New Delhi:Drug maker Dr Reddy’s Laboratories will contest the patent infringement case filed against it by global pharmaceutical giant Pfizer over its cholesterol lowering drug ‘atorvastatin’, said a company spokesperson on Wednesday.
On 27 December last year, Pfizer had moved the US District Court of Delaware against Dr Reddy’s Laboratories Ltd and Dr Reddy’s Laboratories Inc for infringement of the US based company’s crystalline atorvastatin patent.
“We had anticipated that Pfizer would be filing suit on our 80 mg ANDA filing of Atorvastatin. If you recall Dr Reddy’s had previously submitted a filing for all other strengths of Atorvastatin for which Pfizer has already filed suit against Dr Reddy’s,” a spokesperson for Dr Reddy’s Laboratories (DRL) said.
DRL had filed an abbreviated new drug application (ANDA) with the US Food and Drug Administration seeking approval to market an 80 mg dosage strength of atorvastatin calcium.
Already, Pfizer and DRL are involved in patent infringement cases over 10mg, 20mg and 40mg strengths of atorvastatin calcium, which the US drug major sells under the Lipitor brand.
According to Pfizer, the Indian firm’s plans to launch a generic version of the world’s best-selling medicine will infringe upon its patent.
“The case is expected to be consolidated with Pfizer’s pending action against DRL in the same court involving the same patent and DRL’s previously filed ANDA seeking to market 10, 20, and 40 mg dosage strengths of atorvastatin calcium,” a Pfizer spokesperson said.
Pfizer’s patent on Lipitor which gets about $12billions in annual sales for Pfizer expires in July 2016 but it has pediatric exclusivity till January 2017.
In June 2008, Pfizer settled for an out-of-court agreement with Daiichi Sankyo-owned Ranbaxy, allowing it to sell a low-priced version of the medicine from November 2011, when one of its key patents on the same drug expires.
Ranbaxy now holds a six-month marketing exclusivity for its low-cost version of the product, as it was the first generic drug maker to challenge Pfizer’s patent for Lipitor.
DRL shares were trading at Rs 1,708.35 on Bombay Stock Exchange in the late afternoon trade, up 0.84 per cent from its previous close.