Category: China

15% Discount on Chinese Patent Annuities for Open Licensing

Per a slightly ambiguous notice from the Ministry of Finance and the National Development and Reform Commission released July 24, 2024 (财政部 国家发展改革委关于调整优化专利收费政策的通知), annuity fees will be reduced by 15% for Chinese patents for participating in China’s open licensing system. As of the time of writing, there were over 2,000 open licenses published on China’s Intellectual Property Administration’s (CNIPA) online publication system.

15% Discount on Chinese Patent

Specifically, section 2 reads:

A 15% reduction in annual patent fees during the implementation period of patent open licensing. If other patent fee reduction policies are also applicable, the most favorable policy can be selected, but it cannot be enjoyed repeatedly.

However, it is unclear if this requires an actual license or simply having an offer to license published on CNIPA’s open license system.

In addition, there appears to be an additional annuity fee due for patents that receive patent term compensation (presumably for both patent term extensions for pharmaceutical patents and patent term adjustment for CNIPA delay in patent examination). It is unclear if this additional annuity is due for the entire patent term or just for the added patent term.

Specifically, section 1 reads, in part:

A patent owner who files a request for patent term compensation shall pay a patent term compensation request fee.

If a request for patent term compensation is found to meet the conditions for term compensation upon review, an annual patent compensation fee shall be paid…

CNIPA earlier this month also released additional information about open licensing system including royalty rates.

The full text of the Notice if available here (Chinese only).

© 2024 Schwegman, Lundberg & Woessner, P.A. All Rights Reserved.
For more news on Chinese Patent Licensing, visit the NLR Intellectual Property section.

China’s Supreme People’s Court Releases Two Recent Patent-Related Typical Anti-Monopoly Cases

On June 24, 2024, China’s Supreme People’s Court (SPC) released five recent typical anti-monopoly cases, two of which relate to patents. The SPC stated that the cases were released so that Courts can “correctly apply the revised Anti-Monopoly Law and accurately understand the new judicial interpretation of anti-monopoly civil litigation issued today, fairly and efficiently hear monopoly cases, ensure the correct implementation of the Anti-Monopoly Law, and maintain fair competition in the market.”

Explanations from the SPC regarding the two cases follows:

Case No.:【案号】（2020）最高法知民终1140号

[Basic facts of the case] Yang XX Pharmaceutical Group Co., Ltd. and its subsidiaries (collectively referred to as Yang) are the manufacturers of the anti-allergic drug desloratadine citrate tablets with the trade name “Beixue.” Hefei Yi XX Pharmaceutical Co., Ltd. owns the relevant patents for desloratadine citrate. The company and its subsidiaries and affiliated companies (collectively referred to as Yi) are the only suppliers of the desloratadine citrate API required for the production of “Beixue”. In addition to producing desloratadine citrate API, Yi also produces desloratadine citrate hard capsules. Yi and Yang are both the supply and demand parties of the desloratadine citrate API involved in the case, and are also competitors in desloratadine citrate preparations. Yang believed that Yi used its dominant position in the market of desloratadine citrate API to restrict Yang to only purchase the API involved in the case from it, significantly raised the price of the API involved in the case, and threatened to stop supplying the API involved in the case to force Yang to accept other commercial arrangements unrelated to the API transaction involved, causing huge losses to Yang and therefore constituting an abuse of market dominance. Yang requested that Yi stop abusing its market dominance and compensate Yang for losses and reasonable expenses of 100 million RMB. The court of first instance found that Yi had abused its market dominance by restricting transactions, setting unfair high prices, and attaching unreasonable transaction conditions, and ordered it to immediately stop the above-mentioned behaviors and compensate Yang more than 68 million RMB. Both parties were dissatisfied and appealed to the Supreme People’s Court.

