As speculated by IP Pharma Doc that Pfizer is interested in rest of the shares of Ranabaxy to keep off generic challenge on Atorvastatin and on similar line 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, a move that may generate billion dollars for the pfizer. Ranbaxy would have enter into the market on March 25, 2010, when the main patent ('893)expires, while Pfizer was using litigation either on Orange book patents or process patents covering amorphous form of Atorvastatin to delay generic competition until 2016. 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. Ranbaxy will also have a license to sell Atorvastatin in other countries, including: Canada, Belgium, Netherlands, Germany, Sweden, Italy and Australia. Ranbaxy and Pfizer have also resolved their disputes regarding Atorvastatin in Malaysia, Brunei, Peru and Vietnam. The Atorvastatin patents involved in this agreement are 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. Futrther, during recent reexamination of ‘893 by USPTO on request from a Lawfirm representing Ranbaxy, the USPTO as per their May 2008 decision upheld the validity of ‘893 patent. Teva and cobalt has filed Para III against this patent
US5273995 (Expiry: 28th June, 2011) -Covers Atorvastatin enatiomer as Product (Specific)
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 has issued convenant 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
US5686104 (Expiry: 11th May, 2015) Covers 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
US6455574 (Expiry: 11 August, 2018): Covers Formulation (Combination of Atorvastatin Form I and Amlodipine Besylate)
Litigation between Ranbaxy and Pfizer relating to Lipitor will continue in five other European countries -- Finland, Spain, Portugal, Denmark and Romania.
Summary of patent litigation settlement
Ranbaxy would have entered the market on 25 March, 2010 with its own generic version of Lipitor as Pfizer has issued convenant not to sue to Ranbaxy on ‘995 patent, but it choose to settled with innovator.The said settlement has delayed Ranbaxy’s entry into the generic market till 30 November, 2011. Now other generic player can market their product after the expiry of Ranabxy’s First to File 180 day’s exclusivity, which will expire on 1 June, 2012. The deal is a setback for other generic players who were expecting their product launch by September 26, 2010. Now the US Federal Trade Commission (FTC) will review the deal. There is a possibility that generic players like Cobalt and Teva would oppose the deal and FTC can consider the public harm by 20 months delayed availability of generic Lipitor to patients
Further, there are many stories after the settlement that what Ranbaxy gained from the settlement? Although some experts have speculated that possibally Ranbaxy would launch its product with crystalline form of Atorvastatin. Ranbaxy has filed its ANDA with amorphous form 27 of Atorvastatin (there are 2 amorphous forms of Atorvastatin form 23 which Pfizer earlier used for development and even conducted clinical trials and Form 27 which is more compact and most generic players have developed their formulation using Form 27). As per citizen petition submitted by Pfizer in 20o5, Pfizer showed that amorphous form degrade quickly in comparison to crystalline and requested USFDA to not approve any amorphous formulation of Atorvastatin.
Link to New york times article on settlement details.
Also, Mint has reported on this settlement here
