Friday 19 December, 2008

Atorvastatin Hemicalcium (Lipitor): Pfizer sued Apotex for filing ANDA with Para IV certification

Innovator Pfizer sued Canadian pharma giant Apotex (as per complaint filed on December, 17, 2008 in federal court in Wilmington, Delaware) for filing ANDA with Para IV certification to United States Food and Drug Administration (USFDA) to import and sell 10, 20, 40 and 80 mg/tablet dosage strengths of the Atorvastatin Hemicalcium, in violation of a enantiomer patent listed in Orange Book.

Apotex has filed Para IV against following Orange Book listed patents:
US4681893 (Expiry: 24 March, 2010)- Covers racemic form of Atorvastatin generically.
Litigation update: Ranbaxy was unsuccessful in invalidating the said patent in US Court of Appeals For Federal Circuit (CAFC) in 2006. Further, during recent reexamination of ‘893 by USPTO on request from a Law firm representing Ranbaxy, the USPTO as per their May 2008 decision upheld the validity of ‘893 patent. Earlier, Teva and cobalt has filed Para III against this patent. Probably, Apotex has also filed Para III against said patent
US5273995 (Expiry: 28th June, 2011) -Covers Atorvastatin enantiomer and salts as Product (Specifically)
Litigation update:
1. The patent was invalidated by CAFC in August 2006

2. Pfizer applied for reissue of the patent to USPTO, which was rejected twice by USPTO. On April 2008, USPTO again rejected Pfizer request

3. In Caudet litigation Pfizer stated that it had issued ‘covenant not to sue’ (will not sue Ranbaxy for the infringement of said patent) to Ranbaxy, in case ‘995 patent is reissued to Pfizer

4. Innovator Pfizer sued Cobalt and Teva for the infringement of ‘995 patent

5. On 15 May 2008, Court entered Judgment in favor of Pfizer and delayed Cobalt ANDA approval till expiry of ‘995 patent
6. On Dec 17, 2008, Innovator sued Apotex for the infringement of ‘995 patent

US5686104 (Expiry: 11th May, 2015)- Covers stable Formulation
Litigation update: Pfizer has sued cobalt but not asserted patent during trial

US5969156 (Expiry: 8th June, 2017)- Polymorph (Form I, II and IV) Litigation update: Pfizer has sued cobalt but not asserted patent during trial
US6126971 (Expiry: 19th July, 2013)- Covers Formulation Litigation update: Pfizer has sued cobalt but not asserted patent during trial


Further, Pfizer has sued Apotex for the infringement of ‘995 patent only and have not asserted other patents in the complaint

Earlier, Innovator had sued Teva, Cobalt and Ranbaxy for this product, however, Cobalt and Ranbaxy have setlled there pending litigation with innovator.
Furthermore, Ranbaxy settled with innovator Pfizer on Lipitor and Caudet on June 18, 2008. Pharma giant Pfizer and Ranbaxy agreed to keep generic version of the cholesterol lowering drug Atorvastatin off the U.S. market with an extra 20 months exclusivity for Pfizer. Under the terms of the agreement, Ranbaxy will have a license to sell generic versions of Atorvastatin and Caudet (Atorvastatin-Amlodipine Besylate) in the United States effective Nov. 30, 2011. Since, Ranbaxy has first to file 180 days exclusivity for this product, accordingly, other generic players will enter into the market from June, 2012 onwards.
Also, Apotex and Pfizer were in litigation w.r.t Lipitor in Canada, however, in August, 2008, both settled there pending patent litigation in Canada. (As reported earlier by IPPharmdoc Here)
Link to Bloomberg news

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