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Australia – Methods Of Treatment Are Patentable, But Aren’t Infringed By Accident.

17 December, 2013

 


Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd [2013] HCA 50

What You Need To Know

  • The High Court has for the first time considered the issue of patentability of claims to methods of medical treatment. The High Court held by a majority of 4 (Chief Justice French and Justices Crennan, Kiefel, and Gageler to 1 (Justice Hayne dissenting) that a method of treatment to the human body can be  a “manner of manufacture”, and, therefore, a patentable invention within 18(1)(a) of the Patents Act 1990 (Cth).
  • The High Court has also unanimously clarified that claims directed to treatment of a disease, being a hitherto unknown therapeutic use of a known pharmaceutical substance (having prior therapeutic uses) are limited in scope to the deliberate or conscious treatment of that disease. Notably, the High Court made it clear that a claim in this form is only infringed if the purpose of the administration is the unknown use which is claimed. That is, there will be no incidental or accidental infringement by administration for the treatment of other diseases.
  • The High Court’s decision, therefore, provides some comfort to both innovator companies (by confirming that claims to methods of medical treatment can be patentable) and generic companies (by clarifying the scope of such claims and risks of infringement).

 

Background


Sanofi-Aventis Deutschland GmbH is the registered owner of Australian Patent No. 670491 entitled “Pharmaceutical for the treatment of skin disorders” (due to expire in March 2014) (Patent). The Patent has one 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 … [leflunomide].


Leflunomide has been registered on the Australian Register of Therapeutic Goods (ARTG) by Sanofi-Aventis Australia Pty Ltd under the names “Arava” and “Arabloc” for the treatment of active rheumatoid arthritis (RA) and active psoriatic arthritis (PsA).


In July 2008, Apotex Pty Ltd (Apotex) successfully obtained registration of its generic version of leflunomide (Apo-Leflunomide) on the ARTG. Apotex’s approved product information (PI) for Apo-Leflunomide stated that it is indicated for the treatment of active RA, active PsA and that it is not indicated for the treatment of psoriasis that is not associated with manifestations of arthritic disease.


Sanofi-Aventis Deutschland GmbH, Sanofi-Aventis Australia Pty Ltd and Aventisub II Incorporated (together, Sanofi) commenced proceedings against Apotex in October 2008, alleging, amongst other things, that Apotex’s proposed supply of Apo-Leflunomide to treat PsA would infringe the Patent under section 117 of the Patents Act 1990 (Cth) (Act).


Apotex denied infringement and filed a cross-claim seeking revocation of the Patent on a number of grounds, including that claim 1 is not a “manner of manufacture” within the meaning of section 6 of the Statute of Monopolies and, therefore, is not a patentable invention under section 18(1)(a) of the Act.


At first instance, Justice Jagot held that the Patent was valid and found that Apotex’s intended supply of its Apo-Leflunomide product for the treatment of PsA would infringe the Patent under sections 117(2)(b) and (c). In reaching that conclusion her Honour found that the claimed method is used where leflunomide is administered to a recipient so that the recipient’s psoriasis is in fact prevented or treated (and that the purpose of the administration is not integer requirement of the claim). Her Honour’s conclusion as to infringement under sections 117(2)(b) and (c) was based on her finding that the evidence established that:


  • Apotex knew that nearly every patient with PsA has or will develop psoriasis and if leflunomide is administered to a patient to treat PsA, leflunomide would be expected also to prevent or treat the patient’s psoriasis (to some extent at least).
  • Apotex’s approved PI instructs a rheumatologist to use Apo-Leflunomide for the treatment of PsA and as almost all people with PsA have or will develop psoriasis the PI instructs rheumatologists to use leflunomide to treat psoriasis (irrespective of the exclusion of psoriasis in Apotex’s PI).

 

The Full Federal Court dismissed Apotex’s appeal. Although the majority (Justices Bennett and Yates ) found that Justice Jagot erred in construing claim 1 and that the claim was directed to the object or purpose of preventing or treating psoriasis, their Honours went on to uphold Justice Jagot’s finding on infringement under sections 117(2)(b) and (c) of the Act.

