Beijing IP Court Report on Proposed Patent Linkage Regime

The Beijing IP Court has recently released a Report on patent linkage, which highlights the legal challenges that the courts may face in implementing the proposed linkage regime, entitled  “Research on the China Pharmaceutical Patent Linkage System” (中国药品专利链接制度研究) (the “Report”) (China Trial magazine (中国审判).  The Report references the various developments in patent reform as well as Notice 55 (2017) of CFDA “Policies Relevant to the Protection of the Rights and Interests of Innovators for the Encouragement of Innovation in Drugs and Medical Devices (Draft for Public Comment)” (食品药品监管总局就鼓励药品医疗器械创新保护创新者权益征求意见) (the “Innovation Proposal”), which I discussed here.  The legal challenges identified in the Report include the following:

1.The Report notes that the proposed regime does not currently impose a compulsory litigation system. In the absence of such a legal requirement to litigate, the administrative power cannot interfere with the free will of the parties, i.e., it cannot require the parties to avail themselves of a linkage system. 

My comment: For a generic company to be able to enter the market in advance of patent expiration, it will need to utilize the litigation system.  Otherwise, it should be denied marketing approval.  On the other hand, if an innovator wants to challenge a generic company that has obtained a marketing approval without a finding of non-infringement/invalidity/patent expiration, it should be able to bring a litigation through the linkage regime as plaintiff.  According to recently proposed rules, generic applicants claiming to fall outside of existing patent scope or seeking to invalidate patents, would be subject to suit by the innovators via a court or CNIPA within 45 days of seeking regulatory approval (Art. 7).  In addition, there should be little incentive to sue outside of the newly established linkage process for generic or innovative companies.  If a generic company wishes to use normal civil and administrative procedures to sue an innovator, courts should be required to implement similar expedited procedures to the linkage regime.

2. The second issue identified by the Court is the conflict between “artificial infringement” and the current Patent Law. According to the Report, the patent linkage system adds the new concept of an application for regulatory approval to the scope of infringing patent acts, or a concept of “artificial infringement.” However, the Patent Law does not stipulate the act of applying for regulatory approval as an act prohibited by patent rights and subject to injunctive or other relief. This will bring a series of problems in the judicial process. In addition to the risk of dismissal due to the lack of a legal basis, a court can determine the accused infringement generic drugs fall into the scope of patent protection, but due to the Bolar exemption, the acts of preparing a generic drug for market may not constitute patent infringement.  

My comment: China’s Bolar exemption is being used, once again to advance an extensive safe harbor from commercial scale infringing acts done in anticipation of market entry, which is a potential TRIPS violation (Art. 30). Although I agree with the Report that this issue should be clarified, I disagree with the absolute necessity of clarifying what constitutes an artificial infringement, as the statute should be interpreted in accordance with China’s international obligations (including the TRIPS Agreement, and the Phase 1 Trade Agreement), as well as with prior practice of China.  It is also wrong to assume that linkage is a wholly new concept to China’s legal system, which this analysis might imply.  China had a limited patent linkage regime in the past without a concept of “artificial infringement.”  It was also administered by the courts.  The late Prof. Benjamin Liu discussed this regime in an article in 2012:

“Previously, Chinese courts reached inconsistent decisions as to whether the unauthorized making and using of patented products during the course of preparing for a drug registration constituted patent infringement. For example, in 2000, the Chongqing Intermediate People’s Court imposed damages against generic company for the unauthorized use of patented technology in connection with drug approval in Glaxo v. Southwestern Pharm.  Later, in 2005, the Jilin Intermediate People’s Court ordered a generic defendant to stop its drug registration process after finding that the unauthorized use of patented traditional medicine formulation in the course of registration is intended for infringing production in Chengdu Kanghong Pharm. v. Liyuan Pharm.Other courts were less sympathetic to the patentee….”

3.The third issue that is there is no guarantee that the specific deadlines will be observed. The Report notes that the timelines are tight, and there could be difficulty in communicating and responding.  Moreover, many of the innovators are multinational companies.  Even if there are representative offices of such multinationals in China, the 20-day period is obviously insufficient to inform the decision-making department and respond. 

My comment: I agree with this assessment. The relationship between the periods being established by the linkage regime and China’s Civil Procedure Law  (Art. 250) which permits the suspension of certain litigation time frames for foreign related cases also needs to be clarified.

4. As a fourth issue, the Report notes that the way to challenge others’ patents is incomplete. The Report notes that in the drug patent linkage systems in the United States, Canada, and Taiwan, the patent challenge program has set two challenges — patent invalidity and patent non-infringement.  However, the challenge set by the Innovation Proposal is only the challenge of non-infringement of patent rights, and not patent invalidation. In fact, a patent invalidation challenge approach is more conducive to competition among generic drug companies as a whole, and it is conducive to subsequent imitation by other generic drug companies, which can play a greater role in drug accessibility. 

My comment: I agree that this is a potential problem.  One solution would appear to be in the first instance to permit the Beijing IP Court to hear both validity and infringement combined, much as has the new national appellate IP Court has piloted late last year in Xiamen Power Electronic Technology Co., Ltd. v.  LG Electronics (Tianjin) Appliances Co., Ltd.  Secondly, administrative validity procedures should be expedited, with the Beijing IP court authorized to reach a final administrative decision on validity, rather than requiring remands to CNIPA.

