Cannabis now being legal in several US states, Canada and some European countries for at least restricted medicinal or, in some rare cases, also for recreational use, has led to a new booming market arising from what was previously known as an illegal trade.
As with any new and growing economic potential, there is a central interest in intellectual property (IP) to protect innovations and investments made to profit on the market.
Patents are pivotal tools to guarantee and maintain a commercial advantage in such a competitive and fast-developing area. Having no IP-protection is a dangerous play as innovations are unprotected against copycat technologies, which compromise hard and cost-intensive efforts done by R & D.
At the time of writing this article, at least the recreational use of cannabis is still illegal, e.g., in most of the European countries and under US federal law (in contrast to some singular US state laws).
Can you patent something illegal or something banned from medicinal use such as Cannabis?
Performing a cursory search on a global patent database (https://patentscope.wipo.int/search/de/search.jsf, status: April 2020) reveals more than 26.800 patent applications worldwide, which include the word “cannabis”, including more than 2.300 patent applications at the European Patent Office (EPO).
National illegality does not count as a measure for patentability
According to European patent convention (EPC) as well as US patent legislation illegality of a claimed product does not exclude it from obtaining a patent.
Instead according to European legislation, only a legally defined “abhorrent immorality” or a violation against “public order” is a measure to be used to deny the grant of European patents (cf. Article 53(a) EPC).
As on the one hand a patent per se only provides the right to exclude others from the invention and not permitting allowance to make use of the invention, and on the other hand, the legislation follows the view that a patented product could be made in a country where using it was illegal, but it may be exported to somewhere where it is legal, the guidelines of the European Patent Office (EPO) summarize:
A patent application should only be morally objected if public opinion would find a patent “so abhorrent” that the grant of patent rights would be incomprehensible. Classical examples given are: Cluster bombs and anti-personnel mines.
A European or US patent directed to cannabis or cannabis-related products is possible, even if cannabis or some uses are considered illegal or are banned from medicinal use according to some national legislation.
There is a multiplicity of forms of IP protection potentially available for cannabis related inventions.
The different categories of potential patent claims
In Europe there are different categories of a patent claim, namely product, apparatus, process or use claims all also potentially to be used for cannabis related inventions. Of note: To fully protect an IP invention in general more than one category is needed or advisable.
The “product claim” category includes e.g. a substance or a composition (e.g. chemical compound or a mixture of compounds; see list below, points 1, 4 and 6: Plants (1); Pharmaceutical compositions (4); Other cannabis-related products (6).
The “apparatus claim” category may be directed to an apparatus, machine, or system of co-operating apparatus; see list below, point 5: Consumption devices (5).
The “process claim” category may be directed to all kinds of activities in which the use of some material product for effecting the process is implied; see list below, points 2, 3 and 6: Detection and analysis (2); Extraction and processing (3); Cultivation methods (6).
The “use claim” category refers to the use of a product or apparatus. In the medicinal sector there are two special kinds of use claims, the so called “first and second medical use claims”, i.e. claims, where an substance is already known but a medical use per se is either not known (first medical use) or a medical use is known but another medical use is allegedly new (second medical use); see list below, point 7: Therapeutical use of cannabis-related products (7).
Potentially protectable Cannabis products and Cannabis related products or uses
2. Detection and analysis
3. Extraction and processing
4. Pharmaceutical compositions (cannabis components + other active compounds)
5. Consumption devices
6. Other cannabis-related products and cultivation methods
7. Therapeutical use of cannabis-related products (compounds) / chemical substances (active substances)
In general, an invention according to European patent Convention or US patent law must among others exhibit four major prerequisites in order to be allowable, namely it must be new, involve an inventive step, be susceptible of industrial application and be sufficiently disclosed.
Novelty is normally assessed regarding a product/apparatus or process/use claim, which must not be disclosed in public before filing the patent application. The purpose of the novelty requirement is to prevent prior art from being patented (again). The novelty of an invention is assessed by a search through the so called “prior art”, the term “art” referring to the relevant technical field of the invention.
The inventive step criterion (EPC) respectively the similar non-obviousness criterion (US) asks, whether an invention has an adequate distance above the state of the art. Only inventions above this distance threshold will be in a condition to be granted.
The disclosure of a patent must enable the skilled person to use the invention across the whole breadth of the claimed subject matter. Such disclosures in the patent are not only an issue in relation to “sufficiency”, but also in relation to an inventive step.
