By Kurt R. Karst – In a recent, 95-page decision from the U.S. District Court for the Eastern District of Pennsylvania in In re Wellbutrin XL Antitrust Litigation, the court once again tackled the issues of “sham” citizen petitions, liability under the Sherman Antitrust Act, and …
By Kurt R. Karst – We’re not economists, but we’re interested in the topic insofar as it concerns Congress’ consideration of FDA-related legislation, such as H.R. 5651, the FDA Reform Act of 2012, which is on tap for consideration by the U.S. House of Representatives later …
By Kurt R. Karst – After days of debate and a slew of proposed amendments, the U.S. Senate passed S. 3187, the FDA Safety and Innovation Act, on Thursday afternoon by a roll call vote of 96-1. Senator Bernie Sanders (I-VT), who cast the lone vote against passage, …
By Kurt R. Karst – FDA’s recent approval of ANDAs for generic versions of sanofi-aventis’ (“sanofi’s”) blockbuster blood thinner drug PLAVIX (clopidogrel bisulfate) Tablets (approved under NDA No. 020839) upon the May 17, 2012 expiration of a period of pediatric exclusivity associated with Orange Book-listed U.S. Patent …
By Kurt R. Karst – A lot has happened since we last updated our Generic Drug Labeling Carve-Out Citizen Petition Scorecard in October 2011. At that time, AstraZeneca had only recently submitted two citizen petitions concerning quetiapine fumarate (SEROQUEL and SEROQUEL XR). Petitions, FDA decisions, lawsuits, …
By Kurt R. Karst – Following the recent decision by the U.S. Court of Appeals for the First Circuit in Bartlett v. Mutual Pharmaceutical Co., which our friends over at the Drug and Device Law Blog commented on as making no sense (“while a simple warning …
By Kurt R. Karst – On Tuesday, May 8th, the House Energy and Commerce Committee, Subcommittee on Health is scheduled to hold a markup session to consider draft legislation to ensure the continuation of existing FDA user fee programs (i.e., PDUFA and MDUFA) and the creation …
By Kurt R. Karst – In yet another decision out of the U.S. Court of Appeals for the Eleventh Circuit concerning patent settlements (or what opponents refer to as "pay-for-delay" deals), the Court affirmed a February 2010 decision by the U.S. District Court for the …
By Kurt R. Karst – Carrying through on his promise to introduce legislation to legislatively overturn the U.S. Supreme Court’s June 23, 2011 landmark decision in PLIVA Inc. v. Mensing, 131 S.Ct. 2567 (2011), Senator Patrick Leahy (D-VT), along with co-sponsor Sens. Al Franken (D-MN), Jeff …
By Kurt R. Karst – In a 2-1 panel decision handed down by the U.S. Court of Appeals for the Federal Circuit earlier this week, the Court affirmed a September 2010 Judgment on the Pleadings by the U.S District Court for the Southern District of New …
By Kurt R. Karst – The wait is over. In a unanimous decision delivered by Justice Elena Kagan (along with a concurring opinion from Justice Sonia Sotomayor) on April 17, 2012, the Court held in Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S that “[a] generic …
By Kurt R. Karst – Last Friday, ViroPharma Incorporated (“ViroPharma”) filed a Complaint and a Motion for Temporary Restraining Order And/Or Preliminary Injunction in the U.S. District Court for the District of Columbia challenging FDA’s approval of three ANDAs for generic versions of ViroPharma’s VANCOCIN (vancomycin …
By Kurt R. Karst – In what might be the longest citizen petition response of all-time (87-pages!), FDA, on April 9, 2012, largely denied a March 17, 2006 petition for stay of action (here and here) (Docket No. FDA-2006-P-0007) submitted by ViroPharma Incorporated (“ViroPharma”) concerning the …
By Kurt R. Karst – It was yet another exciting day in the Hatch-Waxman world when news broke Wednesday morning that Teva Pharmaceuticals USA, Inc. (“Teva”) and Cephalon, Inc. (“Cephalon”) filed a Complaint and Motions for a Temporary Restraining Order and Preliminary Injunction against FDA in …
By Kurt R. Karst – We recently got our hands on a copy of the latest report FDA submitted to Congress on citizen petitions covered by FDC Act § 505(q). The report, titled “Third Annual Report On Delays In Approvals Of Applications Related To Citizen …
