Study On Antitrust Regulation Of Reverse Payment Agreement

The reverse payment protocol is a topic that has been paid attention to in recent years.It comes from drug patent litigation,which is signed between patent pharmaceutical enterprises and counterfeit pharmaceutical enterprises.As to how to regulate this special agreement on the market,there are many cases which can be used for reference in the United States and the European Union.China has not yet appeared similar cases at present.However,as a big country of generic medicine,China is also working hard to advance the research and development of patent medicine.China's trade is becoming more and more frequent,and it is possible for Chinese enterprises to touch such agreements,thus triggering a lawsuit.In order to avoid being unprepared in such cases,it is necessary to make a deep study of the problem in order to perfect the loopholes in the present work.The first two parts of the article are mainly discussed from a theoretical point of view,and the latter three parts are analyzed from the perspective of practice.The article first briefly combs the background of the payment agreement,especially the cause of the reverse payment under the special patent system in the United States.In the field of drug market in the United States,the competition between generic and patent medicines has been kept in the fight to make the vitality of the copy drug able to be stimulated.Enough to enjoy cheaper drugs,the birth of the Hatch-Waxman bill.The emergence of the bill greatly stimulated the enthusiasm of the imitation pharmaceutical enterprises,and began to seize opportunities and develop vigorously.The patent medicine enterprises that had been dominant were seriously threatened.In the process of seeking their own development,a reverse payment protocol was gradually generated.Because the reverse payment agreement is generated under certain background,so it has its rationality,but it has been controversial in practice.Then it introduces the basic situation of the reverse payment agreement of the typical American case Actavis case,which leads to the discussion of the reasonableness of the existence and the different views of the parties.The second part of the article focuses on the analysis of the reverse payment agreement,which needs to be regulated by the anti-monopoly law.Starting from the definition and forming conditions of the reverse payment agreement,it analyzes the risk of its violation of the anti-monopoly law.On the surface,the reverse payment agreement is a proprietary patent for the patent pharmaceutical enterprises to exercise its exclusive patent right.It is completely not in violation of the law to exclude other pharmaceutical enterprises from the market.But after further analysis,it will be found that in a certain case,the reverse payment agreement obstructs the early entry of the generic drug into the market.The possibility of welfare for patients is not conducive to healthy competition in the market.The patent law is responsible for conferring power.When power is abused,it is beyond the scope of patent law.Then it discusses the basis for the regulation of the reverse payment agreement by the antitrust law.The original intention of the law is to emphasize the maintenance of the public interests,protect the overall economic interests and the interests of the people to coordinate the development of the anti payment agreement,and it is illegal to evaluate the counter payment agreement.It has its theoretical basis.The third part of the article,starting with the regulation of the reverse payment protocol,focuses on the difficulties faced by the evaluation of its antitrust law,such as the difficulty of balancing and choosing the multiparty value interests,and thecomplexity of the reverse payment agreement,so it is difficult to identify the anti competitive agreement.In order to clarify the dilemma of regulation,we should draw lessons from foreign experience more clearly.The fourth part of the article draws on the experience of the European and American countries in the anti-monopoly regulation of the reverse payment agreement.The United States is the first country to produce the reverse payment agreement,and so far has accumulated a lot of this case.In the current cases in the United States,there is a difference in the attitude that is applied when dealing with the reverse payment agreement,not in a district or not a level,and the principles that are used are different.In this part,we introduce the idea of applying different principles in combination with cases,and make a brief analysis of them.Although the European Union does not have a bill similar to the Hatchie-wex act of the United States,the development of its reverse payment agreement has also been developed rapidly,and a lot of relevant experience has been accumulated.But the attention also greatly promote the progress of the investigation.The last part of the article is about effective response to possible reverse payment in China,first of all,discuss the necessity of intervention.Due to the late appearance,there is no special provision for special agreements in the field of medicine in China.In view of the fact that there is no case of antitrust investigation in China at present,there is still no experience in the relevant anti-monopoly law enforcement.In general,there are still a lot of shortcomings in our legislation and law enforcement work in this respect.China's generic drug market now occupies a considerable position.Almost 90% of the new drugs that we can buy on the market are generic drugs.The better development of generic drugs is of great benefit to everyone.In the face of the patent period of a large number of patent drugs,China's pharmaceutical industry is facing both opportunities and challenges.Therefore,China should improve the antitrust review mechanism of drug patents as soon as possible,and timely find and control the anti competitive agreements in order to promote the healthy development of the pharmaceutical market in our country.Finally,combined with the actual situation of our country,we put forward corresponding suggestions in this regard.