The Supreme People’s Court held in the second instance that Yi has a dominant market position in the desloratadine citrate API market in China, but its dominant market position has been weakened to a certain extent due to the strong indirect competition constraints from the downstream second-generation antihistamine preparation market. Based on the existing evidence, it is difficult to determine that it has abused its dominant market position. First, desloratadine citrate falls within the scope of protection of Yi’s patent rights. The time and scope of Yi’s restriction that Yang can only purchase the patented API involved in the case from it do not exceed the scope of the legitimate exercise of patent rights, and the resulting market blocking effect does not exceed the statutory exclusive scope of patent rights, so it does not constitute a restricted transaction behavior that abuses the dominant market position. Second, considering the internal rate of return after the price increase and the matching degree of price and economic value, it is more likely that the initial price of the patented API involved in the case is a promotional price, and the subsequent large price increase is likely to be a reasonable adjustment from the promotional price to the normal price. The fact that the price increase is significantly higher than the cost increase is not enough to determine that there is an unfair high-price behavior that abuses the dominant market position. Third, the existing evidence is insufficient to prove that Yi has explicitly or implicitly bundled the sales of the patented API involved in the case with unrelated products, so it is difficult to determine that there is an act of attaching unreasonable transaction conditions. Therefore, the judgment was revoked and the first-instance judgment was changed to dismiss Yang’s lawsuit request.

[Typical Significance] This case is the first monopoly civil lawsuit in China involving raw material pharmaceuticals. The judgment clarified the consideration of indirect competition constraints from the downstream market when judging the market dominance of intermediate input operators, the relationship between the market blocking effect of limited trading behavior and the statutory exclusive scope of patent rights, and the basic ideas and specific methods for judging unfair high prices. It has positive significance for promoting the accurate application of the Anti-Monopoly Law and effectively maintaining fair competition in the pharmaceutical market.

【案号】（2021）最高法知民终1482号

[Basic facts of the case] Ningbo XX Magnetics Co., Ltd. is an enterprise engaged in the production of sintered NdFeB materials in Ningbo, Zhejiang Province. A Japanese metal company has more than 600 sintered NdFeB patents in the field of rare earth materials worldwide. After licensing eight companies in China to implement its patented technology, it decided not to add new licensees. From March 2014 to March 2015, Ningbo XX Magnetics Co., Ltd. repeatedly requested a license from the Japanese metal company but was rejected. Therefore, it filed a lawsuit in December 2014, requesting that the Japanese metal company stop the abuse of market dominance such as refusal to trade and compensate Ningbo XX Magnetics Co., Ltd. for economic losses of 7 million RMB. The court of first instance determined that the Japanese metal company had a dominant position in the patent licensing market for essential patents for sintered NdFeB and that its refusal to trade had no legitimate reason. Therefore, it ordered the Japanese metal company to stop abusing its market dominance by refusing to trade and compensate Ningbo XX Magnetics Co., Ltd. for economic losses of 4.9 million RMB. The Japanese metal company was dissatisfied with the decision and filed an appeal.

The Supreme People’s Court held in the second instance that the evidence in this case was insufficient to prove that the sintered NdFeB patent of a Japanese metal company was irreplaceable, nor was it sufficient to prove that there was an independent licensing market for patents necessary for the production of sintered NdFeB. Therefore, it was difficult to determine that the relevant market in this case was the patent licensing market for patents necessary for the production of sintered NdFeB owned by the Japanese metal company. In this case, based on the demand substitution of sintered NdFeB material production technology, the relevant market in this case should be defined as the global sintered NdFeB material production technology market, including patented technologies and non-patented technologies with close substitution. Given that sintered NdFeB material production technology is used to produce sintered NdFeB materials, and the market share of sintered NdFeB materials (products) and other conditions can more accurately and conveniently reflect the market conditions of sintered NdFeB production technology, the market power of the technology owner in the relevant market involved in the case can be evaluated through the market share of the sintered NdFeB material market. Taking into account the evidence in the case, the Japanese metal company does not have a dominant position in the global sintered NdFeB material production technology market. Therefore, the court ruled to revoke the first-instance judgment and dismiss the lawsuit filed by the Ningbo magnetic company.

