专利与药品监管不断变化的功能平衡。

The shifting functional balance of patents and drug regulation.

作者信息

Eisenberg R S

机构信息

University of Michigan Law School, Ann Arbor, USA.

出版信息

Health Aff (Millwood). 2001 Sep-Oct;20(5):119-35. doi: 10.1377/hlthaff.20.5.119.

DOI:10.1377/hlthaff.20.5.119

PMID:11558697

Abstract

Patents are often portrayed as the necessary reward to compensate pharmaceutical firms for the huge costs and risks associated with Food and Drug Administration (FDA)-mandated clinical trials of new drugs. But the relationship between the patent system and other regulation of drugs is more complex than this simple formulation suggests. Drug regulation operates in tandem with patents to make proprietary products profitable, and patents themselves increasingly threaten to limit profitability by diverting profits elsewhere. At the same time, resistance to high drug prices is prompting new state and federal regulatory initiatives that threaten to reduce the value of drug patents. The distinctive intertwining of patents with other regulatory regimes and the shifting role of patents in the biopharmaceutical sector call into question how this singular success story for innovation policy will play out in the future.

摘要

专利常常被描绘成一种必要的奖励，用以补偿制药公司在食品药品监督管理局（FDA）强制要求的新药临床试验中所承担的巨额成本和风险。但专利制度与药品其他监管措施之间的关系，比这种简单表述所暗示的更为复杂。药品监管与专利协同运作，以使专利产品盈利，而专利本身却越来越有可能通过将利润转移到其他地方，从而威胁到盈利能力。与此同时，对高药价的抵制正促使州和联邦出台新的监管举措，这些举措可能会降低药品专利的价值。专利与其他监管制度独特的交织以及专利在生物制药领域不断变化的作用，让人质疑这一创新政策的非凡成功故事在未来将如何发展。