Key Considerations For Patenting Nutraceuticals/Dietary Supplements

When your doctor says you are suffering from a lifestyle disease, they aim to recommend specific dietary/food/ nutritional supplements in addition to the prescribed medicine for stemming the symptoms and curing the disease. They also recommend healthy lifestyle changes as preventive measures. Food supplements, dietary supplements, and nutraceuticals are recommended to achieve improved health and wellness conditions. For example, if a doctor suggests taking pills that contain single components like vitamins to treat deficiencies, it is recommended to take food supplements that are necessary to meet the requirement deficiency of the patient. If they suggest taking a composition of nutraceuticals derived from food sources, they may include natural compounds like dietary fibres, flavonoids, and probiotics.

The purpose of taking food /dietary supplements is essentially to meet the patient’s nutrient deficiencies in the body. Nutraceuticals, on the other hand, go beyond supplementing the body’s needs to reduce the risk of disease and facilitate treatment. Understanding the complexity of how diet and the genome interact leads to developing varieties of personalised nutrition regimes for individuals. The word “nutraceutical” is a portmanteau of the words “nutrition” and “pharmaceutical”, coined in 1989 by Stephen L. DeFelice.

The term ‘Nutraceutical’ is given by marketing experts to imply a pharmaceutical effect from a compound or food product yet to qualify as a product that has a clinical benefit. They are considered and regulated as a subset of foods, such as dietary supplements, by the food and drug authorities. As the term ‘nutraceutical’ suggests, they are products derived from food sources that have extra health benefits apart from being a provider of basic nutritional value found in foods. Some of these products claim to prevent chronic diseases, improve health, delay the ageing process, increase life expectancy, support the structure or function of the body or act as an adjuvant to therapy with standard medications.

Nutraceutical Definition

The term ‘nutraceutical,’ coined by Stephen DeFelice, was originally defined as a food or part of a food that has medical or health benefits, including the prevention and treatment of disease. With passing time, this is reshaped to mean that nutraceuticals are constituted by the Phyto complex if they derive from a food of vegetal origin and as the pool of the secondary metabolites if they derive from a food of animal origin in a concentrated form. In both cases, they must be administered in the most suitable pharmaceutical form, and they must have a beneficial health effect substantiated by clinical data.

Nutraceutical vs Pharmaceutical Supplements

The use of food /dietary supplements has been phenomenal, as positive results were visible in the treatment of lifestyle diseases like depression, heart disease, osteoporosis, etc. In the early nineties, we have seen nutraceutical products like eggs with fish-derived fatty acids to lower the risk of heart disease; orange juice fortified with calcium to fight osteoporosis; herbal teas with antioxidants that may lower cancer risks; and margarine laced with a wood pulp ingredient that lowers cholesterol by 10% being sold in open market. Vitamin C chewable tablets or calcium tablets are specific supplements. Examples of nutraceuticals include soy protein, garlic, green tea, and many others.

Therefore, the main difference between nutraceuticals vs. pharmaceutical supplements is that the former are nutritionally rich whole foods while the latter are pills and tablets that contain an isolated nutrient. Calcium, omega-3 polyunsaturated fatty acids, vitamin D, folic acid, resveratrol, alpha-lipoic acid, zinc, inositol, and probiotic supplements are potentially proven candidates as novel nutraceuticals. No doubt, functional foods designed to optimise health or prevent chronic illness will be a future era of health-savvy GenNext.

Nutraceutical: Novelty and Obviousness Hurdle

Like any other pharmaceutical invention, the nutraceutical /dietary supplement patent application should clear the hurdle of novelty and obviousness under the patent law to become eligible for patent protection. This requirement is more stringent than that of a pharmaceutical patent application, as most of the nutraceuticals/dietary supplements are derived from known medicinally useful food sources. Since nutraceuticals are derived from food sources and can include natural compounds like dietary fibres, flavonoids, probiotics, etc., they are subjected to close scrutiny by the patent examiner in all jurisdictions, including India.

In the USA and even in other jurisdictions, the scope of getting a patent on a product of nature has not changed over time since the first pure-form patent was granted. In a 2019 US district court in a pure form cannabinoids case, claims of UCANN’s patent [US 9,730,911] for “[a] liquid cannabinoid formulation, wherein at least 95% of the total cannabinoids is” a specified cannabinoid (CBD or THC or a combination) were allowed denying Pure Hemp’s early motion for partial summary judgment. The court, in this case, did not deviate from the precedent for granting patents for purified natural products, thus leaving enough room for the grant of such patents.

Patent Law and Dietary Supplements!

Dietary supplements are clearly the product of naturally occurring substances possessing properties to help improve immunity or cure the deficiency in vitamins, amino acids, or other minerals required for a healthy body. They come in various forms, such as herbs, potions, or combinations of nutritional substances. They include protein powder, creatine, probiotics, omega-3 fatty acids, fibre supplements, and energy drinks. Recently, weight management and sports nutrition supplements were added to the list.

