Originally published on IPKat.
Cases relating to the exclusion of patentable subject matter on moral grounds are rare, and always serve to highlight the underlying moral and political framework necessary for a well-functioning IP system.
The decision T 2510/18 considered whether an invention derived from traditional remedies by dishonest means was immoral. The objections related not to the direct exploitation of the invention itself, but to the alleged dishonesty and breach of trust associated with how the invention was derived. The case also considered the important interaction between prior use and novelty, specifically whether a prior use falling under the scope of a claim necessarily impinges the novelty of the claim.
Case Background
The patent (EP2443126) related to the plant extract Simalikalactone E and its use to treat malaria. The patent acknowledged that the plant from which Simalikalactone E was extracted, Quassia amara (“bitter ash”) had long been used in traditional medicine to treat fever. The patent described the extraction of Simalikalactone E from the leaves of bitter ash. Claim 1 of the patent was a simple product claim for the chemical formula of Simalikalactone E, with dependent claims related to Simalikalactone E for medicinal use and a processes for extracting Simalikalactone E.
The invention arose from research by The Institute for Development Research (IRD) into traditional antimalarial remedies used by indigenous communities in French Guiana. A survey of these communities, involving interviews with 117 indigenous people, identified 45 remedies using 27 different plant species, including bitter ash. The researchers focused on bitter ash to subsequently identify and extract the anti-malaria compound, Simalikalactone E.
The Opponents argued that the granted claims contravened Article 53(a) EPC. Article 53(a) EPC states that a European patent shall not be granted for “inventions the commercial exploitation of which would be contrary to ‘ordre public‘ or morality”. In this case, the Opponents argued that the commercial exploitation of a claim directed to Simalikalactone Ewould be contrary to morality and public order within the accepted norms of European culture, particularly as related to the exploitation of indigenous communities and the commercialisation of traditional knowledge.
In short, the Opponent argued that the invention represented “biopiracy” on behalf of the patentee against the indigenous people involved in the original research. Specifically, the Opponent submitted that the interactions with the indigenous communities had been conducted in an immoral fashion, involving deception and an abuse of trust. According to the Opponent, the members of the communities involved had not been fully and transparently informed of the nature of the research project, its objectives, the filing of the patent, and other risks and benefits of the project to community members and their knowledge. As such, the Opponent argued, the IP rights of the communities over their traditional knowledge had been violated. The Opponent submitted that the deception and breach of trust displayed was contrary to ordre public and would jeopardize relations between indigenous and local communities and researchers.
The morality of the use of an invention versus the morality of how an invention was derived
The factual submission on the conduct of the research was accepted by the Board of Appeal. However, the Board was not convinced that the behaviour of the patentee excluded the subject matter from patentability under Article 53(a) EPC. The exclusion to patentability provided for in Article 53(a) EPC requires the stated offense to morality to reside in the “commercial exploitation” of the claimed invention. The claims of the patent were directed to the formula of the antimalarial, a process of manufacturing the antimalarial and its use in therapy. Given the dire need for effective antimalarial medication, the Board of Appeal found that the commercial exploitation of these inventions would not be contrary to public morality (on the contrary, they would be beneficial to society). Specifically, the Board of Appeal made a clear distinction between the morality of the commercial exploitation of an invention, and the morality of how the invention itself occurred (r.2.14). The Board of Appeal thus concluded that the claimed invention was not excluded from patentability pursuant to Article 53(a) EPC.
The interaction between novelty and prior use
The Board of Appeal then went on to consider whether the claims were novel. The prior art cited against the invention were documents describing use of bitter ash to treat malaria. The active compound Simalikalactone E was not specifically disclosed. However, the Opponents argued that Simalikalactone E would clearly have been present in the preparations of bitter ash described, and that therefore the claimed invention was anticipated. Notably, the granted claims did not specify that the Simalikalactone E was “isolated” (as is the norm to avoid objections that a claim relates to a natural phenomena in the US).
The Board of Appeal, however, disagreed. The Board of Appeal pointed out that the test for novelty is whether the prior art contains a clear and unambiguous disclosure of the claimed invention. The invention in this case was the molecular structure of Simalikalactone E. Given that the prior art did not include any explicit disclosure of Simalikalactone E, the invention could not be said to be anticipated. The Board of Appeal found that the novelty objection still did not hold even if the preparations of bitter ash described in the prior art could be said to fall under the scope of the claim: “the question is what was made available to the public, not what could be contained intrinsically in what was made available to the public” (r. 3.17, machine translation). The Opponent argued that if the claims were not found to lack novelty, the patent would give the patentee the right to prohibit indigenous people from using bitter leaf in their traditional remedies. However, the Board of Appeal cited the finding of the EBA in G 2/88 that the question of rights based on the prior use of an invention is a matter for national law. The claims were therefore found novel in view of the prior use of bitter leaf. An inventive step argument was also rejected and the patent maintained.
What about the referral on prior use?
The Board of Appeal took note of the pending referral to the Enlarged Board of Appeal (EBA) on the issue of prior use (G1/23). The referral asks whether the non-enabling prior use of a product excludes the composition of the product from the prior art or whether it also excludes the product per se, such that the product itself cannot be used as a starting point for inventive step. In other words, if the product is a drug comprising compound X, and compound X is not enabled, can the existence of the drug itself be used as a starting point for inventive step? The Board of Appeal in the present case found that the referral was not relevant as the referral related to the question of inventive step, not the absolute disclosure test of novelty.
Final thoughts
The background to this case raises the spectre of a familiar philosophical and moral conundrum within the medical field. Should the less-than-sanitary (in some cases abhorrent) means by which an invention was derived prevent its use? One of the most well-known examples of immoral research leading to an unequivocal moral benefit to society is the human cancer cell line, HeLa cells. HeLa cells have been widely used in medical research and have contributed to many significant life-saving scientific breakthroughs, including the polio vaccine. However, HeLa cells were derived from a African-American woman cancer patient, Henrietta Lacks, in 1951 without her knowledge or consent. Science is littered with examples of other beneficial discoveries arrived at by immoral means.
However, as the Board of Appeal notes in the present case, there is no provision in the EPC that relates to the morality of how an invention was derived. Article 53(a) EPC only relates to the morality of the commercial exploitation of the invention itself. Questions over the morality of scientific discovery must therefore be dealt with in a different forum than the patent office. In this case, despite the decision of the Board of Appeal, the European patent in question appears to have lapsed on all member states due to failure to pay renewal fees. The US case has similarly been abandoned. It thus appears that the substantial political pressures on the IRD outside the patent system have impacted their desire and/or ability to commercialise the invention.
This complex case underscores the critical intersection of ethics, innovation, and intellectual property. Navigating such nuanced legal and moral landscapes demands an IP strategy that is not only scientifically sound but also commercially astute and ethically aware. Don’t let complex IP challenges stifle your breakthroughs. If you’re a pharmaceutical or biotech company seeking to protect your innovations with an IP strategy that truly evolves with your science and business, contact Evolve today.
Further reading
New EBA referral: When is prior use of a product excluded from the prior art for lack of enablement?
