EP 2 443 126 B1 relates to a molecule, simalikalactone E (SkE), and its use as medicament.
Brief outline of the case
The opposition was rejected and the opponents appealed.
The board confirmed the revocation.
Background of the patent
It was acknowledged in the patent that the Quassia amara plant had been used in traditional medicine against fevers and malaria throughout the north-western Amazon and as far afield as Central America.
The proprietor identified and isolated SkE using a specific process from, mature and dried, Quassia amara leaves. This molecule has been shown to be active against malaria.
The opponents’ point of view
The opponents pointed out that the commercial exploitation of the claimed invention was contrary to good morals and public policy under Art 53a), insofar as it did not conform to morality or to the set of accepted norms deeply rooted in European culture. These norms concern those governing research with indigenous and local communities and the use of their traditional knowledge.
According to the opponents, in the early 2000s, the proprietor conducted research on traditional anti-malarial remedies with the populations of French Guyana. It also examined and analysed traditional remedies used to treat malaria. This led to the identification of an antimalarial molecule, SkE.
The behaviour of the proprietor, are contrary to accepted norms, particularly those governing research with aboriginal communities and the use of their traditional knowledge, constituted a deception of aboriginal and local communities and a breach of their trust in the development of the invention in question.
Indeed, it was thanks to the contribution of traditional knowledge that the proprietor’s researchers succeeded in identifying the SkE molecule.
No benefit sharing was organized between the holders of this traditional knowledge and the proprietor’s researchers. As a result, the communities have lost control over the circulation of their knowledge, and all intellectual rights to this knowledge have been violated.
The commercial exploitation of the claimed invention was likely to cause serious public disorder and jeopardize the relationship of trust between indigenous and local communities and researchers, with serious consequences for the advancement of science. The protection conferred by claim 1 of the contested patent would enable the respondent to prevent indigenous populations from using Quassia amara leaves in the preparation of their traditional remedies.
The opponent’s also referred to, inter alia, G 2/06 as well as T 315/03.
The opponents argued that claim 1 was not limited to SkE in “isolated” form. It therefore conferred absolute protection on the SkE molecule, in any circumstance and in any context, this protection therefore extending to any preparation, or even any plant part, including leaves and extracts of Quassia amara containing the SkE molecule. Thus, extracts of D2, D3 and D5 fell within the scope of claim 1 of the main application, and thus destroyed the N of the claimed subject matter.
The board’s decision
Application of Art 53a
None of the opponents’ allegations concern the commercial exploitation of the invention, a prerequisite for concluding that the invention would be excluded under Art 53.
The commercial exploitation of the molecule, the drug containing it and its isolation process is not contrary to contrary to “ordre public” or morality. On the contrary, there is a great need for anti-malarial drugs, and finding new ones is a mission whose aim is to treat at-risk populations and save lives.
In the same way as R 28c), Art 53a) EPC refers to an “invention” and not to “claims”. In the case of G 2/06, the elements likely to harm ordre public and morality, namely the destruction of human embryos, was a prerequisite for the preparation of the claimed cultures. Consequently, this precondition was also a requirement for the commercial exploitation of the invention.
As for G 2/06, in T 315/03, the exception to patentability provided for in Art 53a) concerns the commercial exploitation of the invention, and not the manner in which it was discovered or developed.
In the present case, the original development of the invention and the historical process by which the SkE molecule was discovered and isolated have no bearing on the commercial exploitation of the present claims, which require only the isolation of SkE from the Quassia amara plant and its administration to patients. The development of an invention is therefore distinct from its commercial exploitation once it has been achieved.
No evidence has been adduced by the opponents that such isolation and administration would be contrary to ordre public or morality.
Novelty of substances of natural origin
The opponents argued that the subject matter of claims 1 to 6 as granted lacked novelty in relation to documents D2, D3 and D5.
Those documents related antimalarial remedies, the evaluation of the antimalarial activity of different plant species, also Quassia amara, concerns the effect of Quassia amara leaf age and state of desiccation on the antimalarial activity of traditional infusions, used in French Guiana.
D2, D3 and D5 do neither explicitly nor implicitly disclose the SkE or SkE molecule in combination with other compounds. Instead, these documents disclose traditional antimalarial remedies, i.e. preparations derived from the leaves or stems of a particular plant, Quassia amara.
Even if one accepts the presence of SkE in the extracts of D2, D3 and D5, and even interpreting the scope of claim 1 as broadly as possible, a direct and unambiguous disclosure of the technical features of claim 1, or even of the SkE molecule alone or in combination with other compounds, is still required to conclude a lack of novelty.
The Board also took note of the referral to the Enlarged Board of Appeal in decision T 438/19. In the present case, the question is different, namely whether the disclosure of a product necessarily discloses the components of the extract, more specifically the SkE molecule, which were unknown prior to the actual patent filing date.
Comments
Even if one can follow and understand the moral concerns of the opponents vis-à-vis the people of French Guiana, moulds or plants are at the origin of many medicines. Just think of penicillin, digitalis or salycilic acid.
The present case reminds that of the use of neem oil, a traditional remedy, cf. T 416/01.
T 2510/18
https://www.epo.org/fr/boards-of-appeal/decisions/t182510fu1
Comments
Leave a comment