Category: 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?

My Reflections on Testifying Before Congress – 2023

Over the course of the last three months, I spoke at a trifecta of Congressional hearings: the House Judiciary Committee, the Senate Judiciary Committee, and the Congressional US-China Economic and Security Review Commission. Before I had testified I was pessimistic about the prospects for positive IP-related legislation in our national competitive interests. I am now mildly optimistic that Congress can pass necessary IP legislation if both parties in Congress and the Administration work together.