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.

Synergies and Contrasts Between The National IP Strategy Action Plan and Fourth Plenum (with contrasting wordclouds)

 

“””NIPS

Here is an unofficial translation of the English language translation of the Action plan of the National IP Strategy (2014 -2020) (NIPS), about which I previously blogged. A wordcloud from this English translation is above – with an obvious focus on “management,” “strengthening,” “promotion” and “enforcement” and some mentioning of the “market.”  As the NIPS was released just weeks after the Fourth Plenum, it make a useful point of contrast on where China is headed on IP, including IP-related rule of law. An annotated version of the Fourth Plenum decision is available here for comparison.   For those with short attention span, or a strong visual orientation a wordcloud of the Fourth Plenum decision is found at the end of this post.  In short, the Fourth Plenum is emphasizing the “market,” “law” and “enforcement.”  The NIPS, however, seems to be all about strengthening the IP system.

The NIPS contains some interesting general goals, particularly in terms of developing IP intensive industries, including developing Chinese patent pools and Chinese cultural industries. promoting IP services, integration of IP into state science and technology plans, and expanding cooperation.   Some sticky issues, such as involving China’s multiple track system of protecting geographical indications will be changed into a unified system of some kind.  The NIPS also calls for a Chinese-type Section 337 remedy, as was originally contemplated in China’s Foreign Trade Law, ie., to “carry out investigations on infringement of Chinese IPR by imported products and other unfair competition acts in import trade.”

Regrettably, the NIPS keeps some of the failed metrics of its first implementation in place.  Patent filings will increase from 4 per 10,000 people in 2013, to 14 per 10,000 in 2020.  This means that SIPO will be receiving in excess of 6 million patent applications per year. In an implicit recognition of the problem I have noted that patent maintenance  is at least as important as patent applications, the NIPS also wants to increase the average maintenance period for invention patents from 5.8  years to 9.0  by 2020.  However this data point doesn’t resolve the problem of low maintenance rates for utility models and designs and it is to be hoped that in all cases, maintenance rates expand due to growth in the market and not due to the kinds of artificial subsidies that already plague China’s patent applications.   Among the market oriented targets, export growth in IP rights is also slated to grow from 1.36 billion USD in 2013 to 8 billion USD in 2020.  Commercialization-related goals reflect the goals of the Third Plenum, to increase IP utilization generally.

Here’s what the NIPS says about the judiciary:

“Strengthen.. the criminal law enforcement and the judicial protection of IP. We will intensify the investigation of IP crime cases and supervise the handling of key cases; persist in the combination of fight and prevention to gradually bring special campaigns onto the track of normalized law enforcement; strengthen the linkup between the administrative law enforcement of IP and criminal justice and intensify the handover of cases of suspected crimes; strengthen the trail of IP-violating criminal cases according to law, intensify the application of pecuniary penalty to deprive infringers of the capability and conditions for committing crimes again; strengthen the civil and administrative trial of IP to create a good innovation environment; provide human, financial and material guarantee and support for the establishment and operation of IP court according to the plan for establishment thereof.”

The NIPS seems to be following the lead of other agencies in judicially-related efforts.  In administrative law, it also supports  the State Council’s effort to promote administrative transparency, including extending it to credit reporting systems:

“We will … solidly push forward the disclosure of information on cases of administrative punishment of IP infringement to deter law violators and, in the meantime, promote standardized, just and civilized law enforcement by enforcers; incorporate the disclosure of case information into the scope of statistical notification of the efforts of cracking down on infringement and counterfeits and strengthen examination; explore the establishment of the credit standard related to IP protection to include acts of mala fide infringement in the social credit evaluation system, disclose the relevant information to credit reporting agencies and raise the social credit level for IP protection.”

However, regarding IPR-related commercial rule of law, one needs to focus a bit more on the Fourth Plenum.  Here are some of the significant judicial reforms that will affect IP:

Reform systems for judicial organs’ personnel and finance management, explore the implementation of separating courts’ and procuratorates’ judicial administrative management affairs and adjudication or procuratorate powers.

