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 …
By Kurt R. Karst – We previously reported on a 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 DORYX (doxycycline hyclate) Delayed-Release Tablets, an …
By Kurt R. Karst – The American Intellectual Property Law Association (“AIPLA”) recently submitted a letter to FDA concerning § 4 of the recently enacted “QI Program Supplemental Funding Act of 2008” (the “QI Act”). (The "QI" stands for Qualifying Individual). As we previously reported, …
By Kurt R. Karst – On February 2, 2009, the Federal Trade Commission (“FTC”) announced that the Commission filed a complaint in federal district court challenging agreements in which Solvay Pharmaceuticals, Inc. allegedly paid two generic drug companies to delay generic competition to Solvay’s drug …
By Kurt R. Karst – Representative Jo Ann Emerson (R-MO) has introduced a bill to amend the FDC Act that would prohibit the marketing of authorized generics during a generic applicant’s 180-day exclusivity period. The bill, H.R. 573, is almost identical to the bill Rep. …
By Kurt R. Karst - FDA has issued a draft guidance document, titled "Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act," explaining the Agency's interpretation of this new statutory provision. FDC Act § …
