by Yvette Flanigan and Wendy Leong
This is the first 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.
Cannabis, also known as marijuana, pot, grass, joints, ganja, hashish or weed, is a plant indigenous to and originating from Central Asia. The active compounds in cannabis are cannabinoids. Cannabis contains more than a hundred cannabinoids, including THC and cannabidiol (CBD). It had once been used freely worldwide to treat pain and other ailments. Although there is published research, derived from clinical trials, on the potential uses of cannabinoids to manage seizures and epilepsy 2, THC can adversely affect one’s mood – causing euphoria, anxiety, disorientation or paranoia. Cannabis can also adversely affect concentration and memory and long term use can result in psychosis.
After an international conference at the Hague in 1912, various countries prohibited use and restricted import and export of cannabis due to the adverse effects. Cannabis is also listed as a Schedule I drug in the 1961 Single Convention on Narcotic Drugs, an international agreement to control the cultivation of opium poppy, coca bush, cannabis plant, and their products which are referred to as “narcotic drugs”. However, recent studies have indicated that THC and CBD may have beneficial properties as listed in Figure 2. Hence, cannabis has come under the spotlight recently and a milestone was reached for legalization of cannabis when Canada announced its legalization last year, thereby becoming the first G7 country to do so. Cannabis has been legalized at various levels from fully legalized (for medicinal and recreational uses) like Canada, Uruguay and the Netherlands to partially legalized (for medicinal use only, recreational use is prohibited) like Australia and the United Kingdom. Currently, cannabis has been approved for recreational use in 10 US states and the District of Columbia, and for medicinal use in 33 US states. In June 2018, the US Food and Drug Administration (FDA) approved the first cannabis-based drug for sale in the US. In particular, GW Pharmaceuticals’ epilepsy treatment Epidolex makes use of CBD. However, cannabis remains illegal at the federal level in the US. In December 2018, Thailand became the first country in Southeast Asia to legalize cannabis for medicinal uses.
According to a recent report by Clarivate Analytics that investigated whether changes in regulation would have an impact on innovation in cannabis and cannabis-related compounds using their in-house developed technology,1 Derwent World Patents Index, patent activity related to cannabinoids experienced a sharp downturn followed by an equally sharp recovery from 2005 to2015 (Figure 1). It is believed that the pivot point in 2012 was due to the electorates of US states, Colorado and Washington, voting in favour of the legalization of cannabis. Global patent activity, regardless of technical content, generally increased through the years (depicted by the green line in Figure 1). Furthermore, Figure 2 illustrates the cannabis-related compounds and their uses which contribute to the patent activity. Several cannabis-related compounds, such as THC and CBD, are experiencing growth.1
Singapore, Malaysia and Thailand are 3 of the 184 signatories to the 1961 Single Convention on Narcotic Drugs which prevents the misuse and illicit trafficking of cannabis. In light of recent legislation changes to cannabis, this three-part series seeks to explore the regulation and patentability of cannabis and cannabis-related compounds in Singapore, Malaysia and Thailand with the aim of educating academics, entrepreneurs and industry professionals.
The Singapore Perspective
Issue 1: Regulation of Cannabis and Cannabis-related Products
Cannabis is listed as a Class A controlled drug in the First Schedule of the Misuse of Drugs Act (MDA). It is illegal to use cannabis in Singapore and heavy penalties relating to cannabis and cannabis-related products may be a fine, a jail term or both or the death penalty. The Central Narcotics Bureau (CNB) takes a serious stand on cannabis and conducts checks at Singapore’s checkpoints. In accordance with the MDA, any Singapore Citizen or Permanent Resident discovered to have abused controlled drugs overseas will be treated as if he/she had abused drugs in Singapore.
