Amgen Canada Inc. v. Mylan Pharmaceuticals ULC, 2015 FC 1244

Drug: cinacalcet hydrochloride

The Federal Court has dismissed an application for prohibition to prevent the Minister of Health from issuing an NOC to Mylan for cinacalcet hydrochloride. 

The ‘879 Patent was described to claim trillions of calcimimetic compounds defined by two separate genera. At issue was a single claim that specifically claims the compound cinacalcet and its pharmaceutically acceptable salts. It was alleged that the single claim was anticipated, obvious or double patented. 

The ‘879 Patent was claimed to be a selection patent over the ‘828 Patent, and the patentee conceded that cinacalcet was disclosed in the prior art. The Court found that calling the ‘879 Patent a selection patent was a retroactive characterization to save cinacalcet.

In construing the single claim, the Court referred to the patent as a whole, and noted that the claim does not include a specific use, the patent does not promise a particular level of activity for cinacalcet, and other compounds are evidently more active such that one is not drawn, at least by implication, to cinacalcet as having outstanding, unexpected features. The Court further noted that cinacalcet was not synthesised and tested until after the claim date, and cinacalcet was not focused on until after the original lead compound showed toxicity issues. Ultimately the Court held that there was no substantial and unexpected advantage, and no advantage was even described in the Patent, therefore this was not considered to be a selection patent.

Following the finding that this was not a selection patent, the Court held the patent to be anticipated and obvious.

Upcoming SCC Decision 

The Supreme Court decision in Canadian Broadcasting Corporation / Société Radio-Canada v. SODRAC 2003 Inc. et al. (35918) is expected this Thursday, November 26, 2015. This is an appeal from Canadian Broadcasting Corporation v. Sodrac 2003 Inc., 2014 FCA 84, which we

originally summarized in our weekly bulletin of April 8, 2014.