State Council Clears Patent Law Amendments, Forwards to NPC, Patent Linkage Is Not Referenced ….

According to the official central Chinese government website, on December 5, 2018, Premier Li Keqiang chaired a State Council meeting which cleared the long awaited proposed draft of the patent law amendments.  The description of the draft is set forth below:

为进一步加强专利权人合法权益保护、完善激励发明创造的机制制度、把实践中有效保护专利的成熟做法上升为法律,会议通过《中华人民共和国专利法修正案(草案)》。草案着眼加大对侵犯知识产权的打击力度,借鉴国际做法,大幅提高故意侵犯、假冒专利的赔偿和罚款额,显著增加侵权成本,震慑违法行为;明确了侵权人配合提供相关资料的举证责任,提出网络服务提供者未及时阻止侵权行为须承担连带责任。草案还明确了发明人或设计人合理分享职务发明创造收益的激励机制,并完善了专利授权制度。会议决定将草案提请全国人大常委会审议。

A rough translation is as follows:

In order to further strengthen the protection of the legitimate rights and interests of the patent rights holder, improve the mechanism system for stimulating creation of inventions, and raise those mature practices for effectively protecting patents into law, the meeting passed the “(Draft) Amendments of the Patent Law of the People’s Republic of China.” The Draft aims to increase the severity of penalties for intellectual property infringement, draws on international practices, significantly increase the amount of compensation and fines for willful infringement and counterfeiting of patents, and significantly increase the cost of infringement to deter illegal acts;  it clarifies the burden of proof for the infringer to cooperate in providing relevant information, and sets forth that the network service provider should bear joint liability for not stopping infringement in a timely manner. The Draft also clarifies the incentive mechanism for inventors or designers to equitably share the proceeds from the creation of service inventions, and improves the patent authorization system. The meeting decided to bring the Draft to the NPC Standing Committee for its review.

In a possibly unrelated development, the National Development and Reform Commission released a Chinese interagency Cooperation Memorandum of Understanding on December 4, 2018  to deal with entities that have lost trust due to IP (patent) infringement. 关于对知识产权(专利)领域严重失信主体 开展联合惩戒的合作备忘录.  Compared to the proposed patent law amendments, this lengthy document focuses even further on public law aspects of a patent law system, including recidivist infringers, “irregular” patent applications, providing false documents to the patent office, etc. and includes a range of 33 different punishments to be meted out from a wide number of agencies, including denial of subsidies, debarment for procurement purposes, denying access to range of government programs, prohibiting leisure travel, etc.

The two documents taken together may suggest a disheartening renewed emphasis on administrative measures to deal with patent infringement and innovation incentives.  Such measures may be intended to address US trade concerns about IP infringement and “IP theft”.  They may also represent a return to China’s increasingly administrative enforcement-oriented approach to patent issues.  However, this renewed focus on administrative measures is also occurring the same time as China is moving to quickly establish a new national appellate IP court attached to the SPC by as early as the beginning of 2019.  This new court will be a national appellate circuit court with jurisdiction over administrative appeals and technical IP matters and will likely include seasoned judges from Beijing and the SPC itself.  Much work needs to be done to get this court off the group quickly.

What, however, is missing from both these documents is any reference to a patent linkage system for pharmaceutical products, which has been much talked about in this blog.  As previously reported, former CFDA Commissioner BI had been dismissed from his post as party secretary to SAMR this past summer in response to China’s tainted vaccine scandal. A State Council notice (no. 83) of August 20, 2018 on deepening reform in China’s medical sector thereafter also ominously omitted any reference to patent linkage.

As the original deadline for passage of the patent law amendments was the end of this year, my guess is that this draft may be referred on to the NPC by the end of this year, and passage may occur as early as the first half of next year.  I assume that a draft for public comment will be released by the NPC sometime early next year.  Generic and innovative pharmaceutical companies that believe a linkage system would help accelerate innovation in the pharmaceutical sector and support early introduction of high quality generics, may consider commenting on these issues once a public comment draft is made available.

The TPP’s IP Challenge for China

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The release of the TPP text on November 5, 2015 has caused many friends in Chinese IP colleagues to wonder what implications, if any, there are for China’s development of its IP system.

China’s recent experience of bilateral investment or free trade agreements has not prepared it for a major regional  IP-related agreement such as the TPP.  China’s  FTA  experience has thus far focused on a limited range of issues, most of which are not “core” IP.   As one academic researcher noted “the majority of China’s RTAs [Regional Trade Agreements] focus… on specific categories of IPRs, namely GIs and genetic resources and traditional knowledge or border measures, often omitting any reference to other categories, i.e. copyright, patents, trademarks or IPRs enforcement.”    The last comprehensive IP agreement that China entered into was its accession to the WTO  with  adherence to the TRIPS Agreement (2001).  The TPP is however more comprehensive and forward looking than TRIPS.

