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​ 

July 4, 2023
Practitioners from Tilleke & Gibbins’ Vietnam offices contributed content for the latest edition of the Practical Law Life Sciences Global Guide. The guide provides a comparative overview, in Q&A format, of laws and regulations on pharmaceuticals, medical devices, and other life sciences products in dozens of jurisdictions around the world. The Life Sciences Global Guide is divided into two sections: Regulation (see more details here) and Commercialization, which covers the following topics: Overview of the life sciences sector Pricing, government funding, and reimbursement: National health care system, price regulation and reimbursement Distribution and sale Cross-border trade and parallel imports Advertising to the public and engagement with patient organizations Advertising to healthcare professionals and organizations: Gifts and incentives and transparency and disclosure Patents: Conditions for patentability, registration, length of protection, infringement, international treaties Trademarks: Requirements, registration Competition law issues: Authorities and legislation, commercial contracts and competition law, licensing approvals and formalities Product liability: Regulators, medicinal product liability law, liable partners, defenses, product liability claims, remedies Practical Law, produced by Thomson Reuters, is the world’s leading legal know-how resource for business lawyers, publishing a huge range of guides covering hundreds of jurisdictions and practice areas. The full “Life Sciences Commercialization in Vietnam” section can be found on the Practical Law website.
July 4, 2023
Practitioners from Tilleke & Gibbins’ Vietnam offices contributed content for the latest edition of the Practical Law Life Sciences Global Guide. The guide provides a comparative overview, in Q&A format, of laws and regulations on pharmaceuticals, medical devices, and other life sciences products in dozens of jurisdictions around the world. The Life Sciences Global Guide is divided into two sections: Commercialization (see more details here) and Regulation, which covers the following topics: Pharmaceuticals: Laws and regulatory authorities Clinical trials: Legal, regulatory, and procedural requirements Manufacturing and distribution Marketing: Authorization for marketing medicinal products, monitoring compliance and penalties, pharmacovigilance and other commitments, foreign marketing authorizations Data privacy Packaging, labeling, and tracking Biological medicines Medical devices: Legislation and regulatory authorities, definition and classification Healthcare IT Combination products and borderlines Natural health products Recent developments and reform proposals Practical Law, produced by Thomson Reuters, is the world’s leading legal know-how resource for business lawyers, publishing a huge range of guides covering hundreds of jurisdictions and practice areas. The full “Life Sciences Regulation in Vietnam” section can be found on the Practical Law website.
June 1, 2023
Life sciences specialists from Tilleke & Gibbins have supplied the Thailand and Vietnam contributions to the International Bar Association (IBA) Healthcare and Life Sciences Law Committee’s global telemedicine survey. The survey, spanning 54 jurisdictions worldwide, functions as a comparative legal guide on the provision of telemedicine and related products and services. It offers practitioners and industry users access to relevant rules and regulations, addressing key aspects such as regulation, data privacy, liability, and recent developments in telemedicine. Telemedicine has emerged as a transformative force in healthcare, revolutionizing the way medical services are accessed and delivered. As in many other jurisdictions, telemedicine has gained prevalence in Thailand and Vietnam, as it enables patients to remotely consult with healthcare professionals, access diagnostic services, and receive timely medical advice while minimizing physical contact. As the global healthcare landscape continues to evolve, understanding the legal and regulatory aspects of telemedicine becomes paramount, making initiatives like the IBA’s telemedicine survey vital for practitioners and industry stakeholders. The IBA is a globally recognized organization that brings together legal professionals and bar associations from around the world, and its Healthcare and Life Sciences Law Committee plays a crucial role in addressing legal issues and developments in the healthcare industry. The complete surveys for Thailand and Vietnam­—and the 52 other participating jurisdictions—are available on the IBA website.
May 23, 2023
Life sciences specialists at Tilleke & Gibbins’ office in Bangkok have contributed a new “Life Sciences Commercialization in Thailand” chapter to the Life Sciences Global Guide from Practical Law. The Q&A-style guide provides strategic information for companies active in the life sciences sector in Thailand. The chapter covers a number of key areas: Overview of the life sciences sector Pricing, government funding, and reimbursement: National health care system, price regulation and reimbursement Distribution and sale Cross-border trade and parallel imports Advertising and engagement with patient organizations Patents: Conditions for patentability, registration, length of protection, infringement, international treaties Trademarks: Requirements, registration Competition law issues: Authorities and legislation, commercial contracts and competition law, licensing approvals and formalities Product liability: Regulators, medicinal product liability law, liable partners, defenses, product liability claims, remedies Practical Law, produced by Thomson Reuters, is the world’s leading legal know-how resource for business lawyers, publishing a huge range of guides covering hundreds of jurisdictions and practice areas. The full “Life Sciences Commercialization in Thailand” section can be found on the Practical Law website.