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.
USTR released its Special 301 Report (the “Report”) on April 30, 2021. The China except is attached here. The Report addresses a wider range of IP issues than in many prior years. […]
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.
USTR’s recently released NTE report shows continuing lack of clarity over key Chinese legal terms. The report also declines to discuss commercial rule of law issues raised in last years Special 301 report. What role does commercial rule of law have in the Biden Administration’s trade diplomacy? The answer is unclear.
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.
USPTO has graciously made available here its unofficial translations of 19 IP related final and/or draft IPR Laws, Regulations, drafting descriptions of Regulations, Rules, explanations on the Rules, as well as judicial […]
Does the WTO / TRIPS Agreement still have teeth on IP? This blog explores the possible claims that could be made involving TRIPS Agreement violations and China. The more important claims are complex, data-dependent, and would require a whole of government approach by the Biden adminisitration.
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.
The Intellectual Property Owners Association (IPO) has submitted bilingual comments to SAMR on the draft Trade Secret Rules 《商业秘密保护规定（征求意见稿) 》. The comments are found here and at the IPO website I blogged […]
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.