| The drug patent link system originated from the US Hatch-Waxman Act of 1984,which links the patent infringement by approving the generic drug application.The system not only solves patent disputes before the listing of generic drugs,but also effectively protects the legal rights of patented drugs.At the same time,it encourages generic drugs to challenge patents,challenges the success of the morning market,and challenges the successful first generic drugs to obtain a data protection period.Exclusive dividend.It can be seen that the drug patent link system not only balances the interests of patented drugs and generic drugs,but also promotes the common development of both,and also improves the system efficiency and reduces social costs in the registration application stage.The drug patent link system is a major innovation in drug policy.The release of a series of drug policies in 2017 means that China has changed “low level and weak protection” and “formally established a high-level,strong protection” drug patent link system,which will It has a profound impact on the corporate interest pattern of generic drugs and patented drugs in China.However,the successful implementation of the drug patent link system in China is also facing the institutional dilemma that needs to be solved:(1)institutional theoretical basis;(2)the necessity of institutional establishment(3)The system is linked to the existing legal system.In view of the theoretical basis of the system,this paper explains the theoreticalbasis of the "balance of interests" from a new perspective-the balance effect of institutional factors.In addition,this paper proposes that “improving efficiency” is also the theoretical basis of the system,supplementing the lack of research on the theoretical basis of the system.It is believed that the system will solve the patent disputes before the listing,which will improve the efficiency of the system and save the judicial and social costs.In view of the necessity of establishing the system,this paper participates in the discussion through a new perspective and new materials-the actual needs of judicial practice.By examining the patent disputes of several typical drug registration application periods in 2018,it was found that: First,the CFDA lacks legal basis for handling patent infringement objections during the registration application phase;second,the court's patent infringement lawsuit at the registration application stage cannot be substantive.Trial;third,the temporary injunction before the complaint can not meet the special needs of the drug as soon as possible,resulting in unreasonable delays in the listing of generic drugs.The patent link system provides a solution to the difficulties of judicial practice.In view of the necessity of establishing the system,this paper starts with the actual needs of the development of China's generic drug industry.First,recognizing that the actual demand for the development of the generic drug industry is to improve the ability to innovate;second,recognizing that the actual demand for the development of generic drugs is to protect its interests,especially the increasing innovation capacity of China's generic pharmaceutical companies,and the peak of patents is coming.The opportunity,the patent link system,the first imitation drug data protection period to stimulate and protect the successful generic drugs at the legislative level,effectively protect the interests of generic drugs,in line with the actual needs of the development of generic drugs to protect their interests.In view of the necessity of establishment,this paper analyzes the detailed design of China's pharmaceutical patent link system,and believes that the detailed design of China's patent link system reflects the protection of the interests of generic enterprises:First,CFDA has discretion to approve the waiting period,so that The curb effect of China's approval waiting period is adjustable,avoiding the abuse of the approval waiting period by patented pharmaceutical companies and the malicious delay of listing of generic drugs through patent challenge litigation.Second,the protection period of China's first generic drug data is 1.5 years.2 times in South Korea and 3times in the United States,the first generic drug companies have been given more guarantees and incentives in China's patent linking system,which is conducive to China's generic pharmaceutical companies to accumulate funds,further improve their ability to innovate,and form a virtuous cycle of industry.After deducing the necessity of establishing the drug patent link system in China,it is necessary to further solve the specific problem of the implementation of the system in China,that is,the second institutional dilemma of the drug patent link system-the connection with China's existing legal system.problem.There are three main problems in the existing system of China and the system:(1)The provisions of the patent registration system in the Catalogue of Listed Drugs in China cannot meet the requirements for the accuracy of patent registration in the patent linking system;b)The Bolar Exception in China's Patent Law makes the legal basis for the lack of prosecution of patent challenge litigation;(3)The ineffectiveness of the patent dispute resolution mechanism of the dual division of our national bank leads to the failure of the function of the approval waiting period system.The third chapter of this paper studies the establishment of the registration system of drug patent information