5.As a fifth issue, the Report notes that many operational regulations of the patent linkage system need to be refined. For example, issues such as the determination of the court of jurisdiction, the choice of the cause of the case, the time limit for prosecution, procedures for challenging invalidity and non-infringement, and the connection between judicial and administrative agencies need to be determined.

My comment: I agree with this assessment as well. 

In addition to the above, the Report makes a recommendation regarding which court should have jurisdiction over linkage disputes. The Report notes that “the Beijing Intellectual Property Court specializes in national patent administrative authorization and confirmation cases and Beijing patent infringement cases. The case has a complete range of categories, a large number of cases, a large number of technical judges, a deep legal literacy, and solid practical skills, and can undertake the trial of patent challenge cases.”

My comment: I agree with an assessment that the Beijing IP court should take exclusive jurisdiction over China’s linkage regime for the reasons stated.  However, in order for a linkage system to work well, it is also important that the courts take a less restrictive view regarding pharmaceutical validity cases, particularly involving post-filing supplementation of data which has long been a bilateral bone of contention.

Any discussion regarding patent linkage in China must also return to basics: if the innovator’s patents are not being granted, then there are not patents to “link” to, and the linkage regime would be of little use.

Translation of Draft Patent Law Available

Thanks to He Jing of the Anjie Law Firm, attached please find an unofficial line-by-line translation of the recently released Patent Law Amendments 2nd reading.   Comments are due August 16, 2020.

Some highlights of this draft:

Partial Design Protection

Article 2 adds language back in to allow partial design protection.  This is a welcome development.  Article 42 also maintains the earlier draft’s extension of the duration of the design patent to 15 years.

Patent Abuse

Article 20 clarifies that the abuse of patent rights to exclude or restrict competition constituting a monopoly shall be dealt with under the anti-monopoly law.  The AML is itself under revision.

Good Faith/Public Interest

Article 20 continues to require “good faith” in patent filings and the exercise of patent rights, an important concept borrowed from the Trademark Law revisions which is having an increasing substantive impact.  The limitation that patents shall not be “allowed to harm public interests” raises similar concerns to me to the recently proposed amendments to the Copyright Law, about the definition of “public interest.”

Pharma Issues – Patent Term Restoration and Linkage

The notices of the NPC regarding the draft law, state that pharma-related IP issues were drafted to implement ‘”trade agreement(s).”   These are reflected in proposed Article 42 which provides for patent term restoration.  This draft removes the requirement of the “synchronous” launching of marketing approval outside of China with approval in China in order for patent term restoration to be granted.

Article 75 also sets forth an outline for a patent linkage regime, and calls for the drafting of more detailed measures to further implement the provisions.  Under this proposal, the innovator challenges a generic applicant for marketing approval within 30 days of the announcement of the application.  If the patentee does not file a lawsuit, a generic company may also request a determination from the courts or patent office of non-infringement based upon the China Patent Information Registration Platform for Listed Drugs.  A court or administrative procedure on patent infringement should render its decision within 9 months.  This draft lacks an incentive provision for a generic to successfully challenge an innovator through granting of a first generic marketing exclusivity due to a successful challenge to the patents. This skeletal section is also drafted as an addendum to the statutory exemptions to infringement, which appears to be an awkward placement.

Damages and Liability

Joint liability of Internet service providers for patent infringement has been removed.

Minimum statutory damages of RMB 100,000 has also been removed.  Statutory damages are capped at 5 million RMB.  Quintuple punitive damages up to 5 times remain from the prior draft.   The statutory damage maximum increases to RMB 5 million (Art. 71). In addition to the continuing focus on increases in damages, this draft also continues the momentum for a larger role for patent administrative enforcement.

The extension of the statute of limitations to three years has been retained from the prior draft (Art. 74).

Several provisions address the proposed “open licensing” system (Chapter 6).

The draft also encourages a flexible remuneration system including “equity, options, and dividends” to enable inventors or designers to reasonably share the proceeds of innovation (Art. 16).

Update of August 16, 2020:  The American Bar Association Intellectual Property Law Section and Section of International Law have made their comments on the draft Patent Law Amendments available here.

 

 

 

2nd Round of Patent Law Amendments Released for Comment

According to the NPC Observer and other sources, the NPC Standing Committee is now seeking comments to the second review draft of the  Patent Law amendments专利法修正案草案二次审议稿.  The official NPC comments released with the draft are here.  A longer report on the status of the revisions of the Patent Law dated June 28, 2020 is found here.  Comments are due by July 31, 2020.

In reviewing this draft, it may be worth referring to the prior draft including a translation provided by the Anjie law firm.

Please send in any translations that you have as well as any comments that you would like to share (chinaipr@yahoo.com).

Along with the recently proposed revisions to the Copyright Law, as well as drafts of recent judicial interpretations and further implementation of the Phase 1 Trade Agreement, this has been a busy season for law and policymaking in IP in China

The Patent Law will be discussed at the concluding webinar that Berkeley will be hosting July 15, 2020.  Prior to that, on July 8, 2020 there will also be a webinar on the Copyright Law including the proposed amendments.  Information on this successful series is available here.