By Kurt R. Karst – FDA’s recent decision to grant in part and deny in part a citizen petition concerning generic versions of DORYX (doxycycline hyclate) Delayed-Release Tablets reaffirms FDA’s policy that in order for two drug product to be in the same “dosage form,” …
By Kurt R. Karst – FDA’s April 2009 response to a September 2007 suitability petition requesting permission to submit an ANDA for a lyophilized generic version of ZOMETA (zoledronic acid) Injection and an FDA determination that such drug product, if approved, would be therapeutically equivalent …
By Kurt R. Karst – FDA’s April 15th decision to approve ANDAs for generic versions of Topiramate Sprinkle Capsules signals a new FDA interpretation of the 180-day generic drug exclusivity provisions of the FDC Act, which were amended in December 2003 under Title XI of …
By Kurt R. Karst – We recently reported on a complaint filed in the U.S. District Court for the District of Columbia by Actavis Elizabeth LLC (“Actavis”) against FDA in which Actavis requested the court to enter an injunction directing FDA to rescind the Agency’s …
By Kurt R. Karst – Over the past year or so, the U.S. Court of Appeals for the Federal Circuit has addressed the proper jurisdictional scope of the “case or controversy” requirement under Article III of the U.S. Constitution for a court to have jurisdiction …
By Kurt R. Karst – FDA’s September 1999 guidance document, “Qualifying for Pediatric Exclusivity Under Section 505A of the Federal Food, Drug, and Cosmetic Act,” includes a section addressing the following question: “If my study qualifies for pediatric exclusivity, to what will the period of pediatric …
By Kurt R. Karst – We previously reported on a lawsuit filed in July 2008 by PhotoCure ASA (“PhotoCure”) against the U.S. Patent and Trademark Office (“PTO”) after the PTO denied PhotoCure’s application for a Patent Term Extension (“PTE”) for U.S. Patent No. 6,034,267 (“the …
By Kurt R. Karst – We previously reported on a complaint filed by Wyeth Holdings Corporation and its Fort Dodge Animal Health Division (collectively “Wyeth”) in the U.S. District Court for the District of Columbia against FDA and the U.S. Patent and Trademark Office (“PTO”) …
The American Intellectual Property Law Association (“AIPLA”) has appointed Hyman, Phelps & McNamara, P.C. attorney Kurt R. Karst as Chair of the organization’s Hatch-Waxman Subcommittee of the Special Committee on the FDA. “I am honored to have been nominated for this position, and look forward …
By Kurt R. Karst – FDA has issued its highly anticipated decision concerning whether the QI Program Supplemental Funding Act of 2008 (“QI Act”) imposes a 30-month stay of approval of an ANDA referencing an old antibiotic drug product if that ANDA contains a Paragraph IV certification …
By Kurt R. Karst – Earlier today, Representative Henry Waxman (D-CA) (along with Representatives Nathan Deal (R-GA), Frank Pallone (D-NJ), and Jo Ann Emerson (R-MO)) announced the introduction of H.R. 1427, the Promoting Innovation and Access to Life-Saving Medicine Act, which authorizes FDA to approve …
By Kurt R. Karst – Last week, we reported on the third citizen petition submitted to FDA requesting that the Agency address whether the 30-month stay provisions of the Hatch-Waxman Amendments apply to a pending ANDA for a generic version of an old antibiotic drug, …
By Kurt R. Karst – Actavis Elizabeth LLC (“Actavis”) has sued FDA after the Agency refused to accept the company’s ANDA for a generic version of the ADHD drug VYVANSE (lisdexamfetamine dimesylate) Capsules earlier this year. FDA’s Orange Book shows that VYVANSE is a Type …
By Kurt R. Karst – Over the past few weeks, we have posted (here and here) on citizen petitions submitted to FDA requesting that the Agency address whether the 30-month stay provisions of the Hatch-Waxman Amendments apply to a pending ANDA for a generic version …
By Kurt R. Karst – In a rare move, the U.S. Court of Appeals for the Federal Circuit affirmed a district court decision extending a 30-month stay available under the Hatch-Waxman Amendments with respect to Teva Pharmaceutical USA, Inc.’s ANDA for a generic version of …
