Bayer Inc. v. Cobalt Pharmaceuticals, 2013 FC 573

Bayer sought an order prohibiting the Minister of Health from issuing a Notice of Compliance (NOC) to Cobalt, in respect of a generic version of Bayer’s patented oral contraceptive YASMIN, covered under Canadian Patent No 2,261,137 (’137 patent). Bayer argued that Cobalt’s generic product would infringe its ‘137 patent.

The main claim at issue was claim 13 of Bayer’s ‘137 Patent which reads “….a product prepared according to the process of claim 12, wherein the product comprises drospirenone and less than 0.2%” of the two contaminants identified in claim 12. Claim 12 in turn claims all of the processes in claims 1 to 11 which yield two named contaminants in a concentration of less than 0.2%. Bayer argued unsuccessfully that claim 13 should be purposively construed to exclude the process described in claim 12. Specifically, Bayer attempted to argue that when construing claims in an infringement analysis, product-by-process claims should be read so that the process component of the claim should always be ignored and excluded from the analysis. The Court clarified that in determining whether the product in a product-by-process claim is valid, even if the process itself is new and otherwise patentable, the product itself must be analyzed separately from the process and must also independently meet all the requirements for an invention.

The Court found that Cobalt’s manufacturing process was different than Bayer’s and would therefore not infringe the ‘137 Patent.