On September 21, 2022, the Electronic Transactions Development Agency (ETDA) held another public hearing on the draft Royal Decree on Digital Platforms and its sub-regulations. This updated draft Royal Decree on Digital Platforms (which is subsequent to a previous round of updates last year) is anticipated to be the final draft before it is proposed to the king for endorsement. Thereafter, it will be published in the Government Gazette and will become effective 240 days after the publication date. The key issues under the latest draft royal decree are as follows: Exemption for certain regulated businesses. The current draft royal decree exempts business operators that are regulated by the Bank of Thailand or the Securities and Exchange Commission, as well as digital platforms operated by government agencies for noncommercial purposes, from the application of the royal decree. Nevertheless, these business operators must ensure that their digital platform has transparency, fairness, and standards which are not less than those required under the Royal Decree. Definition of digital platform. According to the public hearing, the definition of a digital platform has been amended to exclude digital platforms that are used to offer the goods or services of a digital platform provider or its affiliate acting on its behalf, regardless of whether the offering of such goods or services is made to a third party or the affiliate. Appointment of a local contact. Instead of appointing a local representative with no limit of liability, the current draft royal decree only requires offshore digital platform providers to appoint a local contact to coordinate with the ETDA. The local contact must not operate any business in Thailand under the Foreign Business Act. Notification of the ETDA. Digital platforms as defined under the royal decree must notify the ETDA of certain information—such as the name of the business operator and its

2022年6月16日、ベトナム国会は、2023年1月1日に発効するベトナムの知的財産法の改正案を承認した（ただし、2022年1月14日に遡及適用された音商標に関する規定、2024年1月14日に施行される農薬の試験データ保護に関する規定は除く）。 改正知的財産法が一貫して効率的に施行されるために、政府は改正知的財産法の施行をガイドする政令（以下、「新政令」という。）の公布に積極的に取り組んでいる。新政令は、承認された後、2006年に従前の2005年知的財産法の下位法令として発行された政令No.103/2006/ND-CPおよび政令No.105/2006/ND-CPと置き換えられ、2023年1月1日に発効する。 改正知的財産法の施行に伴い、改正知的財産法に準拠した法律の公布が急務であることから、政府は簡易な手続で新政令を制定・公布する。 政令をドラフトした機関は2022年10月10日、関係者の意見を求めるために新政令のドラフト案を回付した。新政令は、知的財産権の確立と執行、知的財産権の代理、知的財産活動の促進のための措置、知的財産関連の輸出入管理など、知的財産の評価、知的財産の国家管理などの、知的財産法の主要な側面に対する包括的なガイダンスと見られている。 新政令は、一般的に、多くの変更なしに従前の2つの政令の規定を統合している。新政令の重要点は、特許および秘密特許のセキュリティ管理（第14条）と、ハーグ協定に基づく意匠出願（第22条、第23条、第24条）と、ハーグ協定に基づく意匠登録の取消・無効（第32.5条）と、特許権者に対する補償金（第43条）とに関するいくつかの新しい規定である。 新政令は現在、評価・検証のために提出される前段階としてレビューされている段階であり、2022年末までに承認される予定である。   備考：本和文は英文記事を翻訳したものです。原文については、以下のリンクをご参照ください。Decree to Implement Vietnam’s Amended IP Law to Be Issued by Year-End

On October 1, 2022, the Vietnamese government promulgated Decree No. 71/2022/ND-CP (“Decree 71”) amending and supplementing Decree No. 06/2016/ND-CP (“Decree 06”) on the Management, Provision, and Use of Radio and Television Services. Decree 71 will take effect on January 1, 2023, at the same time as the new Cinema Law. Decree 71 is the result of the government’s long-time attempt to regulate the cross-border provision of “over-the-top” (OTT) television services, which deliver TV content to viewers over the internet, bypassing the traditional broadcast, cable, and satellite platforms, as well as to reinforce the requirements for content on demand. The key issues of Decree 71 are set out below. 1. Expanded Scope of Application Decree 71 expands the scope of Decree 06 to clearly cover OTT video-on-demand (VOD) services by amending some definitions: “Radio and TV services” is redefined to mean “services which provide intact domestic program channels and foreign program channels, on-demand radio and TV content [newly added], and value-added service content to users over radio and TV transmission and broadcasting infrastructure. Radio and TV services can be provided directly to service users without the use of storage or delay devices (online radio and TV services), or upon the specific request of subscribers (on-demand radio and TV services).” “On-demand radio and TV content” is newly defined to include “films, domestic programs, and foreign programs.” Films (phim in Vietnamese) follow the definition under the Cinema Law, and in this context include movies/feature films as well as what would be considered “TV shows” or “TV series” (e.g., scripted comedies and dramas) in other countries. Domestic and foreign “programs,” on the other hand, follow the definition of radio and TV programs under Article 3.10 of the Press Law: “a collection of news and articles in spoken or visual press about a topic for a fixed amount of

The Factory Act B.E. 2535 (1992) is one of the most important laws regulating manufacturing businesses in Thailand. It applies to businesses either with machinery of 50 horsepower or more in total, or with a minimum of 50 workers in a facility that conducts “factory work” as defined under related ministerial regulations. The act was recently amended to extend the period of validity for factory licenses and to make other miscellaneous changes that facilitate business. However, the act’s criminal liabilities were left unchanged, and they remain a vital tool for the authorities to exert control over relevant standards and prosecute violations. Both fines and imprisonment are available as sanctions under the law. Examples of common violations of the Factory Act and their potential penalties include: Setting up and operating a factory without acquiring a license: up to two years’ imprisonment, a fine of up to THB 200,000 (approx. USD 5,365), or both. Operating with noise level exceeding the standard set by the Ministry of Industry: a fine of up to THB 200,000. Not displaying a factory license in an open and easily visible location in the factory: a fine of up to THB 5,000 (approx. USD 134). Doing a test run of machinery prior to the start of the factory operations without notifying the authorities: a fine of up to THB 20,000. As factory activities are regulated in considerable detail, overlooking a minor change could potentially put the company at risk. The risk of violating the Factory Act increases when compliance is not a proactive policy—such as by instituting systems or safeguards to ensure adherence to the rules. Criminal Liability Violation of the Factory Act is especially a concern because criminal liability under the act is not limited to juristic persons (i.e., companies) but also applies to the director, manager, and any other person responsible for the offense.

