Plavix patent from 2008 SCC Sanofi judgment now invalidated

In 2008 the Supreme Court of Canada handed down one of the most significant patent law judgments of the past decade in Apotex v. Sanofi, 2008 SCC 61. That judgment set the modern tests for evaluating novelty and obviousness in Canadian patent law. The SCC case arose under the Notice of Compliance procedure of the PMNOC Regulations, and in the end Sanofi’s patent no. 1,336,777 (the ‘777 Patent) survived all the allegations of invalidity from Apotex.

Now the same patent has been invalidated by the Federal Court after a full trial for infringement and invalidity in Sanofi v. Apotex, 2011 FC 1486.

Following in line with a string of recent Federal Court cases, the ‘777 Patent (a selection patent) was invalidated for lack of utility because the description failed to disclose the factual basis and reasoning that underlay the inventors’ sound prediction of utility.  Boivin J. found that the inventors had a perfectly good basis for soundly predicting that the compound would be useful for the purpose envisioned, but the text of the patent fails to detail the full factual background and thinking that justified their prediction.  In this case, the utility promised by the patent was that the compound would be effective for inhibiting platelet aggregation in humans.

Boivin J. undertakes an exhaustive and richly detailed analysis of the science and contextual history of the development and testing of clopidogrel bisulfate and earlier candidates, which results in a rather lengthy 271 page set of reasons.  Once the issue of disclosure of the sound prediction is reached, he relies upon Hughes J.’s judgment in Eli Lilly v. Apotex, 2008 FC 142, and the Federal Court of Appeal cases that have followed it.

Boivin J. also found the ‘777 Patent invalid for obviousness under the “obvious to try” test.

The ‘777 Patent, even if found valid on appeal, will expire in August this year.

Comments are closed.