The most familiar and well-protected IP rights are copyrights, patents, and trademarks. However, geographical indications (GIs) are also protected by TRIPS, and are perhaps the most contested rights worldwide. Like a trademark, a GI identifies the origin of goods, but refers to a particular region which yields product qualities that cannot be replicated elsewhere. In practice, most GIs relate to agricultural products, and many originate from Europe, such as the terms Champagne, Mozzarella, and Parmesan. Due to the fundamental relationship between place and product, there have been major arguments that producers outside a specified region are not permitted to use the place name on product labels, no matter how similar their product is to the GI-protected product. A few years ago, a series of European GIs for cheese products were opposed in Vietnam by U.S. producers who considered the terms common names that should not be monopolized under the GI protection scheme. In addition, the overlapping rights between trademarks and GIs and their historically tempestuous relationship add more trauma to lawmakers and IP practitioners. Amid this controversy, Vietnam has joined many international agreements with regard to IP and GI rights, including the TRIPS Agreement, the CPTPP, and the EU-Vietnam Free Trade Agreement (EVFTA). Although Vietnam’s IP Law has been amended to reflect these agreements, Vietnamese lawmakers still bear a heavy responsibility in drafting and issuing legislation to further guide the implementation of the amended law, to not only correctly reflect Vietnam’s international commitments, but also to balance the rights of many sides with conflicting interests regarding GIs and trademarks. This legislation includes an upcoming circular regarding industrial property rights (the “draft Circular”). Information Transparency The CPTPP requires GI applications or petitions to be published for opposition, and provides procedures for opposing such GIs. In addition, it requires Vietnam to “make available information sufficient

Myanmar’s Ministry of Commerce has announced its E-commerce Guidelines to regulate stakeholders engaging in e-commerce. The guidelines—which were issued on September 5, 2023, and took immediate effect—are mandatory for e-commerce business operators (both entities and individuals), and failure to comply with the guidelines’ requirements may result in penalties under relevant laws. The E-commerce Guidelines come as Myanmar seeks to increase its regulation of e-commerce activities. The guidelines were preceded by a July 2023 notification requiring e-commerce business operators to register their activities with the Ministry of Commerce by January 21, 2024. Definitions “E-commerce” is defined as the sale of goods or services on the internet or other digital platforms. The term also covers sales promotions, marketing, logistics, ordering, and delivery. An “e-commerce platform entrepreneur” is a person who manages an e-commerce platform where two or more entrepreneurs can conduct e-commerce. An “e-commerce business operator” is a person operating or authorized to operate e-commerce activities. This includes e-commerce platform entrepreneurs, entrepreneurs selling on e-commerce platforms, and sellers through social media platforms. Electronic Contracts Acceptable forms of electronic contracts, which must comply with the Electronic Transactions Law, Contract Act, and other relevant laws, include: Click-wrap, click-through, and web-wrap contracts; Browse-wrap contracts; and Agreements between seller and buyer on social media platforms, such as by accepting or rejecting an offer via direct message. Samples of contract forms are appended to the guidelines. Consumer Protection Disclosure notices for consumers must be comprehensible, correct, consistent, simple, accessible, and visible. They can be written in Myanmar language, English, or Myanmar language and another language. They must also comply with the relevant provisions of the Consumer Protection Law. The guidelines provide that if the agreed delivery date is eclipsed by more than 15 days, the consumer may terminate the contract and request a full refund of payment unless the contract specifically provides otherwise. To address problems like returns,

