You are using an outdated browser and your browsing experience will not be optimal. Please update to the latest version of Microsoft Edge, Google Chrome or Mozilla Firefox. Install Microsoft Edge

April 14, 2017

IP Linkage: The Thai Government’s Efforts to Connect Agencies

Bangkok Post, Corporate Counsellor Column

On February 24, 2017, Prime Minister Prayut Chan-o-cha spoke to the nation and discussed the 12,000+ patent applications before the Thai Patent Office that are currently being processed and awaiting final decision on whether they will be granted. With Thailand having one of the world’s longest patent pendency periods, the Prime Minister noted that this matter must be addressed urgently.

Currently, local Thai and foreign patent applicants are awaiting the announcement of a government order that is expected to introduce a modified examination process for qualifying applications. This is not the first time the Prime Minister has affirmed the government’s policy to strengthen intellectual property (IP) protection and enforcement in Thailand. 

Just last year, the Suppression of Intellectual Property Infringement Subcommittee was set up to resolve issues related to preventing IP infringement, reduce problems for IP rights holders, increase IP protection in accordance with international standards, and improve Thailand’s image as an IP-friendly country (a particularly important undertaking, as Thailand has been listed on the U.S. Trade Representative’s Priority Watch List for the past nine years for providing insufficient IP protection).

The agencies that are part of the Subcommittee include the Thai Food and Drug Administration (FDA) and 15 other government agencies. Their inclusion in the Subcommittee is a clear indication that the Government has recognized the importance of linkage between intergovernmental agencies whose work touches on IP. The next agency to be added to the Subcommittee should be the Ministry of Agriculture, in order to ensure that agricultural inputs, animal health, and new plant variations are adequately protected.

Intellectual property linkage refers to connecting an IP office, through open communication lines and complementary processes, to other government agencies that work on IP. This generally includes agencies tasked with regulating food, drugs, and agricultural products, in order to ensure not only that there is proper communication between the officials of both agencies, but also that each agency’s regulations are in line with one another, and the agencies do not promulgate conflicting requirements. IP linkage is also useful in suppressing IP infringement, especially when health regulators work closely with IP offices.

On March 8, the Government held a meeting to discuss its plan to clear the longstanding patent backlog. The inclusion of various government agencies and private associations including the FDA, the Department of Intellectual Property (DIP), the National Science and Technology Development Agency (NSTDA), the Pharmaceutical Research and Manufacturers Association (PReMA), the Intellectual Property Association of Thailand (IPAT), Fair Trade Area Watch (FTA Watch), and the Thai Pharmaceutical Manufacturers Association (TPMA) is a clear sign of the government’s intention to connect various interested parties together in order to address Thailand’s patent pendency problem.        

There are many examples of IP linkage around the world. For instance, the National Intellectual Property Rights Coordination Center (IPR Center) in the United States is composed of 23 partner agencies, of which 19 are federal agencies and 4 are foreign agencies (Interpol, Europol, and the Canadian and Mexican governments). The IPR Center is structured as a cohesive task force, in order to allow resources and skills to be pooled and leveraged, and to foster the sharing of information. A similar body has been created in the Philippines.

There is also a patent linkage system in the United States. When filing a New Drug Application with the U.S. FDA, an applicant must list any patents that cover the drug. The U.S. FDA will take these existing patents into consideration when reviewing the application, and if a patent exists, marketing approval will not be granted to a generic applicant unless and until the patent expires or is found invalid.

In the European Union, the EU Agencies Network is comprised of various agencies across EU member states, including the EU Intellectual Property Office. It promotes the sharing of information and expertise among these agencies. While the EU does not have a patent linkage system in place, generic drugs are still not allowed to be placed on the market until an existing patent expires.

Thailand can look to Singapore, its regional neighbor, for guidance on moving forward. After entering into a free trade agreement with the United States, Singapore introduced patent linkage as one of the requirements in an application for marketing approval. This system allows patent owners to monitor for potential infringement before generic drugs are launched by providing a framework that warns a patent owner any time a competitor’s application is submitted to market the same drug.

Thailand has begun to provide linkage between the DIP and the Thai FDA, but the system is in a very undeveloped stage. Since 2008, the Thai FDA has imposed a requirement on all applicants that are applying for a new drug to fill out a form listing all of their existing patents. While this is a step in the right direction, this type of mandatory disclosure should be enforced on applications for generic drugs, as infringement is most likely to occur with such drugs.

The Thai government’s recent efforts to connect the various ministries and agencies whose work touches on IP is an important step in addressing many of the issues long identified as obstacles to further encouragement of Thai innovation and value creation.