[Typical Significance] This case is a typical case in which intellectual property rights and antitrust are intertwined, and has received widespread attention. The second-instance judgment properly handled the relationship between the exercise of patent rights and antitrust, and through scientific and reasonable definition of the relevant market, revised the judgment in accordance with the law to determine that the foreign right holder’s refusal to license the patent involved did not constitute monopoly behavior. The judgment in this case demonstrates the judicial concept of Chinese courts to equally protect the legitimate rights and interests of Chinese and foreign parties and the trial ideas of antitrust cases involving intellectual property abuse in accordance with the law, and actively responded to the concerns of the industry at home and abroad.

The original text including three additional cases is available here (Chinese only).

© 2024 Schwegman, Lundberg & Woessner, P.A. All Rights Reserved.
For more news on Chinese Patent Litigation, the NLR Intellectual Property section.

Conviction Under China’s Version of the Economic Espionage Act for Theft of Trade Secrets

On April 26, 2024, the Shanghai Pudong Court released the “Typical cases of intellectual property judicial services provided by the Shanghai Pudong New Area People’s Court to ensure high-quality development of new productivity” (上海市浦东新区人民法院知识产权司法服务保障新质生产力高质量发展典型案例), which included a criminal case involving a newer provision of the Chinese Criminal Law that is somewhat analogous to the U.S. Economic Espionage Act. This is believed to be the first case in Shanghai under this provision and may be related to last year’s police raids on Bain and/or Capvision although the Court did not release information identifying the entities involved.

As explained by the Shanghai Pudong Court:

Case 12

Determination of the elements of the crime of illegally providing trade secrets to foreign countries – the first case of spying and illegally providing trade secrets to foreign countries in Shanghai

Judgment Summary

Article 219-1 of the Criminal Law states that “the crime of spying on and illegally providing commercial secrets for foreign countries” should be determined based on the following elements: first, the object of the perpetrator’s infringement is a commercial secret protected by China’s criminal law; second, the perpetrator objectively carried out the act of spying on and illegally providing commercial secrets; third, the commercial secrets were spied on and provided to foreign institutions, organizations, and personnel, and the perpetrator knew it. Among them, foreign institutions and organizations include not only institutions and organizations established in other countries or regions abroad, but also their branch (representative) institutions and branch organizations established in China, as well as institutions and organizations in Hong Kong, Macao and Taiwan. If the perpetrator is not clearly informed that the commercial secrets are spied on and provided to foreign countries, but subjectively should know and takes a laissez-faire attitude, it constitutes knowing.

Basic facts

From August 2017 to 2020, the defendant Zheng worked as a thin film equipment engineer in a storage company. He signed the “Employment Contract” and “Secrecy Commitment Letter on Resignation” and promised to keep the company’s trade secrets confidential. In August 2021, the defendant Zheng accepted the invitation of an information company and became the company’s industry expert consultant. From October 2021 to the time of the incident, the defendant Zheng violated the confidentiality agreement with the storage company where he originally worked, used the information he had mastered and spied on the employees of the storage company, and accepted the arrangement of the information company many times in the name of an expert of the storage company to provide paid consulting services to companies with similar or competitive businesses to the storage company. Among them, Zheng accepted a telephone interview with the consulting company (whose shareholders are foreign companies) in February 2022. Knowing that the actual consulting party was an overseas organization, he still illegally provided the trade secrets of the storage company that he had spied on and learned to overseas organizations and personnel through the information company, and illegally made a profit of 2,062.40 RMB. On September 17, 2022, the defendant Zheng was detained and summoned by the Shanghai National Security Bureau. After being brought to justice, he truthfully confessed the main facts of the crime and, with the help of his family, surrendered the illegal gains of 2,062.40 RMB.

