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 Federal Circuit’s decision. The decision was released yesterday, in the case of Gilead Sciences, Inc. et al. v. Natco Pharma Limited et al, 2013-1418.
In the 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 case has been remanded to the District of New Jersey where the validity of U.S. Patent No. 5,763,483 will continue to be challenged.
About Natco Natco Pharma Limited was incorporated in Hyderabad in 1981 and today, has five manufacturing facilities spread across India with dedicated modern research laboratories and capabilities in new drug development. The Natco family currently consists of more than 2,500 employees, and is consistently ranked amongst the fastest growing pharmaceutical companies in India. For more information about Natco, please visit,www.natcopharma.co.in.