Pharmacapsules @ Gowlings - January 20, 2012 - Volume 11, Number 1

Edited by Jennifer L. Wilkie and Isabel Jaen Raasch. Apotex Inc. v. sanofi et al., December 6, 2011, 2011 FC 1486, Plavix

On December 6, 2011, the Federal Court granted Apotex's impeachment action in respect of the '777 Patent, which relates to PLAVIX®. The Court declared the claims of the '777 Patent to be invalid. As a consequence of the declaration of invalidity, the relief sought in sanofi's infringement action, heard at the same time, was dismissed.

This was Apotex's second validity challenge to the '777 Patent. In a previous PM(NOC) Proceeding, Apotex' allegations of invalidity were found to be unjustified by all three levels of the Canadian courts. Of significance the validity of the '777 Patent had been upheld by the Supreme Court of Canada in 2006. The Court there had affirmed the decisions below that Apotex's allegations of anticipation, obviousness and double patenting were unjustified.

In the impeachment proceeding, the Federal Court rejected Apotex' allegations that the '777 Patent was invalid for lack of novelty, insufficient disclosure, overbreadth and double patenting. However, the Court held that the '777 Patent was invalid since it lacked utility. Further, in obiter, the Court stated that, if necessary, that it would have found that the patent was obvious – in direct contradiction to the Supreme Court decision on this issue in the previous litigation.

The finding in favour of impeachment was made on the allegation of inutility, and in particular lack of a sound prediction. The Court held that the '777 Patent "promised" that clopidogrel could be used in humans.

The Court then held that although the patentee had an ample factual basis and sound line of reasoning for the utility, there was insufficient disclosure of these two elements in the patent specification. This finding was made despite the fact that the Court had held that sanofi had met its statutory disclosure requirement.

The Court also held that if the '777 Patent had been valid, it would have held that Apotex infringed it.

The full text of this decision can be accessed at:

"http://decisions.fct-cf.gc.ca/en/2011/2011fc1486/2011fc1486.html"

Allergan Inc. v. Canada (Health), November 17, 2011, 2011 FC 1316, Combigan:

This proceeding under the NOC Regs dealt with two patents covering Allergan's COMBIGAN product. Crampton J. granted an order of prohibition with respect to the more recently issued of the two patents (the '764 Patent) , finding that it was not obvious. In obiter, he then denied Allergan's request...