Intellectual Property
UK High Court upholds Pfizer’s patent in part, preventing Indian company from introducing generic version of drug

The High Court of UK has permitted Ranbaxy Laboratories to appeal against its ruling of October 12, 2005 which held that Ranbaxy’s product atorvastatin would infringe Pfizer’s patent. Atorvastatin is a cholesterol-lowering drug marketed by Pfizer as Lipitor. The ruling is the result of a lawsuit brought by Ranbaxy to challenge two patents protecting Lipitor. If the appeal does not succeed, Ranbaxy would fail in its attempts to introduce a generic version of atorvastatin in the United Kingdom before the expiration of Pfizer’s patent in November 2011.

The court, however, ruled that a second patent covering the calcium salt of atorvastatin is, however, invalid. Pfizer said that it will appeal the decision on this patent, which expires in July 2010.

Lipitor was originally developed by Warner Lambert, which company was acquired by Pfizer. Lipitor’s worldwide sales in 2004 totalled over US$ 10 billion. Since it was introduced in the United States in 1997, Lipitor has become the world's most prescribed cholesterol-lowering therapy. More than 18 million people in the United States have been prescribed Lipitor and it is approved in more than 70 countries. Clinical research has also shown that Lipitor provides unique benefits that go beyond LDL cholesterol reduction, such as reducing cardiovascular events and halting the progression of atherosclerosis, or hardening of the arteries.

Pfizer claimed that while it makes significant investments in research and development, generic companies such as Ranbaxy focus on finding loopholes in intellectual property laws to manufacture copycat versions of its medicines. Ranbaxy, on the other hand, states that having been able to invalidate one of the two key Pfizer atorvastatin patents in the UK, it was encouraged to have been granted the opportunity to make its case on the other patent before the UK Court of Appeal, and that it remains committed to bring an affordable generic formulation of atorvastatin to the UK’s National Health Service.

Ranbaxy Laboratories, headquartered in India, is an integrated, research based, international pharmaceutical company producing a wide range of generic medicines. It exports to over 100 countries, has ground presence in 46 countries and manufacturing operations in 7 countries. Ranbaxy is ranked amongst the top ten generic companies worldwide. Its global sales for the year 2004 stood at US$ 1.1 billion. Overseas markets accounted for 78% of global sales. The US alone accounted for 36% of global sales.

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