Innovator Pfizer has initiated patent infringement proceedings against generic player Sandoz for filing ANDA with Para IV certification against Orange Book listed patents on Atorvastatin + Amlodipine Besylate (Caudet) Tablets (80+5 mg and 80+10 mg tablets) in the U.S. District Court for the District of Delaware.
Earlier, the generic player Sandoz send Para IV notice letter to innovator on August 24, 2009, subsequently, innovator sued generic player on Oct 6, 2009 in U.S. District Court for the District of Delaware
Following patents are listed in Orange Book for Atorvastatin + Amlodipine Besylate (Caudet) Tablets:
US4681893 (Expiry: 24 March, 2010)- Covers racemic form of Atorvastatin generically.
USRE40667/ US5273995 (Expiry: 28th June, 2011)- Covers Atorvastatin enantiomer and salts as Product (Specifically)
US5686104 (Expiry: 11th May, 2015)- Covers stable Formulation
US5969156 (Expiry: 8th June, 2017)- Polymorph (Form I, II and IV)
US6126971 (Expiry: 19th July, 2013)- Covers stable formulation
US6455574 (Expiry: Aug 11, 2018)- Which covers combination of Atorvastatin + Amlodipine
As per complaint, innovator has sued generic player for the infringement of ‘574 patent.
Probably, Sandoz has filed Para IV with invalidation grounds against ‘574 patent.
Atorvastatin + Amlodipine Besylate (caudet) combination is indicated for the treatment of hypertension and hyperlipidemia
1 comment:
The use of the individual drugs for treatment of hypertension and hyperlipidemia were known and it would have been obvious for a person skilled in the art(KSR vs teleflex) to combine them for the uses, for which they were already known .............no new use, it would be interesting to study the course of litigation and opinions for the basis.
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