland GmbH, is the registered owner of the Patent. The first respondent, Sanofi-Aventis Australia Pty Ltd, supplies Leflunomide in Australia under the trade names "Arava" and "Arabloc". Apotex obtained registration of generic versions of Leflunomide (collectively, "Apotex Leflunomide Products") on the Australian Register of Therapeutic Goods in or about July 2008. Its intention was to supply the products and offer them for supply in Australia as treatments for psoriatic arthritis and rheumatoid arthritis. The respondents initiated proceedings against Apotex in the Federal Court of Australia on 23 October 2008[5]. They alleged that Apotex's proposed supply of the Apotex Leflunomide Products for the treatment of psoriatic arthritis would infringe the Patent. Other causes of action not material to this appeal were also asserted.
[5]The third respondent to these proceedings, Aventisub II Incorporated, was the third applicant in the proceedings in the Federal Court of Australia and was said to be the holder of copyright in product information documents relating to the product Arava.
In support of their infringement claim, the respondents alleged, inter alia:
•Apotex intended to supply and offered to supply in Australia the Apotex Leflunomide Products for the treatment of active psoriatic arthritis.
•The use by a person of the Apotex Leflunomide Products for the treatment of active psoriatic arthritis would infringe claim 1 of the Patent.
•That use would be in accordance with instructions for the use of the products given by Apotex to such a person.
•Each supply or offer to supply made by Apotex of any of the Apotex Leflunomide Products for the treatment of active psoriatic arthritis would infringe claim 1 of the Patent pursuant to s 117 of the 1990 Act.
Apotex cross-claimed for revocation of the Patent on a variety of grounds, none of which succeeded.
On 18 November 2011, the primary judge dismissed the cross-claim and made a declaration that Apotex had threatened to infringe claim 1 of the Patent "by threatening to import, market, take orders for, sell, supply and offer to supply products containing leflunomide … in Australia for the treatment of psoriatic arthritis."[6] Her Honour granted injunctive relief restraining Apotex from infringing claim 1 and from supplying or offering to supply products containing Leflunomide for the treatment of psoriatic arthritis. Apotex appealed to the Full Court of the Federal Court. On 18 July 2012, the Full Court (Keane CJ[7], Bennett and Yates JJ[8]) dismissed the appeal and ordered that Apotex pay the respondents' costs of the appeal.
[6]Sanofi-Aventis Australia Pty Ltd v Apotex Pty Ltd (No 4) (2011) 202 FCR 56.
[7]Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd (No 2) (2012) 204 FCR 494 at 517–518 [85]–[86].
[8](2012) 204 FCR 494 at 541 [209].
On 14 December 2012, this Court (French CJ and Kiefel J) granted special leave to Apotex to appeal from the judgment of the Full Court in relation to the validity of the Patent and referred the application for special leave in relation to infringement to an enlarged Bench for further consideration so that it could be argued as if it were on an appeal[9].
[9][2012] HCATrans 357.
Patentability of medical treatments — A "common law" question?
The single ground upon which special leave was granted was that the Full Court erred in finding that the claim of the Patent claimed a manner of manufacture within the meaning of s 18(1) of the 1990 Act. The first question raised by Apotex in support of that ground is whether a method of medical treatment of human beings is capable of being a patentable invention. That question directs attention to the relevant statutory language and the body of case law which has informed its application.
Section 18 of the 1990 Act lists necessary conditions for an invention to be a patentable invention for the purposes of a standard patent. One of those conditions, set out in s 18(1)(a), is that the invention, so far as claimed in any claim:
"is a manner of manufacture within the meaning of section 6 of the Statute of Monopolies".
Despite the classificatory character of the criterion, the question whether it is to be met in respect of a claim for an invention is not answered simply by asking whether such a claim is "a manner of manufacture". As this Court said in National Research Development Corp v Commissioner of Patents ("NRDC")[10]:
"The right question is: 'Is this a proper subject of letters patent according to the principles which have been developed for the application of s 6 of the Statute of Monopolies?'"
It is relevant to that inquiry that the term "manner of manufacture" originated as part of a statute which was seen as declaratory of the common law. Its application in various statutory embodiments since the Statute of Monopolies 1623 ("the Statute")[11] was enacted has evolved according to common law processes. It has always been applied[12]:
"beyond the limits which a strict observance of its etymology would suggest, and ... a widening conception of the notion has been a characteristic of the growth of patent law."
[10](1959) 102 CLR 252 at 269; [1959] HCA 67.
[11]21 Jac I c 3.
[12](1959) 102 CLR 252 at 269–270, citing Maeder v Busch (1938) 59 CLR 684 at 706 per Dixon J; [1938] HCA 8.
The Statute was a response to the abuse of grants of monopolies[13] in the purported exercise of the royal prerogative[14]. It declared all monopolies void, subject to the proviso in s 6:
"Provided also That any Declaration before mentioned shall not extend to any Letters Patents and Grant of Privilege for the term of fourteen years or under, hereafter to be made of the sole working or making of any manner of new Manufactures within this Realm, to the true and first Inventor and Inventors of such Manufactures, which others at the time of making such Letters Patents and Grants shall not use, so as also they be not contrary to the Law nor mischievous to the State, by raising prices of Commodities at home, or hurt of Trade, or generally inconvenient …" (emphasis added)
The Statute did not alter the common law[15]. It did not confer rights upon inventors[16]. Coke said of it[17]:
"[T]his act maketh them [patents] no better, than they should have been, if this act had never been made".
The objectives of s 6, as Cornish, Llewelyn and Aplin observed in the 8th edition of their textbook on Intellectual Property, "were the encouragement of industry, employment and growth, rather than justice to the 'inventor' for his intellectual percipience."[18]
[13]3 Co Inst, c 85 at 181 defined "monopoly" as:
"an institution, or allowance by the king by his grant, commission, or otherwise to any person or persons, bodies politique, or corporate, of or for the sole buying, selling, making, working, or using of any thing, whereby any person or persons, bodies politique, or corporate, are sought to be restrained of any freedome, or liberty that they had before, or hindred in their lawfull trade."
[14]For a history of the patent system as an exercise of the prerogative see Hulme, "The History of the Patent System under the Prerogative and at Common Law", (1896) 12 Law Quarterly Review 141; Klitzike, "Historical Background of the English Patent Law", (1959) 41 Journal of the Patent Office Society 615; Pila, "The Common Law Invention in its Original Form", (2001) 5 Intellectual Property Quarterly 209.
[15]Feather v The Queen (1865) 6 B & S 257 at 284–285 [122 ER 1191 at 1201]; Australian Gold Recovery Co v Lake View Consols Ltd [1901] AC 142 at 149.
[16]Von Heyden v Neustadt (1880) 14 Ch D 230 at 232.
[17]3 Co Inst, c 85 at 184. See Cunynghame, English Patent Practice, (1894) at 20; Edmunds, The Law and Practice of Letters Patent for Inventions, 2nd ed (1897) at 3; Roberts, The Grant and Validity of British Patents for Inventions, (1903) at 18.
[18]Cornish, Llewelyn and Aplin, Intellectual Property: Patents, Copyright, Trade Marks and Allied Rights, 8th ed (2013) at 123.
Legislation enacted in the United Kingdom after the Statute provided machinery for the grant and enforcement of patents but left unaffected the central requirement for their grant in s 6[19]. The source of power to grant patents remained the prerogative. It seems that between the enactment of the Statute and the mid-18th century the patent system was little used[20]. The decision of the Court of Common Pleas in Boulton v Bull[21] was the first case in which so-called "inherent patentability" received close consideration. That case apart, there was little accumulated authority on inherent patentability in the United Kingdom before the first consolidation of patent laws in the Patents, Designs, and Trade Marks Act 1883 (UK) ("1883 UK Act")[22].
[19]Statutory Declarations Act 1835 (5 & 6 Will IV c 62), s 11; Letters Patent for Inventions Act 1835 (5 & 6 Will IV c 83); Patents Act 1839 (2 & 3 Vict c 67); Judicial Committee Act 1844 (7 & 8 Vict c 69); Patent Law Amendment Act 1852 (15 & 16 Vict c 83).
[20]See generally Pila, "Methods of Medical Treatment within Australian and United Kingdom Patents Law", (2001) 24 University of New South Wales Law Journal 420 at 424.
[21](1795) 2 H Bl 463 [126 ER 651].
[22]See generally Pila, "Methods of Medical Treatment within Australian and United Kingdom Patents Law", (2001) 24 University of New South Wales Law Journal 420 at 424.
The 1883 UK Act defined "invention" as "any manner of new manufacture the subject of letters patent and grant of privilege within section six of the Statute of Monopolies"[23]. Its effect was to confer upon an inventor "the right to a patent under certain conditions"[24]. Subject to various amendments it remained in place for 24 years and provided a model for patents legislation in the Australian colonies prior to federation[25] and for the first Commonwealth patent law, the Patents Act 1903 (Cth) ("1903 Act"). The 1883 UK Act was superseded by the Patents and Designs Act 1907 (UK) ("1907 UK Act"), which continued the definition of "invention" by reference to the Statute[26]. Both the 1883 and 1907 UK Acts preserved the prerogative to grant letters patent[27]. In the 6th edition of Terrell on the Law of Patents, published in 1921, the effect of the successive UK statutes, up to and including the 1907 statute, was described as[28]:
"declaratory of the limits within which that [the royal] prerogative should be exercised, and of the method of procedure to be adopted in obtaining letters patent for inventions."
[23]1883 UK Act, s 46.
[24]Fletcher Moulton, The Present Law and Practice Relating to Letters Patent for Inventions, (1913) at 3.
[25]Hack, "A History of the Patent Profession in Colonial Australia", paper delivered at the Annual Conference of the Institute of Patent Attorneys of Australia, Brisbane, 29–31 March 1984.
[26]1907 UK Act, s 93.
[27]1883 UK Act, s 116; 1907 UK Act, s 97.
[28]Terrell on the Law of Patents, 6th ed (1921) at 3.
The 1907 UK Act and subsequent amending legislation was repealed by the Patents Act 1949 (UK) ("1949 UK Act")[29]. That Act also defined "invention" in terms of "any manner of new manufacture" within s 6 of the Statute[30]. Like its predecessors, it preserved the prerogative of the Crown[31]. The 1949 UK Act was superseded by the Patents Act 1977 (UK) ("1977 UK Act"). The term "manner of manufacture" and reference to the Statute were replaced in the 1977 UK Act with a codification of the requirements of patentability. Those requirements were set out in ss 1(1) to 1(4), which were based on and intended to have, as nearly as practicable, the same effect in the United Kingdom as Arts 52 to 57 of the European Patent Convention of 1973[32]. Methods of treatment of the human body were excluded from patent protection by s 4(2) of the 1977 UK Act as not capable of industrial application. The patent law of the United Kingdom was thereby aligned with the exclusion derived from Art 52(4) of the European Patent Convention. The Patents Act 2004 (UK) repealed s 4(2)[33] and introduced a new s 4A[34] into the 1977 UK Act, excluding methods of treatment of the human body from patent protection without reference to industrial applicability, subject to "an invention consisting of a substance or composition for use in any such method." That amendment implemented changes brought about by the revision of the European Patent Convention in 2000[35]. Apotex and the respondents debated in their written submissions whether the exclusion in the 1977 UK Act was based on policy grounds or reflected pre-existing United Kingdom case law relating to inherent patentability. It is unnecessary and unhelpful to explore the factors which may have influenced the introduction of a statutory exclusion in the 1977 UK Act. There is, however, no doubt about the existence of the exclusion prior to its express enactment.
