04 December 2013

High Court Rules Methods of Medical Treatment Patent-Eligible

Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd [2013] HCA 50 (4 December 2013)

High Court of AustraliaA panel of five judges of the High Court has decided, by a majority of 4-1, that methods of treating the human body by the administration of a therapeutic drug constitute patent-eligible subject matter in Australia.  More particularly, the court ruled in favour of claims directed to a subsequent therapeutic use, i.e. a method of administering a known compound (in this case, leflunomide) for treatment of a condition (psoriasis) for which its efficacy was not previously known.

This is a significant decision.  There have been just a handful of cases over the years in which the issue of patentable subject matter (i.e. ‘manner of manufacture’ under the Australian law) has been considered in cases that the High Court would regard as influential.  In a number of these, the courts expressed doubts as to the eligibility of methods for treating ailments of human subjects for patent protection, but in none of the cases was it actually required to decide the question. 

For a period up until 1992 there was a presumption that methods of ‘medical treatment of human disease, malfunction, disability or incapacity of the human body or of any part of it’ were excluded from patentability, based upon these doubts.  However, that changed in 1992 when a Federal Court judge upheld claims directed to a method for treatment of sleep apnoea – a decision which was affirmed on appeal to a full bench of the court.  Again in 2000 a Full Court of the Federal Court of Australia reached the same conclusion.  While the question of patent-eligibility of treatment methods has generally been considered settled since these Full Court decisions, in the absence of a High Court ruling, some uncertainty necessarily remained.

That uncertainty has now been eliminated, at least in relation to treatments involving the administration of therapeutic drugs.  It appears that the High Court has, however, left open the question of whether the activities or procedures of doctors (and other medical staff) when physically treating patients (i.e. surgical methods and the like) are eligible for patent protection.

Background

I have previously discussed the full background to this case when reporting the first instance decision of the Federal Court in Sanofi-Aventis Australia Pty Ltd v Apotex Pty Ltd (No 3) [2011] FCA 846 and the subsequent Full Court appeal decision in Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd (No 2) [2012] FCAFC 102.  Notably, although the High Court appeal ultimately proceeded primarily on the issue of whether the patent claimed an eligible ‘manner of manufacture’, that particular issue was dealt with so easily in the Federal Court that it barely merited comment at the time.

In brief, Sanofi’s patent no. 670491 claims a method of preventing or treating the skin condition psoriasis by the compound leflunomide.  An earlier patent, directed to the compound itself, expired in 2004.

Apotex registered a generic version of leflunomide on the Australian Register of Therapeutic Goods (ARTG), for the purpose of treating rheumatoid arthritis and psoriatic arthritis (PsA).  The evidence established that almost every person with PsA also has, or will develop, psoriasis.

Sanofi argued that marketing the generic product in this way would infringe its patent because, even if prescribed only for the purpose of treating PsA, because it would then inevitably also treat, or prevent, associated psoriasis – a fact of which prescribing physicians could be expected to be aware.

While Apotex originally attacked the Sanofi patent on a range of available grounds (as is commonly the case), the only ground of invalidity ultimately taken on appeal to the High Court was lack of manner of manufacture.  The finding of the Full Federal Court that Apotex would infringe the patent by supply of its generic leflunomide product was also the subject of an application for Special Leave to appeal to the High Court.

Patent-Eligibility of Methods of Medical Treatment

In Australia the main legal test of whether an invention is patentable subject matter is whether it is a ‘manner of manufacture’.  The term is derived from section 6 of the UK Statute of Monopolies 1623, and remains part of the Australian law because the Australian government decided, when developing the Patents Act 1990, that the question of what types of invention should be patentable ought to remain in the hands of the courts, so as to ensure a flexible application of the law in the face of ever-advancing technology.

The defining case on ‘manner of manufacture’ remains the High Court’s decision in National Research Development Corporation v Commissioner of Patents [1959] HCA 67 (the NRDC Case).  That case set out the principle, which remains the law to this day, that the phrase ‘manner of manufacture’ is not to be applied in any literal sense, but that: ‘[t]he 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?’”

