To view this article in Vietnamese, please click here. In accordance with Article 59.2 of the Law on Intellectual Property issued in 2005, as amended and supplemented in 2009 and 2019 (“IP Law”), Vietnamese law currently does not recognize the protection of computer programs as inventions. However, in practice, if the subject-matter of an invention related to a computer program has technical characteristics and the program, when running on a computer, creates a further technical effect going beyond the usual physical interactions between a program and a computer, this subject-matter is likely to be protected as an invention. This condition is not codified, but is reflected in Article 5.8.2.5 of the patent examination guidelines issued in 2010, as amended and supplemented in 2020 – a reference document showing the guidance issued by the Intellectual Property Office of Vietnam (“IP Office”). Currently, at the formality examination stage, these “technical” conditions for inventions related to computer programs are quite easy to meet as it is only necessary to show that the subject-matter is a “Method performed by a computer for a purpose …”, “Processing apparatus…”, or “Computer-readable storage medium storing a program to perform the method…”. In the substantive examination stage, however, the “technical” condition is further scrutinized through the assessment of technical features stated in the subject-matter to determine whether the interaction between the program and the computer creates a further technical effect. The IP Office often issues office actions on substantive examination results because the computer-related patent application does not solve any technical problem and does not produce a further technical effect going beyond the normal interactions between the program and the computer. On December 31, 2021, the IP Office added to the patent examination guidelines mentioned above by issuing an annex with specific guidelines for examining patent applications relating to computer programs. The annex provides detailed guidance on assessing “technicality” in both the formality and substantive examination stages, gives some examples of further technical effects, and outlines several types of subject-matters related to computer programs. Below are some interesting examples of further technical effects that a program can produce when running on a computer. Example 1: In addition to a subject-matter related to a computer program being executed by a computer, a corresponding computer program that executes features of the subject-matter will produce a further technical effect when running on the computer. For example, a computer program to implement the method of controlling an anti-lock braking system (ABS) on a car, or determine emissions by X-ray equipment. Example 2: If a computer program is designed on the basis of specific technical considerations about the internal operations of the computer on which the program is run, such as the program being adapted to a particular computer architecture, it can be seen as producing a further technical effect. For example, the computer program controlling an execution of a function or an internal operation of the computer, such as balancing a processor’s load or allocating memory, often produces a further technical effect. Example 3: Programs for low-level code processing, such as generators or compilers, are likely technical. However, a computer program for a non-technical purpose that requires less computation time than a known program for the same purpose will not produce a further technical effect. A subject-matter related to a computer program cannot be considered technical only because the computer program is designed so that it can be performed automatically by the computer. Specific Guidelines for Subject-Matter Types The last section of the annex provides an analysis of 10 types of subject-matters related to computer programs, explaining whether and when they can be protected. These types include those in which computer programs implement features related to: (i) mathematical methods; (ii) artificial intelligence and machine learning; (iii) simulation, design, or modeling; (iv) diagrams, rules, and methods of playing games; (v) business methods; (vi) information modeling, programming operations, and programming languages; (vii) data retrieval, formats, and structures; (viii) database management and information retrieval systems; (ix) information display; and (x) user interfaces. The guidelines for three of these are summarized below: Artificial Intelligence and Machine Learning Artificial intelligence and machine learning rely on computational models and algorithms with an inherently abstract mathematical nature. However, there are still cases in which subject-matters related to artificial intelligence and machine learning can be protected as inventions in Vietnam, for example. “1. Computer-readable storage medium comprising a computer program that powers the computer to output quantitative values of the reputation of a hotel based on textual data about the reputation of the hotel, in which: this program consists of the first neural network and the second neural network connected in such a way that the second neural network receives the output from the first neural network mentioned above; The first neural network mentioned above includes… weights of the second neural network above…; and program causes the computer to do…” In this subject-matter, the purpose of “output[ting] quantitative values of