Category Archives: Pharmaceutical Patents

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Translation of Draft Patent Law Available

Thanks to He Jing of the Anjie Law Firm, attached please find an unofficial line-by-line translation of the recently released Patent Law Amendments 2nd reading.   Comments are due August 16, 2020.

Some highlights of this draft:

Partial Design Protection

Article 2 adds language back in to allow partial design protection.  This is a welcome development.  Article 42 also maintains the earlier draft’s extension of the duration of the design patent to 15 years.

Patent Abuse

Article 20 clarifies that the abuse of patent rights to exclude or restrict competition constituting a monopoly shall be dealt with under the anti-monopoly law.  The AML is itself under revision.

Good Faith/Public Interest

Article 20 continues to require “good faith” in patent filings and the exercise of patent rights, an important concept borrowed from the Trademark Law revisions which is having an increasing substantive impact.  The limitation that patents shall not be “allowed to harm public interests” raises similar concerns to me to the recently proposed amendments to the Copyright Law, about the definition of “public interest.”

Pharma Issues – Patent Term Restoration and Linkage

The notices of the NPC regarding the draft law, state that pharma-related IP issues were drafted to implement ‘”trade agreement(s).”   These are reflected in proposed Article 42 which provides for patent term restoration.  This draft removes the requirement of the “synchronous” launching of marketing approval outside of China with approval in China in order for patent term restoration to be granted.

Article 75 also sets forth an outline for a patent linkage regime, and calls for the drafting of more detailed measures to further implement the provisions.  Under this proposal, the innovator challenges a generic applicant for marketing approval within 30 days of the announcement of the application.  If the patentee does not file a lawsuit, a generic company may also request a determination from the courts or patent office of non-infringement based upon the China Patent Information Registration Platform for Listed Drugs.  A court or administrative procedure on patent infringement should render its decision within 9 months.  This draft lacks an incentive provision for a generic to successfully challenge an innovator through granting of a first generic marketing exclusivity due to a successful challenge to the patents. This skeletal section is also drafted as an addendum to the statutory exemptions to infringement, which appears to be an awkward placement.

Damages and Liability

Joint liability of Internet service providers for patent infringement has been removed.

Minimum statutory damages of RMB 100,000 has also been removed.  Statutory damages are capped at 5 million RMB.  Quintuple punitive damages up to 5 times remain from the prior draft.   The statutory damage maximum increases to RMB 5 million (Art. 71). In addition to the continuing focus on increases in damages, this draft also continues the momentum for a larger role for patent administrative enforcement.

The extension of the statute of limitations to three years has been retained from the prior draft (Art. 74).

Several provisions address the proposed “open licensing” system (Chapter 6).

The draft also encourages a flexible remuneration system including “equity, options, and dividends” to enable inventors or designers to reasonably share the proceeds of innovation (Art. 16).

Update of August 16, 2020:  The American Bar Association Intellectual Property Law Section and Section of International Law have made their comments on the draft Patent Law Amendments available here.

 

 

 

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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.

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100 Priority IP Projects for 2020

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What does the recently released CNIPA document listing “100  Projects in 2020  to Deeply implement the National Intellectual Property Strategy to Accelerate the Construction of the Intellectual Property Powerful Country Promotion Plan” (2020年加快建设知识产权强国推进计划提出 100项具体措施) (the “100 Project List”) (May 28, 2020) add to the discussion around where China is headed on IP?

The projects reveal much more than its lengthy, bureaucratic-sounding title might indicate. There are several  themes worth noting:

  1. It is ambitious. It includes doing many things over a short period of time, including reducing patent examination time for “high value” patents to 16 months and trademark examinations to 4 months (Projects 55-56).
  2. China is paying attention to its IP quality vs quantity dilemma. This document calls for ending local subsidies for utility model and design patents, as well as trademark (task 59).  It also discusses problems with incentives that are intended to encourage high quality patenting in universities and research institutions, SOE’s, and major government projects (Projects 3, 4, 5, 12, 55, 60 -61, 66, 77-79, 93, 96-97).
  3. There is increased attention to defense patenting. The word “defense” appears 17 times.  Defense patenting also occupies a greater role than in prior plans of type (Projects 6-10, 25, 80).
  4. Trade secrets as well as improving the criminal IP process play important roles (Projects 24, 44, 49, 51-54).
  5. We can expect some important developments in plant variety protection (Projects 26, 47, 57, 92).
  6. There is no attention to innovative pharma IP challenges. There are tasks related to generic medicines and traditional Chinese medicine (Projects 38, 73).  Patent linkage does not appear in this list of tasks.  These omissions could suggest a lack of CNIPA commitment to Phase 1 pharmaceutical IP reforms.
  7. There is a big focus on improving IP-related services (Projects 1, 2, 62, 72, 74, 77, 86).
  8. China reiterates its commitment to plurilateral IP policy (Projects 82, 87).
  9. The drafters are committed to the  Phase 1 Agreement.  China is also doing a lot more on IP than what the Phase 1 Agreement requires (Projects 24, 49, 51, 83, 87, and others).

The word cloud above is drawn from a machine translation of the 100 Project List.

Further background: I have been blogging about China’s national IP plans for years now, including in  2014,  2015 , 2016 as well as in my discussions on the National IP Strategy.  Readers may wish to compare this document with some of the prior strategy documents.