Functional foods like fortified cereals for breakfast and energy bars are becoming popular in health-conscious society. Innovative products relating to nutritional or dietary supplements are developed by leading companies, and they are seeking patents throughout the world, including India. Patenting nutraceuticals/dietary supplements can be complex and challenging as such innovations are subjected to the provisions of the stringent national patent law requirement for patentability.

Like pharmaceuticals, nutraceuticals are also subjected to the same patentability requirements, such as novelty, non-obviousness, and industrial applicability. Additionally, under Indian patent law, the subject matter should not be barred under Section 3(c) being naturally occurring (Natural products exception) if a nutraceutical is derived from a natural source. When the patents are sought for composition and method claims, such as for specific formulations, dosing regimens, or methods of use, they are subjected to Section 3(e) exceptions where patents are not available for mere admixtures. In certain cases where the patent claims are sought for a new form of known substance, the applicant is required to demonstrate its therapeutic efficacy to become patent eligible under Section 3(d).

Obviousness Hurdle of Nutraceuticals

It is not true that every substantially pure form of a natural product would have a free ride on patent grants. The product of nature so claimed would be subjected to Section 2(1)(j) in India and other jurisdictions to cross the obviousness threshold to pass the patent grant. For example, a patent for pharmaceutical compositions of substantially pure levoleucovorin in [US 6,500,829] was in dispute between Spectrum Pharmaceuticals, Inc., v. Sandoz Inc., [Fed. Cir. October 2, 2015].

The Federal circuit court in this case held that claims of a mixture comprising at least 92% of the (6S) isomer of leucovorin are obvious when both the 50/50 mixture of isomers and the pure (6S) isomer were known in the art. The court also found that there was no evidence to indicate that the claimed mixture “possessed unexpected advantages over the prior art pure material” so as to overcome obviousness.” Another aspect which went against the patent was the evidence that clearly demonstrated that purified (6S) leucovorin and a 50/50 mixture of isomers are clinically interchangeable.

There is no blanket ban on the patent eligibility of nutraceuticals under patent law in India or other jurisdictions. Many patents are granted for nutraceuticals in all jurisdictions, including India. In an appeal case, The Research Foundation of State University of New York vs Assistant Controller of Patents [IPAB August 10, 2012], the Board observed that when a claim for product-by-process is obvious from a prior product, such is not patentable irrespective of prior art being made available in another process. Therefore, a claim must define novelty and non-obviousness in a product along with an inventive step. Interestingly, an amended claim for a method of preparing ceramic nanoparticles loaded with one or more photosensitive drugs for the treatment of cancer was allowed in this case. This precedence is applicable to nutraceuticals as well.

Position in USA

The US is perhaps the first patent office to grant patents for nutritional supplements. US 4839281 (June 13, 1989) and 5032399 (July 16, 1991) are among the first patents about the probiotics use of Lactobacillus acidophilus for humans. A representative list of granted patents in the US is given below:

Position in EPO

The position of the European patent office in relation to the allowability of nutraceutical patents is like USPTO as we see patents for nutraceutical compositions such as Probiotic compositions, Omega-3 fatty acid composition, Curcuminoid compositions, etc., were granted in EPO as well. The representative list of food supplement patents granted by the European Patent Office (EPO) is given below:

Position in India

As stated earlier, inventions relating to nutraceuticals may not be patentable if they are deemed a “product of nature” under Section 3(c). However, an Indian patent for “A process for the preparation of novel herbal nutraceutical” (IN211254) was granted to the CSIR-Indian Institute of Integrative Medicine (CSIR-IIIM), Jammu, in 2007. The applicant here disclosed novel herbal jams and jellies with proven pharmacological activities such as memory enhancers, antioxidants, anti-depressants, immuno-modulators, adaptogens, health promoters, and chemically standardised on the basis of one or more bioactive constituents. Similarly, the Council of Scientific and Industrial Research granted a patent for a novel method of preparing sugar-free bread (IN 251558) in 2012, highlighting patentable innovation in nutraceuticals.

Section 3(d) and Nutraceuticals

In the Indian context, if the product of nature substantially differs from the product which is the result of the handiwork of the inventor, he may cross the 3(d)-line directed to one of those patent-ineligible concepts such as pure form. The only requirement in India for such products would be that they are mandated to prove their efficacy over the known product. Therefore, in India, purity per se is not a guarantee that a patent would be granted.

However, the claim to a process to isolate a substance occurring in nature and making it available in pure form is patentable. Where the claims for isolation of a product of nature or substance occurring in nature is characterised by its process or structure, it would also qualify as patent-eligible subject matter. In such a situation, the claims may include the patenting of the product of nature per se.

Indian position about patent eligibility of the product of nature remains in the realms of elusive debates for want of any judicial precedence on the subject in India. Section 2(1)(j) defines an invention as any new product or new process without differentiating between ‘product of nature’ or ‘manmade’ products. However, Section 3(c) clearly points out that the discovery of living things or non-living substances is not a patentable invention.

