Agritech Thymes: The EPO Looks at the Morality and Patentability of Therapeutics Derived from Traditional Knowledge

This case (T2510/18¹) heard before the Technical Boards of Appeal at the EPO in May 2024 relates to the morality and novelty of substances of a natural origin.

The invention covered under the patent (EP 2 443 126 B1) was based on the extraction, using a specific method, of simalikalactone E (SkE) from the dried leaves of the plant Quassia amara and its use in the prevention and treatment of malaria.  Claim 1 of the patent simply claims the molecule according to a defined formula.

It was acknowledged in the patent that the plant Quassia amara had been used in traditional medicine against fevers and malaria throughout the north-western Amazon and as far as Central America.

Contrary to public morality

On appeal following rejection of the opposition, the appellants made an interesting argument in which they argued that the commercial exploitation of the invention was contrary to good morals and public policy within the meaning of Article 53(a) EPC.  This article of European patent law excludes from patentability any subject matter which is contrary to public policy or accepted principles of morality.  Specifically, the appellant argued that the protection of the invention was not in accordance with European culture and standards governing research with indigenous communities and use of their traditional knowledge.   The appellant argued that the manner in which the patent applicant had engaged with the indigenous community was deceptive and constituted a breach of trust.  Essentially, the appellant alleged that the applicant engaged in biopiracy to obtain the invention from indigenous populations in Guyana, who had been using Quassia amara leaves in the preparation of their traditional remedies for many years.

The Board rejected these arguments, on the basis that the Article 53(a) EPC is intended to prevent protection of inventions whose commercial exploitation would be contrary to public policy or accepted principles of morality.   In this case, the commercial product, namely the molecule per se, and its use in treating malaria, were not contrary to morality but in fact necessary to treat populations and save lives.  The appellant did not provide any evidence that the molecule or its extraction from the Quassia amara plant was itself contrary to public morality.

The EPO can deal with the patentability of an invention, but it does not yet have any means to deal with the concept of biopiracy. The Nagoya Protocol, amongst other international treaties, is the relevant legislation which aims at the fair and equitable sharing of benefits arising out of the utilisation of genetic resources (Article 5 in particular²). It is not clear if any other actions against the applicant have been taken for contravening this protocol, however due to the controversy around this patent, the applicant did announce that they would work out a protocol with Guianan authorities to guarantee the fair sharing of the scientific and economic benefits if the drug makes it to the market and to ensure that people in Guiana can get it at an affordable price³.

Novelty of substances of natural origin

In addition to the morality attack, the appellant argued that the claims lacked novelty in light of three articles which described leaf or stem preparations of the Quassia amara plant, for the treatment of malaria.  In assessing novelty, the Board applied the “gold standard” test, hereto before used for assessment of added subject matter and priority.   As such, the Board considered whether the prior art, either explicitly or implicitly “directly and unambiguously” disclosed the claimed SkE compound.   It was clear that there was no explicit disclosure of SkE in the prior art, but had the compound been implicitly disclosed?  According to established case law, a feature is implicitly disclosed if the skilled person immediately recognises that nothing else other than the implicit feature is disclosed.  The Board concluded that just because SkE may be found in the disclosed extracts, this did not amount to a direct and unambiguous implicit disclosure.  Interestingly, they reasoned that because the identification of SkE required significant effort and therefore an inventive step, it could not have been implicitly disclosed.

The appellants had also argued that the claimed subject matter could not be novel if it was infringed by the existing use, commonly referred to as the “squeeze” argument.  In rejecting this argument, the Board referred to G2/88, in which the Enlarged Board of Appeal pointed out that the test for novelty is what has been “made available” to the public and not what is “intrinsically contained” in the prior art.

This case has similarities with a line of case law, including T416/01, in which lack of novelty was argued on the basis of prior traditional knowledge.  Although the moral concerns of the indigenous people of French Guiana can be appreciated, the conclusions of the Board in this case are consistent with established case law.

References:

1. https://www.epo.org/fr/boards-of-appeal/decisions/t182510fu1
2. https://www.cbd.int/abs/text/articles?sec=abs-05#:~:text=in%20the%20Annex.-,5.,local%20communities%20holding%20such%20knowledge.
3. https://www.science.org/content/article/french-institute-agrees-share-patent-benefits-after-biopiracy-accusations

This article was prepared by Partners Punita Shah and Ellie Purnell