and patent links in the Catalogue of Listed Drugs in China.The provisions of the Catalogue cannot guarantee that the accuracy of the patent registration information will lead to the convergence of the two.According to the existing "Catalogue Collection" regulations in China,the main reasons are as follows: First,the "Registration Collection" patent registration rules are rough,there are no specific administrative implementation rules for the patent registration review rules,and the administrative objections to the wrong registration are corrected.The procedures and judicial relief procedures are not clearly defined.Second,the CFDA'sterms of reference are limited to administrative management and do not include substantive examination of patents.The accuracy of patent registration with the Catalogue,especially the examination of registered patent types,necessarily requires CFDA to There are natural contradictions in the review.On the basis of fully studying the American system,this paper combines the relevant laws and policies of drugs that are currently being formulated and solicited in China,and proposes specific measures for(1)the specific rules of China's drug patent registration system and(2)administrative objections and judicial remedies for wrong registration.Suggest and demonstrate feasibilityFor the construction of the specific rules of the Catalogue of Patent Registration System,the following four key factors should be considered: First,the general rule of increasing the “association” of patent registration can not only make up for the shortcomings of unresolved patents that are not specified,but also It can make up for the limitation and non-permanence of the statute method enumeration method,and flexibly adapt to the new development and new changes of the pharmaceutical industry.Second,the written guarantee is added to the patent registration application form,so that the patent drug right holders are listed in the "China Listed Drug List".The responsibility for the authenticity and accuracy of the information in the article is as follows.Third,increase the form of registration of the patent registration application form “yes or not”,so as to strictly enforce the patent information registration procedure,clarify the patent status,and avoid patent escaping and avoiding patents.Practical use;Fourth,strengthen the functional links between SIPO and CFDA.For technical problems,CFDA can submit SIPO filing consultations,and according to the results of the filing consultation,the registration of patents is deleted to ensure the accuracy of the registered patents.In view of the administrative objection and judicial relief rules for the incorrect registration of the Catalogue,this paper studies the 2016 FDA's latest administrative regulations MMA Final,and believes that the following two key elements should be emphasized: First,the administrative objection to the wrong registration It is proposedthat China's CFDA passively corrects,and can also take the initiative to check and make decisions on the patent information with the patent administration authority under the State Council.In addition,the administrative registration procedure for wrong registration can refer to the MMA Final,and the request and the dissident are submitted by the dissidents.Declare the specific reasons for disagreement that is registered or not registered,and improve the efficiency of objection.Second,the judicial relief procedure for wrong registration.The "countersuit clause" in the US judicial relief clause can be understood in the judicial practice of China.In the patent challenge litigation,the generic drug company can propose to the court to "correct or delete" the registered patent information.However,in the patent trial in China Under the system of dual separation of the people,the court could not hear the claim.If China conducts a trial of the unification of the people's bank in the trial of patent challenge cases in the Beijing Intellectual Property Law Court,the judicial remedy for the wrong registration of the “countersuit clause” may be realized in China.The fourth chapter of this paper studies the connection between patent challenge litigation and the Bolar exception of the Patent Law.Because of the particularity of the patented challenge litigation infringement: "manufacturing,use behavior" falls into the Patent Law Bolar exception and is considered non-infringement,"submission of registration application" does not fall under Article 11 of the Patent Law According to the provisions of the Patent Law,the patentee cannot initiate a patent challenge lawsuit,which leads to the problem of convergence between the two.The United States has solved this convergence problem through a “artificial infringement”.However,the US law practice study on the “prescribing application system” found that although the “application behavior” in the United States provides a legal basis for patent link litigation,“proposed system for infringement” does not clarify the “place of occurrence” of the act,the patentee Abuse of jurisdictional rules leads to “choice of the court”.In recent years,the United States has proposed a centralized jurisdiction for the abuse of jurisdictional rules in the proposed infringement system.China has introduced a “artificial infringement” and conflicts with the existing patent infringement rules in China.It is mainly reflected in two points: First,the court of the defendant's domicile may have violations of judicial justice.The defendant's domicile