The draft amendment to the Patent Act (the Draft) was released last week. The Draft was prepared by the Secretary of the Law Reform Commission on Patent and reviewed by the Commission subcommittee but has not yet been finalized. This alert provides a broad overview of some significant changes contemplated in the Draft.
Access to Genetic Resources and Benefit Sharing (ABS)
The Draft contains a new section regarding ABS and includes definitions of "genetic resource," "genetic material," "derivative." and "traditional knowledge." It stipulates that the patent applicant must declare the source of origin of genetic resource or traditional knowledge and submit documents showing a request for permission prior to accessing the genetic resource or the traditional knowledge and agreements on benefit sharing. While the Draft does not currently specify which official or body will be authorized to grant such permission, there will be criminal punishment for any patent applicant who does not comply with these requirements.
The concept above seems to be adopted from "The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization" (the Protocol) under the Convention on Biological Diversity (the CBD). The Protocol is an international treaty to support the implementation of the CBD on the fair and equitable sharing of benefits arising from the utilization of genetic resources. It is worth noting that Thailand became a member of the CBD in 2004 and signed the Protocol in 2012, though it has yet to be ratified.
For traditional knowledge to comply with the ABS standard under the Protocol, it must be traditional knowledge associated with genetic resource. However, the definition of "traditional knowledge" in this Draft is broad, as it refers to cultural expression, practice, or skills of local and indigenous communities that may include, for example, more traditional works of art that are not associated with genetic resources, like textile, pottery, mosaic or woodwork.
Compulsory Licensing for Public Health Needs
Another ground for granting compulsory patent licensing has been added to the Draft, (i.e. in a case where the competition commission has an order that a patent owner has violated any of the trade competition laws and such violation restricts public access to medicine) and provisions on associated remuneration and conditions are addressed. In terms of remuneration, the Draft stipulates, in line with Article 31(h) of TRIPS Agreement, that adequate remuneration in the circumstances of each case shall be allocated by the Ministry of Commerce, taking into account the economic value of the authorization with respect to the license. However, "adequate remuneration" and "economic value" are not clearly defined.
It is of particular significance that the obligation to remunerate rights owners can be waived if a compulsory license is issued for import of patented pharmaceutical products to Thailand where there is a non-existent or insufficient domestic manufacturing capacity to meet public demand and the patent holder already receives remuneration in an exporting country. On a related note, the Draft also includes a new section regarding exportation of patented medicines to less-developed countries or countries that do not have a production capacity. In cases of emergency or for these non-commercial purposes, the Ministry of Commerce does not need to issue a compulsory license prior to export.
The Draft provides a new stage in the Thai patent process, (i.e. a publication of the grant of patent). Currently, Thai patent applications are published only after the preliminary examination (publication of an application) and any person may file an opposition against a patent application within 90 days of the publication of the application (a so called pre-grant opposition). According to the new system proposed in the Draft, the pre-grant opposition is changed to "third-party observation," so any person may challenge the validity of a pending patent application by presenting observations concerning patentability to the examiner following publication of the application. An additional "post-grant opposition" proceeding is proposed, for which the filing deadline is 90 days from the publication of the grant of patent.
Other changes made in an effort to speed up the patent registration process include:
- a patent application will be published within 18 months of the filing date
- the time limit for filing a request for substantive examination is reduced from 5 to 3 years
- the subject matter eligibility determination will be excluded from preliminary examination
The Draft adds surgical methods as patent ineligible subject matter. However, in terms of current practice, surgical methods are already excluded from patentability with respect to the guidelines for patent examination.
Many new sections have been inserted specifically to comply with Patent Cooperation Treaty (PCT) regulations, including those covering things like definitions of "International Search Authority" and "International Preliminary Examining Authorities," qualifications of a PCT applicant, and the restoration of a priority right.
In order to enhance the rights of a patent applicant/patent holder, additional amendments will allow for:
- an applicant to withdraw a patent application at any time up to the grant of such application
- an applicant to voluntarily file a divisional application(s) before publication of the application
- a patent holder to submit a request for a post-grant amendment to correct errors or mistakes, provided that such amendment does not change the subject matter of the invention nor extend the protection conferred by the patent
While the Draft has not yet been finalized and is still subject to a public-hearing process, you can trust that we are watching the process closely. We will of course keep you informed of any important updates on this issue as they become available.