the reputation of a hotel” can be considered to be non-technical, for business purposes. However, the features in the claims identify a particular technical embodiment that goes beyond aspects of a mere business method. Therefore, from the aspect of pre-processing training data for machine learning, these features are considered to serve a technical purpose, and contribute to the technical characteristic of the present invention. Therefore, the above subject-matter can be protected as an invention. Information Modeling, Programming Operations, and Programming Languages Information modeling is a mental activity being considered non-technically. However, if an information model is intended to be used in the context of an invention to solve a particular technical problem, it may contribute to a technical characteristic of the invention. Features that determine how the model is actually stored (using relational database technology, for example) can also contribute technically. In a visual programming environment, providing specific graphical building blocks is a part of the programming language and makes no technical contribution if the only effect is to reduce the mental effort of the programmer. Providing specific programming

New technologies and production processes in the food industry have led to novel foods becoming increasingly important to both food manufacturers and the consuming public worldwide. This is very much the case across a number of jurisdictions in Southeast Asia. “Novel foods” refer to new food production processes, foods, and ingredients that have not yet been commonly used for human consumption, so these innovative foods require safety assessments before companies can produce and market them. While rules for these safety assessments are already part of novel food regulations in several other jurisdictions—such as the novel food regulations in the United Kingdom and European Union adopted in 2003, and the major reform of food safety laws in the United States passed in 2011 under the Food Modernization Act—similar rules governing the assessment of novel foods are relatively new or yet to be introduced in many parts of Asia. Nevertheless, it is important to understand the laws and practices that apply to safety assessments and the process of bringing novel foods to market in jurisdictions in the region. This article provides some clarity in this regard by summarizing important practical information on novel foods and the relevant required safety assessments in Indonesia, Thailand, and Vietnam.   Indonesia Regulator National Agency for Drug and Food Control (NADFC); frequently referred to as BPOM (Badan Pengawas Obat dan Makanan). Relevant Measures BPOM Regulation No. 27 Year 2018 concerning Public Service Standards in BPOM; Decision of the Director of Processed Food Standardization No. HK.02.02.51.511.06.21.21 Year 2021 concerning Public Service Standard Directorate Processed Food Standardization Definitions General “food ingredients” are basic fresh or processed ingredients that can be used to produce food; novel food is any food ingredient not listed in BPOM’s positive list of ingredients. Official Fees None   Process and Timeline Before submitting an application for novel food safety assessment, the applicant or a representative should first consult with BPOM’s Directorate of Processed Food Standardization. This consultation can help the applicant identify the data requirements for submission. For obtaining approval of novel foods, applicants must submit the required items through the directorate’s online submission system. BPOM will then check the application to verify its completeness, and will contact the applicant within five working days either to confirm that the submission is complete or to direct the applicant to rectify any shortcomings. Once all requirements have been fulfilled, BPOM is to assess the application within 85 working days—or around 4–6 months in practice.   Required Documents The application requirements differ depending on the category of novel food. There are two main categories: Novel food substances, mixtures of substances, mixtures of food ingredients, or other ingredients Novel foods sourced from plants or animals Ingredient name(s) Ingredient specification Physicochemical properties Composition Production process Certificate of analysis Toxicity data Potential allergenicity Regulation or distribution in other countries Name of type of processed food (final food product) Purpose of adding ingredients Amount of ingredients added Composition of processed food Processed food production process Use or application of processed food Suggested consumption (if any) Ingredient name(s) Parts of plant or animal used Chemical and/or nutritional content of ingredients Ingredient specifications and composition Production process Certificate of analysis History of use as food Toxicity data Potential allergenicity Regulation or distribution in other countries Name of type of processed food (final food product) Purpose of adding ingredients Amount of ingredients added Composition of processed food Processed food production process Use or application of processed food Suggested consumption (if any) Thailand Regulator Food and Drug Administration (FDA) Relevant Measures Notification of the Ministry of Public Health (No. 376) B.E. 2559 (2016) Re: Novel Food Definitions “Novel food” is any substance used as food or food ingredients that either has been used widely for human consumption for less than 15 years based on scientific