By Kurt R. Karst – Although much discussion has been devoted over the past few days to Sen. Byron Dorgan’s (D-ND) proposed amendment (SA 2793) to the Senate Health Care Reform Bill that would let U.S. pharmacies and drug wholesalers import FDA-approved drugs from certain …
By Kurt R. Karst – A recent decision from the Patent and Trademark Office (“PTO”) in which the Office granted an interim Patent Term Extension (“PTE”) for U.S. Patent No. 5,407,914 but denied interim extensions for U.S. Patent Nos. 5,260,273 and 5,789,381 covering the drug product …
By Kurt R. Karst – Returning from the Thanksgiving Holiday, we found our inbox chock-full of recent preemption decisions of note involving generic drugs. First off is a decision from the U.S. Court of Appeals for the Eighth Circuit in Mensing v. Wyeth. That case …
By Kurt R. Karst – In June, we reported on a citizen petition Galderma Laboratories L.P. (“Galderma”) submitted to FDA requesting that the Agency interpret the QI Program Supplemental Funding Act of 2008 (“QI Act”) to impose a 30-month stay of approval on an ANDA referencing the old …
By Kurt R. Karst – Buried in the Conference Report (Report No. 111-279) accompanying the recently-enacted Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act of 2010 (Public Law No. 111-80) is a request that FDA examine and report on “A” rated …
By Alan M. Kirschenbaum & Kurt R. Karst – Last Thursday we reported on the release by the House of H.R. 3962, the health care reform bill that will soon be considered on the House floor. As we have done with other health care reform …
By Kurt R. Karst – The Medicines Company is reportedly continuing its multi-year and multi-million dollar lobbying effort to obtain a Patent Term Extension (“PTE”) for U.S. Patent No. 5,196,404 (“the ‘404 patent”) covering ANGIOMAX (bivalirudin), an anticoagulant drug product FDA first approved on December …
By Kurt R. Karst – Consistent with recent wins concerning generic PROGRAF (tacrolimus) and generic ZOSYN (piperacillin sodium; tazobactam sodium) Injection (here and here), the U.S. District Court for the Central District of California recently ruled that FDA’s April 2008 denial of a citizen petition and decision …
By Kurt R. Karst – On October 14, 2009, Sens. Jeanne Shaheen (D-NH) and David Vitter (R-LA) announced the introduction of S. 1778, the Access to Affordable Medicines Act. The bill would amend the FDC Act’s ANDA provisions at § 505(j) to add a new …
By Kurt R. Karst – In what could shape up to be a very interesting (and important) precedent, the U.S. District Court for the Eastern District of Michigan (Southern Division) recently ruled and issued an Order and Injunction requiring Novo Nordisk, Inc. (“Novo”) to change an Orange …
By Kurt R. Karst – Last week, the U.S. District Court for the District of New Hampshire ruled in a 67-page opinion that various state law tort claims brought against generic drug manufacturer Mutual Pharmaceutical Company, Inc. (“Mutual”) are not preempted by Title I of the …
By Kurt R. Karst – At a September 24th Senate Judiciary Committee Executive Business Meeting, Senator Herb Kohl’s (D-WI) substitute amendment to S. 369, the Preserve Access to Affordable Generics Act, was adopted by unanimous consent. As we previously reported, the amendment makes significant changes to …
By Kurt R. Karst – Many thanks to all of those who participated in our little Hatch-Waxman trivia contest. Although no single person was able to correctly answer all of the questions, just about all of them were correctly answered through your collective knowledge. The answers are provided …
By Kurt R. Karst – Late yesterday (Sept. 22nd), Wyeth Pharmaceuticals (“Wyeth”) sued FDA in the U.S. District Court for the District of Columbia over the Agency’s recent decision to approve two ANDAs for generic versions of ZOSYN (piperacillin sodium; tazobactam sodium) Injection. Both ANDAs …
By Kurt R. Karst – September 24, 2009 is the 25th anniversary of the enactment of the Drug Price Competition and Patent Term Restoration Act (Public Law No. 98-417) – commonly known as “Hatch-Waxman” or “Waxman-Hatch” depending on when you became familiar with the law. …
