Atorvastatin Patent Settlement Agreement Opens the Way for Generic Market Entry in Canada

Pfizer Inc (Pfizer) and Ranbaxy Laboratories Ltd (Ranbaxy) have entered into a patent settlement agreement that will end the majority of the worldwide patent litigation between the companies over the hyperlipidaemic drug atorvastatin (LIPITOR), litigation which has continued since 2003. Under the agreement, Ranbaxy will delay its launch of generic atorvastatin in the US until November 30, 2011, more than five months after the expiry of the atorvastatin enantiomer patent. In exchange, the agreement enables Ranbaxy to launch its generic atorvastatin in the US prior to the expiry of the atorvastatin crystalline and amorphous patents, which extend out to 2017. It also clears the launch in seven other markets, including Canada, at other dates, some of which are prior to expiration of the enantiomer patent. According to Ranbaxy's CEO Malvinder Singh, the agreement will allow Ranbaxy to launch generic atorvastatin in Canada "this calendar year". The finality of the deal is uncertain, as the US Federal Trade Commission (FTC) has stated that it will "take a very close look at [the deal]". The FTC has challenged a number of similar patent settlement agreements in the past, including agreements involving Sanofi-Aventis and Bristol-Myers Squibb's Plavix, and Cephalon Inc's Provigil (See E-TIPS®, "Questions Remain Over the Legality of Patent Settlement Agreements", Vol 5, No 5, August 30, 2006; and "Plavix Ruling is Good News for Innovator Drug Companies", Vol 5, No 6, September 13, 2006). For a copy of the Ranbaxy press release, see: http://www.ranbaxy.com/news/newsdisp.aspx?cp=890&flag=LN For a copy of the Pfizer press release, see: http://tinyurl.com/5sm5kz For commentary on the settlement agreement, visit: http://tinyurl.com/6prstf; and http://economictimes.indiatimes.com/articleshow/msid-3143801,prtpage-1.cms Summary by: Michael Migus