Ethinyl estradiol & Drospirenone – Canada

Ethinyl estradiol & Drospirenone – Canada

On September 7, 2016, the Federal Court (Canada) found that Apotex and Cobalt infringed three claims of Bayer’s Canadian Letters Patent No. 2,382,426.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.

During invalidity challenge, 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. 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.

The Court found that Bayer’s Phase III clinical trial was necessary to evaluate pregnancy prevention in real situations. It thus fell under the experimental use exception. Pharmaceutical companies ought to nonetheless remain vigilant in protecting, through adequate confidentiality agreements and express use restrictions during clinical trials (eg. explicitly specifying drug ingestion and return protocols), their inventions which may be the subject of or accessed through clinical trials. This applies in particular to inventions which could be easily reversed engineered.

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