As consumer demand shifts towards healthier lifestyles, the food industry is rapidly evolving beyond traditional nutrition.
From functional beverages and plant-based alternatives to enhanced infant formulas and botanically enriched foods, a new category of “functional foods” is gaining commercial traction.
These products are designed not only to nourish but to deliver specific health benefits or support defined physiological outcomes. That commercial proposition, however, raises an important legal and strategic question for businesses: can these innovations be protected under patent law?
A growing IP battleground
In principle, functional foods can be patented in several ways. Protection may attach to a novel composition, its use, or the health benefits associated with its consumption.
The complexity lies in whether those benefits are therapeutic: if they are, method-of-treatment exclusions must be navigated; if they are not, the claimed benefit cannot confer novelty on a known composition.
Under South African patent law, methods of treating humans or animals by therapy are excluded from patentability. However, substances or compositions intended for use in such methods may still qualify for protection.
This creates a nuanced distinction: while treatment methods cannot be patented, the product used in that treatment potentially can. This framework closely aligns with European patent law, to which South African courts frequently look for guidance.
Patrick O'Brien and Jonathan Whittaker 29 Mar 2023 Drawing the line between nutrition and therapy
A key issue for companies developing functional foods is whether a claimed benefit is considered “therapeutic”. Although South African courts have not directly interpreted the term in this context, guidance from the European Patent Office suggests that therapy includes treatment aimed at curing, alleviating or preventing disease.
Crucially, this does not extend to general health maintenance, nutrition or normal physiological development. That distinction can determine whether a product falls within or outside the statutory exclusion.
Recent European decisions highlight how finely balanced this line can be. In a case involving Nestlé and Nutricia, the EPO Board of Appeal considered an infant formula claimed to promote postnatal growth comparable to breastfed infants. The Board concluded that supporting normal growth did not amount to therapy, as it did not address a pathological condition.
As a result, the claim was treated as a standard product claim rather than a therapeutic one. Under patent law, only therapeutic uses can confer novelty on known compositions through special “for use” provisions. Without a therapeutic benefit, and without a novel composition to distinguish it, the patent was ultimately revoked for lack of novelty.
For businesses, the implication is clear: where a product’s benefits are framed as general wellness, novelty must lie in the formulation itself - not the claimed outcome.
Patrick O'Brien and Dina Biagio 1 Feb 2024 Where therapeutic claims succeed
By contrast, patents have been granted where functional foods demonstrate clear therapeutic effects. For example, Nestlé has secured patent protection for a composition containing cocoa polyphenols and dietary fibre designed to prevent or treat gastrointestinal and allergy-related disorders.
In that instance, the EPO accepted purpose-limited product claims, commonly referred to as products “for use” in treating specific conditions, because the therapeutic effect was both credible and properly supported. Given the alignment between European and South African law, similarly structured claims are likely to be viable locally under the right conditions.
Claim strategy is key
South African case law also provides guidance on how such claims should be framed. Courts have endorsed “for use” for first medical uses of known substances, while requiring so-called Swiss-type claims for subsequent uses.
However, Swiss-type claims, which are directed to use of a substance in the manufacture of a medicament, do not sit comfortably with functional foods. This is because functional foods are consumed as finished products rather than being manufactured into a separate medicament.
This makes purpose-limited product claims a more practical route in cases involving therapeutic benefits, particularly in light of European practice.
Lance Abramson 9 May 2022 Commercial implications
For businesses operating in the functional food sector, the legal position translates into a clear strategic divide.
Where a product offers general nutritional or physiological benefits, patent protection should focus on the composition, formulation and manufacturing process. Any associated health benefits will support the invention but will not, on their own, establish novelty for the purposes of patenting.
Where a product delivers a genuine therapeutic effect, such as preventing or treating a medical condition, there may be scope to pursue more targeted protection through purpose-limited claims. However, these must be carefully drafted to navigate the patentability exclusion for methods of treatment.
A complex but valuable opportunity
For companies investing in this space, securing meaningful patent protection is not straightforward. It requires careful alignment between scientific evidence, commercial positioning and legal strategy.
Those that get it right stand to gain a significant competitive advantage as the sector matures.
