China’s “Naked Bolar” and the Tapering Momentum to Protect Innovative Pharmaceuticals

There have been several important developments in recent weeks involving pharmaceutical IP protection in both mainland China and Taiwan.  Based on these developments, mainland China appears to be slowing its momentum to afford better IP protection to innovative pharmaceutical products (perhaps as a negotiating position in the Trade War), while Taiwan is pursuing a more protective approach.

On August 26, 2019, China’s National People’s Congress adopted the new Drug Administration Law (“DAL”), which will take effect on December 1, 2019. The DAL was passed after almost two years of review and deliberation.  The legislative history is set forth in the  NPC Observer.    The new law addresses some important issues involving counterfeit and substandard medicines.  However, it does little to improve the IP regime for innovative medicines.

As noted in this blog, there had been expectations that certain IP issues such as patent linkage and regulatory data protection might be reflected in the DAL and especially pending IP legislation.  In the latest draft of the Chinese Patent Laws presented to the State Council in December 2018, no detailed improvement mechanisms of the patent examination/granting system were included with respect to pharmaceutical patents were included.   It was hoped that a linkage system would emerge as part of a package of legal reforms to resolve the US-China trade war or to implement as earlier CFDA policy decision.

China has long adopted one small part of a modern IP/regulatory approval mechanism to encourage its generic sector.  China’s “Bolar Exemption” which was incorporated into the 2008 Patent Law amendments (Article 69), exempts from infringement producing, using, or importing patented drugs or patented medical apparatus and instruments, for the purpose of providing the information required for administrative examination and approval.   This type of Bolar Exemption has often been called a “naked Bolar exemption” as it provides for the erosion of the innovator’s patent rights to exempt from infringement research to introduce competing generic drugs.  It is “naked” as it it does not compensate the innovator for the losses of the patent term caused by this exemption nor for the resultant instability to any marketing exclusivity the innovator may face by reason of accelerated challenges to the patents it holds.   One way of compensating the innovator for such erosion of the term is to extend it on the “back end”  before its expiration.  A 2019 draft of the patent law amendments sought to correct this lack of a patent term extension.  Another way of providing for greater stability would be establishing a patent linkage regime which “links” marketing authorization with patents that read on the relevant pharmaceutical product or successful challenges to its exclusivity.

The current naked Bolar regime has several adverse consequences. The most obvious and significant is that it does not provide legal support for approval and marketing of generic drugs that are proven not to infringe an innovator’s patent rights, as a “patent linkage” regime might.   A Bolar exemption only addresses research intended to support regulatory approval and is not an exemption from infringement.  To the extent that Chinese regulatory authorities may be relying on the Bolar exemption to approve the marketing of infringing generics, such an effort is legally misguided.  A naked Bolar is not a substitute for an IP and regulatory regime that balances the needs of generics and innovators.  As Amcham noted in its comments on the original Bolar exception provision: “Effective IP protection for pharmaceutical products requires notice, transparency, and time to resolve legal issues prior to the approval of a generic product.” Such protections are not afforded under the existing regime and could be with an effective linkage regime.

Another adverse consequence is that it erodes the term of the patentee without the kind of bargaining that went into the US Bolar exemption, creating a kind of sui generis exemption from infringement for additional acts of research to facilitate product introduction which is not otherwise permitted under the patent law.  To the extent that the naked Bolar expands research exemptions to production and warehousing of an infringing generic pharmaceutical, and does not adequately limited or compensate the rights holder,  it may violate the terms set forth the in the WTO decision EU v Canada (DS/114) where the WTO noted that the Canadian Bolar exception could only apply to regulatory review where  “no commercial use is made of resulting final products.” (line 7.45).   The Bolar exemption should not be used to bootstrap a broader researcher or pre-marketing exemption.  As former Chief Judge Rader noted of the US patent law in discussing research exemptions: “the Patent Act leaves no room for any de minimis or experimental use excuses for infringement. Because the Patent Act confers the right to preclude ‘use,’ not ‘substantial use,’ no room remains in the law for a de minimis excuse.”  (Embrex v. Service Engineering, 216 F.3d 1343 (Fed. Cir. 2000).

Finally,  the “naked Bolar” sends a wrong signal by suggesting that China is not fully committed to developing an innovative pharmaceutical sector, despite China’s considerable human resources, investments, rhetoric and planning to the contrary.

