China Patent and Licensing Discussions – Week of June 14th

On Wednesday, June 17th at 4:30 PM PST,  former Chief Judge Paul Michel (ret.) will be moderating a star-studded panel hosted by Berkeley Law on one aspect of one of the great ironies of this current moment in US-China IP relations: the weakening of the US IP system with respect to patent eligibility and China’s concurrent strengthening in those areas.  Judge Michel will be joined by former PTO Director David Kappos, Berkeley Law Professor Robert Merges, Beijing East IP Partner Liaoteng Wang, and Tsinghua Professor Guobin Cui.  Liaoteng Wang has recently written an article in anticipation of this event.  Information and registration information is available here and here.

The United States-China Intellectual Property Exchange and Development Foundation, of which I am a board member, will be hosting two webinars on pharmaceutical-related IP.  The first session focuses on the Phase 1 Trade Agreement including post-filing supplementation of data and patent term extension (June 16, 7 AM PST).    The second session focuses on patent linkage (June 17, 7 AM PST).   Former Chief Judge Randall Rader and several notable practitioners will be joining the discussions.

On June 16th at 9 AM  PST, I will also be speaking along with Jim Harlan of InterDigital on the US Department of Commerce’s Bureau of Industry and Security’s (BIS) ban on Huawei and its effect on global Standards Developing Organizations (SDOs). This program is sponsored by the American Intellectual Property Law Association’s Standards and Open Source Committee.  Non-AIPLA members may join this open event without charge.  Call: +1 (347) 991-7204, passcode 251151532, or join the Skype Meeting.

Resources for the Week of May 18, 2020

On May 20, 2020 (4:30 PM PST), Berkeley will be hosting the next in our China series: Following the Data: What the Latest Research Says about China’s Legal and IP Environment. The webinar will cover data-driven research on Chinese legal developments and how these tools can provide strategic insights.  The speakers include: Benjamin Liebman, Columbia University; Tobias Smith, UC Berkeley; Melissa Schneider, Darts IP; Robert Merges, UC Berkeley; and Fei Deng, Charles River Associates.  I will be moderating.

On May 13, Berkeley hosted a book warming for Mara Hvistendahl’s The Scientist and the Spy: A True Story of China, the FBI and Industrial Espionage concerning a Chinese economic espionage case involving hybrid corn seed.  We had a lively discussion among the author, the former FBI agent in charge of the case (Mark Betten), the Dupont IP lawyer representing the victim (Jennifer Johnson), Jim Pooley, and myself involving IP and competition issues, racial profiling, criminalization of trade secrets issues and other issues. Here is the link to the recording.

Attendees are also invited to attend a series of webinars on IP-related issues in China which will include such topics as pharmaceutical IP matters, trade secret issues, licensing and antitrust, ‘101 issues in China, and abusive trademark registrations.  Please consult the website for fees for further information on the program, CLE credit, and the possibility of earning a certificate from Berkeley Law after completion.  We begin on May 25 with a discussion on the important pharma-related IP developments in China, many of which were agreed to in the Phase 1 Trade Agreement, and will include several speakers from the US and China who have been tirelessly working on these issues.

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Upcoming Berkeley Law Privacy Conference

China is developing a robust commercial privacy and cybersecurity framework. A cybersecurity law took effect in 2017, multiple agencies are issuing guidelines, and a new e-commerce law with privacy and cybersecurity provisions just entered into force on January 1, 2019.  Further privacy legislation is being drafted, as China may be looking to develop a companion to the comprehensive privacy law of Europe. (Meanwhile, the US has no comprehensive privacy or cybersecurity law; Congress will debate the issue this year, but the outcome is quite uncertain.)

This raises a number of provocative question: In terms of the relationship between consumers and corporations, is China becoming more privacy-protective than the US? How should we understand the overall privacy and cybersecurity trends in China? How well does China’s overall legal environment support the implementation of the new and proposed laws?

To try to answer some of these questions, the Berkeley Center for Law & Technology is organizing a one-day conference in San Francisco on March 1.  The agenda is here; registration is here.

Much of the focus will be comparative, with an emphasis on interoperability and cross-border compliance: Given the rapid developments in privacy and cybersecurity law in China and Europe, how can innovative companies that want to offer their goods and services worldwide comply? Topics will include the definition of reasonable cybersecurity standards under the laws of China, the EU and the US; corporate data governance strategies in the face of overlapping requirements; and enforcement.

The event is co-sponsored by Peking University, The EastWest Institute, The United States Information Technology Office (USITO), The Asia Society, JD.com, and New America.

Draft of Data Exclusivity Rules Released by CFDA

CFDA just released on April 25, 2018, its Public Comment Draft of Pharmaceutical Data Exclusivity Implementing Rules  (provisional)  药品试验数据保护实施办法(暂行)征求意见稿, available here (the web version is here).  Comments are due by May 31, 2018, at yhzcszhc@cfda.gov.cn.

Article 5 proposes six-year data protection (which was China’s WTO commitment) for “innovative new drugs”.  “Innovative therapeutic biologics” are eligible for 12-year data protection (the previous May 2017 CFDA circular said 10 years).  The draft clearly encourages MNCs to include China in international multicenter clinical trials and to concurrently apply for market introduction in China (which can include other countries).  Full-term protection (6/12 years) is only available in this scenario.  Reduced Chinese data protection terms of one to five years may occur due to delays in introduction in China.  As a policy matter, this draft appears intended to help encourage conducting clinical trials in China as well as new product introduction into the Chinese market

Thanks to my friend and former student Jill (Yijun) Ge at Clifford Chance for bringing this to my attention and providing an initial review.  I welcome readers to submit English translations of this draft for me to post.

This is one of several exciting new developments in the pharma IP sector in China.  To help better understand the business implications of these changes, the Berkeley Center for Law and Technology is planning on hosting a half-day roundtable discussion on pharmaceutical IP developments in China on May 30, one day before the comment period closes.  Seats are limited.  Please contact chinaipr@yahoo.com or mark.cohen@law.berkeley.edu for further information.