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In this article, Matt England explores the European Patent Office’s (EPO) approach to Article 53(a) EPC, showing that an invention is excluded from patentability only if its commercial exploitation is immoral, not because of the circumstances of its derivation, as confirmed in T 2510/18.
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In T 2510/18, an EPO Board of Appeal found that the morality of actions taken when deriving an invention is not relevant to its patentability, so long as it is not immoral to commercially exploit it. In other words, an invention will only be excluded from patentability under Article 53(a) EPC when it is being used.
Legal background
Article 53(a) EPC expressly prohibits the patenting of inventions “the commercial exploitation of which would be contrary to “ordre public” or morality”, and clarifies that “such exploitation shall not be deemed to be so contrary merely because it is prohibited by law or regulation in some or all of the [EPC] Contracting States”.
The purpose of this provision is to prevent patents being granted for inventions which are “likely to induce riot or public disorder, or to lead to criminal or other generally offensive behaviour” (EPO Guidelines for Examination, G-II, 4.1), as assessed by the culture inherent in European society and civilisation (T 356/93).
Rule 28 EPC also specifies a non-exhaustive list of biotech inventions which fall within Article 53(a) EPC, which includes processes for cloning human beings or modifying their genetic identity, and the use of human embryos for commercial or industrial purposes. Landmines have also been deemed contrary to “ordre public” or morality in the UK. These technologies have a general theme of being potentially (or actually) harmful to human beings and, to a lesser extent, animals and the environment.
T 2510/18
This was an appeal against an Opposition Division’s Decision to maintain the claims of EP2443126 (EP’126) as granted. The claims of EP’126 relate to the compound simalikalactone E (SkE), and its use as a medicine − primarily in treating malaria − as well as a method for isolating it from Quassia amara, also known as “bitter ash”.
Patenting substances derived from plants is not new or uncommon, but in this case the opponent-appellant alleged that the invention was immoral because of the circumstances of its discovery and derivation.
According to the appellant-opponent’s submissions (which were not contested by the proprietor-respondent), the invention was derived from a traditional anti-malarial remedy known among the populations of French Guiana. The respondent is said to have surveyed French Guianan communities for traditional healing recipes:
“without fully and transparently informing them of the nature of the research project, its objectives, the filing of the patent, and other risks and benefits of the project for the community members and their knowledge. Moreover, their consent to the collection of this knowledge and its use was not approved, this being even confirmed by the respondent in press articles (D54 and D55). No benefit-sharing was arranged between the knowledge holders and the respondent’s researchers. Community members have had neither the opportunity nor the right to decide on the use of their knowledge. As a result, communities have lost control over the circulation of their knowledge with the violation of all intellectual rights to this knowledge” (T 2510/18, Reasons 2.4).
From these surveys of traditional knowledge, the respondent was eventually able to derive the SkE and its usefulness in treating malaria. The submissions from the appellant alleged that the invention was excluded under Article 53(a) EPC because these actions constituted a deception of indigenous and local communities and a breach of their trust, which is contrary to “ordre public” or morality”. The appellant further suggested that the claims were so broad that they could be used to prevent use of the traditional remedies from which the invention is derived.
The Board of Appeal disagreed, primarily on the basis that the EPC specifies that an invention must be immoral during “commercial exploitation” to be excluded from patentability, and that this does not include the circumstances of the invention’s derivation. The Board also highlighted that there is a “great need for antimalarial drugs”, and that a goal of finding them is to treat at-risk populations and save lives. In other words, the allegedly immoral action occurred too early for the invention to be excluded from patentability.
Analysis
This is not the only instance of “when” being a relevant question for matters relating to Article 53(a) EPC. In G 2/06 the Enlarged Board of Appeal ruled that the date at which an application must be assessed as being immoral (or not) is its date of filing, and that it is irrelevant whether subsequent developments would allow an invention to be carried out in a less immoral fashion − for example, as in G 2/06, a way to produce stem cells without destroying human embryos.
The Board of T 2510/18 also followed the approach taken by previous Boards of Appeal in considering the invention’s potential benefits to humanity against any suffering that may be caused (as in, for example, T 19/90 which considered the morality of the “OncoMouse”).
The Decision of T 2510/18 thus appears to be a confirmation of the EPO’s approach to assessing Article 53(a) EPC, rather than a change of direction.
That said, while the behaviour of the patentee in T 2510/18 did not exclude the invention from patentability, there have still been efforts to prevent this type of behaviour. An example is Article 7 of the Nagoya Protocol (which entered into force in 2014) that prevents the taking of “genetic resources”, stating that:
“In accordance with domestic law, each Party shall take measures, as appropriate, with the aim of ensuring that traditional knowledge associated with genetic resources that is held by indigenous and local communities is accessed with the prior and informed consent or approval and involvement of these indigenous and local communities, and that mutually agreed terms have been established.”
However, even if SkE had fallen under the protocol’s definition of a “genetic resource”, there is no guarantee that an EPO Board of Appeal would consider its use to be immoral under the EPC.
In summary, an invention must be deemed immoral when being commercialised, and at the application’s filing date, to be excluded under Article 53(a) EPC, not when it is being derived or discovered.
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This is for general information only and does not constitute legal advice. Should you require advice on this or any other topic then please contact hlk@hlk-ip.com or your usual HLK advisor.