China (PRC) and the United States (USA) Economic & Trade Agreement, look at the bilateral agreement.

https://ustr.gov/sites/default/files/files/agreements/phase%20one%20agreement/Economic_And_Trade_Agreement_Between_The_United_States_And_China_Text.pdf

International Affairs Academy, Document of the Day - Free Professional Development



ECONOMIC AND TRADE AGREEMENT BETWEEN THE GOVERNMENT OF THE UNITED STATES OF AMERICA AND THE GOVERNMENT OF THE PEOPLE’S REPUBLIC OF CHINA PREAMBLE


The Government of the United States of America and the Government of the People’s Republic of China (collectively the “Parties”), RECOGNIZING the importance of their bilateral economic and trade relationship; REALIZING that it is in the interests of both countries that trade grow and that there is adherence to international norms so as to promote market-based outcomes; CONVINCED of the benefits of contributing to the harmonious development and expansion of world trade and providing a catalyst to broader international cooperation; ACKNOWLEDGING the existing trade and investment concerns that have been identified by the Parties; and RECOGNIZING the desirability of resolving existing and any future trade and investment concerns as constructively and expeditiously as possible, HAVE AGREED as follows:


CHAPTER 1 INTELLECTUAL PROPERTY Section A: General Obligations The United States recognizes the importance of intellectual property protection. China recognizes the importance of establishing and implementing a comprehensive legal system of intellectual property protection and enforcement as it transforms from a major intellectual property consumer to a major intellectual property producer. China believes that enhancing intellectual property protection and enforcement is in the interest of building an innovative country, growing innovation-driven enterprises, and promoting high quality economic growth.


Article 1.1: China and the United States hereby affirm that they undertake provisions with respect to intellectual property, as set forth in Sections A through K.


Article 1.2: The Parties shall ensure fair, adequate, and effective protection and enforcement of intellectual property rights. Each Party shall ensure fair and equitable market access to persons of the other Party that rely upon intellectual property protection. Section B: Trade Secrets and Confidential Business Information The United States emphasizes trade secret protection. China regards trade secret protection as a core element of optimizing the business environment. The Parties agree to ensure effective protection for trade secrets and confidential business information and effective enforcement against the misappropriation of such information.1 1 The Parties agree that the term “confidential business information” concerns or relates to the trade secrets, processes, operations, style of works, or apparatus, or to the production, business transactions, or logistics, customer information, inventories, or amount or source of any income, profits, losses, or expenditures of any person, natural or legal, or other information of commercial value, the disclosure of which is likely to have the effect of causing substantial harm to the competitive position of such person from which the information was obtained.


Article 1.3: Scope of Actors Liable for Trade Secret Misappropriation 1. The Parties shall ensure that all natural or legal persons can be subject to liability for trade secret misappropriation. 2. China shall define “operators” in trade secret misappropriation to include all natural persons, groups of persons, and legal persons. 3. The United States affirms that existing U.S. measures afford treatment equivalent to that provided for in this Article.


Article 1.4: Scope of Prohibited Acts Constituting Trade Secret Misappropriation 1. The Parties shall ensure that the scope of prohibited acts subject to liability for trade secret misappropriation provides full coverage for methods of trade secret theft. 2. China shall enumerate additional acts constituting trade secret misappropriation, especially: (a) electronic intrusions; (b) breach or inducement of a breach of duty not to disclose information that is secret or intended to be kept secret; and (c) unauthorized disclosure or use that occurs after the acquisition of a trade secret under circumstances giving rise to a duty to protect the trade secret from disclosure or to limit the use of the trade secret. 3. China and the United States agree to strengthen cooperation on trade secret protection. 4. The United States affirms that existing U.S. measures afford treatment equivalent to that provided for in this Article.


Article 1.5: Burden-Shifting in a Civil Proceeding 1. The Parties shall provide that the burden of production of evidence or burden of proof, as appropriate, shifts to the accused party in a civil judicial proceeding for trade secret misappropriation where the holder of a trade secret has produced prima facie evidence, including 1-3 circumstantial evidence, of a reasonable indication of trade secret misappropriation by the accused party. 2. China shall provide that: (a) the burden of proof or burden of production of evidence, as appropriate, shifts to the accused party to show that it did not misappropriate a trade secret once a holder of a trade secret produces: (i) evidence that the accused party had access or opportunity to obtain a trade secret and the information used by the accused party is materially the same as that trade secret; (ii) evidence that a trade secret has been or risks being disclosed or used by the accused party; or (iii) other evidence that its trade secret(s) were misappropriated by the accused party; and (b) under the circumstance that the right holder provides preliminary evidence that measures were taken to keep the claimed trade secret confidential, the burden of proof or burden of production of evidence, as appropriate, shifts to the accused party to show that a trade secret identified by a holder is generally known among persons within the circles that normally deal with the kind of information in question or is readily accessible, and therefore is not a trade secret. 3. The United States affirms that existing U.S. measures afford treatment equivalent to that provided for in this Article.