The China-Swiss FTA (2013) calls for some important, but limited improvements in China’s IP regime, particularly in areas involving designs, customs protection and plant variety protection.  To take plant varieties as one limited example, the TPP requires all member countries to sign on to UPOV ’91.  This was a step that Switzerland, a member of UPOV ’91 since 2008, did not secure in its bilateral FTA with China despite Switzerland’s having a flourishing agroscience sector.   By any measure the demands that would be placed on China by acceding to the TPP would be greater than most of the developed world, particularly for countries like Singapore, Chile, and Australia that have concluded free trade agreements with significant IP chapters with the United States in the past several years.

Despite these challenges, it would be difficult for China to stay outside of a regional trade agreement that includes such important regional trade partners.  Leaving China outside of the TPP may also not be the most desirable IP strategy.  China is the second largest global economy with the largest IP system in the world, and with rapidly growing innovative sectors and global business models (including in e-commerce).   The TPP and the global trading system could also be greatly strengthened if China were to play a constructive role, conform to and join TPP, and if reformers in China were empowered to bring China in adherence to TPP to spur another effort at market-reform.   As Amb. Holleyman recently noted in discussing the TPP: “the rules that China adopts to promote IPR protection directly impact our economy.  If IPR protection in China were improved to a level comparable to the United States, U.S. net employment might increase by 2.1 million jobs and American companies would benefit from an estimated $107 billion in additional annual sales, according to U.S. International Trade Commission estimates.”

A further systemic challenge is that the TPP appears to be based in part on its members experience on the difficulties in engaging China on IP.  As one former senior diplomat recently noted before a Japanese audience:

Rampant violations of intellectual property continue, state-owned enterprises are advantages over private competitors, and U.S. companies invested in China have become increasingly disillusioned by China’s unique standards and preference for “indigenous innovation”—not to mention evidence of large-scale cybersecurity violations…

TPP allows the U.S., Japan and our partners, to offer a high-standard, rules-based alternative to China’s state capitalism.

China has already acceded to all the major treaties enumerated as required for TPP accession with the exception of UPOV ’91 — namely the Madrid Protocol, Budapest Treaty,  Singapore Treaty, WCT. WPPT, as well as the Patent Cooperation Treaty, Paris and Berne Conventions, and of course the TRIPS Agreement.    I believe that most of the challenges to China are likely not in the form of adherence to required treaties, but in the more granular implementation of those treaties and in commitments that are not found in any current treaty that China is a part.  For example, in the pharma sector, the TPP contains extensive provisions on patent linkage, patent term restoration, and data exclusivity which go beyond the TRIPS Agreement.  In addition to these substantive IP issues, there are significant challenges in non-IP area chapters that affect commercialization and utilization of IP, such as in market access for lawyers, restrictions on state owned enterprises, e-commerce, and investor-state dispute resolution.

The focus in the TPP on treaties that support greater IP office to IP office cooperation in the TPP (e.g, PCT, Madrid), also underscores that this is a treaty that not only aims to raise substantive norms, but also aims to facilitate greater utilization of IP in the TPP region among its members to facilitate economic integration.   It would be wrong of critics to characterize this agreement as solely a North-driven effort to impose its IP norms on the South.  In addition to cooperative commitments, there are also provisions on genetic resources, access to medicines (aligning with the Doha Declaration), traditional knowledge and capacity building that reflect the interests of developing countries.

China’s recent past has shown that China can enter into WTO plus commitments on IP.  The most notable are China’s  joining the WIPO Internet Treaties, and thereafter hosting and ratifying the Beijing Treaty on Audiovisual Performances.  However, there are also important areas that have not been specifically addressed in recent trade-related agreements, such as trade secrets, have generally shown little norm setting progress since China first enacted its trade secret law in 1993, which had arguably been undertaken in response to US pressure in 1992.

The history of the past several decades of foreign engagement with China has, however, generally shown that linkage-based diplomacy, where trade concessions may be extended or removed in exchange for / or due to violations of IP-related commitments, has likely been the most effective single factor in driving IP-related changes in China.   Many of the key IP-related commitments  evolved in response to normalization of US-China trade relations, as well as WTO accession.

With modern China’s professed interests in becoming an innovative economy, will the TPP spur additional changes that are in China’s long term interests?  What kind of challenge does the TPP set for China’s own economic plans, including the revisions to the current five year plan, the National IP Strategy and China’s efforts to become a strong IP country?

