| Medicine is the basis and guarantee for the maintenance of human life and health,and it is a special commodity closely related to public health.Drug R&D relies on the incentives of patent protection.Excessive degree of patent protection will hinder the people’s access to medicines.How to achieve a balance between medicine patent protection and social public health is a common problem faced by all countries in the protection of pharmaceutical intellectual property rights.The drug patent term extension system originated in the United States.It is a compensation for the delayed patent validity period due to drug marketing approval.Its essence is to substantially ensure that patented drugs can fully enjoy the legal market monopoly period granted by the patent protection period,thereby realizing the patent law.It has the function of stimulating innovation and enhancing the general well-being of society.In November 2019,the General Office of the Central Committee of the Communist Party of China and the General Office of the State Council issued the"Opinions on Strengthening the Protection of Intellectual Property Rights" clearly"exploring the establishment of a drug patent term compensation system";in January 2020,China and the United States signed the "The Government of the People’s Republic of China and the United States of America" The "Government Economic and Trade Agreement" also has a clause that "the patent validity period should be extended to compensate for unreasonable delays in the drug marketing approval process";Article 42 of the "Patent Law of the People’s Republic of China" revised and approved by the Standing Committee of the National People’s Congress in October 2020 A new "Extension of Drug Patent Term" Clause was added.The newly revised "Patent Law" will come into effect on June 1,2021;on November 27,2020,the State Intellectual Property Office announced the "Proposals for Amendments to the Implementation Rules of the Patent Law" Draft for comments),the drug patent term extension system is one of the key content.From the perspective of the national legislative process and the international development trend of intellectual property protection,China’s implementation of the drug patent term extension system is already on the line,and the effective implementation of the system in China still needs details.The content of the system is standardized,clear and operable application and approval procedures are established,and the relevant supporting legal mechanisms are closely coordinated and operated.Drawing on the experience of the legislation and practice of the drug patent term extension system in typical foreign countries(regions),and based on the national conditions,the implementation of the drug patent term extension system in my country should start from the following aspects:First,in accordance with the purpose of the patent law to stimulate innovation,limit In the scope of drug patent application for extension of the patent period,only the original and innovative drugs that have been patented in my country will be included in the objects that can apply for the extension of the drug patent period.Second,refine the content of the drug patent term extension system and standardize its operating procedures,and formulate clear and clear drug patent term extension application and approval procedures:clarify the subject of the application,application,approval,opposition process,specific extension term calculation rules,etc.,so that It is operable;finally,the drug.patent term extension system should be coordinated with supporting legal mechanisms such as drug patent experiment exceptions,drug patent links,drug test data protection,etc.,in order to realize drug patent protection,encourage new drug research and development,improve drug supply security capabilities,and maintain The legislative goal of public health. |
