Supreme Court agrees with Natco/Alvogen and denies petition for certiorari on generic Tamiflu patent

Posted on 11.3.2015

Alvogen and Natco Pharma Limited (“Natco”), who have partnered on the first Abbreviated New Drug Application containing a paragraph IV certification filed with the U.S. Food and Drug Administration for the generic version of Tamiflu® oral capsules (oseltamivir phosphate), are pleased with the Supreme Court’s decision to deny certiorari. 

The denial was issued on March 9, 2015, in the case of Gilead Sciences, Inc. et al. v. Natco Pharma Limited et al, No. 14-647.

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.

The Supreme Court today declined to review the Federal Circuit’s decision. The case remains pending in the District of New Jersey where the validity of U.S. Patent No. 5,763,483 continues to be challenged.