Regulation and Patentability of Cannabis and Cannabis-related Compounds in Malaysia

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by Soon Kheng Lim and Dan Yi Wong

This is the third 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 and second
article here and 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 the trend. This article seeks to explore the regulation and patentability of cannabis as well as cannabis-related compounds in Malaysia with the aim of educating academics, entrepreneurs and industry professionals.

The Malaysia Perspective

Issue 1: Regulation of Cannabis and Cannabis-related Products

The case of Muhammad Lukman has significantly drawn the attention of the public as to whether medicinal marijuana should be legal in Malaysia. On 30 August 2018, Muhammad Lukman was given capital punishment by the Shah Alam High Court for having medicinal cannabis oil.1 Lukman was sentenced to death for possessing, processing and distributing medicinal marijuana (cannabis oil)2 after he was arrested in 2015 for the possession of 3.1 litres of cannabis oil, 279g of compressed cannabis and 1.4kg of substance containing tetrahydrocannabinol (THC).1

Figure. 11

Following the case of Muhammad Lukman, the Ministry of Health Malaysia (“the Ministry”) stated that cannabis oil can only be used for research and not as alternative medicine as the Ministry has yet to find any evidence or sufficient data to support the claim that cannabis oil can be used as medicine. Additionally, the Ministry has further emphasized that cannabis is classified as a dangerous drug under the Dangerous Drug Act 1952.2

The case of Muhammad Lukman spurred Malaysia to start talks to legalise marijuana for medical use, as well as, review and amend the relevant laws. According to the Water, Land and Natural Resources Minister, Dr Xavier Jayakumar on 26 September 2018, the Cabinet has reached consensus to remove capital punishment of Muhammad Lukman, but garnering support for legalising medical marijuana will be “an uphill battle”. The challenge for Malaysia in allowing medical marijuana is to draft new laws that are specific enough to differentiate the uses of the drug. In addition, the Ministry of Health Malaysia, which holds the final decision, remains sceptical about the medical use of marijuana due to lack of evidence.5

Muhammad Lukman and the medical use of marijuana have seen light at the end of the tunnel when the Cabinet on 12 October 2018 agreed to place a moratorium on the death sentence of Muhammad Lukman, as well as, a moratorium on death penalty withrespect to the use of medical marijuana.6

According to the Deputy Health Minister Dr Lee Boon Chye on 26 December 2018, the Ministry of Health Malaysia would consider legalising
medical marijuana only if pharmaceutical firms can establish the effectiveness and safety of the substance that is currently classified as narcotic.
Pharmaceutical firms that venture into medical marijuana must submit dossiers with the necessary information to prove the efficacy of the substance in treating medical conditions. Dr Lee further said that his Ministry cannot initiate steps to consider medical marijuana in Malaysia until pharmaceutical firms register their dossiers evidencing the medical use of marijuana with the National Pharmaceutical Regulatory Agency (NPRA), an agency under the Ministry of Health Malaysia.7 Any products containing ingredient(s) from Cannabis Spp. (all species),commonly known as marijuana is to be regulated as drug and under the purview of the NPRA. At the moment, marijuana for medical use is still under talks on how to regulate it, as such, there is no medicine of marijuana nature have been registered.8

Issue 2:
Patentability

Malaysian patent law prohibits the patentability of plant, animal varieties or essentially biological processes for the production of plants or animals, other than man-made living micro-organisms, micro-biological processes and the products of such micro-organism processes which are classified as non-patentable inventions in Malaysia. It follows that discovery of any new variants/species of a marijuana plant (also known as a cannabis plant) is unlikely to be patentable in Malaysia.3

However, any technical intervention by man in the biological process of the marijuana plant, where such intervention plays a significant part in determining or controlling the result it is desired to achieve, is unlikely to be regarded as “essentially biological” and hence not excluded from patentability. For example, a method of crossing, inter-breeding, or selectively breeding, which merely selects plants with certain characteristics for breeding is likely to be essentially biological and therefore unpatentable. On the other hand, modifying a marijuana plant to improve its properties or yield or to promote or suppress its growth, is unlikely to be essentially biological although a biological process is involved, because the essence of the invention can be regarded as technical and hence patentable.4

To date, the acceptance of “medicinal marijuana” in Malaysia is under consideration. In any event, even if cannabis is accepted (conditionally or otherwise) for medical use in Malaysia; a method of treatment using cannabis on the human or animal body is unlikely to be regarded as patentable inventions in Malaysia. Malaysian patent law prohibits methods for the treatment of human or animal body by surgery or therapy, as well as diagnostic methods practised on the human or animal body.3 However, this exclusion does not apply to products used in any such methods. Patents may, therefore, be obtained for surgical, therapeutic or diagnostic instruments or apparatus for use in such methods. Patents may also be obtained for new products for use in these methods of treatment or diagnosis, particularly substances or compositions.4

We hope that the information provided in this article is helpful and provides insight into the ongoing cannabis-related issues in Malaysia. 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, please feel free to contact: my@yusarn.com.

References

  1. https://www.freemalaysiatoday.com/category/nation/2018/09/20/lawyer-ag-can-reduce-charge-against-man-with-medicinal-cannabis-oil/
  2. https://www.nst.com.my/news/nation/2018/09/413001/cannabis-oil-only-research-says-health-ministry
  3. Patents Act 1983 (Act 291) & Regulations (Malaysia)
  4. Intellectual Property Corporation of Malaysia (MyIPO). (October 2011). Guidelines for Patent Examinations. Page 21-24.
  5. https://www.thestar.com.my/news/nation/2018/09/26/malaysia-in-talks-to-become-first-in-asia-to-allow-medical-marijuana/
  6. https://www.malaymail.com/news/malaysia/2018/10/12/minister-cabinet-agrees-on-moratorium-of-death-sentence-for-medical-marijua/1682317
  7. https://www.malaymail.com/news/malaysia/2018/12/26/health-ministry-wants-documented-evidence-of-medical-marijuana-benefits-fir/1706394
  8. National Pharmaceutical Regulatory Agency (NPRA). (16 July 2018). Product Classification Guideline.

Above information is correct at the time of publication.

Featured image: Pixabay

Authors

Lim Soon Kheng, Serene has a BSc in Biotechnology from Monash University and a MBA from Victoria University. She is a registered patent, trade mark and industrial design agent in Malaysia and is a Patent Associate at Yusarn Audrey IP Services Sdn Bhd, Malaysia.

Wong Dan Yi has a Bachelor of Laws (Honours) from the University of Malaya and was called to the Malaysian Bar in 2012. She is a registered patent, trade mark and industrial design agent in Malaysia and is an Associate at Yusarn Audrey IP Services Sdn Bhd, Malaysia.

Biotech Connection Singapore (BCS) is part of an international network of non-profit organizations, that aims to promote the transfer of ideas from theory to real world applications by providing a platform for fostering interaction between academia, industry and businesses.

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