SAMR Releases Legislative Work Plan for 2020

On 26 March 2020, SAMR released its Legislative Work Plan for 2020 (“2020 Legislative Plan”) 国家市场监督管理总局2020 年立法工作计划. In 2020, 7 draft laws and administrative regulations行政法规, including the Amendment to the Detailed Rules for the Implementation of the Patent Law and the Amendment to the Anti-Monopoly Law, will be proposed for deliberation to the Ministry of Justice. Additionally, 48 administrative rules部门规章 will be formulated or amended.

SAMR’s practice is to designate one or two SAMR bureaus/departments with primary drafting responsibility for these projects. This is likely the second time that a yearly legislative work plan was publicly released since SMAR was organized in 2018. The prior legislative work plan is here.

The Class I Projects of administrative rules shall be submitted for legal review by June 30, 2020,  and completed by the end of the year. The 2020 Legislative Plan does not give a specific deadline for the 7 laws and administrative regulations, as well as the Class II Projects of administrative rules. It simply states that these categories shall be submitted for review on time, ensuring high-quality and efficiency (“部门规章第二类项目以及法律、行政法规,要确保高质高效推进,按期送审”).

IP-related projects, drafting departments, and some brief comments follow below:

Laws and Administrative Regulations:

1.Anti-Monopoly Law 中华人民共和国反垄断法. On January 2, 2020, SAMR issued the Draft Amendments to China’s AML (Draft for Public Comment) “反垄断法”修订草案 公开征求意见稿) (“Draft AML Amendments”). The ABA’s Antitrust Law and International Law Sections submitted comments to SAMR on the Draft AML Amendments. According to the NPC Observer, the Draft AML Amendments are on the State Council’s calendar for the 13th NPC Standing Committee Legislative Plan. It is a priority Class II Project. According to the recent government reorganization, it would otherwise be expected that the Ministry of Justice would prepare a draft of the AML revisions for consideration by the State Council which would then forward on to the NPC for three readings.  As mentioned in a previous blog, Article 55 of current AML (Article 62 of the Draft AML Amendments) stayed unchanged in the most recent draft and there are otherwise very little IP-related amendments contemplated at this time. 

Drafting Department: Anti-Monopoly Bureau

6.Regulations for the Implementation of the Drug Administration Law 中华人民共和国药品管理法实施条例  On August 26, 2019, China’s National People’s Congress adopted the new Drug Administration Law (“DAL”), which took effect on December 1, 2019. The legislative history is set forth in the NPC Observer. As noted in the previous blog, the new law addresses some important issues involving counterfeit and substandard medicines. However, it does little to improve the IP regime for innovative medicines.

In order to coordinate the implementation of the DAL, the revision of other supporting regulations and administrative rules will be further implemented this year.

The Regulations for the Implementation of the DAL had been amended and published on March 2, 2019. It has now been put into the Legislative Plan again. These revisions may be intended to implement changes in the newly revised DAL. On the other hand, it is also hoped that a linkage system would emerge as part of a package of legal reforms as contemplated by the US-China Phase 1 Agreement and to implement an earlier CFDA policy decision.

In addition, this 2020 Legislative Plan includes more than ten Drug/Medical Devices-related administrative rules, including: Measures for the Administration of Drug Registration药品注册管理办法, Measures for the Supervision and Administration of Drug Production药品生产监督管理办法, Measures for the Supervision and Administration of Drug Operations药品经营监督管理办法, Measures for the Supervision and Administration of Drug Online Sales药品网络销售监督管理办法, Measures for the Administration of Registration of Medical Devices医疗器械注册管理办法, Measures for the Supervision and Administration of Medical Devices医疗器械生产监督管理办法, and the Measures for the Supervision and Administration of Medical Devices医疗器械经营监督管理办法

Drafting Department: National Medical Products Administration (NMPA)

7.Rules for the Implementation of the Patent Law 中华人民共和国专利法实施细则. The Rules for the Implementation of the Patent Law, were last amended in 2010. It is likely that these amendments will also be in the form of amendment to the previous Rules,  and perhaps may anticipate some of the changes expected in a revised patent law

On January 4, 2019, the National People’s Congress released a public comment draft of the long-awaited revised patent law. The NPC Observer’s summary of the legislative history to date is here. As we noted previously, a major disappointment remains the absence of a patent linkage regime, including a notion of “artificial infringement.” If the new Patent Law fails to address patent linkage, then the Rules for the Implementation of the Patent Law are also very likely to omit a patent linkage regime.

