Federal Court Clears Path for Regulatory Approval of Cobalt’s Generic Contraceptive Based on YASMIN®

In Bayer Inc v Cobalt Pharmaceuticals Company, 2013 FC 573 [Cobalt], the Federal Court refused the application of Bayer for an order prohibiting the issuance of a Notice of Compliance to Cobalt for a generic version of the oral contraceptive YASMIN® (drospirenone + ethinyl estradiol). Justice O’Reilly found Cobalt’s allegation of non-infringement justified on the grounds that Cobalt did not use the process set out in the product-by-process claim at issue. In patent law, there are several ways to describe an inventive product in a patent claim. A product-by-process claim describes the product, in whole or in part, through the process used in its production. In Cobalt, for example, the claim at issue protected “[a] product according to the process of Claim 12”, where the product was drospirenone substantially free from named contaminants. Claim 12 claimed a series of processes for the synthesis of drospirenone. Bayer relied on the principle established in Hoffman LaRoche & Co v Comm of Patents, [1955] SCR 414 [Hoffman LaRoche], that known products cannot be claimed by simply making them dependent on a new process. According to Bayer, because it was granted a patent and drospirenone was not a new compound, its patent must be interpreted to claim a new form of drospirenone (one substantially free from named contaminants), regardless of the process used in its synthesis. Justice O’Reilly found this logic flawed. While Hoffman LaRoche speaks generally to the validity of a product-by-process claim, the reasoning does not extend to claims construction. In other words, the presumption that Bayer was granted a valid patent does not operate in reverse to establish the scope of the claims. Though not mentioned in the decision, this conclusion finds support in the common law rule that claims construction precedes any inquiry into validity. In Cobalt, the process was found to be essential to the invention due to its unambiguous incorporation and a lack of disclosed alternatives. Because Cobalt employed a different process, its allegation of non-infringement was justified. Heather Watts, counsel for Cobalt in the case (as was Douglas Deeth), comments on the judgment:

The decision reached in this case confirmed a number of key principles of Canadian patent law. Dependent claims include all the features and limitations of the claims that they incorporate by reference and cannot be construed in a manner that is inconsistent with the claims on which they depend. An inventor is free to claim a product made by a certain process, but doing so governs the bounds of the patent right. Where a product is claimed as being made according to a certain process and a second person makes the product by a completely different process, then the second person’s product cannot be found to infringe the product-by-process claim.

Summary by: John Lucas