China’s new patent linkage regime involves parallel civil and administrative enforcement mechanisms. Innovative pharmaceutical companies should prepare for the possibility of generic challengers and determine which mechanism will best suit their purposes. Biologics are not protected under this new regime.
There is still time to register for our program on patent linkage in China for today (July 15, 2021) at 5:00 PM. The registration link is here. Currently the speaker lineup includes: […]
There are numerous heirarchies to Chinese legislation and IP laws are certainly not an except to this. Due to the government reorganization in 2018, Chinese efforts to become an innovative economy, and external political pressure from the Trade War, there has also been extensive external political pressure on Chinese IP legislative efforts. The different approaches to legislating may indicate potential weaknesses in the laws. They may also be the outcome of internal bureaucratic struggles.
Here is a listing of recordings of some recent programs that are now available as well as a listing of upcoming events. The Third Berkeley-Tsinghua Conference on Transnational IP Litigation was held […]
Several new rules from China’s State Administration for Market Regulation portend a more active role for administrative enforcement of patents, in both patent linkage and major disputes affecting Chinese national interests. How much due process do these rules afford? Are they compatible with the TRIPS Agreement? Will foreigners be treated fairly? Will the administrative agencies be transparent in their decisions and make their cases publicly available. SAMR’s database of IP cases is also relatively new.
There are a number of open issues.
Even during a time of trade conflict, there was considerable litigation and patent licensing activity with China, including a pronounced role in global markets for Chinese companies and in China for US companies. Patent disputes and licensing involved a diverse group of technologies. Chinese companies have become more active in SEP litigation overseas. The United States is an important venue for litigating overseas patent disputes with Chinese entities. Both the patent licensing and pharma data show the importance of tracking market value and trends to determine the real-world impact of IP-related policies.
IPO’s Comments on recently proposed examination guidelines and on the SPC’s patent linkage reveal an increasingly complex web of IP legislation which is dependent on clarity in higher level laws.
The Berkeley Center for Law and Technology will be launching a five-part webinar series on “Innovation, Regulation in the Life Sciences” on November 17 from 4:30-6:00 PM. The launch program is devoted to “China’s Emerging Regime for IP In the Life Sciences”.
The Supreme People’s Court issued the its draft patent linkage Judicial Interpretation, the “Provisions on Several Issues Concerning the Application of Law in the Trial of Civil Cases Involving Drug Marketing Review and Approval of Patent” (Draft for Solicitation of Comments)” The deadline for submission of comments on the JI is Dec. 14. The JI sets up a possible jurisdictional battle between the courts and administrative agencies in adjudicating patent linkage cases.
Judicial involvement in this legislation is needed to harmonize the legal complexities of patent linkage which complex issues of patent law, civil law, administrative law, and pharmaceutical regulation.