Patenting natural products (part 1): newly isolated material
The approach under European law to patenting newly isolated natural material.
Products containing natural ingredients are popular with consumers in a variety of fields, such as cosmetics, personal care, foods and dietary supplements. The natural cosmetics market alone is projected to grow over 5% annually and to be worth $48.04 billion by 2025, with Europe as the largest regional segment1. The market is also highly competitive, making intellectual property protection, including patents, an important tool for securing and retaining market share. However, patenting natural products can present significant challenges.
This first article on patenting natural products looks at the approach under European law to patenting newly isolated natural material. Following articles will look at new uses, new formulations and new combinations of known natural ingredients, as well as the topic of "biopiracy".
In order for a natural product to be patentable it must (like any other invention) be new and inventive. Novelty and inventive step are assessed against everything made available to the public by means of a written or oral description, by use, or in any other way, before the date of filing of the patent application. However, 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?"
Yet, according to Rule 27(a) of the European Patent Convention, biotechnological inventions may be patentable if they concern "biological material which is isolated from its natural environment or produced by means of a technical process even if it previously occurred in nature". For example, a patent might be granted under European law to a specific extract that is isolated from a naturally occurring plant in a form that does not exist in nature as such.
The European Patent Office's Guidelines for Examination go on to explain that "to find a previously unrecognised substance occurring in nature is... mere discovery and therefore unpatentable. However, if a substance found in nature can be shown to produce a technical effect, it may be patentable. An example of such a case is that of a substance occurring in nature which is found to have an antibiotic effect." This introduces a further "utility" requirement that the natural product must produce a technical effect and therefore be useful. However, it is important to recognise that this "utility" technical effect does not need to be new as such, as long as the natural product has not been isolated from its natural environment before and is thus a novel product per se.
In other words, the simple fact that a substance is derived from nature does not, in itself, prevent it from being patentable in Europe, as long as the substance has not been isolated from its natural environment before and has a useful effect.
In this context, Europe appears much more permissive than the USA. In the famous Myriad decision2, the US Supreme Court ruled (in the context of a naturally occurring segment of DNA) that "A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but cDNA is patent eligible because it is not naturally occurring". Following this, the United States Patent and Trademark Office has typically been rejecting claims to naturally occurring products. As a consequence, patents may be granted in Europe for natural products that may not be eligible for patent protection in the USA following Myriad.
Yet, in practice, things are rarely that simple. For example, merely stating that an ingredient is "natural" is unlikely to be considered clear and may not be able to provide patentability on its own. In a recent decision by the European Patent Office Boards of Appeal (T2322/15 of 14 May 2019) claim 1 of the patent was directed to "A hypoallergenic high intensity fragrance composition in which all the ingredients are natural...". The Board disregarded the natural character of the ingredients for assessing patentability, stating that "The feature that all the ingredients of the composition must be natural does not make it possible to clearly distinguish the claimed composition from the state of the art as natural compounds can also be synthesized." This illustrates the importance of making a compelling case that a natural product is truly natural and isolated for the first time, as well as being clearly defined.
Moreover, in order to satisfy the requirement that the natural product produces a useful effect, it is important for the patent application as filed to include supporting data to demonstrate this effect (at least plausibly). For a cosmetic or personal care product, this effect could be, for example, reducing the appearance of wrinkles or blemishes, or improving skin hydration. For a food or dietary supplement, this could be, for example, improving health or nutrition.
Finally, a brief mention of sufficiency of disclosure, which is another requirement for patentability. A patent must disclose the invention in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art. For a natural product isolated from its natural environment for the first time, it will be of crucial importance that the patent discloses the means for isolating the natural product.
In summary, European law may allow patents to be granted to natural products that are isolated for the first time from the natural environment, where such products may not be eligible for patent protection in the USA. However, the patent application will require compelling evidence that the natural product produces a useful technical effect, as well as details of the means to isolate the product. Due to the European Patent Office's strict assessment of priority and added subject matter, it is important that all 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 situations where a natural product is already known in an isolated form, but for a different use.
For further information, contact Frederick Nicolle, Managing Associate (Patent Attorney), Intellectual Property at Simmons & Simmons.
2 Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013)
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