Replication Data for: Post-Grant Adjudication of Drug Patents: Agency and/or Court?

The America Invents Act of 2011 (“AIA”) created a robust administrative system—the Patent Trial and Appeal Board (“PTAB”)—for challenging the validity of granted patents. Congress determined that administrative correction of errors made in initial patent grants could be cheaper and more scientifically accurate than district court litigation over patent validity. In terms of private economic value per patent, few areas of technology can match the biopharmaceutical industry. Particularly for small molecule drugs, a billion-dollar drug monopoly may be protected from competition by a relatively small number of patents. Accordingly, the social cost of invalid patents—and, by extension, the potential benefit of PTAB review—is particularly acute in the biopharmaceutical industry. Conversely, to the extent that PTAB is overly assertive and improperly targets high-quality patents, the decrease in innovation incentives may be quite problematic. To investigate the issue empirically, our paper uses a novel dataset (made publicly available via the publication of this article) to study the respective roles of the PTAB and the district courts

2011年《美国发明法案》（America Invents Act of 2011，简称AIA）设立了一套完善的行政体系——专利审判与上诉委员会（Patent Trial and Appeal Board，简称PTAB），用于对已授权专利的有效性提出质疑。国会认定，相较于针对专利有效性的地区法院诉讼，通过行政程序纠正初始专利授权中的错误，成本更为低廉且科学性更具严谨性。从单专利的私人经济价值维度而言，几乎没有技术领域能与生物制药行业比肩。尤其是小分子药物领域，市值数十亿的药品垄断地位或许仅依靠为数不多的数项专利，就能免受竞争冲击。由此，无效专利所带来的社会成本——以及延伸而言，PTAB审查的潜在收益——在生物制药行业中尤为突出。反之，若PTAB过于激进，不当针对高质量专利，则创新激励的削弱可能会引发极为严重的问题。为实证研究这一议题，本文采用一套全新的数据集（将随本文发表公开获取），探究PTAB与地区法院各自的职能作用。