Pfizer sued Ranbaxy for the infringement of two process patents (process patents are not listed in Orange book) on Lipitor (Atorvastatin) and Caduet (Atorvastatin and Amlodipine combination). The suit filed by Pfizer in the U. S District Court of Wilmington, Delaware claims that Ranbaxy's generic version of Lipitor would infringe two patents covering the process for making amorphous Atorvastatin, the active ingredient in the cholesterol lowering drug. Following are the process patents
US6087511- which covers a process for the preparation of amorphous Atorvastatin where crystalline Form I of Atorvastatin is dissolved in a non-hydroxylic solvent and after removal of the solvent affords amorphous Atorvastatin
US6274740- which covers a process for the preparation of amorphous Atorvastatin or hydrates thereof which comprises: (a) dissolving crystalline Form I Atorvastatin in a non-hydroxylic solvent at a concentration of about 25% to about 40%; and (b) removing the solvent by drying to afford said amorphous atorvastatin or hydrates thereof
The two patents will expire in July 2016. Pfizer has asked for a court order that would ban Ranbaxy from making, selling or importing generic Lipitor until that time. Separately, Pfizer filed a suit against Ranbaxy citing the same patents in order to extend the exclusivity of Caduet by a similar amount of time. Lipitor is the world's best-selling medicine and Pfizer's top seller. It clocked sales of US$12.7 bn in 2007, about 26% of Pfizer's total revenues, but faces generic competition in March 2010. Caduet had 2007 sales of US$568mn. Ranbaxy already is banned from selling generic versions of Lipitor and Caduet until product patent 893’ expires in 2010. The new lawsuits seek to extend that ban another six years. The innovator has many process, derivative and intermediate patents covering Atorvastatin which innovator can use to block generic entry.
US6087511- which covers a process for the preparation of amorphous Atorvastatin where crystalline Form I of Atorvastatin is dissolved in a non-hydroxylic solvent and after removal of the solvent affords amorphous Atorvastatin
US6274740- which covers a process for the preparation of amorphous Atorvastatin or hydrates thereof which comprises: (a) dissolving crystalline Form I Atorvastatin in a non-hydroxylic solvent at a concentration of about 25% to about 40%; and (b) removing the solvent by drying to afford said amorphous atorvastatin or hydrates thereof
The two patents will expire in July 2016. Pfizer has asked for a court order that would ban Ranbaxy from making, selling or importing generic Lipitor until that time. Separately, Pfizer filed a suit against Ranbaxy citing the same patents in order to extend the exclusivity of Caduet by a similar amount of time. Lipitor is the world's best-selling medicine and Pfizer's top seller. It clocked sales of US$12.7 bn in 2007, about 26% of Pfizer's total revenues, but faces generic competition in March 2010. Caduet had 2007 sales of US$568mn. Ranbaxy already is banned from selling generic versions of Lipitor and Caduet until product patent 893’ expires in 2010. The new lawsuits seek to extend that ban another six years. The innovator has many process, derivative and intermediate patents covering Atorvastatin which innovator can use to block generic entry.
Earlier On March 23, Pfizer announced that a Canadian court has ruled in its favour upholding a patent for Atorvastatin, a molecule for making Lipitor, thereby preventing Ranbaxy from launching a generic version until 2010. The Federal Court of Appeal of Canada has reversed a lower court ruling that held that Pfizer's enantiomer patent could not block generic manufacturer Ranbaxy from obtaining approval for a cheaper copy of Lipitor. In canada it was also found that Ranbaxy's Amorphous API will infringe Pfizers crystalline polymorphic forms patent as Ranbaxy was using crystalline form in their process of manufacturing amorphous Atorvastatin (Link to bloomberg news) (Link to economictimes)
