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