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 …
By Kurt R. Karst – Will FDA apply the Agency’s pre-Medicare Modernization Act (“MMA”) “holding-on-the-merits standard” to the post-MMA “failure to market” 180-day exclusivity forfeiture provisions? It is a reasonable question, and one that FDA has not yet definitively answered. Nevertheless, there appears to be …
By Kurt R. Karst – On June 10th, the Federal Trade Commission (“FTC”) announced the release of its highly anticipated report on Follow-On Biologics (“FOBs”). The 120-page report, titled “Emerging Health Care Issues: Follow-On Biologic Drug Competition” is the product of an FTC Roundtable held …
By Kurt R. Karst – The U.S. Court of Appeals for the Federal Circuit’s recent decision in Abbott Labs. v. Sandoz, Inc. concerning U.S. Patent No. 4,935,507 (“the ‘507 patent”) covering OMNICEF (cefdinir) has been discussed at length in the blogosphere for its possible implications …
By Kurt R. Karst – Galderma Laboratories L.P. (“Galderma”) recently submitted a citizen petition to FDA (also see our Citizen Petition Tracker) requesting that the Agency interpret the QI Program Supplemental Funding Act of 2008 (“QI Act”) to impose a 30-month stay of approval of …
By Kurt R. Karst – Recent decisions by the U.S. District Court for the Eastern District of Virginia and the U.S. District Court for the District of Columbia in PhotoCure ASA v. Dudas and Wyeth Holding Corp. v. United States, respectively, concerning certain Patent Term Extension …
By Kurt R. Karst – The recent addition of numerous patents to the Orange Book covering various GlaxoSmithKline (“GSK”) drug products, such as VENTOLIN (albuterol sulfate), FLOVENT (fluticasone propionate), ADVAIR (fluticasone propionate; salmeterol xinafoate), and SEREVENT (salmeterol xinafoate), begs the question why? Many of the new patent …
By Kurt R. Karst – The Washington Legal Foundation is publishing a Legal Backgrounder authored by Hyman, Phelps & McNamara, P.C., attorneys Robert A. Dormer and Kurt R. Karst. The article, titled “The Drug User Fee Catch-22,” argues that FDA should be more flexible in receiving and …
