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Irene Djalim

Manager, Regulatory Affairs

Biography

Irene Djalim is the manager of the regulatory affairs department in Tilleke & Gibbins’ Jakarta office. With a strong technical background and detailed knowledge of Indonesian intellectual property law, Irene handles prosecution of patent applications in mechanical, chemical, and pharmaceutical fields, in which she helps inventors protect their innovations. She prepares and files applications for patents, petty patents, and industrial design patents, prosecutes the patents until they are granted, and maintains the patents after they are granted. Irene also regularly performs patent searches as well as freedom-to-operate analyses and infringement assessments.

Irene graduated with a degree in chemical engineering from the Georgia Institute of Technology and obtained a Magister Akuntansi from Institut Bisnis dan Informatika Indonesia. Prior to specializing in patent work, she had experience working in a United States government agency and an automotive manufacturing facility in Indonesia. Irene is a registered IP consultant in Indonesia.

Experience

  • Formulated strategic advice for clients on patent filing and prosecution in Indonesia, as well as PCT filing to maximize protection.
  • Provided regulatory advice and assistance with regard to product registration of hazardous substances in Indonesia, and collaborated with the Ministry of Agriculture.
  • Prepared and filed patent, utility model, and industrial design applications.
  • Represented clients in maintaining their patent portfolios through payment of annuity fees and other actions.
  • Provided regulatory advice on product registration of traditional medicine in Indonesia with the Indonesian FDA (BPOM).
ABOUT Irene

