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.