Mumbai: Ranbaxy Laboratories Ltd reported a mixed win with the US Court of Appeals for the Federal Circuit (CAFC) handing down a judgement invalidating one of Pfizer's atorvastatin patents while validating its claim of patent infringement by the company in another case.
The court rejected the view that Ranbaxy's product infringed Pfizer's atorvastatin patents - US patent No. 5,273,995 ('995) - and invalidating a Delaware district court's judgement in that regard. However, the CAFC accepted the portion of the district court's judgement, which held that the company's product infringed Pfizer's US patent No. 4,681,893 ('893).
Atorvastatin is a cholesterol-lowering drug, marketed by Pfizer as `Lipitor', and is the largest-selling drug in the world with estimated annual US sales of $48.5 billion.
Subject to the appellate process and market authorisation by the US FDA, Ranbaxy now can advance the launch date of its product by one year to March 2010, with 180-day exclusivity in the US market.
"We are pleased by the courts decision on the '995 patent and are evaluating our options with respect to the '893 patent." said Jay R Deshmukh, senior vice president, global intellectual property for the company.
The ruling followed a hearing of appeals in the US CAFC, which started in May this year.
Ranbaxy can now launch Lipitor alternative Enantiomer for which it has a patent in the US. Its Enantiomer patent will expire in 2011. Pfizer's basic patent on Lipitor expires in 2010.
With global sales of $1,178 million and representative offices across the globe, with a presence in 23 of the top 25 markets, Ranbaxy is the largest pharmaceutical company in India. Overseas markets account for 76 per cent of the company's sales and its US sales topped $328 million last year.
Pfizer Inc, founded in 1849, is a global leader in research, discovery and development of new medicines - for prevention, wellness and treatment - and follows high-quality manufacturing practices. With a team of over 12,000 researchers globally, Pfizer works in partnership with governments, individuals, and other payers for healthcare and drug delivery.