The Berkeley Center for Law and Technology will be launching a five-part webinar series on “Innovation, Regulation in the Life Sciences” on November 17 from 4:30-6:00 PM. The launch program is devoted to “China’s Emerging Regime for IP In the Life Sciences”.
Joining me for the program will be He Jing from the Gen Law firm, Dr. Karen Guo from Novo Nordisk, Xuejiao Hu from Beigene, Prof. Guobin Cui from Tsinghua Law School and Dr. Can Cui from Morrison & Foerster. CLE credit will be provided.
Students and media are free of charge, BCLT sponsors are half-price. We expect to cover the full range of issues in this first session: patent linkage, regulatory data protection, patent prosecution, the recent SAMR rule and SPC judicial interpretation, etc. A package of English language reading materials is also available for attendees. The programs costs $75.00 for the session and $300.00 for the series.
Other sessions in the series include: FDA Innovation, Food Innovation, Drug Pricing and Sharing Data for Research and Development.
On October 29, 2020, the Supreme People’s Court issued the its draft patent linkage Judicial Interpretation, the “Provisions on Several Issues Concerning the Application of Law in the Trial of Civil Cases Involving Drug Marketing Review and Approval of Patent” (Draft for Solicitation of Comments)” 《关于审理涉药品上市审评审批专利民事案件适用法律若干问题的规定》（征求意见稿）(the “JI“). The deadline for submission of comments on the JI is Dec. 14.
Among the highlights of the JI are:
The Beijing IP Court will have jurisdiction over patent linkage cases. Jurisdiction will attach even if administrative proceedings have commenced
The Court may consolidate lawsuits involving the same patent or generic drug in most cases.
Applicants are required to submit to the Court the relevant technical materials related to the disputed patents that were submitted to NMPA for marketing approval.
Patentees or interested parties may apply for preliminary injunctions upon payment of a bond.
Each party is under a duty of confidentiality with respect to trade secrets in the disputes.
Generic companies s can claim damages suffered by delays in market launch due to the abuse of litigation rights by patentees and interested parties, if the patent linkage case is withdrawn without justification and the claims were not supported by the Court (Art. 17). This is similar to Canada’s patent linkage regulations, which permits claiming of damages (but not profits) by reason of abusive litigation.
The JI might help define the scope of a possible jurisdictional battle between the courts and administrative agencies in adjudicating patent linkage cases. This was briefly discussed in my blog of October 28, 2020: “The Cart Before the Horse in China’s Patent Linkage Regime.” This jurisdictional issue raises the interesting possibility of a domestic Anti-Suit Injunction (“ASI”) under Article 100 of the Civil Procedure Law to stay administrative proceedings. China has recently been aggressively exploring use of ASI’s to address jurisdictional conflicts in standards essential patent cases. ASI’s were also used in the United Kingdom to address domestic conflicts between the jurisdiction of courts of law and equity and have also been used to address conflicts between arbitration and judicial proceedings. ASI’s could be necessary to prevent misuse or arbitrage between administrative and civil patent linkage proceedings.
Update of October 29-30, 2020: IPO has submitted comments on the draft NMPA/CNIPA rules on linkage. The comments are here, and my blog about those rules is here.
Update of November 20, 2020: USPTO has made available its translation of the JI here.
Since China’s legislature amended the patent law on October 17, 2020 and China’s National Medical Products Administration (NMPA) and its National IP Administration (CNIPA) published the Implementation Measures for the Early Resolution Procedures for Drug Patent Disputes (Trial) (Draft for Comment) ( 国家药监局综合司 国家知识产权局办公室公开征求《药品专利纠纷早期解决机制实施办法（试行）(征求意见稿）》意见) (the “Rule”) on September 11, 2020, several people have written to me who are bewildered about the sequence of rules being proposed on patent linkage in advance of the enactment of patent linkage into law. This post analyzes whether this “cart before the horse” scenario should be a concern for US pharmaceutical companies, and what this counter-intuitive sequencing may suggest for China’s new patent linkage regime.