Judgement

After trial, the Pudong Court held that the commercial information of the relevant products accused by the public prosecution agency was the result of a storage company’s creative labor and embodied the wisdom of many R&D personnel. The above-mentioned trade secrets have an important impact on the company’s competitiveness and future development in the international and domestic industries. The company has never publicly released it, and the defendant Zheng also confirmed that the above-mentioned information belongs to the company’s undisclosed information. Therefore, this information is not generally known and not easily accessible to relevant personnel in the field. The storage company has taken reasonable confidentiality measures for the commercial information involved by formulating the “Confidential Information Protection Policy Text” and signing the “Employment Contract” and “Resignation Confidentiality Commitment Letter” with the defendant Zheng. Therefore, the commercial information involved is the company’s trade secrets. After the defendant Zheng resigned, he violated the agreement on keeping trade secrets with the storage company and the company’s confidentiality system. Knowing that the consulting party was an overseas organization, he still provided the trade secrets involved in the case that he illegally discovered from his former colleagues, together with the trade secrets he possessed, to the consulting party. His behavior has constituted the crime of overseas espionage and illegal provision of trade secrets. Based on this, the court sentenced the defendant Zheng to two years and six months in prison and a fine of RMB 10,000 for the crime of spying and illegally providing trade secrets abroad; the illegal gains were confiscated.

After the first-instance judgment, the defendant Zheng did not appeal and the public prosecution agency did not file a protest, and the judgment is now effective.

Typical significance

This case is the first case accepted by the Shanghai court for the newly added crime of “stealing, spying, buying, and illegally providing trade secrets for foreign countries” since the implementation of the Criminal Law Amendment (XI). It involves former employees of key enterprises in China’s high-tech field, who, in the name of expert consultation, leaked important trade secrets they spied on and learned to foreign organizations through consulting companies and made profits, causing serious harm to the development and economic interests of the enterprises. The judgment in this case strictly grasps the constituent elements of the crime, severely cracks down on commercial espionage crimes of foreign organizations against key high-tech enterprises in China, protects the independent intellectual property rights of Chinese enterprises in accordance with the law, helps to enhance international competitiveness, and safeguards China’s national security and national interests.

The original text (with 14 other typical case summaries) is available here (Chinese only).

© 2024 Schwegman, Lundberg & Woessner, P.A. All Rights Reserved.
For more news on Theft of Trade Secrets in China, visit the NLR Intellectual Property section.

U.S. House of Representatives Passes Bill to Ban TikTok Unless Divested from ByteDance

Yesterday, with broad bipartisan support, the U.S. House of Representatives voted overwhelmingly (352-65) to support the Protecting Americans from Foreign Adversary Controlled Applications Act, designed to begin the process of banning TikTok’s use in the United States. This is music to my ears. See a previous blog post on this subject.

The Act would penalize app stores and web hosting services that host TikTok while it is owned by Chinese-based ByteDance. However, if the app is divested from ByteDance, the Act will allow use of TikTok in the U.S.

National security experts have warned legislators and the public about downloading and using TikTok as a national security threat. This threat manifests because the owner of ByteDance is required by Chinese law to share users’ data with the Chinese Communist government. When downloading the app, TikTok obtains access to users’ microphones, cameras, and location services, which is essentially spyware on over 170 million Americans’ every move, (dance or not).

Lawmakers are concerned about the detailed sharing of Americans’ data with one of its top adversaries and the ability of TikTok’s algorithms to influence and launch disinformation campaigns against the American people. The Act will make its way through the Senate, and if passed, President Biden has indicated that he will sign it. This is a big win for privacy and national security.

Copyright © 2024 Robinson & Cole LLP. All rights reserved.
by: Linn F. Freedman of Robinson & Cole LLP

For more news on Social Media Legislation, visit the NLR Communications, Media & Internet section.

Huawei U.S. Patent Grants Drop 24% in 2023; BOE Drops Out of the Top 10

Accordingly to analysis by Harrity Patent Analytics, Huawei ranked 10th for US patent grants in 2023, down 3 spots from 2022 with a 24% drop in patent grants. BOE Technology Group Co., Ltd. dropped even further to 19th down from 8th in 2022. BOE had a 38% drop in granted US patents. Tencent was 54th this year with an 11% drop in patent grants. Oppo was down 32%. Baidu was up only 1%. Xiaomi was down 7% and didn’t make the top 100 in 2023. Alibaba was down 49%. In contrast, US companies advanced with Qualcomm patent grants up 46%, Alphabet (Google) up 23% and Apple up 11%.

