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.

Survey on China’s “National Intellectual Property Strategy”

TianNIPS

SIPO is conducting a survey to coincide with the 10th anniversary of the Outline of the National Intellectual Property Strategy” , which was issued in June 2008.   The online survey is available here.

When the first National IP Strategy was being drafted, I had the pleasure of discussing concerns with the former Director General of the Law and Treaties Division of SIPO, Yin Xintian (尹新天), attending two meetings/hearings on the NIPS, including one involving outside experts (February 28, 2006) and another involving diplomats, and attending a meeting with then Secretary Carlos Gutierrez and SIPO Commisioner Tian Lipu to discuss the implementation of the NIPS (see picture above, March 29, 2006).

The NIPS introduced many important IP-related reforms in China, some of which are still under development.  I  advocated for the creation of a specialized appellate IP Court at the “experts hearing,” where I recall I was the only foreigner.  I noted at that time that there was a “need to concentrate expertise in more complicated patent cases to insure they are more efficiently and effectively handled.“  Regarding substantive IP matters, I noted that “In the patent area … a robust patent linkage system also could help improve enforcement for pharmaceutical patents by providing advance notice to prospective generic manufacturers through denial of regulatory approval until relevant patents have expired, been invalidated or otherwise have been determined to not be infringed.”  The prospects for both a specialized IP court and patent linkage have indeed improved significantly in recent years.

With SIPO’s expanded role of examining trademarks and geographical indications in the government restructuring, as well as it being co-housed with antimonopoly/unfair competition (trade secret)  and food and drug agencies, the NIPS may be even more important in both articulating policies and implementing them.

Here are some prior postings on the NIPS: “Outline of the National Intellectual Property Strategy” ; “National IP Strategy Action Plan” and  “Action Plan for Further Implementation of the National IP Strategy (2014-2020)” .  Another document that might be helpful is the “State Council Decision on Intellectual Property Strategy for China as a Strong IP Country (in Chinese).”  This website of the National IP Strategy Office is http://www.nipso.gov.cn.

This survey request is being posted on behalf of  Intellectual Property Publishing House.  Commentary is by Mark A. Cohen.

Picture Source:
 http://www.sipo.gov.cn/gk/ndbg/2006/201310/t20131025_859773.html

 

Semiconductor Industry Association Seeks Asian Policy Director

The Semiconductor Industry Association (SIA) is seeking to hire a Manager or Director Global Policy (China focused)  to join SIA’s Global Policy Team.  The ideal candidate will have an education and prior work experience relevant to Chinese technology or international trade issues.  The position reports directly to the Vice President of Global Policy.  The position requires a Bachelors degree (B.A.), Masters degree preferred; 2-7 years of professional experience in international trade or global technology issues; good understanding of China’s political-economy and tech policy; working-level fluency in Chinese, with strong Chinese source material reading and research skills; etc. Here is the link to the posting.

In recent months, semiconductor policy has become a hot bilateral area, and this position would likely bring the successful applicant directly into the range of bilateral semiconductor issues and opportunities, including technology policy, trade, antitrust and intellectual property.