Intellepharm, Inc., Laguna Beach, California 92651-2809.
J Pharm Sci. 2011 Aug;100(8):3044-3054. doi: 10.1002/jps.22564. Epub 2011 Apr 6.
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.
《 Hatch-Waxman 法案》提供了 180 天的市场独占期，以鼓励 generic 公司对创新型制药公司发布的药品专利的有效性提出质疑。由于 2007 年最高法院 KSR 裁决的持有量被司法机关和美国专利商标局应用于药品可专利性的问题，因此导致了专利损失的加剧。讨论了这对制药科学家对新药和制剂发现的支持产生的负面影响。为了抵消这种负面影响对社会造成的损害，建议为所有批准的新化学实体（包括前药）采用为期 12 年的美国食品和药物管理局（FDA）市场独占性范式。这种市场独占性已经在美国对后续生物制品生效，并且与欧盟、日本和加拿大的市场独占性基本一致。还应考虑将现有根据《美国法典》第 21 篇第 505(b)(2)节对新配方的 3 年 FDA 市场独占性延长至 5 年。
