T2510/18 – Exceptions to Patentability and Novelty of Naturally Occurring Substances

In the recent decision T2510/18, the European Patent Office (EPO)’s Technical Board of Appeal 3.3.02 confirmed that the exception to patentability under Article 53(a) EPC relates to the commercial exploitation of an invention, rather than the manner of its discovery or development. Additionally, the Board clarified that the standard under novelty is what has been made available to the public, not what could be intrinsically contained in the disclosed information.

Background

The patent in suit related to a molecule, Simalikalactone E (SkE), which can be extracted from the plant Quassia amara and its use as a medicinal product in the prevention and treatment of malaria.

The patent recognised that the Quassia amara plant had been used in traditional medicine against fevers and malaria throughout the northwestern Amazon and as far as Central America. The Respondent-Patentee (RP) had identified and isolated SkE using a specific process from the leaves of Quassia amara. SkE was shown to be active against malaria.

Public policy – Articles 100(a) and 53(a) EPC

The Appellant-Opponent (AO) contended that the commercial exploitation of the claimed invention was contrary to morality and public policy under Article 53(a) of the European Patent Convention (EPC).

The AO referred to research conducted by the RP on traditional antimalarial remedies among the populations of French Guiana. This research involved a survey of 117 individuals from different communities. The project identified 45 healing recipes involving the use of 27 different plant species, including Quassia amara. The RP's investigation into these traditional remedies ultimately led to the identification of the antimalarial molecule, SkE.

The AO argued that the development of claimed invention constituted a deception of indigenous and local communities and a breach of their trust. The AO claimed that the indigenous community members were not fully and transparently informed about the project's nature, its objectives, the patent filing, and the associated risks and benefits of the project for the community members and their knowledge. The AO continued that the indigenous community did not provide consent, and no benefit-sharing arrangements were established between the knowledge holders and the RP. As a result, the community members lost control over the circulation of their knowledge with the violation of all intellectual rights to this knowledge. The AO argued that the deception and breach of trust had created a deleterious climate for research within indigenous and local communities.

The Board disagreed with the AO's assertions.

The Board held that none of the AO's claims related to the commercial exploitation of the invention, which is a prerequisite for the conclusion that the invention would be excluded under Article 53 EPC.

The Board held that the commercial exploitation of SkE, the medicinal product containing it, and its isolation process was not contrary to morality, good customs or public order. On the contrary, the Board held that there is great need for new antimalarial drugs, and the pursuit of such innovations is essential for treating vulnerable populations and saving lives.

The Board further clarified that the original development of the invention and the historical process by which the SkE molecule was discovered and isolated are unrelated to the commercial exploitation of the claims as granted, which require only the isolation of SkE from the Quassia amara plant and its administration to patients. Thus, the development of an invention is distinct from its commercial application once it has been carried out. In other words, the Board held that the exception to patentability under Article 53(a) EPC relates to the commercial exploitation of the invention, not to the manner in which it was discovered or developed.

 
Novelty – Articles 100(a) and 54 EPC

The AO argued that claims 1-6 lacked novelty based on documents D2, D3, and D5.

Documents D2, D3 and D5 described the use of Quassia amara as an antimalarial remedy. However, D2 and D3 did not identify any active molecules, while D5 referenced an earlier study that identified Simalikalactone D as the active compound.

The Board held that none of these documents explicitly described the SkE molecule.

Furthermore, the Board held that the fact that the SkE molecule may be contained in the extracts of D2, D3 and D5 does not amount to an implicit disclosure. With reference to G2/88, the Board held that the question to be answered under novelty is what has been made available to the public, not what could be intrinsically contained in what has been made available to the public. The presence of SkE in the leaves of Quassia amara or their decoction was not disclosed by the extracts of D2, D3, or D5.

AO also argued that the protection conferred by the patent would give the respondent the right to prohibit indigenous people from using Quassia amara leaves in the preparation of their traditional medicines. Since the claims were infringed by an existing use, they could not be considered novel.

The Board disagreed. The Board noted that a similar question arose in G2/88. In G2/88, the Enlarged Board of Appeal emphasised that under Article 54(2) EPC the question was what had been “made available” to the public, and not what could be “intrinsically contained” in what had been made available. Consequently, the question of “inherent content” did not arise as such under Article 54 EPC. The Enlarged Board of Appeal also noted that the question on the prior use of an invention is a matter for national law.

Final remarks

The Board ultimately found the claims as granted inventive and dismissed the AO’s appeal.

The exclusion to patentability under Article 53(a) EPC has been applied rarely at the EPO. The AO objection was therefore always going to be a difficult objection to run. In this case, the Board’s finding that the exception to patentability under Article 53(a) EPC relates to the commercial exploitation of the invention, not to the manner in which it was discovered or developed seems correct. Indeed, it is noted that Article 53(a) EPC explicitly states that European patents shall not be granted in respect of “inventions the commercial exploitation of which would be contrary to “ordre public” or morality…” (emphasis added).

The Board’s finding on novelty is consistent with the case law on taking intrinsic features into account. As stated in G2/88, “a line must be drawn between what is in fact made available [to the public] and what remains hidden or otherwise has not been made available”. In this instance, the documents cited under novelty neither disclosed nor hinted at the presence of SkE in Quassia amara leaves and thus this information had not been made available to the public.

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