Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) announced today that it is pleased with the U.S. Supreme Court's decision to deny certiorari for the generic version of Tamiflu® oral capsules (oseltamivir phosphate). Natco is partnered with Alvogen in the USA for marketing of this product. 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.
Natco has already received a tentative approval on March 14, 2014, for Oseltamivir Phosphate Capsules USP,30 mg (base), 45 mg (base) and 75 mg (base) on the Abbreviated New Drug Application (ANDA) containing a paragraph IV certification filed with the United States Food & Drug Administration (USFDA).
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.