Judging by recent generic drug approvals in China, there may be decreased momentum on the ground to protect innovative pharmaceuticals through limiting regulatory approval during the pendency of relevant patent protection.  Several generic versions of innovative pharmaceutical products have recently been approved by China for different manufacturers at the time of these recent DAL amendments, including Azilsartan, a product originally developed by Takeda that addresses hypertension, and is now produced by Zhaoke Pharma, a wholly-owned subsidiary of Lees Pharma. Azilsartan and Esketamine (a Janssen product for treatment-resistant depression) are also now being produced by Jiangsu Hengrui Medicine.  Pomalidomide,  a Celgene-developed product for treating multiple myeloma,  is produced by Chiatai Tianqing Pharma.  Bendamustine, a Teva product for  chronic lymphocytic leukemia, is being produced by Nanjing Simcere Pharma.  These products have obtained approval priority from CFDA and are expected to be approved by the time the new DAL comes into effect.  As is evident from this list, some products (Azilsartan) are being produced in generic form by more than one manufacturer.  This phenomenon of multiple competing generic manufacturers who may not have had to pursue patent challenges to the innovator to obtain marketing approval (as in a linkage regime), could also result in competition amongst generic manufacturers without strong incentives for follow-on innovation to the original compound.

By comparisons to this apparent backsliding in Mainland China, the Taiwan Executive Yuan has passed the bill to enact the new Pharmaceutical Affairs Act (“PAA”) on January 31, 2018. Patent linkage was specifically approved in Chapter 4 of the new PAA. Previously, in 2018, the Taiwan Food and Drug Administration had issued two drafts of the Enforcement Rules for Patent Linkage. Further, in May 2019, the Taiwan Ministry of Health and Welfare and the Ministry of Economic Affairs held a public hearing to clarify the intent to extend the patent linkage system in PAA to biosimilars. In July 2019, the Ministry of Health and Welfare officially announced that it is considering adding transitional clauses to exempt biosimilars which have obtained official clinical trial approvals during the implementation phase of patent linkage system in Taiwan.

While there appears to be weakening momentum for patent linkage, the DAL does change the regulatory regime for counterfeit medicines and vaccines.  In an apparent effort to address public health needs, the DAL, as revised, modifies the definition of counterfeit drugs.   Under the prior version of the DAL, unapproved imported drugs are deemed as counterfeit. Although the new DAL still prohibits importing and selling of unapproved drugs in large quantity, the importation of small amounts of drugs which have been legally marketed in other countries for urgent clinical needs is exempted under the new DAL, subject to other relevant laws and regulation.  The DAL also seeks to strengthen regulation over vaccine manufacturing, most likely in response to the vaccine scandal of 2018. Under the DAL, out-sourcing of vaccine manufacture is strictly prohibited. The punishment on manufacture and supply of counterfeit vaccine has increased from 5 times of revenue to 30 times of illegal proceeds.  The vaccine Marketing Authorization Holder (“MAH”) must meet certain standards set out in the new Vaccine Administration Law. The regulators will also establish a national traceable platform for the production, transportation, and storage of vaccines.  Lastly, new mechanisms such as the MAH system, defective drug recall system, filing system of clinical trial institutions will be implemented.  The existing “Good Manufacturing Practice for Pharmaceutical Products” (GMP) certification system for drug manufacturers and the “Good Supply Practice for Pharmaceutical Products (GSP) certification system for drug suppliers will be canceled.

Looking at all of the various legislative and regulatory developments in Mainland China and Taiwan, it is hoped that mainland China will ultimately find the right balance of incentives to encourage the further development of its innovative pharmaceutical sector, much as the US did with its Hatch-Waxman Act, while continuing to develop a secure supply of high quality innovative and generic products.

This article was written by Mark A. Cohen and Angel Liu.

Collaboration or Confrontation: Beyond the False Dichotomy in US-China IP Relations

Recently several articles have criticized the Trump administration’s strategic choice of confrontation over collaboration with China.  Amongst them was an open letter published in the July 2, 2019, Washington Post, “China is Not an Enemy,” or “Making China A US Enemy is Counterproductive” (based on its hyperlink) that was signed by several distinguished former officials and scholars. Prof. Alastair Iain Johnston of Harvard University also wrote an excellent article, “The Failures of the ‘Failure of Engagement’ with China.”  Chinese commentators have also chimed in.  One of the signatories of the July 2, 2019 letter, Jim McGregor. delivered a great podcast that provides a nuanced view of the limitations of collaboration.  A counter-letter, “Stay The Course On China: An Open Letter To President Trump” has also emerged with the July 2, 2019 letter.  The debate to a degree is an extension of the Stanford University report “China’s Influence and American Interests: Promoting Constructive Vigilance” from 2018, which also generated its share of controversy.

The authors of these studies discuss all aspects of the US-China relationship- trade, security, scientific, intellectual property, etc., into the collaboration vs. confrontation dichotomy. I lack the breadth of this vision to discuss all aspects of a complex relationship.  My focus for this blog is solely on IP and innovation. 

A basic assumption of many of these authors is that we should avoid making China an enemy unnecessarily.  I agree. At the same time, many of the commentators seem to suggest that either IP engagement or confrontation may be counterproductive because of systemic failures of the WTO, or past disappointments.  As Prof. Johnston notes: “[T]here is no doubt that there are persistent WTO incompatible non-tariff trade barriers, including weak intellectual property protection, technology theft, and non-transparent regulatory practices, among others.” 

