Anti-monopoly Regulation Of Reverse Payment Behavior In The Pharmaceutical Industry

The pharmaceutical industry has become a patent-intensive industry due to its high cost of product development,long time-consuming research and development,and high risk of clinical trials.Encourage the research and development of the pharmaceutical industry and promote the development of medical care in various countries.However,the strong dependence of the pharmaceutical industry on patent protection has indirectly led to the emergence of an absolute monopoly anti-competitive phenomenon in some pharmaceutical products in the pharmaceutical industry.The uniqueness of the pharmaceutical industry determines the need for intellectual property protection.However,the excessive use of patent rights by patent holders will inevitably lead to the abuse of intellectual property rights,limit fair competition in the market,and deprive consumers of the right to purchase medicines at reasonable prices.Therefore,how to find a balance between free competition and patent innovation,patent innovation protection and public health protection is the key and difficult problem faced by countries in the regulation of medicine in the future.The reverse payment behavior first appeared in the United States,and it was accompanied by the emergence of the ? Hatch-Waxman Act 1984 ?.In the patent litigation,the patented pharmaceutical enterprise as the patentee enjoys the absolute monopoly price of the patented drug,and once the generic drug produced by the generic drug enterprise enters the market,it will inevitably affect the market control power of the patented drug enterprise,causing the drug price to fall.The reverse payment agreement is a patent settlement agreement between the patented drug company and the generic drug company based on the principle of mutual benefit.By granting certain economic value or economic benefits to the generic drug companies,the patented pharmaceutical companies will enter the market for a certain period of time,and the patented pharmaceutical enterprises can maintain the monopoly high price through the agreement,and the generic drug enterprises can obtain high economic benefits.A seemingly reasonable economic agreement between a patented drug company and a generic drug company actually harms the rights of consumers and undermines the market competition order.Therefore,it has attracted the attention of the US Federal Trade Commission.In judicial practice,different courts in the United States use different censorship principles to identify reverse payment associations.They mainly use their own illegal principles and reasonable principles to determine that patentexclusion tests and fast principles have been applied in different courts in different cases,but the author believes that The two methods of review are also based on their own illegal principles and reasonable principles.In the law enforcement practice,the United States and the European Union have gradually formed a review method based on reasonable principles.Up to now,China's anti-monopoly law enforcement agencies have not yet imposed penalties for reverse payment behavior,but this does not mean that there is no monopolistic incentive for reverse payment behavior in China.On the contrary,China is a large country producing and using generic drugs,many major diseases.The use of drugs depends on imports.Under the current situation of such industries and the lack of relevant laws,the reverse payment behavior has the possibility of inducing in China.In the future,China will also face the problem of how to balance between free competition and patent innovation,patent innovation protection and public health protection.In addition,how to regulate the monopoly problem induced by reverse payment behavior,China should fully draw on the law enforcement practice outside the domain,and should also combine the development status of the domestic pharmaceutical industry,engage in ex ante or ex post suggestions and legislation,justice,law enforcement,industry.Associations,policy guidance and other aspects comprehensively put forward suggestions for improving China's regulation of reverse payment behavior,with a view to improving the development speed of China's pharmaceutical industry,and efforts to promote innovation and safeguard the public interest of consumers.