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.

Slouching Towards Innovation – A Survey of the Surveys on China’s IP Environment

Here is a summary of the business surveys on IP protection in China, drawn from the European Chamber of Commerce in China, Business Confidence Survey 2015 (June, 2015), the US China Business Councils’ 2015 USCBC China Business Environment Member Survey (Sept. 2015), the American Chamber of Commerce 2016 Business Climate Survey (“Amcham China” Report, Jan. 2016), and Amcham Shanghai’s 2016 China Business Report (“Amcham Shanghai” Report, Jan. 2016), and others.

IP Issues a Core Concern

While IP issues are less dominant than in recent years, businesses report that IP is still critical to them. When Amcham China respondents in all sectors addressed what they considered their competitive advantage versus Chinese domestic entities, three of their top four perceived advantages were IP-related: Brands (74%), Technology & IP (63%), and Development and Innovation (59%). USCBC respondents listed IP concerns in a number four priority slot, having dropped from number 2 in 2014. However IP issues have averaged as a number 4.5 priority over the past ten years, so the drop is not that significant. According to Amcham Shanghai’s survey, 49% of respondents believed that lack of IPR protection and enforcement constrains their investment in innovation and R&D in China.

Still different IP concerns vary in their impact on different businesses. For example, tech companies in the USCBC survey noted the following IP-related issues in their top 10 challenges: Innovation policies (number 2), IPR enforcement (number 5), cybersecurity (number 6), government procurement policies (number 7), standards and conformity assessment (number 8) and antitrust/antimonopoly law (number 10).

IPR Enforcement is Improving

On the brighter side, 91% of respondents of the Amcham survey indicated that IPR enforcement had improved over the past five years, a view that was generally shared by USCBC respondents (38% reported some improvement over the past year).

USCBC’s survey addressed the most viable options for IP enforcement: administrative enforcement had a slight edge in terms of viability in some or most cases (78%), followed by civil cases (70%) and criminal courts (57%).

The data also suggests that trade secrets will be of continuing concern. Amcham China respondents were least satisfied with trade secrets legislation and enforcement (45/40%).  Amcham China respondents were most satisfied with patent legislation and patent enforcement (66%/54%), followed by trademarks (62%/51%) and copyrights (57%/48%). USCBC respondents similarly rated trade secrets as their top area of concern (32%) followed by trademarks (28%), patents (22%), and copyright (9%).

Of particular importance for trade secret protection are challenges noted in responses to surveys in attracting and retaining talent.   According to the Amcham survey, among the principal challenges in attracting the right talent were competition from local businesses (45%), and competition from other foreign businesses (34%). Data security and cybersecurity were also identified as concerns by many surveys.

China’s Efforts to Innovate Leads to More Foreign R&D in China

Innovating in China has clearly become a priority for the foreign business community. The EU Chamber notes that China R&D centers are increasingly achieving global levels of innovation, although a large percentage (42%) are primarily focused on product localization. According to USCBC, about 43% of large member companies had established an R&D center.

European companies viewed innovation as one of five most critical drivers needed to move the Chinese economy up the value chain. The USCBC report notes that more than 9 out of 10 US companies believe that innovation in China will be critical to their company’s future in China, with 40% of the companies reporting that that half their profits came from products designed, developed or tailored to local requirements (an increase from 32% last year). Companies prioritizing investment in R&D, according to the Amcham Shanghai survey, were in hardware, software and services (81%), automotive (65%), industrial manufacturing (55%) and health care (35%).

Continuing Concerns about Technology Transfer

USCBC reported that 59% of respondents expressed concern about transferring technology to China. Twenty three percent of USCBC respondents advised that their company had been asked to transfer technology to China and that central or local governments had requested the technology transfer 60% percent of the time. Concerns about technology transfer included maintaining protection of the proprietary information during certification/ approval (83%), protection of IP (75%), enforcing license agreements (51%) and the government dictating or influencing licensing negotiations (32%). Nonetheless, according to USCBC, technology transfer concerns fell out of the top twenty this year, to number 23 out of 30. However the USCBC noted that the companies impacted by this issue felt it “very acutely”.

Innovation Policies Not All Positive

Thirty two percent of technology and other R&D Intensive industries that responded to the Amcham China survey indicated that China’s increasing capability for innovation presented an important opportunity for their business. However, as the preceding data suggests, not all of China’s innovation and IP policies have been perceived to be positive by foreign industry. Fifty-five percent of USCBC tech companies stated that China’s innovation promotion policies had a significant negative impact on sales to date, or had a significant negative impact on sales or operation. Also of note was that 75% of USCBC respondents indicated that they limited the products that they introduced into China because of IPR concerns. In addition, 37% of USCBC respondents indicated that China’s level of IPR enforcement limited R&D activities in China, as well as limited products co-manufactured or licensed in China. The Amcham China survey also noted that 83% of technology R&D intensive companies feel less welcome than before.

