by Kamonphan Minjoy, Chanida Chantarakunpongsa and Saowanee Leewijitsin
This is the second article of a three-part series on regulation and patentability of cannabis and cannabis-related compounds in three ASEAN countries, namely Singapore, Thailand and Malaysia by Yusarn Audrey which has operations in these countries.
Read the first article here.
As mentioned in the first article of the three-part series, cannabis has become a hot topic since Canada announced the legalization of cannabis last year. The world is watching who would be the next to follow this trend. This article seeks to explore the regulation and patentability of cannabis and cannabis-related compounds in Thailand with the aim of educating academics, entrepreneurs and industry professionals.
A Bittersweet View of Cannabis – The Thailand Perspective
Issue 1: Regulation of Cannabis and Cannabis-related Products
On 25 December 2018, Thailand legalized the use of cannabis for medicinal purposes and research at the National Legislative Assembly. Consequently, Thailand became the first country in Southeast Asia to legalize medical use of cannabis1.
Cannabis has been used for centuries for recreation and/or medicinal purposes in Thailand. There is evidence showing that cannabis was included in Thai traditional medicine formulations in late 2100 B.E (1557 AD). In particular, it is referred to in an ancient poem as a recreational plant. It was in 2465 B.E. (1922 AD) that cannabis became a narcotic drug due to the enactment of the first Narcotics Act. Since then, cannabis started to disappear from the everyday life of Thais.2 According to the previous Narcotics Act B.E.2522 (1979 AD), cannabis was classified as a category 5 narcotic, the same classification as another strictly controlled narcotic plant called ‘Kratom’ (Mitragyna speciosa), a plant that is indigenous to South East Asia and has opioid properties as well as stimulant-like effects. However, away from the public eye, cannabis has long been used for both medicinal and recreational purposes. Various stakeholders such as medical practitioners, patients and NGOs found that cannabis provides benefits and therefore tried to call for legalization.3 This resulted in the Thai government reconsidering legalization of cannabis, thereby decriminalizing the “underground” use of cannabis.
Narcotics Act B.E. 2522 and its amended Acts and the recently published Narcotics Act B.E. 2562 (2019 AD)
Narcotics Act B.E. 2522 and its amended Acts prohibits one from producing, importing, exporting, possessing, selling, consuming and transporting this substance. The penalty can be up to 15 years in jail and/or a 1.5 million Baht fine.4
On 19 February 2019, a new Narcotics Act B.E. 2562 came into effect which legalizes category 5 narcotics such as cannabis to a certain extent, for example:
- Producing, importing, exporting, selling or possession of cannabis are prohibited except those intended for medical, governmental, research & development or any other purposes related to medical use, provided that permission is obtained from the Narcotics Control Board;
- Permission for producing, importing, exporting, selling or possession of category 5 narcotics can be granted only to an applicant who is, for example, (1) a government organization involving medical, pharmaceutical, agricultural research or etc., (2) a medical practitioner, pharmacist, dentist, Thai traditional medical practitioner or etc. under conditions defined by the Narcotics Control Board, (3) a medical or pharmaceutical educational institution, or (4) a patient carrying into or out of Thailand for his/her own treatment.
However, within five years from the effective date of 19 February 2019, permission for producing, importing or exporting of category 5 narcotics (cannabis) can only be granted to a particular organization or person defined under Section 21 of the new Narcotics Act.5
The Thai FDA under the Ministry of Public Health, is drafting subordinate legislation on implementing the new Narcotics Act, which may include a secondary law defining medical conditions which permit the use of medical cannabis.6
Issue 2: Patentability
A Controversy involving Cannabis-related Patent Applications
While the government is preparing to legalize cannabis, an issue of patent protection has arisen in Thailand. Many Thai patent applications related to cannabis have been filed by foreign companies. Consequently, this has raised public attention on whether these patent applications will restrict access to cannabis for medicinal purposes, as the patent holders will have the rights for 20 years to exclude others from making, using, offering to sell, selling, or importing the patented invention. Therefore, a monopoly market could appear and the price of cannabis-based medicines may rise beyond the reach of many patients in Thailand.7
Current Situation of Cannabis-related Patent Applications
In a recent meeting on 11 January 2019, 13 patent applications were specifically discussed on whether they are eligible for a patent because these patent applications contain claims related to natural cannabis, cannabis extracts and/or cannabis extract-containing compositions, which can be considered as unpatentable subject matter under the Thai Patents Act.8
To be patentable under the Thai Patents Act, an invention must meet the general requirements of novelty, inventive step and industrial application.9