Thailand is preparing to open its first renewal period for drug marketing authorizations (MAs) since the passage of the Drug Act (No. 6) B.E. 2562 (2019). Before 2019, MAs for pharmaceuticals and vaccines in Thailand had lifelong validity. The 2019 Drug Act stipulated that all new MAs would be valid for seven years and could be renewed. The 2019 law also set out expiration dates for existing pharmaceutical products registered and approved prior to the implementation of the law (i.e., before October 13, 2019): Drug MAs issued before January 1, 1997, expire on October 13, 2024. Drug MAs approved between January 1, 1997, and December 31, 2007, expire on October 13, 2026. Drug MAs approved between January 1, 2008, and October 13, 2019, expire on October 13, 2028. Based on these dates, the first renewal period for drug MAs will commence in the fourth quarter of 2023. To facilitate the renewal process, the Thai Food and Drug Administration (FDA) has publicized draft regulations and notifications on the required application form and documents, the rules and conditions, and the process for renewing an MA. In May 2023, the Thai FDA issued Ministerial Regulation Re: Renewal of Drug MA Licenses B.E. 2566 (2023) to prescribe the essential requirements for filing a renewal application: To renew a drug MA, holders must submit their renewal application to the Thai FDA within the one-year period before the MA’s expiration date. Renewal applications can only be submitted online via the Thai FDA’s electronic system. The Thai FDA will grant approval for an MA renewal if the following conditions are satisfied: The documents in relation to efficacy and safety are up-to-date, accurate, and in accordance with academic principles. The specification and analytical method comply with the official pharmacopeias as prescribed in the Drug Act, as amended. For noncompendial specifications or methods, justification or evidence that substantiates the quality,

Attorneys from Tilleke & Gibbins have prepared the Laos, Myanmar, and Thailand sections of the recently released Global Merger Notification Guide from Lex Mundi. The guide provides answers to key questions related to the merger notification requirements in jurisdictions of Lex Mundi member firms in 57 jurisdictions around the world. Each country-specific section contains in-depth information on the jurisdiction’s legal framework governing merger notifications, addressing the following questions and topics: Regulatory agency for merger notifications Transactions subject to national rules Timeline for filing merger notifications Merger review process Sanctions for not fulfilling merger notification requirements Remedial options for addressing the regulator’s competition concerns Current regulatory outlook and other notable information The guide draws on the expertise of Lex Mundi member firms from around the world. Its innovative format allows users to compare current information from multiple jurisdictions in a side-by-side, customizable report. To browse the contributions, generate country-specific reports, and compare regulatory guidance on merger notification requirements across multiple jurisdictions, please visit the Lex Mundi website.

In May 2023, Thailand issued a regulation on conditional approval for emergency use of medicinal products, replacing a series of similar notifications that had been issued to aid mitigation efforts during the COVID-19 pandemic. During the pandemic, regulatory authorities worldwide—including the Thai Food and Drug Administration (FDA)—reshaped the approval pathway for emergency drugs intended for the treatment of COVID-19. The Thai FDA published five Notifications Re: Conditional Approval for the Emergency Use of Medicinal Products to outline the registration requirements and channels of distribution for drugs intended for the diagnosis, treatment, or prevention of COVID-19. As the threat from COVID-19 was receding, the Thai FDA saw fit to prepare for the potential emergence of other serious communicable diseases by enabling the supply of timely medications for disease diagnosis, treatment, and prevention. The Thai FDA therefore cancelled the five COVID-19-related emergency use notifications, which were published in 2020 and 2022, and replaced them with the Notification Re: Conditional Approval for Emergency Use of Medicinal Products published in May 2023. Under the May 2023 FDA notification on emergency use, conditional approval can be applied to drugs supported by empirical scientific evidence demonstrating their capacity to diagnose, treat, alleviate, cure, or prevent a serious communicable disease. The drugs eligible for approval under this new emergency pathway include novel drugs that are not yet approved in Thailand, as well as existing drugs approved in Thailand but recently discovered to have additional potential indications for the diagnosis, treatment, alleviation, cure, or prevention of a serious communicable disease. Distribution The 2023 FDA notification also clearly defines permissible distribution channels based on the dosage form of drug products: Vaccines can be distributed to governmental organizations that have a duty to prevent or treat diseases, such as the Thai Red Cross Society (TRCS), the Government Pharmaceutical Organization (GPO), public hospitals, private hospitals, medicinal

