Expert Opin Ther Pat. 2013 Aug;23(8):915-8. doi: 10.1517/13543776.2013.813935. Epub 2013 Jul 6.
The Biologics Price Competition and Innovation Act provides a pathway for regulatory approval of generic drugs and the associated patent challenge. This article reviews strategic considerations during the patent litigation and injunction phases. Considerations during the initial patent litigation phase include when and whether to exchange a paragraph k application and the listing and exchange of patent information during the volley phase.
《生物制品价格竞争与创新法案》为仿制药的监管批准和相关专利挑战提供了途径。本文回顾了专利诉讼和禁制令阶段的战略考虑因素。在初始专利诉讼阶段需要考虑的因素包括何时以及是否提出 Paragraph k 申请，以及在交锋阶段列出和交换专利信息。
