On September 7, 2020, China responded to the EU Article 63 request. The one-page Chinese response repeats the position taken by China in 2006, that Article 63 only affords an opportunity for a member to make a transparency request of another member. As China notes in its response, “there is no such obligation under the TRIPS Agreement for China to respond.” This position repeats the position taken by China that “the TRIPS Agreement only refers to a Member’s right to request information, but there is no mention of a corresponding obligation of the requested Member to actually follow the request.” (Para. 8, P/C/W/465, Jan. 23, 2006). As this prior Article 63 response appears to be the template for some elements of the current response, I have inserted it below. The Chinese responses might be understood as rejecting a teleological interpretation of the TRIPS Agreement to effectuate its purposes, or one based on the good faith of the parties, as it is difficult to conceive of the reason for a treaty provision that offers an opportunity to make an inquiry of another country, but does not require that country to respond. The response also ignores the significant developments in case law in China in recent years.
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.
On July 6, 2021, the European Union filed an “Article 63.3” request at the WTO requesting further information on four SEP cases in China. publication of these importance cases will benefit all parties through increased transparency and disclosure of how China has evolved its policy in this contentious area.
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.
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.
Why is this year’s Special 301 Report (the “Report”) from USTR (April 29, 2019) different from prior reports? In prior years, this report often repeated materials found elsewhere, such as in the […]
CNIPA released on April 20, 2020, its 2020-2021 Implementation of the “Opinions on Strengthening the Protection of Intellectual Property” Promotion Plan” (2020—2021年贯彻落实《关于强化知识产权保护的意见》推进计划) (the “Promotion Plan”). Attached are a copy of the Promotion […]
Foreign Investment Law Implementing Regs Open For Public Comment: Administrative and Punitive Enforcement Ascends Again
The Ministry of Justice had published a draft of the Foreign Investment Law Implementing Regulations for public comment. Chinalawtranslate has prepared an English translation of the proposed regulations and of the law […]
Jill Ge of Clifford Chance has brought to my attention that the changes proposed to the Trademark Law and Anti-Unfair Competition Law that I reported on April 21, have now been passed at […]