 

Apotex’s Appeal To the High Court


Apotex applied for, and was granted special leave to appeal to the High Court. The main issues before the High Court were:


  • as regards validity, whether the subject matter of claim 1 is a “manner of manufacture” and hence a patentable invention within the meaning of section 18(1)(a) of the Act (a narrower issue to be determined was whether claim 1 for a hitherto unknown therapeutic use of a pharmaceutical substance (having prior therapeutic uses) is a manner of manufacture);
  • (if infringement remains to be determined) whether the proposed supply by Apotex of leflunomide to treat PsA would infringe the Patent under section 117(1).

Patentability Of Methods Of Medical Treatment For Human Beings


The High Court held by majority (Justice Hayne dissenting) that claims to methods of medical treatment of the human body can be a manner of manufacture and, therefore, a patentable invention within the meaning of section 18(1)(a) of the Act. Justices Crennan and Kiefel (delivering a joint judgment) found that such claims are patentable assuming the other requirements of patentability are met and satisfies the NRDC case test (National Research Development Corporation v Commissioner of Patents (NRDC case) (1959) 102 CLR 252), namely the method is a contribution to a useful art having economic utility. In this regard their Honours noted a distinction 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 not deciding the point, their Honours observed that the latter are, as a general matter, non-economic and not capable of industrial application.

 

Construction Of Claims To Methods Of Treatment


Notably, the High Court (Justices Crennan and Kiefel with whom Chief Justice French and Justice Gageler agreed) held that claim 1 of the Patent is a claim limited to the specific purpose of preventing and treating psoriasis. Their Honours found that because any novelty and inventive step is confined to a hitherto unknown therapeutic use of leflunomide (a substance having prior therapeutic uses), the monopoly granted in respect of claim 1 is limited to that hitherto unknown purpose.


The High Court also clarified that a claim in this form is only infringed if the purpose of the administration is the unknown use which is claimed. That is, there will be no “incidental” or “accidental” infringement because the specific purpose of administration is effectively an essential integer of the claim.

 

Indirect Infringement Under Section 117 Of The Act


Section 117 of the Act provides that, if use of a product by a person would infringe a patent, the supply of that product by a person is an infringement of the patent in certain circumstances. Sanofi was successful at first instance and on appeal to the Full Court in its claim of infringement under sections 117(2)(b) and (c) of the Act.


Section 117(2)(b) applies to any use of a product (which is not a staple commercial product) if the supplier had reason to believe that the person would put it to that use. Section 117(2)(c) applies in the case of use of the product in accordance with (amongst other things) any instructions for the use of the product, or any inducement to use the product, given to the person by the supplier.


The High Court (Justices Crennan and Kiefel with whom Chief Justice French and Justice Gageler agreed) found that Apotex’s proposed supply of Apo-Leflunomide did not did not infringe claim 1 of the Patent under sections 117(2)(b) or (c) of the Act. As regards section 117(c), the High Court found that Apotex’s approved PI for Apo-Leflunomide specifically excludes the method of claim 1 and does not instruct recipients to use the product for the treatment or prevention of psoriasis.


The High Court gave consideration in this context to the regime under which therapeutic goods are registered by the Therapeutics Goods Administration (TGA) in the Australian Register of Therapeutic Goods (ARTG) and noted that the indication in the PI is an emphatic instruction to recipients to restrict use of Apo-Leflunomide to use it other than in accordance with claim 1.


As regards section 117(b) the High Court found that it had not been shown, nor could it be inferred, that Apotex had reason to believe that Apo-Leflunomide would be used by recipients to deliberately treat psoriasis in accordance with the method of claim 1 contrary to the indications in Apotex’s PI.


Conclusion


The High Court’s decision provides some comfort to both innovator and generic pharmaceutical companies. For the first time the High Court has confirmed that claims to methods of medical treatment of the human body can be patentable in Australia, a question which has raised doubts over a considerable period of time.


The High Court’s decision on claim construction and infringement of method of treatment claims directed at new therapeutic uses of known substances will also provide clarity to generic companies in terms of the effect of carving out indications from product information documents and minimising the risks of indirect infringement under section 117 of the Act.


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For further information, please contact:


Ben Miller, Partner, Ashurst

ben.miller@ashurst.com


Paula Iannitti, Ashurst

paula.ianitti@ashurst.com


Marcus Fleming, Ashurst

marcus.fleming@ashurst.com


Bruce Hardy, Ashurst

bruce.hardy@ashurst.com

 

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