Patenting natural products (part 3): new combinations of actives

Products containing natural ingredients are popular with consumers in a variety of fields, such as cosmetics, personal care, foods and dietary supplements. However, patenting natural products can present significant challenges. For a natural product to be patentable it must (like any other invention) be new and inventive. But, a natural product (by definition) must have existed previously in nature, which immediately raises the question "how can a natural product ever be new and patentable?"

In part 1 (here), we saw that European law may allow patents to natural products that are isolated for the first time from the natural environment. In part 2 (here), we looked at situations where a natural product is already known and isolated, but is found to have a new use. In this part, we look at new combinations of natural products that show a synergistic effect.

Cosmetics, personal care products, foods and dietary supplements may contain multiple active ingredients of natural origin. These active ingredients may already be known in isolation, but not together in combination, which means the combination of active ingredients may be new and patentable. However, difficulties can arise for such combinations when considering inventive step under European law. A recent decision by the European Patent Office's Boards of Appeal (T2322/15 of 14 May 2019) illustrates these difficulties, where claim 1 of the Patentee's patent (as a first auxiliary request) was directed to "A hypoallergenic high intensity fragrance composition in which all the ingredients are natural, which comprises by weight: 75% to 100% of at least 4 fragrance ingredients selected from [a list of natural ingredients]".

The Patentee relied upon the specific combination of 4 natural ingredients for novelty. However, objections were raised to a lack of inventive step for the combination. The Patentee filed a test report comparing the olfactory properties of specific compositions falling within the scope of claim 1 against a composition of the prior art, and this indeed showed that the tested fragrance compositions of the invention had a higher odour intensity. However, the Board dismissed the experiments, because it was not considered credible from the data that all fragrance compositions covered by claim 1 would show the higher odour intensity. The Board objected that the test report did not substantiate why the effects for the specific tested compositions could be extrapolated to any composition covered by the claim. For example, the natural fragrances were selected from a diverse list with no structural characteristic in common, meaning it could not be assumed that a similar effect would be seen for any of the listed fragrances. Moreover, for a comparative test to properly demonstrate an improved effect, the nature of the comparison against the closest prior art must show its origin in the novel feature of the invention (in this case the combination of 4 natural ingredients). In the Board's view, the Patentee's test report did not convincingly link the higher odour intensity to the novel combination of ingredients. As a result, the objective technical problem for determining inventive step over the prior art had to be defined as "the provision of alternative hypoallergenic fragrance compositions". The claimed combination of 4 known natural ingredients to provide an alternative (i.e. not improved) composition was found to lack inventive step as an obvious routine activity of the skilled person.

This decision emphasises the importance of robust data / comparative tests when dealing with new combinations of known active ingredients. It can be tempting for an applicant to argue that a new combination of active ingredients is inventive simply because a skilled person would not have been motivated to reach the specific combination as claimed. However, such arguments are unlikely to succeed at the European Patent Office, if no technical effect is shown for the combination of active ingredients. According to European case law, no specific motivation is required for a skilled person to make an arbitrary choice when providing a mere alternative.

Supporting data need to show an advantage that is specifically tied the novel feature of the claim. Where this novel feature is a new combination of known active ingredients, the data should show an improved synergistic effect for the combination that goes beyond a mere additive effect. Ideally, experiments should show a comparison of the combination against each active ingredient in isolation, as well as against the closest prior art.

In summary, new combinations of natural products can be patentable at the European Patent Office, but such inventions can be vulnerable to objections of lack of inventive step. Supporting data may be required to show an unexpected synergistic effect for the combination. These data could be provided after filing, but only on the condition that the effect is at least plausible from the application as filed. Applicants may therefore find it valuable to consult a European patent attorney with experience in natural products at an early stage of patent drafting.

In the next article on patenting natural products, we will look at the topic "biopiracy" and how this interacts with the patent system.

For further information, contact Frederick Nicolle, Managing Associate (Patent Attorney), Intellectual Property at Simmons & Simmons.