Is a method of treatment of the human body a patentable invention?

Is a method of treatment of the human body a patentable invention?

Is a method of treatment of the human body a patentable invention?

In what will undoubtedly be an important decision for the medical and pharmaceutical industries, the High Court of Australia will this year1 consider:

  1. whether a claim for a method of treatment of the human body is a patentable invention within the meaning of s 18(1)(a) of the Patents Act 1990 (Cth); and
  2. whether a claim for a second or subsequent medical use of a previously known product claims a patentable invention.

Update on the Apotex Pty Ltd v Sanofi-Aventis Pty Ltd case

We previously reported the Full Federal Court’s decision in Apotex Pty Ltd v Sanofi-Aventis Pty Ltd (No. 2) [2012] FCAFC 102.2 On 14 December 2012, the High Court granted Apotex special leave to appeal from that decision.

The parties have now filed their written submissions in the Appeal.3

Patentability of a method of treatment of the human body (Issue 1)

Before the Full Federal Court, Apotex submitted that claims to methods of medical treatment should not be patentable. The Full Court rejected that submission. In doing so, Justices Bennett and Yates observed that the patentability of methods of treatment represented “orthodoxy in Australian patent law”.4 They also observed that, both before and since the Patents Act 1990 was passed, it had been commonplace for patents to be granted for methods of treatment.5 They also noted that although it had ample opportunity to do so in recent years, the Australian Parliament had not been persuaded to legislate to change the Patents Act to exclude such methods from patentability.6

S18(1)(a) of the Patents Act requires that the claimed invention be a manner of manufacture within the meaning of section 6 of the Statute of Monopolies 1623. In National Research Development Corporation v Commissioner of Patents (NRDC)7, the High Court said that “the right question” in this regard was whether a claimed invention is a “a proper subject of letters patent according to the principles which have been developed for the application of section 6 of the Statute of Monopolies?”.

Apotex’s Submissions

It appears from Apotex’s submissions that Apotex will argue that, according to the High Court’s dicta in the NRDC case, the answer to that question with respect to methods of treatment of humans was “probably not”.9

Furthermore, Apotex will argue that the High Court in the NRDC case saw methods of treatment as remaining outside the broader concept of invention it was articulating and that a method of treatment is “essentially non-economic”, particularly where the question is whether the physician’s intent accords with the claimed method.10

Sanofi-Aventis’ submissions

On the other hand, it appears from Sanofi-Aventis’ submissions that it will argue that given the wording and context of the Patents Act 199011, the fact that methods of treatment have been held to be patentable at the Federal Court level12, and the fact that no High Court decision has held to the contrary, methods of treatment of the human body are patentable.13

Furthermore, Sanofi-Aventis has noted that no decision of the Federal Court or High Court has upheld the exclusion of methods of treatment from patentability on the grounds that they are “non-economic”.14

Also, to the extent that there might be any exclusion of methods of treatment on the ground of “general inconvenience” as opposed to the matter being “non-economic”, Sanofi-Aventis will apparently argue that that ground is not open to Apotex15, and, in any event, is not an appropriate basis for excluding methods of treatment from patentability.16

Patentability of the second or subsequent use of a previously known product (Issue 2)

Apotex’s alternative argument is that methods of treatment of the human body are not patentable if they involve a second or subsequent use of a previously known product.17 The rationale given for this is that an invention limited by purpose is not patentable.18 That is, a claim to a new purpose is not a manner of manufacture.19

Sanofi-Aventis’ submissions in this regard note that, inter alia, the Full Court’s construction of the relevant claim20 did not compel an enquiry into the subjective purpose or “state of mind” of the medical practitioner. Rather, the construction required an objective assessment to be made of the object or end in view of the medical practitioner in prescribing or administering leflunomide for the treatment of the patient.21

Full Federal Court decision on Section 117

As we also previously reported22, the Full Court relied on Apotex’s own Product Information Document (PID) as well as expert evidence to determine whether section 117 would apply. The evidence established that psoriasis is a diagnostic criterion of psoriatic arthritis (PsA), and that patients with psoriatic arthritis will have or eventually develop psoriasis. Thus it was accepted that rheumatologists would routinely prescribe leflunomide to treat PsA as well as psoriasis in patients presenting with concurrent conditions. Furthermore, although the PID expressly disclaimed the treatment of psoriasis in the absence of manifestations not associated with arthritic disease, the Full Court agreed with the primary Judge and construed the double negative as a positive instruction by Apotex for the treatment of psoriasis associated with arthritic disease. On that basis, the Full Court concluded that either of sections 117(2)(b) or (c) would be sufficient to engage the application of section 117(1) and render Apotex liable for infringement.

Apotex’s application for special leave to appeal

Apotex’s application for special leave to appeal the Full Court’s decision in respect of this point will be heard at the commencement of the hearing of Apotex’s Appeal.

Endnotes

  1. Probably in April or May 2013
  2. /pub/detail/637/method-of-treatment-claims-to-be-construed-with-the-object-or-end-view-in-mind-but-apotex-still-liable-for-contributory-infringement
  3. Apotex on 25 January 2013 and Sanofi-Aventis on 15 February 2013
  4. [2012] FCAFC 102 at [193]
  5. [2012] FCAFC 102 at [193]; Anaesthetic Supplies Pty Ltd v Rescare Ltd (1994) 50 FCR 1 at 17G; Bristol-Myers Squibb Co v FH Faulding & Co (2000) 97 FCR 524 at [16]
  6. [2012] FCAFC 102 at [193]
  7. (1959) 102 CLR 252
  8. (1959) 102 CLR 252 at 269
  9. Appellant’s submissions, para 17
  10. Appellant’s submissions, paras 36 – 37. The method in this case is a “method of preventing or treating … psoriasis, which comprises administering to the recipient an effective amount of … [leflunomide]”.
  11. Respondent’s submissions, paras 19 – 29
  12. Respondent’s submissions, paras 39 – 48
  13. Respondent’s submissions, paras 30 – 38
  14. Respondent’s submissions, paras 49 – 60
  15. Respondent’s submissions, paras 36 – 38
  16. Respondent’s submissions, paras 61 – 66
  17. Appellant’s submissions, paras 2, 46 – 53
  18. Appellant’s submissions, para 51
  19. Appellant’s submissions, para 48
  20. “method of preventing or treating … psoriasis, which comprises administering to the recipient an effective amount of … [leflunomide]”; [2012] FCAFC 102 at [37], [40], [125] – [128]
  21. Respondent’s submissions, para 72
  22. /pub/detail/637/method-of-treatment-claims-to-be-construed-with-the-object-or-end-view-in-mind-but-apotex-still-liable-for-contributory-infringement