药品专利反向支付协议的反垄断规制——欧美的经验与启示

Antitrust Regulation on Reverse-payments of Pharmaceutical Patent——Experience and Implications from EU and USA

反向支付协议客观上具有维持药品价格超竞争水平的效果,极易构成以牺牲消费者利益为代价的横向垄断协议。我国横向垄断协议的规制原则不明确,援引至反向支付协议反垄断规制时存在重大分歧,而反向支付协议的特殊性使该问题进一步复杂化。比较法视野下,欧盟混合分析方法侧重于审查价值转移的合理性,其假定前提因未考虑基础专利的强阻碍作用而存有瑕疵。美国合理原则将专利诉讼的可能结果和反向支付的必要性作为考量因素,可有效弥补混合分析方法的缺陷。因此,对反向支付协议反垄断规制时,可将药品专利依据专利强度一分为二:基础专利和次级专利,结合我国反垄断法制度体系、实施体制和药品产业现状综合判断,分别借鉴美国合理原则和欧盟混合分析方法,以实现竞争利益的内部平衡。在外部平衡层面,缔约方可基于个案豁免原则适用比例原则限制下的公共政策抗辩。

Reverse-payment agreements have the objective effect of keeping the drug price beyond the competitive lev⁃el,which may readily form horizontal monopoly agreements at the expense of consumers'interests.In China,the regu⁃latory principle of horizontal agreements is not clear,and there are significant disagreements when the anti-monopoly regulation of reverse payment agreement is cited,the particularity of reverse-payment agreements further complicates the problem.From the perspective of comparative law,the European hybrid approach focuses on examining the ratio⁃nality of value transfer,and its assumption premise is flawed without considering the strong blocking effect of primary patents.The rule of reason of the United States takes the possible outcome of patent litigation and the necessity of re⁃verse-payment as consideration factors,which can effectively make up for the deficiency of the hybrid approach.Therefore,in the antitrust regulation on reverse-payment agreements,drug patents can be divided into two parts ac⁃cording to patent strength:primary patents and secondary patents.Based on the comprehensive judgment of China's an⁃titrust law,the implementation system and status quo of pharmaceutical industry,the United States rule of reason and the European hybrid approach are taken respectively as references to achieve the internal balance of competing inter⁃ests.At the level of external balance,the contracting parties can apply the counterplea public policy under the princi⁃ple of proportionality based on the principle of individual immunity.