This is indeed an unexpected circumstance. There was no advance word that the Rule was being prepared for public release. CNIPA and NMPA’s parent agency, the State Administration for Market Regulation (SAMR), did not include a patent linkage rule in its 2020 legislative work plan. CNIPA also had not included a patent linkage rule among its top 100 IP projects for 2020. However both SAMR and CNIPA did include the more general Implementing Regulations for a revised patent law in their anticipated legislative work for 2020. By contrast, the Beijing IP Court issued a research report on Patent Linkage (中国药品专利链接制度研究) in late September, which advocated judicial reforms to support a linkage regime. In addition, the Supreme People’s Court in its 2020 annual plan announced its intention to draft a judicial interpretation (JI) for patent linkage cases. They have not yet released their draft JI.
This “cart before the horse” Rule may trace part of its origins to the Phase 1 Trade Agreement (January 15, 2020) (the “Agreement”). The Agreement did not explicitly require that the civil courts play the leading role for patent linkage disputes. The Agreement also failed to establish an “artificial infringement” regime for the Courts to rule that an application for marketing approval of a patent drug constitutes infringement. Instead, it required that China adopt “procedures for judicial or administrative proceedings and expeditious remedies”, and that China “may … provide” administrative remedies for resolution of linkage disputes (Art. 1.11). In so doing, the Agreement left open the possibility that the administrative agencies would play the dominant role in a patent linkage regime.
More generally, the Agreement also authorized a leading role for administrative IP enforcement in a range of areas with its repeated references to campaign-style administrative enforcement. The Agreement also did not acknowledge or seek improvements to China’s notable IP-related judicial reforms. The Agreement was also immediately preceded by an important State Council/Party Central Committee plan that called for strengthening of administrative enforcement (Nov. 24, 2019), and that was considered in its time to be a high-level policy precursor to the Agreement. This policy evolution has also been accompanied by changes to all of China’s major IP laws including the Trademark law, the Patent Law, the Anti-Unfair Competition Law, as well as proposed Copyright Law Amendments, that all further commit China to strengthened administrative enforcement of IP.
CNIPA and NMPA took the next step of securing a key role for their agencies in patent linkage when they drafted and published the Rule. I use the term “Rule” (規章) or “Departmental Rule” (部門規章) in this blog as a term of art, consistent with China’s Law on Legislation 立法法. The nomenclature is also consistent with China’s own descriptions of its legal system upon acceding to the WTO. A Rule is a legislative document enacted by a departmental agency that is inferior to a Law （法律）that has been passed by the National People’s Congress or a State Council-enacted Regulation （法規）. As set forth in the hierarchy of the Law on Legislation, it is also inferior to many types of local legislation. As with other Rules, NMPA/CNIPA does not use the word “rule” in its September 11 pronouncement. It instead calls its legislation “procedures” (办法). However, do not be misled! The Law on Legislation does not use “Procedures” as a term to categorize legislation, even if regulatory agencies use this term in their own enactments. When a Departmental Agency enacts a legislative document it is typically a “Rule” under the Law on Legislation based on the enacting agency and the legislative process. The categorization of legislation is often not immediately clear from its own wording. Moreover, the legal status can also become murkier if sui generis or inter-agency procedures not otherwise in the Law on Legislation are involved.
In amending the Patent Law, the NPC cemented the leading role of NMPA and CNIPA by declining to legislate on linkage in detail and delegating rule-making authority to these agencies. According to Article 76, “procedures” (or a “Rule”) will be drafted by NMPA and CNIPA to govern “pharmaceutical approvals and applications for marketing approvals.” Article 76 further requires the “procedures” to be delivered to the State Council for its approval before implementation (国务院药品监督管理部门会同国务院专利行政部门制定药品上市许可审批与药品上市许可申请阶段专利权纠纷解决 接办法，报国务院同意后实施). By delegating drafting authority to NMPA and CNIPA and legislating that the State Council will be the final arbiter of its contents, the Patent Law has likely placed the NMPA and CNIPA Rule within that murky class of sui generis enactments.