Overall, the IP-related arguments present a false dichotomy between engagement or confrontation.  Bilateral engagement is only one tool, and it need not be sacrificed to more assertive strategies.  The toolbox should include different approaches. Softer advocacy might include training programs in China on novel issues, supporting more focused strategies by businesses, joint collaboration on shared challenges and trade agreements that include China (such as a bilateral investment treaty), to name a few.  More assertive postures might involve critical white papers or non-papers, multilateral engagement, WTO or other international law diplomacy or cases, trade agreements that exclude China (TPP), and in appropriate circumstances quid pro quo retaliation such as tariffs and sanctions.  Simply put, carrots and sticks are not exclusive of each other.  Sticks, however, carry a cost and need to be carefully considered before deploying.

One of the legacies of the Obama administration on IP was that it was over-committed to dialogues.  As Chinese trade diplomacy has been highly transactional, this had permitted China to “buy time” without committing to any trade concession.  For those who lived through Obama’s excesses and opposed them, President Trump has demonstrated himself to be Obama’s Hegelian opposite.

The explosion in IP dialogues during the Obama period is well documented. For example, the 2015 Joint Commission on Commerce and Trade (JCCT), which was co-chaired by the Department of Commerce and USTR and was the highest-ranking trade-specific bilateral dialogue established IP-specific dialogues, exchanges and programs on such topics as: standards, trade secrets, geographical indications, sports broadcasting, media boxes and copyright, on-line enforcement (including referrals to another IP-related working group involving criminal law), case law and databases with the judiciary, bad faith trademarks, copyright legislation, IP legislation and protection of plant varieties.  Additionally IP was discussed outside of the JCCT in dialogues with a range of US agencies, including antitrust (DOJ/FTC), criminal law (DOJ/DHS), innovation (OSTP) and strategic and economic dialogues (State, USTR, Treasury), as well as at the WTO (USTR), WIPO (PTO), and in plurilateral discussions, such as the IP-5 (the five largest patent offices), TM-5 (the five largest trademark offices) and ID-5 (the five largest industrial design offices).  There were also other dialogues, including judicial exchanges (2016) and commercial rule of law (2016), which also focused on IP.

Properly and economically utilized, dialogues can advance understanding where ignorance of perspectives is a major impediment to resolving differences. They can build trust and long-lasting government to government relationships.  Dialogues may also spread the burden of advocacy among the US government, industry and trade associations and even foreign governments.  Educational training and assistance can also be leveraged for seeking additional concessions.  They also help establish a measured approach to escalating issues to increasingly higher political levels.  However, dialogues should never become ends in themselves and need to be periodically evaluated for their effectiveness and efficiency.  

In a typical, hypothetical IP matter, a strategic approach to dialogues and engagement might involve a white-boarded multiple-year plan for the US that reflects the varying interests of the US government, foreign governments, industry, and academia over a multi-year period.  The plan might progressively escalate concerns from a discussion around, say, bad faith trademarks, to a seminar on this topic, a meeting between the heads of the US and Chinese trademark offices, a JCCT meeting at a political level, a TM-5 meeting, a program with the International Trademark Association or the EU’s technical “IP Key” assistance effort, and perhaps a meeting amongst cabinet-level officials and/or a WTO case.  These approaches may be consecutive or simultaneous. This type of strategy is also well known in Chinese military history, as “coordinating one’s strategies” 连环计 i.e., never relying on a single strategy but having many to fall back on, which is the 35th of the 36th classical military stratagems 三十六计. 

There have been several successful examples of coordinated engagement in IP that have delivered real changes over the years.  Examples include China’s providing design patent protection for graphical user interfaces, which involved multi-year engagement by industry, academia, the Chinese and US patent offices, and ultimately the good offices of the JCCT, to deliver a tangible commitment in Chinese patent office practices.  Another example during the Obama period is the reform of China’s pharmaceutical patent examination process, which involved a similar process.   A longer-term engagement focused on the creation of China’s specialized appellate IP court.  It also involved several judges of the Court of Appeals for the Federal Circuit (CAFC) (including former Chief Judge Rader), the Federal Circuit Bar Association, academia, and others over a nearly 20-year period.  

To be effective, however, dialogues must be strategic.  The 2015 JCCT, by contrast, seemed to have an approach of letting “a 100 dialogues bloom”  (百对话齐放).   

The 2015 JCCT also provided a counter-factual in the strategic use of coordinated strategies in its handling of the US request of China to revise China’s discriminatory Administration of Technology Import/Export Regulations (TIER).  The 2015 JCCT included a commitment to “support a technology licensing joint seminar to be convened by MOFCOM in the first quarter of 2016.”  This was a strikingly modest ask of the very senior US and Chinese officials that chaired the JCCT: a Chinese Vice Premier and three US Cabinet-level officials.  However, JCCT support was necessary to overcome entrenched Chinese resistance. Moreover, despite the JCCT commitment, China did not follow through on this modest ask.  It did not host the seminar. 

