| The drug patent term compensation system is to compensate the period of the marketing of drugs requires clinical trials and marketing approval which leads to the occupation of the term of drug patent rights.According to the civil law,there is a right to remedy,and if there are obstacles in the administrative law,there is a concept of relief,and it is necessary to provide relief for the obstacles encountered in the exercise of drug patent rights.The listing of new drugs needs to be approved by the Drug Administration,which is more time than ordinary patents due to the review and approval of the Drug Administration.The laws of many countries,such as the United States and Japan,stipulate that patentees can apply for patent rights for this period of time.The purpose of compensation is to compensate pharmaceutical companies for the shortening of patent rights due to the consumption of clinical trials and drug marketing approval time,so as to encourage pharmaceutical companies to research and develop new drugs and improve the health and well-being of the people.The new drug patent term compensation system in the "Patent Law of the People’s Republic of China" passed on October 17,2020 has achieved integration with developed countries and even the world.The legislative opportunity for the pharmaceutical patent term compensation system is to implement the negotiation results of the "China-US Phase One Economic and Trade Agreement" signed on January 5,2020.After the "Patent Law" added a new drug patent term compensation system,the revision of the "Detailed Rules for the Implementation of the Patent Law"was also put on the agenda.On November 27,2020,the State Intellectual Property Office issued the "Proposals for the revision of the "Detailed Rules for the Implementation of the Patent Law"(draft for comments))",Article 85 of the "Patent Law" clarified the "new drug-related invention patents",how to calculate the compensation period of drug patents,and the number of times that drugs apply for patent period compensation.However,through research and analysis,it is found that "The "Draft for Comments" stipulates how to implement the drug patent term compensation system and the "Patent Law" is difficult to link up,and its own provisions are also unreasonable.The reason for this is that although the drug patent term compensation system has been implemented in Western developed countries for decades and the system has been in a relatively mature and mature state,it is still a new thing for my country,and all aspects of the system need to be continuously improved.Promote the establishment of the drug patent term compensation system in my country.Based on the above-mentioned purposes,this article will expand from four aspects: Chapter One explains the problems in China’s drug patent term compensation system,mainly in three aspects.First,the lack of medical device patent term compensation,the upcoming "Patent the Law and the Draft for Comments limit the scope of application of the drug patent term compensation system to invention patents and therapeutic drugs,excluding medical devices;second,the design of the drug patent term compensation system is not only reasonable,first of all,it is stipulated in the Patent Law.The double time limit and the cumbersome calculation of the compensation period stipulated in the consultation draft caused the drug patentee to be confused in the application process of the system.Secondly,the consultation draft contradictorily stipulated the full calculation and time period calculation methods,which led to the application of Difficulty: Third,the number of compensation periods is too strict,and the draft for comments stipulates that only one drug and one patent can be compensated for the patent right period.The second chapter is to explain the theoretical basis of the drug patent term compensation system.There are three main theoretical foundations.The first is the balance of interests theory,which mainly involves the balance of interests between pharmaceutical companies and public health,and the legal policy between original research drugs and generic drugs.The second is the right remedy theory.According to the civil law “where there is a right,there must be remedy” theory,the patentee can implement the patent to recover the cost after the patent is granted,but because of the particularity of the drug patent itself,it must be To conduct clinical trials to obtain the safety and effectiveness data required for marketing approval,that is,the patent cannot be implemented immediately after the patent is granted,and it must go through clinical trials and marketing approval.During this period,the patent right period is occupied.Although the patentee has the right,Cannot enjoy the benefits brought by rights,and their interests are harmed and need relief;the last is the innovative incentive theory.The ultimate goal of granting drug patent term compensation is to encourage pharmaceutical companies to invest in drug research and development,increase the supply of drugs on the market,and improve the pharmaceutical industry.Innovation level.The third chapter is an extraterritorial investigation of the drug patent term compensation system,mainly examining the relevant regulations of the United States,the European Union and Japan,starting with the above-mentioned countries’ regulations on medical devices,the calculation method of the compensation period,and the scope of compensation for drug patents.The last chapter is to put forward suggestions on the improvement of China’s drug patent term compensation system.First,medical devices should be included in the scope of drug patent term compensation,and the regulations of major developed countries should be reviewed.The United States regards medical devices as new drug grant term compensation,while Japan belongs to Semi-closed regulations,that is,medical devices cannot be extended in principle,but when they are used in combination with drugs,they can also apply for patent term compensation.A recent German judgment has opened a precedent for the extension of patents for medical devices in the country.It can be seen that medical device patents are extended.It has become a trend;secondly,for the calculation of the compensation period,full calculation should be carried out and the limit is 5 years.From the research and development of original research drugs in China’s pharmaceutical market,the research and development cycle of drugs in China is generally short,and full calculation is more effective.For the purpose of stimulating the research and development of pharmaceutical companies,at the same time,limiting the compensation period of pharmaceutical patents to no more than 5 years can narrow the development gap of the pharmaceutical industry to achieve fairness and justice;finally,the scope of compensation for the pharmaceutical patent period should include multiple drugs and patents,not limited to a single drug patent.The Japanese Patent Examination Guidelines can learn from the provisions of the Japanese Patent Examination Guidelines.When a patent involves multiple drugs,multiple drugs can be compensated for the term,while limiting the remaining rights must also be implemented;for a drug with multiple patents at the same time,if The active ingredients of the drug applied for marketing are the same as those previously listed,but the latter covers the former in terms of indications and efficacy,that is,the latter is more technologically advanced than the former.After excluding the overlap between the two,you can apply for patent term compensation. |
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