April 24 – May 7, 2018 Summary

1.NPC Standing Committee Releases 2018 Legislative Plan. The NPC Standing Committee (NPCSC) on Friday released its annual legislative plan for 2018. As usual, the plan is divided into two sections—the first listing specific legislative projects slated for discussion at the NPCSC’s remaining five sessions in 2018, and second setting forth general guiding principles for its legislative work this year. The plan divides the legislative projects into three categories: (1) those for continued deliberation (that is, those carried over from 2017); (2) those for initial deliberation (that is, bills first submitted in 2018); and (3) preparatory projects.

Below is a list of laws and amendments that implicate IP matters:

E-commerce Law 电子商务法: passed under initial deliberation and is set for continued deliberation. December 2016 draft, October 2017 draft. 

Patent Law (Revision) 专利法(修订): set for initial deliberation in June. Draft released for public comments by the State Council in December 2015.  There have been several blogs previously on the drafting process and controversial issues.

Foreign Investment Law 外商投资法: set for initial deliberation in December. Draft released by the State Council for public comments in January 2015

The 2018 legislative plan also includes a list of preparatory projects, most of which won’t be submitted for deliberation this year. That list includes an Atomic Energy Law and Export Control Law and revision/amendments to Copyright Law.

2. New initiatives released by SIPO on World Intellectual Property Day. During a press conference for the World Intellectual Property Day, Shen Changyu, head of SIPO, made remarks of new initiatives planned by SIPO. According Shen, China is revising its Patent Law and establishing a punitive damages system for intellectual property infringement to increase the cost of illegal behavior and create a deterrent effect. In addition, China pledged to establish more intellectual property protection centers, in addition to the 19 intellectual property protection centers established nationwide. Meanwhile, SIPO planned to release a working guide for Anti-Monopoly law in the field of intellectual property. Should SIPO move ahead with this project, it may be an indication of an increased role for it in the newly reorganized government structure which it shares with China’s antitrust agencies.

As reported before, SIPO and other IP agencies are under reorganization. According to Shen, after the reorganization, SIPO will become the world’s biggest IP office. The new office will have 16000 staff, with 11000 patent examiners and more than 1500 trademark examiners.

3. China’s top court rules in favor of Dior in trademark case. In a judgement on World Intellectual Property day, China’s Supreme Court ruled in favor of Dior in a suit against the Trademark Review and Adjudication Board after a multi-year court battle. The board wrongly rejected a 2015 application by Dior to register a trademark of its tear drop shaped J’adore perfume bottle, the top court said in a statement on its website. Alert blog readers may remember that the Michael Jordan trademark case was similarly held on World IP Day in 2016.

4. Shanghai seizes U.S.-made microchip equipment over IPR. At the start of 2018, Chinese company Advanced Micro-Fabrication Equipment Inc (AMEC) learned that U.S. equipment suspected of infringing the company’s patents would arrive at Shanghai Pudong International Airport. Shanghai customs authorities then seized the suspected products, Jiefang Daily reported on Friday, citing customs officers. Customs suspended the clearance of the products worth 34 million yuan ($5.36 million). With the customs’ involvement, the U.S. company, whose name was not revealed, negotiated with AMEC. The two sides agreed to settle the dispute by offering cross licenses to each other. The case is a rare but important example of using Chinese Customs remedies to address imports of products infringing a Chinese patent to effect a cross-license.

Other:

A summary of SPC’s IPR Report 2017 was released, but the whole report will be released in hard copy soon. Here’s the link to the summary.

Of Qipao’s and Cultural Misappropriation

Mongolian clothing___ , Lightsabers and Cameras, oh my_ Character Discussion_ Padme Amidala

The controversy over a decision by a Utah native, Keziah Daum, to wear a qipao to her prom stirred up a tweet storm over “cultural misappropriation.”  The South China Morning Post reported that generally the response from China was quite different —  it was an act of “cultural appreciation”, not appropriation.   As often happens in this type of discussion, false assumptions are made about the insularity of any culture, including in matters of fashion.

The qipao was hardly a Han innovation, and is widely attributed to the Nuzhen people – a Manchu tribe.  In the early 17th century, Nurhachi, the Manchu military strategist, unified the Nuzhen tribes and set up the  Banner System. Qipao in Chinese may be literally translated as “banner gown”, for it came from the Manchu people who lived under the Banner System and used it to govern China.  In fact, the Manchu domination over the majority Han people had been long resented by the Han, contributing to the 1911 revolution by Sun Yat-sen and reflected in the political slogan to “Overthrow the [Manchu] Qing and return to the [Han] Ming “(反淸复明).

Chinese minorities have contributed much to dress and culture in addition to the qipao.  The Newark Museum in New Jersey has an excellent collection of Tibetan and Mongolian art, which also shows some other minority influences, such as in the clothing used in Star Wars by Padmé Amidala (see above).  One can also try on Tibetan clothing if one wishes to further appreciate the clothing and its origins (see below).