Article 1.6: Provisional Measures to Prevent the Use of Trade Secrets 1. The Parties shall provide for prompt and effective provisional measures to prevent the use of misappropriated trade secrets. 2. China shall identify the use or attempted use of claimed trade secret information as an “urgent situation” that provides its judicial authorities the authority to order the grant of a preliminary injunction based on the specific facts and circumstances of a case. 3. The United States affirms that existing U.S. measures afford treatment equivalent to that provided for in this Article. 1-4


Article 1.7: Threshold for Initiating Criminal Enforcement 1. The Parties shall eliminate any requirement that the holder of a trade secret establish actual losses as a prerequisite to initiation of a criminal investigation for misappropriation of a trade secret. 2. China shall: (a) as an interim step, clarify that “great loss” as a threshold for criminal enforcement under the trade secret provision in the relevant law can be fully shown by remedial costs, such as those incurred to mitigate damage to business operations or planning or to re-secure computer or other systems, and substantially lower all the thresholds for initiating criminal enforcement; and (b) as a subsequent step, eliminate in all applicable measures any requirement that the holder of a trade secret establish actual losses as a prerequisite to initiation of a criminal investigation for misappropriation of a trade secret.


Article 1.8: Criminal Procedures and Penalties 1. The Parties shall provide for the application of criminal procedures and penalties to address willful trade secret misappropriation. 2. China’s criminal procedures and penalties shall at least encompass cases of trade secret misappropriation through theft, fraud, physical or electronic intrusion for an unlawful purpose, and the unauthorized or improper use of a computer system in the scope of prohibited acts. 3. The United States affirms that existing U.S. measures afford treatment equivalent to that provided for in this Article.


Article 1.9: Protecting Trade Secrets and Confidential Business Information from Unauthorized Disclosure by Government Authorities 1. To further strengthen the protection of trade secrets, as well as better encourage various enterprises to innovate, China shall prohibit the unauthorized disclosure of undisclosed information, trade secrets, or confidential business information by government personnel or third party experts or advisors in any criminal, civil, administrative, or regulatory proceedings 1-5 conducted at either the central or sub-central levels of government in which such information is submitted. 2. China shall require administrative agencies and other authorities at all levels to: (a) limit requests for information to no more than necessary for the legitimate exercise of investigative or regulatory authority; (b) limit access to submitted information to only government personnel necessary for the exercise of legitimate investigative or regulatory functions; (c) ensure the security and protection of submitted information; (d) ensure that no third party experts or advisors who compete with the submitter of the information or have any actual or likely financial interest in the result of the investigative or regulatory process have access to such information; (e) establish a process for persons seeking an exemption from disclosure and a mechanism for challenging disclosures to third parties; and (f) provide criminal, civil, and administrative penalties, including monetary fines, the suspension or termination of employment, and, as part of the final measures amending the relevant laws, imprisonment, for the unauthorized disclosure of a trade secret or confidential business information that shall deter such unauthorized disclosure. 3. The United States affirms that existing U.S. measures afford treatment equivalent to that provided for in this Article. Section C: Pharmaceutical-Related Intellectual Property Pharmaceuticals are a matter concerning people’s life and health, and there continues to be a need for finding new treatments and cures, such as for cancer, diabetes, hypertension, and stroke, among others. To promote innovation and cooperation in the pharmaceutical sector and to better meet the needs of patients, the Parties shall provide for effective protection and enforcement of pharmaceutical-related intellectual property rights, including patents and undisclosed test or other data submitted as a condition of marketing approval. 1-6


Article 1.10: Consideration of Supplemental Data 1. China shall permit pharmaceutical patent applicants to rely on supplemental data to satisfy relevant requirements for patentability, including sufficiency of disclosure and inventive step, during patent examination proceedings, patent review proceedings, and judicial proceedings. 2. The United States affirms that existing U.S. measures afford treatment equivalent to that provided for in this Article.


