Pfizer files patent-infringement suits against Lupin, four others
06 Mar 2013
US drug giant Pfizer Inc yesterday filed patent-infringement lawsuits against five generic-drug makers including India's Lupin Pharmaceuticals in order to prevent them from selling a generic version of its anti-inflammatory painkiller drug Celebrex until December 2015.
The patent for Celebrex is to expire on 30 May 2014, but the US patent office has now extended the validity of patent for celecoxib, the active ingredient in Celebrex by 18 months to 2 December 2015, including six months of pediatric exclusivity.
The New York-based company said that the US Patent & Trademark Office has granted what is called a "reissue patent" that replaces an older patent.
Israeli generic drug manufacturer Teva Pharmaceuticals had challenged the celecoxib patent in 2008, but Pfizer won the case and prevented Teva from entering the market until May 2014.
Pfizer has now filed a suit in the federal court in Norfolk, Virginia against Teva Pharmaceuticals, Mylan Pharmaceuticals, Lupin's US subsidiary Lupin Pharmaceuticals USA Inc, Apotex Inc and Watson Laboratories Inc for infringement of the reissued patent. Watson has now became Actavis, whom it acquired in April 2012.
Each of these generic drug companies had previously filed an abbreviated new drug application with the US Food and Drug Administration (FDA), seeking approval to market a generic form of celecoxib in the US beginning in May 2014.