Industries

Automotive

Life Sciences

Practices

Intellectual Property

Regulatory Affairs

Location

Languages

    English

    Bahasa Indonesia

Education

    BSChE, Georgia Institute of Technology

    M.Ak, Institut Bisnis dan Informatika Indonesia

Insights

October 1, 2024
The Indonesian food and drug authority, also known as “BPOM,” issued a draft regulation on September 9, 2024, proposing standard labeling disclosing the sugar, salt, and fat content of packaged food products sold in the country. The draft Regulation on Nutritional Value Information on Food Labels to implement Government Regulation No. 28 of 2024 on the Implementation of the Health Law seeks to mandate “Nutri-Level” front-of-pack nutrition labeling to indicate the amount of sugar, salt, and fat at four possible levels, with a modified stoplight-color system: Level “A” (lowest amount) has a dark green background Level “B” has a light green background Level “C” has a yellow background Level “D” (highest amount) has a red background These levels are shown in the following sample image: The requirements for sugar, salt, and fat content for each level are based on amounts per 100 milliliters of ready-to-eat processed food as follows: Further requirements relating to nutrients reflected in the Nutri-Level labeling include: Foods labeled as level A are not allowed to contain natural or artificial sweetening food additives, either through direct addition or carried over from other ingredients. Foods labeled as level B may only contain natural sweetening food additives. Foods labeled as level C or D may use natural and artificial sweetening food additives. “Sugar” includes all monosaccharides and disaccharides, excluding lactose. Processed plain liquid milk and plain milk powder are exempt from the requirement to declare total fat content on the Nutri-Level label. Labeling Implementation The implementation of Nutri-Level labeling must comply with the following requirements: The Nutri-Level label must list all four letters (as shown in the examples below) unless the package meets the criteria for display of a simplified format label. The Nutri-Level of the processed food must be indicated by enlarging the relevant letter, as shown
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September 6, 2024
Addressing technical barriers to trade is a key priority for the Association of Southeast Asian Nations (ASEAN) as part of trade facilitation in achieving the single market and production base under the ASEAN Economic Community directive agreed in 2015. The region has been undertaking positive steps toward standard harmonization in ASEAN priority sectors, integrating and bringing about regulatory convergence by taking into account the diversities that exist in the ten ASEAN member states. Health supplements in ASEAN are under the responsibility of the Traditional Medicine and Health Supplement Product Working Group (TMHS PWG). One of the TMHS PWG’s outputs is the ASEAN Agreement on a Regulatory Framework for Health Supplements, which includes various technical requirements for health supplements that participating member states must adopt by adjusting their domestic regulations. The key ingredients of these health supplements are vitamins and minerals. While all ASEAN countries allow the use of vitamins and minerals in health supplements, the amounts allowed for use vary, depending on the nutritional requirements deemed appropriate by each country. Partly in response to these efforts for regional harmonization, there have been important changes to vitamin and mineral limits in certain ASEAN countries that are worth monitoring. Some of these are outlined below. Thailand In January 2024, the Thai Food and Drug Administration (TFDA) updated the Thai Recommended Daily Intake (Thai RDI) guidelines for the Thai population. Subsequently, the TFDA adjusted the vitamin and mineral limits in order to comply with the updated Thai RDI and to follow the ASEAN Agreement on a Regulatory Framework for Health Supplements. The TFDA’s adjustment of vitamin and mineral limits for use in food supplements came in Notification of the Ministry of Public Health (No. 448) B.E. 2566 (2023) Re: Food Supplements (No. 5), which was published in the Government Gazette on January
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September 4, 2024
Government Regulation No. 28 of 2024 (“GR No. 28”) was issued on July 26, 2024, to implement Law No. 17 of 2023 on Health (the “Omnibus Health Law”). GR No. 28 contains extensive provisions on tobacco products and electronic cigarettes in an effort to reduce the health risks associated with addictive substances, decrease the prevalence of smokers, and prevent the initiation of smoking among beginners in Indonesia. The Indonesian FDA (known as “BPOM”) is working to implement the relevant provisions in GR No. 28 and has subsequently issued a draft regulation on the control and distribution of tobacco products and electronic cigarettes. This draft regulation is set to replace current BPOM Regulation No. 41 of 2013, which only covered tobacco products. The new draft regulation, however, also incorporates rules on electronic cigarettes. This article outlines some of the measures on electronic cigarettes contained in GR No. 28 and the draft implementing regulation, focusing particularly on testing and reporting requirements, sale and pack size requirements, and labeling and advertising requirements. Testing and Reporting The draft regulation requires that each variant of electronic cigarettes produced or imported be tested for nicotine content. These tests must be conducted in an accredited laboratory, and the results must be reported to BPOM. The use of additive materials is prohibited unless they have been proven safe for public health. To enforce this, electronic cigarettes must be tested for the presence of prohibited additives before they are distributed. Additionally, a verification of the content of prohibited additives must be conducted during the distribution period, with the testing and verification being carried out in different laboratories. The results of both tests (i.e., the pre-distribution test and the subsequent verification) must be reported to BPOM. Sale and Pack Size GR No. 28 prohibits the sale of electronic cigarettes:
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June 11, 2024
Advances in biotechnology have enabled the development of a range of new agricultural tools. From DNA sequencing to plant tissue culture and gene editing, these advances are facilitating the development of better crops. Genetically modified organisms (GMOs) are one well-known example of agricultural biotechnology. GMOs are organisms whose genetic material has been artificially altered by inserting a piece of foreign DNA. This DNA may be synthetic in origin or sourced from other organisms. Genome editing (also called gene editing or GEd) involves making precise changes to an organism’s genome without the integration of foreign DNA elements. Several approaches to genome editing have been developed. A well-known one is called CRISPR-Cas9, in which scientists make precise “cuts” in the DNA to create a new genetic variation. Unlike with GMOs, this introduces only minor modifications that are indistinguishable from natural mutations, typically by transplanting genes that code desirable traits from one species into another. GEd technology has been recognized and supported by the Food and Agriculture Organization of the United Nations (FAO). Thirteen FAO-member countries who are also members of the Organization for Economic Cooperation and Development (OECD) announced their support of the use of GEd technology for commercial uses and consumption at a recent WTO meeting. In addition, over 40 countries around the world, such as Argentina, Australia, Brazil, Canada, Chile, China, England, Japan, Kenya, the Philippines, Russia, the UK, and the US, have published policies emphasizing that foods free of transgenes (i.e., foods that do not contain genes transferred from external sources) are not GMOs, concluding that GEd plants are as safe as normal plants. In February 2024, the European Parliament approved new genomic techniques (NGTs), or GEd. As a result, plants that are produced using GEd technology are not classified by the EU as GMOs, and the EU
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Awards & Rankings

