Press Releases

March 12, 2010 - The High Court of Australia has on Friday 12th March dismissed Sanofi's bid to appeal the Full Federal Court's September 2009 judgment in favour of Apotex. Apotex now has right to market Clopidogrel in Australia.

In August 2007, Apotex applied to the Federal Court of Australia for an order revoking Australian Patent No. 597784 in the name of sanofi-aventis, which covers clopidogrel and its pharmaceutically acceptable salts (the Clopidogrel Patent). In August 2008, the Federal Court found that a number of the claims in the Clopidogrel Patent were invalid, but did not invalidate claims for particular clopidogrel salts. Apotex appealed the decision of the Federal Court, and on 29 September 2009, the Full Court of the Federal Court of Australia delivered its judgment in this case.

The Full Court found that all of the claims in the Clopidogrel Patent, including claims to a single enantiomer, particular clopidogrel salts and a process for preparing the enantiomer, are invalid for lack of inventive step. In relation to the clopidogrel salts, the Full Court determined that, taking either the racemate or the single enantiomer as the starting point, there was no inventive step involved in creating the salts, as it merely involved the application of common processes with common laboratory acids. The Full Court also upheld the decision of the Court at first instance, insofar as the claims to the single enantiomer and the process for resolving the enantiomer were found to be invalid for lack of novelty.

Apotex is now clear to market its TGA registered products, and can now also seek compensation from Sanofi for the 29 months Apotex has been prevented from marketing its brands.

Apotex is a Canadian based company, head quartered in Toronto, with a global presence in over 115 countries. Apotex looks forward to continuing to look for opportunities to fulfil its commitment to providing Australians with the widest possible access to high quality, affordable medicines.