[29]1949 UK Act, s 106, Second Schedule.
[30]1949 UK Act, s 101(1).
[31]1949 UK Act, s 102(1).
[32]Convention on the Grant of European Patents, opened for signature on 5 October 1973 (entered into force 7 October 1977); 1977 UK Act, s 130(7). See Terrell on the Law of Patents, 17th ed (2011) at 10–11, 31.
[33]Patents Act 2004 (UK), Sched 2, par 4(b).
[34]Patents Act 2004 (UK), s 1.
[35]Act revising the Convention on the Grant of European Patents of 29 November 2000 (entered into force on 13 December 2007); European Patent Convention 1973, Art 53(c).
In the Report of the Banks Committee[36], which preceded the enactment of the 1977 UK Act, examples were given of matter which had never been considered to be an "invention" as defined, including "treatment of human beings"[37]. The Committee observed that a process consisting of using a known compound for treating a human being medically had never been held to be patentable because the courts had consistently expressed the opinion that a process for medical treatment of a human being was not a proper subject for a patent monopoly[38]. The Committee expressed doubt whether the grant of such patents would accord with the requirements of the Strasbourg Convention[39] that protection should be granted for inventions susceptible of "industrial application"[40].
[36]Committee to Examine the Patent System and Patent Law, The British Patent System, (1970) Cmnd 4407.
[37]Committee to Examine the Patent System and Patent Law, The British Patent System, (1970) Cmnd 4407 at 62 [213].
[38]Committee to Examine the Patent System and Patent Law, The British Patent System, (1970) Cmnd 4407 at 67 [238].
[39]Convention on the Unification of Certain Points of Substantive Law on Patents for Invention, opened for signature on 27 November 1963 (entered into force 1 August 1980).
[40]Committee to Examine the Patent System and Patent Law, The British Patent System, (1970) Cmnd 4407 at 67 [240].
The Patents Act 1952 (Cth) ("1952 Act"), which replaced the 1903 Act, was based upon the 1949 UK Act. It was enacted following the Report of the Dean Committee in 1952[41]. A point made in the Report was that "in the matter of patents for inventions, there should be as close a correspondence as possible between the two Acts."[42] The Committee did not recommend any change to the definition of "invention" under the 1903 Act.
[41]Committee Appointed by the Attorney-General of the Commonwealth, Report of Committee Appointed to Consider what Alterations are Desirable in the Patent Law of the Commonwealth, (1952).
[42]Committee Appointed by the Attorney-General of the Commonwealth, Report of Committee Appointed to Consider what Alterations are Desirable in the Patent Law of the Commonwealth, (1952) at 3 [5].
Following a Report of the Industrial Property Advisory Committee in 1984[43], the 1952 Act was repealed[44] and the 1990 Act was enacted. The criterion that an invention must be a "manner of manufacture within the meaning of s 6 of the Statute of Monopolies" was retained. In recommending its retention, the Committee said[45]:
"We consider that the existing concept operates quite satisfactorily. It has the advantage of being underpinned by an extensive body of decided case law which facilitates its application in particular circumstances."
The Committee rejected the alternative of a codified definition. The rationale for retaining the existing criterion was reflected in the Explanatory Memorandum for the Patents Bill 1990, which said of the proposed definition of "invention"[46]:
"The requirement in paragraph 18(a) ... invokes a long line of UK and Australian court decisions. It means little more than that an invention must belong to the useful arts rather than the fine arts. The Government accepted the Industrial Property Advisory Committee's recommendation that this flexible threshold test of patentability be retained in preference to adopting a more inflexible codified definition."
The legislative purpose reflected in s 18(1)(a) of the 1990 Act is that the "manner of manufacture" criterion for a patentable invention ought to continue to be applied on a case-by-case basis.
[43]Industrial Property Advisory Committee, Patents, Innovation and Competition in Australia, August 1984.
[44]1990 Act, s 230 (as enacted).
[45]Industrial Property Advisory Committee, Patents, Innovation and Competition in Australia, August 1984 at 41.
[46]Australia, Senate, Patents Bill 1990, Explanatory Memorandum at [31].
The processes for the ascertainment, application and development of the principles determining whether a claimed invention is a "manner of manufacture" can appropriately be described as common law processes. They accord with the fourth and fifth senses in which the term "the common law" is used, as described by Professor AWB Simpson in the New Oxford Companion to Law[47] and referred to in the joint majority judgment of this Court in PGA v The Queen[48]. According to those senses of the term, the common law is "law based on cases, or law evolved through adjudication in particular cases, as opposed to law derived from the analysis and exposition of authoritative texts."[49] Particularly apposite is the paraphrase in PGA of what was said by six members of this Court in the Native Title Act Case[50]:
"the term 'common law' might be understood not only as a body of law created and defined by the courts in the past, but also as a body of law the content of which, having been declared by the courts at a particular time, might be developed thereafter and be declared to be different."
[47]Cane and Conaghan (eds), The New Oxford Companion to Law, (2008) at 164–166.
[48](2012) 245 CLR 355; [2012] HCA 21.
[49](2012) 245 CLR 355 at 370 [22].
[50](2012) 245 CLR 355 at 371 [23], citing Western Australia v The Commonwealth (Native Title Act Case) (1995) 183 CLR 373 at 484–486; [1995] HCA 47.
Case-by-case decision-making and associated development of the law is a process characteristic of the common law. It is also a characteristic of the application by courts of broadly stated statutory provisions, the interpretation, fleshing out, and application of which the legislature has left to the courts. The prohibition of misleading or deceptive conduct in trade or commerce is one example[51]. Such a provision sets out broad textual parameters within which principles of law are to be ascertained, applied and developed. The boundaries between the common law process detached from a statutory context and analogous processes in a statutory setting are not firm and fixed. Indeed there are many examples of statutes which incorporate, by reference, common law concepts[52].
[51]Competition and Consumer Act 2010 (Cth), Sched 2 (Australian Consumer Law), s 18.
[52]A particularly striking example is found in s 20(1) of the Australian Consumer Law, which provides that "[a] person must not, in trade or commerce, engage in conduct that is unconscionable, within the meaning of the unwritten law from time to time."
The respondents submitted that, having regard to existing practice and case law in Australia, which accepts the patentability of methods of medical treatment, the omission of the legislature to provide for the express exclusion of such claims was inconsistent with "an implied exclusion that was plainly never intended." That submission should not be accepted. As appears from the shifting history of the understanding of "manner of manufacture", legislative silence in this field is an unsure guide to the development of principle[53]. Its invocation in this context attracts the kind of caution, only with greater emphasis, associated with the invocation of the maxim expressio unius exclusio alterius[54]. In any event, as explained above, s 18(1)(a) of the 1990 Act was enacted on the basis that within the framework of the case-by-case common law process, the continuing exposition and application of the criterion which it embodied would be left to the courts.
[53]Atiyah, "Common Law and Statute Law", (1985) 48 The Modern Law Review 1 at 25–26; Williams, "Statutes as Sources of Law Beyond their Terms in Common-Law Cases", (1982) 50 George Washington Law Review 554 at 566–567.
[54]George v Federal Commissioner of Taxation (1952) 86 CLR 183 at 206; [1952] HCA 21; Benning v Sydney City Council (1958) 100 CLR 177 at 196 per Fullagar J; [1958] HCA 48.
The term "manner of manufacture" has long been given a wide application, which was widened by the decision of this Court in NRDC. In Boulton v Bull[55], four Judges of the Court of Common Pleas divided equally on whether a patent granted to James Watt for an improved steam engine was void. It was conceded by counsel in that case that the word "manufacture" was "of extensive signification" and that it applied "not only to things made, but to the practice of making, to principles carried into practice in a new manner, to new results of principles carried into practice."[56] The elaboration by Eyre LCJ of that concession was described by Dixon J in Maeder v Busch[57] as one of the earliest statements, and "[p]erhaps the widest", on patentability. Eyre LCJ included in the scope of "manufacture"[58]:
"new processes in any art producing effects useful to the public."
[55](1795) 2 H Bl 463 [126 ER 651].
[56](1795) 2 H Bl 463 at 492 per Eyre LCJ [126 ER 651 at 666].
[57](1938) 59 CLR 684 at 705.
[58](1795) 2 H Bl 463 at 492 [126 ER 651 at 666].
A perhaps unintended narrowing of the scope of patentability was effected in 1942 by a list of sufficient conditions, set out in GEC's Application[59], for characterising a method or process as a "manner of manufacture". The conditions, formulated by Morton J sitting as the Patents Appeal Tribunal, provided that a method or process could be so characterised if it resulted in the production, improvement, restoration or preservation of a vendible product[60]. That the conditions were sufficient, disjunctive and not exhaustive appeared from Morton J's comment that[61]:
"In saying this I am not attempting to cover every case which may arise by a hard and fast rule."
Human nature being what it is however, linkage of a method or process to a "vendible product" seems to have been treated in practice as something approaching a necessary condition. Perhaps for that reason Morton J's list elicited a rather cautious response from Evershed J in Cementation Company Ltd's Application[62].
[59](1942) 60 RPC 1.
[60](1942) 60 RPC 1 at 4, a concept foreshadowed in the judgment of Heath J in Boulton v Bull: see generally Pila, "Methods of Medical Treatment within Australian and United Kingdom Patents Law", (2001) 24 University of New South Wales Law Journal 420 at 425–426.
[61](1942) 60 RPC 1 at 4.
[62](1945) 62 RPC 151.
Having stated a reservation[63] about the approach taken in GEC, Evershed J expressed the view that Morton J had used the word "product" in a broad sense[64]. Later, in Rantzen's Application[65], Evershed J suggested that the term "vendible product" originated with the need to exclude from the scope of the Patent Acts methods or processes, such as those for treating diseases of the human body, which, however useful, could not be contemplated as falling within their ambit. That somewhat enigmatic, if not circular, observation may have reflected an underlying ethical objection to the patentability of such methods or processes[66]. In the event, constraints on the patentability of methods or processes generally, which flowed from the focus on "vendible product" in GEC, were effectively removed as a result of the response of the courts of the United Kingdom to this Court's decision in NRDC. Before turning to the relevant decisions of this Court and the Federal Court of Australia it is necessary to look to the ways in which, historically, the courts of the United Kingdom dealt with the application of the term "manner of manufacture" to such methods or processes.
[63]Namely, that having regard to the absence of any right of appeal from the decisions of the Tribunal, it was undesirable for it to lay down rules or principles for the interpretation of the Acts of Parliament which regulated the grant of patents: (1945) 62 RPC 151 at 153.
[64](1945) 62 RPC 151 at 154.
[65](1946) 64 RPC 63 at 66.
[66]Kell, "Expanding the Frontier of Patentability: Methods of Medical Treatment of the Human Body", (1995) 17 European Intellectual Property Review 202 at 202.
The starting point is the late 18th century decision of Boulton v Bull. Medical treatment may seem a long way from improved steam engines. However, in Boulton v Bull, Buller J discussed the scope of the term "manner of manufacture" in its application to methods and processes by reference to an hypothetical example of a medicine[67] for the treatment of fever found by an ingenious physician to be "a specific cure for a consumption, if given in particular quantities"[68]. Could the physician be given a patent for the new use? The answer was[69]:
"I think it must be conceded that such a patent would be void; and yet the use of the medicine would be new, and the effect of it as materially different from what is now known, as life is from death."
