By Kurt R. Karst – Late last year, Impax Laboratories, Inc. (“Impax”) filed a Complaint in the U.S. District Court for the District of New Jersey seeking a judgment with respect to U.S. Patent No. 6,911,217 (“the ‘217 patent”). The ‘217 patent is one of four …
By Kurt R. Karst – The drama in the decade-old fight over a Patent Term Extension (“PTE”) for U.S. Patent No. 5,196,404 (“the ‘404 patent”) covering The Medicines Company’s (“MDCO’s”) ANGIOMAX (bivalirudin) has taken yet another turn. The U.S. Court of Appeals for the Federal Circuit …
By Kurt R. Karst – The ANDA backlog in FDA’s Office of Generic Drugs (“OGD”) continued to grow unabated in 2010. OGD started out the year with a backlog of 1963 original applications and ended the year up almost 400 applications, for a grand total of …
By Kurt R. Karst – Among the several FDA-related bills that have already been introduced in the 112th Congress – see our 112th Congress FDA Legislation Tracker – is Senator Herb Kohl’s (D-WI) Preserve Access to Affordable Generics Act (S. 27) concerning patent settlement agreements (or what …
By Kurt R. Karst – In yet another letter to FDA Commissioner Hamburg concerning the 12-year period of reference product exclusivity (which can be extended to 12.5 years with pediatric exclusivity) created by the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”), a bipartisan group …
By Kurt R. Karst – Yesterday, we posted on FDA’s report to Congress on encouraging the early submission of citizen petitions covered by FDC Act § 505(q). Today, we take a look at the two annual reports FDA has submitted to Congress detailing the Agency’s experience …
By Kurt R. Karst – On January 24th, the U.S. Court of Appeals for the Ninth Circuit issued its decision in Gaeta v. Perrigo, reversing a decision from the U.S. District Court for the Northern District of California (San Jose Division) that Plaintiff-Appellant Gaeta’s state law …
By Kurt R. Karst – Reports FDA submitted to Congress on the Agency’s implementation of FDC Act § 505(q) recently became available and show that only a few applications have been delayed by certain citizen petitions covered by the law, and that the Agency is timely …
By Kurt R. Karst – In an unpublished, and subsequently sealed, decision handed down earlier this week by Chief Judge Garrett Brown, Jr. of the U.S. District Court for the District of New Jersey, the court dismissed without prejudice an Amended Complaint filed by Paddock Laboratories, …
By Kurt R. Karst – On January 18th, the U.S. Supreme Court denied Apotex Inc.’s Petition for Writ of Certiorari asking for a review of the U.S. Court of Appeals for the District of Columbia Circuit’s decision involving Teva’s 180-day exclusivity for generic versions of Merck’s …
By Kurt R. Karst – In a Complaint for Declaratory Judgment filed in the U.S. District Court for the Eastern District of Michigan (Southern Division) last week by Apotex Inc., the company is trying to trigger 180-day exclusivity for generic LEXAPRO Tablets. Apotex heavily relies on …
By Kurt R. Karst – In a Complaint lodged against the U.S. Patent and Trademark Office (“PTO”) in the U.S. District Court for the Eastern District of Virginia last September, but only recently served, the Genetics & IVF Institute (“GIVF”) is challenging the PTO’s August 2010 …
By Kurt R. Karst – In a January 7th letter sent to FDA Commissioner Margaret Hamburg, a group of four U.S. Senators take exception to FDA’s recent characterization of the 12-year exclusivity period provided by the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”) as …
By Kurt R. Karst – Last Friday, 32 State Attorneys General filed an amicus brief with the U.S. Supreme Court asking the Court to grant the Petition for Writ of Certiorari filed last month by a group of drug purchasers in Louisiana Wholesale Drug Co., Inc., …
By Kurt R. Karst – In a letter recently submitted to FDA by the three principal authors of the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”) – Representatives Anna Eshoo (D-CA), Jay Inslee (D-WA), and Joe Barton (R-TX) – the legislators take issue with …