One need not travel far to see evidence of cultural borrowings.  Whenever a man wears a tie, he is following a tradition set by Croatians during the Napoleonic wars.  Indeed, the French word cravate is a corrupt French pronunciation of Croate.  The origin of the tie is a source of some pride to the many Croatians I have met over the years.tibetclothing.jpg

No rights are asserted in any of the pictures from Star Wars or the Newark Museum.  The photograph above is the property of Mark Cohen.

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.

April 10 – 16, 2018 Updates

1.New Policies for  Innovative Drugs in China.  Premier Li Keqiang held an executive meeting of the State Council on April 12, 2018 to adopt a series measures to encourage the importation of innovative medicines into the Chinese market, to enhance intellectual property protection, and to lower the price of medications. The measures involve the exemption of cancer drugs from customs duty, reduction of drug prices, expedition and optimization of the process for authorization on the commercialization of imported innovative medicines, enhancement in intellectual property protection and quality monitoring.

The measures on enhancement in intellectual property protection includes the 6-year maximum data exclusivity period for innovative chemical medicines.  Further, a maximum of 5 years’ compensation of patent term will be offered for innovative new medicines which are applied for commercialization on domestic and overseas markets simultaneously (which appears to be a patent term extension system). See more discussion of the original CFDA proposals which these these appear to draw on here.  It’s still unclear how such policies will be implemented, The specific policies announced by the official in English is available here.

2.China to introduce punitive damages for IP infringements. According to an interview with Shen Changyu on April 12, China will soon introduce punitive damages for IP infringements. Shen said a fourth revision of the Patent Law will come faster than expected. “We are introducing a punitive damages system for IPR infringement to ensure that offenders pay a big price.” Shen also called on foreign governments to improve protection of Chinese IPR.

3.Commerce Blocks China’s ZTE from Exporting Tech from U.S.  The U.S. blocked Chinese telecommunications-gear maker ZTE Corp. from exporting sensitive technology from America.  According to a statement by the Commerce Department, ZTE made false statements to the Bureau of Industry and Security in 2016 and 2017 related to “senior employee disciplinary actions the company said it was taking or had already taken.”. ZTE did not disclose the factthat it paid full bonuses to employees who engaged in illegal conduct, and failed to issue letters of reprimand, the Department said.  Alleged export control violations had also been implicated in the NDA dispute between Vringo and ZTE involving settlement of patent claims, which were previously discussed here.

4.Judge Orrick Issues Anti-suit Injunction Against Huawei.  In the continuing transpacific saga of Huawei v Samsung, Judge Orrick of the N.D. of California issued an anti-suit injunction against Huawei’s implementing a Shenzhen intermediate court’s injunction against Samsung for the same patents in suit.  A good summary from the essentialpatentblog is found here.  The redacted decision is here.   One possible explanation for Huawei’s strategy might be that Huawei was trying to get a quick decision from Shenzhen, its home court, on a matter also involving an overseas litigation, such as Huawei obtained in the Interdigital dispute, and is also a common enough Chinese litigation tactic.  Such a decision might have tied Judge Orrick’s hand on at least the Chinese patents in suit, as well as on licensing behavior.  Judge Orrick in fact noted that “Chinese injunctions would likely force [Samsung] to accept Huawei’s licensing terms, before any count has an opportunity to adjudicate the parties’ breach of contract claims.”  (p. 17). 

Although anti-suit injunctions may be more common in common law jurisdictions,  it is wrong to assume that Chinese courts take a strictly “hands-off” attitude towards foreign proceedings.  One aggressive Chinese response might be to borrow a page from a Chinese (Wuhan) maritime court decision of last year, where the Chinese court issued an anti-anti-suit injunction, ordering a foreign ship owner to withdraw an anti-suit injunction in Hong Kong.  Commentators have also suggested that generally Chinese courts more commonly ignore these injunctions entirely.  Another approach was taken by the Shenzhen court in Huawei v Interdigital,  where the court imposed imposed damages on a US party seeking injunctive relief (an exclusion order) in a US Section 337 proceeding involving FRAND-encumbered SEP’s.   This did not constitute an anti-suit injunction, but rather “anti-suit damages.”  These actions may be based more on notions of judicial sovereignty than comity.  Judge Orrick for his part, did undertaken a comity analysis in rendering his decision, which is part of the non-confidential order he signed.

Probably the best approach however is for the parties to amicably resolve their disputes through arbitration or mediation. After all, even Huawei and Interdigital were ultimately able to settle their differences.

April 3 – 9, 2018 Updates

1.China pushes generics over brands with another round of new pharma policies. The General Office of the State Council on April 3rd, 2018 issued “The Opinion on Reforming and Improving Supply and Use of Generic Drugs” (国务院办公厅关于改革完善仿制药供应保障及使用政策的意见 国办发〔2018〕20号), to promote China’s generic pharmaceutical industry. The State Council said it would draw up new incentives aimed at encouraging the development and production of generic drugs, a move it said would help safeguard public health, reduce medical bills and spur innovation.

