Patent compensation system extends the term of drug patent protection and stimulates the innovation of original research drugs!

JiangsuHengrui MedicineCompany limited by shares(hereinafter referred to“Hengrui Medicine”）YesMainland ChinaLargest drug research and production baseIt has hundreds of patents worldwide. Arecoxib is Hengrui Medicine14 years of independent research and development of the original drug, related.Patent(The patent name isSulfonyl pyrrolidone-containing compounds and their preparation and pharmaceutical use, patent application No.CN00105899.1)The 15th China Patent Award. Patents related to imrecoxib2000Year04Month17day to apply,Hengrui MedicineInIt was only in June 2011 that China's State Drug Administration approved the drug for marketing. April 17The patent expires. In fact, from listing to patent expiration of irecoxib is insufficient10Year. The head of Hengrui Pharmaceuticals's patent department said that the company has developed a number of innovative drugs, suchErecoxib, thiopelafil, apatinibDue to the early patent application, the research and development process is limited by factors such as domestic clinical research capabilities and the length of review and approval, the patent protection period of drugs is very small after its listing, which is also a common problem faced by the original research and development industry in mainland China.

Drugsclinical trials andof the regulatory authoritiesReview and approvalIt is an important link to ensure the safety of drugs. It lasts for several years. If the patent is about to expire after the drug is put on the market, the monopoly interest granted by the patent to the right holder will be difficult to cover the research and development cost. Early in2017Year10Month08The General Office of the State Council of China issuedOpinions on Deepening the Reform of the Review and Approval System and Encouraging the Innovation of Drugs and Medical Devices,For the first time clearly stated:"Appropriate patent term compensation for delays in marketing due to clinical trials and review approvals".

Why should the original drug be tested in clinical trials? The original drug has been tested on animals before clinical trials, proving its safety and effectiveness. However, the new drug cannot be widely used in clinical treatment only through animal tests, and rigorous clinical tests must be carried out to confirm the efficacy and safety of the new drug in human body,Drug clinical trials are generally dividedI、II、III、Phase IV clinical trialsand drug bioequivalence tests and human bioavailabilityTest. Depending on the characteristics of the drug and the test conditions, the time spent on clinical trials varies. In general, successful clinical trials require3-8Year.

Drug approval is a common drug supervision and management system in countries around the world, such as the United States.FDA certified,JapanPMDA CertificationWait. In mainland China, the original research drugBefore listing, you must first obtainChinaReview by the State Food and Drug Administration, conduct clinical trials, and then report toChinaThe State Food and Drug Administration submits an application for listing, which can only be produced and sold after approval.The review refers to ChinaState Food and Drug AdministrationRight.Acceptance and Technical Review of Drug Clinical Trials,The duration of clinical review is3 months, the actual time spent at least half a year;Approval meansin accordance with legal procedures,ChinaThe State Food and Drug Administration on the proposed sale.DrugsThe safety, effectiveness, quality controllability, etc.systematic evaluationand decide whether to agreeListingthe process,Most current new drug approvals requireNearly two yearsthe time.

drug patent period compensation systemHow to motivate the original research drug innovation? Pharmaceutical R & D hasWith the characteristics of "long cycle, high risk and large investment", the original research enterprises can not make profits from the market after investing a lot of financial resources and manpower, which will greatly dampen the enthusiasm of R & D.The drug patent period compensation system is a system that makes up for the loss of the effective patent period of innovative drugs in order to obtain marketing approval and appropriately increases the patent protection period, mainly to compensate for the long clinical trials and the large amount of time spent in the drug approval process.To compensate for the market monopoly benefits conferred by the patent right, so that the research and development enterprise can reasonably recover the research and development costs and expected benefits..DrugsPatent Period Compensation SystemOriginated in the United StatesPromulgated in 1984ofDrug Price Competition and Patent Term Restoration Act》，Subsequently, Japan, the European Union, Australia, Israel, South Korea, Russia and TaiwanRegionThe patent period compensation system has been established.

The Amendment to the the People's Republic of China Patent Law published in April 2019 stipulates that "in order to compensate for the time for examination and approval of the listing of innovative drugs, the State Council may decide to extend the term of the patent right for innovative drug invention patents that are applied for listing simultaneously in China and abroad, and the extension period shall not exceed five years, and the total effective patent right period after the innovative drug is on the market shall not exceed 14 years."This revised draft is determined.drug patent period compensation system, but the specific content may have an impact onChinaContinentEnterpriseofactual situationLack of consideration. Mainland China currently has moreMore than 200Original researchdrug companies,AndPercentage of the number of companies participating in the U. S.-China Double ReportUsuallyLess than 1/4,Original researchPharmaceutical companies submit listing applications simultaneously in China and abroadThe cases are in the minority.. Therefore, the author believes that the patent period compensation should not be limited to the invention patents of innovative drugs that are applied for listing simultaneously in China and abroad, but should be compensated for the patent period of innovative drugs that are listed in China for the first time. Although there is a big gap between mainland China's independent original research and pharmaceutical industry and European and American countries, it has been developing continuously in recent years. It has developed heavy products in many fields and established in line with actual needs.drug patent period compensation systembeneficialMotivationOriginal drugInnovation.