Buller J put it thus: "[t]he medicine is the manufacture, and the only object of a patent, and as the medicine is not new, any patent for it, or for the use of it, would be void."[70] Cunynghame's English Patent Practice referred to that observation as an example of the general proposition that for an "art" to be capable of being patented "[i]t must be an art connected with trade, that is to say, an industrial art."[71] The author went on[72]:
"The art of curing an illness cannot be said to be an art of manufacture, and it follows therefore that all old things may be used in new ways by private persons, provided always that in so using them they are not manufacturing anything."
Cunynghame also used the example to support the proposition that a new use of an old material could not be patented unless such use itself constituted a manufacture[73].
[67]Long before the enactment of the 1883 UK Act, medicines were regarded as satisfying the criterion of a "manner of manufacture" within s 6 of the Statute: R v Wheeler (1819) 2 B & Ald 345 at 349 per Abbott CJ [106 ER 392 at 394]; see also Schering AG's Application [1971] 1 WLR 1715 at 1717–1718 per Whitford J; [1971] 3 All ER 177 at 178–179.
[68](1795) 2 H Bl 463 at 487 [126 ER 651 at 663].
[69](1795) 2 H Bl 463 at 487 [126 ER 651 at 663].
[70](1795) 2 H Bl 463 at 487 [126 ER 651 at 663].
[71]Cunynghame, English Patent Practice, (1894) at 42.
[72]Cunynghame, English Patent Practice, (1894) at 42–43.
[73]Cunynghame, English Patent Practice, (1894) at 42.
The earliest reported case in the United Kingdom dealing directly with the patentability of a process of medical treatment arose under the 1907 UK Act in C & W's Application[74]. The Solicitor-General, Sir Stanley Buckmaster, on appeal from the Comptroller-General, held that "a manner of new manufacture" had to be "in some way associated with commerce and trade."[75] A method for the extraction of lead from human bodies, which was the subject of the patent in that case, was not such a process[76]. A process to enhance the marketability of animals might be viewed differently. The decision reflected a constrained commercial notion of "manner of manufacture", which prevailed at the time[77]. It accorded with what had appeared in Cunynghame's textbook 20 years earlier.
[74](1914) 31 RPC 235. In Schering AG's Application [1971] 1 WLR 1715 at 1718; [1971] 3 All ER 177 at 179–180, Whitford J said that C & W's Application was the earliest "record relating to any Office practice" of refusing to allow such an application to proceed to grant.
[75](1914) 31 RPC 235 at 235.
[76](1914) 31 RPC 235 at 236.
[77]Wellcome Foundation Ltd v Commissioner of Patents [1979] 2 NZLR 591 at 616 per Davison CJ.
In his reasons for decision in C & W's Application, the Solicitor-General also attributed to the Patent Office a broad view that the application should be refused because it related to medical treatment simpliciter. He said[78]:
"I notice that the Patent Office have based their refusal upon the ground that the alleged invention relates simply to medical treatment, and I think that the foundation for that refusal is sound."
There was no elaboration in the brief reasons for judgment of the foundation for that refusal. Whatever its foundation, the Solicitor-General made clear that it had nothing to do with "humanity" or the ethics of the medical profession. He said[79]:
"I have altogether excluded such considerations from my mind."
It has been suggested that despite that disclaimer, the Solicitor-General's judgment was "fuelled by his view that doctors should not, on moral grounds, seek commercial monopolies in respect of their professional skills."[80] It cannot be said that a clear and stable principle underlying the exclusion posited in C & W's Application was spelt out in that case. However that may be, the practice of the Patent Office in the United Kingdom following C & W's Application was to refuse to allow applications for grants of patents where the alleged invention related simply to a medical treatment[81].
[78](1914) 31 RPC 235 at 236.
[79](1914) 31 RPC 235 at 236.
[80]Pila, "Methods of Medical Treatment within Australian and United Kingdom Patents Law", (2001) 24 University of New South Wales Law Journal 420 at 433.
[81]Joos v Commissioner of Patents (1972) 126 CLR 611 at 619–620; [1972] HCA 38; Puharich and Lawrence's Application [1965] RPC 395 at 401 per Lloyd-Jacob J; London Rubber Industries Ltd's Patent [1968] RPC 31 at 34 per Lloyd‑Jacob J; Schering AG's Application [1971] 1 WLR 1715 at 1720; [1971] 3 All ER 177 at 181.
The definition of "invention" in the 1903 Act and the 1952 Act has been considered in a number of decisions of this Court. Obiter dicta and passing references to the patentability of medical treatments have been made in four of those decisions, but in none of them has the question of patentability been determined.
The first of the four decisions of this Court was Maeder v Busch, which concerned "a process for forming permanent waves in hair". The patent was held to be invalid on the basis of prior user and want of novelty. However, it was also argued that the claimed invention was not patentable "because it deals with the living tissues of the body, and no particular method will, in all circumstances and conditions, produce upon all persons the same results"[82]. Latham CJ, citing C & W's Application, was "very doubtful" whether a method or process of conducting an operation upon a part of the human body could be regarded as a "manner of manufacture"[83]. The Chief Justice thought the question "so important and possibly so far-reaching, that it is wise to abstain from deciding it until the necessity for doing so arises."[84] Dixon J appeared to accept that there must be a commercial dimension to the relevant "art" in order to enable a process to be patented. There was, however, difficulty in basing legal distinctions on the motive or purpose of the operator[85]:
"The process may be intended for use in ordinary trade or business such as that of hairdressing, manicure, pedicure. The purpose, on the other hand, may be the relief of suffering by surgical or manipulative means. But the object is not to produce or aid the production of any article of commerce. No substance or thing forming a possible subject of commerce or a contribution to the productive arts is to be brought into existence by means of or with the aid of the process."
In the reference to "article of commerce" may be seen an anticipation of Morton J's "vendible product" and a reflection of Heath J's observation in Boulton v Bull[86] equating "manufacture" with a vendible machine or substance. However, foreshadowing what would be said in NRDC, Dixon J referred to the "widening conception of a manner of new manufacture [that] has been a characteristic of the growth of patent law."[87] In the event, like Latham CJ, he preferred to leave undecided the question whether a process for treating hair could be patentable[88]. Evatt J agreed with the trial judge's finding of invalidity for prior public and common user.
[82](1938) 59 CLR 684 at 696.
[83](1938) 59 CLR 684 at 699.
[84](1938) 59 CLR 684 at 699.
[85](1938) 59 CLR 684 at 706.
[86](1795) 2 H Bl 463 at 481–482 [126 ER 651 at 660–661].
[87](1938) 59 CLR 684 at 706.
[88](1938) 59 CLR 684 at 707 per Dixon J, see also at 699 per Latham CJ.
The views expressed by Latham CJ and Dixon J in Maeder v Busch were obiter and inconclusive, but consistent with the views of the courts of the United Kingdom and Patent Office practice in the United Kingdom. Beyond Dixon J's reference to the connection of patentability to commercial purposes, there was no discussion of the underlying general principle. There was, however, a recognition of the logical difficulty involved in trying to draw a legal distinction between methods of medical treatment and other processes for treatment of the human body such as cosmetic procedures.
In 1959, this Court held in NRDC, which concerned a method for using a herbicide on crops, that the application of the criterion "manner of manufacture" to a method or process was not constrained by requiring the method or process to be linked to a narrowly defined understanding of a "vendible product". The Court accepted, as had Dixon J in Maeder v Busch, that a widening conception of the notion of "manufacture" had characterised the growth of patent law[89]. The word "product" was not to be confined to a "thing" in the sense of a physical article[90]:
"It is, we think, only by understanding the word 'product' as covering every end produced, and treating the word 'vendible' as pointing only to the requirement of utility in practical affairs, that the language of Morton J's 'rule' may be accepted as wide enough to convey the broad idea which the long line of decisions on the subject has shown to be comprehended by the Statute."
The Court applied that approach to processes, observing that[91]:
"The point is that a process, to fall within the limits of patentability which the context of the Statute of Monopolies has supplied, must be one that offers some advantage which is material, in the sense that the process belongs to a useful art as distinct from a fine art—that its value to the country is in the field of economic endeavour." (citation omitted)
[89](1959) 102 CLR 252 at 270.
[90](1959) 102 CLR 252 at 276.
[91](1959) 102 CLR 252 at 275.
The question of medical treatment arose almost peripherally in NRDC. Reference was made to R v Wheeler[92], decided in 1819, in which Abbott CJ had said that the word "manufacture" required something of a corporeal and substantial nature that could be made by man from matters subjected to his art or skill or at least some new mode of employing practically his art and skill[93]. The Court was not prepared to treat that statement as conclusive of the question. It said[94]:
"The need for qualification must be confessed, even if only in order to put aside, as they apparently must be put aside, processes for treating diseases of the human body: see Re C & W's Application; Maeder v Busch." (footnotes omitted)
Immediately after the passage about processes quoted in the preceding paragraph of these reasons, the Court speculated, in parentheses, that the exclusion of methods of surgery and other processes for treating the human body could well lie outside the conception of invention "because the whole subject is conceived as essentially non-economic"[95]. It did not otherwise identify a rationale for the exclusion.
[92](1819) 2 B & Ald 345 [106 ER 392].
[93](1819) 2 B & Ald 345 at 350 [106 ER 392 at 395], cited in (1959) 102 CLR 252 at 270.
[94](1959) 102 CLR 252 at 270.
[95](1959) 102 CLR 252 at 275.
So far as it held that the notion of "manner of manufacture" in its application to a method or process was not limited by a narrow requirement related to the production, improvement, restoration or preservation of a "vendible product", NRDC was approved and followed in the United Kingdom[96]. Initially it was not seen as displacing the authority of C & W's Application or the Patent Office practice of rejecting claims for methods of medical treatment[97]. Arguments that such claims should be accepted after NRDC did not find favour with supervising examiners in United States Rubber Co's Application[98] and London Rubber Industries Ltd's Patent[99], the latter decision being supported on appeal by Lloyd-Jacob J[100].
[96]Swift & Co's Application [1962] RPC 37 at 47 per Parker LCJ.
[97]London Rubber Industries Ltd's Patent [1968] RPC 31 at 34–35 per Lloyd-Jacob J.
[98][1964] RPC 104.
[99][1968] RPC 31 at 32–33.
[100][1968] RPC 31 at 34–35.
In Schering AG's Application[101], Whitford J, delivering the decision of the Patents Appeal Tribunal, consisting of Graham J and himself, accepted that it was "difficult to see any logical justification for the practice in relation to processes for medical treatment"[102]. However, he found a distinction relevant to the patentability of medicines and the non-patentability of medical treatments in s 41 of the 1949 UK Act, which provided for the compulsory licensing of medicines. There was no such provision in relation to methods of medical treatment[103]. Whitford J foreshadowed the possibility of change following the implementation of the Report of the Banks Committee, and said[104]:
"On a consideration of the terms of the statute as it now stands, it does, however, seem that claims to processes for medical treatment must be considered as being excluded from the scope of the Act and the practice of the office. Whatever, therefore, the origin of the exclusion may be, in so far [as] it relates to processes for the medical treatment of human beings to cure or prevent disease, it must be considered sound."
That observation left unrevealed the continuing basis for the exclusion beyond its long existence.
[101][1971] 1 WLR 1715; [1971] 3 All ER 177.
[102][1971] 1 WLR 1715 at 1720; [1971] 3 All ER 177 at 181.
[103][1971] 1 WLR 1715 at 1721; [1971] 3 All ER 177 at 182.
[104][1971] 1 WLR 1715 at 1721; [1971] 3 All ER 177 at 182.