Tilleke & Gibbins’ intellectual property team in Bangkok has provided the latest updates to the Thailand chapter of Practical Law’s Intellectual Property Transactions Global Guide, a high-level comparative overview of intellectual property (IP) laws and regulations in 36 jurisdictions worldwide. The Intellectual Property Transactions in Thailand chapter focuses on business-related aspects of IP, such as the value of intellectual assets in M&A transactions and the licensing of IP portfolios. The topics covered include the following: IP assignment and licensing: Basis/scope and formalities, trade secrets and confidentiality, main terms for assignment/licensing Research and development collaborations: Improvements and derivatives, joint ownership Conducting IP audits to determine the contents of an IP portfolio IP aspects of mergers and acquisitions: IP due diligence, warranties and indemnities, transfer of IP rights Lending and security interests over IP rights Settlement agreements in IP litigation Agreements regarding rights over IP created by employees and consultants Competition law and exploitation of IP rights Tax (e.g., for IP licensing) and nontariff trade barriers To read the full Intellectual Property Transactions in Thailand chapter, please visit the Practical Law website.

Patent specialists from Tilleke & Gibbins have contributed the Myanmar chapter to the 2023 edition of Patents: Practical Cross-Border Insights into Patent Law from International Comparative Legal Guides (ICLG), published by Global Legal Group. This comprehensive guide provides readers with an in-depth look at patent laws and regulations in 23 jurisdictions around the world. Each chapter of the guide, which is in Q&A format, is organized into eight sections: Patent Enforcement Patent Amendment Licensing Patent Term Extension Patent Prosecution and Opposition Border Control Measures Antitrust Law and Inequitable Conduct Current Developments The complete Myanmar chapter is available as a PDF below. The Myanmar chapter—and the full Patents guide—are also freely available on the ICLG website.

Interest in organic farming, soil health, and regenerative agriculture has increased rapidly in recent years, and the demand for biological and organic fertilizers has accordingly undergone dramatic growth. Biological fertilizers contain specific levels of microorganisms (such as nitrogen-fixing bacteria); organic fertilizers similarly contain microorganisms and typically come from animals and plants, such as livestock manure and crop residues. Although responsible fertilizer use is still necessary to prevent unintended effects, these “living fertilizers” can boost yields and promote plant productivity without many of the adverse environmental effects and safety concerns of chemical fertilizers. This makes them highly sought after for organic farming, and prized by agricultural operators looking to promote soil health as a bedrock of sustainable agricultural practices. As the global trade for organic and biological fertilizers has scaled up, producers and agribusiness companies have expanded organic and biological fertilizer offerings to new markets. Not only do different countries have their own regulations for fertilizers in general, but they also often have specific requirements and rules for biological and organic fertilizers. This guide provides fertilizer producers and traders with an overview of the legal landscape for these fertilizers in three major Southeast Asian markets so that businesses can make their fertilizers available and foster sustainable agricultural practices in the region. The full Biological and Organic Fertilizers in Indonesia, Thailand, and Vietnam guide can be downloaded through the button below.

On September 5, 2022, the Ministry of Health of Vietnam issued Circular No. 07/2022/TT-BYT on drugs requiring bioequivalence (BE) studies and requirements for dossiers reporting BE data when registering drugs in Vietnam (Circular 07). Circular 07 will take effect on November 1, 2022, replacing Circular No. 08/2010/TT-BYT guiding the reporting of bioavailability/bioequivalence data when registering drugs. Circular 07 includes provisions on (i) generic drugs containing active pharmaceutical ingredients (APIs) or having dosage forms that require BE reporting when registering the drugs in Vietnam and (ii) dossiers for BE reporting of generic drugs. The most outstanding point under Circular 07 is that the list of APIs requiring the submission of BE reports in their drug registration dossier includes 26 APIs instead of 12 APIs as specified in the previous circular. In addition, generic drugs having the following dosage forms must have a BE report in the drug registration dossier: Drugs in immediate-release dosage form, with systemic effects, containing APIs included in the list of 26 APIs and not falling in the cases of BE reporting exemption, Drugs in modified-release dosage form, with systemic effects, that do not fall in the cases of BE reporting exemption. Roadmap for Application From November 1, 2022, the registrants of the following drugs must submit a report on BE study data along with the drug registration dossier: Generic enteric-coated drugs, in immediate-release or modified-release form, containing single APIs or fixed-dose API combinations in which the APIs are included in the list of 26 APIs mentioned above. Other generic drugs in modified-release form, except for enteric-coated drugs with APIs excluded from the list of 26 APIs. From November 1, 2025 (36 months after the effective date of Circular 07), the registrant must submit a BE data dossier along with the drug registration dossier for all generic enteric-coated drugs in modified-release form. From November 1, 2026 (48 months