The term “medical cannabis” (MC) or “medical marijuana” is frequently used to describe the medicinal usage of herbal cannabis and its components. The two most important substances utilized in medicine are cannabidiol (CBD) and delta-9-tetrahydrocannabinol (THC).Â
The Intellectual Property Rights (IPR) relevant to technical advancements in MC and related products are patents and Plant Breeder’s Rights (PBR). Patent filings are a way for technical information to be represented, and it grows along with economic and legislative activities. Agritech, or cannabis-specific patents, is the term used to describe agricultural innovations that aim to increase yield, efficiency, and quality. These agritech-focused patents are the result of original, novel, and applied MC research accomplishments that target particular issues in cannabis cultivation, including crop protection, cannabis yield optimization, cannabis harvesting, Â post-harvesting, and the development of new beneficial varieties.Â
The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) was passed by the World Trade Organization (WTO), which was established in 1995 and is the leading organization for regulating international trade. Benchmark criteria for numerous sorts of intellectual property rights are provided under the TRIPS agreement. IPR refers to intangible property rights that a business or person owns and is legally entitled to safeguard from unauthorized use or implementation by third parties. Patents, trade secrets, copyrights, know-how, franchises, and trademarks are all examples of intellectual property (IP). IPRs are viewed as the transmission gear at the intersection of business, law, and innovation.Â
Utility Patents:Â
A utility patent is an intellectual property right granted to a patent owner(s) by a state within its borders. It prevents third parties from commercializing a technology that is considered novel and inventive and is the subject of the granted patent for a specific period of time (up to 20 years with rare judicial exceptions). A patented technique or its products are considered to have been commercialized when they are used, offered for use, sold, offered for sale, manufactured, or distributed.Â
Plant Breeders’ Rights:
Plant Variety Protection Rights (PVPR) or Plant Breeder’s Rights are intellectual property measures that restrict the selling of innovative cannabis plant types developed through traditional breeding (PBR). This IP tool may be used in most nations to protect a new cannabis strain that has distinctive physical traits. The new variety must be sufficiently uniform and stable under cultivation, and it must be easily recognizable from any other widely used variety to qualify for a PBR.Â
Plant Patents (USA):
A plant patent, an additional IPR protection for plant types that is exclusive to the USA, is available. A unique and different variety of plant that displays traits dictated by their genotype is covered by a plant patent, which increases the owner’s control and protection. Plant patents may be secured for induced or spontaneous mutants, hybrids, or altered plants.Â
Progress in this area of knowledge is encouraged, accelerated, and rewarded through the use of IPR in the MC industry. Every country and region has a unique history and legacy intertwined with constantly shifting social, economic, and cultural circumstances. This affects local regulations regarding the extent and use of IPR in MC.
Marijuana is currently categorized as a Schedule I restricted substance under federal law. At the federal level, it is unlawful to possess, distribute, and/or cultivate any form of the substance because it has “no currently acknowledged medicinal purpose and a high potential for misuse.” In spite of this, the United States continues to provide patent protection for certain distinctive plant variants.Â
The United States maintains its neutral position while many other nations throughout the world refuse to patent illicit inventions. The same rules that govern legal inventions also apply to substances that are banned. In fact, the US government even holds a patent for cannabis. You can obtain legal patent protection as long as you can demonstrate that your cannabis-related invention is novel and distinctive.Â
The ultimate goal of medical cannabis research is commercialization. Therefore, whether the researchers are associated with academics, research institutes, enterprises, or collaborations, it is imperative that they take into account the possibility that patent law would prevent a research program.Â
Wide-ranging exclusive rights granted to a patent holder are intended to encourage investment in practical technological advancement for the benefit of society as a whole. The public’s best interests might not always be served by uniformly strict enforcement of these IPRs. Most national governments are aware of the necessity to strike a balance between the rights of the patent owner and the larger interests of society. Exceptions and safe harbors to the maximum patent exclusivity privilege are provided by laws, regulations, and procedures adopted by national and regional authorities.Â
Research exemptions to the rights granted by patents, particularly in the case of medications when regulatory or marketing approval is sought, are likely to be relevant to the MC researchers. These exemptions are known as Hatch-Waxman exemptions or § 271(e)(1) exemptions in the United States, but they are also known as Bolar exemptions in many other nations.Â
However, academic researchers must be aware of potential pitfalls, especially in light of the restrictions to ostensibly academic research at research institutes in the USA. Researchers in the field of medical cannabis should note that patent law allows sufficient room for research activities to promote innovation.Â
Due to the relatively recent acquisition of the IPR for MC research, there hasn’t been any patent infringement litigation to date, but this tendency is likely to alter. In order to alter plant DNA without introducing foreign genetic material, patented CRISPR technology is being employed more and more. The gene editing patents frequently provide broad plant coverage or apply universally to all plants, including cannabis.Â
The use of a gene repair oligonucleotide, or “GRON,” when delivered into any plant cell when combined with a CRISPR is claimed in US patent 9957515 to Cibus. The GRON can be used in conjunction with other strand-breaking gene-editing components in addition to CRISPR, according to another CIBUS patent, US10287594. It is advisable for applied researchers in MC to be well-versed on such patents that may prevent or limit their patentability in MC or limit an applied MC researcher’s freedom to operate while thinking about employing gene editing.Â
There is a lot of room for research in the domain of agri-technology specializing in the development of cannabis plants because it is not thoroughly covered. Work on genetically altering the cannabis plant has been published, which is expected to have an impact on the discussion surrounding MC as a natural herbal remedy. Cannabis-related gene editing patents are beginning to appear in academic journals. Researchers in this field will likely need to be cautious of the litigiousness of CRISPR/Cas9 system patent holders in their endeavor to avoid freedom to operate restrictions on their study.Â
It is not difficult to predict that the development of agreements like the Nagoya Protocol and its future amendments will play a significant role in the global and multicultural partnerships that are developing around the commercialization of medical cannabis and IPR rights. Â
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