The drop in Chinese patent grants reverse the trend of growing US patent grants for Chinese companies. Huawei’s patents grants in 2022 were up 3%, BOE up 27%, Baidu up 43% and Xiaomi up 33%.

Possible reasons for the drop in grants to Chinese entities may include a poorly performing Chinese economy, the reduction and elimination of government subsidies for foreign patent grants, the impact of COVID-19 on patent application filings the past few years; and geopolitical tensions.

Top 10 Chinese Grantees of U.S. Patents in 2023

Rank Company 2023 Patents % Change from 2022
10 HUAWEI TECHNOLOGIES CO., LTD. 2290 -24%
19 BOE TECHNOLOGY GROUP CO., LTD 1695 -38%
54 TENCENT HOLDINGS LTD 702 -11%
67 BAIDU, INC. 626 +1%
77 LENOVO GROUP LIMITED 530 -16%
84 OPPO MOBILE TELECOMMUNICATIONS CORPORATION 516 -32%
101 XIAOMI INC. 461 -7%
115 TSINGHUA HOLDINGS 372 -3%
121 ZTE CORPORATION 351 -14%
122 BYTEDANCE LTD. 350 +119%

Source: https://harrityllp.com/patent300/

© 2024 Schwegman, Lundberg & Woessner, P.A. All Rights Reserved.
For more news on Granted US Patents, visit the NLR Intellectual Property section.

University of Texas at Austin Permanently Blocks TikTok on Network

On Tuesday, January 17, 2023, the University of Texas at Austin announced that it has blocked TikTok access across the university’s networks. According to the announcement to its users, “You are no longer able to access TikTok on any device if you are connected to the university via its wired or WIFI networks.” The measure was in response to Governor Greg Abbott’s December 7, 2022, directive to all state agencies to eliminate TikTok from state networks. Following the directive, the University removed TikTok from university-issued devices, including cell phones, laptops and work stations.

Copyright © 2023 Robinson & Cole LLP. All rights reserved.

For  more Cybersecurity Legal News, click here to visit the National Law Review.

Nineteen States Have Banned TikTok on Government-Issued Devices

Governors of numerous states have issued Executive Orders in the past several weeks banning TikTok from government-issued devices and many have already implemented a ban, with others considering similar measures. There is also bi-partisan support of a ban in the Senate, which unanimously approved a bill last week that would ban the app from devices issued by federal agencies. There is already a ban prohibiting military personnel from downloading the app on government-issued devices.

The bans are in response to the national security concerns that TikTok poses to U.S. citizens [View related posts].

To date, 19 states have issued some sort of ban on the use of TikTok on government-issued devices, including some Executive Orders banning the use of TikTok statewide on all government-issued devices. Other state officials have implemented a ban within an individual state department, such as the Louisiana Secretary of State’s Office. In 2020, Nebraska was the first state to issue a ban. Other states that have banned TikTok use in some way are: South Dakota, North Dakota, Maryland, South Carolina, Texas, New Hampshire, Utah, Louisiana, West Virginia, Georgia, Oklahoma, Idaho, Iowa, Tennessee, Alabama, Virginia, and Montana.

Indiana’s Attorney General filed suit against TikTok alleging that the app collects and uses individuals’ sensitive and personal information, but deceives consumers into believing that the information is secure. We anticipate that both the federal government and additional state governments will continue to assess the risk and issue bans on its use in the next few weeks.

Copyright © 2022 Robinson & Cole LLP. All rights reserved.
For more Cybersecurity Legal News, click here to visit the National Law Review.

