US SC denies review of Fed circuit ruling on Tamiflu: Natco

The US Supreme Court has declined a review of a federal circuit court ruling that favoured Natco Pharma in a patent infringement litigation over swine flu treatment drug Tamiflu.

The Hyderabad-based firm said it is "pleased with the US Supreme Court's decision to deny certiorari for the generic version of Tamiflu oral capsules (oseltamivir phosphate)". The denial was issued on March 9 in the case of Gilead Sciences Inc et al v Natco Pharma Limited et al No 14-647, Natco Pharma said in a filing to BSE.

"In the April 22, 2014 Federal Circuit decision, Circuit Judges Chen and Prost agreed with Natco and Alvogen's position that an earlier filed and earlier expiring patent qualifies as an obviousness-type double patenting reference for a later filed, and later expiring patent," Natco Pharma said.

The Supreme Court has declined to review the Federal Circuit's decision. The case remains pending in the District of New Jersey where the validity of US Patent No 5,763,483 continues to be challenged, it added.

The company had received a tentative approval on March 14, 2014, for Oseltamivir Phosphate Capsules USP 30 mg, 45 mg and 75 mg on its Abbreviated New Drug Application (ANDA) containing a Paragraph IV certification filed with the US Food and Drug Administration (USFDA), it said.

The firm had filed ANDA under Para-IV with the USFDA challenging Gilead's patent on the drug in February 2011. Natco has partnered with Alvogen in the US for marketing this product, the company said.

Gilead had exclusively licensed their relevant patents of Tamiflu to Roche.