The pandemic has been a turning point for the destigmatisation of discussions about mental health, with more people than ever speaking to their friends and colleagues about suffering from stress, anxiety, sleeplessness and depression. Joanna Thurston, Partner, and Georgia Mann, Associate, at Withers and Rogers, report
As a result, consumers seeking to take control of their health and well-being in a proactive way are turning to vitamins, minerals and supplements (VMS) to find off-the-shelf remedies to help manage these conditions. Over-the-counter or OTC products appeal to consumers who are seeking to take responsibility for their own health before exploring prescribed medicines, which may induce unwelcome side-effects.
Often, these off-the-shelf remedies are used in combination with a healthier lifestyle. As such, players in the VMS market have seen a spike in demand; some companies have been looking to reformulate and rebrand existing products to highlight their benefits in this area and meet demand for specific ailments such as anxiety or a lack of sleep.
However, the efficacy of a VMS product can depend on the method used to match them to a particular individual. Historically, such products would be truly “off-the-shelf” with the consumer being wholly responsible for the selection of which remedy to purchase. However, this selection process (and even the products themselves) is becoming far more tailored to the individual.
The most general method of personalising a VMS is the assessment method, during which a consumer answers a series of questions and receives suggestions regarding what they may be predisposed to and what remedies may help.
However, this method is relatively subjective and driven by wider demographic data; plus, there are more accurate ways of understanding one’s body, such as genetic or biomarker testing, which are examples of techniques currently being explored in personalised medicine. The ability to make use of these techniques to tailor the VMS gives consumers the confidence to take their health and well-being into their own hands.
Genetic testing is based on a snapshot of a person’s DNA, informing them of their genetic predispositions, such as anxiety for example; the results can indicate what solutions would be most effective. However, even this method has some drawbacks.
DNA provides an overview of a person’s predispositions, but not an indication of their current state of health — ultimately meaning that a genetic test cannot be used to monitor progress with time because the results will not change with further testing.
The use of biomarker and microbiome-based testing may be more appropriate for this burgeoning market, with the former looking at the whole body and the latter focusing on the chemistry of an individual’s gut. As the body’s composition regularly changes according to an individual’s lifestyle choices, these tests can be undertaken every few months to get an up-to-date picture of what is going on. This information can then be used to adjust their remedy regimen.
These testing methods allow nutraceutical companies to create more innovative products that are specifically focused on the customer’s individual needs.
With the increase in discussion around mental health and well-being, and the associated surge in demand for natural remedies, there has also been a dramatic increase in innovation in the VMS space.
One of these exciting innovations is discussed in US20200352206A1, which describes a mushroom mycelial compound and botanical mixture aimed at calming anxiety.1 Key to the invention is cultivating mushroom fungi in the presence of nutritional enhancements, which increases the nutrient absorption capabilities of the fungi and brings additional nutritional benefits to the final mixture.
Another new technology is found in WO2020189899A1, an antidepressant, antianxiety, antistress, or tension-relieving composition, containing fermented Perilla frutescens extract.2 This innovation demonstrates how a formulation that makes use of a known natural herb can be inventive.
Perilla frutescens has been used primarily for pain relief and its antibacterial properties; however, the inventors have found that fermenting an extract of the herb using various micro-organisms can be used to treat anxiety and depression.
A third example features in a patent filed in the US, US20210212946, a cannabinoid composition that promotes well-being and pain management in the elderly.3 Cannabinoids are known to promote well-being, but this innovation focuses on improved oral bioavailability through mucus and the intestine. The compound has a long shelf-life and can be taken without the side-effects brought on by traditional medicinal marijuana.
Despite their novelty and high levels of demand, securing patent protection for these new VMS products is not always straightforward. To obtain a patent, a product must be both new (undisclosed) and inventive, for example, offering an unexpected advantage. It can be difficult to meet these criteria when using natural products that in some cases have been used therapeutically for thousands of years.
Moreover, countries including India and Australia have rules surrounding the granting of patents that infringe on what they consider to be “traditional knowledge.” India, through the Traditional Knowledge Digital Library (a resource documenting traditional knowledge for future generations), has a particular focus on ensuring that this knowledge is not appropriated unfairly.
The Traditional Knowledge Digital Library’s activities will often involve blocking attempts to patent remedies that they believe offer nothing new or inventive compared with what has always been known. In doing so, they are preserving the medicines of the ayurvedic tradition, which have been utilised for millennia.
Formulations that make use of these traditional medicaments may find it more challenging to secure patent protection; however, it is not impossible. Even though the key active ingredient may be well known, all that needs to be proven is that the formulation of the active (or the method used to prepare it) is new and inventive.
One way to achieve this is through the reformulation of ingredients such that the finished product itself (actives, carriers, etc.) is new and offers some unexpected advantage. One way to show this is to demonstrate synergic or other benefits.
For instance, it may be that the efficacy of a formulation is greater than the sum of the efficacy of its individual actives, or it may be the case that a specific choice of carrier enhances the efficacy of one or more actives. For example, an ingredient commonly used in pain relief, if included in a sleeping draught, may be found to have the unexpected benefit of enhancing the effects of the known sedative ingredients.
Additionally, with any chemical invention, it is always important to be able to back up claims of any inventive step when possible, for example with test data, to prove that the product is effective.
This is even more important in this sphere of innovation in which some of the components may have been used for many years (for example, the use of sedatives for their calming effect); as such, it is all the more necessary to demonstrate that a reformulation has an effect that is “over and above” what has gone before.
This is a great time of innovation for the nutraceutical industry. The growing interest in personalised health and well-being will only increase as consumers look to engage more with the latest forms of testing on offer and track their outcomes.
Although these tests are currently accurate enough to be useful to individuals, they are still quite expensive and further innovation will be needed to drive down the price points to make them truly accessible to all. Until then, given the increase in demand for VMS, innovators in the field will continue to develop new formulations and bring them to market, continuing to broaden the choices of products available to the off-the-shelf user.