In recent years, the EPO practice has evolved the requirement of plausibility, meaning that in the disclosure of an application as filed it must be rendered “plausible” or “credible” that a claimed invention has a technical effect. In other words the invention has to show and mention that it brings any real benefit (technical effect) to the society already within the application as filed. Only when such an effect is rendered plausible, later filed data verifying that the effect indeed exists can and will be taken into account by EPO examiners when assessing inventive step.
From a history point of view this is to some extent a reaction of the EPO to biotech inventions of the early 1990s relating to newly discovered gene sequences and only later identifying their utility. This new practice of the EPO to question plausibility, prevents that applicants speculatively fill in boilerplate list or language of potentially possible uses for the subject matter without a clear understanding whether those uses could be truly realized. Additionally, with regards to first and second medical use claims it is advisable to present data in the patent application as filed showing / indicating e.g. the efficacy of the use of a known substance for a special disease, medical disorder or condition.
To fulfill the industrial application criterion (EPC) – respectively the “utility” criterion as is it referred to in the US patent law – is another prerequisite for patentability in Europe and US.
In the European Union (EU) the industrial use of special cannabis plant varieties (so called industrial cannabis/hemp), i.e. to cultivate and supply cannabis plants for e.g. hemp fibre production is legal, provided the variety is registered in the EU’s “Common Catalogue of Varieties of Agricultural Plant Species” and the THC content is low, not exceeding 0.2% (EU Regulation 1307/2013).
However, in Europe many national governments ban or have banned natural cannabis for medicinal use (“medical cannabis”; generally THC content ≥ 0.2%) in various ways, e.g.:
- In Austria, cannabis is only marketable and may be prescribed as a medicinal product only if it is present in formulations (not natural) that are approved as certified medical product.
- In Germany: natural cannabis or related products were formerly banned by a national law, “Betäubungsmittelgesetz” (German Narcotics Act), which was revised in 03/2017 to allow certified natural cannabis flowers and natural cannabis extracts as medicines.
- In the Netherlands, the use of medicinal cannabis has been allowed since 2003 but strictly regulated by the Dutch Office of Medicinal Cannabis (BMC). In the Netherlands, so far only one company – Bedrocan – is authorized to cultivate cannabis for medical use.
- In France, natural cannabis, its extracts and resins and THC are legally prohibited. However, exceptionally medical use is allowed:
- for the purposes of research, product control or the production of authorized derived products, as authorized by the Director of the French National Agency for Drug Safety (ANSM);
- if the concerned product received a Marketing Authorization (MA) or a Temporary Marketing Authorization (ATU);
Recent developments: The ANSM has currently started an experimentation on the usage of therapeutic cannabis in order to test for allowance of the medicinal use of natural cannabis for specific diseases including epilepsy, neuropathic pain or to treat side effects of chemotherapy. In 09/2020 the first tests should begin and will go on for two years.
- In Italy, growing, selling and importing natural cannabis for medical purposes is allowed on condition that the authorization of the Italian Ministry of Health is obtained.
- In Poland, the growing of natural cannabis that contains more than 0.2% THC in flowering or fruiting tops of plants from which the resin has not been removed (“non-fibrous cannabis”) is prohibited. Exceptionally, scientific entities may grow non-fibrous cannabis with permission from the polish Chief Pharmaceutical Inspectorate. Nevertheless, it is possible to import and sell such cannabis for medical use as a pharmaceutical raw material intended for preparing prescription drugs.
- In the Czech Republic the growing of natural cannabis for medical use is allowed provided that a license from the Czech State Institute for Drug Control is obtained. Such a license is issued in a public tender proceeding and last for a maximum of five years. Natural cannabis for medical use which was cultivated in the Czech Republic may only be sold to the State Institute for Drug Control.
- Finally, the US government does not appreciate the medicinal effect of natural occurring cannabis plant constituents and only recognize the medicinal effect of cannabis derived limited compound groups as e.g., cannabinoids.
Despite these restricted laws and policies of the EU national states or the US government, under the EPC these policies are meaningless for the evaluation of the industrial applicability.
There is a variety of protection potentially available through patents for “cannabis related uses or cannabis derived products” in the leading western markets of Europe and USA. However, there may be some unique patenting issues and pitfalls to be kept in mind. Thus, allow us to assist you with our professional experience before rushing to file a patent application referring to your cannabis invention.