It appears that no matter who wins the presidential election this November, both Barack Obama and John McCain back expanded use of generic drugs as a way to lower drug costs,  According to their advisers, both campaigns have pledged their support to help create a market for generic biotech drugs or biosimilars. As a part […]

Jon Dudas, Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office has (proudly?) highlighted the fact that the allowance rate for patents is currently 42%.  This is in contrast to allowance rates in excess of 70% just eight years ago.  So, did patent applications really get that […]

In Janssen Pharma v. Apotex (08-1062), Apotex tried to get the federal circuit to grant a do-over of the dismissal of its declaratory judgment action for noninfringement against Janssen. Janssen holds an approved NDA for its drug Risperdal® Oral Solution for which the Orange Book listed U.S. Patent Nos. 4,804,663, 5,453,425 and 5,616,587.  The ’663 […]

The Food and Drug Administration (FDA) issued two Warning Letters to Ranbaxy Laboratories and an Import Alert for generic drugs produced by Ranbaxy’s Dewas and Paonta Sahib plants in India. The Warning Letters identify the agency’s concerns about deviations from U.S. current Good Manufacturing Practice (cGMP) requirements at Ranbaxy’s manufacturing facilities in Dewas and Paonta […]

The USPTO is developing a Continuing Education for Practitioners (“CEP”) system for on-line delivery of educational materials for patent practitioners.  The goal of this whole business — according to the USPTO — is to increase efficiency, reduce pendency, and improve quality in the patent process. For now, the USPTO trying out the system in a […]

Senate Finance Committee Chairman Max Baucus (D-MT) and Sen. Orrin Hatch (R-Utah) introduced the International Intellectual Property Protection and Enforcement Act of 2008, legislation meant to crack down on the theft of U.S. intellectual property around the world. The bill would compel the U.S. Trade Representative to develop action plans for countries on the piracy […]

In Prasco v. Medicis Pharmaceutical (07-1524), Prasco tried to get a declaratory judgment that one of its products did not infringe various patents owned by Medicis Pharmaceutical Corp. and Imaginative Research Associates. The district court dismissed the action for lack of jurisdiction, concluding that Prasco’s complaint failed to establish a case or controversy under Article […]

here at Patent Baristas, we get all giddy when a case comes down the pike involving protein synthesis and gene cloning vectors.  It doesn’t happen all that often and, when it does, we’re treated to BIO 101 introductions explaining how proteins are biomolecules that “are encoded by particular deoxyribonucleic acid (“DNA”) sequences known as genes.” […]