According to the document, CFDA and the National Health Commission will compile and actively update a drug list that encourages companies to produce generic versions. That list will include medications for rare diseases, major infectious diseases and pediatric treatments, as well as important drugs that are short in supply. Certain qualified generics makers are allowed to be designated as High and New Technology Enterprises (HNTE) with commensurate income tax reductions (see more about China’s practice of providing tax incentives to high tech enterprises here).

The State Council also said that with regard to IP protections, China will “strike a balance between the interests of patent holders and the public,” and would strengthen anti-monopoly enforcement. (Note that the recent combination of agencies involved with antitrust enforcement, IP with CFDA may offer increased opportunities for such antitrust enforcement). An “early warning” mechanism to prevent generic drug producers from infringing patents will be established. The policy also restates that China considers compulsory patent licensing (CPL) a bona fide option during public health emergencies or shortages of key drugs; however China has not explicitly implemented a CPL to date.

China is a major branded generics market and innovative pharma companies are heavily dependent on this market in the absence of a robust market and incentives for innovative pharmaceuticals. The Opinion also states that when there is a bioequivalence determination, the generic drug should be marked as a substitute for the innovative drug and release such information to the public. In the absence of special circumstances, no brand name could be written on the prescription.

With regard to intellectual property, the Opinion further states:

“…In accordance with the principle of encouraging the creation of new drugs and the development of generic drugs, research and enhance a system of pharmaceutical intellectual property protection that is compatible with China’s economic and social development level and industrial development stage, and fully balance the interests of drug patent holder and the public. Implement the patent quality improvement project and cultivate more core, original and high-value intellectual property. Strengthen the enforcement of anti-monopoly law in the field of intellectual property rights, prevent the abuse of intellectual property rights and promote the listing of generic drugs while fully protecting innovations in the pharmaceutical field. Establish and improve the patent early-warning mechanism in the pharmaceutical field to reduce the risks of patent infringement of generic pharmaceutical companies.”

按照鼓励新药创制和鼓励仿制药研发并重的原则,研究完善与我国经济社会发展水平和产业发展阶段相适应的药品知识产权保护制度,充分平衡药品专利权人与社会公众的利益。实施专利质量提升工程,培育更多的药品核心知识产权、原始知识产权、高价值知识产权。加强知识产权领域反垄断执法,在充分保护药品创新的同时,防止知识产权滥用,促进仿制药上市。建立完善药品领域专利预警机制,降低仿制药企业专利侵权风险.”

2. SIPO releases the 2017 China Patent Survey Report.  The State Intellectual Property Office (SIPO) recently released the 2017 China Patent Survey Report, which is the third time that the national patent-related survey results are publicized.

In 2017, the patent survey covered 23 provinces nationwide and was carried out concerning the valid patents and the patent holders who owned such valid patents at the end of 2016. The survey was launched in March 2017 and was completed at the end of 2017. 15,000 questionnaires about patent holders and 43,000 questionnaires about patent information were released. Over 85% of the questionnaires were returned.

According to the report, China’s overall environment of patent protection has been significantly enhanced, but still not to a level that is satisfied. More than 88% of patent holders believe that patent protection needs to be further improved in China. The report also notes that the emerging industries with strategic significance rely more on patents to gain their competitive edge and have better utilization of patents. Chinese universities have strong innovation capabilities, but their utilization rate of patents in 2016 (12.7%) was much lower than enterprises (59%). The lack of professional technology transfer team was considered to be the biggest obstacle for Chinese universities. The continuing focus on Chinese universities is odd, since universities should have a primary goal of information dissemination, not patent acquisition, but this is not necessarily a bad thing.

3. Chinese national convicted in US for stealing a valuable U.S. trade secret: Kansas rice seeds.  A scientist from China has been sentenced to 10 years in prison in the United States for stealing seeds of genetically modified American rice, the Department of Justice announced Wednesday.  The Chinese scientist Weiqiang Zhang is a U.S. legal permanent resident residing in Manhattan, Kansas. Zhang was convicted on Feb. 15, 2017 of one count of conspiracy to steal trade secrets, one count of conspiracy to commit interstate transportation of stolen property and one count of interstate transportation of stolen property. Zhang was working as a rice breeder at Ventria Bioscience, a biopharmaceutical company that creates genetically modified rice. According to trial evidence, Zhang stole hundreds of rice seeds from the company that had cost millions of dollars and taken years of research to develop and kept at home. In the summer of 2013, personnel from a crop research institute in China visited Zhang at his home in Manhattan.  On Aug. 7, 2013, U.S. Customs and Border Protection officers found seeds belonging to Ventria in the luggage of Zhang’s visitors as they prepared to leave the United States for China.