USTR Seeks Comments on Section 301 Tariffs on Chinese Goods; Portal Opens Nov. 15

The Office of the U.S. Trade Representative (USTR) announced Oct. 17 that starting Nov. 15, it will begin soliciting comments on the effectiveness of Section 301 tariffs the Trump administration placed on Chinese goods. The notice and request for comments relate to USTR’s ongoing four-year statutory review of the Section 301 investigation of China’s Acts, Policies, and Practices Related to Technology Transfer, Intellectual Property, and Innovation.

In the Federal Registrar Notice, USTR said it is seeking “public comments on the effectiveness of the actions in achieving the objectives of the investigation, other actions that could be taken, and the effects of such actions on the United States economy, including consumers.”

The USTR is specifically interested in comments on the following:

  • The effectiveness of the actions in obtaining the elimination of China’s acts, policies, and practices related to technology transfer, intellectual property, and innovation.
  • The effectiveness of the actions in counteracting China’s acts, policies, and practices related to technology transfer, intellectual property, and innovation.
  • Other actions or modifications that would be more effective in obtaining the elimination of or in counteracting China’s acts, policies, and practices related to technology transfer, intellectual property, and innovation.
  • The effects of the actions on the U.S. economy, including on U.S. consumers.
  • The effects of the actions on domestic manufacturing, including in terms of capital investments, domestic capacity and production levels, industry concentrations, and profits.
  • The effects of the actions on U.S. technology, including in terms of U.S. technological leadership and U.S. technological development.
  • The effects of the actions on U.S. workers, including with respect to employment and wages.
  • The effects of the actions on U.S. small businesses.
  • The effects of the actions on U.S. supply chain resilience.
  • The effects of the actions on the goals of U.S. critical supply chains.
  • Whether the actions have resulted in higher additional duties on inputs used for additional manufacturing in the United States than the additional duties on particular downstream product(s) or finished good(s) incorporating those inputs.

The continuing assessment of these additional duties has been criticized by some business groups and lawmakers who believe they have hurt both U.S. businesses and U.S. consumers but have not checked China’s behavior. They also have called for the reinstatement of previously issued exclusions and for a new, robust tariff exclusion process. Some labor and civil society groups, however, want the tariffs to remain in place. The fate of these tariffs is closely tied to the Biden administration’s ongoing review and the overall U.S.–China trade relationship. The controversial tariff program that covers upwards of $300 billion worth of imports from China has sparked lawsuits from more than 3,500 importers.

The comment period begins on Nov. 15 and extends until Jan. 17. USTR said it will post specific questions on its website Nov. 1 before the portal opens.

Article By Laura Siegel Rabinowitz, Donald S. Stein, and Madeline Orlando of Greenberg Traurig, LLP

For more trade regulation news, click here to visit the National Law Review.

©2022 Greenberg Traurig, LLP. All rights reserved.

Supreme People’s Court Upholds China’s First Patent Linkage Ruling – Decision Released

On August 28, 2022, 知识产权那点事 published the first patent linkage decision from the Supreme People’s Court (SPC). The SPC upheld the Beijing IP Court ruling that Wenzhou Haihe Pharmaceutical Co., Ltd.’s application for marketing authorization for a generic form of “Aidecalcidol Soft Capsule” did not fall within scope of protection of the relevant patent. China’s patent linkage system prevents marketing authorization for a generic prior to the expiration of the patent term on the branded equivalent unless the Beijing IP Court or the China National Intellectual Property Administration (CNIPA) rules that the generic does not fall within the scope of the relevant patent rights or is invalid.

