China and the United States trade agreement signed 3 pharmaceutical related content has an impact

On January 15, China and the United States signed the economic and trade agreement between the government of the people's Republic of China and the government of the United States of America: the two sides agreed to increase bilateral cooperation in intellectual property protection and promote practical cooperation in this field China's State Intellectual Property Office and the U.S patent and Trademark Office will discuss the biennial cooperation work plan for intellectual property, including joint projects, industrial outreach, information and expert exchange, regular interaction through meetings and other means, and cooperation in the field of public awareness Among them, there are 3 drug-related contents in total: Section 1.10 consideration of supplementary data 1、 China should allow drug patent applicants to rely on supplementary data to meet the requirements of patentability in patent examination, patent reexamination and judicial procedures, including the requirements of full disclosure and creativity 2、 The United States confirms that the measures in force in the United States give equal treatment to the provisions of this article Article 1.11 effective mechanism for early resolution of patent disputes 1、 As a condition for approval of the listing of drugs, including biological drugs, if China allows others other than the person who originally submitted the safety and effectiveness information to rely on the evidence or information of the safety and effectiveness of previously approved products, such as the evidence of listing approval in China or other countries and regions, China shall: （1） To provide a system for notifying the patentee, the licensee or the holder of the listing license that such other person is seeking to market the approved product or its approved use method within the patent validity period; （2） Provide sufficient time and opportunity for the patentee to seek the remedies provided in paragraph (3) prior to the launch of the alleged infringing product; and （3） Provide for judicial or administrative procedures and expedited relief, such as action preservation measures or equivalent effective interim measures, in order to resolve disputes in a timely manner over the validity or infringement of patents applicable to approved drugs or their approved methods of use 2、 China should establish a drug-related system consistent with the first paragraph above nationwide, including the right for patentees, licensees or marketing license holders to file a lawsuit before the alleged infringing products are licensed for marketing, and seek civil judicial procedures and rapid relief for the dispute resolution of the applicable patent validity or infringement China can also provide administrative procedures to resolve such disputes 3、 The United States confirms that the measures in force in the United States give equal treatment to the provisions of this article Section 1.12 extension of patent validity 1、 Both parties shall provide for the extension of patent validity to compensate for unreasonable delay in the process of patent authorization or drug listing approval 2、 (1) at the request of the patentee, China shall extend the validity of the patent to compensate for unreasonable delay not caused by the applicant in the process of patent authorization For the purposes of this article, unreasonable delay shall include at least the fact that no patent right has been granted within 4 years from the date of filing the application in China or 3 years after the request for examination, whichever is later （2） At the request of the patentee, China shall adjust the validity period or patent validity period of the new drug product patent, its approved use method or manufacturing method patent approved for listing in China, so as to compensate the patentee for the patent validity period caused by the first listing approval process of the product in China Reasonable reduction Any such adjustment shall, subject to the same restrictions and exceptions, grant all the exclusive rights of the original patent to the patent claim of the product, its use method or manufacturing method applicable to the approved product and its use method China can limit this adjustment to no more than 5 years, and the total period of validity of the patent from the date of approval of listing in China is no more than 14 years 3、 The United States confirms that the measures in force in the United States give equal treatment to the provisions of this article Section 1.18 counterfeit drugs 1、 The parties shall take effective and prompt law enforcement action against counterfeit drugs and related products containing active pharmaceutical ingredients, bulk chemicals or biological products 2、 Measures to be taken by China include: （1） Take effective and rapid law enforcement action against counterfeit drugs and biopharmaceutical related products, including active pharmaceutical ingredients, bulk chemicals and biopharmaceutical products; （2） To share with the United States the registration information of drug raw material sites inspected by Chinese regulatory authorities and in compliance with Chinese laws and regulations, as well as the necessary information of relevant law enforcement inspections; （3） Within six months after the effective date of this agreement, the relevant data of law enforcement measures shall be published on the Internet every year, including the investigation, revocation of business license, fines and other actions of the State Drug Administration, the Ministry of industry and information technology or successor agencies.