The High Court in the NRDC Case (which concerned a method for applying herbicide to crops) applied these principles to processes, stating that:

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)

As I have already indicated, a number of court decisions through the 20th century expressed doubts about the application of the ‘manner of manufacture’ test to methods of medical treatment:
  1. in the UK case of C & W’s Application (1914) 31 RPC 235, the Solicitor-General, Sir Stanley Buckmaster held that ‘a manner of new manufacture’ had to be ‘in some way associated with commerce and trade’, and that 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 (although a process to enhance the marketability of animals might be viewed differently);
  2. the Australian High Court, in Maeder v Busch [1938] HCA 8, considered a patent for a process for forming permanent waves in hair, which was found to be ineligible for patent protection, with the court finding it ‘very doubtful’ that a method or process of conducting an operation upon a part of the human body could be regarded as a ‘manner of manufacture’;
  3. in the NRDC Case, the High Court reiterated doubts about the patent-eligibility of methods of medical treatment, noting parenthetically (on the basis of Maeder v Busch) that ‘[t]he exclusion of methods of surgery and other processes for treating the human body may well lie outside the concept of invention because the whole subject is conceived as essentially non-economic’;
  4. in Joos v Commissioner of Patents [1972] HCA 38, the High Court reversed a decision of the Deputy Commissioner of Patents rejecting an application for a patent on a process for the treatment human hair and nails, whilst attached to or growing upon the human body, distinguishing this from a (potentially unpatentable) ‘method of treatment of a disease, malfunction, disability or incapacity of the human body or of any part of it’; and
  5. in Advanced Building Systems Pty Ltd v Ramset Fasteners (Aust) Pty Ltd [1998] HCA 19, the majority of the High Court noted that ‘[s]ection 6 of the Statute of Monopolies excluded any manner of new manufacture which was “contrary to the Law” or “generally inconvenient”’, and that ‘[t]he 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.’
Notwithstanding these doubts, the Full Court of the Federal Court of Australia upheld claims directed to methods of medical treatment on two occasions, in
Anaesthetic Supplies Pty Limited v Rescare Limited [1994] FCA 1065 and Bristol-Myers Squibb Co v FH Faulding & Co Ltd [2000] FCA 316, leading to the widespread belief (and corresponding practice of the Australian Patent Office) that such claims are patent-eligible.

The High Court Rules on Methods of Treatment

The decision in Apotex v Sanofi-Aventis sets any remaining doubts to rest.  The majority (French CJ, Crennan, Kiefel, Gageler JJ; Hayne J dissenting) confirmed that a method of treating the human body by the administration of a therapeutic drug is a patentable 'manner of manufacture'.

As stated by French CJ, at [50]:

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. ... . 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.

Kiefel & Crennan JJ delivered a joint opinion (with Gageler J concurring), stating at [286]-[287]:

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’.

Dissent

The lone dissenting voice is that of Hayne J, who stated at [53]:

…that a method of prevention or treatment of human disease is not a patentable invention. Such a method, even if it is novel, involves an inventive step and is useful, 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 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.

Infringement

On the further issue of whether Apotex’s proposed marketing of its generic leflunomide would infringe the Sanofi patent, the High Court granted Special Leave to Appeal, and overturned the finding of the Full Court that this constituted threatened infringement of the patent.

Reasons for this finding were given by Kiefel & Crennan JJ, with French CJ and Gageler J concurring.  In essence, the claim to the use of leflunomide for the treatment of psoriasis was found to be limited to the stated purpose.  As stated by Kiefel & Crennan JJ, at [302]-[304]:

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.  ….  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

This decision of the High Court settles the Australian law relating to patents on methods of medical treatment in two respects.

First, it confirms that such methods are patent-eligible, at least insofar as they relate to methods of treatment by the administration of a therapeutic drug.  This includes the administration of drugs comprising previously known active ingredients, for the purpose of treating conditions for which the ingredients’ efficacy was not previously known.

Second, it confirms that claims limited by purpose, and in particular treatment claims limited by the objective purpose for which the treatment is administered, are relatively narrow in scope, and will not be infringed in the absence of fairly strong indications that the treatment will be applied for the claimed purpose.

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