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Chad Landmon Discusses a Recent U.S. Court of Appeals Ruling with The Pink Sheet
March 8, 2010

On March 2, 2010, the U.S. Court of Appeals for the District of Columbia ruled against FDA’s interpretation of the 2003 amendments to the Food, Drug, and Cosmetic Act by finding that Teva was entitled to marketing exclusivity for its generic version of Merck’s hypertension drugs Cozarr and Hyzaar. Because of this ruling,  generic companies will no longer lose the 180-day marketing exclusivity because a brand name company delists a patent they have challenged. Chad Landmon, partner at Axinn, noted to The Pink Sheet that the ruling “shows the willingness by the D.C. Circuit to pay attention to Congressional intent and the impact of FDA’s decision on the balance struck by Hatch-Waxman.”

The article, titled, “ANDA Exclusivity Protected From Patent Delisting Under Appeals Court Ruling,” was published by The Pink Sheet on March 8, 2010.