Aggressive Antimonopoly Enforcement of Concern to Foreign Companies

Eighty percent of USCBC respondents were concerned about antimonopoly law enforcement in China. Among the key substantive issues were: (a) lack of transparency in AML cases (55%), excessive focus on foreign companies (50%), lack of clarity on key criteria and definitions (49%), lack of due process (29%), and inability to have legal counsel (26%).

Rule of Law: Another Overarching Concern

One common thread amongst antimonopoly and IP concerns was rule of law. The EU Chamber Report contains the most information on desires of foreign companies for the Chinese government to improve the rule of law, with 39% of European businesses rating the Chinese government’s efforts in 2015 as “below expectations”, and rule of law perceived as the main driver of future economic growth by 78% of respondents. For Amcham China, 57% of respondents believed that inconsistent regulatory interpretation and unclear laws were their top business challenge in China. Legal reforms were identified as the top reform priority by Amcham Shanghai members.  USCBC respondents rated uneven enforcement of Chinese laws, as their number nine challenge, however companies reported that the problems are persistent and worsened in the last year.

Putting China in Context: Not All That Patents Is Innovative

There are other reports that have been released have recently been released that also place China in a comparative perspective. The Information Technology & Innovation Forum, for example, recently issued a report Contributors and Detractors: Ranking Countries’ Impact on Global Innovation, which ranked 56 nations on how much they contribute or detract from global innovation. China ranked 44, and was classified as an “innovation mercantilist” that “significantly balkanize[s] both global production and consumption markets” and has “generally weaker protection” for intellectual property than the global norm. However, China does perform better than “innovation follower” countries in contributing to the global innovation ecosystem, largely due to investments in STEM fields and high numbers of graduates in those areas. China ranked twenty eight out of fifty six in terms of contributions, and was among the top five detractors from global innovation, according to this report (behind Thailand but ahead of India, Argentina and Russia).

Thomson Reuters in its China’s IQ (Innovation Quotient) Report (December 2015) analyzed China patent filings. The IQ Report noted that citations of Chinese patents had increased. In data processing patents, China had forward citation data of 1.17 This was much less than the United States (6.72), but comparable to Japan (1.82), and Europe (1.31), and better than South Korea (.78). Interestingly, another Thomson Reuters report on the top 100 innovators (2015), declined to include a single Chinese company. Huawei did appear as a top innovator in 2014. Its antitrust adversary, InterDigital, was considered a top innovator in 2015.

Policy Outcomes

The USCBC’s Board of Directors recently outlined its priorities for the year, which included: strengthening IP enforcement, including deterrent civil and criminal remedies; improving enforcement against online infringements; strengthening trade secret protections; harmonize patent examination practices; reforming China’s system of innovation incentives (HNTE incentives/service inventions). Other USCBC recommendations in transparency, antimonopoly law, and ecommerce also have IP-related implications.

Summary

There may be a number of reasons for the repetition in these reports, including a common core of concerns, a focus on issues in the media and bilateral relations, and common membership among the organizations. The location and membership of each organization can still result in different perceptions. Moreover, certain rights, such as copyrights, tend to be of core concern to fewer industries some of which, such as the entertainment sector, may be less extensively invested in China. As such, the surveys reflect concerns and priorities, and may not necessarily represent researched approaches to resolving specific problems of concern to all American industries. The surveys may also not align well with China’s own surveys such as on software piracy, where China has offered a counter-survey that counts other incidences of piracy, or on satisfaction with China’s IP system. As for satisfaction at least, it is all subjective. In some cases, the survey data likely aligns well with other factual or empirical data, such as licensing revenues, damages in antimonopoly law cases, IP enforcement activity, etc.

Here’s what this survey of the surveys suggests to me:

  1. China’s IP laws are generally good and its enforcement is improving but still problematic.
  2. China has become deeply interested in patents and innovation, which will present important strategic opportunities over time.
  3. There remains a low level of confidence in trade secret protection in China, which can be a significant impediment to China’s innovative ecosystem.
  4. China’s innovation environment has become increasingly complex and nationalistic, leaving many foreign tech companies with a sense that they are less welcome.
  5. Reforms in the legal system and antitrust enforcement are a high priority.

The US Chamber will be issuing its latest International IP Index February 10 in Washington, DC. Let’s see how China stacks up there…

Any corrections or comments? Something I have missed? Please write us!