By Kurt R. Karst – FDA recently announced that the Agency has established within the Center for Drug Evaluation and Research (“CDER”) an Exclusivity Board “to provide oversight and recommendations regarding exclusivity determinations made by the Center, with a primary focus on clarity and consistency of …
By Kurt R. Karst – The recent lawsuit filed against FDA in the U.S. District Court for the District of Columbia in which Mylan Laboratories Limited and Mylan Pharmaceuticals Inc. are challenging FDA’s decision that Ranbaxy Inc. is eligible for 180-day exclusivity for its generic …
By Kurt R. Karst – When the word came out early last week that Judge Amy Berman Jackson of the U.S. District Court for the District of Columbia ruled against FDA in litigation over 180-day exclusivity for generic versions of ACTOS (pioglitazone HCl) Tablets, we …
By Kurt R. Karst – A lot has been happening at FDA over the past two months – and in particular in recent weeks – as the Agency works diligently to implement the Generic Drug User Fee Amendments of 2012 (“GDUFA”). There have been various …
By Kurt R. Karst – We were hardly surprised when we learned that Momenta Pharmaceuticals, Inc. and Sandoz Inc. (“Plaintiffs-Appellees”) filed a Petition for Rehearing en banc seeking reconsideration of an August 3, 2012 decision by a divided (2-1) panel of judges from the U.S. …
By Kurt R. Karst – The Federal Trade Commission (“FTC”) is seeking leave to file a second amicus brief in private antitrust litigation espousing the Commission’s views that a branded drug company’s commitment, as part of a settlement agreement, not to launch an Authorized Generic …
By Kurt R. Karst – In a Complaint recently filed in the U.S. District Court for the District of New Jersey, Actelion Pharmaceuticals Ltd. and Actelion Clinical Research, Inc. (collectively “Actelion”) seek declaratory relief that Actelion is under no duty or obligation to supply prospective …
By Kurt R. Karst – Just weeks after Federal Trade Commssion (“FTC”) Chairman Jon Leibowitz signaled in a speech that the Commission would appeal to the U.S. Supreme Court the U.S. Court of Appeals for the Eleventh Circuit’s April 2012 ruling (and subsequent July 2012 …
By Kurt R. Karst – Those of us who work in the drug approval world know that a high degree of coordination among various FDA components is necessary for a smooth and efficient approval process. This is particularly true for ANDA generic drug …
By Kurt R. Karst – The question was not whether, but when, FDA would be sued over a decision involving 180-day generic drug exclusivity and the so-called “failure to obtain timely tentative approval” forfeiture provision at FDC Act § 505(j)(5)(D)(i)(IV). That day has finally come. …
By Kurt R. Karst – Legislation co-sponsored by Representatives Brian Bilbray (R-CA), Carolyn Maloney (D-NY) and Rosa DeLauro (D-CT), and supported by the Melanoma Research Foundation, seeks to encourge the development of so-called “significant drug combinations” by offering the carrot of an extension of marketing …
By Kurt R. Karst – Legislation allowing FDA to collect several user fees under the Generic Drug User Fee Amendments of 2012 (“GDUFA”) is expected to be introduced this week (and perhaps voted on by both the U.S. House of Representatives and the U.S. Senate). …
By Kurt R. Karst – In our recent post, “Hot Ticket Item – Patent Settlement Agreement Challenges,” we provided a round-up of the latest and greatest from ongoing litigation concerning patent settlement agreements (or “pay-for-delay” agreements if you prefer that term – we don’t). It’s …
By Kurt R. Karst – In the world of Hatch-Waxman, disputes over 180-day generic drug exclusivity have been commonplace for well over a decade now. Indeed, in 2012 alone there have already been a few lawsuits filed against FDA concerning generic ACTOS and generic PROVIGIL …
By Kurt R. Karst – As we patiently await FDA’s next annual report to Congress on 505(q) citizen petitions (see our previous posts on FDA’s annual reports here, here, and here) we thought we would take a minute to share with our readers some observations …
