Gilead, Natco Battle Over Supreme Court Bid On Tamiflu Patents

March 12, 2015

Gilead Sciences has ratcheted up efforts to get the Supreme Court to hear a double patenting lawsuit, arguing the Federal Circuit’s ruling invalidating patent protection for its influenza drug Tamiflu effectively rewrites the obviousness-type double patenting doctrine.

In a brief filed last month, Gilead and licensee Hoffmann-La Roche once again asked the Supreme Court to look at the April 2014 appellate decision, which ruled in Natco Pharma’s favor.

The brandmakers argue that the U.S. Court of Appeals for the Federal Circuit erred when it deemed Tamiflu’s ‘483 patent invalid for obviousness-type double patenting, meaning Gilead can’t reference that patent because it was issued before the drug’s ‘375 patent, but expires later. Natco first challenged Tamiflu in 2011 with a Paragraph IV ANDA.

According to Gilead and Hoffman-La Roche, existing law actually allows double patenting with different expiration dates if the Patent Office, rather than the patent holder, is the cause of the delay of the grant of the patents.

The brandmakers are currently arguing their case, Gilead Sciences v. Natco Pharma, in the New Jersey district court under the ground rules set by the Federal Circuit decision, even as they ask the Supreme Court to upend that decision, according to a Gilead SEC filing.

The FDA lists no therapeutic equivalents to Tamiflu. Pediatric exclusivity pushes the drug’s patent protection to June 2017, according to the Orange Book. — Bryan Koenig