is under the jurisdiction of the court.There may be violations of judicial justice,especially the patent tort trial and the patent administrative trial separation.Secondly,the "Several Provisions of the Supreme People's Court on the Application of Legal Issues in the Trial of Patent Dispute Cases" did not regard "submission to Beijing as a place of infringement",resulting in a lack of legal basis for the jurisdiction of Beijing Intellectual Property Court.In response to the resolution of the conflict between the “artificial infringement”and the jurisdictional rules of China,this paper suggests: First,the Supreme Court issued a judicial interpretation to amend the “Several Provisions of the Supreme People's Court on the Application of Laws in the Trial of Patent Dispute Cases”,and submit the generic drugs.Beijing applied for as a place of infringement;secondly,the patent challenge litigation was placed under the centralized jurisdiction of the Beijing Intellectual Property Court,not only because of the advantage of the Beijing Intellectual Property Court's function “People's Bank Two-in-One”,but also in line with the characteristics of patent challenge litigation and general principle of litigation jurisdiction.The fifth chapter of this paper studies the connection between the binary separation system of patent trials and the patent links in China.The dualistic three-dimensional system of the patent trial of patent trials established in China for fair trials inevitably leads to lengthy judgments.However,the efficiency of court trials plays a decisive role in the effectiveness of the approval waiting period: the low trial efficiency leads to the effective judgments being made after the approval waiting period.The approval waiting period only curbs the listing of generic drugs,and does not play a role in solving the disputes in advance to speed up the listing of generic drugs,thus affecting the realization of the interests of the drug patent link system,leading to the convergence of the two.This paper first analyzes the judicial changes in the existing dual-dimensional system of the People's Bank of China to improve the efficiency of trials,and whether it can solve the problem of convergence.First,“first refusal,separate prosecution”,but can the ruling of “rejection of prosecution” be used as the basis for ending the approval waiting period? And the 42 and 55 documents have different provisions for the end of the approval waiting period: the former contains the effective judgment,the ruling and the mediation;the latter only contains the effective judgment.Does the former ruling contain a “ruling to refusal of prosecution”? Through the experience of the US patent link system,the author believes that the ruling and the judgment should be made in the substantive trial of the court.Since the ruling of dismissal of the prosecution is not made through substantive trials,it is not the legal basis for ending the approval waiting period.Therefore,"first bargaining,separate prosecution" cannot solve the problem of convergence.The invention patent "cannot be suspended" can improve the efficiency of trials,and theoretically can solve the problem of convergence to some extent.However,the premise of the judicial interpretation is that the invention patent has high stability and is unlikely to be declared invalid.However,the patent for drug invention,especially the patent invention patent for patent challenge litigation,is highly unstable and may be invalidated.Sexuality is large,so in practice,judges tend to “substantially not stop”,so they cannot really improve the efficiency of trials,and the judicial interpretation cannot solve the problem of convergence.Under the premise that the judicial practice of the dual division mechanism of our nationality to improve the efficiency of trials cannot solve the problem of convergence between the two,the attempt to reform the unification of the people,improve the efficiency of trials,solve the problem of convergence,and thus ensure the effectiveness of the patent link system.This paper analyzes the attempt of the Supreme Court of China in the guidance case of the People's Bank of China,and the initial establishment of the intellectual property court in China.It believes that China's current institutional reform provides agood condition for the gradual realization of the integration of the people.This article further specifically recommends that the Beijing Intellectual Property Court conduct a pilot project for the unification of the People's Bank of China.There are two main reasons for this: First,the Beijing Intellectual Property Court collects the patent infringement patent examination and the administrative first trial “two in one”,and in the court,the “one yuan unity” "There is a natural institutional advantage;secondly,it is in line with the demand for the patent infringement lawsuit for Beijing intellectual property centralized jurisdiction.In summary,this paper conducts a comprehensive,systematic and specific research and analysis on the establishment of the drug patent link system in China.It not only analyzes the theoretical basis of the system itself from a new perspective,but also uses the latest judicial case to prove the establishment of China's drug patent link system.Sexuality,and the specific implementation of the system,that is,to link with the existing legal system in China to propose solutions and fully demonstrate its possibilities. |
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