Supreme Court of Canada to Hear Appeal on Sufficiency of Disclosure in Pharma Patent Case

The Supreme Court of Canada (SCC) has granted leave to appeal from a decision of the Federal Court of Appeal (FCA) in Novopharm Limited v Pfizer Canada Inc et al [2010] FCA 242, dismissing an appeal from a Federal Court decision regarding the issue of sufficiency of disclosure in a pharmaceutical patent case. In 2009, the Federal Court ruled that the Minister of Health was prohibited from issuing a Notice of Compliance to Teva Canada Limited, formerly Novopharm Limited (Teva), for a generic version of sildenafil citrate until the expiry of Pfizer’s Canadian Patent No 2,163,446 (‘446 Patent). Pfizer markets sildenafil citrate under the brand name “Viagra”. Teva alleged that the ‘446 Patent was invalid for reasons of obviousness, insufficient disclosure, and lack of utility. The Federal Court ruled that the ‘446 Patent was not obvious, sufficiently disclosed the invention and did not lack utility. Teva appealed the issues of insufficient disclosure and lack of utility. In 2010, the FCA upheld the lower court decision. Teva further appealed the issue of insufficient disclosure to the SCC. Regarding the issue of insufficient disclosure, Teva asserted that Pfizer failed to provide sufficient disclosure to identify sildenafil in the ‘446 Patent as the only effective compound for treatment of erectile dysfunction (ED) from 260 quintillion compounds said to be useful for the treatment of ED. For the brief note on the leave-to-appeal decision by a three-judge panel of the Supreme Court of Canada, follow this link. Summary by: Lauren Lodenquai