Patenting natural products (part 2): new uses and formulations

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. However, in many cases, cosmetics, personal care products, foods and dietary supplements contain natural ingredients that have been known for many years (sometimes thousands of years), meaning it is not possible to patent the natural ingredient as an isolated compound per se. Instead, other forms of patent protection may be available. In this article, we look at situations where a natural product is already known and isolated, but is found to have a new use.

In most cases, merely claiming that the natural ingredient is 'for' a specific use is unlikely to provide patentability in Europe, because this will be interpreted as a product 'suitable for' the use. The claim would likely lack novelty over a previous disclosure of the natural ingredient for any use, if this is considered 'suitable for' the new use.

This leaves essentially three options for patent protection of new uses in Europe. In each case, the natural ingredient may already be known, but becomes patentable by virtue of the way it is used or the form in which it is used.

Firstly, it might be possible to claim a new method of using the natural ingredient, such as a 'method of dyeing hair using [natural ingredient X]'. However, this will require care that the claimed method does not inadvertently encompass a method of therapy, which is excluded from patentability under European law for public policy reasons (see our article Patenting cosmetic methods encompassing therapy)

Secondly, where the natural ingredient has a new therapeutic use, it might be possible to claim the natural ingredient in the form of a second medical use claim, such as '[natural ingredient X] for use in the treatment of diabetes mellitus'. This is a specific exception to the 'suitable for' principle discussed above, but is limited to therapeutic substances and may be of less relevance for cosmetics, personal care, foods and dietary supplements.

Thirdly, where the natural ingredient is made up in a new formulation, it might be possible to claim the formulation itself. This option may be especially valuable, because it is directed to a product without limitation to its use and may be easier to enforce for patent infringement. A claim to a new formulation is subject to the same requirements for patentability as any other invention, in particular that it must be new and inventive. For example, a formulation could derive novelty by defining specific ingredients in new amounts and/or ratios, such as 'A cosmetic composition comprising: 0.05 to 1.0 wt% [natural ingredient X], 0.01 to 2.0 wt% [excipient Y], 0.001 to 0.2 % wt% [excipient Z], and the remainder up to 100 wt% water'. Or, a formulation could derive novelty by defining a new form in which the natural ingredient is presented, such as 'A formulation comprising [natural ingredient X], where the formulation is in a product form of a soap, cosmetic wipe, spray or cream.' Inventive step will typically require that the novel feature of the formulation shows an unexpected technical effect. It is important that this effect can be shown to be tied to the new feature of the formulation, which may require comparative tests against formulations of the prior art.

In summary, there are various options for patenting natural products in Europe, such as by claiming new uses and formulations. However, care is needed to select the appropriate form of protection in each individual case and to determine what supporting data may be required. Moreover, due to the European Patent Office's strict assessment of priority and added subject matter, it is important that all necessary subject matter is included in the first application for the invention. 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 formulations containing more than one active ingredient.

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