Patent Baristas

As of July 2008, twenty-five states and the District of Columbia have filed antitrust suits against Abbott Laboratories and Solvay’s Fournier Industrie et Santé and Laboratories Fournier in Delaware District Court, charging them with blocking generic competition by engaging in product hopping, among other “anti-generic strategies.”  Patent Baristas reported the initial filing here. As Stephen […]

The U.S. Court of Appeals for the Federal Circuit gave a high-five to settlement agreements between a patent holder and a generic manufacturer saying it doesn’t violate antitrust laws under the Hatch-Waxman Act.  In re Ciprofloxacin Hydrochloride Antitrust Litigation (08-1097). The agreements in question involved a reverse payment from the Bayer to Barr, but did […]

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 […]

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 […]

Today, I gave a webinar presentation with Ken Phelps, President of Camargo Pharmaceutical Services, on the interaction of patents and exclusivity of drugs approved by the FDA under section 505(b)(2). Ken is an expert at 505(b)(2) filings so my job (covering patent issues) was pretty easy. Ken notes that large pharma and small start-ups alike […]

Forest Labs had a bit of a reversal of fortune in its patent dispute with Caraco Pharmaceutical Labs over its drug Lexapro®, which is used to treat depression and generalized anxiety disorder. The U.S. Court of Appeals for the Federal Circuit reversed and remanded the case back to the U.S. District Court, which had dismissed […]

Eighteen states and the District of Columbia have filed suit against Abbott Laboratories and Solvay’s Fournier Industrie et Santé and Laboratories Fournier for allegedly entering into a scheme to block the generic version of the cholesterol lowering drug TriCor®  (fenofibrate), indicated for the treatment of hypercholesterolemia and hypertriglyceridemia. According to the AGs in the states, […]

What happens when a brand name drug company asserts that a patent covers its drug and then pulls it out from the Orange Book? You fight to get it back in, that’s what. In August, Teva Pharmaceuticals USA submitted a Citizen Petition pursuant to section 505 of the Food, Drug, and Cosmetic Act (FDCA) asking […]