While TPP members were negotiating the final text of their agreement, China’s state planners were drafting a new five year plan, which will further underscore China’s commitment to developing an innovation-oriented economy (see chart below, prepared by Barclays on frequency of ‘innovation’ in the current five year plan).  China will need to look at what it gains in TPP accession in exchange for IP commitments which China may believe it is not yet prepared for, but that in the long run will clearly benefit in the Chinese economy and enable it to become more innovative.  Hopefully, Chinese reformers will seize on the TPP as a way to drive a new era of economic reform, prosperity and IP harmony.

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Top picture: Amb. Robert Holleyman noted at a November 8, 2015 US Chamber event discussing TPP.

Second US-China IPR Cooperation Dialogue Report Released

Dialogue Photo

The 2014-15 US – China IP Cooperation Dialogue report has been just released by the US Chamber of Commerce.  The  Chinese title: 中美知识产权学者对话纪要. Here is a link to last year’s report for comparison.

The report was chaired by former PTO Director Dave Kappos on the US side, and Dean Liu Chuntian of Renmin U. on the Chinese side.  Former judges Rader and Cheng Yongshun were also were part of the team.  At our various meetings we hosted former SIPO Commissioner Tian Lipu, NCA Vice Commissioner Yan Xiaohong, senior judges from the IP courts and Supreme People’s Courts, trademark officials, academics and others.  I was part of the U.S. side for a second year, and was joined by Tony Chen of Jones Day and Eric Priest of the University of Oregon.

The report looks at several issues: IP and innovation in the technical sector; IP and innovation in the pharmaceutical sector;  judicial protection of IP; trade secrets protection; and copyright enforcement.  The following are some of the baskets of proposals agreed to by both sides (more granular detail is found in the report itself):

  • Use quality instead of quantity as the measure of innovation.
  • Explore the possibility that a judicial interpretation be issued to ensure no injunctive threat is available until utility model patents have been substantively examined for validity.
  • Adopt a more balanced and market-driven approach to promote innovation by entrepreneurs, inventors and universities.
  • Improve the patent linkage system, and provide effective protection for clinical data of new chemical entities by using the ongoing effort to amend the Patent Law and the Drug Administration Law as an opportunity for change.
  • Initiate a special study on establishing a single IP appellate court to unify China’s judicial adjudication of IP.
  • Improve the guiding case system with respect to procedures for reviewing, selecting and releasing cases and support better adoption of case law information.
  • Recommend research on the possibility to have a stand-alone and uniform trade secret law, in order to effectively maintain a fair market competition environment.
  • Address new problems created by changing technology and business models; develop a good ecosystem for innovation by the interaction of law and the marketplace; and provide more market opportunities for copyright holders while dealing with piracy.

I have strongly supported the Dialogue since its inception, when I was at Fordham Law School, in order to provide a de-politicized, expert and wide ranging engagement on Chinese IP issues.  If last year’s report is an indication of how this year’s report will be received, it will likely be widely circulated inside and outside the Chinese government.

open dialogue meeting with Amb. Baucus, US and Chinese colleagues in Beijing in early 2016.

Photos above by Mark Cohen.  Top photo at Hainan Island meeting, bottom photo in Beijing at public meeting with U.S. Amb. Max Baucus, US and Chinese guests and dialogue experts (both photos early 2015).

Pharmaceutical Patent Linkage: Are Rumors of Its Death Premature?

At the end of last year, I  noted that CFDA’s proposed new Drug Registration Rule could spell the end of China’s limited patent linkage regime.  A new public comment draft of the Drug Registration Rule was posted on the SCLAO’s website on Feb 19, 2014, with comments due March 23, 2014.   

This version of the DRR has new several references to patents, notably Article 19, which provides as follows: “第十九条  对他人已获得中国专利权的药品,申请人可以提出注册申请。国家食品药品监督管理总局按照本办法予以审查,符合规定的核发药品批准文号、《进口药品注册证》或者《医药产品注册证》专利期满后生效.”  Art 19: “An applicant can submit a drug registration application when another party has obtained a patent in China for the pharmaceutical product.  CFDA’s division of Pharmaceutical Product Supervision and Management will review the application in accordance with these Rules, and if the applicant is in conformity with these Rules, the drug will be granted a drug approval number, and an “Imported Drug License” or “Drug License”, with the registration coming into effect upon expiration of the patent term.”   Article 18 further requires a declaration or explanation of non-infringement by the generic applicant when there is a relevant Chinese patent relating to the drug approval, with publication of such notice on CFDA’s website.  Patent disputes, according to Article 18, are to be governed by relevant patent law.

Retention of a patent linkage regime, even one that has been weak, is a positive development in China’s efforts to develop an innovative pharmaceutical industry.  Equally important, this amendment shows responsiveness by CFDA to concerns about the direction of China’s innovative pharmaceutical sector.  Although I have no additional information on the reasons for this change and the expectations regarding its implementation, the rumors of the death of patent linkage in China seem, at this time, to have been premature.