The draft amendment to the Drug Act (Draft) was recently released by the Office of the Council of State (Krisdika) via its website. The Draft was prepared by the Ministry of Public Health, reviewed by relevant government agencies as stipulated by Cabinet Resolution. As the current Drug Act was enacted in 1967, the amendment is intended to bring the law up to date, increase the efficiency of the drug approval process in Thailand, and support Thailand's strategic position as Asia’s medical hub as part of the broader Thailand 4.0 initiative. Public hearing on the Draft recently ended on 12 December 2018.
One proposed addition to Section 80 of the Draft is that a new drug or a new traditional drug applicant would be required to include documents showing patent/petty patent rights (Patent Information) or rights related to traditional Thai medicinal wisdom for regulatory approval of a drug. This proposed addition is not an entirely new concept, as over the past several years the Thai Food and Drug Administration had already been asking new drug applicants to provide Patent Information during the regulatory approval process. In effect, the Section 80 addition simply formalizes what is already an unofficial step, but may ultimately lead to the establishment of a patent linkage system.
There has been ongoing speculation as to whether the Drug Act will ultimately adopt patent linkage, and opinions vary greatly. Some continue to suggest broader patent linkage concepts could be adopted in future amendments.
In general, one of the primary purposes of a patent linkage system as implemented in other jurisdictions is to promote effective and adequate protection of intellectual property rights, as generic drug approval is linked to the expiration and validity of the pioneer drug patent. Therefore, a patent linkage system could be used to avoid (or resolve) patent infringement disputes at early stages. In countries where patent linkage exists, local health authorities will consider the existence of patents as part of the approval process when reviewing a drug registration application, and an approval will be granted to a generic drug applicant only if a patent is not enforceable (i.e. the patent has expired or is declared invalid by the court). Thus, a patent linkage system also prevents regulatory bodies from facilitating patent infringement via administrative actions.
While this current Draft comes short of providing a standard patent linkage system, it is a step in the right direction which will still confer some benefits to patent holders once implemented.
There is currently no clear timeline for passage of the updated Draft, and further amendment is possible. We will provide updates on future developments as they occur. In the meantime, should you have any questions about patent linkage, please contact the authors.