title: Drug discovery market exclusivity after KSR: the challenge to pharmaceutical scientists and the US congress.
abstract: The Hatch-Waxman Act provides 180 days of market exclusivity to encourage generic companies to challenge the validity of pharmaceutical patents issued to innovator pharmaceutical companies. The consequent patent losses have been exacerbated owing to the application of holdings of the 2007 Supreme Court KSR decision to questions of pharmaceutical patentability by the judiciary and the US Patent Office. The resulting negative effect on support for new drug and formulation discovery by pharmaceutical scientists is discussed. To counteract the societal detriment of this negative effect, the adoption of a 12-year US Food and Drug Administration (FDA) market exclusivity paradigm for all approved new chemical entities including prodrugs is proposed. Such market exclusivities have already been enacted in the United States for follow-on biologicals and are in substantial harmony with those of the European Union, Japan, and Canada. An extension of the existing 3-year FDA market exclusivity for new formulations under 21 U.S.C. (United States Code) §505(b)(2) to 5 years should also be considered.
authors.affiliation: Intellepharm, Inc., Laguna Beach, California 92651-2809. Electronic address: drwolff@aol.com.
authors.forename: Manfred E
authors.initials: ME
authors.lastname: Wolff
mesh_terms: D035843:Biomedical Research / Q000191:economics / Q000331:legislation & jurisprudence*; D055808:Drug Discovery / Q000191:economics / Q000331:legislation & jurisprudence*; D004345:Drug Industry / Q000191:economics / Q000331:legislation & jurisprudence*; D016568:Drugs, Generic / Q000191:economics; D033161:Government Regulation; D007883:Legislation, Medical; D040541:Marketing / Q000331:legislation & jurisprudence*; D010330:Patents as Topic / Q000331:legislation & jurisprudence*; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D016568:Drugs, Generic