Atorvastatin (Lipitor): Pfizer Sues Matrix (Mylan) for filing ANDA with Paragraph IV certification

Pharma giant Pfizer has sued generic player Matrix (Mylan) for filing ANDA No. 91-226 with Paragraph IV certification against Orange Book listed patents for Atorvastatin (lipitor) instant release tablet formulation.

In the complaint filed in United States District Court For the District Of Delaware on June 15, 2008, innovator has requested court to block generic version till the expiry of crystalline polymorphic form patent.

In the complaint, Pfizer has alleged infringement of following patents under 35 USC 271:

US5969156 (Expiry: Jan 8, 2017): Which covers crystalline Polymorphic Form I, II and IV

US6087511 (Expiry: July 16, 2016): 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 (Expiry: July 16, 2016): 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

As per complaint, Matrix (Mylan) has filed ANDA with amorphous form of Atorvastatin and notified innovator about ANDA filing by Paragraph IV notice letter dated May 1, 2009.

Innovator in it's complaint has alleged that an intermediate used by generic player for the synthesis of Atorvastatin is crystalline in nature, which will infriges pfizer's crystalline polymorph patent '156 and amorphous process patent '740 and '511.

The disputed patent ‘156 is Orange Book listed patent, however, ‘740 and ‘511 are process patents and are not listed in Orange Book.

Para IV filers on this product: Ranbaxy (First para IV filer), Teva, Cobalt, Apotex and Matrix (Mylan)

Generic player in litigation: Teva , Apotex and Matrix (Mylan)

Settlement: Ranbaxy has settled its pending patent litigation on Lipitor and Caudet on June 18, 2008 and will launch its generic product in November, 2011