Article 1.11: Effective Mechanism for Early Resolution of Patent Disputes 1. If China permits, as a condition of approving the marketing of a pharmaceutical product, including a biologic, persons, other than the person originally submitting the safety and efficacy information, to rely on evidence or information concerning the safety and efficacy of a product that was previously approved, such as evidence of prior marketing approval by China or in another territory, China shall provide: (a) a system to provide notice to a patent holder, licensee, or holder of marketing approval, that such other person is seeking to market that product during the term of an applicable patent claiming the approved product or its approved method of use; (b) adequate time and opportunity for such a patent holder to seek, prior to the marketing of an allegedly infringing product, available remedies in subparagraph (c); and (c) procedures for judicial or administrative proceedings and expeditious remedies, such as preliminary injunctions or equivalent effective provisional measures, for the timely resolution of disputes concerning the validity or infringement of an applicable patent claiming an approved pharmaceutical product or its approved method of use. 2. China shall establish a nationwide system for pharmaceutical products consistent with paragraph 1, including by providing a cause of action to allow the patent holder, licensee, or holder of marketing approval to seek, prior to the marketing approval of an allegedly infringing product, civil judicial proceedings and expeditious remedies for the resolution of disputes concerning the validity or infringement of an applicable patent. China may also provide for administrative proceedings for the resolution of such disputes. 1-7 3. The United States affirms that existing U.S. measures afford treatment equivalent to that provided for in this Article. Section D: Patents


Article 1.12: Effective Patent Term Extension 1. The Parties shall provide patent term extensions to compensate for unreasonable delays that occur in granting the patent or during pharmaceutical product marketing approvals. 2. China shall provide that: (a) China, at the request of the patent owner, shall extend the term of a patent to compensate for unreasonable delays, not attributable to the applicant, that occur in granting the patent. For purposes of this provision, an unreasonable delay shall at least include a delay in the issuance of the patent of more than four years from the date of filing of the application in China, or three years after a request for examination of the application, whichever is later. (b) With respect to patents covering a new pharmaceutical product that is approved for marketing in China and methods of making or using a new pharmaceutical product that is approved for marketing in China, China, at the request of the patent owner, shall make available an adjustment of the patent term or the term of the patent rights of a patent covering a new product, its approved method of use, or a method of making the product to compensate the patent owner for unreasonable curtailment of the effective patent term as a result of the marketing approval process related to the first commercial use of that product in China. Any such adjustment shall confer all of the exclusive rights, subject to the same limitations and exceptions, of the patent claims of the product, its method of use, or its method of manufacture in the originally issued patent as applicable to the approved product and the approved method of use of the product. China may limit such adjustments to no more than five years and may limit the resulting effective patent term to no more than 14 years from the date of marketing approval in China. 3. The United States affirms that existing U.S. measures afford treatment equivalent to that provided for in this Article. 1-8 Section E: Piracy and Counterfeiting on E-Commerce Platforms In order to promote the development of e-commerce, China and the United States shall strengthen cooperation and jointly and individually combat infringement and counterfeiting in the e-commerce market. The Parties shall reduce piracy and counterfeiting, including by reducing barriers, if any, to making legitimate content available in a timely manner to consumers and eligible for copyright protection, and providing effective enforcement against e-commerce platforms.


Article 1.13: Combating Online Infringement 1. China shall provide enforcement procedures that permit effective and expeditious action by right holders against infringement that occurs in the online environment, including an effective notice and takedown system to address infringement. 2. China shall: (a) require expeditious takedowns; (b) eliminate liability for erroneous takedown notices submitted in good faith; (c) extend to 20 working days the deadline for right holders to file a judicial or administrative complaint after receipt of a counter-notification; and (d) ensure validity of takedown notices and counter-notifications, by requiring relevant information for notices and counter-notifications and penalizing notices and counter-notifications submitted in bad faith. 3. The United States affirms that existing U.S. enforcement procedures permit action by right holders for infringement that occurs in the online environment. 4. The Parties agree to further cooperate, as appropriate, to combat infringement.