or reliable evidence, or has undergone a production process not currently used, where that process gives rise to significant changes in the composition or structure of the food that affect their nutritional value, metabolism, or level of undesirable substance Official Fees THB 3,000 (approx. USD 90)   Process and Timeline Seeking approval for novel foods consists of two stages. Novel food safety assessment registration In this stage, the applicant submits safety data to one of four safety assessment organizations accepted by the FDA. The maximum or estimated duration of this step depends on the organization: Bureau of Quality and Safety of Food, Ministry of Public Health – 95 business days; National Food Institute, Ministry of Industry – 93 business days Thailand Risk Assessment Center (TRAC), Mahidol University – 90 business days National Center for Genetic Engineering and Biotechnology (BIOTEC) – 7–12 months Novel foods that contain any ingredient derived from a genetically modified organism (GMO) must undergo a BIOTEC review. Novel food safety assessment registration considered by the FDA To apply for the FDA’s approval of a novel food, the applicant must submit the letter from the safety assessment organization, along with other relevant documents, to the FDA via their online system. The FDA will consider the application and make a determination within 40 business days.   Required Documents General product and ingredient information Information on history of consumption as food Finished product and ingredient specifications Certificate of analysis Storage Production process, synthesis, or extraction method Basic information on chemical substances used in production Characteristics and recommendations for consumption Safety information, usually including three toxicology studies: 90-day subchronic toxicity study using rats Test for induction of gene mutations in bacteria (Ames Test, OECD Guidelines 471) In vitro assay to detect chromosomal aberrations (OECD Guideline 473), in vitro micronucleus assay (OECD Guidelines 487), or mouse lymphoma TK assay with colony sizing (OECD Guidelines 476) Nutritional data Results of safety assessments by international agencies or recognized countries.   Vietnam Regulator Vietnam Food Administration (VFA) Relevant Measures No specific regulations or guidance on novel foods and ingredients; however, both imported and domestically produced food products must comply with the Law on Food Safety as well as the following measures on genetically modified organisms

Attorneys from Tilleke & Gibbins’ offices in Vietnam have contributed the Vietnam chapter to Pharmaceutical Advertising 2022 from Chambers & Partners. Pharmaceutical Advertising 2022—the fifth annual edition of this practice guide—provides information on pharmaceutical advertising regulations in 18 jurisdictions around the world. The guidance is especially useful for pharmaceutical manufacturers looking to share their products and innovations with the public in a responsible, transparent way that is compliant with local laws. The Vietnam chapter specifically the following topics: Regulatory Framework for pharmaceutical advertising Scope of advertising and general principles Advertising of unauthorized medicines or unauthorized indications Advertising pharmaceuticals to the general public Advertising to healthcare professionals Vetting requirements and internal verification compliance Advertising of medicinal products on the internet Inducement and antibribery Gifts, hospitality, congresses and related payments Transparency considerations for pharmaceutical companies Enforcement of pharmaceutical advertising rules Tilleke & Gibbins also provided the Thailand chapter to this guide. Chambers & Partners’ Global Practice Guides provide in-house counsel with expert legal commentary focusing on practical legal issues affecting business, and enable readers to compare legislation and relevant procedures across a range of key jurisdictions. The full Pharmaceutical Advertising 2022 guide—including the Vietnam chapter—is available for free on the Chambers and Partners website. The Vietnam chapter is also available as a PDF through the button below.

Intellectual property experts from Tilleke & Gibbins were engaged by ARISE+ IPR, a regional support program funded by the European Union and implemented by the European Intellectual Property Office, to craft a series of IP enforcement guides for Southeast Asian countries, aimed at raising local awareness of the importance of IP protection. The five-year, EUR 5.5 million ARISE+ IPR program supports regional integration through IP cooperation and aims to upgrade national IP systems for creation, protection, utilization, administration, and enforcement to be in line with international best practices and standards and the strategic objectives of the ASEAN Intellectual Property Rights Action Plan 2016-2025. The guides were developed by Tilleke & Gibbins’ lawyers in cooperation with the IP offices of each participating country, and cover issues related to trademarks, industrial designs, and geographical indications. Each guide was produced in a compact leaflet form in English as well as the local language, and is considered an official publication of the respective national IP office. The guides can be accessed from the ARISE+ IPR site (under “Leaflets, brochures and booklets”), or by clicking on the links below: Cambodia: English | Khmer Indonesia: English | Bahasa Indonesia Thailand: English | Thai Vietnam: English | Vietnamese