In its final form the State-Council approved patent linkage Rule is unlikely to be in conflict with any explicit Patent Law Amendment provisions. The State Council approval mechanism also still leaves open the possibility for additional policy interventions that are consistent with the Patent Law. One important modification that might be considered would be to authorize the Ministry of Justice (MOJ) take a more active role in the drafting of the Rule or craft the Rule as a Regulation promulgated by the State Council itself. Pursuant to the administrative restructuring of March 13, 2018, MOJ is required to perform the legislative functions formerly performed by the Legislative Affairs Office of the State Council (《第十三届全国人民代表大会第一次会议 关于国务院机构改革方案的决定》，批准《国务院机构改革方案》, which previously prepared Regulations.
If the State Council were to take a leading role in drafting on patent linkage, past practice would suggest it will ensure that all agencies concerned would have an opportunity to comment. The agencies would not only include NMPA and CNIPA but could also include the courts, trade, health, science or industrial planning and development agencies, as well as authorities responsible for personnel and budgeting. A Regulation or sui generis Rule which involves all relevant agencies might also obviate the failures of a prior linkage rule in 2002 which relied exclusively on administrative rule making. As the late Prof. Benjamin Liu wryly observed at that time: “the SFDA [predecessor agency to NMPA] does not always succeed with its gate-keeping function.” Deputy Director Ding Jianhua of SFDA also succinctly stated the problem: “SFDA is not responsible for IPR.” 
Judicial involvement in this legislation is needed to harmonize the legal complexities of patent linkage which complex issues of patent law, civil law, administrative law, and pharmaceutical regulation. A lack of judicial involvement confounded the implementation of the 2002 rule. This 2002 Rule (and subsequent amendments) was further stymied by later legislative changes in the patent law when China added a “Bolar exemption” to exempt pre-marketing approval efforts by generic companies from claims of infringement. In Prof. Liu’s words, this exemption “swallowed the rule of patent linkage.” Bolar exemptions are well-known in international practice, being an exemption from civil infringement claims and are within the purview of the courts. Overly-broad Bolar exemptions can raise concerns over compliance with TRIPS and other international IP obligations.
China’s vast administrative system must surmount other challenges to lead a patent linkage regime. These challenges include: a lack of administrative enforcement transparency; uncertainty regarding coordination between judicial and administrative enforcement; differing legal appeal routes and standards for litigating infringement which may lead to undermining of one system over another; concern for the systemic impacts on China’s IP regime by relying on administrative interventions rather than the civil system; limited foreign utilization of the patent administrative enforcement system particularly for high value pharmaceutical rights; and the inherent “fox guarding the hen house” fear when the administrative agencies that grant patent rights and marketing authorizations are also tasked with enforcing these important rights.
Long-term observers may also fret that CNIPA and NMPA are an “odd couple” to administer a linkage regime Although they are housed in the same mega-agency, SAMR, NMPA in recent years has been a leading advocate for patent linkage, while CNIPA had been viewed as less supportive. There are also continuing concerns over CNIPA’s excessive invalidation of pharma patents.
At this stage, the most appropriate corrective to these various challenges would be to leverage the State Council’s authority to take a leadership role in implementing Article 76 of the Patent Law, as well insure that there is conforming language in the Patent Law Implementing Regulations which MOJ will likely be coordinating in the near future. An effective linkage regime for China will not only need to balance the interests of generics and innovators in China’s linkage regime, but also between the courts and the range of concerned administrative agencies.
Where will China go next at this important juncture on patent linkage? Berkeley Law will be convening a webinar on China’s patent linkage regime as part of a multi-part series on food and drug law. I will be joined by He Jing from the GEN law firm, Cui Can from Morrison and Forster, Dr. Karen Guo from Novo Nordisk and Xuejiao Hu from Beigene. The event will take place on November 17. Registration information is available here
 Benjamin Liu, ”Fighting Poison with Poison? The Chinese Experience with Pharmaceutical Patent Linkage,” 11 J. Marshall Rev. Intell. Prop. L. 623 (2012).