By Kurt R. Karst – On Tuesday, September 8, 2009 (just shy of the 25th anniversary of the September 24, 1984 enactment of the Drug Price Competition and Patent Term Restoration Act – i.e., the “Hatch-Waxman Act”), the U.S. Court of Appeals for the Federal …
By Douglas B. Farquhar – Pharmaceutical manufacturer Pfizer has agreed to the largest drug marketing settlement yet – $2.3 billion (yes, that is “billion” with a “b”) to resolve claims originally brought by six whistleblowers that the firm illegally marketed four drugs – according to …
By Kurt R. Karst – In a recent opinion, Judge Richard E. L. Strauss of the Superior Court of California, County of San Diego, granted motions for summary judgment ruling that Bayer AG and several generic drug manufacturers, including Barr Pharmaceuticals Inc., The Rugby Group, …
By David B. Clissold & Ricardo Carvajal – Five tobacco manufacturers including R.J. Reynolds Tobacco Company, Lorillard Tobacco Company, and Commonwealth Brands, Inc. (the second, third, and fourth largest tobacco manufacturers in the U.S., respectively), and a retailer of tobacco products have sued FDA in a …
By JP Ellison & Ricardo Carvajal – A Massachusetts district court has ordered marketers of calcium and herbal supplements touted as effective in preventing, treating, or curing diseases such as cancer, heart disease, and diabetes to pay $70 million in consumer redress. The court’s order dated …
By Ricardo Carvajal – In an apparent effort to leverage against the scientific resources of other federal agencies, FDA’s National Center for Toxicological Research (“NCTR”) has entered into a Memorandum of Understanding (“MOU”) that provides for the sharing of nanotoxicology information with the Air Force …
By Susan J. Matthees – After years of anticipation, FDA has finally published a final rule establishing a specific small number of animals for each of the seven major species for purposes of the Minor Use and Minor Species Animal Health Act of 2004 (MUMS Act). …
By David B. Clissold & Ricardo Carvajal – As required by the Family Smoking Prevention and Tobacco Control Act (“Tobacco Act”), FDA has established the Tobacco Products Scientific Advisory Committee (“TPSAC”) and is requesting nominations for voting and non-voting members. The Commissioner will select the …
By Kurt R. Karst – FDA’s recent response denying and granting in part two citizen petitions submitted by King Pharmaceuticals, Inc. (“King”) to FDA in September 2007 and January 2009 provides helpful guidance for companies developing generic versions of drug products containing a device component, such …
By Kurt R. Karst – The recent controversy over the approval of generic versions of Sanofi-Aventis U.S. LLC’s (“Sanofi’s”) colon cancer drug ELOXATIN (oxaliplatin) is one for the books and will most certainly go down in Hatch-Waxman lore. The story begins in 2007 with patent infringement …
Hyman, Phelps & McNamara, P.C.’s Kurt R. Karst will be speaking at two upcoming conferences on various Hatch-Waxman issues. The first conference is the American Conference Institute’s (“ACI’s”) popular Maximizing Pharmaceutical Patent Life Cycles (10th Anniversary Edition), and is scheduled for October 6-10, 2009 at …
As directed by the Family Smoking Prevention and Tobacco Control Act (“Tobacco Act”), FDA has created its new Center for Tobacco Products (“CTP”). CTP will be led by Dr. Lawrence Deyton of the George Washington University School of Medicine and Health Sciences. FDA’s press release …
By Susan J. Matthees– The United States District Court for New Jersey recently denied a motion by the Federal Trade Commission (“FTC”) to hold Lane Labs-USA, Inc. (“Lane Labs”), Andrew Lane, and William Lane in contempt for allegedly violating a consent decree. Lane Labs entered into …
By Kurt R. Karst & Frank J. Sasinowski – A Senate floor amendment to the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act of 2010 (H.R. 2997) would establish within FDA two new review groups to recommend solutions for the prevention, diagnosis, …
By JP Ellison – With the seemingly endless flow of news reports announcing yet another unsealed False Claims Act (“FCA”) case, and the regular announcement of FCA settlements for what would have only a few years ago been unheard of amounts, it is easy to …