Thirteen years after NRDC, in Joos v Commissioner of Patents[105] Barwick CJ reversed a decision of the Deputy Commissioner of Patents that an application for the grant of letters patent for a process for the treatment of parts of the human body, namely human hair and nails, whilst attached to or growing upon the human body, should not proceed. The Chief Justice put to one side, as obiter, what had been said in Maeder v Busch concerning the patentability of processes for treating human beings[106]. He expressed scepticism about the speculation in NRDC that medical treatment was excluded as essentially non‑economic[107]. He spoke of the national economic interest in "the repair and rehabilitation of members of the work force, including management"[108]. He accepted, for the purpose of the appeal before him, that a narrowly defined class of process for the medical treatment of a part of the human body, the arrest or cure of a disease or diseased condition, or the correction of some malfunction or the amelioration of some incapacity or disability was not a proper subject of letters patent[109]. The Chief Justice was not concerned to discover and express a basis for the exclusion. If he had to do so he would "place the exception, if it is to be maintained, on public policy as being, in the language of the Statute of Monopolies, 'generally inconvenient', not limiting what may fall within those words to things of a like kind to those described by the preceding words."[110] As to that, it may be noted that Apotex has expressly disclaimed any reliance upon the "generally inconvenient" proviso in s 6 of the Statute.
[105](1972) 126 CLR 611.
[106](1972) 126 CLR 611 at 618.
[107](1972) 126 CLR 611 at 618.
[108](1972) 126 CLR 611 at 618.
[109](1972) 126 CLR 611 at 619.
[110](1972) 126 CLR 611 at 623.
In Eli Lilly & Co's Application[111], decided in 1974, the same Patents Appeal Tribunal which had decided Schering AG's Application asserted an ethical support for the exclusion. Their Honours cited NRDC as an authority against a limited approach to the definition of "invention" by reference to the idea of making tangible goods[112]. Nevertheless, NRDC was not seen as warranting a judge-made change to the exclusionary rule[113]:
"It has long been established that claims to methods of medical treatment should not be accepted ... The reasons for such an exclusion appear to us to be based in ethics rather than logic but if there is to be a change of policy, which would appear to us to be sensible, this ought in our view to be effected by legislation rather than by interpretation."
In similar vein, the Court of Appeal in The Upjohn Company (Robert's) Application[114] held that[115]:
"If the law in this regard should be changed, it must be for the legislature."
[111][1975] RPC 438.
[112][1975] RPC 438 at 444.
[113][1975] RPC 438 at 445.
[114][1977] RPC 94.
[115][1977] RPC 94 at 98.
In Australia, following Joos, Patent Office practice excluded claims falling within the narrow definition of medical treatment adopted by Barwick CJ[116]. In 1992, however, an important change in Australian law was initiated by the judgment of Gummow J in Rescare Ltd v Anaesthetic Supplies Pty Ltd[117] in reasoning upheld by the Full Court of the Federal Court on appeal[118]. Those decisions were much influenced by the first instance decision, in 1979, of the former Chief Justice of New Zealand, Davison CJ, in Wellcome Foundation Ltd v Commissioner of Patents ("Wellcome Foundation")[119]. Reference should be made to that decision.
[116]Australian Patent Office, Patent Examiner's Manual, (1984) at [35.80].
[117](1992) 111 ALR 205.
[118]Anaesthetic Supplies Pty Ltd v Rescare Ltd (1994) 50 FCR 1.
[119][1979] 2 NZLR 591.
Davison CJ held that the rationale for C & W's Application, namely that a method of treatment lacks connection with any form of manufacture or trade, could not stand in the light of NRDC[120]. The Chief Justice could find no other grounds for refusal of a patent for medical treatment stated in the decided cases in the United Kingdom and Australia from 1914 to 1961[121]. Any long‑established practice based on C & W's Application was no longer applicable[122]. He rejected the proposition in Eli Lilly that the ground for the exclusion was ethical[123]. The basis of the exclusion had always been that medical treatment was neither "an art of manufacture" nor a "form of manufacture or of trade". He quoted and relied upon the observations of Witkon J in the Supreme Court of Israel in The Wellcome Foundation Ltd v Plantex Ltd[124]:
"There is thus no ground, either in law or in logic, for holding that a method of therapeutic treatment is unpatentable and any consideration that at one time might possibly have justified such a holding, is nowadays devoid of any substance. It may certainly not be said that such an invention is not within the realm of economic endeavour in accordance with the test laid down in NRDC's Application or that it is within the realm of 'fine art' as distinct from 'useful art'." (citation omitted)
Kahn and Kister JJ agreed with Witkon J, subject to a qualification against the patentability of a new use for a known therapeutic substance, composition or device[125]. The decision of the Supreme Court of Israel involved the application of the Mandatory Patents and Designs Ordinance. It was common ground that in the general administration of the Ordinance, the Court was guided by the English law and practice on patents.
[120][1979] 2 NZLR 591 at 617–618.
[121][1979] 2 NZLR 591 at 617.
[122][1979] 2 NZLR 591 at 617.
[123][1979] 2 NZLR 591 at 619–620.
[124][1979] 2 NZLR 591 at 609, citing [1974] RPC 514 at 536.
[125][1974] RPC 514 at 540 per Kahn J, 542 per Kister J.
Davison CJ's decision was reversed by the Court of Appeal[126]. Cooke J held that the law had not developed "to the point of holding patentable a process for the treatment of human illness or a new use of a known therapeutic drug."[127] While acknowledging what Barwick CJ had said in Joos about the national economic interest, Cooke J invoked countervailing ethical considerations referring to "a deep-seated sense that the art of the physician or the surgeon in alleviating human suffering does not belong to the area of economic endeavour or trade and commerce."[128] McMullin J[129] and Somers J[130] took similar approaches. The Court of Appeal in Wellcome Foundation held that any alteration to favour the grant of patents for methods of treating illness would best be left to parliament. It was the kind of alteration that demanded "a far wider range of review than is available to courts following our traditional and valuable adversary system"[131].
[126]Wellcome Foundation Ltd v Commissioner of Patents [1983] NZLR 385.
[127][1983] NZLR 385 at 388.
[128][1983] NZLR 385 at 388.
[129][1983] NZLR 385 at 398–399.
[130][1983] NZLR 385 at 404.
[131][1983] NZLR 385 at 391, quoting from Pirelli General Cable Works Ltd v Oscar Faber & Partners [1983] 2 AC 1 at 19 per Lord Fraser of Tullybelton quoting Lord Simon of Glaisdale in Miliangos v George Frank (Textiles) Ltd [1976] AC 443 at 480.
The Rescare decisions concerned a patent for a device for treating sleep apnoea. Gummow J, at first instance, deciding in favour of patentability of a method claim, accepted the reasoning of Davison CJ in Wellcome Foundation[132]. He rejected arguments that the patenting of such methods would be "generally inconvenient" within s 6 of the Statute[133]. He also accepted the proposition, reflecting what Dixon J had said in Maeder v Busch, that under the 1952 Act "there was no normative distinction to be drawn between those processes for treatment of the human body for disease, malfunction or incapacity, and for cosmetic purposes."[134]
[132](1992) 111 ALR 205 at 238.
[133](1992) 111 ALR 205 at 238–239.
[134](1992) 111 ALR 205 at 239.
On appeal, a majority of the Full Court of the Federal Court agreed with Gummow J[135]. Lockhart J accepted that NRDC expounded the exclusion of processes for medical treatment of the human body, but found the ground of the exclusion "not entirely clear"[136]. The United Kingdom cases did not disclose a persuasive ground for the exclusion after the foundation for the decision in C & W's Application had been removed[137]. Adopting the reasoning of Davison CJ, his Honour said[138]:
"In my opinion, there is no justification in law or in logic to say that simply because on the one hand substances produce a cosmetic result or a functional result as opposed to a curative result, one is patentable and the other is not. I see no reason in principle why a method of treatment of the human body is any less a manner of manufacture than a method for ridding crops of weeds as in NRDC."
His Honour would have included a new use for an old compound as within the scope of a patentable invention. He said[139]:
"If a process which does not produce a new substance but nevertheless results in 'a new and useful effect' so that the new result is 'an artificially created state of affairs' providing economic utility, it may be considered a 'manner of new manufacture' within s 6 of the Statute of Monopolies". (citations omitted)
Wilcox J agreed with Lockhart J, adding the observation that the Australian Parliament had not been persuaded by policy considerations against patentability to provide an express exclusion for methods of medical treatment of human beings[140]. Sheppard J rested his dissent upon the proposition that the grant of a patent for medical treatment was "generally inconvenient" within the meaning of s 6 of the Statute[141]. In so doing he explicitly invoked ethical considerations[142]:
"the Court should not contemplate the grant of letters patent which would give to one medical practitioner, or perhaps a group of medical practitioners, a monopoly over, for example, a surgical procedure which might be greatly beneficial to mankind. Its denial might mean the death or unnecessary suffering of countless people."
[135](1994) 50 FCR 1. His Honour's decision turned on a finding that the claims of the patent were not fairly based on the provisional specification. The conclusions on the patentability of medical treatment were strictly obiter, as were the comments of the Full Court on appeal.
[136](1994) 50 FCR 1 at 10–11.
[137](1994) 50 FCR 1 at 18.
[138](1994) 50 FCR 1 at 19.
[139](1994) 50 FCR 1 at 19.
[140](1994) 50 FCR 1 at 42.
[141](1994) 50 FCR 1 at 32.
[142](1994) 50 FCR 1 at 41.
The fourth and most recent reference by this Court to the question of patentability of medical treatments was made in 1998 in Advanced Building Systems Pty Ltd v Ramset Fasteners (Aust) Pty Ltd[143]. In considering the operation of s 100 of the 1952 Act, setting out the grounds of revocation of a standard patent, the majority, Brennan CJ, Gaudron, McHugh and Gummow JJ, referred to the content of s 100(1)(d) having regard to the other specific grounds for revocation and observed[144]:
"Section 6 of the Statute of Monopolies excluded any manner of new manufacture which was 'contrary to the Law' or 'generally inconvenient'. The classification of certain methods of treatment of the human body as an inappropriate subject for grants under the Act appears to rest on this footing." (footnote omitted)
That observation was footnoted by reference to Joos. It appears to have been no more than an acknowledgement, rather than an adoption, of a basis upon which the claimed exclusion was said to rest.
[143](1998) 194 CLR 171; [1998] HCA 19.
[144](1998) 194 CLR 171 at 190 [34].
In Bristol-Myers Squibb Co v FH Faulding & Co Ltd[145], the Full Court of the Federal Court followed its earlier decision in Rescare[146]. Black CJ and Lehane J in their joint judgment identified[147]:
"the insurmountable problem, from a public policy viewpoint, of drawing a logical distinction which would justify allowing patentability for a product for treating the human body, but deny patentability for a method of treatment".
A second compelling consideration was[148]:
"the very limited extent to which the Parliament dealt with patents with respect to the human body when it enacted the 1990 Act, bearing in mind, too, that it did so at a time when the long-standing practice in Australia was ... to grant patents for methods of medical treatment of the human body."
The question whether the exclusion from patentability of methods of medical treatment subsisted had been resolved in the negative by two decisions of the Full Court of the Federal Court. In the meantime, in New Zealand, the decision of Davison CJ, which had been influential in the reasoning adopted at first instance in Rescare and by the Full Court in Rescare and Bristol-Myers, was itself to receive a short-lived vindication from the Court of Appeal.
[145](2000) 97 FCR 524.
[146](2000) 97 FCR 524 at 529–530.
