Tomas Marta Cavero, Peng Bo
Intellectual Property, Ironwood Pharmaceuticals Inc., Cambridge, MA 02142, USA.
Intellectual Property, Editas Medicine, Cambridge, MA 02141, USA.
Pharm Pat Anal. 2017 Jul;6(4):161-170. doi: 10.4155/ppa-2017-0010. Epub 2017 Jul 11.
As the two leading markets for pharmaceutical and biotech companies, the USA and Europe offer incentives to stimulate drug innovation, including patent and regulatory exclusivities. These exclusivities extend periods during which companies can market their products free of generic or other competition and recoup their investment. Pharmaceutical and biotech companies should carefully assess the different types of exclusivities available when developing regulatory submissions, patent filing strategies. The authors have previously summarized the USA exclusivities in an earlier publication. This article focuses on European exclusivities. Due to space limitations, it focuses on small molecule drugs. Analogously to the format previously used, we have provided a cheat sheet of European exclusivities for small molecule drugs in Figure 1 .
作为制药和生物技术公司的两个主要市场,美国和欧洲提供激励措施以刺激药物创新,包括专利和监管独占权。这些独占权延长了公司可以在无仿制药或其他竞争的情况下销售其产品并收回投资的期限。制药和生物技术公司在制定监管申报、专利申请策略时应仔细评估可用的不同类型的独占权。作者曾在较早的一篇出版物中总结过美国的独占权。本文重点关注欧洲的独占权。由于篇幅限制,本文重点关注小分子药物。与之前使用的格式类似,我们在图1中提供了小分子药物欧洲独占权的速查表。