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The Australian High Court Upholds Patentability of Methods of Medical Treatment in Apotex v Sanofi-Aventis

16 April 2014

This case concerned Apotex’s generic version of Sanofi-Aventis’ leflunomide drug, ARAVA®.

Sanofi-Aventis obtained a patent which claims: “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 [leflunomide]”.

Leflunomide is used in Australia to treat psoriatic arthritis and rheumatoid arthritis, but not psoriasis alone, and these were the indications for which Apotex’s generic version was approved. However, psoriasis and psoriatic arthritis are now understood to be related disorders, and almost all patients with psoriatic arthritis will have, or are likely to develop, psoriasis.

Apotex asked the High Court to consider:

  • whether the patent was invalid on the basis that it was not a “manner of manufacture” because it was a method of medical treatment and was therefore excluded from patentability;and
  • if the patent was valid, whether Apotex had infringed the patent.

A majority of the High Court held that the invention was a “manner of manufacture”, and therefore its subject matter was eligible for patentability, upholding the view of the Full Federal Court.

The majority of the Court applied the principle of a process which does not produce a new substance but results in “a new and useful effect”. If the new result is “an artificially created state of affairs providing economic utility” it may be considered a “manner of new manufacture”. The court pointed to the economic interest in ensuring that individuals are fit and healthy.

Previously, the Federal Court had held that Apotex had infringed the patent under section 117 of the Australia Patents Act, which deals with indirect infringement, i.e. where the supplier has reason to believe the person receiving the product will put it to an infringing use, or there are instructions for or inducements advertising an infringing use of the product.

Apotex’s product information document stated that its drug was to be used for the treatment of rheumatoid arthritis and psoriatic arthritis, and expressly stated that its use to treat “psoriasis that is not associated with manifestations of arthritic disease” was not indicated. Despite this, the Federal Court held that Apotex’s supply would infringe the patent because they had reason to believe that it would treat any psoriasis that the patient had, even if it was not administered for that purpose, as almost every person who has psoriatic arthritis will also have or develop psoriasis.

The High Court overturned this decision on infringement. It held that the patent would not be infringed by a person who administered Apotex’s leflunomide product for the purposes of treating a condition other than psoriasis. The High Court also noted that Apotex’s product was registered only for the indicated uses (namely, psoriatic and rheumatoid arthritis). They held that “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”.

This is the first decision of the Australian High Court confirming that methods of medical treatment are patentable subject matter. The decision also suggests that it will be very difficult in Australia to establish infringement of a claim to the use of a medicine for a patented purpose wherein the patented purpose is not one of the indications for which the supplier has obtained approval.

Kirsty Simpson
Life Sciences & Chemistry