On November 10, 2021, the Beijing IP Court announced that the plaintiff of the case, Chugai Pharmaceutical Co., Ltd., a subsidiary of Roche, claimed that it was the patentee as well as the holder of the marketing license for the patented drug “Aidecalcidol Soft Capsule”, and the patent involved in the drug was CN 2005800098777.6 entitled “ED-71 preparation.” The plaintiff discovered that the defendant Wenzhou Haihe Pharmaceutical Co., Ltd. had applied to the National Medical Products Administration (NMPA) for a generic drug marketing license application named “Aidecalcidol Soft Capsule”. The public information on the Chinese listed drug patent information registration platform showed that the defendant had made a 4.2 category statement regarding the generic drug (the generic drugs do not fall into the scope of protection of the related patents). Therefore, the plaintiff filed a drug patent linkage lawsuit with the Beijing Intellectual Property Court in accordance with the provisions of Article 76 of the Amended Patent Law, requesting the court to confirm that the generic drug “Aidecalcidol Soft Capsule” that the defendant applied for registration fell into the scope the rights of Patent No. 2005800098777.6 enjoyed by the plaintiff.

 

The Beijing IP Court held:

The technical solution used by the generic drug involved is neither the same nor equivalent to the technical solution of claim 1 of the involved patent, so the technical solution does not fall within the protection scope of claim 1 of the involved patent. Since claims 2-6 are dependent claims of claim 1, if the technical solution of the generic drug involved does not fall within the protection scope of claim 1, it also does not fall within the protection scope of claims 2-6. Accordingly, the plaintiff’s claim that the involved generic drug falls within the protection scope of claims 1-6 of the involved patent cannot be established, and the court will not support it.

In the decision, the Supreme People’s Court stated there were two key points:

1. In the process of drug marketing review and approval, disputes arising from the patent rights related to the drug to be registered between the drug marketing license applicant and the relevant patentee or interested parties are only one type of the related patent rights between the two parties – often referred to as drug patent link disputes. For chemical generic drugs, the drug regulatory department of the State Council conducts drug marketing review and approval based on the application materials of the generic drug applicant, and decides whether to suspend the approval of the relevant drugs according to the effective judgment made by the people’s court [or the China National Intellectual Property Administration] on such disputes within the prescribed time limit. Therefore, when judging whether the technical solution of a generic drug falls within the scope of patent protection, in principle, it should be compared and judged on the basis of the application materials of the generic drug applicant. If the technical solution actually implemented by the generic drug applicant is inconsistent with the declared technical solution, it shall bear legal responsibility in accordance with the relevant laws and regulations on drug supervision and administration; if the patentee or interested party believes that the technical solution actually implemented by the generic drug applicant constitutes infringement, a separate lawsuit for patent infringement may also be filed. Therefore, whether the technical solution actually implemented by a generic drug applicant is the same as the application materials is generally not within the scope of examination to confirm that the dispute falls within the scope of patent protection.

2. The court of second instance held that both the donation [to the public] rule and the estoppel rule can constitute a restriction on the application of the principle of equivalence, both of which aim to achieve a reasonable balance between equitably protecting the interests of the patentee and safeguarding the interests of the public. If the conditions for limiting the application of the principle of equivalence are met, there is usually no need to judge whether the two features constitute similar means, functions, and effects, and whether those skilled in the art can conceptualize them without creative work. In this case, since Haihe Company claimed the application of the estoppel rule by virtue of the amendment of the claims by Chugai Pharmaceutical Co., Ltd., and claimed the application of the donation rule by the patent text as the result of the amendment, the court of second instance first rendered a judgment on whether the rules on estoppel should be applied on the basis of the amendment of the claims by the patentee.

The case numbers are:

北京知识产权法院（2021）京73民初1438号民事判决书

最高人民法院（2022）最高法知民终905号民事判决书

The full text of the decision courtesy of 知识产权那点事 is available here (Chinese only).

Article By Aaron Wininger of Schwegman, Lundberg & Woessner, P.A.

For more intellectual property legal news, click here to visit the National Law Review.

© 2022 Schwegman, Lundberg & Woessner, P.A. All Rights Reserved.

