Patent Baristas

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.” […]

In a nonprecedential decision, the Court of Appeals for the Federal Circuit looked at the issue of whether there is an Article III case or controversy between a patentee drug company and a generic drug company in the context of the Hatch-Waxman Act.  Merck v. Apotex (07-1362). Merck had sued Apotex for patent infringement when […]

The U.S. Court of Appeals for the Federal Circuit affirmed a district court decision that Apotex and Impax infringed on patents covering AstraZeneca’s heartburn drug Prilosec.  In re Omeprazole Patent Litigation (Astrazeneca v. Apotex Corp., Apotex and Impax; 07-1414, -1416, -1458, -1459).  This ruling comes on the heels of its earlier affirmation of a decision […]