During this same time period, the US Chamber of Commerce, Global IP Center,  published a report through its “Track II”, IP Cooperation Dialogue calling for reform in the TIER. The Track II Dialogue seeks to encourage expert non-government IP-engagement and not rely solely on over-politicized official bilateral dialogues.  It includes former judges and patent office officials, as well as academics (including this author). The 2016 Report also did little to convince official China to reform the TIER.

USG persisted.  The 2017 JCCT reiterated the commitment to “hold a joint seminar”. This program was ultimately convened on March 18, 2017,  However, the program concluded with no change in China’s position regarding the reform of the TIER.     

With no demonstrable momentum by China, USTR identified the TIER in its 301 investigation of China’s technology transfer practices.  It also filed a WTO case in March 2018. China finally took notice and amended these discriminatory provisions in 2019. Now that the offending provisions of the TIER have been amended, the WTO case has been suspended.  Today, with the suspension legal case, its full implementation should be monitored.

While it is likely that China would not have amended the TIER absent the WTO case, dialogue on the TIER also played the important roles of coordinating USG positions, elevating an issue politically, involving other foreign governments, testing the waters with senior leadership in China, and making sure that the US proceeded in a measured and thoughtful manner.   Many foreign governments, including the European Union and Japan were involved in these dialogue efforts and many also supported the WTO case.  The WTO “win” on the TIER is ironic as it came from an administration has generally shown opposition to multilateral institutions as well as dialogues.   

China has contributed to the demise of dialogues and similar mechanisms in its use of bilateral meetings as instruments of delay and retaliation.  It responded to the first WTO IP case that the US brought in 2007 as an “act of aggression” that it would “fight to the bitter end” in 2007 (DS/362).  China thereafter suspended many forms of IP-related cooperation with the US.   In the build-up to DS/362, the United States also sought to compel China to publish all its IP cases, which the WTO declined to support (a TRIPS “Article 63” request).  China also did not oblige in that request. 

DS/362  was the only WTO case brought against China on IP prior to the Trump administration. That case dealt with infringement of consumer goods – notably, copyright piracy and trademark counterfeiting, particularly criminal and customs remedies. DS/362 did not involve technology. Anybody claiming that the WTO has been a failure with respect to China’s enforcement of patents and trade secrets should look elsewhere.  That case has not yet been brought.

USTR likely viewed DS/362  was a failure. The US did not succeed in compelling China to amend its criminal IP laws in DS/362, nor in requiring China to make its cases publicly available.  As a consequence of losing the case, the US government lost faith in the WTO as a mechanism for resolving IP-related disputes. USTR instead launched a series of bilateral and multilateral negotiations, including a proposed Anticounterfeiting Trade Agreement and revised model IP texts in bilateral and plurilateral trade agreements.  

The ensuing devaluation of WTO mechanisms was, in my view, premature.  While lawsuits in the US often appear binary in their outcomes, pressuring foreign countries to adopt legal regimes that they are otherwise opposed to at the WTO is much more complex.  Additionally, US impatience is not well-justified as the US has also been slow in responding to many WTO rulings.  

USTR’s assessment regarding DS/362 may also have reflected its own institutional limitations. USTR is thinly staffed and lacks resources to engage in technical training or monitoring programs.  USTR relies heavily on industry suggestions, which may also be short-term in nature.  Unlike other US government agencies involved in IP, USTR is not the lead USG agency in a number of important IP exchanges, such as at the World Intellectual Property Organization, Interpol or the World Customs Organization. It does not participate in or promote IP office related exchanges,  does not have IP officers or law enforcement officers posted to China, and does not have a China Resource Center like the USPTO, which provides statistical analyses of IP-trends in China.  It can and does negotiate deals with trade officials or bring disputes. These are two important but limited options from a much broader set that can be brought to bear on an IP issue. 

The arguments that the WTO does not work in addressing IP-related disputes also ignore the success achieved by the Trump administration in seeing the TIER revised, as well as the demonstrable impact that DS/362 had in elevating the importance of criminal trademark and copyright enforcement to China, despite the setback of a loss in dispute proceedings.  The victory the US achieved in the criminal enforcement case materialized in the form of an uptake in criminal IP prosecutions. China increased its criminal IP cases from 904 in 2007 (the date DS/362 was filed) to 15,121 cases, involving 17,869 people in 2012This is a  16 fold increase.  By 2012, the Chinese criminal IP docket also grew to over 200 times the  US criminal IP docket of 2018. which consisted of 117 defendants in 67 cases.  One Chinese Supreme People’s Court judge confided in me that he attributed that increase to the spotlight that the US gave to the importance of criminal IP in China’s evolving IP ecosystem. For some recent analysis on these trends, please see Dan Prud’homme and Zhang Taolue’s excellent book “China’s Intellectual Property Regime for Innovation” (Springer 2019) which summarizes recent research on this increase, and provides data on criminal IP cases, defendants, prosecutions and convictions.  