[147](2000) 97 FCR 524 at 530 (emphasis in original).
[148](2000) 97 FCR 524 at 530.
In 1999, the Court of Appeal of New Zealand, sitting a Bench of five Judges in Pharmaceutical Management Agency Ltd v Commissioner of Patents ("Pharmac")[149], overruled its earlier decision in Wellcome Foundation insofar as it would have excluded, from patentability, so-called "Swiss form" claims. As described in Wellcome Foundation, in such a claim the integer representing the inventive subject matter and novelty is the new use for which the medicament is made. In delivering the judgment of the unanimous Court in Pharmac however, Gault J made some broader observations antithetical to the reasoning of the Court of Appeal in Wellcome Foundation. His Honour agreed with Davison CJ's conclusion at first instance in Wellcome Foundation that there was little logic in maintaining the exclusion[150]. In so doing, he referred to the decisions of Gummow J and the Full Court of the Federal Court in Rescare. Gault J said[151]:
"What emerges from this is that it no longer can be said that a method of treating humans cannot be an invention. To the extent that the judgments in Wellcome express that view we depart from them. The exclusion from patentability of methods of medical treatment rests on policy (moral) grounds. The purpose of the exclusion is to ensure that medical practitioners are not subject to restraint when treating patients. It does not extend to prevent patents for pharmaceutical inventions and surgical equipment for use in medical treatment."
Despite the generality of his Honour's observations about the patentability of methods of medical treatment, Gault J indicated later in his reasons for judgment that the Court of Appeal was only deciding the "narrow question", namely whether there could be invention and novelty in the discovery of unrecognised properties of known pharmaceutical compounds[152].
[149][2000] 2 NZLR 529.
[150][2000] 2 NZLR 529 at 538 [27].
[151][2000] 2 NZLR 529 at 538 [29].
[152][2000] 2 NZLR 529 at 546 [64].
The Court of Appeal of New Zealand in Pfizer Inc v Commissioner of Patents[153] characterised the decision in Pharmac as one concerned with the patentability of Swiss form claims and said[154]:
"In our view the medical treatment exclusion does have a statutory base, and to the extent that the obiter observation in Pharmac may cast doubt on that, we would respectfully differ."
The generality of the observation in Pharmac was at odds with what was decided in Wellcome Foundation. Nevertheless, following Pfizer the position in New Zealand appears to be that the exclusion of methods of medical treatment of human beings from patentability is maintained.
[153][2005] 1 NZLR 362.
[154][2005] 1 NZLR 362 at 376 [64].
Approach to resolution of the question of patentability
It may be concluded from the preceding survey that the question whether a particular class of claimed invention meets the criterion of being "a manner of manufacture" requires for its resolution the application of the common law process discussed earlier in these reasons. The question whether medical treatments for human beings generally and new medical uses of non‑pharmaceutical products in particular are capable of being "manners of manufacture", must be decided according to principles and constraints of the kind applicable to the development of the common law. An important constraint is that a propounded development of legal principle involving large questions of public policy and reconciliation of interests in tension is, for the most part, best left to the legislature. On the other hand, a qualification or exception to a general principle may have become anomalous to such an extent that its removal would enhance the logical and/or normative coherence of the law. The history of the exclusion of medical treatments from patentability does not disclose a stable, logical or normative foundation and seems to depend upon rather nice distinctions for its maintenance. As recognised in Eli Lilly, there is a logical and normative tension between the patentability of pharmaceutical products and the exclusion from patentability of methods of medical treatment. Moreover, there is difficulty in drawing a boundary between medical and cosmetic procedures. The latter may include procedures having both medical and cosmetic benefits: for example, lap band surgery. The endeavour to achieve coherence in this area falls more readily within the institutional competence of the courts than an endeavour to strike some balance between competing public and private interests.
The field of intellectual property law generally is notoriously one in which there are public interests and private interests in fierce competition with each other. A public interest may lie in using the grant of monopoly to encourage technical innovation. A competing public interest may lie in ensuring unconstrained access by medical practitioners and their patients to new medical methods and processes. The interests of inventors and investors in inventions and the interests of members of the public whose lives could be improved or saved by use of innovative medical treatments may be in tension with each other and with aspects of the public interest. There is room for debate about whether the law does or should reflect "proprietarianism" as its "dominant normative influence"[155] or whether it should be seen as "instrumental" in support of publicly beneficial goals. Professor Peter Drahos has written of the latter approach[156]:
"The practical import of the theory would be that the interpretation of intellectual property law would be driven in a systematic fashion by the purpose of that law rather than more diffuse moral notions about the need to protect pre-legal expectations based on the exercise of labour and the creation of value."
The identification of the public policy objectives of a statute is a matter within the institutional competency of the courts. Choosing between or balancing competing objectives may overlap with the legislative function.
[155]Drahos, A Philosophy of Intellectual Property, (1996) at 203.
[156]Drahos, A Philosophy of Intellectual Property, (1996) at 220.
As a general proposition, the reasoning of Gummow J at first instance in Rescare and of Lockhart J on appeal to the Full Court, and that of Davison CJ at first instance in Wellcome Foundation, lend powerful support to the proposition that the exclusion of medical treatment is an anomalous qualification on the principles governing patentability under the rubric "manner of new manufacture". A decision to dispense with the exclusion may be seen as a development of existing principle. To the extent that the Court enunciates such a development to enhance coherence in the law, it is not required to endeavour to resolve complex tensions between public and private interests which may be affected. Such tasks are largely matters for the legislature. They may require informed appraisal of a range of considerations backed by empirical evidence and expert advice concerning the practical significance of striking the balance in any particular way. The question whether, in the interests of coherence, this Court should support or reject the propounded exclusion of methods of medical treatment should now be considered in light of the decisions below and the submissions put to this Court by the parties. First it is appropriate to refer briefly to the decisions at first instance and in the Full Court.
The decisions in the Federal Court
At first instance, Apotex did not challenge the correctness of the Full Court's decisions in Rescare and Bristol-Myers, but reserved the right to do so on appeal[157]. In its written submissions to the Full Court, Apotex contended first that methods of medical treatment are not patentable, and second that methods of medical treatment for a "second or later medical use" are not patentable[158]. In oral argument to the Full Court, Apotex did not press the first contention, that methods of medical treatment are not patentable. Apotex's second use contention fell away because of the view that the Full Court formed of the proper construction of the claim in the Patent. On the first contention, Keane CJ, having referred to the decision of the Full Court in Rescare, said that the question whether or not patentability should be expanded to cover methods of medical treatment was a matter for determination by the legislature, rather than the judiciary below the level of this Court[159]. Bennett and Yates JJ took a similar approach to the Rescare and Bristol-Myers decisions. Like Keane CJ[160], and like Wilcox J in Rescare[161], they placed some weight upon legislative silence on the topic[162]. Their Honours expressed no view on Apotex's contention relating to second or later use[163].
[157](2011) 196 FCR 1 at 37 [143].
[158](2012) 204 FCR 494 at 500–501 [23].
[159](2012) 204 FCR 494 at 501 [26].
[160](2012) 204 FCR 494 at 501 [26].
[161](1994) 50 FCR 1 at 42–43.
[162](2012) 204 FCR 494 at 537 [193].
[163](2012) 204 FCR 494 at 538 [195].
Patentability of medical treatments — A common law answer
Apotex submitted, correctly, that a method of treating a human being with a known substance was never held to be capable of being an invention under the 1949 UK Act and its predecessors. Its submission that that was the position which had been accepted before 1990 as the law in Australia attached a more definite characterisation to Maeder v Busch and NRDC than the reasons in those decisions could bear. It is, however, correct to say that the exclusionary proposition has not been examined directly in any decision of this Court. While the obiter observations in the decisions reviewed in these reasons invite respect and close attention, they do not determine the answer to the question before this Court in this appeal.
The respondents submitted that Apotex's argument required the recognition of a special exclusion from the concept of patentability in relation to methods of human treatment. They invoked legislative inaction on the question as negativing an implied exclusion. That aspect of their submission should not be accepted. The resolution of this important question cannot rest upon the shifting sands of legislative silence. The argument has to engage with the case-by-case development of principle, which the legislature has left to the courts, as appears from the Explanatory Memorandum to the 1990 Act and the acceptance, reflected in that Memorandum, of the rationale for retaining "manner of manufacture" as a criterion of patentability.
The primary submission of the respondents on the question of the exclusion should be accepted. The exclusion from patentability of methods of medical treatment represents an anomaly for which no clear and consistent foundation has been enunciated. Whatever views may have held in the past, methods of medical treatment, particularly the use of pharmaceutical drugs, cannot today be conceived as "essentially non-economic". Although Barwick CJ's reference in Joos to the national economic interest in "the repair and rehabilitation of members of the work force" may be seen as reducing human beings to economic units, there is no gainsaying the economic significance of medical treatments independently of the flow-on benefits of a well-maintained work force. Recognition of the economic dimensions of this question is not inconsistent with the concurrent recognition of the large public policy questions which it raises. They may involve competing philosophies of proprietarianism and instrumentalism and the relative values to be accorded to different public goods: alleged incentives to innovation on the one hand, and the widest possible availability of new methods of medical treatment to relieve suffering on the other. To decide that the concept of "manner of new manufacture" does not logically exclude methods of medical treatment from patentability does not engage with those large questions, although it may have significant consequences for public policy. This is a case in which such considerations are best left to the legislature. In my opinion the application of the rubric "manner of new manufacture" in a logically and normatively coherent way is not served by excluding from its scope methods of medical treatment of human beings. Methods of medical treatment can fall within the scope of a manner of new manufacture within the meaning of s 6 of the Statute and therefore within s 18(1)(a) of the 1990 Act. Nor, on the reasoning which supports that conclusion, does "general inconvenience" (upon which, in any event, Apotex placed no reliance) appear to provide any basis for their exclusion.
Conclusion
On the remaining questions concerning the purposive character of the Patent and the application for special leave on the question of infringement, I agree with the reasons given by Crennan and Kiefel JJ. I agree with the orders proposed by their Honours[164].
[164]Reasons of Crennan and Kiefel JJ at [306].
HAYNE J.
The issue
The issue in the appeal to this Court is whether the method of prevention or treatment of human disease claimed in the patent in suit is a patentable invention. There is no decision of this Court which determines that a method of prevention or treatment of human disease is a proper subject for the grant of a patent. In this case, the Full Court of the Federal Court followed[165] two earlier decisions[166] of that Court holding that a method of prevention or treatment of human disease is a patentable invention.
[165]Apotex Pty Ltd v Sanofi‑Aventis Australia Pty Ltd(No 2) (2012) 204 FCR 494.
[166]Anaesthetic Supplies Pty Ltd v Rescare Ltd (1994) 50 FCR 1; Bristol‑Myers Squibb Co v F H Faulding & Co Ltd (2000) 97 FCR 524.
These reasons will demonstrate that a method of prevention or treatment of human disease is not a patentable invention. Such a method, even if it is novel[167], involves an inventive step[168] and is useful[169], is a method or process used to produce a product (a result, outcome or effect) which is personal to the individual concerned. Use of the method or process may allow the individual better to exploit his or her capacities economically (whether by selling his or her labour or otherwise). The individual's more effective use of his or her capacities may be of economic advantage to society or some section of it. But that advantage follows from what the individual can do and chooses to do. Others, including the person who owns the right to use the method or process, cannot trade in or otherwise exploit the improvement in health that results from using the method or process to prevent or treat disease in the individual concerned. That kind of result places the process beyond the (very wide) ambit of a "manner of manufacture" within the meaning[170] of s 6 of the Statute of Monopolies 1623 (21 Jac I c 3). A method of preventing or treating human disease is a process which is not a proper subject for the grant of a patent.
