By Kurt R. Karst – Earlier this week, Astellas Pharma US, Inc. (“Astellas”) filed a Complaint and an accompanying Memorandum of Points and Authorities in the U.S. District Court for the District of Columbia requesting declaratory and injunctive relief in connection with FDA’s response to a citizen …
By Kurt R. Karst – Judge Rosemary M. Collyer of the U.S. District Court for the District of Columbia ruled in a 27-page opinion issued last Friday that the 180-day exclusivity forfeiture patent information withdrawal provision at FDC Act § 505(j)(5)(D)(i)(I)(bb)(CC) is not ambiguous and …
By Kurt R. Karst – Last Friday, the House Energy and Commerce Committee favorably reported its version of “America’s Affordable Health Choices Act” (H.R. 3200) by a 31-28 vote after adopting several amendments. A copy of the bill and amendments are available here. Importantly, the …
By Kurt R. Karst – On July 28, 2009, FDA will publish a final rule amending the Agency’s regulations requiring that NDA holders submit in annual reports certain information to the Agency concerning authorized generics. The regulations, which were first proposed in September 2008 – …
By JP Ellison – The amicus brief recently filed by the Department of Justice’s (“DOJ”) Antitrust Division makes it clear that at least on the issue of so-called “reverse payments” the antitrust lawyers at DOJ agree with their colleagues at the Federal Trade Commission (“FTC”) …
By Kurt R. Karst – Following the introduction of several proposals last week, as well as a proposal from Senator Sherrod Brown (D-OH), the U.S. Senate Health, Education, Labor, and Pensions (“HELP”) Committee voted 16-7 late Monday night in favor of a proposal offered by Sens. …
By Kurt R. Karst – We recently reported on a Complaint and a Motion for Preliminary Injunction Teva Pharmaceuticals USA, Inc. (“Teva”) filed in the U.S. District Court for the District of Columbia against FDA concerning 180-day exclusivity forfeiture for generic versions of Merck & …
By Kurt R. Karst – There has been a frenzy of activity on Capitol Hill in recent days over Follow-On Biologics (“FOBs”). At least four different proposals – all titled as the “Biologics Price Competition and Innovation Act of 2009” – have reportedly been floated …
By Kurt R. Karst – The recent challenge to FDA’s five-year New Chemical Entity (“NCE”) exclusivity determination concerning the ADHD drug VYVANSE (lisdexamfetamine dimesylate) Capsules and the reportedly ongoing debate over whether to grant NCE exclusivity with respect to certain pancreatic enzyme products are not the …
By Kurt R. Karst – Over the past week, generic drug manufacturer Apotex, Inc., which we understand recently parted ways with the generic drug trade association, GPhA, has filed two similar declaratory judgment actions in an effort to “unpark” 180-day exclusivity eligibility that is reportedly …
By Kurt R. Karst – Teva Pharmaceuticals USA, Inc. (“Teva”) recently filed a Complaint and a Motion for Preliminary Injunctive Relief (and a memorandum supporting the company’s motion) in the U.S. District Court for the District of Columbia against FDA concerning 180-day exclusivity forfeiture for generic versions of …
By Kurt R. Karst – The Federal Trade Commission (“FTC”) announced the publication of an interim report on authorized generic drugs. The report, titled “Authorized Generics: An Interim Report,” presents the first set of results from an FTC study conducted, at the request of several members …
By Kurt R. Karst – On June 22nd, Senator Bill Nelson (D-FL) introduced S. 1315, the “Drug Price Competition Act of 2009.” (At this point we have a copy of the discussion draft; however, we understand that it is the same as the version of …
By Kurt R. Karst – Section 11 of the Best Pharmaceuticals for Children Act (“BPCA”) of 2002 amended the FDC Act to add a new provision, which was reauthorized under the FDA Amendments Act of 2007 and is located at FDC Act § 505A(o), to …
By Kurt R. Karst & Frank J. Sasinowski – FDA’s recent decision to approve the Pancreatic Enzyme Product (“PEP”) CREON (pancrelipase) to help patients with cystic fibrosis and others with Exocrine Pancreatic Insufficiency (“EPI”) digest and absorb nutrients from foods has apparently left the Agency …