A similar argument regarding the ultimate success of the US claims might be made about the request of the US that China should make all its IP cases publicly available in 2005/2006 (the so-called “Article 63 Request”). By 2014, China had decided to publish nearly all its cases of all types.  This publication of cases has been welcomed by the legal and judicial community alike and has helped to provide greater predictability in adjudication, minimize corruption and provide a basis for strategic IP enforcement.  

By contrast to these successes, there was one claim in DS/362 that had no significant positive impact.  This failure was not due to China’s intransigence. In DS/362 USTR also alleged that China’s disposal of seized infringing goods by auction offended WTO requirements.  However, WTO rules only require Chinese Customs to seize goods upon importation (TRIPS Agreement Art. 51). China was and remains primarily an exporter of counterfeit and pirated goods.  The WTO was unable to identify a single instance where China had auctioned off counterfeit goods imported into China.   “No infringing goods destined for importation”, the panel stated “have ever been auctioned…during the period for which statistics are available.” (Para. 7.351).  The Customs claim, criminal IP claim and the case publication achievement all underscore the continual need for good data to support IP engagement.

Arguing over whether China is becoming our enemy and the need for confrontation is redolent of the post-Korean War China rhetoric in the US.  A better approach might be to remake the US government into an institution that better understands, persuades and strategizes on complex technological and IP issues in China.  During the past 30 – 40 years, the US government has defunded or terminated every technology–oriented agency that cared to engage in a significant way with China, including the Office of Technology Assessment in Congress, the Technology Administration in Commerce, and the Office of Science and Technology Policy in the White House.  USTR’s mandate is also too limited to effectively engage in collaboration. USPTO has the deepest technical resources on IP and innovation issues, but lacks political clout. We need to coordinate more closely, and provide incentives for deeper engagement among all US agencies as well as with industry in order to be effective.   These issues have been apparent since at least the time of China’s WTO accession.  As I noted at a conference at the 24th Annual Fordham University IP Conference in 2016 (Session 4B-b “Asia and the Political Landscape”):

MR COHEN:… One of the lessons from WTO accession was — and I don’t know how to say this gently — how … under-informed US industry was about the legal system.  I say that because if you look at the number of civil cases involving intellectual property, in the year that China joined the WTO — and the negotiations occurred in the years before — there were about thirty.  So one could, theoretically, have contacted every company that had filed a lawsuit involving IP and you still wouldn’t have a very large cohort.

So a lot of trade negotiations, unfortunately but necessarily, are based on hypothetical constructs.  What makes a good legal system, with big words like “impartial,” “fair”?…

METALITZ:  So who was under-informed in that situation?  Was it the US negotiators or was it the US industry?  US industry — you’re right — was not bringing these cases.  But that may not have been out of ignorance. That may have been out of a supposition that they would not be useful.

BAI:  May I chime in?… I have seen US government officials talking about China when they don’t get their briefing right…. 

One way to improve policy is to hire the right people.  We need to promote and reward individuals who have the three “magic” skills: knowledge of Chinese law, knowledge of Chinese IP  or technology, and Chinese language skills. These individuals should also be given roles commensurate with their knowledge and skills.  The 2013 Report of the Commission to Stop American IP Theft, also identified this as an issue in the staffing of our embassies overseas: 

Strengthen American diplomatic priorities in the protection of American IP. American ambassadors ought to be assessed on protecting intellectual property, as they are now assessed on promoting trade and exports. Raising the rank of IP attachés in countries in which theft is the most serious enhances their ability to protect American IP. 

The need to restructure US government on tech and IP issues has long affected the quality of our “engagement.”   

Whether confrontation or engagement are pursued, the choice is complex, should be well-coordinated, and will need to evolve based on circumstances.  It should be based on the right information made by well-informed people.  It is not, ultimately, an ideological issue.  

Revised: July 21, 2019

 

SO MANY CHINA IP CONFERENCES, SO LITTLE TIME…

markatjmls

Here’s a rundown of some past events, and some upcoming ones.  I will provide an update on some of the legal developments at a later date (I know I have been a bit remiss).

On October 4, 2018, I spoke about China at the University of Nevada Las Vegas’ program  on “Intellectual Property Enforcement at Trade Fairs.”   My observations: (a) China does not routinely great preliminary injunctions at trade fairs, despite heavy reliance on injunctive relief in final adjudication of IP infringements;  (b) The United States does have robust preliminary injunction/temporary restraining order trade fair remedies; (c) the use of sui generis administrative or quasi-administrative enforcement mechanisms for trade fair enforcement in China may be one reason that judicial remedies are not that common; (d) trade fairs do afford other opportunites – they are excellent evidence gathering opportunities, their use can help satisfy use requirements for a trademark, and they may constitute infringing conduct as an “offer for sale” under the patent law.  Please look through my  power point and tell me if you have any comments.

