Federal Circuit Rules for Axinn Client Natco Pharma Ltd. in Tamiflu Patent
HARTFORD, Conn. -- April 25, 2014
A ruling by the U.S. Court of Appeals for the Federal Circuit has given Axinn,
Veltrop & Harkrider LLP client Natco Pharma Ltd. a second chance at
invalidating Gilead Sciences Inc.’s patent on the popular flu drug Tamiflu.
The decision could pave the way to Natco’s planned issuance of a generic
version of the drug in the United States. Natco was represented by Axinn
attorneys Jeremy Lowe and Thomas Hedemann.
The April 22 Federal Circuit ruling vacated a December 2012 district court
ruling that Gilead did not unlawfully extend a patent covering Tamiflu and
remanded the issue of the patent’s validity back to the district court for
This is the first time the Federal Circuit has addressed whether a
commonly-owned patent that issues after—but expires before—another patent can
be rendered invalid for double-patenting. By ruling that it can, the court
reaffirmed the double patenting doctrine, which prohibits inventors from
unreasonably extending patent protection past the statutory limit.
The ruling also establishes a bright-line rule for patent practitioners and
continues to provide inventors like Natco Pharma with the ability to use
terminal disclaimers to overcome obviousness-type double patenting rejections.
In March, the U.S. Food and Drug Administration (USFDA) granted Natco
tentative approval to sell its generic version of Tamiflu in the U.S. market.
The approval, however, is contingent upon Natco successfully resolving its
patent dispute with Gilead Sciences.
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Steven Andersen, 212-687-0935
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