October 31, 2024
Tilleke & Gibbins has been recognized as the Medical and Healthcare Firm of the Year at the 11th Annual Asian Legal Business (ALB) Indonesia Law Awards, held on October 24, 2024, at the Pullman Jakarta Indonesia Thamrin. This award celebrates Tilleke & Gibbins’ strength in serving life sciences clients in Indonesia, and is the firm’s first win in the ALB Indonesia Law awards. The ALB Indonesia Law Awards honor exceptional work from private practitioners and in-house teams across Indonesia and the region, celebrating excellence in legal practice and innovation. For more information on the awards, and to browse a full list of the winners, please see the ALB website.
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September 13, 2024
The 2024 edition of the IFLR1000 Asia-Pacific rankings, released by International Financial Law Review (IFLR), highlights Tilleke & Gibbins’ continued excellence in financial and corporate transactional work. The firm has retained its strong rankings across multiple jurisdictions and practice areas, reaffirming its position as a leading firm in the Asia-Pacific region. This year, Tilleke & Gibbins received firmwide rankings in key jurisdictions, including: Thailand Banking & Finance – Tier 3 Capital Markets: Debt – Tier 3 Capital Markets: Equity – Tier 3 M&A – Tier 2 Project Development – Tier 2 Restructuring & Insolvency – Tier 3 Vietnam Banking & Finance – Other Notable M&A – Tier 3 Project Development – Tier 3 Cambodia Financial & Corporate – Tier 2 Project Development – Tier 2 Laos Financial & Corporate – Tier 2 In addition to these firmwide rankings, Tilleke & Gibbins had several standout individual recognitions, with 10 lawyers honored in the 2024 individual rankings, including new entries for John Frangos, Niti Muangkote, Santhapat Periera, and Tram Ngoc Bich Nguyen. The full list is as follows: Charunun Sathitsuksomboon – Highly Regarded, M&A, Thailand Charuwan Charoonchitsathian – Rising Star, M&A, Thailand David Mol – Rising Star, Corporate and M&A, Cambodia Jay Cohen – Highly Regarded, Banking, Cambodia John Frangos – Notable Practitioner, Restructuring & Insolvency, Thailand (new ranking) Niti Muangkote – Rising Star, Financial & Corporate, Laos; Highly Regarded, Banking & Finance, Thailand (new ranking) Saithong Rattana – Notable Practitioner, Project Development and M&A, Laos Santhapat Periera – Highly Regarded, Banking, M&A, Laos; Highly Regarded, Banking & Finance, Thailand (new ranking) Supasit Boonsanong – Highly Regarded, Project Development, Thailand Tram Ngoc Bich Nguyen – Highly Regarded, M&A, Vietnam (new ranking) To see the full set of IFLR1000 rankings for Tilleke & Gibbins’ jurisdictions, please see the Cambodia, Laos, Thailand, and
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September 12, 2024
Tilleke & Gibbins has once again secured impressive rankings in the recently released Asialaw 2024 rankings. The firm has maintained its position as a top legal service provider across multiple jurisdictions, earning a total of 39 rankings in practice and industry groups, 19 of which are in the highest tiers. The firm’s performance continues to reflect its exceptional client service and legal expertise across Southeast Asia. Tilleke & Gibbins is recognized in all available categories for Cambodia, Laos, and Thailand, demonstrating the firm’s strong presence across the region. In the individual rankings, 22 of the firm’s practitioners have been recognized, including three notable promotions and three new entries: Charunun Sathitsuksomboon (Thailand), newly ranked as a Notable Practitioner for Corporate and M&A. Linh Thi Mai Nguyen (Vietnam), promoted to Distinguished Practitioner for Intellectual Property. Loc Xuan Le (Vietnam), promoted to Elite Practitioner for Intellectual Property. Niti Muangkote (Laos), a new entry as a Rising Star for Banking and Finance. Prisna Sungwanna (Laos), newly ranked as a Distinguished Practitioner for Corporate and M&A and Banking & Finance. Suebsiri Taweepon (Thailand), promoted to Distinguished Practitioner for Intellectual Property and Technology and Telecommunications. Client feedback remains a key component of the Asialaw rankings, with Tilleke & Gibbins earning high praise for its responsiveness and commercial awareness. The firm’s sector-specific knowledge also continues to stand out, with clients expressing their appreciation of the firm’s understanding of their businesses’ operational contexts. For more details and to browse the full rankings, please visit the Asialaw website.
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July 19, 2024
Tilleke & Gibbins has been shortlisted for six awards at the Asialaw Awards 2024. The nominations highlight the firm’s outstanding performance and leadership in Southeast Asia’s legal landscape. The firm has received the following nominations: Regional Corporate/M&A Firm of the Year Cambodia Firm of the Year Laos Firm of the Year Thailand Firm of the Year In addition to the firm nominations, two individuals from Tilleke & Gibbins have been recognized for their exceptional contributions: Prisna Sungwanna – Laos Female Lawyer of the Year Charunun Sathitsuksomboon – Thailand Female Lawyer of the Year The Asialaw Awards celebrate the leading law firms and legal professionals across the region, recognizing excellence in practice and service. The winners will be announced at a ceremony in Kuala Lumpur, Malaysia, on September 26. For more information on the Asialaw Awards 2024 and to browse a full list of the winners, please visit the Asialaw website.
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