On November 2, 2018.  John Marshall Law School (JMLS) convened its 62nd annual IP conference I chaired a great breakout session on international developments, with Kira Alvarez, Peter Yu, Cynthia Ho, Tobias Hahn and Prof. Dennis Crouch.   The session discussed the state of global IP and China-specific IP negotiations in the Trump administration.   Kira Alvarez noted the success of the administration in negotiation trade secret commitments in the revised NAFTA.  The panel, along with the audience, also discussed the role of soft diplomacy, rather than trade disputes, to resolve IP-related trade conflicts.  Prof. Dennis Crouch attributed many of the changes in civil litigation globally to the work of former Chief Judge Rader “who was really using his gregarious nature to reach out and become close friends with the leading jurists around the world.”  This point was restated by many during the conference and thereafter.  The photo above is from the JMLS international IP panel with Kira to my right.

I also participated at the JMLS annual IP  conference in a plenary discussion on antitrust and IP developments, moderated by Prof. Hugh Hansen of Fordham with  Carlos Aboim, David Djavaherian, Suzanne Munck (FTC),  Prof. Ioannis Lianos, University College London and  Annsley Merelle Ward.   I looked at the evolution of Chinese judicial practice regarding SEPS, which are a remarkable set of steps in light of there being no substantive change in antitrust or patent law during this period, and likely reflect increased judicial experience as well as the impact of economic changes in China as an emerging licensor.  These developments were previously discussed in this blog.  I also discussed China’s historical reliance on civil law measures to deal with IP misuse, rather than remedies under the patent law or antitrust law, and how these compare with US practice.

On November 5, 2018, Dan Rosen (Rhodium Group) launched another path breaking paper “Missing Link – Corporate Governance in China’s State Sector” at the Asia Society of Northern California.  A copy can be found here.  The video of the launch can be found here.  The focus of my comments was on whether SOE’s can play a more active role in China’s innovation plans, and the awkward fit between SOE’s and global trading rules.  I believed that existing efforts to provide greater market accountability and transparency for SOE’s (and more broadly, China) have not achieved their intended outcomes despite  the extensive commitments negotiated with China at WTO accession.

I gave a talk at the IP Dealmakers Forum in NY on November 8, 2018 with several individuals involved in financing litigation, providing patent analytics, buying Chinese patents  – Roger Tu, Y. P. Jou,  Brian Yates, iPEL, and Bill Yuen.  Brian Yates’ company had just been the subject of a Chinese article regarding whether patent assertion entities will now be/should now be coming to China, that was posted by IPHouse.  I think many in the room shared my skepticism that China was now “ripe” for this type of activity, particularly for litigation by foreigners against Chinese.  There was however a general sense that the IP and litigation environment was improving.

In addition to these programs, here are some upcoming events;

November 12, 2018, I will be talking at NYU.  I have always greatly enjoyed the open discussions with Prof. Jerome Cohen (no relation), Ira Belkin and others, and I believe this upcoming event will be no different in my current role at UC Berkeley.

On November 13, 2018, I will be at Columbia University talking about “IP and the China Trade War: Long Overdue, a Pretext, or Both?”     I may be guided by the discussions around that topic at JMLS earlier in November, where many concurred that these actions on IP in China are both overdue and dwarfed by other concerns.

On December 2, 2018, I will be in Shenzhen. Peking University School of Transnational Law (“STL”) will be partnering with Berkeley to present an exciting program on “Legal and  Funding Issues for Successful Startups.”  Both the topics and speakers promise to make this an especially exciting launch event. Here’s the link to register.

On December 3, 2018, I will be at IPBC  Asia moderating a session on “China’s Mandate to Innovate” and its impact on IP commercialization. IPBC has constituted a great panel, including former SPC Chief IP Judge Kong Xiangjun, now Dean at Jiaotong University Law School, and Prof. Yang Guohua of Tsinghua Law School (former Chinese IP Attaché in the US, and DDG of MOfCOM), as well as Liren Chen, from Qualcomm, Eeva Hakoranta from Nokia and Roger Tu from Marconi.

On December 4, I will be at Tsinghua University speaking at the first annual Tsinghua/Berkeley conference on “Transnational IP Litigation: Opportunities and Challenges”.  A copy of the agenda (Chinese) is found here.   We will also have some great speakers for this launch event which focuses, non-exclusively, on US developments.  The speakers include several Tsinghua and Berkeley professors, and leading attorneys from practice in the US and China.  The program will cover a full range of issues including empirical data on litigation trends, venue, jury trials, Section 337 litigation, antitrust, the role of expert witnesses, and licensing strategies to mitigate risk.

