In T 2510/18 the Board considers the morality and patentability of therapeutic compounds originating from traditional knowledge

Case Law Summary T 2510/18

Background
The Board of Appeal’s decision T 2510/18 concerns an appeal to the Opposition Division’s [OD] decision to reject the opposition against EP 2 443 126 B1. This patent relates to a molecule, Simalikalactone E (SkE), which can be isolated from the plant Quassia amara, also known as bitter wood, and its use as a medicinal product in the prevention and treatment of malaria. The plant has been used as part of traditional medicine against malaria and fever in parts of the Amazon and Central America. 

The Patentee (P) had identified and isolated SkE from the leaves of Quassia amara and found that SkE was active against malaria. The OD held, contrary to the objections raised by the Opponent, that i) the invention as claimed was not contrary to ‘’ordre public’’ or morality within the meaning of Article 53(a) EPC, and that ii) the plant extracts described in the prior art do not unambiguously disclose that the SkE molecule was present and therefore the claimed subject-matter was novel.

The Appeal
The appellant-opponent (AO) argued that the exploitation of the SkE molecule isolated from Quassia amara for anti-malarial treatment, violated public morality and “ordre public” under Art. 53(a) EPC due to alleged deceptive and unethical conduct during research involving indigenous knowledge. AO contended that the lack of consent and benefit-sharing with indigenous communities constituted a breach of ethical norms.

The Board held that unethical research practices by which the SkE molecule was discovered, even if proven, pertained to the development phase and not to the commercial exploitation of the claimed invention. The Board emphasizes that the exception to patentability under Art 53(a) EPC is intended to prevent protection of inventions whose commercial exploitation would be contrary to public policy or accepted principles of morality, not the way it is discovered or obtained. The invention's use in treating malaria served a significant public health purpose and the commercial exploitation of the SkE molecule was found not contrary to public morality or “ordre public”.

Novelty
AO argued that the SkE molecule lacked novelty, asserting that claim 1 was not limited to SkE in isolated form and that SkE was inherently present in traditional remedies derived from Quassia amara leaves, as disclosed in several prior art documents (D2, D3, and D5). The Board found that none of those documents identified the SkE molecule as the active compound against malaria. The mere fact that the skE molecule may be present in the leave extracts described in the prior art was not considered an implicit disclosure of SkE. The Board further explained with reference to the gold standard in G2/88 that the question to be answered under novelty aways is ‘’what has been made available to the public’’, not what ‘’could intrinsically be contained’ in that what is available to the public. 

In addition, the board found there is also no implicit disclosure of the subject-matter of claim 1 in view of the decision of the Enlarged Board of Appeal in G 1/92. According to that decision: “The chemical composition of a product forms part of the state of the art if the product as such is available to the public and can be analysed and reproduced by a person skilled in the art, irrespective of whether it is possible to identify special reasons for analysing that composition" 

In the present case, for the prior art to make the SkE molecule available to the public alone or in combination with other compounds, it was necessary for the skilled person to identify the SkE in the extracts of D1, D3 or D5. Since SkE was not directly and unambiguously derivable from the prior art, the identification of SkE was considered an unreasonable effort for the skilled person, as a result the Board found that SkE was not part of the publicly available prior art. 

The Board also shortly discussed the pending referral G1/23 (discussed by the NLO case law team here). G1/23 is concerned with whether a product of which the internal structure cannot be analyzed is relevant for inventive step. As the current case has a different question, namely whether the disclosure of a product necessarily discloses the components of the extract, G1/23 was deemed not relevant. 

AO additionally argued the claimed subject matter could not be novel due to its existing use with the same therapeutic effects. In other words, the protection conferred by the patent would give P the right to prohibit indigenous populations from using the leaves of Quassia amara for the preparation of their traditional remedies. The Board did not agree. A similar question arose in G2/88 wherein was argued that issues of infringement might arise if the invention were not deemed to lack novelty: specifically, someone using the previously described process could risk being sued for infringing a subsequently granted patent. 

In response to these allegations, the Enlarged Board of Appeal emphasized that under Art 54 EPC, the question is what was "made accessible" to the public, not what might be "inherently contained" within what was made accessible. Consequently, the issue of "inherent content" is simply not relevant in the context of Art 54 EPC. The Enlarged Board of Appeal also noted that the question of rights based on prior use of an invention falls under national law and is not dealt with by the EPO.

Decision of the Board
The Board decided that while the prior art disclosed preparations using Quassia amara, it did not explicitly or implicitly disclose the molecule SkE or its isolation. The mere presence of a molecule in a plant extract does not render it accessible to the public unless its existence and characteristics are disclosed.

The Board decided to dismiss the Appeal and maintain the patent.

Summary written by the NLO EPO Case Law Team.