Nootropics revolution – patentability in the UK and EU – Lexology

Data and commentary provided by Mathys & Squire has featured in an article byThe Nutraceutical Business Review, providing an update on the growth of the nootropics market.

A condensed version of the article is available below.

The global nootropic market is set to reach a value of $6.61 billion by 2026 at a compound annual growth rate of 13.7%, according to some projections. The term nootropic describes a broad category of nutraceuticals and pharmaceuticals offering cognitive function benefits. Caffeine is the most recognisable nootropic, but there are other examples that consumers will ingest on a regular basis, such as L-theanine (found in black and green tea), anthocyanins (found in blackberries), nicotine and creatine.

The increasing popularity of nutraceuticals, and particularly nootropics, appears to reflect consumers taking a more active approach to their health and wellbeing, as a consequence of evolving lifestyle choices, increased health awareness, and a shift toward a preventative healthcare paradigm.

Why are nootropics so popular?

Nootropics have established a wide and cross-generational appeal as individuals seek to biohack their cognitive function with supplements and functional foods.

Competitive gamers and eSports professionals are increasingly using nootropics to improve gaming performance. However, there is also a growing use of nootropics in sports nutrition by athletes, particularly those involved with team sports requiring swift decision making, motor control, coordination and timing. Nootropic sports drinks formulated with herbal nootropics for instance already exist and are marketed as helping improve focus, as well as energy levels.

It is not surprising that nootropics are also being marketed towards working professionals wanting to be more productive and stay focused, as well as to older generations wishing to retain mental acuity and stave off any mental decline.

Innovation driving popularity

Another notable reason for the increasing popularity of nootropics is that they are becoming more convenient and appetising to consume. Nootropic supplements are readily available in the form of chewable gummies, and in a variety of flavours, for those who have pill fatigue. In addition, nootropics are becoming increasingly prevalent in functional foods and beverages that can be integrated more readily into peoples existing routines. For example, there are nootropic snack bars, protein bars, performance drinks, stimulant-free functional beverages, and even adaptogenic coffee blends and alcohol-free nootropic mocktails.

The growth of personalised/individualised healthcare has also infiltrated the nootropics sector, as innovators have started offering personalised/individualised nootropic formulations determined by algorithms that take consumers responses to lifestyle questionnaires and convert them into a tailored formulation.

Protecting innovation

Unsurprisingly, the nootropics market is a hotbed for innovation, as companies fight to distinguish their products from those of their competitors and capitalise on the shift in consumer trends. Branding and marketing strategy play a significant role in the commercial success of such products, but innovators are also recognising the value in protecting their innovations through patents. New European patent applications in the food chemistry category increased by 6.1% in 2021 over the previous year, suggesting that the innovation seen in the sector is translating to increased numbers of patent filings year on year.

As with other food chemistry products, there are numerous options for protecting technical innovation underpinning nootropic products through patents. For instance, protecting a new composition or formulation of ingredients (including, for example, a synergistic stack of actives), and uses thereof, is often the most desirable protection sought by applicants.

There are also other patent protectable innovations relating to improvements in product bioavailability, organoleptics, shelf life, or for overcoming challenges to meet consumer preferences (e.g. to be derived from sustainable sources or to be vegan). There are also patentable innovations relating to extraction techniques of natural products and processing methods for producing a food product having, for instance, particularly high purity or particularly high active concentration, as well as new uses of known nutraceuticals that innovators may seek to protect.

Use claims (patents) at the EPO where things can get more complicated

Patenting nootropic products, or indeed any form of nutraceutical product, does not come without its challenges. The European Patent Office (EPO) does not, for instance, distinguish between a pharmaceutical or a nutraceutical product (for example, a functional food with a purported health benefit), which can be problematic when it comes to claiming the use of a nootropic product.

The EPO does not allow claims to methods of treatment of the human or animal body by surgery or therapy and many readers will know that claims relating to a medical use must be formulated in a specific manner to avoid such exclusions to patentability at the EPO. Nutraceutical products which may have a health benefit can fall into a grey area where they might not be intended for the treatment of a particular disease, but a claim to their use might be considered to constitute a method of treatment and therefore, fall foul of the exclusions.

Non-therapeutic / cosmetic method claims are allowable at the EPO, however, the non-therapeutic use must not be inseparably associated or inextricably linked with a therapeutic use which is not always clear. Some cosmetic methods can also help prevent disease. One can, for instance, imagine how there might be confusion if a nootropic product may improve cognitive performance in a healthy subject, but may have a therapeutic effect in a subject with a cognitive disorder.

Helpfully, a relatively recent EPO Board of Appeal decision T 1916/19 has clarified that a non-therapeutic method is allowable, so long as there are realisations of the claimed method that are purely non-therapeutic. Thus, in the case of the EPO, it seems that there are signs of a permissive approach to the assessment of non-therapeutic method claims, which is likely to be particularly welcome to nootropics innovators and the nutraceutical sector more widely.

Health claims (labelling) in Europe

Innovators in the nutraceutical sector must also navigate EU and UK regulation when seeking to market their innovative products. EU Regulation on food labelling and equivalent UK regulation prohibits labelling of foods with assertions that they prevent, treat or cure human diseases, which is understandable since they do not go through the same regulatory approval as medicinal products do. However, the regulation does allow assertions that a foodstuff reduces the risk of disease, provided it is listed on the EC Register of acceptable health claims.

If a nootropic or a nutraceutical product, cannot be marketed in the EU or UK as being useful for preventing or treating a human disease, how much value is there in granted patent claims directed to a medical use of a nutraceutical product? The answer to that is not so straightforward, but it certainly means that applicants should be considering ways to maximise the benefit of such claims, for instance by mirroring the allowable labelling language by referring to reducing the risk of a disease in the patent claim itself.

Summary

The nootropics sector is a particularly fast-growing branch of the nutraceuticals market which seems set to cement itself in the public consciousness in the future, if it hasnt already. It is clear that nootropics have a wide appeal to consumers and the innovations in the sector continue to mean that there are more options available for consumers to integrate nootropic products into their routine, and inevitably more options to biohack in a personalised and individualised fashion. Whilst there are certain hurdles for innovators to market such products, it is apparent that they can enjoy the full remit of patent protection for their innovations within the sector, at least as far as Europe and the UK are concerned.

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Nootropics revolution - patentability in the UK and EU - Lexology