By Kurt R. Karst – Just days after Judge Claude M. Hilton of the U.S. District Court for the Eastern District of Virginia (Alexandria Division) issued his opinion and order vacating the Patent and Trademark Office’s (“PTO’s”) denial of a Patent Term Extension (“PTE”) for …
By Jamie K. Wolszon & David B. Clissold – FDA published two Federal Register notices Friday, March 19th related to its oversight and regulation of cigarettes and smokeless tobacco, including a much heralded final rule to restrict the sale of cigarettes and smokeless tobacco to …
By Kurt R. Karst & Dara Katcher Levy – Last week, FDA issued Warning Letters (here and here) to Glenmark Generics (“Glenmark”) and Konec Inc. (“Konec”) for marketed unapproved and misbranded 0.3 mg, 0.4 mg, and 0.6 mg nitroglycerin sublingual tablets. According to the letters, …
By John A. Gilbert – The UN Commission on Narcotic Drugs (“CND”) held its 53rd meeting last week in Vienna, Austria. This meeting routinely coincides with the publication of the International Narcotics Control Board’s (“INCB’s”) annual report. The INCB report provides an annual summary of …
By Kurt R. Karst – It has been quite a wild ride since a 3-judge panel of the D.C. Circuit issued its March 2, 2010 opinion ruling that FDA’s interpretation of the 180-day exclusivity forfeiture provision at FDC Act § 505(j)(5)(D)(i)(I)(bb)(CC) fails at Chevron step one …
By Kurt R. Karst – In a March 16, 2010 opinion and order, Judge Claude M. Hilton of the U.S. District Court for the Eastern District of Virginia (Alexandria Division) vacated the Patent and Trademark Office’s (“PTO’s”) denial of a Patent Term Extension (“PTE”) for U.S. …
By Riëtte van Laack – For several years, the Consumers Union and the Organic Consumers Association (“Petitioners”) have urged the U.S. Department of Agriculture (“USDA”) to require that personal care products that use the term “organic” in product labeling comply with the requirements of the Organic …
By Kurt R. Karst – FDA’s recent response to a 2009 citizen petition filed by Sandoz, Inc. concerning the appropriate certification to certain Orange Book-listed patents for Takeda’s ACTOS (pioglitazone HCI) Tablets and ACTOPLUS MET (pioglitazone HCl; metformin HCI) Tablets can be summed up in …
By Kurt R. Karst – Just one day after FDA Commissioner, Dr. Margaret Hamburg, testified last week before the U.S. Senate Committee on Appropriations, Subcommittee on Agriculture, Rural Development, FDA, and Related Agencies on FDA’s Fiscal Year 2011 budget request, which includes new user fees, …
By Ricardo Carvajal – During a webinar on immunity claims sponsored by the Food and Drug Law Institute, Richard Cleland, Assistant Director of FTC's Division of Advertising Practices, confirmed that enforcement actions are in the works against probiotic products that make inadequately substantiated claims. FTC …
By Susan J. Matthees – A new preemption decision has just come down from a California appeals court (the sixth circuit appellate district). In two consolidated cases, McGuan v. Endovascular Technologies, Inc., et al. and Johnson v. Endovascular Technologies, Inc., the appeals court upheld a lower …
By Kurt R. Karst – FDA’s recent announcement that the Agency approved IMPAX Laboratories, Inc.’s (“IMPAX”) ANDA No. 90-377 for the first generic version of Boehringer Ingelheim Pharmaceuticals, Inc.’s (“BI”) popular ($2.1 billion/year) treatment for benign prostatic hyperplasia, FLOMAX (tamsulosin hydrochloride) Capsules, has an interesting …
By Nisha P. Shah and Ricardo Carvajal – The title of a report issued by the U.S. Government Accountability Office (“GAO”) neatly sums up that agency’s perspective: “FDA Should Strengthen Its Oversight of Food Ingredients Determined to Be Generally Recognized as Safe (GRAS).” The report …
By Kurt R. Karst – FDA’s recent approval of Nycomed U.S., Inc.’s ANDA No. 78-548 for a generic version of ALDARA (imiquimod) Cream, 5%, appears to be the first instance in which FDA has determined that a first ANDA applicant is eligible for 180-day exclusivity …
By Kurt R. Karst – The U.S. District Court for the Eastern District of Michigan (Southern Division) recently dismissed without prejudice a Complaint filed by Wyeth and granted a Motion to Dismiss filed by Sun Pharmaceutical Industries, Ltd. and Caraco Pharmaceutical Laboratories, Ltd. (“Sun”) in a Lanham Act …
