Amgen Canada Inc. v. Mylan Pharmaceuticals ULC., 2015 FC 1244 (Phelan J.)
November 3, 2015
Andrew Shaughnessy, Andrew Bernstein, and Alexandra Peterson of Torys LLP, for Amgen Canada Inc. (Applicant)
J. Bradley White, Vincent M. de Grandpré, and Geoffrey Langen of Osler, Hoskin & Harcourt LLP, for Mylan Pharmaceuticals ULC (Respondent)
In this judgment, the Court dismissed an application by Amgen for an order prohibiting the Minister of Health from issuing a Notice of Compliance to Mylan for Mylan’s cinacalcet product (“Mylan-Cinacalcet”), in view of Canadian Patent No. 2,202,879 (the “‘879 Patent”) to Amgen. In its Notice of Allegation, Mylan alleged that the ‘879 Patent was invalid, and that in any event Mylan-Cinacalcet would not infringe the ‘879 Patent. To avoid any issue of mootness, and the possibility that section 8 damages would not be available, the parties requested that the Court render its judgment before the expiry of the ‘879 Patent. The Court issued its judgment dismissing Amgen’s application on October 19, 2015 – four days before the expiry of the ‘879 Patent.
The claim at issue in the ‘879 Patent was Claim 5, which was related to cinacalcet and its pharmaceutically acceptable salts. Mylan alleged that Claim 5 was anticipated, obvious or invalid for double patenting at least in view of Canadian Patent No. 2,115,828 (the “‘828 Patent”). The ‘828 Patent claimed a genus of compounds which included cinacalcet. Both the ‘828 and ‘879 patents were directed to compounds that mimicked the effect of extracellular calcium at the parathyroid calcium receptor. Amgen, however, argued that the ‘879 Patent was a selection patent based on the theory that cinacalcet had an unexpected utility over the genus compounds of the ‘828 Patent as a CaSR modulator.
The Court rejected Amgen’s argument, and found that the ‘879 Patent was not a selection patent. Particularly the Court found that the ‘879 Patent had “no substantial and unexpected advantage, and no advantage was even described in the Patent”. In reaching this conclusion, the Court noted that: (i) the mechanism by which cinacalcet worked, and the target upon which cinacalcet acted, were the same as those described in ‘828 Patent; (ii) 47 of the 61 compounds listed in Table 1a of the ‘879 Patent had a greater potency than cinacalcet; and (ii) cinacalcet’s potency was within the range described in the ‘828 Patent.
Having found that the ‘879 Patent was not a selection patent, the Court found that the ‘828 Patent anticipated the ‘879 Patent. Amgen argued that the ‘828 Patent should not be regarded as prior art since it issued after the ‘879 Patent despite being filed first. However, the Court noted that “Amgen erroneously conflate[d] the publication date with the issue date to contend that [the ‘828 Patent was] not prior art”.
In addition, the Court found that the ‘879 Patent was obvious in view of the ‘828 Patent and WO 959 application. Cinacalcet (as recited in Claim 5 of the ‘879 Patent) was not a selection in view of the prior art. Since the prior art disclosed a genus which included cinacalcet, and the clinical structure and function of cinacalcet fell within the disclosure of the prior art, the Court opined that Claim 5 of the ‘879 Patent “merely gave further specificity” to what was already in the ‘828 Patent and WO 959 application. According to the Court, “if there [was] a difference between the state of the art and Claim 5, it was obvious to try to achieve the invention covered by Claim 5”.
Because the Court found that claim 5 of the ‘879 Patent did not recite a selection and was both anticipated and obvious in view of the prior art, there was no need to address Mylan’s further allegations of double-patenting. The application to prohibit the Minister of Health from issuing a Notice of Compliance was dismissed with costs.
By: Marc Crandall and Pablo Tseng, Gowling Lafleur Henderson LLP