陈兴平 吴红丽 李梦景 陈丽君

摘要：Bolar例外也称Bolar豁免，是一项专门适用于产品上市申报的专利侵权豁免原则，其在美国医疗器械专利侵权纠纷中得到广泛应用，成为美国塑造医疗器械良性市场竞争环境，促进医疗器械行业持續创新的政策利器。本文结合美国Bolar例外政策由来以及美国医疗器械Bolar例外专利侵权纠纷司法判例，剖析美国医疗器械Bolar例外政策立法目的及适用标准，认为美国医疗器械Bolar例外政策立法初衷在于，寻求创新与仿制的利益平衡，塑造医疗器械良性市场竞争环境，为社会公众提供更优质的医疗资源，满足患者可及性问题。

关键词：Bolar例外侵权豁免  利益平衡  上市监管

Abstract：Bolar exception， also known as Bolar exemption， is a patent infringement exemption principle specially applicable to product listing declaration. It has been widely used in medical device patent infringement disputes in the United States and has become a policy weapon for the United States to shape a benign market competition environment for medical devices and promote sustainable innovation in the medical device industry. Combined with the origin of American borar exception policy and the judicial precedents of American medical device borar exception patent infringement disputes， this paper analyzes the legislative purpose and applicable standards of American medical device borar exception policy， and holds that the original intention of American medical device borar exception policy legislation is to seek the balance of interests between innovation and imitation， and create a benign market competition environment for medical devices， Provide the public with better medical resources to meet the accessibility of patients.

Key word：Borar exception  Infringement Exemption Principle  Balancing Of Interest pre-market supervision

Bolar例外始于美国Roche Product Inc.v.Bolar Pharmaceutical Co案，在1984年Hatch-Waxman法案中固化成文。目前Bolar例外已被欧盟、日本、韩国、加拿大、阿根廷、以色列、马来西亚等多个国家或地区均采用。虽然我国2008年正式引入Bolar例外，但其具体如何适用并没有在《专利法》、《专利法实施细则》以及最高院各部审理专利侵权案件司法解释给出明确指示。本文结合美国Bolar例外政策由来以及美国医疗器械专利侵权豁免纠纷的司法判例，剖析美国医疗器械Bolar例外政策的立法初衷及适用标准，为我国医疗器械Bolar例外政策的相关法律法规及配套政策的制定及完善提供参考。

1.美国Bolar例外政策确立初期未将医疗器械纳入适用范围

美国根据Hatch-Waxman法案修订专利法，在第271条（e）中规定Bolar例外：在美国境内制造、使用、许诺销售、销售或进口发明专利药品、兽医生物产品，仅用于研究或提供根据联邦关于制造、使用或销售联邦法律所需监管信息的，不属于侵权行为。……