NEWS

Looking at the Future Market Game from the Drug Patent Link System

Release time:

2018-03-19 02:05

In May 2017, the State Food and Drug Administration (hereinafter referred to as the "Food and Drug Administration") issued the "Relevant Policies on Encouraging Pharmaceutical and Medical Device Innovation and Protecting the Rights and Interests of Innovators (Draft for Comment)" (hereinafter referred to as "Draft"). In October 2017, the General Office of the Central Committee of the Communist Party of China and the General Office of the State Council jointly issued the "Opinions on Deepening the Reform of the Review and Approval System and Encouraging the Innovation of Drugs and Medical Devices" (hereinafter referred to as the "Opinions"), and once again the drug patent link system The public solicits opinions in order to promote the implementation of the drug patent link system in China.

1. What is the patent link system?

The system originated from the Hatch-Waxman Act introduced in 1984 in the United States, which aims to balance the development of original drug companies and generic drug companies.

2. What does the patent link system bring?

The Food and Drug Administration issued an announcement on December 28, 2017, publishing the Catalogue of Listed Drugs in China on the Internet, which not only includes newly approved newly registered classified drugs and drugs that have passed the quality and efficacy consistency evaluation of generic drugs, but also links to patent information database, data protection information database, market exclusive period database and review and approval/verification/inspection report database. This means that both original drug research companies and generic drug companies can basically understand the approval and patent status of relevant drugs before conducting drug research and development and applying for registration, so as to plan and adjust R & D and registration arrangements in advance, which can avoid duplication. Research can also reduce the risk of patent infringement.