The Supreme People’s Court will establish circuit courts, to hearing major administrative and civil cases that cross administrative regions. Explore the establishment of People’s Courts and people’s procuratorates that cross administrative districts and handle cross-regional cases…

Reform systems for court acceptance of cases, change the case filing review system to a case filing registration system, and in cases that should be accepted by the People’s Courts, ensure parties’ procedural rights by requiring filing when there is a case, and requiring acceptance where there is a lawsuit…

Perfect systems for witnesses and experts appearing in court, ensure that courtroom hearings play a decisive role in ascertaining the facts, identifying the evidence, protecting the right of action, and adjudicating impartially.”

More broadly, here’s what the Fourth Plenum says about IP:

“Perfect a property rights system and an intellectual property rights system that encourage innovation, and structures and mechanisms to stimulate the transformation of scientific and technological achievements. Strengthen the construction of a legal system for the market, compile a civil code, … stimulate the free circulation, fair exchange and equal use of commercial products and factors, strengthen and improve macro-level coordination and market supervision according to the law, oppose monopolies, stimulate reasonable competition, safeguard a market order of fair competition. ”

Conclusion: It should come as no surprise that the Fourth Plenum, although more general, may more greatly impact IP-related judicial / legislative issues.  Based on a recent trip to Beijing, I understand that work is already underway to draft IP provisions of a civil code.  The new chief judge of the Supreme People’s Court IP tribunal (Song), the new Chief Judge of the Beijing IP Court (Su), the new Vice President of the SPC with authority over the IP tribunal  (Tao) all have civil law backgrounds.  In addition, consideration is being given to the specialized IP courts having a circuit court type role.  New technology assessors in the IP courts will affect the way that evidence is considered and will likely enhance the independence and professionalism of the courts. 

Will the Fourth Plenum further push China towards a more market-oriented approach to IP?  I personally believe that for the NIPS to work effectively, the decisive factors has to be the market.  Metrics for IP creation are meaningless unless there is utilization of IP.  Hopefully the Fourth Plenum will push the NIPS implementation even further in a market orientation, which is a key factor of the Fourth Plenum, as this wordcloud shows…

Fourthplenum

 

 

Action Plan for Further Implementation of the National IP Strategy (2014-2020) Approved

According to a Chinese Government website, on  December 29, the State Council reviewed and approved the Action Plan for Further Implementation of the National IP Strategy (2014-2020) (Action Plan). The Outline of the National IP Strategy (NIPS) had been implemented for 6 years.  Premier Li Keqiang, and SIPO Commissioner Shen are quoted in the this brief summary.

Chinese authorities have pointed to three key aspects of the NIPS Action Plan:

A.  First, to “Strive to Build A Strong IPR Country”  (努力建设知识产权强国).

B.  To improve IP utilization and protection (知识产权运用和保护).

C.  Practical new steps are to be announced, including plans to promote the development of IP intensive industries (知识产权密集型产业发展).  This  includes greater coordination amongst various branches of national and local government.  Interestingly, and perhaps of greater concern, it also includes “strengthening patent pilot projects,  joint utilization of patents and collective management of patents… to strengthen the competitive advantages of industries.” (强化专利导航、专利协同运用、专利集群管理等工作…增强产业竞争优势).

Here is how I read the tea leaves on this announcement:

First, the references to China becoming an IP “strong country” , and not merely an IP “big country” is a new concept in the NIPS, and likely reflects the observations and approaches of former Commissioner Tian Lipu.  In fact, many observers believe that too much patenting, particularly patenting of a low quality, can be harmful to innovation. I have often noted in this blog that patent quality is a continuing negative side effect of China’s metric-driven approaches to innovation.  In addition, innovation is largely a local phenomenon – China’s efforts to become a strong innovative country this time will also include programs to make strong IP provinces and cities in China.

