On November 3, 2015, Justice Phelan of the Federal Court of Canada issued his judgment in Amgen Canada Inc v Mylan Pharmaceutical ULC, 2015 FC 1244, dismissing Amgen’s application for an order prohibiting the Minister of Health from issuing a Notice of Compliance (NOC) to Mylan for its generic cinacalcet products (Amgen’s SENSIPAR®). Justice Phelan found that Amgen’s Canadian Patent No.  2,202,879 (the ‘879 patent), claiming the compound cinacalcet, was invalid on the grounds of being an invalid selection patent, anticipation and obviousness.

Phelan J rejected Amgen’s argument that cinacalcet was a selection invention over the prior art genus.  He noted that the ‘879 patent identified cinacalcet but did not identify it as the most active compound or as having special properties.  He held that Amgen had failed to establish a substantial and unexpected advantage of cinacalcet. The mechanism by which cinacalcet works was disclosed in the prior art and cinacalcet’s potency also fell within the range disclosed in the prior art.

Justice Phelan concluded that claim 5 for cinacalcet in the ‘879 patent was anticipated by the same prior art genus, noting that testing 200 molecules disclosed in the prior art to arrive at cinacalcet was simply a mechanical process.

Lastly, Justice Phelan held that claim 5 of the ‘879 patent was obvious.  He determined that the inventive concept of claim 5 is cinacalcet per se, and not cinacalcet’s unexpected activity as a modulator of the calcium-sensing receptor, because its activity had been described in the prior art genus.  He held that there was no difference between the inventive concept and the prior art and that at best, claim 5 merely gave further specificity.

Mylan received an NOC for its cinacalcet products on October 19, 2015.  Amgen did not file an appeal to the Federal Court of Appeal.

E-TIPS® ISSUE

15 12 02

Disclaimer: This Newsletter is intended to provide readers with general information on legal developments in the areas of e-commerce, information technology and intellectual property. It is not intended to be a complete statement of the law, nor is it intended to provide legal advice. No person should act or rely upon the information contained in this newsletter without seeking legal advice.

E-TIPS is a registered trade-mark of Deeth Williams Wall LLP.