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创新和公平竞争是市场经济的两大主题。如何在保护专利权、激励创新、扶持自主创新、保证有效竞争等矛盾之中找到最佳平衡点,是我国知识产权和反垄断法律及政策面临的一个重要课题。而药品行业因其仿制药产品的存在成为知识产权领域研究的重点之一。其相关市场的界定及替代性程度分析对其他行业反垄断规制有较大的借鉴意义。药品行业反向支付协议涉及专利药厂和仿制药厂的利益平衡和价值转移,反映知识产权保护、反垄断原则以及公共利益的互动。2013年6月,美国联邦最高法院在Actavis案中否定了专利范围测试规则和本身违法原则,指出应当适用合理原则对反向支付进行个案合法性评估;欧盟委员会在Lundbeck案中首次对反向支付处以罚款。本文梳理了专利药与仿制药的相关市场界定以及反向支付在美国、欧盟和亚太地区的发展态势,通过评析Actavis案及Lundbeck案,探讨了美欧有关反向支付协议反垄断规制的分歧与调和,以及对我国的借鉴。
Innovation and fair competition are the two major themes of a market economy. How to find the best balance among the contradictions of patent protection, incentive innovation, independent innovation support and effective competition is an important issue for China’s intellectual property and antitrust laws and policies. The pharmaceutical industry has become one of the focuses in the field of intellectual property due to the existence of its generic drug products. The definition of the relevant market and the analysis of the degree of substitution have great reference to the antitrust regulation in other industries. The pharmaceutical industry reverse payment agreement involves the balance of interests and the value transfer of patent pharmaceutical factories and generic pharmaceutical factories, reflecting the interaction of intellectual property protection, antitrust principles and the public interest. In June 2013, the Supreme Court of the United States denied the test of the scope of the patent range test and its own principle of illegality in the Actavis case, pointing out that reasonable principles should be applied to evaluate the legality of reverse payments. The European Commission first conducted a case against reverse payment in the Lundbeck case Fined. This article reviews the related market definition of patented drugs and generic drugs as well as the development trend of reverse payment in the United States, the European Union and the Asia Pacific region. By analyzing the Actavis case and the Lundbeck case, this article explores the differences between the anti-monopoly regulations in the United States and Europe on reverse-payment agreements and Reconcile, and learn from our country.