Patent Survives Anticipation Attack Based On Use In Phase III Clinical Trial

On September 7, 2016, the Federal Court found that Apotex and Cobalt infringed three claims of Bayer's Canadian Letters Patent No. 2,382,426.1 The Court also found those claims to be valid. The Court reached these conclusions in the context of consolidated patent infringement actions in connection with generic copies of Bayer's Yasmin and Yaz contraceptive products. These parties had previously been involved in related NOC litigation involving these products which ultimately resulted in Cobalt receiving regulatory approval for a generic Yasmin product and Apotex receiving approval for both products.2

Clinical Trials did not Anticipate Patent

The Court's analysis of the validity attacks on the 426 Patent on the basis of anticipation may be of particular interest to pharmaceutical innovators. Apotex had alleged that the claims in issue were anticipated based on Phase III clinical trials conducted by Bayer in Europe and the United States more than one year before the 426 Patent was filed in Canada. The Court, however, rejected this allegation.

First, the Court acknowledged that there was a theoretical possibility that one of the tablets had made its way to a public person who was skilled in that art. In particular, no restrictions were imposed on participants in the clinical study regarding disclosure of information concerning the tablets. In addition, while participants were asked to ingest all of the tablets they were provided or return any unused tablets, the evidence established that hundreds of tablets were recorded as lost or not returned during the clinical trials.

Nonetheless, the Court was not persuaded that access to a tablet would have been sufficient to reverse engineer the invention of the 426 Patent. Specifically, the Court found that certain central aspects of the invention (ie. rapid dissolution and the location of the exposure of the pharmaceutically active ingredient) could not have been discovered without inventive insight. In particular, such discovery could not occur without access to several tablets, the ability to obtain a reference standard through the synthesis of the active ingredient and the establishment of a dissolution profile. The skilled person would also have required knowledge of the importance of the location and speed of dissolution. The Court found that the skilled person would not have been able to gather such information without inventive insight. As a result, there was no anticipatory disclosure of the...