Category: Pharmaceutical Patents

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.

Navigating Innovation: How the Presidential Candidates Address Technology, IP, and the China Challenge

This article examines the candidates’ positions and accomplishments in four key areas implicating technological competition: derisking, negotiating, and advancing new trade policies, reorganizing government structures to promote competitiveness, and developing policies to address new technology issues.  On the surface, the differences in approaches appear to focus primarily on matters of degree.  Both parties support such tools as continued tariffs against Chinese imports, use of export controls and other trade sanctions, and enhanced efforts to “de-link” or “de-risk” from dependency on Chinese imports.  Nonetheless, candidates Trump and Harris have sparred over the extent and impact of the tariffs, and the track records and rhetoric of the candidates suggest more differences than may initially be evident.

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?

RCEP And Phase 1: Strange Bedfellows in IP

RCEP and the Phase 1 Trade Agremeent are strange historical bedfellows, joined by common approaches to IP that diminish its role as a private right. The differences between the two agreements are also significant. The Phase 1 Agreement explicitly contemplated a Phase 2 Trade Agreement. It also only involved one country. RCEP intends to be comprehensive and regional, if not global. It is an alternative to the TPP. It will help China establish global IP norms.