Ranbaxy Appeals Lipitor Case to Supreme Court

Lipitor (atorvastatin calcium), indicated for the reduction of cholesterol, is the world's best-selling pharmaceutical.  Ranbaxy has applied to market a generic version of Lipitor and has challenged Pfizer's patents on Lipitor in many countries around the world--usually without success.  For instance, in August 2006 the Federal Circuit upheld the validity of Pfizer's U.S. Patent No. 4,681,893.  (In the same decision the Federal Circuit invalidated Pfizer's U.S. Patent No. 5,273,995, but Pfizer has vowed to correct the defect through a re-issue.)  Now, Ranbaxy has appealed the case to the Supreme Court, on somewhat unconventional grounds.

The Federal Circuit's August 2006 decision affirmed the district court's claim construction and found that Ranbaxy's generic Lipitor infringed the '893 patent claims.  In addition, the Federal Circuit upheld the validity of Pfizer's patent term extension on the '893 patent, rejecting (in just a couple paragraphs) Ranbaxy's argument that the extension was invalid due to Pfizer's failure to disclose material information to the patent office.  Ranbaxy is appealing only this latter finding to the Supreme Court.

According to Ranbaxy's cert petition:

This case presents an important federal question: In seeking a patent term extension under 35 U.S.C. 156 on the basis that the patent claims an approved drug, do the controlling statute and regulation require a pharmaceutical company to disclose (1) its own prior, inconsistent representations made before the United States Patent and Trademark Office that the patent does not cover the approved drug, (2) a patent office Board of Patent Appeals and Interferences decision adopting those representations, and (3) a later patent claiming the drug on which the patent term extension application is premised, or is this information per se irrelevant to the patent term extension proceedings?

Pfizer obtained a patent term extension of more than three years for the '893 patent, due to the lengthy FDA approval process for Lipitor.  Without the extension, the patent would have expired on May 30, 2006.  Ranbaxy unsuccessfully argued in the Federal Circuit that the extension is invalid.  Chances that the Supreme Court will take the case seem remote.

Thank you to a helpful reader for passing along a copy of Ranbaxy's cert petition.

RELATED READING:

• Jan. 26, 2007 Ranbaxy press release, announcing favorable Lipitor ruling in Canada
• Aug. 31, 2006 and Oct. 23, 2006 OBB posts on Lipitor cases

UPDATE:

• On April 2, 2007, the Supreme Court denied Ranbaxy's cert petition

Comments

[Harshad Arole]

Will ranbaxy retain 180 day exclusivity in the event that Pfizer is successful in reissuing the 995 patent till 2011?