[167]Patents Act 1990 (Cth), s 18(1)(b)(i).
[168]s 18(1)(b)(ii).
[169]s 18(1)(c).
[170]s 18(1)(a).
The organisation of these reasons
These reasons will describe the facts of the matter shortly (under the headings: "Leflunomide" and "Apotex's product") and then record the essential features of the proceedings in the Federal Court and in this Court.
Consideration of the substantive issues in the appeal commences with the statutory framework (under the headings: "Patentable invention – a statutory question" and "Asking the right question about the statute"). One issue which was not raised, and must be put aside from consideration, is identified (under the heading: "'[G]enerally inconvenient'"), and two warnings are given (under the headings: "Analogical reasoning" and "The dangers of verbal formulae").
Consideration of the substantive issues proceeds thereafter (under the headings: "The NRDC Case and 'vendible product'" and "Methods of prevention or treatment of human disease"). Separate consideration is then given to six cases bearing on the patentability of methods of prevention or treatment of human disease (In the Matter of C & W's Application for a Patent[171], Maeder v Busch[172], National Research Development Corporation v Commissioner of Patents[173] ("the NRDC Case"), London Rubber Industries Ltd's Patent[174], In re Schering AG's Application[175] and Joos v Commissioner of Patents[176]). Having summarised the position reached in those cases (under the heading: "The state of authority after Joos"), these reasons then examine the Federal Court's earlier decisions in Anaesthetic Supplies Pty Ltd v Rescare Ltd[177] and Bristol‑Myers Squibb Co v F H Faulding & Co Ltd[178].
[171](1914) 31 RPC 235.
[172](1938) 59 CLR 684; [1938] HCA 8.
[173](1959) 102 CLR 252; [1959] HCA 67.
[174][1968] RPC 31.
[175][1971] 1 WLR 1715; [1971] 3 All ER 177.
[176](1972) 126 CLR 611; [1972] HCA 38.
[177](1994) 50 FCR 1.
[178](2000) 97 FCR 524.
In the light provided by all eight of the cases that have been mentioned, four questions which arise from the decisions are further identified (under the heading: "The questions presented by the cases"). Those questions are then examined (under the headings: "Legislative silence in the face of past practice?"; "Distinguishing between patentability of pharmaceutical substances and methods of treatment"; "Economic significance of process or product?"; and "The product of prevention or treatment of human disease").
Finally, brief consideration is given to an issue of threatened infringement which would arise if the patent in suit were valid.
Leflunomide
In December 1979, Hoechst AG[179] was granted Australian Patent Number 529341 ("the 341 patent"). Claim one of the 341 patent claimed a compound called, in these proceedings, "leflunomide", which has since been used to treat active rheumatoid arthritis ("RA") and active psoriatic arthritis ("PsA"). Claim four of the 341 patent claimed a "[m]ethod for the treatment of inflammations, rheumatic complaints or multiple sclerosis by administering to the patient an effective amount" of leflunomide. The 341 patent expired in 2004.
[179]The appeal to this Court was conducted on the basis that Hoechst AG later became a part of the second respondent. The parties drew no distinction in argument between the respondents. Consequently, these reasons do not distinguish between the respondents.
In 1999, leflunomide was included on the Australian Register of Therapeutic Goods ("the ARTG") then maintained under s 17 of the Therapeutic Goods Act 1989 (Cth) ("the TGA"). Section 16(1)(e) of the TGA provided that, for the purposes of those provisions of the TGA which concerned the ARTG, "therapeutic goods are to be taken to be separate and distinct from other therapeutic goods if they have ... different indications". The term "indications" was defined[180], in relation to "therapeutic goods", as "the specific therapeutic uses of the goods".
[180]Therapeutic Goods Act 1989 (Cth), s 3(1).
Leflunomide was initially registered on the ARTG giving, as its indication, the treatment of active RA. That registration was later extended to include an indication for active PsA. Leflunomide was "not indicated for the treatment of psoriasis that is not associated with manifestations of arthritic disease".
On 29 March 1994, Hoechst AG applied for the patent in suit (Australian Patent Number 670491). It claimed "[a] method of preventing or treating a skin disorder, wherein the skin disorder is psoriasis, which comprises administering to a recipient an effective amount of a pharmaceutical composition containing as an active ingredient" leflunomide. The patent will expire in 2014.
Apotex's product
In 2008, the appellant ("Apotex") obtained registration on the ARTG of its generic version of leflunomide. The product information document for Apotex's product ("Apo‑Leflunomide") indicated the use of the product for the treatment of active RA and active PsA and, like leflunomide, said that Apo-Leflunomide was "not indicated for the treatment of psoriasis that is not associated with manifestations of arthritic disease" (emphasis added).
The proceedings
The respondents brought proceedings in the Federal Court alleging, among other things, that Apotex would infringe the patent in suit by supplying Apo‑Leflunomide in Australia for the treatment of PsA. Apotex disputed the validity of the patent in suit and denied that its supply of Apo‑Leflunomide for the treatment of PsA would infringe that patent.
The primary judge, Jagot J, held[181] that the patent in suit is valid and that, because use of the compound to treat PsA would inevitably treat or prevent psoriasis, Apotex's intended supply of Apo‑Leflunomide for the treatment of PsA would infringe the patent in suit. The primary judge noted[182] that Apotex reserved its right to challenge the correctness of what had been said in the two earlier Full Court decisions about whether a method of prevention or treatment of human disease was patentable.
[181]Sanofi‑Aventis Australia Pty Ltd v Apotex Pty Ltd (No 3) (2011) 196 FCR 1.
[182](2011) 196 FCR 1 at 37 [143].
Apotex's appeal to the Full Court of the Federal Court (Keane CJ, Bennett and Yates JJ) was dismissed[183]. The plurality (Bennett and Yates JJ) observed[184] that "the position represented by the dicta in this Court that support the patentability of methods of medical treatment" was a position which "represent[ed] orthodoxy in Australian patent law". How or why those dicta were to be regarded as concluding the issue was neither explored nor explained.
[183]Apotex Pty Ltd v Sanofi‑Aventis Australia Pty Ltd(No 2) (2012) 204 FCR 494.
[184](2012) 204 FCR 494 at 537 [193].
By special leave, Apotex appealed to this Court, alleging that the patent in suit is invalid. Apotex also sought special leave to appeal against the Full Court's dismissal of its appeal against the finding of threatened infringement. That application for special leave was referred for argument, as if on appeal, together with the appeal.
Resolution of the issue of patentability must begin by identifying the right question to ask, and that, in turn, must begin with the statute.
Patentable invention – a statutory question
The patent in suit was granted under the Patents Act 1990 (Cth) ("the 1990 Act"). At that time, s 18 of the 1990 Act provided that:
"(1)Subject to subsection (2), a patentable invention is an invention that, so far as claimed in any claim:
(a)is a manner of manufacture within the meaning of section 6 of the Statute of Monopolies; and
(b)when compared with the prior art base as it existed before the priority date of that claim:
(i)is novel; and
(ii)involves an inventive step; and
(c)is useful; and
(d)was not secretly used in the patent area before the priority date of that claim by, or on behalf of, or with the authority of, the patentee or nominated person or the patentee's or nominated person's predecessor in title to the invention.
(2)Human beings, and the biological processes for their generation, are not patentable inventions."
Section 6 of the Statute of Monopolies relevantly provided:
"That any Declaration before‑mentioned shall not extend to any Letters Patents and Grants of Privilege for the Term of fourteen Years or under, hereafter to be made, of the sole Working or Making of any manner of new Manufactures within this Realm, to the true and first Inventor and Inventors of such Manufactures, which others at the Time of Making such Letters Patents and Grants shall not use, so as also they be not contrary to the Law, nor mischievous to the State, by raising Prices of Commodities at home, or Hurt of Trade, or generally inconvenient".
Asking the right question about the statute
Section 18(1)(a) of the 1990 Act provided that a patentable invention is an invention that (among other things) is "a manner of manufacture within the meaning of section 6 of the Statute of Monopolies". In this respect, the 1990 Act, like its predecessors the Patents Act 1903 (Cth)[185] and the Patents Act 1952 (Cth)[186] ("the 1952 Act"), and corresponding Acts of the United Kingdom[187], defined "the word 'invention', not by direct explication and in the language of its own day, nor yet by carrying forward the usage of the period in which the Statute of Monopolies was passed, but by reference to the established ambit of s 6 of that Statute"[188]. That is, the statutory expression – "a manner of manufacture within the meaning of section 6 of the Statute of Monopolies" – is not to be understood, or applied, by taking its words and attempting to assign one or more synonyms to any or each of them to produce some other collection of words intended to mark out the metes and bounds of the field which the expression as a whole, or the particular phrase "manner of manufacture", is to be understood as describing. Rather, as was held[189] in the NRDC Case:
"The inquiry which the definition [of 'invention'] demands is an inquiry into the scope of the permissible subject matter of letters patent and grants of privilege protected by the section. It is an inquiry not into the meaning of a word so much as into the breadth of the concept which the law has developed by its consideration of the text and purpose of the Statute of Monopolies. ... It is therefore a mistake, and a mistake likely to lead to an incorrect conclusion, to treat the question whether a given process or product is within the definition as if that question could be restated in the form: 'Is this a manner (or kind) of manufacture?' It is a mistake which tends to limit one's thinking by reference to the idea of making tangible goods by hand or by machine, because 'manufacture' as a word of everyday speech generally conveys that idea." (emphasis added)
[185]s 4.
[186]s 6.
[187]Patents, Designs, and Trade Marks Act 1883 (UK), s 46; Patents and Designs Act 1907 (UK), s 93; Patents Act 1949 (UK), s 101(1). By contrast, the Patents Act 1977 (UK), reflecting the terms of Art 52 of the Convention on the Grant of European Patents (1973), did not define a patentable invention by reference to the Statute of Monopolies.
[188]NRDC Case (1959) 102 CLR 252 at 269.
[189](1959) 102 CLR 252 at 269.
It appears that significant numbers of patents have been granted in the United States in respect of methods of medical treatment of the human body (including surgery)[497]. Sanofi was able to point to an example where a method of treatment claim was in similar form to claim 1 of the Patent[498].
[497]Dworkin, "Patents Relating to Methods of Medical Treatment", in Hansen (ed), International Intellectual Property Law & Policy, (2001), vol 6 at 12‑17 and 12‑24.
[498]Merck & Co Inc v Teva Pharmaceuticals USAInc 395 F 3d 1364 (2005).
However, after an eye surgeon sued other surgeons for patent infringement in respect of a new technique for cataract surgery[499], the Patents Act 1952 was amended by the inclusion of §287(c), the effect of which is to permit the patenting of surgical methods to continue but to bar actions for patent infringement against medical practitioners (and "related health care entit[ies]") for "the performance of a medical or surgical procedure on a body".
[499]Pallin v Singer 36 USPQ 2d 1050 (1995).
Canada
Section 2 of the Patent Act[500] defines an "invention" as "any new and useful art, process, machine, manufacture or composition of matter, or any new and useful improvement in any art, process, machine, manufacture or composition of matter". It contains no express exclusion from patentability of methods of medical treatment of the human body.
[500]RSC 1985, c P‑4.
