On 4 December 2013 the High Court issued its decision in is
Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd & Ors.
Sanofi-Adventis Australia patented the use of the pharmaceutical
drug, Leflunomide, as a method to treat or prevent psoriasis. The
Australian patent on the preparation and composition of Leflunomide
had expired. Apotex intended to supply Leflunomide products in
Australia under the name Apo-Leflunomide for the treatment of
active psoriatic arthritis and rheumatoid arthritis. The product
information of Apo-Leflunomide stated that it was "not
indicated for the treatment of psoriasis that is not associated
with manifestations of arthritic disease".
Sanofi-Adventis Australia sued Apotex for infringement of the
patent. Apotex counter-sued for revocation of the patent on
The High Court held that medical treatment methods that make use
of a previously unidentified therapeutic use of a pharmaceutical
product are patentable in Australia, unlike in New Zealand and the
UK. The Court came to this view because it found that a method of
medical treatment can be seen to be a "manner of
manufacture", a requirement in order for an invention to be
Accordingly, Apotex's application for the revocation of
Sanofi-Adventis' patent was refused. However, it was found that
Apotex had not infringed the patent because the product information
stated that Apo-Leflunomide was not to be used for the purpose that
was the subject of that patent.
It is now clear that it is possible to patent methods of medical
treatment using a pharmaceutical product to treat a particular
It is still unclear whether surgical methods are patentable. In
their joint judgment Justices Crennan and Kiefel said that the
patentability of methods used by medical staff and doctors when
physically treating patients is a different issue that did not need
to be further considered in this case.
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
To print this article, all you need is to be registered on Mondaq.com.
Click to Login as an existing user or Register so you can print this article.
As a licensor or a licensee, here are some tips you should consider when negotiating your next licence agreement.
Some comments from our readers… “The articles are extremely timely and highly applicable” “I often find critical information not available elsewhere” “As in-house counsel, Mondaq’s service is of great value”
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).