On December 24, 2020, the Federal Court issued a decision in a patent infringement action pursuant to s. 6(1) of the Patented Medicines (Notice of Compliance) Regulations relating to silodosin (Allergan’s RAPAFLO): Allergan Inc v Sandoz Canada Inc, 2020 FC 1189. Chief Justice Crampton found that Canadian Patent No. 2,507,002, relating to a capsule formulation of silodosin, is not invalid on the basis of obviousness but not infringed as “the Sandoz Product does not contain ‘granules’ and does not involve ‘granulating’ or a ‘wet granulation process’”, all of which were found to be essential elements.

The Court declined to consider the prosecution file history in determining whether certain claim elements were essential on the basis that s. 53.1 of the Patent Act permits admission of the prosecution history to rebut representations made by the patentee (Kissei in this case) in an action or application, not a licensee (Allergan in this case). The patentee made no representations to the Court regarding construction.