Article 1.14: Infringement on Major E-Commerce Platforms 1. The Parties shall combat the prevalence of counterfeit or pirated goods on e-commerce platforms by taking effective action with respect to major e-commerce platforms that fail to take necessary measures against the infringement of intellectual property rights. 1-9 2. China shall provide that e-commerce platforms may have their operating licenses revoked for repeated failures to curb the sale of counterfeit or pirated goods. 3. The United States affirms that it is studying additional means to combat the sale of counterfeit or pirated goods. Section F: Geographical Indications The Parties shall ensure full transparency and procedural fairness with respect to the protection of geographical indications, including safeguards for generic2 terms (also known as common names), respect for prior trademark rights, and clear procedures to allow for opposition and cancellation, as well as fair market access for exports of a Party relying on trademarks or the use of generic terms.


Article 1.15: Geographical Indications and International Agreements 1. China shall ensure that any measures taken in connection with pending or future requests from any other trading partner for recognition or protection of a geographical indication pursuant to an international agreement do not undermine market access for U.S. exports to China of goods and services using trademarks and generic terms. 2. China shall give its trading partners, including the United States, necessary opportunities to raise disagreement about enumerated geographical indications in lists, annexes, appendices, or side letters, in any such agreement with another trading partner. 3. The United States affirms that existing U.S. measures afford treatment equivalent to that provided for in this Article.


Article 1.16: General Market Access-related GI Concerns 1. China shall ensure that: (a) competent authorities, when determining whether a term is generic in China, take into account how consumers understand the term in China, including as indicated by the following: 2 The term “generic” may be deemed by a Party to be synonymous with “a term customary in the common language as the common name for the associated good.” 1-10 (i) competent sources such as dictionaries, newspapers, and relevant websites; (ii) how the good referenced by the term is marketed and used in trade in China; (iii) whether the term is used, as appropriate, in relevant standards to refer to a type or class of goods in China, such as pursuant to a standard promulgated by the Codex Alimentarius; and (iv) whether the good in question is imported into China, in significant quantities, from a place other than the territory identified in the application or petition, and in a way that will not mislead the public about its place of origin, and whether those imported goods are named by the term, and (b) any geographical indication, whether granted or recognized pursuant to an international agreement or otherwise, may become generic over time, and may be subject to cancellation on that basis. 2. The United States affirms that existing U.S. measures afford treatment equivalent to that provided for in this Article.


Article 1.17: Multi-Component Terms 1. Each Party shall ensure that an individual component of a multi-component term that is protected as a geographical indication in the territory of a Party shall not be protected in that Party if that individual component is generic. 2. When China provides geographical indication protection to a multi-component term, it shall publicly identify which individual components, if any, are not protected. 3. The United States affirms that existing U.S. measures afford treatment equivalent to that provided for in this Article. Section G: Manufacture and Export of Pirated and Counterfeit Goods Pirated and counterfeit goods severely undermine the interests of the general public and harm right holders in both China and the United States. The Parties shall take sustained and 1-11 effective action to stop the manufacture and to block the distribution of pirated and counterfeit products, including those with a significant impact on public health or personal safety.


Article 1.18: Counterfeit Medicines 1. The Parties shall take effective and expeditious enforcement action against counterfeit pharmaceutical and related products containing active pharmaceutical ingredients, bulk chemicals, or biological substances. 2. Measures China shall take include: (a) taking effective and expeditious enforcement action against the related products of counterfeit medicines and biologics, including active pharmaceutical ingredients, bulk chemicals, and biological substances; (b) sharing with the United States the registration information of pharmaceutical raw material sites that have been inspected by Chinese regulatory authorities and that comply with the requirements of Chinese laws and regulations, as well as any necessary information of relevant enforcement inspections; and (c) publishing online annually, beginning within six months after the date of entry into force of this Agreement, the data on enforcement measures, including seizures, revocations of business licenses, fines, and other actions taken by the National Medical Products Administration, Ministry of Industry and Information Technology, or any successor entity. 3. The United States affirms that existing U.S. measures afford effective and expeditious action against counterfeit pharmaceutical and related products.


Article 1.19: Counterfeit Goods with Health and Safety Risks 1. The Parties shall ensure sustained and effective action to stop the manufacture and distribution of counterfeit products with a significant impact on public health or personal safety. 2. Measures China shall take include significantly increasing the number of enforcement actions within three months after the date of entry into force of this Agreement, and publishing data online on the measurable impact of these actions each quarter, beginning within four months after the date of entry into force of this Agreement. 1-12 3. The Parties shall endeavor, as appropriate, to strengthen cooperation to combat counterfeit goods that pose health and safety risks.




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