Pfizer gains six months patent life for Lipitor on pediatric data; Bayer Yasmin patent scotched

US drugs behemoth Pfizer (NYSE: PFE) could extend the European patent term for its al-time blockbuster cholesterol lowerer Lipitor (atorvastatin) as a result of pediatric studies, which could mean an additional $800 million in sales for the drugmaker, reports the UK’s Financial Times.

The company has sought a supplementary protection certificate in most European Union countries, extending its exclusivity until May 2012. Pfizer plans to launch a chewable grape-flavored low-dose version of Lipitor, which last year generated global sales of around $11 billion, in the European Union in November, at the time its patents expire and the product would normally be exposed to generic competition.

The action will spark fresh debate about the EU’s pediatric regulations, which were introduced in 2007 with the offer of extended exclusivity as a financial incentive to encourage drug companies to ensure they expanded testing of experimental medicines to include children, the FT’s Andrew Jack warns.