Patent enablement requirements are provided under Article 102 of Vietnam’s Law on Intellectual Property (IP Law). In particular, a patent specification must “fully and clearly disclose the nature of the invention to such an extent that, based on the specification, a person having ordinary skill in the relevant art can implement the invention.” In pharmaceutical and biotechnology patents, this requirement is more complicated and subject to more rigorous assessment. The Patent Examination Guidelines (Guidelines) of the Intellectual Property Office of Vietnam (IP Office) were amended in March 2026 to introduce Annexes III and IV for the pharmaceutical and biotechnology sectors, in which Annex III provides detailed guidelines on the assessment of specification requirements. These amendments were made under a project for strengthening capacity in industrial property examination between the Japan International Cooperation Agency (JICA) and the IP Office. Annex III provides detailed instructions on how examiners assess enablement in a pharmaceutical or biotechnology application, and offers examples of acceptable and unacceptable descriptions with regard to the enablement aspect. Enablement Requirements in Pharma and Biotech Patents Article 12.7 of Circular 10/2026/TT-BKHCN (Circular 10) adds to the requirements of Article 102 of the IP Law that the description must demonstrate the novelty, inventive step, and industrial applicability of the technical solution. For pharmaceutical composition subject matters, Article 12.9 of Circular 10 sets out that the description must present the results of clinical trials and/or the pharmacological effects of the claimed pharmaceutical composition, and must include at least the following information: Substance/mixture used. Testing method (system) employed. Information on the test results. Correlation between the pharmacological effects obtained from the tests and the application of the pharmaceutical product in the prevention, diagnosis, and treatment of diseases. The Guidelines note that pharmacological study results should be presented in a quantified manner, and pharmacological

In March 2026, the Intellectual Property Office of Vietnam (IP Office) issued a decision refusing a trademark application after considering an opposition based primarily on copyright grounds. The outcome is noteworthy because the foreign brand owner had neither trademark registrations nor applications in Vietnam at the time the opposition was filed, and the IP Office has historically applied a stringent approach to oppositions relying on copyright. The Opposition Maurten is a well-known Swedish sports nutrition brand recognized globally for its innovative hydrogel technology, which is designed to help endurance athletes fuel more effectively without gastrointestinal discomfort. The brand’s distinctive logo is characterized by clean lines and a bold black-and-white color scheme, and has long been associated with the company’s performance products. The brand’s logo is displayed above. An identical mark was filed for registration by a Vietnamese trademark squatter. In 2023, a Vietnamese individual filed an application for registration of an identical mark (Application No. 4-2023-38668), a practice commonly observed in Vietnam as trademark squatting. The brand owner engaged Tilleke & Gibbins to assist with strategy and filing an opposition to the mark. At the time, Maurten had no trademark rights or meaningful use in Vietnam, and global marketing data showed only modest figures without any local presence. Thus, to convince the IP Office to refuse the squatter’s application, instead of relying on trademark rights or use evidence, the opposition strategy centered on the copyright protection of the logo itself, as copyright arises automatically in Vietnam upon creation of the work and does not require registration. (It is worth noting, however, that the IP Office has traditionally been cautious in accepting copyright as a basis for refusing trademark applications.) On September 24, 2024, an opposition was filed on three main grounds: confusing similarity, copyright infringement of the artistic work,

On May 25, 2026, Vietnam’s Ministry of Health issued Circular No. 16/2026/TT-BYT governing free-of-charge medicine support programs for medical establishments (Circular 16). Circular 16 will take effect on July 10, 2026, replacing Circular No. 31/2018/TT-BYT, which currently regulates the same subject matter. Circular 16 introduces several significant changes compared to the existing legal framework. Removal of Prior Approval Requirement Under the current regulations, free-of-charge medicine support programs are divided into two categories: (1) entirely free-of-charge provision of medicines for all types of drugs and (2) partially free-of-charge provision applicable only to brand-name drugs under patent protection or drugs whose generic products with identical active ingredients and dosage forms are available in Vietnam. Under the current regulations, partially free-of-charge programs are subject to mandatory registration with the competent authority, while entirely free-of-charge programs could be implemented without prior approval. A key reform under Circular 16 is that it stipulates only entirely free-of-charge medicine support programs applicable to all types of medicines, thereby eliminating the partially free-of-charge category. In addition, free-of-charge medicine support programs may be carried out solely based on a written agreement between the pharmaceutical company and the medical establishment, without any requirement for prior approval from competent authorities prior to implementation. Written Agreement Requirements Circular 16 requires the pharmaceutical company and medical establishment to enter into a written agreement in accordance with a prescribed template. This agreement must include the following compulsory information: Information on the supported medicines Form of support (entirely free-of-charge provision to patients) Quantity of medicines provided Target patient groups and applicable indications Duration of the program Rights and obligations of each party Transitional provisions on the protection of patients’ rights upon completion of the program The agreement may contain other contents as agreed by the parties, provided that these do not contradict applicable laws.

Vietnam’s AI regulatory framework has reached an important milestone. While the Law on Artificial Intelligence No. 134/2025/QH15 (AI Law) established the foundation for AI governance, many practical compliance requirements were left to implementing regulations. On April 30, 2026, the government issued Decree No. 142/2026/ND-CP (Decree 142), which took effect on May 1, 2026, and provides the first detailed guidance on the implementation of the AI Law. Although an official list of high-risk AI systems is still pending from the prime minister, Decree 142 provides valuable insight into how Vietnam’s risk-based AI regulatory framework will operate in practice. Risk Classification Framework The AI Law adopts a risk-based approach under which AI systems are classified as high-risk, medium-risk, or low-risk. Decree 142 builds on this framework by providing detailed guidance on how these classifications are determined. High-risk AI systems are determined based on factors such as (i) their potential impact on life, health, property, human rights, public interests, or national security; (ii) the sector in which they are deployed; and (iii) the scale of affected users or integration with critical infrastructure. The latest draft list of high-risk AI systems appears to follow these same principles. Medium-risk AI systems generally include systems that may mislead, influence, or manipulate users, particularly where users may not realize they are interacting with AI or AI-generated content. The focus is therefore on transparency and authenticity risks rather than broader societal or safety concerns. Low-risk AI systems are those that do not meet the criteria for either high-risk or medium-risk classification. Importantly, Decree 142 seeks to avoid over-classification. Certain systems may fall outside the high-risk or medium-risk regimes, including internal-use systems, office-support tools, technical editing applications, certain back-end processing systems, and AI systems used in artistic, gaming, cinematic, or other creative contexts. Providers must also review and