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Guidelines for patenting natural products

Article-Guidelines for patenting natural products

With so many products and formulations coming onto the market, patenting creations should be a part of any brand’s strategy to protect extensive research and development efforts.

Fred Nicolle, managing associate in intellectual property at law firm, Simmons & Simmons, highlights the recent trend of organisations increasingly obtaining patents for natural products such as dietary supplements. The trend also reflects the highly competitive nature of the natural products market, meaning organisations are proactively seeking ways to protect their new innovative products.

However, patenting natural products does not come without its challenges, and Nicolle highlights two main issues that are particularly relevant. The first is the novelty required to be granted a patent, whereby an invention must be new to be patentable. Natural ingredients can encounter difficulties in this regard because a natural ingredient, by definition, already exists in nature and is arguably not new. However, Nicolle outlines ways to overcome this, such as by defining newly isolated natural ingredients (existing in nature but not previously isolated by means of a technical process), new uses (such as new therapies or cosmetic uses of natural ingredients), new combinations (such as new combinations of active natural ingredients that work together synergistically), new formulations (such as new amounts and ratios of natural ingredients and excipients that bring about a benefit), and new delivery devices (such as therapeutic dosage forms of natural ingredients) that may be patentable depending on the jurisdiction.

The second issue concerns allegations of 'biopiracy.' Nicolle’s highlights that this is where an organisation can be accused of commercially exploiting naturally occurring biochemical or genetic material, such as by obtaining patents, while failing to pay compensation to the community from which it originates. For example, in 2016, the French Institute for Development Research (IRD) was accused of patenting the new malaria drug, Simalikalactone E. Moreover, he outlines a rise in biopiracy in cases of his own with anti-biopiracy groups filing arguments at the patent office, a trend he thinks brands should be aware of, and one he expects to continue as consumer interest in natural products increases.

In addition to the issues mentioned above, some ingredients can be particularly complex to patent, and brands should be aware of the intricacies involved. Nicolle outlines that a combination of multiple active ingredients can be tricky to patent. This is because—under European law—a beneficial synergistic effect must be proven beyond a simple additive effect. This generally requires the applicant to provide experimental data, demonstrating that a synergistic effect is achieved by the specific combination of actives, not other components of the product. Therefore, not only does patenting protect a brand’s research and development efforts but allows a brand to add credibility by separating it from those without the experimental data required for such patents.