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​ 

December 12, 2024
On November 21, 2024, the National Assembly of Vietnam adopted a law amending and supplementing the 2016 Law on Pharmacy (“Amended Law on Pharmacy”). The Amended Law on Pharmacy simplifies some procedures for the pharmaceutical field, and will take effect on July 1, 2025, except for regulations on drug registration and rights and responsibilities of certain types of pharmaceutical business. Some outstanding points in the Amended Law on Pharmacy are presented below. E-commerce Distribution The Amended Law on Pharmacy allows trading in pharmaceutical products by the e-commerce channel, including e-commerce trading floors, e-commerce sales applications, and e-commerce sales websites with online ordering functions. Accordingly, e-commerce retail of non-prescription drugs is permitted if the drugs are neither specially controlled drugs nor drugs included in the list of drugs restricted for retail sale, and e-commerce wholesale of drugs and drug materials is permitted, as long as they are not specially controlled drugs. New Rights for Import FIEs The amendment provides some additional rights to foreign-invested enterprises (“FIEs”) that import drugs, including the rights to: Repurchase drugs and drug materials manufactured through the technology transfer of the FIE itself in Vietnam, and sell such products to wholesalers; Import drug materials to supply to drug manufacturers in Vietnam that are hired by or receive technology transfer from the FIE itself under a processing contract or technology transfer contract; Deliver and transport drugs and drug materials the FIE has imported, outsourced for processing, or transferred technology for in Vietnam, from the FIE’s warehouse to its wholesalers; Deliver and transport drugs used in aid, sponsorship, humanitarian, and disease prevention and control programs to medical facilities receiving funding; and Transport drug materials imported by the FIE from its warehouse to drug manufacturers that are hired by or receive technology transfer from the FIE itself under a
December 9, 2024
Cambodia’s Law on Seed Management and Plant Breeder’s Rights was enacted in 2008, but it was not until recently that new plant varieties could successfully be registered for protection in the country. Although the law has been in place for some time, recent developments confirmed the application process and a schedule of charges for the registration of new plant varieties. With these developments, breeders have been able to register their new plant varieties in Cambodia since March 1, 2024. Applicants for new plant variety protection must be Cambodian nationals, foreign nationals domiciled in Cambodia, or permanent residents of either a country that is a contracting party to the International Union for the Protection of New Varieties of Plants (UPOV) Convention or a country with which Cambodia has signed a memorandum of understanding on plant variety protection. Applicants can also claim a priority date from the first application for the same plant variety filed in any contracting party of the UPOV Convention within 12 months of the earliest application’s filing date. To be eligible for protection, new plant varieties must satisfy the following criteria: Novelty: A variety is considered “new” if, at the date of filing the application for new plant variety protection, it has not been sold, marketed, or otherwise disposed of others—by or with the consent of the breeder—for more than: One year for any plant variety in Cambodia; Six years for trees and vines or four years for all other plant varieties in countries besides Cambodia. Distinctiveness: A variety must be clearly distinguishable from any other existing varieties. Uniformity: A variety must be sufficiently uniform in its relevant characteristics. Stability: A variety must remain unchanged in its essential characteristics at the end of each cycle of propagation and in each generation. The last three criteria are often
December 4, 2024
On October 28, 2024, Indonesia officially amended its existing Patent Law when the president ratified Law Number 65 of 2024. This comprehensive update—the third such amendment in the history of Indonesia’s Patent Law—introduces several key changes that will significantly impact patent protection and application processes in Indonesia. Key highlights and changes are outlined below. Definition of Invention The new law broadens the definition of “invention” to explicitly include systems, methods, and uses. Additionally, the law introduces formal definitions for traditional knowledge and genetic resources. Patentability Criteria Notable changes include: Computer programs are now excluded, with an exception for computer-implemented inventions. Theories and methods in science and mathematics are added to the list of excluded inventions. Previous restrictions on new uses of existing products are removed. Grace Periods The grace periods for some patent-related actions have been adjusted: The grace period for disclosures has been extended to 12 months (from 6 months previously), providing inventors with more flexibility in filing patent applications after initial disclosure. A newly introduced item is the grace period for a conventional patent application claiming priority rights, which is 4 months after the 12-month filing deadline under the Paris Convention. The grace period for annuity payments is 6 months (from 12 months previously) with a fine for late payments of 100% of the annual fee payable. Patent Holder Rights and Obligations Patent holders can now grant permissions to enforce patents. There is a new requirement for patent holders to submit annual statements on patent implementation in Indonesia. Compulsory Licensing Significant changes to compulsory licensing include: Establishment of licenses based on the principle of expediency. Limitations on license scope and transferability. Prioritization of domestic market needs. New provisions for technical improvements and economic significance. Government Patent Exploitation The new law contains specific provisions for the government’s implementation
December 4, 2024
Thailand Legal Basics, a valuable primer for foreign investors, explores all aspects of living and doing business in Thailand. Written by specialists at Tilleke & Gibbins in Bangkok, it is the only comprehensive English-language guide to the Thai legal system with a focus on the concerns of foreign business and investment.