The Supreme Court of Canada has held that such methods are not patentable[501]. However, a novel use of a known compound is considered patentable subject matter[502]. Applying that approach, in Apotex Inc v Wellcome Foundation Ltd[503] the Supreme Court upheld a claim to the use of a known drug, AZT, in the following form[504]:
"A pharmaceutical formulation comprising an amount of (AZT) effective for the treatment or prophylaxis of an AIDS infection, in association with a pharmaceutically accepted carrier."
[501]Tennessee Eastman Co v Commissioner of Patents [1974] SCR 111; see also Shell Oil Co v Commissioner of Patents [1982] 2 SCR 536 at 554.
[502]Shell Oil Co v Commissioner of Patents [1982] 2 SCR 536 at 549.
[503][2002] 4 SCR 153 at 177; see also GlaxoSmithKline Inc v Canada (Minister of Health) (2003) 28 CPR (4th) 307 at 318 [30].
[504]See Apotex Inc v Wellcome Foundation Ltd (2000) 195 DLR (4th) 641 at 672 [107].
Canada's Manual of Patent Office Practice states that such "use" claims are permitted, as long as they do not include a medical or surgical step. For example, a claim to the "[u]se of compound Y as an antiarrhythmic agent" is considered acceptable[505]. However, a claim encompasses non‑patentable subject matter when it "covers an area for which a physician's skill or judgment is expected to be exercised"[506].
[505]Canadian Intellectual Property Office, Manual of Patent Office Practice, (1998) at 11-18.
[506]Janssen Inc v Mylan Pharmaceuticals ULC [2010] FC 1123 at [26] (a dosing regimen of a pharmaceutical).
Sanofi submitted that in these overseas jurisdictions the subject matter of claim 1 would be patentable, either directly as a method of treatment or through one of the drafting devices referred to above.
Can methods of medical treatment of the human body be patentable inventions?
Claim 1, for a method of preventing or treating psoriasis, claims a hitherto unknown therapeutic use of a pharmaceutical substance which was first disclosed, together with prior therapeutic uses, in Patent 341 (now expired).
Apotex's submissions, derived from obiter dicta in the NRDC Case, that the subject matter of claim 1 is "essentially non‑economic" must be rejected.
First, in the context of patent law, the expression "essentially non‑economic" takes its meaning from the long‑understood requirement that the subject matter of a patent (whether a product, or a method or process) must have some useful application, that is, must be capable of being practically applied in commerce or industry. A requirement that an invention have "economic utility" raises the same considerations as the requirement in the Patents Act 1977 (UK) and the EPC that an invention must be susceptible or capable of industrial application. So much is apparent from the definition of "exploit" in the 1990 Act, referring to products and to methods or processes, and the case law developed and applied for a very long time in respect of the requirement of utility[507], now found in ss 18(1)(c) and 18(1A)(c).
[507]See generally Eli Lilly and Co v Human Genome Sciences Inc [2008] RPC 733.
Secondly, the 1990 Act contains no specific exclusion from patentability of methods of medical treatment of the human body, nor can any be implied. Section 133, which provides for compulsory licensing, is in general terms and covers both patented articles and patented methods or processes. Section 70, providing for extensions of term in respect of pharmaceutical substances that are defined in terms of effects on the human body, infers that patents which claim a method of treatment of the human body can be granted, but not extended. Section 119A, the operation of which has been explained above, defines a "pharmaceutical patent" to include method patents for using or administering a pharmaceutical substance.
Parliament accepted the IPAC's recommendation that the 1990 Act should not include a codification of requirements for patentability. Section 119A, described above, was introduced in 2006. It can be noted that Parliament has amended the 1990 Act 24 times since its enactment, including 20 times since the TRIPs Agreement entered into force on 1 January 1995. Relevantly, amendments to the 1990 Act following the TRIPs Agreement did not enact Art 27(3) into Australian domestic law. That Article gives contracting States the option to exclude methods of medical treatment of the human body from patent protection. However, to construe s 18(1)(a) of the 1990 Act as excluding methods of medical treatment of the human body would be to introduce a lack of harmony between Australia and its major trading partners, where none exists at present.
Thirdly, as noted by the primary judge in Rescare Ltd v Anaesthetic Supplies Pty Ltd[508], there is no normative distinction to be drawn from the provisions of the 1990 Act between methods of treatment of the human body which are cosmetic and those which are medical[509].
[508](1992) 111 ALR 205.
[509](1992) 111 ALR 205 at 239.
Fourthly, and critically, the subject matter of a claim for a new product suitable for therapeutic use, claimed alone (a product claim) or coupled with method claims (combined product/method claims)[510], and the subject matter of a claim for a hitherto unknown method of treatment using a (known) product having prior therapeutic uses (a method claim)[511], cannot be distinguished in terms of economics or ethics. In each case the subject matter in respect of which a monopoly is sought effects an artificially created improvement in human health, having economic utility. It could not be said that a product claim which includes a therapeutic use has an economic utility which a method or process claim for a therapeutic use does not have. It could not be contended that a patient free of psoriasis is of less value as a subject matter of inventive endeavour than a crop free of weeds. Patent monopolies are as much an appropriate reward for research into hitherto unknown therapeutic uses of (known) compounds, which uses benefit mankind, as they are for research directed to novel substances or compounds for therapeutic use in humans. It is not possible to erect a distinction between such research based on public policy considerations.
[510]As in claims 1 and 4 of Patent 341.
[511]As in claim 1 of the Patent.
Fifthly, leaving aside, for the moment, the relevant obiter dicta in the NRDC Case, a method claim in respect of a hitherto unknown therapeutic use of a (known) substance or compound satisfies the general principle laid down in the NRDC Case. Such a method belongs to a useful art, effects an artificially created improvement in something, and can have economic utility. The economic utility of novel products and novel methods and processes in the pharmaceutical industry is underscored by s 119A of the 1990 Act and by their strict regulation in the Therapeutic Goods Act 1989 (Cth) ("the TGA").
Sixthly, while not determinative of the construction issue, the practice of the Australian Patent Office, following Joos (which practice was in evidence in Rescare, and about which there was no negative evidence led in this case), is consonant with Art 27(1) of the TRIPs Agreement.
Seventhly, the obiter dicta in the NRDC Case, upon which Apotex relied, conveys some hesitation about "putting aside" methods of treatment of the human body[512]. That hesitation arose in circumstances where this Court was not called upon to decide whether the position under the 1952 Act, in relation to methods of medical treatment of humans, differed from the position in the United Kingdom under the Patents Act 1949 (UK) and case law in the United Kingdom following Re C & W's Application[513]. In other respects, the decision in the NRDC Case diverged from the case law in the United Kingdom, not only in respect of a "vendible product" requirement for a patentable process, but also in respect of the eligibility of agricultural products for patenting. The obiter dicta plainly refers to medical treatments, which are readily distinguishable from therapeutic uses of pharmaceutical substances as defined in the 1990 Act.
[512]NRDC Case (1959) 102 CLR 252 at 270.
[513](1914) 31 RPC 235.
Conclusion on patentability
Assuming that all other requirements for patentability are met, a method (or process) for medical treatment of the human body which is capable of satisfying the NRDC Case test, namely that it is a contribution to a useful art having economic utility, can be a manner of manufacture and hence a patentable invention within the meaning of s 18(1)(a) of the 1990 Act.
There is, however, a distinction which can be acknowledged between a method of medical treatment which involves a hitherto unknown therapeutic use of a pharmaceutical (having prior therapeutic uses) and the activities or procedures of doctors (and other medical staff) when physically treating patients. Although it is unnecessary to decide the point, or to seek to characterise such activities or procedures exhaustively, speaking generally they are, in the language of the NRDC Case, "essentially non‑economic" and, in the language of the EPC and the Patents Act 1977 (UK), they are not "susceptible" or "capable" of industrial application. To the extent that such activities or procedures involve "a method or a process", they are unlikely to be able to satisfy the NRDC Case test for the patentability of processes because they are not capable of being practically applied in commerce or industry, a necessary prerequisite of a "manner of manufacture".
Apotex's claim for revocation of the Patent, on the ground that claim 1 does not disclose a patentable invention, cannot succeed and should stand dismissed.
Construction of claim 1
Claim 1 is recognisably a claim limited to the specific purpose of preventing and treating psoriasis. Given the prior art, any novelty and inventive step reposes in, and is confined to, that hitherto unknown therapeutic use of leflunomide. The compound (with prior therapeutic uses) was disclosed in Patent 341. The monopoly granted in respect of claim 1 is limited to the purpose (hitherto undiscovered) for which the (known) compound can be used.
Drawing on jurisprudence in Europe and the United Kingdom, Apotex contended that in Australia, a hitherto unknown therapeutic use of a substance (having prior therapeutic uses) is not a manner of manufacture. This appeared to be a reinvigorated attack on novelty, or a suggestion of obviousness, in the guise of a s 18(1)(a) objection, stimulated by the construction of claim 1 favoured by the primary judge. Reliance was placed on the circumstance that there is no equivalent in the 1990 Act to sub-ss (3) and (4) of s 4A of the Patents Act 1977 (UK), which "deem" novel known substances and compounds in respect of their first and subsequent (hitherto unknown) therapeutic uses. Those deeming provisions are the legislative response in the United Kingdom to the express exclusion from patentability of pharmaceutical method patents, from which the 1990 Act is free.
Novelty of purpose can confer novelty even if a substance is known, a principle determined in the NRDC Case, which can be seen in the relevant passages extracted above. Provided a hitherto unknown therapeutic use of a pharmaceutical substance or compound can satisfy the requirements of novelty and inventive step and is not obvious, such a use can be an invention within the meaning of s 18(1)(a) of the 1990 Act, irrespective of whether it is a first or subsequent novel use.
It is true, as noted above and as contended by Apotex, that a claim in a patent specification limited to a hitherto unknown use of a substance (with prior therapeutic uses) may pose difficulties in the context of infringement, as observed by Lord Hoffmann in the Merrell Dow Case[514]. Nevertheless, for the reasons given, Apotex's second attack on the validity of claim 1 of the Patent must also be rejected.
[514][1996] RPC 76.
Infringement
Infringement proceedings may be brought to enforce the exclusive rights granted to a patentee under s 13 of the 1990 Act to "exploit" an invention, as that term is defined in Sched 1, for the term of the patent. Infringement is determined by reference to those exclusive rights.
Claim 1, for a hitherto unknown therapeutic use of a pharmaceutical substance (having prior therapeutic uses), is limited to the purpose of treating or curing psoriasis and cannot be directly infringed by the exploitation of leflunomide for the treatment of PsA.
However, Sanofi's claim of infringement rests on s 117 of the 1990 Act, headed "Infringement by supply of products", which sets out the conditions under which a supply of a product will constitute an infringement of an indirect or contributory kind. Section 117 relevantly provides:
"(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)...
(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."
The TGA must also be considered in the context of the claim of infringement under s 117. The TGA provides for the establishment and maintenance of a national system of controls relating to the quality, safety, efficacy and timely availability of therapeutic goods that are used in Australia, whether produced in Australia or elsewhere, or exported from Australia[515]. "Therapeutic goods" are goods likely to be taken to be for "therapeutic use", which is, in turn, defined to include use in or in connection with "preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in persons"[516]. Therapeutic goods which are entered on the ARTG are taken to be "separate and distinct" from other therapeutic goods if they have "a different name", "different indications", or "different directions for use"[517], amongst other things.
[515]Therapeutic Goods Act 1989 (Cth), s 4(1)(a).
[516]Therapeutic Goods Act 1989 (Cth), s 3(1).
[517]Therapeutic Goods Act 1989 (Cth), s 16(1)(d), (e) and (f).
