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This report originally appeared in the April 2010 issue of DOTmed Business News
Teva Pharmaceuticals USA, Inc., (Teva) a generic drug manufacturer, has prevailed in a Federal Court of Appeals decision in the District of Colombia Circuit. Teva had sued over an interpretation of a Congressional incentive in federal law 21 U.S.C. 355 that allowed companies to bring generic versions of branded drugs to market more swiftly. Teva had received tentative approval from the U.S. Food and Drug Administration (FDA) to sell losartan potassium products (used for hypertension). After Merck's brand patent expires in April, the approval would be final. Teva asserts that it is then entitled to a six-month period of marketing exclusivity provided in the law.
A generic manufacturer can challenge through certification that the generic version doesn't violate a patent because of the generic design or because of the invalidity of the brand patent. That challenge carries the risk of litigation over patent infringement. The law in 21 U.S.C. 355 compensates generic manufacturers for those risks by providing that the first company to file an Abbreviated New Drug Application with the certification earns the 180-day "exclusivity" period, during which the FDA can't approve other competing generic versions of the drug. However, the FDA has interpreted the laws to allow events that would trigger a forfeiture of the exclusivity. Teva sued for a declaration that the FDA policy is unlawful, and an injunction compelling the FDA to act in accordance with Teva's position. The District Court had ruled in the FDA's favor.
The Appellate Court overturned that decision. According to the Appellate Court, Teva challenged the FDA policy that allows a brand manufacturer's request to "delist" a challenged patent-which would trigger the statutory "forfeiture event" negating the exclusivity provision. The delisting then deprives the generic applicant of the marketing exclusivity and thereby diminishes the incentive to challenge a patent. The Appellate Court found that the FDA's interpretation is inconsistent with the original Congressional statutory scheme, and remanded the case for further action.