While there are no studies to-date that support claims of unprocessed or raw cannabis being able to treat medical conditions, there is evidence showing potential therapeutic uses of cannabinoids. In a recent joint statement by the Ministry of Home Affairs and the Ministry of Health, the Singapore government differentiated between products containing unprocessed or raw cannabis, and pharmaceutical products containing cannabinoids.2, 3, 4
In order to be registered for supply in Singapore, such cannabinoid-related pharmaceutical products need to undergo rigorous scientific review by the Health Sciences Authority (HSA). There are strict frameworks in place for the supply, prescription and dispensation of controlled drugs used for medical purposes in Singapore. All such drugs must be prescribed by a Singapore doctor, and must be prescribed for the medical condition registered with HSA. Furthermore, manufacturers are required to substantiate the safety, quality and efficacy of the cannabinoid-related pharmaceutical products with scientific evidence from clinical studies and data on the manufacturing process.
Issue 2: Patentability
Cannabinoids are also the focus of research initiatives in Singapore. The National Research Foundation Singapore (NRF) has launched a Synthetic Biology Research and Development (R&D) Programme5, 6 to advance Singapore’s synthetic biology research agenda and expertise, as part of efforts to promote a bio-based economy built on deep science capabilities. As part of NRF’s SGD 25 million initiative to promote the biotech industry, one of the research thrusts involves developing a Synthetic Cannabinoid Biology Programme to deliver life-saving therapeutics derived from the cannabis plant in a sustainable manner as promising therapeutics. Accordingly, the Synthetic Cannabinoid Biology Programme aims to discover cannabinoid genes for the sustainable production of medicinal cannabinoids and their derivatives.
We provide some general guidelines regarding the patentability of subject matter related to cannabis and cannabis-related compounds.
To be a patentable invention in Singapore, the following
conditions need to be satisfied:
- the invention is new;
- it involves an inventive step; and
- it is capable of industrial application.
Further, an invention which is expected to encourage offensive, immoral or anti-social behaviour is not a patentable invention. In this regard, a behaviour shall not be regarded as offensive, immoral or anti-social only because it is prohibited by any law in force in Singapore.
The Singapore Court of Appeal has distinguished between a discovery and an invention, which is generally the subject matter for patent protection.7 At times, the difference between the two can be unclear. According to guidelines issued by the Intellectual Property Office of Singapore (IPOS),8 there must be “something more” to a discovery to constitute an invention. For instance, the mere isolation of a naturally occurring material (such as a cannabinoid) without a specific use would represent a mere discovery. However, if a new use of the naturally occurring material is found, then the use could be claimed, as well as the isolated naturally occurring material. However, if the isolated naturally occurring material is not clearly distinguished from prior art, an objection with regard to novelty may be raised by a patent examiner.
Methods of medical treatment are not patentable in Singapore because they are deemed to lack industrial applicability. Although methods of treatment are not patentable, it is possible to seek patent protection for a compound, such as a cannabinoid, or a composition which is used in methods of medical treatment. Furthermore, known compounds or compositions which have not been previously used for medical purposes may be claimed in the form of a first medical use. Even if a prior medical use of the compound or composition has been disclosed, a second medical use of the compound or composition may be claimed.
We hope that the information provided in this article is helpful. Kindly note that the information is for general information and does not constitute legal advice. You may wish to discuss with professionals that can help you strategize patent-related activities to align research activities with business objectives. As the saying goes “if you fail to plan, you are planning to fail”.
- Markley, M., White E., Money in the Pot, Clarivate Analytics.
- Merck & Co Inc v. Pharmaforte Singapore Pte Ltd  SGCA 39
Above information is correct at the time of publication.
Featured image: Pixabay
Enjoyed the article? For more information about the regulation and patentability of cannabis and cannabis-related compounds in Thailand, stay tuned for the next article.
Yvette has a PhD in Biochemistry from University of Queensland and is a founding member of BioSingapore and Biobeers. She has more than a decade of experience in intellectual property (IP) and specializes in the life sciences. She is a regular lecturer at Singapore Biodesign since 2011 and ESSEC business school since 2012.
Wendy has a PhD in Chemistry from NTU and is Chairman of the Membership Committee of the Singapore National Institute of Chemistry. She has more than five years of experience in IP and was awarded a Book Prize for a Singapore Patent Agents Qualifying Examination.
For further enquiries or specific advice, Yvette, Wendy and their colleagues in Yusarn Audrey can be reached at: email@example.com.