Section 23(2)(ba) of the TGA provides that an application for registration or listing of therapeutic goods on the ARTG, in the case of a restricted medicine (which leflunomide is), must be accompanied by product information in the form approved under s 7D. Appendix 8[518] of the Therapeutic Goods Administration's Australian Regulatory Guidelines for Prescription Medicines (2004)[519] (which the parties agreed were applicable) stated that a product information document:
"is to present a scientific, objective account of the medicine's usefulness and limitations as shown by the data supporting the application. It is to be devoid of promotional material."
[518]Now Guidance 8: Product Information, published on the website of the Therapeutic Goods Administration.
[519]The Australian Regulatory Guidelines for Prescription Medicines have been updated and now consist of a series of web pages which replace the 2004 version of the Guidelines and their appendices.
In relation to its supply of Apo‑Leflunomide, Apotex's approved product information document contains the following statements:
"INDICATIONS
Apo‑Leflunomide is indicated for the treatment of:
. Active Rheumatoid Arthritis.
.Active Psoriatic Arthritis. Apo‑Leflunomide is not indicated for the treatment of psoriasis that is not associated with manifestations of arthritic disease."
As mentioned, the primary judge held that despite those instructions, Apotex's approved product information document instructed rheumatologists to use leflunomide to treat psoriasis, thus engaging s 117(2)(c) of the 1990 Act.
Turning to s 117, the legislative history of that section was outlined by this Court in Northern Territory v Collins[520]. The difficulties of enforcing a patentee's rights against indirect or contributory infringers under the common law rules, described by Dixon J in Walker v Alemite Corporation[521], were also considered by the IPAC report, to which reference has already been made. Recommendation 33 of the report, subsequently accepted[522], stated that "in general the supply of goods whose only use would infringe a patent, or which are accompanied by a positive inducement for the ultimate consumer to perform actions which would innocently or knowingly infringe a patent should itself be an infringement of the patent" (emphasis added). Whether a supply of a product is an infringement under s 117 depends on the nature of the product and the use or uses to which it is put.
[520](2008) 235 CLR 619 at 631 [44]‑[45] per Hayne J, 642‑645 [100]‑[110] per Crennan J; [2008] HCA 49.
[521](1933) 49 CLR 643 at 658; [1933] HCA 39.
[522]Australia, Senate, Patents Bill 1990, Explanatory Memorandum at 28 [170].
A decision of the Supreme Court of the United States, Dawson Chemical Co v Rohm & Haas Co[523], is illustrative of the scope of s 117(2)(b) and (c) of the 1990 Act and was used by the IPAC to illustrate the need for relieving a patentee from indirect or contributory infringement. The patentee in Dawson (the respondent on appeal to the Supreme Court) owned a patented method claim for the use of an unpatented product to inhibit the growth of certain weeds. The appellants supplied the unpatented product to persons (which was not a direct infringement of the method patent) with instructions to apply the product in accordance with the patented method. Unanimously, the United States Court of Appeals for the Fifth Circuit found that the appellants' conduct constituted contributory infringement of the patent[524]. That finding was not disputed on appeal to the Supreme Court[525].
[523]448 US 176 (1980) ("Dawson").
[524]Rohm and Haas Co v Dawson Chemical Co 599 F 2d 685 at 688 (1979).
[525]Dawson 448 US 176 at 185-186 (1980).
Having regard to the definition of "exploit" in relation to a "method" in the 1990 Act, which must be read with s 117, a person who supplies Apo‑Leflunomide, but does not use the patented method to do any act set out in the definition of "exploit" referable to method patents, does not directly infringe the method patent. It is difficult to understand how the supply of an unpatented product, the use of which by a supplier would not infringe a method patent, can give rise to indirect infringement of a method patent by a recipient of the unpatented product from the supplier. The difficulty reflects the prior art and Sanofi's limited novelty in the hitherto unknown therapeutic use of the pharmaceutical substance, which is the claimed subject matter of the Patent.
Further and separately, as an item registered on the ARTG, Apo‑Leflunomide is a therapeutic good registered for its indicated uses, which specifically exclude use of the patented method identified in claim 1. In light of the provisions of the TGA, to which reference has been made, the expression "indication" in the product information document is an emphatic instruction to recipients of Apo‑Leflunomide from Apotex to restrict use of the product to uses other than use in accordance with the patented method in claim 1. Apotex's approved product information document does not instruct recipients to use the unpatented pharmaceutical substance, which it proposes to supply, in accordance with the patented method, and therefore the product information document does not engage s 117(2)(c) of the 1990 Act.
For the purposes of the application of s 117(2)(b), it was not shown, nor could it be inferred, that Apotex had reason to believe that the unpatented pharmaceutical substance, which it proposes to supply, would be used by recipients in accordance with the patented method, contrary to the indications in Apotex's approved product information document.
Conclusion on infringement
For the reasons given, Apotex's proposed supply of Apo‑Leflunomide does not engage s 117(2)(b) and (c). Thus, Sanofi's claim of infringement, resting on s 117 of the 1990 Act, fails.
Orders
We would make the following orders.
Matter No S1 of 2013
Appeal dismissed with costs.
Matter No S219 of 2012
1.Special leave to appeal on ground 3 of the Draft Notice of Appeal filed on 10 September 2012 granted.
2. Appeal allowed with costs.
3.Set aside the orders of the Full Court of the Federal Court of Australia made on 18 July 2012 and, in their place, order that:
(a) the appeal be allowed in part;
(b)orders 2, 3 and 6 of the Federal Court made on 18 November 2011 be set aside;
(c)order 1 of the Federal Court made on 24 February 2012 be set aside; and
(d)so much of the Amended Application dated 22 September 2009 as made in paragraphs 14 to 22 be dismissed.
4. Remit the matter to the Full Court on the questions of the costs of the appeal to that Court and the costs of the trial (which latter question may, at the discretion of the Full Court, be remitted to the primary judge).
GAGELER J. National Research Development Corporation v Commissioner of Patents ("NRDC") held that a process must have "two essential qualities" to be recognised as a manner of manufacture within the meaning of s 6 of the Statute of Monopolies 1623 (21 Jac I c 3). First, the process must result in an "artificially created state of affairs". Secondly, that resultant state of affairs must have "its own economic utility"[526].
[526](1959) 102 CLR 252 at 277; [1959] HCA 67. See also Wellcome Foundation Ltd v Commissioner of Patents (1980) 145 CLR 520 at 528; [1980] HCA 21.
NRDC suggested, without deciding, that "processes for treating the human body may well lie outside the concept" of a manner of manufacture "because the whole subject is conceived as essentially non-economic"[527]. Underlying that suggestion was a reluctance to characterise as having economic utility a state of affairs, created by treatment of the human body, which might in different gradations be described as an "improvement in ... physical welfare" or as "relief of suffering"[528].
[527](1959) 102 CLR 252 at 275, citing Maeder v Busch (1938) 59 CLR 684 at 706; [1938] HCA 8.
[528]Maeder v Busch (1938) 59 CLR 684 at 706.
NRDC nevertheless emphasised: that the purpose of s 6 of the Statute of Monopolies was to "encourage national development"[529]; that "a widening conception" of manner of manufacture "has been a characteristic of the growth of patent law"[530]; and that any attempt to fetter the exact meaning of manner of manufacture was "unsound to the point of folly"[531].
[529](1959) 102 CLR 252 at 271.
[530](1959) 102 CLR 252 at 270.
[531](1959) 102 CLR 252 at 271. See also Lockwood Security Products Pty Ltd v Doric Products Pty Ltd [No 2] (2007) 235 CLR 173 at 201 [66]; [2007] HCA 21.
The evolution of the conception continued. The suggestion that all processes for treating the human body might lie outside the concept of a manner of manufacture did not survive Joos v Commissioner of Patents[532]. The holding in Joos was that a process which produced a cosmetic result lay within the concept of a manner of manufacture[533]. Whether processes for treating the human body which produced therapeutic or prophylactic results lay inside or outside the concept of a manner of manufacture remained undecided. Neither party to this appeal suggested that Joos was wrongly decided at the time or that its precise holding should now be revisited.
[532](1972) 126 CLR 611; [1972] HCA 38.
[533](1972) 126 CLR 611 at 618.
When s 18(1)(a) of the Patents Act 1990 (Cth) ("the Act") incorporated the concept of a manner of manufacture within the meaning of s 6 of the Statute of Monopolies into the definition of a "patentable invention" for the purposes of the Act, the holding in Joos represented the minimum extent to which the conception of a manner of manufacture within the meaning of s 6 of the Statute of Monopolies had relevantly developed.
Whether all processes for treating the human body ought now to be recognised as within the concept of a manner of manufacture within the meaning of s 6 of the Statute of Monopolies as incorporated by s 18(1)(a) of the Act, other than those specifically excluded by s 18(2)-(4) of the Act, need not be determined.
The principal issue in the appeal can be resolved by asking and answering a narrower question. That narrower question is whether a process of using a pharmaceutical product to produce a therapeutic or prophylactic result ought now to be recognised as within that concept as so incorporated[534].
[534]Cf Apotex Inc v Wellcome Foundation Ltd [2002] 4 SCR 153 at 177 [48]-[50], citing Shell Oil Co v Commissioner of Patents [1982] 2 SCR 536 at 549, 554.
The seven reasons given by Crennan and Kiefel JJ for concluding that methods of medical treatment of the human body can be patentable inventions persuade me to answer that narrower question "yes". The fourth reason is to me the strongest. Black CJ and Lehane J gave it in Bristol-Myers Squibb Co v F H Faulding & Co Ltd in the form of a rhetorical question: "if (say) an antivenene for spider bite is patentable, on what ground can a new form of treatment for the same life-threatening bite be denied?"[535] Where the new form of treatment is use of another pharmaceutical product, I can think of no satisfactory answer. In particular, I know of no reason for thinking in principle (and am aware of no data which suggest) that such net national economic benefit as might potentially result from the availability of a patent would be greater in the case of a patent for a pharmaceutical product than in the case of a patent for a process by which another pharmaceutical product is used to produce the same therapeutic or prophylactic result.
[535](2000) 97 FCR 524 at 530 [17].
To the seven reasons given by Crennan and Kiefel JJ, I would add an eighth. Irrespective of the weight now to be accorded to the earlier administrative practice to which Crennan and Kiefel JJ point, an affirmative answer to the question whether a process of using a pharmaceutical product to produce a therapeutic or prophylactic result ought to be recognised as within the conception of a manner of manufacture within the meaning of s 6 of the Statute of Monopolies as incorporated by s 18(1)(a) of the Act was given unequivocally and unanimously by the Full Court of the Federal Court in 2000 in Bristol-Myers Squibb. As Bennett and Yates JJ emphasised in their joint reasons for judgment in the decision under appeal, the position reached in Bristol-Myers Squibb has since been regarded as "representing orthodoxy in Australian patent law"[536]. That judicially sanctioned orthodoxy was assumed in the framing of the definition of "pharmaceutical patent" in s 119A of the Act, introduced into the Act in 2006. Now to substitute a negative answer would depart from that orthodoxy; disappoint commercial expectations legitimately formed and acted upon for at least 13 years; undermine the legislative assumption made seven years ago; and render the current legislative definition in part redundant.
[536]Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd (No 2) (2012) 204 FCR 494 at 537 [193].
I also agree with Crennan and Kiefel JJ in relation to the separate issue of construction in the appeal and in relation to the issue of infringement raised by the application for special leave to appeal. I therefore join in making the orders their Honours propose.