BY OUR PHARMA CORRESPONDENT
15 July, 2005: The United States Patent and Trademark Office has rejected all 44 claims on one of Pfizer's patents on its atorvastatin calcium product, Lipitor, reports the Public Patent Foundation.
The PTO's re-examination of the patent was initiated in December 2004 following a request from the Public Patent Foundation, an organisation that claims to represent the public's interest in the patent. The organisation claimed that the PTO relied on evidence provided by the Foundation.
The Patent Office has agreed with the Public Patent Foundation’s conclusion that it should have never granted Pfizer the Lipitor patent. Revoking Pfizer's patent is a critical step towards providing American consumers with access to atorvastatin at a fair price, which will not only provide substantial economic benefit, but will also improve public health, as even Pfizer admits that many Americans in need of the drug are not getting it, states the Foundation.
However, Pfizer, responding to the event,said the PTO's communication was not a final decision, but was a preliminary finding. It added the communication invited a response from Pfizer, which the company would file in due course.
Lipitor is protected by five patents listed in the FDA's Orange Book; all five have six-month periods of paediatric exclusivity. The patent that has been re-examined by the PTO will expire on 8th July 2016, with its paediatric exclusivity expiring on 8th January 2017. The other four patents expire on 24th September 2009 (with paediatric exclusivity expiring on 24th March 2010); 28th December 2010 (28th June 2011); 11th November 2014 (11th May 2015); and 19th January 2013 (19th July 2013), PTO's communication did not concern the first two of the five patents, the drug's basic and enantiomer patents, which provided marketing exclusivity through March 2010 and June 2011 respectively. The company added that these two patents are the subjects of litigation with Ranbaxy Laboratories in the US District Court of Delaware, Pfizer commended.
Lipitor is the largest selling anti-cholesterol drug in the world. Last year, Lipitor sales jumped 17 percent to $2.36 billion and accounted for 19 per cent of Pfizer’s total revenue.