Second, the reference to IP utilization directly quotes the negotiated language of the Third Plenum and its commitment to “Strengthen the Utilization and Protection of IP” (加 强知识产权的运用和保护).  This was also something that former Commissioner Tian discussed as a positive outcome of that meeting.

Third, the reference to IP intensive industries is new to China’s strategic planning, and, as noted by Commissioner Shen, reflects the influence of the influential US government  2012 report on Intellectual Property and the US Economy.   Reference is also made by Commissioner Shen to IP intensive industries being low on resource demands and low polluting.

The legislative basis for the National IP Strategy is the China Science and Technology Promotion Law (Dec 2007).  Article 7 of that law provides that China will establish a NIPS, in order to promote innovation, encourage indigenous innovation (激励自主创新), and raise the utilization protection and management of IP.  This 2007 law was famous for codifying the concept of indigenous innovation, which elicited considerable concern at the time over potential discrimination against the foreign technology community.  This Action Plan introduces several new and useful concepts which, if implemented fairly, will benefit foreign and domestic investors alike.

 

 

China’s Patent Domination?

Thomson Reuters just released a new report on China’s Innovation Quotient  (Trends in Patenting and China’s Trends in Global Innovation).  This is the fourth in a very useful multi-year series on Chinese patenting trends.

The report looks at Chinese domestic patent data to conclude that China has “risen in patent dominance” and, hence, innovation.  The report also notes that pharma is driving the patent boom.  China has nearly 80 percent of world share in patents for alkaloid/plant extracts, and around 60 percent of global share of pharmaceutical activity – general patents. However, the plant extract filings are held by thousands of individual inventors with a handful of patents each, rather than portfolios maintained by universities or corporate entities that would be seen stateside.  Many of these patents may also involve traditional Chinese medicine (TCM).  Low service invention rates, such as may be reflected in these patents,  may also reveal problems in patent quality.  A deeper analysis would need to correlate new patents with marketing approvals and actual patent maintenance and utilization rates.

The report also notes increasing numbers of forward-looking citations to Chinese data processing patents (1.17 times each).  This is far behind the United States (6.72 times forward looking citations), but exceeds South Korea and is close to Japan and Europe (p. 9).  To me this useful data suggests that the United States remains the source of pioneering innovations and corroborates Chinese notions that it has yet to achieve any breakthroughs in IT technology, despite it having become a manufacturing powerhouse and an overall increase in Chinese patenting activity.

The key weakness with this report is that it equates increases in patenting activity with “surge[s] in innovation.” (p. 6).  That assumption may apply in other countries, but it is less clear in China due to a number of factors including: low patent maintenance rates, patent subsidies and other government-supported market “distortions” such as awards to localities or enterprises, lower quality associated with the large number of non-service invention patents, lack of correlation with commercialization data, and the apparent disparity between low quality domestic patents and high quality overseas filings, amongst other factors.

The report also analyzes patent litigation data from the Ciela database (www.ciela.cn).   It properly notes that “Foreign plaintiffs in patent litigation win materially more often against domestic defendants than domestic plaintiffs do: a 75 percent win rate against a 63 percent win rate sinc 2006.”  However, the report does not underscore that this data – like the patenting data – needs to be treated critically. Foreigners are a disproportionately small percentage of the civil IPR docket.  Indeed, foreigners may only be filing a small share of cases out of concern for other risks of litigation, including low damages, government relations “costs,”difficulties of enforcing judgments, and difficulties in sustaining judgments on appeal.  This information might also be compared with data from the United States on foreign “win” rates .  In fact, the initial data that I collected showed that foreigners due worse on appeals in China than they do in the United States, and then they also do worse on appeal than they do in trials of first instance in China.

In an important but unrelated event, IPKey posted the presentations from its recent conference on IP and innovation.  The conference addressed many of the topics I outlined above, including the role of subsidies in China’s innovation strategies.