I have some other events upcoming in Taiwan in December – but that will be another posting, along with some overdue updates on Chinese IP developments.

A Data Download on Semiconductor Patent Litigation in China

Because of its strategic importance to both the United States and China, the IC sector is a useful example of how Chinese policies and plans may – or may not – be influencing the Chinese government in the protection of foreign-owned IP.

A useful starting point for evaluating the challenges in IC IP protection in China is the data collected from China’s court cases.  IP House has conducted a heretofore unpublished and useful study of all semiconductor-related patent disputes in its database, attached here (in Chinese).  The data shows that there have been 166 first instance civil patent infringements IP judgments with the word “chip” (芯片), and 86 second instance cases.    There have also been 142 first instance administrative decisions, typically involving validity matters, and ninety second instance decisions. 52.91% of the first instance cases involved invention patents, 10.31% involved utility model patents and 36.77% involved design patents.

Regarding civil cases, 39 were heard in Zhejiang, 35 in Guangdong, 27 in Beijing, 21 in Jiangsu and 11 in Shanghai.  Every other jurisdiction had fewer than five cases, and no cases were reported for Fujian Province.

The data suggest a comparatively low “success” rate for plaintiffs in semiconductor patent disputes.   Amongst the 183 reported judgments, only 51 cases were fully or partially successful — a 38.34% success rate.  This compared to an overall success rate of about 80% for litigants in patent cases in 2014 in China, as reported by Bian Renjun at Berkeley. Cases were not reversed to a significant degree on appeal; 60 out of 70 cases supported the original decision of the first instance court.  Amongst the “top 10 “ courts in terms of litigation volume, the success rate for semiconductor patent plaintiffs varied dramatically.   Guangdong had the highest success rate (60%), followed by Beijing (43.75%), Zhejiang (23.08%) and Jiangsu (19.05%).  76 of 77 successful litigants obtained an injunction to stop infringement; one litigant did not request an injunction.

Regarding administrative reviews, 117 out of 140 cases involved affirming the original administrative decision, an “affirmance rate” of 83.57 percent.  Eighty one out of ninety cases were affirmed on appeal.

The United States was the principal foreign civil litigant, with seven cases, followed by the British Virgin Islands and the Netherlands, each with two cases.  The United States was the principal first instance administrative plaintiff challenging SIPO’s decisions, with 30 cases, followed by Japan (5), Netherlands (3) and several countries with only one civil case (France, Germany, Cayman Islands, Korea,   Singapore and Israel).

I draw the following tentative conclusions from this data:

  1. Success rates for semiconductor cases vary dramatically by jurisdiction in China. My guess is that the Guangdong courts, which have the highest success rates, have greater expertise in both semiconductor patent litigation and patent litigation overall, which may make them more “expert” on these matters. Due to variations in success rates amongst jurisdictions, the semiconductor sector is a useful example of why China needs a national appellate IP court.
  2. No matter what major court one looks to, success rates for these cases are lower than the average for other types of patent litigation. This may suggest either a lack of familiarity with the technology or an unduly skeptical view of the courts regarding semiconductor patent assertions at this time. Considering that the vast majority of the cases do not involve foreigners, the low success rate primarily affects Chinese litigants.
  3. Foreigners, and especially Americans, use the courts primarily to litigate patent validity matters. There were 4.5 times more administrative semiconductor patent cases brought by Americans compared to infringement cases. Overall foreigners brought four times more validity cases compared to infringement cases in this area.  This means that the Beijing IP Court, which hears all validity disputes, plays a key role for foreigners on semiconductor patent matters.  Semiconductor patent cases also follow the general pattern where foreigners are disproportionately willing to challenge SIPO in court, but are less willing to bring infringement cases to final adjudication.
  4. Utility model and design patents are frequently asserted in patent disputes in China and may have value to foreign companies needing to protect their IP in this important market.
  5. The Fujian courts do not appear in this IP House report. However, Fujian has already heard one high profile case (AMEC v Veeco), which was settled and does not appear to be publicly available at this time. The second high profile case, involves Micron Technologies, and is currently on-going.

I hope to blog further about the AMEC cases in the United States and China in a subsequent posting.

 

False Friends (形似神异): Comparing US and Chinese Administrative Patent Enforcement

The China Patents and Trademarks journal has now made publicly available the article I wrote late last year with former USPTO Director David Kappos and former Chief Judge Randall Rader (ret.)  “Faux Amis: China-US Administrative Enforcement Comparison”, in both  English, and Chinese (形似神异:中美专利行政执法制度对比).  Kevin Lu 吕行 of USPTO also assisted in researching the article.

The article discusses the differences between administrative enforcement of patents in the United States International Trade Commission (Section 337) and by SIPO in China and notes that the comparisons of China’s administrative patent system to the USITC system are misleading, as the two systems are different both qualitatively and quantitatively. 

The opinions in the article are of course strictly the authors’ own.

