Category: Law on Legislation

Post-Filing Data in Chinese Pharma Patents: Why It Took So Long — and What Finally Worked

Recently, the Supreme People’s Court of China (SPC) upheld a decision of the Beijing Intellectual Property Court reversing a China National Intellectual Property Administration (CNIPA) invalidation decision and confirming the validity of Novo Nordisk’s semaglutide compound patent. Although the final written decision has not yet been publicly released, official summaries indicate that the court accepted post-filing experimental data where “the technical effect can be derived from the original specification” (技术效果可由原说明书得出), reversing an administrative invalidation decision. Public reporting further indicates that the dispute turned on whether CNIPA would accept post-filing experimental data demonstrating semaglutide’s surprising pharmacokinetic effects in animal models, where the application as filed contained no experimental data.

SAMR’s “Choreography” of  SEP AML Rulemaking

How should one understand the overlapping rules enacted by SAMR on IP, SEPS and antitrust? Is a new wave of legislation under way? Is China planning on ramping up antitrust enforcement in SEPs? What do these legislative experiments portend in terms of China’s commitments to rule of law and the challenges faced by high tech companies – whether implementer or licensor in China?

Transitioning to China’s New Patent and Copyright Laws on June 1: Where Have All the Implementing Regulations Gone?

On June 1, 2021, both the revised Copyright Law and Patent Law will come into effect.  On May 24, 2021, CNIPA published its “Interim Measures on Disposition of Examination-Related Activities Post Patent Law Implementation” (CNIPA Notice Number 423)《关于施行修改后专利法的相关审查业务处理暂行办法》的公告(第423号)(“Interim Measures”).  The Interim Measures address the needs of the patent office of CNIPA to address concrete examination issues in the absence of higher-ranking implementing regulations. Why has China been so slow to pass implementing regulations for its new IPR-related laws? What is the significance of the delay in drafting and implementing these regulations?

Bureaucracy and Politics in Recent SAMR Legislation

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.