RELATED INSIGHTS​ 

May 2, 2025
Attorneys from Tilleke & Gibbins have updated the latest edition of Doing Business in Thailand, a Q&A-style guide from Thomson Reuters Practical Law that offers an overview of key legal considerations for companies operating in jurisdictions worldwide. The contribution outlines the country’s legal and regulatory framework for foreign investment and business operations and reflects the latest legislative developments. The chapter addresses the following core topics: Legal system: Structure of the courts and the codified nature of Thai law. Foreign investment: Business restrictions under the Foreign Business Act, sector-specific regulations, exchange control rules, and investment incentives. Business vehicles: Overview of partnerships, private and public limited companies, and other legal entities. Employment: Labor protections, employment contracts, foreign worker requirements, and termination procedures. Tax: Corporate and personal income tax, indirect taxes, and tax obligations for residents and non-residents. Intellectual property: Registration and enforcement of patents, trademarks, designs, and copyrights. Data protection: Key provisions of the Personal Data Protection Act and related compliance obligations. Competition law: Regulatory framework under the Trade Competition Act. Anti-bribery and corruption: Relevant legislation and enforcement mechanisms. E-commerce and digital business: Legal regime for online transactions and digital platforms. Marketing and advertising: Consumer protection laws and regulations affecting advertising and marketing practices. Product regulation and liability: Safety standards, liability regimes, and roles of enforcement authorities. Practical Law, a legal reference resource from Thomson Reuters, publishes a range of guides for hundreds of jurisdictions and practice areas. The insurance and reinsurance guide is a valuable resource for legal practitioners, covering numerous jurisdictions worldwide. To view the latest version of the guide, please visit the Practical Law website and enroll in the free Practical Law trial to gain full access.
March 7, 2025
On November 22, 2024, the Ministry of Health (MOH) in Laos issued Decision No. 3730/MOH, which regulates the management, processing, production, and use of biopharmaceutical products, genes, and stem cells. This decision came into force on January 18, 2025, 45 days after its publication in the Lao Official Gazette on December 4, 2024. This decision signifies Laos’ recognition and acceptance of biopharmaceutical products, genes, and stem cells for use in medical treatments and the beauty industry, and it aligns with the ongoing development of biomedical sciences in the country. Definitions The MOH’s decision defines biopharmaceuticals, gene therapy, and stem cells as follows: “Biopharmaceutical products” refers to a type of biological or drug product that is produced or synthesized from natural substances, objects, or chemicals. This group of products includes blood, blood components, allergens, cells or cellular components, gene therapies, tissues, protein-based medicines, drugs derived from living cells, and biologics, which can be produced from sugars, proteins, amino acids, or substances with complex characteristics derived from organic sources such as human, animal, and plant parts; yeast; and microorganisms. These products exclude vaccines and biosimilar products, which will be specified under separate regulations. “Gene therapy” refers to a treatment approach that applies the principle of arranging amino acids (which could involve DNA or RNA sent to the patient’s cells in the form of a drug with the purpose of treating a certain disease). “Stem cells” are defined in the decision as cells or immature cells that can be sourced from various organs in the They are characterized by being undifferentiated, having the potential for differentiation, and being self-renewing. Stem Cell Production The decision outlines comprehensive provisions for managing and using raw materials in stem cell production. Key points include: Production location standards: Ensuring facilities meet specific standards of the MOH. Personnel
December 13, 2024
Experts from Tilleke & Gibbins have provided updates for the latest edition of The Pharma Legal Handbook: Vietnam, published by Pharma Boardroom. This comprehensive guide to the legal framework regulating the healthcare and life sciences industries in Vietnam was authored by by the Hanoi-based team of Hien Thi Thu Vu, head of regulatory affairs for Vietnam, and Mai Thi Le, regulatory affairs consultant, the handbook is a must-read for healthcare and life sciences companies that are interested in the Vietnam market. The guide includes eight sections on various important aspects of local regulations: Regulatory, Pricing, and Reimbursement Overview Preclinical & Clinical Trial Requirements Marketing, Manufacturing, Packaging & Labeling, and Advertising Traditional Medicines and Over-the-Counter Products Product Liability Patents and Trademarks Regulatory Reforms Orphan Drugs and Rare Diseases Tilleke & Gibbins has also authored The Pharma Legal Handbook: Thailand, which was updated at the same time as the Vietnam guide. The Pharma Legal Handbook: Vietnam, like all of the country guides from Pharma Boardroom, is available for purchase on the Pharma Boardroom website.
December 13, 2024
Attorneys from Tilleke & Gibbins in Bangkok have provided updates for the latest edition of The Pharma Legal Handbook: Thailand, published by Pharma Boardroom. This comprehensive guide to the legal framework regulating the healthcare and life sciences industries in Thailand was authored by Alan Adcock, partner and director, intellectual property, and head of the firm’s life sciences practice; Dr. Atthachai Homhuan, manager of regulatory affairs; and San Chaithiraphant, senior associate. The handbook is a must-read for healthcare and life sciences companies that are interested in exploring expansion into the Thai market.