THAILAND DRAFT AMENDED PATENT ACT : IMPACT ON PHARMACEUTICAL / MEDICAL INVENTIONS

The current Thai Patent Act first came into force on September 12, 1979 (B.E. 2522).  It has been amended several times over the years, with the latest amendments carried out in 1999. Amendment is required due to the advancement of technology, emergence of new technologies and also to improve efficiencies in the handling of the increasing number of patent applications. The Thai Patent Act B.E. 2522 is once again undergoing a major revision. The draft amendments underwent a second public hearing in late 2020.

The new draft Patent Act introduces various changes to procedures relating to the filing and prosecution of patent and petty patent applications in Thailand. This article explores how these changes will impact patent applications, as well as granted patents for pharmaceutical inventions.

Nonpatentable Inventions

Under the current Thai Patent Act, methods of diagnosis, treatment or cure of human or animal diseases are non-patentable inventions. Despite this, a considerable number of applications still contain or are entirely comprised of claims relating to methods of diagnosis, treatment or cures of human or animal diseases, and hence objections are inevitable.

Based on the current draft Patent Act, the scope of non-patentable inventions will be expanded not only to prohibit methods of diagnosis, treatment or cure of human or animal diseases from being patentable, but also to prohibit methods of surgery for treating human and animal disease.  Specifically, Section 9(4) was amended from its original wording of “a method of diagnosis, treatment or cure of human or animal diseases to “a method of diagnosis, treatment and surgery for curing human or animal diseases”. Note here that the wording in the amended Section 9(4) can be interpreted such that the prohibited methods of surgery appears to be limited to methods of surgery for the purposes of curing human or animal diseases. Based on a literal interpretation of the Section, it gives the impression that cosmetic surgery, or plastic surgery for aesthetic purposes, does not fall within this exclusion from protection. However, as a customary practice at the Thai Patent Office, the reading of the Thai Patent Act is often taken together with the Implementing Regulations, Notifications, and Examination Guidelines the features of methods of treatment or cure of human or animal diseases are strictly interpreted under this regime. Thus, according to the local practice and interpretation, features in the claim relating to, for example, administration of a composition to a subject in an effective amount in order to cause a certain effect, including increasing/reducing/inhibiting a particular effect/condition within the subject, are regarded as methods of treatment. Consequently, objections to features not necessarily regarded as a method of treatment such as preventative features or features for the well-being of human or animal are common. It will be interesting to see how the scope of method of surgery will be interpreted after the draft amendment takes effect.

Compulsory Licensing

The current Thai Patent Act includes a provision on compulsory licensing for a patented technology in accordance with the flexibility offered by the TRIPS Agreement. Under this provision, Thailand, between late 2006 and early 2008, made the decision to grant compulsory licenses to a series of patented drugs including efavirenz, lopinavir/ritonavir, clopidogrel, letrozole, docetaxel, erlotinib, and imatinib. Back then, the decision by the Thai government caused quite a controversy with the right holders, as well as the pharmaceutical industry as a whole.

The draft Patent Act, in accordance with the amended TRIPS Agreement, includes additional grounds for issuing compulsory licenses, in particular for pharmaceutical patents. The new grounds for compulsory licensing allows the Thai government, or its agents, to produce and export patented drugs to Least Developed Countries (LDCs) or World Trade Organization (WTO) member states with shortages of supplies of pharmaceutical products, or without the capacity to manufacture needed drugs. Thus, not only can a normal compulsory license be granted to supply domestic use, the government may grant a compulsory license specifically for the production and export of a patented drug to meet the needs of one or more LDCs or WTO member countries. With the current global pandemic of COVID-19, the idea of this additional type of compulsory licensing may one day be inevitable and a major challenge to patent owners.

New Schedule of Official Fees

Official fees related to obtaining patent protection in Thailand are among the cheapest in the region. The draft Patent Act will introduce a new fee structure for official fees. The most notable increase is the official fee for requesting substantive examination.  Under the proposed draft Patent Act, not only the basic official fee for requesting substantive examination will be increased by 40 fold, the draft also introduces an excess claim fee for each claim in excess of 10 claims. As is common in a pharmaceutical invention, the number of claims in most instances far exceeds 10 claims. Therefore, the new fee structure will considerably increase the cost for filing and prosecuting a patent application for pharmaceutical inventions in Thailand.

As mentioned above, the draft Patent Act will be scrutinized by the Office of the Council of State and will be subject to other further legislative procedures. It is not expected to come into force anytime soon.

We will provide further updates as the draft progresses.

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