New case law by the Technical Board of the European Patent Office (EPO) establishes that new active principles contained in natural extracts used in traditional remedies qualify as patentable.

According to article 54 (1) and (2) of the European Patent Convention (EPC), an invention shall be considered to be new if it does not form part of the state of the art, that is, everything made available to the public before the filing date of the patent application, or the priority date as the case may be (article 89 EPC).

In order to determine whether the subject matter of a claim has been made available to the public and therefore lacks novelty, the rule is that it will not be considered novel if, bearing in mind the common general knowledge of a person skilled in the art, the subject-matter has been disclosed in the state of the art, whether explicitly or implicitly, but always directly and unambiguously.

According to consolidated case law by the boards of appeal of the EPO, and as indicated above, a prior art disclosure destroys the novelty of the claimed subject matter if the subject matter derives directly and unambiguously from such prior art, also including the characteristics of the product that may be implicit for the person skilled in the art. However, a disclosure may only be considered “implicit” if the person skilled in the art verifies from the outset that only the supposed implicit characteristic forms part of the disclosed subject matter.

The determination of whether this requirement is met in cases where the state of the art prior to the filing of the patent application is presented in writing (scientific publications, patent documents, etc.) does not tend to give rise to debate. However, this assessment becomes complicated when the prior art occurs through prior use, for example, the use or launch of a certain product in the market.

It is here that questions arise which are, at times, difficult to answer: What is really being disclosed with the prior use of a product? Only those characteristics that are visible, such as shape and color? The characteristics of the product that are apparent when the product is being used, such as its properties or effects? Or is it the product’s intrinsic characteristics, such as the composition or components which are hidden in a first visual inspection?

In this regard, the EPO’s position has been clear to date: in cases of prior use of products, the decision of the EPO’s board of appeal in case G1/92 is applicable. This decision determined, inter alia, that the chemical composition of a product forms part of the state of the art from the time that product is available to the public and can be analyzed and reproduced by the person skilled in the art.

Therefore, it is clear from the above that placing a product in the market, apart from the characteristics that are apparent following a visual inspection, also discloses at least other characteristics that are not immediately visible, such as their composition for example, provided that these characteristics can be obtained from a technical analysis of the product through methods and procedures of which the skilled person is aware. Whether or not such analysis has been performed is not decisive, but it is vital that it can be performed.

However, a recent decision by the EPO’s technical board of appeal in case T2510/18 of May 31, 2024 offers a new interpretation of this rule, which is of particular importance when dealing with natural extracts and active principles. These active ingredients are particularly relevant in the food, cosmetics and pharmaceutical industries, where trends in innovation are often aimed at natural products with biological activity made from plants or which stem from natural sources.

We analyze the key aspects of this important decision below.

The underlying issue: which characteristics of a natural product can be considered disclosed through the prior use of the product

Decision T2510/18 ruled on the dismissal of an opposition against the grant of European patent EP2443126B1 aimed at protecting the molecule Simalikalactone E (SkE) (which can be extracted from the Quassia amara plant), its use as a drug in the prevention and treatment of malaria, as well as a particular method of extracting the molecule from dried mature leaves of this plant.

The patent recognized that the Quassia amara plant had been used in traditional medicine against fever and malaria, in the north-west of the Amazon and Central America. The granted patent identified and isolated the molecule SkE, the main component of the extract from this plant, through a specific process obtained from the (dried mature) leaves. This molecule has proven to be active against malaria.

However, during the opposition stage, the opponent alleged lack of novelty of the granted patent based on documents that evidence the traditional use in French Guyana of extracts (aqueous decococtions) obtained from leaves of the Quasia amara plant as remedies against malaria. That is, the opponents argued that the invention lacked novelty, because the prior use of extracts from the leaves of the same plant that were also used to treat the same disease, entailed a complete disclosure of the subject-matter of the patent in line with the interpretation of novelty applied by the EPO based on the above-mentioned case law.

Therefore, if the extract from the leaves of the plant in question had already been obtained and used (disclosure due to prior use) with the same biological effect, the intrinsic characteristics of the extract of the plant (such as, for example, its composition and the elements of this composition) should also form part of the state of the art and, consequently anticipate the patentability of any molecule contained in said extract.

Moreover, the opponents managed to identify the molecule SkE in the aqueous extracts of the leaves of the plant, which confirmed that the molecule SkE was indeed present as an ingredient of those extracts that had been used traditionally in the past.

However, although the presence of SkE in the extracts used previously was accepted, the board of appeal held that for this prior use to be considered an anticipation of novelty with respect to the molecule SkE, it was essential for such use to reveal a direct and unambiguous disclosure of what had explicitly been defined as an “invention” in the claims of the patent in question. That is, the evidence related to the prior use had to directly and unambiguously disclose the presence of the molecule SkE in the extracts, since the patent’s claims precisely protect that molecule. In the case under debate, the molecule SkE was not found to be directly and unambiguously disclosed, either explicitly or implicitly.

The fact that the molecule SkE may be contained in extracts that have been used traditionally in the past was not considered to amount to implicit disclosure either. According to the board of appeal, the key issue was what had been made available to the public, and not what could be intrinsically contained in what had been made available. In this regard, the board of appeal concluded that the presence of the molecule SkE in the leaves of Quassia amara or in its decoction was not tantamount to making the molecule SkE available to the public as such.

Consequently, the patent proprietor may maintain the protection of the molecule SkE and extend said protection to any product that contains the molecule and any use or application of same.

Decision T2510/18 paves the way to new patent options

Decision T2510/18 is important because it confirms new patent perspectives for developments in research projects involving new natural ingredients – which are currently witnessing such a boom – to make food products, natural cosmetics and effective pharmaceuticals.

According to article 63 of Patents Law 2015, the proprietor of these possible patents may not claim rights in the patent against those who were already exploiting the extracts before it was granted, but may do so against third parties that start to exploit said extracts as from the filing date of the patent application that was finally granted.