Drafting Department: China National Intellectual Property Administration (CNIPA)

Administrative Rules:

 Class I Projects

10.Provisions on Prohibiting Infringements upon Trade Secrets禁止侵犯商业秘密若干规定.  SAIC, as a predecessor agency to CNIPA, promulgated the Provisions on Prohibiting Infringements upon Trade Secrets in 1995 and amended it in 1998. These Provisions were formulated in accordance with the relevant provisions of the Unfair Competition Law then in effect.  These early rules were especially important for administrative enforcement of trade secrets and do need to be amended in light of recent revisions to the Anti-Unfair Competition law.  One overdue change is to correct language that specifically enumerated rights in trade secrets to Chinese citizens, legal persons or other organizations, and not to all natural persons such as foreign natural persons, which is a legacy that unnecessarily violates national treatment obligations (Art. 2): “The term ‘rights holder’ in these regulations refers to citizens, legal persons or other organizations that have ownership or use rights over trade secrets according to law. ” 本规定所称权利人,是指依法对商业秘密享有所有权或者使用权的公 民、法人或者其他组织。

In addition, in the Phase 1 IP Agreement, the trade secret provisions generally memorialize amendments already made to China’s Anti-Unfair Competition Law, including an expanded scope in defining “operator” (Art. 1.3), acts that constitute trade secret infringement (Art. 1.4), as well as a shifting of the burden of proof in civil proceedings where there is a reasonable basis to conclude that a trade secret infringement has occurred (Art. 1.5). The Agreement also requires China to change its trade secret thresholds for “initiating criminal enforcement.” (Art. 1.7).  It is hoped that some of these provisions will be incorporated into China’s administrative trade secret enforcement mechanisms.

Drafting Department: Price Supervision and Inspection and Anti-Unfair Competition Bureau

36.Measures for the Administration of Trademark Agency 商标代理管理办法

Drafting Department: CNIPA

37. Provisions on Protecting Geographical Indication Products地理标志产品保护规定. Prior rules in this area had been adopted by one of the precursor agencies to SAMR, the State Administration for Quality Supervision, Inspection and Quarantine in furtherance of China’s sui generis GI system. On April 3, 2020, CNIPA promulgated the Administrative Measures for the Use of Geographical Indications (Trial) 地理标志专用标志使用管理办法(试行). These measures will hopefully also be harmonized with China’s trademark-based GI system, which is also undergoing reform (see item 55, below). 

Drafting Department: CNIPA

38. Official Logo Protection Measures官方标志保护办法. On March 24, CNIPA released Official Logo Protection Measures (Draft for Public Comment). Comments will be due on April 23, 2020.  

 Drafting Department: CNIPA

 Class II Projects

54. Provisions on the Determination and Protection of Well-Known Trademarks驰名商标认定和保护规定.

Drafting Department: CNIPA

55Administrative Measures Concerning the Registration of Collective Marks and Certification Marks集体商标、证明商标注册和管理办法.

Drafting Department: CNIPA

Class I Projects Administrative Rules Nos. 36 and 37 and Class II Projects Nos. 54 and 55 all have prior effective versions that were issued in 2014 or earlier.  It is likely that these projects will be in the form of amendments to the previous Administrative Rules.

Prepared by Dr. Xu Xiaofan and Mark Cohen

EPISODE 900: THE STOLEN COMPANY

Recently National Public Radio’s Planet Money aired an extensive radio broadcast entitled “Episode 900: The Stolen Company” about a counterfeiting case involving a US adhesives company, ABRO.  The case occurred over 10 years ago but continues to have meaning today.  Owing to my role at the US Embassy at the time, I was interviewed along with Bill Mansfield, who implemented ABRO’s anti-counterfeiting strategies, ABRO’s executive team, and others.   The Planet Money segment recalls the extreme measures that the counterfeiter undertook as well as Bill Mansfield’s creative countermeasures.  I won’t spoil the show by telling you now.   The case continues to stand for the proposition that it is possible to win complex counterfeiting cases in China.

One of the individuals who was not included in the final broadcast was Jack Chang 张为安.  Jack is a friend and fellow veteran of many anti-counterfeiting campaigns, and he has been particularly active in the Quality Brands Protection Committee (QBPC), an association of foreign-invested enterprises (FIE’s) that work together to improve China’s IP system.  He remembered those early days involving ABRO.  Jack noted the following to me in a recent email exchange regarding ABRO after this program aired:

“1) After the Hunan counterfeiter was arrested in London but managed to return to China, he conducted a press conference blaming on USG and ABRO for cheating and framing him. His story was widely spread in China. Even within QBPC, many Chairs circulated the counterfeiter’s one side story. It was Mark Cohen, whom I checked with and who provided me with ABRO’s story. Mark did not disclose that he was involved in the operation at that time though. After learning that the Hunan counterfeiter was the bad guy, I asked the QBPC Chairs and members not to repeat the counterfeiter’s one side story and they did.

2) I know Bill [Mansfield]  for many years. His drinking tea and presenting appreciation plaques served in fact as an important value that “a U.S. citizen, who was so frustrated with China’s counterfeiting problem, ended up recognizing Chinese authorities’ sense of honor.” … Chinese Customs and Economic Crime Police are the heroes in the minds of many U.S. (European as well) companies. … Having said that, why the western world is still so frustrated? The simple answer is that the magnitude of counterfeit trade is huge and the technology related IP issues have caught almost every western leaders of public and private sectors’ attention.

