Life sciences specialists from Tilleke & Gibbins have updated the firm’s guide to pharmaceutical data exclusivity regulations and practices in Southeast Asia. This guide contains quick-reference information on the availability of data exclusivity protections and limitations in Cambodia, Indonesia, Laos, Malaysia, Myanmar, Thailand, and Vietnam. Developing and launching a new drug on a commercial scale requires an enormous amount of time and investment in research and development (R&D), including pre-clinical testing and clinical trials. When considering the aggregate amount of drug development costs, it is important to recognize that this includes not only the investment in developing new drugs that get approved by a government food and drug regulator and are successfully brought to market, but also the R&D expenditures on a large number of potential pharmaceutical compounds and products that never actually make it to market. In particular, considerable investment is required in order to conduct and produce clinical trial data—to prove safety, efficacy and effectiveness of a new drug—that would warrant marketing approval by the regulatory authority. Such data is proprietary in nature and highly valuable for a research-based pharmaceutical company that develops an original drug. On the other hand, patent law typically confers generic drug manufacturers with the ability to engage in various preparatory activities with a view to obtaining marketing approval for a generic product before the patent for the original drug expires (commonly known as a “Bolar provision”). Since a generic drug maker may submit an application for marketing approval of a generic product before the relevant patent expires, the extent to which the drug originator’s data submitted to the regulatory authority is protected—or in other words, the extent to which the generic company may rely on the drug originator’s previously filed data, which underpins the safety and efficacy of the drug, to support

Vietnam is making notable strides in decentralization, aiming to grant greater autonomy to local government entities to streamline administrative procedures. As part of this effort, the government issued Decree No. 133/2025/ND-CP on decentralization of state management of the Ministry of Science and Technology dated June 12, 2025 (Decree 133). Effective from July 1, 2025, Decree 133 decentralizes and delegates numerous state management functions—including in intellectual property (IP) and technology transfer—to provincial-level People’s Committees (PCs). This reform signals a profound shift in how IP rights are administered and enforced across Vietnam. While this offers new opportunities for IP owners, agents, and innovators, it also introduces additional operational complexities. Impact on IP and Technology Transfer Decree 133 significantly reallocates responsibilities in IP and technology transfer, primarily to provincial-level PCs. Provincial PCs and other provincial authorities are now empowered to handle a wide range of tasks, including but not limited to the following: Issuance of duplicates and reissuance of certificates of registration. Registration of license agreements for the transfer of usage rights for industrial property objects (e.g., trademarks, patents) and recording amendments, extensions, or early terminations of such agreements. Enforcing decisions on compulsory licensing of patent use rights. Evaluation and approval of technology transfer contracts—a key step in facilitating localized technological advancements. Permitting the establishment of foreign-invested scientific organizations and their branches, to encourage foreign direct investment in local R&D and technology development. Approval of provincial-level R&D tasks, aligning with local socio-economic development priorities. Legal Implications The decentralization and delegation brought forth by Decree 133 carry several significant legal implications: Echoing Decree 133, the Intellectual Property Office of Vietnam issued Notification No. 2351/TB-SHTT on June 26, 2025, announcing the cessation of 19 administrative procedures at the national level. Specifically, from July 1, 2025, the IP Office will no longer accept requests related

Three American giants are actively protecting their intellectual property rights against generative AI, as two legal battles commence on both sides of the Atlantic. In the UK, Seattle-based media company Getty Images accuses UK-based Stability AI of multiple IP infringements. In the US, The Walt Disney Company and Universal Studios are teaming up against Midjourney, an AI startup, with their main ground being copyright infringement. Both cases are centered around questions legal minds have been posing since the introduction of generative AI: Is the output of generative AI an infringement? And who is ultimately responsible for the output, the platform or the user? Getty Images v. Stability AI Getty initially filed a claim in the High Court in 2023, which resulted in Stability applying for reverse summary judgment on the grounds that Getty had no real prospect of success, arguing that their operations took place outside the UK. However, the High Court judge hearing the case decided that the claims brought by Getty did have a real prospect of succeeding in court. Despite this, Stability saw a small victory when the court ruled that the representative action brought by Getty would not succeed due to the difficulties in identifying who qualified for the class. The proposed class was comprised of 50,000 rightsholders who alleged their rights were also infringed. Stability was successful in arguing that identifying these individuals would be challenging due to the unclear definition of the class. This current trial is centered around four main grounds: Copyright infringement. Getty accuses Stability of using content that Getty owns or has an exclusive license for when training their model, Stable Diffusion, resulting in the generated output containing substantial parts of that content. Getty is also alleging secondary copyright infringement, arguing that Stability is importing an article into the UK

As modern business strategies increasingly embrace sustainability, the influence of ESG principles is reshaping product design, packaging, and brand protection. From label-free bottles to the legal importance of 3D marks in Thailand, these developments highlight the growing connection between environmental responsibility and intellectual property. The Rise of ESG ESG principles have become critical in shaping business strategies worldwide. Companies are increasingly required to disclose ESG data, which influences investor decisions, loans, and consumer behavior. Studies show that consumers are willing to pay more for sustainable packaging, and businesses with strong ESG commitments often achieve higher growth rates. Product Minimization Trend One sector experiencing significant transformation is the consumer product industry, where brands worldwide are adapting their packaging to align with ESG principles. A notable approach is packaging minimization, exemplified by Pepsi’s introduction of its first label-free PET bottle in China in 2022. Similarly, in Thailand, several bottled water brands have embraced label-free designs, including Sprinkle drinking water’s “Redesign to Reduce” initiative and other similar efforts. These shifts not only enhance brand perception but are also warmly welcomed by consumers and business associates alike. For instance, Cathay Pacific has introduced label-free bottled water on select flights and cabins as part of their ongoing commitment to boosting onboard recycling efforts. From Design to Distinctiveness with 3D Marks Packaging has evolved into a critical component of brand identity, blending functionality with distinctiveness to strengthen consumer recognition and loyalty. This shift carries significant implications for intellectual property. Protecting these designs is no longer optional but essential, given their substantial commercial value. Securing legal protection—whether through design rights or three-dimensional (3D) trademarks—has become a strategic necessity. In an era shaped by sustainability and innovation, safeguarding distinctive packaging is not just a precaution but a fundamental step in maintaining competitive advantage and ensuring enduring brand