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Focus: Methods of medical treatment of the human body are patentable

6 December 2013

In brief: In a significant decision, the High Court has confirmed that methods of medical treatment of the human body are patentable inventions in Australia. Partner Sarah Matheson (view CV) and Lawyer Lauren John report.

How does it affect you?

  • This decision confirms that claims to methods of medical treatment and claims to methods of treatment for second or later medical uses are patentable.
  • It provides certainty for medical and pharmaceutical inventors that their innovations will continue to be protected.
  • The High Court's narrow interpretation of indirect infringement may lessen the scope for enforcing valid claims covering method of treatment claims.

Introduction

Australia has for many years permitted patents for methods of medical treatment of the human body, that position having evolved beyond older authority that they are 'essentially non-economic' and therefore not patentable.

The status quo was recently challenged by generic pharmaceutical manufacturer Apotex, in a proceeding that ultimately came before the High Court in Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd & Ors.1 By a majority of 4:1, the court held that claims to methods of medical treatment are patentable.

However, in a decision that leaves Sanofi-Aventis with an ultimately unsatisfactory outcome, the High Court allowed Apotex's appeal on the issue of indirect infringement, with the result that while the patent at issue is valid, it is not infringed.

Background

Sanofi-Aventis Deutschland GMBH (Sanofi-Aventis) is the registered owner of a patent entitled 'pharmaceutical for the treatment of skin disorders' (the patent) that expires on 29 March 2014. Its single claim is for a method of preventing or treating psoriasis by administering a pharmaceutical composition containing the active ingredient leflunomide.

The compound leflunomide (and other therapeutic uses for it – not psoriasis) was the subject of an earlier Sanofi-Aventis patent, which expired in 2004.

Sanofi-Aventis Australia Pty Ltd (Sanofi) supplies leflunomide in Australia. Apotex sought to market a generic version of leflunomide for psoriatic arthritis (PsA) and rheumatoid arthritis (RA). Sanofi commenced proceedings against Apotex, alleging that its supply of its leflunomide product for the treatment of PsA infringed the patent.

Apotex denied infringement and claimed that the patent was invalid on a number of grounds, including that the patent claim did not identify a patentable invention within the meaning of section 18(1)(a) of the Patents Act 1990 (Cth) (the Patents Act).

Section 18 of the Patents Act requires that a patentable invention must meet a number of requirements, including that it be a 'manner of manufacture' within the meaning of the language of s6 of the Statute of Monopolies 1623, which continues to underpin the definition of patentable subject matter in Australia.

Relevantly, the Patents Act does not prohibit patents for methods or processes of medical treatment of the human body, nor subsequent medical uses of previously known products.

At first instance in the Federal Court, Justice Jagot held that the patent was valid and infringed by Apotex.

On appeal, Apotex sought to raise two additional grounds in relation to patentability:

  • methods of medical treatment of human beings are not patentable inventions; and
  • methods of medical treatment for a 'second or later medical use' are not patentable inventions.

The Full Federal Court did not disturb Justice Jagot's findings at first instance and declined to decide Apotex's argument that claims to a method of treating the human body are not patentable.

Apotex was granted special leave to appeal to the High Court on the issues of patentability and infringement.

The High Court's decision

Patentability of methods of medical treatment

Apotex argued, on the basis of the principles laid down in National Research Development Corporation v Commissioner of Patents,2 that a claim to a method of treatment of the human body is not a patentable invention because it does not belong to the useful arts, does not effect an artificially created improvement and has no economic utility. Apotex distinguished the (undoubted) patentability of medical equipment and pharmaceutical compositions, on the basis that to make a human being 'a better working organism' is not proper subject matter for a patent, as it is 'essentially non-economic'.

The majority (Chief Justice French and Justices Crennan, Kiefel and Gageler) confirmed that methods of medical treatment of humans may be patented. The reasons of Justices Crennan and Kiefel included3

  • The 'long understood requirement' of 'economic utility' requires no more than that the subject matter of a patent must have some useful application, which in turn requires no more that it must be capable of being practically applied in commerce or industry.
  • The Patents Act contains no specific exclusion from patentability of methods of medical treatment of the human body, and nor can any be implied.
  • There is no basis in economics or ethics to distinguish between the subject matter of a claim for:
    • a new product suitable for therapeutic use, claimed alone (product claim) or coupled with method claims (combined product / method claims); and
    • a hitherto unknown method of treatment using a known product having prior therapeutic uses (method claim).
  • The long-standing practice of the Australian Patent Office of granting patents of methods of treating humans.

Justice Gageler stated further that to answer the question of patentability in the negative would be to depart from the 'orthodoxy in Australian patent law', thereby disappointing legitimate commercial expectations and undermining legislative assumptions.4

Interestingly, Justices Crennan and Kiefel distinguished the activities or procedures of doctors and other medical staff when physically treating patients as 'essentially non-economic',5 and therefore not likely to be patentable. Although they did not have to decide the point, this suggests their Honours would take a different route from that in the United States, where medical practitioners and healthcare entities are expressly excluded from liability for patent infringement 'for the performance of a medical or surgical procedure on a body'.