3) …In terms of fighting counterfeiting trademark and copyright piracy, there is no difference between industries. Pfizer, J&J and many other pharm giants got tremendous support from the Chinese police to conduct serious criminal investigations on counterfeit rings. Our semiconductor members got the support too. The problem was with prosecutors and courts, which believe that IP owners were not the victims of IP crimes … and that paying civil damages would suffice while no need to put people in jail. The Chinese police are on our side. Some procuratorates are too… [I]n terms of fighting counterfeiting, industrial differences is not an issue at all. However, I agree with Mark partially that technology-related IP protection may be a different story. As I said earlier in this email, forced tech transfer is NOT a real issue from the perspective of many QBPC front line IP soldiers. But lack of effective legal framework for trade secret protection, which threatens both foreign and domestic companies, national treatment for FIEs in terms of the implementation of national innovation and technological policies, FIEs’ participation in the national technological standard setting, the harmonization of “Regulations on Administration for Import and Export of Technology Transfer” and the tech transfer section of Contract Law etc. are the real concerned areas of QBPC IP experts. …”

The ABRO case may also have some parallels with the current controversy involving extradition of Meng Wanzhou of Huawei.  In the ABRO case, the Chinese government also reacted strongly to the arrest of Yuan Hongwei, the alleged Hunanese counterfeiter in London, on a writ of extradition to the US.  Ultimately the ABRO case quieted down as the facts became better known.

Jack also graciously noted of my own involvement in the ABRO case: “Without your telling me the ABRO story in the old days, QBPC might have rejected ABRO’s application to join QBPC and the Chinese colleagues might turn their anger to the USG. You probably did not know how critical your contribution was to the QBPC (possibly to China’s anti-counterfeiting momentum). I thank you now!! All the best!”

Thank you Jack, Bill Mansfield, the team at ABRO and NPR and others for working together on this important case and sharing your memories and insights.

 

 

“Dying to Survive” and Pharmaceutical IP Reform in China

Last week while in Beijing, I finally had the opportunity to see “Dying to Survive” (Chinese title: “我不是药神”[translation: I am not the god of medicines]), the hit Chinese movie which concerns the problem of high priced cancer medicines that were not available through insurance on the Chinese market and had also been subject to patent validity and infringement disputes.  The screening I saw was filmed in Mandarin and subtitled in English.  When it opened in China, the movie was the second highest grossing movie in the world, and it is now on track to gross over 3 billion RMB.

The cancer medicine that is the focus of the movie is Imatinib Mesylate (Gleevec/Glivec), which was marketed by Novartis and is used to treat Leukemia.  The protagonist, Cheng Yong 程勇, was approached by a leukemia patient to travel to India and supply this person and others with a generic form of Novartis’ Gleevec.  Cheng Yong buys Gleevec for 500 RMB a box, and resells it at a 2,000 RMB, but which is still cheaper than Novartis’ offering (40,000 RMB).

Cheng Yong evolves over time from an unsympathetic trafficker in black market drugs  and possibly substandard medication for local patients to the lifeline of leukemia patients of an effective generic throughout China.  The evolution begins after nearly being arrested for selling counterfeit medicines when he briefly renounces his business in favor of a competitor.  However, he is soon approached by leukemia patients who desperately need his product at a reasonable price. He ultimately subsidizes the sale of Gleevec in China with his own money by distributing the product at cost.  Cheng Yong is thereafter arrested and sentenced.  He is released from jail early after petitioning by patients he has helped.  By contrast, the Novartis anti-counterfeiting investigator’s role remains a one-dimensional villain throughout the movie. The movie closes by noting that Imatinib Mesylate was ultimately made available legally and placed on insurance reimbursement lists and that new laws and regulations have been introduced since the incident described in the film.

The movie is based on an actual incident involving an individual named Lu Yong 陆勇.  The movie also bears some similarity to Dallas Buyers Club, which involved distribution of AIDS medication in the United States.  In real life, generic forms of Gleevec were approved by Chinese regulatory authorities in 2013. The product was also placed into the Chinese insurance reimbursement list in 2017.

The official and public reactions to the film suggest that China is indeed dedicated to both pharmaceutical IP and regulatory reform.  Premier Li Keqiang cited the movie in encouraging accelerated new product introduction and lower drug prices.  A translation by the Anjie law firm of an article by IPHouse on a screening of the film with leading judges, academics and lawyers is attached.   Based on this article and meetings I held in China, I believe that most people thought that the movie’s message was that China needs to continue to engage in a range of legal reforms, including:  accelerating approval of new drugs by China’s National Drug Administration; improving IP protection to encourage innovative drug development; and providing insurance to cover treatments.