Pharmaceutical Patent Compulsory License Under The Perspective Of Competition Law

Currently,public health crises occur frequently around the world,especially in developing countries.Pharmaceutical patents have created high price barriers while stimulating innovation,and affected the access to medicines.Many countries have chosen to issue pharmaceutical patent compulsory license to solve the problems.The grant of a pharmaceutical patent compulsory license is usually based on the patent law or competition law.The reason provided in the patent law is usually based on the public interest.In December 2005,Article 31bis was added to the TRIPS agreement in order to solve the public health problems.Subject to relevant conditions,WTO members may grant pharmaceutical patent compulsory license to domestic companies for manufacturing and exporting specific patented drugs to the "qualified importing member",which breaks through the limit of domestic market.However,the implementation of this mechanism also has many limitations.In reality,it has little effect on improving the access of poor countries to medicines.This thesis aims to analyze the pharmaceutical patent compulsory license under the perspective of competition law.There is no contradiction between the protection of pharmaceutical patents and the regulation of the anti-competitive behavior of patent owners under the competition law.Both are to promote competition and increase the efficiency of resource allocation.Article 31(k)of the TRIPS Agreement is the main international legal basis for granting the compulsory license to remedy anti-competitive behaviors.The thesis further discusses the advantages of implementing pharmaceutical patent compulsory license under the competition law.The compulsory licensing system under the competition law is advanced in the United States and the European Union.The United States mainly applies the "rule of reason" to analyze anti-competitive practices,while the EU adopts the "essential facilities doctrine".The refusal of IP holders to license their intellectual property would constitute anti-competitive practices only in exceptional circumstances.The European Court of Justice has developed standards of "new product" and "probability of eliminating all competition" in the IMS case and Microsoft case.The Merck case in Italy provided new ideas for granting pharmaceutical patent compulsory license based on the "essential facilities doctrine".South Africa's practices provided a reference for developing countries to issue pharmaceutical patent compulsory license in the circumstances of merger and where pharmaceutical patent holder abuse its dominant market position to set excessive prices and restrict competition.At the end of the thesis,it puts forward recommendations on the legislation and issuance of pharmaceutical patent compulsory license by Chinese authority under the competition law.The thesis proposes to establish a unified anti-monopoly authority which also has the authority to grant warrants for transferring indispensable technologies when necessary and to establish a system of judicial review and supervision.