Patents are a powerful tool in Europe to protect inventions in the rapidly-growing field of cannabis-derived therapeutics.
Commercialisation and uptake of natural cannabis-based products is increasing, particularly in the medical field. Breakthroughs in research are yielding effective cannabis-based therapies for a variety of medical indications. Sativex/Nabiximols is approved for the treatment of spasticity. Epidiolex is approved for the treatment of seizures in rare and severe forms of childhood epilepsy. Cannabis is touted as a wonder-drug by many. Its effects on the human body are numerous and these approved therapies are the tip of the iceberg – more will surely follow.
Cannabis products typically comprise a class of compounds known as cannabinoids, which are often derived directly from the natural cannabis plant. The human body also produces its own similar compounds in the endocannabinoid system. At least 140 different cannabinoids are known to exist naturally, but the most widely researched cannabinoids for medicinal use are ∆9-tetrahydrocannabinol (THC) and cannabidiol (CBD).
It is well known that research is costly, particularly in the field of medicine. The patent system supports this research by granting a monopoly to patent proprietors. This enables patentees to recoup the investment required. However, patenting cannabis and other naturally-occurring substances can present a challenge, since significant legal roadblocks exist in some territories.
Legality and practice
While cannabis and many cannabinoids are illegal for recreational use in many European states, this does not present a barrier to patenting inventions relating to cannabis. It is true there are restrictions on patenting inventions contrary to “public policy and morality” in Europe (Article 53(a) EPC). However, these restrictions also explicit state an invention shall not be deemed contrary to public policy and morality merely because it is prohibited by law or regulation.
As a result, the illegality of cannabis presents no outright bar to filing and prosecuting patents for inventions in this field in Europe. This illegality contrasts somewhat with the position in the US, where federal (as compared with state) illegality can cause challenges when filing and prosecuting patent applications for cannabis.
Are inventions based on naturally-occurring substances, such as cannabinoids, patentable in Europe?
The European Patent Office (EPO) applies the same standards for patentability of naturally-occurring substances as it does to any other inventions. Principally, the invention must be novel (new), possess an inventive step and be industrially applicable. Provided these criteria are met, inventions based on naturally-occurring substances are generally patentable in Europe.
Since an invention must be novel (new), it is only possible to obtain a patent on a substance which is somehow different to its naturally-occurring form. For example, it would not be possible THC, CBD or another natural cannabinoid per se, since these already occur in the cannabis plant and hence are not novel.
Nonetheless, the EPO recognises novelty under a wide variety of circumstances. Broadly speaking, if a natural substance has been “isolated” from its natural environment, then this can be enough to confer novelty. Alternatively, compositions having different ingredients or ratios of ingredients as compared with the naturally-occurring equivalent could be considered novel. For example, if it was determined that a composition comprising a certain ratio of THC, CBD and other cannabinoids was particularly effective at treating a medical condition, then this could be patentable as long as that composition did not already exist in the naturally occurring cannabis plant.
Other options relate to purified products, polymorphic crystalline forms, use in specific therapeutic indications, dosage regimens, new derivative compounds, etc. See our articles on some of the specifics:
Second medical uses at the EPO
Patenting second and subsequent medical uses.
Patenting high-purity chemicals
Why it is now easier to patent high-purity chemicals at the EPO, and how to do it.
Crystal clear? Patenting polymorphs in Europe.
Actavis v. ICOS
The death knell for dosage regime patents in the UK?
The criterion of inventive step is satisfied if the invention is not obvious to a hypothetical person skilled in the technical field of the invention. This means the skilled person would not be minded to modify or adapt a closest prior art teaching to arrive at the invention and achieving what the invention achieves without exercising inventive skill. (See the articles above on some of the specifics.)
Industrial applicability is typically a low bar, simply meaning that the invention has some utility in industry.
The EPO position contrasts with that of the US, where a substance derived from a natural product must have “markedly different characteristics” from the natural substance (US Supreme court decision Diamond v. Chakrabarty, 447 U.S. 303 (1980)). At the EPO, there is no need to demonstrate “markedly different characteristics” beyond the need to demonstrate novelty (see above).
Are cannabis plants themselves patentable in Europe?
Plant varieties, plants obtained exclusively from essentially biological processes (i.e. basic sexual crossing of plants) and the essentially biological processes themselves are all largely excluded from patentability (Article 53(b) EPC). This means that any cannabis plants occurring in nature or which have been produced by standard cross-breeding and selection are excluded from patentability at the EPO.
Nonetheless, this does not entirely close the door to patenting cannabis plants. The key to patentable subject matter here is that some technical intervention must have taken place to produce the plant (e.g. genetic modification). The legal position on this is evolving – for our deep dive analysis on the EPO’s current stance, see here.
Alternative protection can be pursued through Community Plant Variety Rights (CPVRs). Protection here is different to patent protection (e.g. in scope and term), but this can nonetheless offer a useful avenue if patent protection is unavailable.
All of this is good news for researchers and patent applicants seeking protection for cannabis inventions in Europe. The EPO is prepared to grant patent protection in Europe and the position on patentability is the same as it is for any other invention.
Clearly there is some nuance behind patent applications of this kind. For more tips and tricks on protection your cannabis-related IP in Europe, please contact James Snaith or your usual Kilburn & Strode advisor.
This article was edited by Tom Leonard.