Thailand is a member state of the ASEAN Economic Community, and next year, it is expected that the ASEAN Harmonization of Traditional Medicines and Health Supplements will be signed by the economic minister of each ASEAN country. Following ratification, the ASEAN Guidelines on Claims and Claims Substantiation for Traditional Medicines and Health Supplements will become the standard guidelines in the region, and various implementation efforts and instruments will follow. These guidelines cover a wide range of medicines and supplements; however, it is not possible to cover all herbal products. There are three types of health supplement claims: nutritional claims, functional claims, and disease risk reduction claims. Examples of the three types of claims include the following: Nutritional claims: supplements nutrition, nourishes the body, supports healthy growth and development, etc. Functional claims: maintains healthy joints, supports immunity, maintains liver function, etc. Disease risk reduction claims: helps to reduce risk of dyslipidemia, helps to reduce risk of osteoporosis, etc. The degree of evidence required for substantiating disease risk reduction claims is higher than for functional claims and nutritional claims. Functional claims and disease risk reduction claims must be substantiated by efficacy studies and the relevant toxicity data. It is the responsibility of the health supplement company to provide the required evidence in order to comply with the criteria for making such claims. Tips on Health Claims for Health Supplements 1. Nutritional Claims For essential nutrients such as vitamins and minerals, as listed by the Thai Food and Drug Administration (FDA), the amount included in a supplement must be between 15% and 100% of the Thai Recommended Daily Intake (RDI) values. Rules for specific kinds of nutritional claims are provided in the Notification of the Thai FDA RE: Nutrient Function Claims. For example, the nutrients that can be claimed as boosting the immune system include vitamin A, B6, B12, folic

With Vietnam’s entertainment industry booming, the demand for music to be used in films and video games has sharply increased. Sometimes a song featured in a movie’s soundtrack can become as popular as the movie itself. In order to use a song in a film, the producer of the film will typically need to enter into an agreement with the owner of a copyrighted work to have permission to use that work – with an agreed amount of royalty. Otherwise, their use could be considered a copyright infringement. However, what happens if the producer enters into an agreement with a song’s purported copyright owner, only to later find that such person does not really own the song entirely? A recent high-profile case in Vietnam brought this issue to light. The Dispute and Court Rulings The film “Face Off 4 – The Walking Guests,” financed and produced by Ly Hai Promotion Co., Ltd (“Ly Hai”) premiered in April 2019, and soon became a big success. In this film, Ly Hai used a song called “Ganh Me” on the basis of a March 2019 contract to use the song signed with the musician Quach Beem, who was recognized as the song owner in a copyright certificate issued on 24 April 2019 by the Copyright Office of Vietnam (COV). The dispute arose in November 2019 when an individual named Truong Minh Nhat discovered that the lyrics of “Ganh Me” were almost identical to a poem he had written and posted on his Facebook page in June 2014, well before the COV had issued the copyright certificate to Quach Beem. Mr. Nhat initiated a lawsuit against two defendants, Quach Beem and Ly Hai, for copyright infringement. In his petition, Mr. Nhat requested the court to, among other things, recognize him as the author and owner of the lyrics

When your company suffers a data breach, taking prudent, careful action can limit and perhaps even rectify some of the damage. First of all, it is important to document everything, starting with the time the data breach was discovered. Secure the data systems and preserve all evidence so that investigators can determine what happened, and begin following the protocol that all companies handling personal data should have in place to guide their data breach response. It is also crucial to seek timely legal assistance to ensure that every aspect of the response is planned and carried out according to the law. While applicable legal advice for each situation can only be obtained by consulting a legal advisor, this guide gives an overview of what companies in Southeast Asian jurisdictions can expect if they suffer a data breach. This guide from Tilleke & Gibbins is a quick-reference resource covering key regulatory issues regarding data breach responses in Cambodia, Laos, Myanmar, Thailand, and Vietnam. The full guide can be downloaded through the button below.