Note: An advertised webinar below is expected to provide information on Chinese patent linkage to be (re) - introduced in China. Chinese National Medical Products Administration and China National Intellectual Property Administration (CNIPA) recently issued a draft of regulation which would be discussed in the webinar and in articles referenced below. See also information on the first implementation of Chinese Drug Patent Register in 2007 and a link to 1900+ records of that Register for 2007-2011.
A global law firm Goodwin (Goodwin Procter LLP, Boston, MA) offers a webinar:
China's Patent Linkage System: Can Strategies that Work in the U.S. System Be Applied to China?
Fri, Dec. 4, 2020 at 9 PM EST (Sat., Dec. 5, 2020 at 10 AM Beijing)
Description:
On September 11, 2020, the National Medical Products Administration (NMPA) and China’s National Intellectual Property Administration (CNIPA) published a draft of the Measures for Implementation of the Early Resolution Mechanism for Drug Patent Disputes, which provides an operating mechanism for the patent linkage system in China. While China’s proposed patent linkage system has adopted provisions similar to the Hatch-Waxman Act in the U.S., there are significant differences between the two systems. Some of the strategies that innovators and follow-on manufacturers have successfully employed in the U.S. may work in China, but others may not. Please join Goodwin for this webinar which will feature a panel discussion comparing and contrasting the new Chinese patent linkage system with the U.S. Hatch Waxman system, and discussing whether 30+ years of litigation under the U.S. system can provide insights into how innovators and biosimilar/generic manufacturers can succeed under the Chinese system.
The panel discussion will cover the following topics:
- Key similarities and differences between the Chinese and U.S. linkage systems
- How will the linkage system affect costs and profits on the brand and generic/biosimilar sides?
- What types of patents will be most important to protect small molecule drugs and biologics in litigation under the patent linkage system?
- The importance of being first to file and first to market
- The significance of patent listings, stays of regulatory approval, court injunctions, joint defense groups and damages
- Patent term adjustments and extensions
Speakers:
Huiya Wu, Moderator, Partner, IP Litigation, New York
Robert Cerwinski, Partner, IP Litigation, New York
Connie Ding, Vice President and Head of Legal, WuXi Biologics
Guiming Liu, Director (Retired), China National Intellectual Property Administration
Lijuan Tang, Ph.D., President/CEO, SPH Phililab, Inc
Registration Link
[Registered participants may receive a link to webinar recording to wtch it in more convenient time - ab]
https://www.goodwinlaw.com/events/2020/12/12_05-goodwin-hatch-waxman-webinar-beijing
Goodwin Procter LLP (known as Goodwin) is a Global 50 law firm consisting of more than 1,200 lawyers with offices in Boston, Cambridge, Frankfurt, Hong Kong, London, Los Angeles, Luxembourg, New York City, Paris, Santa Monica, Silicon Valley, San Francisco, and Washington, D.C…..[2017] U.S. News and World Report has named Goodwin Biotechnology Law Firm of the Year five times (https://en.wikipedia.org/wiki/Goodwin_Procter)
Related articles:
Wexler, Bruce M., et al. (Paul Hastings LLP) “Takeaways from China’s Proposed Regulation to Implement a Drug Patent Linkage System.” October 05, 2020 [comparison with US system]
Che, Jennifer and Wang, Yolanda (Eagle IP, Hong Kong). “China Forges Ahead with Draft Measures for New Patent Linkage System.” October 19, 2020..
Susie Cheng. 2020. “China’s NMPA and CNIPA Propose Draft Measures on Patent Linkage for Public Comment: Implications for the Future of Innovative and Generic Drugs.” IPWatchdog.Com | Patents & Patent Law (blog). October 20, 2020.
The new version of Chinese patent linkage has been introduced under obligation of: Article 1.11 of Phase 1 U.S. China Trade Deal entered into effect February 14, 2020. See Section C Pharmaceutical-Related IP, Article 1.11 Effective Mechanism for Early Resolution of Patent Disputes (Text of the Economic and Trade Agreement, p.7). See discussion of patent provisions of this agreement in a Jan. 27, 2020 Fiinnegan article.
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Historical Notes
Former SFDA Chinese patent linkage regulation (SFDA Order # 28, effective Oct. 1, 2007)
According to Article 18 of [SFDA] "Administrative Measures for Drug Registration", the applicant shall provide an explanation of the patent and the ownership status of the applicant or others in China for the drug applied for registration or the prescription, technology, purpose, etc.; If there is a patent in China, the applicant shall submit a statement that it does not constitute infringement of the patent of others. For the explanations or declarations submitted by the applicant, the drug regulatory authority shall make public on the website of the administrative agency. Where patent rights disputes occur during the drug registration process, they shall be resolved in accordance with relevant patent laws and regulations.
Patent Records of (former) Chinese Drug Patent Register, hosted by NMPA (National Medical Products Administration), successor of SFDA
药品注册相关专利信息公开公示" 的内容列表,共有 1935 条记录 (in Chinese) [The content list of "Public Publication of Patent Information Related to Drug Registration", a total of 1935 records] (for drugs registered in 2007-2011)
[Note: Tips how to search patent information on SFDA website was presented by Minli Tao (Novartis) in her poster "Searching IP Related Information for Pharmaceuticals in China" at 2013 IPI-ConfEx,10-13 March, 2013, Seville, Spain]
See also an article of late Prof. Benjamin Liu discussing a failure of previous patent linkage system in China:
Liu, Benjamin P. 2011. “Fighting Poison with Poison - The Chinese Experience with Pharmaceutical Patent Linkage.” John Marshall Review of Intellectual Property Law 11: 623-672
Countries after countries are adopting a controversial regulatory system of linking the market approval for pharmaceuticals to the status of potentially blocking patents as part of their bilateral and multilateral trade agreement package with the United States. Surprisingly, China took up pharmaceutical patent linkage in the absence of any treaty obligations and became the first country to adopt this regulatory regime outside of North America, despite the presence of a flourishing generics pharmaceutical industry and its developing country status. In fact, the Chinese regulation promised more intellectual property ("IP") protection than what even the United States FDA is capable of deliver under the Hatch-Waxman Act. This quest for more IP protection may have destabilized the food and drug administrative system and led to reduced IP protection in actuality. Although China can benefit from some form of patent linkage given the current state of its technological development, it must revise the current rules towards greater administrative feasibility-a poignant lesson that is applicable to other developing countries in the process of adopting pharmaceutical patent linkage.
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