Lipitor patents upheld in US
A federal court in Delaware, US, has ruled in favour of Pfizer in its dispute with Ranbaxy over two patents on its cholesterol-lowering drug Lipitor, the biggest selling prescription drug in the world.
A federal court in Delaware, US, has ruled in favour of Pfizer in its dispute with Ranbaxy over two patents on its cholesterol-lowering drug Lipitor, the biggest selling prescription drug in the world.
The patents concern atorvastatin, the active ingredient in Lipitor, and were deemed to be both valid and, consequently, infringed upon by Ranbaxy's generic version. They are Lipitor's basic patent (US Patent No. 4,681,893), which expires in March 2010, and the pat-ent covering the calcium salt used in Lipitor (US Patent No. 5,273,995), which expires in June 2011.
As a result of the decision, Pfizer is entitled to a permanent injunction prohibiting Ranbaxy from obtaining approval for, or marketing its, generic version of atorvastatin until 2011.
The decision follows a hearing on 12 October 2005 in the UK's High Court of Justice, which upheld the basic patent on the US$11bn-a-year (£6bn) medicine that expires in November 2011, but ruled a more specific patent, concerning the calcium salt patent, terminating in July 2010 to be invalid. The ruling prevents Ranbaxy from launching an early biogeneric version in the UK, although Pfizer is currently planning an appeal against the second decision.
Hank McKinnell, Pfizer's chairman and ceo, said that the decision 'marks a major victory for medical innovators and the patients who depend on them for important new therapies'.
'We have now successfully defended our Lipitor patent rights in two important jurisdictions. We will continue to defend against any and all patent challenges that seek to undermine our mission of finding new therapeutic innovations for the patients we serve,' he added.
Malvinder M. Singh, president and executive director of Ranbaxy, said: 'We remain undeterred in our resolve on this issue, and we will press our case in the US Court of Appeals for the Federal Circuit. We are committed to bringing lower cost, reliable medicines to healthcare systems, worldwide.' The injunction against Ranbaxy remains in place throughout the appeals process
Introduced in the US in 1997, more than 18 million people in the US have been prescribed Lipitor, which has been approved in more than 70 countries.