Research On The Establishment Of Drug Patent Linkage System In China

As a developing country,China’s pharmaceutical industry has developed rapidly after the reform and opening up,but there are still many problems.Pharmaceutical companies are still mainly generic,innovative drugs are few.We need to encourage innovation and give full play to the protection of new drugs by the patent system,so as to support the technological innovation of drugs.We also need to ensure the availability of generic drugs,reduce the price of drugs and make them affordable for patients.The drug patent link system not only protects the patent rights of new drugs but also ensures the marketing of generic drugs,thus ensuring the accessibility of drugs,meeting the needs of patients and balancing the interests of all parties.This paper is divided into five parts.The first part is the introduction.It is mainly about the research background and significance,research methods and contents,and the research status of drug patent link system at home and abroad.The second part defines the basic concept,stating that the drug patent link system is an important process for the Authority to review the relationship between generics drugs and valid patent rights on previously approved drugs.Subsequently,the core values and theoretical foundations of the drug patent link system are presented to justify the construction of such a system.The third part is the establishment and development of the drug patent link system abroad.First of all,to introduce the main elements of the U.S.drug patent link system.The Hatch-Waxman Act,as the founder of the drug patent link system,established an effective legal mechanism for the co-development of original and generic drugs in the country.Secondly,the main contents and evaluation of the data protection system implemented in Europe and the review system of new drugs on the market in Japan were introduced.And it was pointed out that under the framework of the existing system in China,the implementation of data protection and patent protection period compensation system does not match with the reality that the pharmaceutical industry in China is still dominated by generic drugs as well as lacks of innovation.The fourth part mainly analyzes the current status of the drug patent link system in China.By analyzing the elements and problems of the patent link system in China and presenting the differences between China and the United States drug patent link system in the form of a table,it is pointed out that with the vigorous promotion of the reform of the pharmaceutical industry and the rapid development of the pharmaceutical industry under the Twelfth Five-Year Plan,there is an urgent need to establish a drug patent link system.The fifth part is a specific design for the construction of Chinese drug patent link system.Analyzing and interpreting the successful experience of the United States system,facing up to the differences between the systems of the two countries,and drawing on the essence of the United States system to develop a drug patent link system based on our actual situation.It is hoped that through the design of the system,a better balance will be struck between the conflict of interest between original and generic drugs,and a point of convergence will be found between the right to drug patent and the right to public health.In this way can our country be transformed from a leading power of generic drugs to a great power of original research drugs.