Uyghur Forced Labor Prevention Act Takes Effect: What Importers Need to Know

The Uyghur Forced Labor Prevention Act (UFLPA) is in effect as of June 21, 2022. Congress passed the Act in December 2021 to increase enforcement of longstanding U.S. policy prohibiting the importation of goods, or components thereof, made with forced labor and to create a “rebuttable presumption” that merchandise from the Xinjiang Uyghur Autonomous Region (XUAR) or by an entity on the UFLPA Entity List is made with forced labor and thereby prohibited from entry into the United States. The rebuttable presumption applies to downstream products that incorporate inputs from XUAR, regardless of where the finished products are manufactured, including goods from outside XUAR in the People’s Republic of China (PRC), or in third countries. There is no de minimis provision in the law – any prohibited content, no matter how small, will make a product subject to the rebuttable presumption made by the law. If an importer can demonstrate by “clear and convincing” evidence that the goods were not produced wholly or in part by forced labor, U.S. Customs and Border Protection (CBP) will grant an “exception” to the presumption. The UFLPA provides for increased detentions and seizures of merchandise and potential civil and criminal penalties. See prior GT Alerts on the UFLPA.

Pursuant to the UFLPA, a multi-agency task force chaired by the Department of Homeland Security was mandated to develop a strategy for the Act’s implementation. On June 17, in anticipation of the June 21 effective date, DHS released the “Strategy to Prevent the Importation of Goods Mined, Produced, or Manufactured with Forced Labor in the People’s Republic of China” (Enforcement Strategy), which includes:

  • An assessment of risk of importing goods mined, produced, or manufactured, wholly or in part, in the PRC; according to the strategy, complex supply chains that touch XUAR are “highly susceptible to contamination by goods made using forced labor.”
  • A list of entities affiliated with forced labor; therefore, their products are subject to the presumption that their goods are prohibited from entry. The Entity list will be updated multiple times per year and will be publicly available.
  • A list of high priority sectors and products including apparel and textiles, cotton and cotton products, polysilicon, and tomato products. Other products listed include footwear, nails, electronics, and toys.
  • Guidance to importers advising that companies need heightened due diligence to ensure compliance with UFLPA and to identify potential supply chain exposure to Xinjiang. Supply chain tracing is the general method to demonstrate that goods are free of inputs from Xinjiang, but CBP expects that barriers to supply chain tracing may make it difficult for importers to be compliant and has stated that third-party audits alone are insufficient to demonstrate due diligence.

Should CBP detain goods on suspicion of being made wholly or in part with forced labor, the importer has options. It can re-export the goods (up until CBP seizes them); it can abandon the goods; it can seek an “exception” for the goods, to get them released from CBP custody; it can also provide information to CBP demonstrating that the goods are not subject in any way to the Act. The evidence and documentation needed for the latter two must be “clear and convincing.”

It should be noted that in order to obtain an “exception” for goods that have been detained, an importer must meet all three of the following requirements:

  • Provide clear and convincing evidence that the detained goods were not made in whole or in part with forced labor, or were sourced from entities on the Entity List.
  • Fully and substantively respond to any questions from CBP.
  • Show that it has complied with all of the requirements set out in the Enforcement Strategy and CBP’s Operational Guidance (i.e., due diligence, supply chain tracing and management, etc.).

The Enforcement Strategy document provides importers with guidance in the following three areas:

  • Due diligence, effective supply chain tracing, and supply chain management measures to ensure that no goods violating the Act enter the importer’s supply chain.
  • The type, nature, and extent of evidence that demonstrates that goods originating in China were not mined (or grown), produced, or manufactured wholly or in part in Xinjiang.
  • The type, nature, and extent of evidence that demonstrates goods originating in China, including goods detained under Section 307 of the Tariff Act, were not mined (or grown), produced, or manufactured wholly or in part with forced labor.

CBP has made it clear that should there be a detention, participants in the Customs and Trade Partnership Against Terrorism program (C-TPAT) will be prioritized for review of submissions to rebut the presumption that the merchandise was made with forced labor.

Importers may wish to plan for contingencies should CBP detain imported merchandise, map complex supply chains and review purchase agreements and supplier codes of conduct.

Article By Laura Siegel Rabinowitz and Donald S. Stein of Greenberg Traurig, LLP

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