The Director-General of the Department of the Intellectual Property Thailand (hereinafter referred to as ‘Director-General’) has explained
that 3 of these patent applications have been rejected due to lack of novelty and inventive step, another 3 patent applications have been abandoned, while the remaining 7 patent applications are currently under examination. Furthermore, there are 20 other patent applications relating to synthetic substances similar to cannabis and cannabis-related substances, which have received objections due to unpatentable subject matter under Section 9 of the Thai Patents Act.8
After a period of discussion about patent applications filed in Thailand, the Thai Prime Minister on behalf of the National Council for Peace and Order (NCPO) issued Article 44 on 25 January 2019, thereby ordering existing patent applications containing cannabis or cannabis extracts, chemicals which have a similar structure to cannabis or cannabis extracts, salts, esters and/or ethers of cannabis and cannabis extracts to be deemed unpatentable according to Section 9(5) of the Thai Patents Act. Section 9(5) of the Thai Patents Act prescribes that inventions contrary to public order, morality, health and welfare shall not be patentable.9,10
The Thai Prime Minister’s order also requires patent applicants to amend the claims which are contrary to Section 9(5) of the Thai Patents Act and authorizes the Director-General to issue a notification which revokes patent applications found contrary to Section 9(5) of the Thai Patents Act. However, patent applicants can file an appeal to the Board of Patents if they do not agree with the notification issued by the Director-General.9,11
Patent Registration for an Invention related to a Pharmaceutical or Biotechnological invention
If an invention is new and capable of industrial application but does not involve an inventive step, it may be eligible for a petty patent under Thai Patent Law. A pharmaceutical-related or biotech-related invention may face an objection regarding unpatentable subject matter under Section 9 (4) of the Thai Patents Act which relates to methods of diagnosis, treatment and cure of animal and human diseases. In other words, methods of diagnosis, treatment and cure of animal and human diseases are not patentable in Thailand.11 You may wish to discuss with professionals that can help you draft a patent application in view of Thai Patent Law.
We hope that the information provided in this article is helpful and provides insight into ongoing cannabis-related issues in Thailand. These issues are conflicts between ethical and legal perspectives, which have been debated in Thailand for several years and the solution remains unclear. Kindly note that the information provided in this article is for general information and does not constitute legal advice. For those interested in further information regarding cannabis-related issues or other intellectual property issues in Thailand, please feel free to contact: firstname.lastname@example.org.
- Thai Narcotics Act B.E. 2522 with amended Acts http://web.krisdika.go.th/data/law/law2/%C207/%C207-20-9999-update.pdf
- Thai Narcotics Act B.E. 2562 http://www.ratchakitcha.soc.go.th/DATA/PDF/2562/A/019/T_0001.PDF
- Thai Patents Act B.E. 2522 amended by Patents Act B.E. 2535 and Patents Act B.E. 2542 http://web.krisdika.go.th/data/law/law2/%CA38/%CA38-20-9999-update.pdf
- Patent and Petty Patent Examination Manual B.E. 2555 https://www.ipthailand.go.th/th/%E0%B8%84%E0%B8%B9%E0%B9%88%E0%B8%A1%E0%B8%B7%E0%B8%AD-%E0%B8%84%E0%B8%B3%E0%B9%81%E0%B8%99%E0%B8%B0%E0%B8%99%E0%B8%B3-%E0%B8%82%E0%B8%B1%E0%B9%89%E0%B8%99%E0%B8%95%E0%B8%AD%E0%B8%99-%E0%B8%AA%E0%B8%B4%E0%B8%97%E0%B8%98%E0%B8%B4%E0%B8%9A%E0%B8%B1%E0%B8%95%E0%B8%A3/2.html
Above information is correct at the time of publication.
Featured image: Yusarn Audrey
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patentability of cannabis and cannabis-related compounds in Malaysia, stay
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Ms. Kamonphan Minjoy, registered Thai Patent Agent
Kamonphan has a B.Sc. in Chemistry from Naresuan University in Thailand, a M. Econ. Business Economics from Kasetsart University in Thailand, and a LL.M in Intellectual Property from Bournemouth University, UK. She has been a registered Thai patent agent practicing in Thailand for more than 14 years and has extensive experience in drafting and prosecution of Thai and international patent applications, conducting Freedom-to-Operate, patentability analyses, patent landscapes and patent infringement analyses.
Ms. Chanida Chantarakunpongsa, Patent Specialist
Chanida has a Bachelor’s Degree in Pharmaceutical Sciences from Prince of Songkla University, Thailand and a Master’s Degree in Business Management from University of Strathclyde, UK. She has worked in various areas of Pharmacy before entering the IP field and is experienced in advising foreign clients on pharmaceutical-related and biotech-related patent applications.
Ms. Saowanee Leewijitsin, Intellectual Property Lawyer
Saowanee has a law Degree from Thammasat University, Thailand. She has extensive experience in intellectual property, particularly trademarks. She also advises and assists clients on IP-related matters such as reviewing and drafting of IP-related agreements and other legal matters such as commercial contracts.