In a lone dissent, Justice Hayne, in essence, accepted Apotex's submission that a method of treating humans is 'essentially non-economic'. His Honour considered that a method of prevention or treatment of human disease is a method or process used to produce a product that is personal to the individual concerned. Any economic utility that may result from the use of the process flows from what the individual chooses to do. The improvement in health is not something in which a patentee can trade, or otherwise exploit.6

Justice Hayne's judgment is interesting in light of debate surrounding the patentability of claims relating to 'personalised medicine' – the tailoring of medical treatment to the individual characteristics of patients, which enables medical professionals to classify into subpopulations. A recent example is the health decision that actress Angelina Jolie was able to make based on genetic testing providing an estimation of her percentage risk of developing breast cancer.

The European Patent Office, the UK Patent Office and the UK courts have been grappling with medical use claims limited only by patient group; not only with questions of patentability but also novelty and inventive step. While these issues are beyond the scope of this article, they raise the question of how the patent system can provide sufficient incentive for ongoing research and development.

But was it infringement?

Despite upholding the validity of the patent, the High Court allowed Apotex's appeal on the issue of whether, in light of the fact that the patent only claims the use of leflunomide for the treatment of psoriasis, Apotex's supply of its leflunomide product indicated for the treatment of diseases other than psoriasis would infringe the patent under s117(1) of the Patents Act.

Section 117(1) concerns infringement by supply of products and imposes liability for secondary infringement if the use of the supplied product would amount to primary infringement. Section 117(1) is of particular importance in cases relating to method of treatment claims.

By the same 4:1 majority, the court held that Apotex's proposed supply of leflunomide to treat PsA would not infringe the patent, overturning the decision of Justice Jagot at first instance and the Full Federal Court in this respect.

In a rather cursory examination of s117, Justices Crennan and Kiefel said that it was difficult to understand how the supply of an unpatented product, the use of which by the supplier does not infringe, can give rise to indirect infringement of a method patent by a recipient of the unpatented product from the supplier.7 This difficulty is said to arise from the confined nature of the patent claim.

Their Honours were also persuaded by the fact that Apotex's product is registered on the Australian Register of Therapeutic Goods only for the indications of PsA and RA, not psoriasis. Further, they considered that the indication listing in the product information document (PI) is an 'emphatic instruction' to recipients of Apotex's product to restrict use of the product as indicated. Accordingly, Apotex's PI did not engage s117(2)(c) of the Patents Act, in that there were no instructions for the use of the product or any inducement to use the product in an infringing way.8

The court also found that Apotex had no reason to believe that its product would be used by recipients contrary to the indications in Apotex's approved PI. Therefore, Apotex did not contravene s117(2)(b), which requires the supplier to have reason to believe that the supplied person would use in an infringing way.

This finding on s117(2)(b) bypasses issues surrounding 'off label' practices: eg prescribing, marketing or using a pharmaceutical for an unapproved indication. Further, the finding in relation to s117(2)(b) appears to be predicated on an absence of evidence as to Apotex's knowledge, or from which knowledge could be inferred, so a different outcome might ensure where compelling evidence of off label practices is presented.

The High Court's finding also seems to align with the proposed 'carve out' to s117, as recommended in the Pharmaceutical Patents Review Draft Report.9 The recommendation that the supply of a pharmaceutical product subject to a patent that is used for a non-patented indication will not amount to infringement where 'reasonable steps' have been taken to ensure that the product will only be used in a non-infringing manner essentially adopted the submission of the Generic Manufacturers Industry Association in this respect. The indications listed in Apotex's product information would satisfy the low bar set for 'reasonable steps' recommended in the review.

Conclusion

The decision settles the issue of whether claims to methods of medical treatment and claims to methods of treatment for second or later medical uses are patentable. The decision provides certainty for medical and pharmaceutical inventors that their innovations will continue to be protected, which, in turn, provides the basis for incentives for the development of solutions for unmet medical needs.

The narrow interpretation of s117 is less positive for the innovative pharmaceutical industry. While patentability is key, commercialisation that provides a return on investment depends on the ability to enforce patent rights against infringers. The High Court's narrow interpretation of s117 may reduce the scope for enforcing valid claims covering methods of treatment. It is to be hoped that this decision does not represent an absolute carve-out position but, rather, will depend on the evidence.

Footnotes
  1. [2013] HCA 50.
  2. (1959) 102 CLR 252.
  3. Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd & Ors [2013] HCA 50 at [278] [285].
  4. At [315].
  5. At [287].
  6. At [2013] HCA 50 at [53].
  7. At [302].
  8. At [303].
  9. Draft Recommendation 6.4, Pharmaceutical Patents Review Draft Report, April 2013, IP Australia.

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