Amgen Canada Inc. v. Mylan Pharmaceuticals ULC

In Amgen Canada Inc. v. Mylan Pharmaceuticals ULC, 2015 FC 1244, the Federal Court dismissed an application brought by Amgen Canada Inc. under the Patented Medicines (Notice of Compliance) Regulations (the “Regulations”) in relation to the drug SENSIPAR (cinacalcet). Amgen was seeking to prohibit the Minister of Health from issuing market authorization to Mylan Pharmaceuticals ULC for its generic version of SENSIPAR (cinacalcet) until the expiry of Canadian Patent No. 2,202,879 (the “879 Patent”).  The drug cinacalcet is used to treat primary and secondary hyperparathyroidism. 

This was the first decision in Canada in relation to cinacalcet, and is a rare instance of the Federal Court invalidating a Canadian patent covering an allegedly new chemical compound on prior art grounds. This decision is also significant because it reaffirms previous jurisprudence that verifying the predicted properties of previously disclosed compounds is undeserving of a patent.  The 879 Patent disclosed and claimed a very large number of compounds, including the cinacalcet molecule.  The only claim at issue, claim 5 of the 879 Patent, was directed to only cinacalcet. Mylan alleged that claim 5 was invalid for anticipation, obviousness and double patenting in light of a prior art patent (the “828 Patent”), which disclosed a large class of compounds that included cinacalcet among trillions of other molecules.  Amgen’s response was that cinacalcet was a valid selection invention over the class of compounds of the 828 Patent, because cinacalcet had unexpected utility over these prior art compounds. 

The Court held that neither claim 5, nor the 879 Patent as a whole, was a selection invention.  In the Court’s conclusion, Amgen’s evidence and the 879 Patent failed to establish that cinacalcet had any relevant substantial and unexpected advantage.  This finding reaffirmed the principle that it is not an invention to make and test compounds that were previously disclosed, even as part of an enormous class, if the selected species do not have unique and unexpected properties.

On substantially similar grounds, the Court also found that Mylan’s allegations that claim 5 was invalid for anticipation, obviousness and double patenting were justified.  The Court accepted Mylan’s evidence that no inventive step was required to arrive at cinacalcet from the 828 Patent, because doing so only involved the mechanical testing of molecules by well-known techniques.

Bradley White, Vincent de Grandpré and Geoffrey Langen of Osler, Hoskin & Harcourt LLP represented Mylan Pharmaceuticals ULC.

Andrew Shaughnessy, Andrew Bernstein and Alexandra Peterson of Torys LLP represented Amgen Canada Inc.