Merck-Frosst-Schering Pharma GP v. Canada (Health) (2010 FC 933)


PMNOC proceedings, Ezetimibe, September 17, 2010

Merck-Frosst (“Merck”) applied for an order prohibiting the Minister of Health from issuing a Notice of Compliance to Teva for its generic version of Ezetimibe. Teva’s Notice of Allegation alleged that claim 21 of Merck’s patent (the ‘149 patent) was obvious in light of an earlier prior art patent filed by Merck (the ‘007 patent).

Mr. Justice Phelan held that the obviousness allegation was unjustified. He did not accept the evidence of Teva’s expert: that a person of ordinary skill in the art would look at the ‘007 patent and immediately, without any ingenuity, undertake a multistep development process and arrive at the disclosure of the ‘149 patent. The Judge found Teva’s multistep process to require a significant degree of ingenuity and inventiveness. He also considered it likely that the multistep process was created as a result of a hindsight analysis and that it did not reflect the realities of commercial drug development. The Judge was particularly influenced by the amount of time, money and effort Merck spent in developing the Ezetimibe compound (which was covered by claim 21 of the ‘149 patent) and contrasted this to the relatively simple and straightforward hypothetical process proposed by Teva.