In the second limb, the word ‘mere’ conspicuously is omitted to perhaps leave room for invention relating to substances occurring in nature which are not discovered but extracted or removed from nature not occurring freely in nature. Here, the structural similarity of the pure form with the natural form at times creates the patentability hurdle of being new as compared to the naturally existing one. Its usefulness, however, can make it cross the patentability line.

New Form of Known Substance: Examiners Consideration

The question before the examiner in nutraceutical application is to distinguish between ‘product of nature’ from ‘products derived from nature.’ He must shed his inherency bias to arrive at a decision on novelty, as every such product of nature does not exist in a free state and in a useful form. In India, the mere discovery of a new form of known substance when it is a product of nature would find a hurdle in Section 3(d). The question which is required to be answered here is whether the new form of a known substance results in the enhancement of the known efficacy of that substance. If we apply Section 3(d) explanation particularly to the ‘pure form’ the nutraceutical application is expected to provide clear and convincing evidence in terms of difference significantly in properties with regard to efficacy.

The difference in its form may cross the line of novelty under Section 2(1)(j), but its improvement in efficacy supported by evidence/data can only beat the threshold of patentability under Section 3(d). Supreme court view on efficacy in Novartis case that “The amended portion of Section 3(d) clearly sets up a second tier of qualifying standards for chemical substances/pharmaceutical products in order to leave the door open for true and genuine inventions but, at the same time, to check any attempt at repetitive patenting or extension of the patent term on spurious grounds”. Here the efficacy as explained by the Supreme court Should in the context of the pharmaceutical/nutraceuticals patenting be understood as “therapeutic efficacy.”

Section 3(p)

If the application of a claimed nutraceutical is for an invention which, in effect, is traditional knowledge or which is an aggregation or duplication of known properties of traditionally known component or components, it is considered non-patentable in India under Section 3(p). For instance, in an application [3089/CHENP/2007] for supplement dietary composition for promoting weight loss filed by Smart Formulations Ltd, Section 3(p) objection was raised by the Controller stating that

“The instant application relates to a supplementary dietary composition comprising extracts of various plant species like Garcinia cambogia, Gymnema Sylvestre, Grape skin, Ginseng, etc., and

However, in the Traditional Knowledge Digital Library (TKDL), there are references [See., RS23/643B-Arsoghna Kvatha; AM04/392-Mukkathaari Ennai; RS8/472A -Ajasringi guna; VK3/608-Vikranta Marana; RG6/454-Tiksnalauhadrutih; VK5/1563B Laksmana Yoga; GP 02/221-Sagala Moolathirkum legyam] wherein the said extracts are used in various formulations.”

In view of the TKDL citations, the applicant allowed the application to be deemed abandoned under Section 21(1).

Nutraceutical/Dietary Supplement Patents Granted in India

There is no inherent stigma or bias on the patentability of nutraceuticals/dietary supplements on materials derived or obtained from nature in India. The patent law clearly distinguishes between finding new substances in nature and making material existing in nature available in a usable form. A list of representative examples of a few more nutraceutical / Dietary supplement patents granted in India is given below:

Parting Remarks: Future Prospects

Nutraceutical subject products fit in for an alternative nonpharmacological treatment to a pathological condition; the incorporation of nutraceuticals into the daily diet may aid in the prevention of pathological disorders. There are claims that foods, including spices and herbs, possess the tendency to decrease the risk of many diseases and can be highly beneficial in improving the quality of life. There is a plethora of patent applications relating to nutraceuticals with promising results in the prevention and treatment of complicated diseases. Nutraceutical applications may include single or combinations of pro- and pre-biotic foodstuff and food for special medical uses, and food supplements include single or combinations of minerals, vitamins, protein supplements, functional foods, and herbal products.

The main issue and challenge for research and patents remains to assess and substantiate with clinical evidence of their clinical efficacy of a nutraceutical to be eligible for grant of patents in India to stay clear from the bar imposed under Section 3(d) This Spectrum Pharmaceuticals discussed above clearly demonstrates that possibility of getting a patent or defending it rests on proving its efficacy over the known product. Patent Act in the Indian context codified this thin line under Section 3(d) to keep obvious or clinically interchangeable products under non-patentable subject matter to put a check on the evergreening of a patent. If the applicant claims the composition of many products, they must cross the mere mixture hurdle under Section 3(e).

Additionally, the applicant claiming the traditional knowledge may face rejection under Section 3(p), as happened in the Smart Formulations case where the application was refused, could have been based on the cited TKDL prior art. According to recent reports, the nutraceutical industry in India reached an estimated 3.5 per cent of the global nutraceutical market in 2023. If such trends continue, it may touch US $18 billion by 2025. Interestingly, India imports US$ 2.7 billion worth of nutraceuticals. This presents an opportunity for inventors engaged in nutraceutical research to seek patents in India as well. Expert help can be handy to obtain patent protection in India and gain an edge over your competitors.

Author: DPS Parmar

First Published by: Mondaq here