By Susan Decker/Bloomberg
Washington: Pfizer Inc., the world’s biggest drugmaker, sued Ranbaxy Laboratories Ltd to block a generic version of the cholesterol and blood pressure medicine Caduet.
Ranbaxy, India’s biggest drugmaker, is seeking US Food and Drug administration approval to sell a low-cost version of the medicine. In a 9 March complaint in federal court in Wilmington, Delaware, Pfizer said that the generic drug would infringe two patents that expire in 2010 and 2018.
Caduet received US approval for the drug in January 2004 and sales of the drug quadrupled to $370 million (Rs1,631 crore) last year. It combines Pfizer’s blood pressure drug Norvasc with the cholesterol treatment Lipitor, the world’s best-selling medicine. Pfizer is promoting the drug since Norvasc is losing patent protection in September and Lipitor in 2010.
“This product presents a significant commercial opportunity,” Ranbaxy spokesman Charles Caprariello said. The company, based in Gurgaon, said it may be the first to apply to sell generic Caduet, which would give it exclusive rights to sell the copycat version for six months.
The patent expiring in 2010 covers atorvastatin, Lipitor’s key ingredient. Ranbaxy lost a lawsuit in which it tried to invalidate the patent or shorten its life to sell a generic version of Lipitor. The patent, first set to expire a year ago, was extended to compensate Pfizer for time spent getting regulatory approval for the drug.
Barred From Attacking
As a result of that loss, Ranbaxy is barred “from attacking the validity or enforceability of the patent term extension” and “the infringement, validity and enforceability” of the patent itself, Pfizer said in the complaint.
The other patent, issued in 2002, is for the combination of atorvastatin and amlodipine besylate, the active ingredient of Norvasc. Pfizer seeks a court ruling barring approval until the expiration of both patents.
“A key component of Ranbaxy’s overall business strategy in the US health care market is to challenge product patents based on invalidity, non-infringement or otherwise,” Caprariello said.
Lipitor generated $12.9 billion in sales last year, and Norvasc had $4.9 billion in revenue.