Can newly discovered cannabis compounds be protected by patents?

A breakthrough discovery has recently hit the news: tetrahydrocannabiphorol (THCP) and cannabidiphorol (CBDP), two new cannabinoid compounds, have been discovered in Cannabis sativa and characterised for the first time. These novel cannabinoids are thought to be up to 30 times more potent than THC, a cannabinoid known for its psychoactive and pharmaceutical properties. Until now, THC was the only known psychoactive cannabinoid. These new compounds could, in theory, elicit much stronger effects, and pharmaceutical uses have been suggested. Given the media hype surrounding this discovery, the groups responsible for the identification and characterisation of these compounds may well want to protect their breakthrough using patents – how could they achieve this?

Patenting the compounds per se

One obvious approach is to patent the newly discovered compounds per se. However, "discoveries" are excluded from patentability worldwide – indeed, the European Patent Office explicitly advises that finding a previously unrecognised substance occurring in nature is a "mere discovery and therefore unpatentable".

Despite this, the compounds are potentially patentable in Europe if a technical effect is demonstrated. A technical effect may be a pharmaceutical use – the demonstrated psychotropic effect could arguably fulfil this criterion. The European Patent Office requires that any claims to naturally occurring compounds explicitly state that the compound is isolated from its natural environment or is produced by means of a technical process. If the groups responsible for this discovery could plausibly identify a technical effect, they could potentially obtain a patent to isolated THCP or CBDP in Europe.

Alternatively, or additionally, a pharmaceutical composition comprising THCP or CBDP could also be patented. Again, it would be necessary to plausibly demonstrate a medical effect for this kind of claim to be allowable.

A patent protecting the compound per se would potentially prohibit any third part from commercially exploiting the compound in any way without the permission of the right holder. This would therefore be an extremely strong form of protection and is generally preferred whenever a new compound is identified.

Patenting use of the compounds

Medical use (in general) of these natural compounds could be patented in many territories worldwide. In Europe, the discoverers could conceivably obtain a patent to THCP or CBDP for use as a medicament if they could demonstrate a plausible medical use. Follow on patents for additional specific medical uses may also be available. Such "second medical use" patents would be limited to a specific disease indication, or indeed a specific patient population.

In the US, methods of treatment are patentable. In practice, method of treatment claims are often very similar to European medical use claims, but applicants should be aware of the regional differences and requirements, and how these differences may affect enforcement of rights.

Medical use patents contain "purpose-limited product" claims, and are sometimes difficult to enforce. This is particularly true when a generic version of a medicament is available, for example recent disputes concerning Lyrica (pregabalin) highlighted the difficulties right holders may encounter when seeking to enforce medical use claims in the UK.

Patenting a synthesis process

Finally, a process for synthesising new compounds could be patented if the process was sufficiently new and inventive over known synthesis routes. It appears that no groups had synthesised the newly discovered cannabinoids before their discovery, and thus a novel synthesis route could well be patentable.

A process patent would prevent third parties from using the same process but would not prevent competitors from finding their own alternative route. A process patent may also be enforced against any party importing or selling the direct product of the process, e.g. a THCP composition produced by a patented process (of course, such a patent could not be enforced against a THCP composition produced via any alternative process).

Conclusion

Patent protection may have been available for these new cannabinoids, though of course now that the discovery has been made public it is unlikely that a subsequent patent application would be novel or inventive over the group's published research. It is currently unknown whether the group has pursued patent protection, and this will most likely remain unknown for at least another 18 months by which time any patent applications concerning this subject matter will publish. New medical uses or synthesis routes may still be patentable, and these compounds will undoubtedly be investigated further.

Of course, there may still be as-yet undiscovered cannabinoids which will be characterised in the coming years. Any research groups happening across such a discovery should be safe in the knowledge that, if they so choose, some form of patent protection will be available for their hard work.

Sources:

1. https://www.nature.com/articles/s41598-019-56785-1
2. https://www.epo.org/law-practice/legal-texts/html/guidelines/e/g_ii_3_1.htm
3. http://ipkitten.blogspot.com/2018/11/breaking-news-supreme-court-unanimously.html