Chinese IP: the Graduating Class of Officials

There have been several Chinese officials with authority over IP over the past few years who have been promoted. In December, the Ministry of Commerce recently reported that DG Li Chengang was promoted to Assistant Minister in December 2016, with authority over law and treaties (which includes trade-related IP).  His predecessor, Assistant Minister Tong Dao-chi, was also promoted and now serves as Vice Governor of Hubei as of December 2016. Across the straits, in July 2016, Madame Wang Mei-hua, who was formerly in charge of TIPO was promoted to Vice Minister of Economic Affairs.

The most prominent of the Chinese officials with deep IP experience who saw their career advance due to IP involvement in recent years is Madame Tao Kaiyuan the former DG in charge of Guangdong’s IP Department, who has served as one of the justices on China’s Supreme People’s Court since 2013, and has been a key advocate for judicial reforms and promoting rule of law.  Several other Chinese IP judges have also seen promotions in the recent years (Madame Tao and several current and former IP judges are pictured below).  Another official with deep IP experience,  Chen Fuli of MofCOM also was promoted from his former position as IP Attaché in Washington, DC and Director at MofCOM, where he oversaw IP engagement with the United States to his current position of Deputy Director General.

Also of note, former Chief Judge Randall Rader is reported to be under consideration to become the next Director of the USPTO under the incoming Trump Administration. Rader has noted that “Yes, several senators have sent my name to the Trump team for the position of director of the USPTO,” and that “The best way to protect U.S. jobs is to protect worldwide the IP that creates and guarantees those jobs.” China has also been quick to recognize Judge Rader’s accomplishments.n December 2016, he was awarded an Honorary Professorship by the President of Tsinghua University.

The current situation for Chinese IP officials contrasts with the experience of only a few years ago when it appeared that many Chinese IP agencies and officials were riding China’s new Antimonopoly Law, and not IP, to advance their agencies or careers. Officials such as DG Shang Ming moved from law and treaties in MofCOM to antitrust. At that time, China’s IP courts also picked up civil antitrust jurisdiction and the unfair competition bureau of SAIC also picked up antitrust authority.During those years, several officials also privately complained to me that their career advancement had been stymied by focusing too much on IP issues or engagement with foreigners. Some may also have seen former Vice Premier Wu Yi’s retirement in 2008 as tied to the filing of a WTO on IPR against China, which she appeared to take as a personal loss and that he had promised to fight vigorously against

As far as I know, the most dramatic and unusual employment engagement of an IP-knowledgeable official was made by another ardent IP supporter, Abraham Lincoln, when he appointed Edwin Stanton as Secretary of War due, in part, to his experience of working with him on a patent litigation when Lincoln was a private lawyer.

When officials who believe in IP are promoted to positions of higher authority it is a good sign of political support for protecting IP. This is true of both the United States and China.

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Jordan/Qiaodan Trademark Case – Translation Now Available Here

Thanks to the hard work of Jessie Zeng 曾 潇 of Tsinghua University Law School, and the support of his professor, former Chief Judge Randall Rader, we now have a translation of the Michael Jordan/Qiaodan case.  Here is a translation of the decision in word formatJessie Zeng has also kindly provided a translation of cited laws in the decision.

On first impression, the case has significant implications for entertainment law, trademark rights for well known foreign individuals in China as well  bad faith issues.  Here are some key points: 

A) The SPC overturned Beijing High Court’s view that required a definitive association between Qiaodan and Michael Jordan, but instead required a stable association.  The court relied heavily on general civil doctrine, including tort law, IP law and advertising law in making its analysis.  The court also noted that, with respect to foreigners,  the key factor is that the relevant public in China has gotten used to calling the foreigner with a Chinese name in translation.

B) The court also admitted a range of evidence to support the fame and reputation of Michael Jordan as proof of bad faith by Qiaodan, including a large number of articles, endorsements and survey data.

C) The court recognized that, with respect to foreign names,  sometimes the public may use a name for the individual that is different from the name the person actively uses, and that this name should be protectable.

D) The court also noted that Qiaodan’s prior investment activities and brand promotion did not give it any “squatter’s rights”, noting that “Qiao Dan Inc.’s operation condition, its efforts in related trademarks’ publicity, use, related trademarks’ awarded prizes and received protection and etc. cannot make the disputed trademark’s registration legitimate.” Qiaodan operates about 6,000 stores in China.  The case is in a sense a warning shot to trademark pirates that a business model based on bad faith is risky in today’s China.

In fact, in the many years that I have followed this case one of my greatest concerns was how much a court would be unwilling to disrupt expectations built around a bad faith business model.  Viewed as a political statement, the SPC is sending a strong and laudable signal by saying that relatively settled expectations based on bad faith registrations will not legitimize these trademark registrations and indeed can end up being quite costly.  Times are changing…

My thanks, once again, to Jessie Zeng! 

(Note: Translation revision: January 6, 2017).