An amended version of the EPO Guidelines for Examination entered into force on 1 March 2022, superseding the edition of March 2021. Here we review the updates relevant to inventions in the field of biotechnology, in particular in relation to inventions relating to the genetic modification of animals and in relation to inventions relating to antibodies.
In overview, there has been a particular emphasis on updating the Guidelines to reflect some well-established but important case law regarding matter contrary to “ordre public” or morality. Also, following the introduction of the new antibody Guidelines in the 2021 edition, there have also been some updates to this section to reflect a broader range of antibody formats and also to provide some further comment on inventive step for antibody claims; specifically referring to the ‘no reasonable expectation of success’ test for obtaining antibodies having the required properties as being a valid test to acknowledge an inventive step. There is also a suggestion that if arguing an antibody is an inventive ‘alternative’ antibody then an applicant can expect to need to demonstrate that the antibody was not arrived at exclusively by applying techniques known in the art, even if the antibody is structurally different from the known antibodies.
Inventions relating to the genetic modification of animals
Exception to patentability - Matter contrary to “ordre public” or morality (G-II, 4.1)
The section on exceptions to patentability, and in particular matter contrary to “ordre public” or morality (G-II, 4.1) has been amended to specifically refer to the Enlarged Board of Appeal decision G 1/03.
As already stated in the 2021 Guidelines, “[a]ny invention the commercial exploitation of which would be contrary to ‘ordre public’ or morality is specifically excluded from patentability. The purpose of this is to deny protection to inventions likely to induce riot or public disorder, or to lead to criminal or other generally offensive behaviour”. The Guidelines further state that “[t]his provision is likely to be invoked only in rare and extreme cases. […] The mere possibility of abuse of an invention is not sufficient to deny patent protection pursuant to Art. 53(a) EPC if the invention can also be exploited in a way which does not and would not infringe ‘ordre public’ and morality”.
The Enlarged Board of Appeal decision G 1/03 dates from 2004 and its findings are already well-established in EPO practice in having defined the requirements for an undisclosed disclaimer to be allowable. In this decision, the Enlarged Board dealt with situations where the matter to be disclaimed falls under exclusions from patentability under the EPC. In this context, the decision referred to inventions the exploitation of which is contrary to "ordre public" or morality under Article 53(a) EPC and gave a “practical example” of this where it would be necessary to exclude human beings from living beings e.g. by reciting non-human beings. This “practical example” has now been incorporated into the 2022 Guidelines which recite:
“G 1/03 explains that practical examples under Art. 53(a) arise from the fact that not everything can be done to human beings that can be done to other living beings. For example, the avoidance of offspring that are unwanted because of certain properties (sex, colour, health) and for economic reasons may be quite legitimate for domestic animals but when applied to human beings it would be contrary to ‘ordre public’ or morality.”
Therefore, the 2022 Guidelines make it clear that “domestic animals” and “humans” are to be treated differently. In practice, this means that where an application defines animals as encompassing humans, subject matter may have to be limited to non-human animals where it would otherwise be “contrary to ‘ordre public’ or morality” to also refer to UK - 664739952.1 2 humans. This is not a new practice at the EPO and the example is based on a decision almost 20 years old. However, it may be taken that this amendment to the Guidelines is reflective of the EPO’s rigorous approach to ensuring that claims do not read on to applying a teaching to a human, to which although theoretically workable, the teaching should never have been applied anyway.
Exclusions and exceptions for biotechnological inventions - List of exceptions (Rule 28) (GII, 5.3)
This section of the Guidelines lists exclusions and exceptions for biotechnological inventions under Rule 28 EPC and has been updated to include references to Technical Board of Appeal decisions T 315/03, T 19/90 and T 1553/15. Notably, decisions T 315/03 and T 19/90 are already referred to in the Case law of the Board of Appeal (2019 Edition) and thus form part of established case law under European practice. Therefore, no change in practice is expected as a result of this update to the Guidelines.
As stated in the 2021 Guidelines, “[u]nder Art. 53(a) the list [of exceptions to patentability laid down in Rule 28 EPC] is illustrative and non-exhaustive and is to be seen as giving concrete form to the concept of ‘ordre public’ and ‘morality’ in this technical field.”
The 2021 Guidelines list the following biotechnological inventions in respect of which patents are not to be granted:
(i) Processes for cloning human beings
(ii) Processes for modifying the germ line genetic identity of human beings
(iii) Uses of human embryos for industrial or commercial purposes
(iv) Processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animal, and also animals resulting from such processes
Part (iv) has been amended in the 2022 Guidelines to refer to Technical Board of Appeal decisions T 315/03 and T 19/90. Again, these are old decisions, and their findings are already well-established in EPO practice. Specifically, the 2022 Guidelines clarify the test to establish whether the requirements of Rule 28(1)(d) EPC are fulfilled and states that “the following needs to be established:
(a) that the subject-matter in question concerns a process for modifying the genetic identity of animals or animals resulting from that process,
(b) the likelihood of animal suffering,
(c) the likelihood of substantial medical benefit and
(d) the necessary correspondence between suffering and substantial medical benefit in terms of the animals claimed.”
The 2022 Guidelines also specify that “[t]he level or standard of proof for establishing animal suffering and substantial medical benefit is likelihood. The correspondence has to be established according to the balance-of-probabilities approach (E-IV, 4.3)”. The 2022 Guidelines further state that “[f]or Article 53(a), a careful weighing-up of the suffering of animals and possible risks to the environment, on the one hand, and the invention's usefulness to mankind, on the other hand, are used to the extent that those two aspects are supported by evidence (see T 19/90 and T 315/03)”.
The 2022 Guidelines further refer to the Technical Board of Appeal decision T 1553/15 stating that “[f]or applications relating to non-genetically modified animals, in all cases where animal suffering or possible risks to the environment is involved, the provisions of Article 53(a) have to be assessed by considering the invention's usefulness to mankind”.
Clarified practice regarding antibodies
In the 2022 Guidelines, sections G-II, 5.6.1, G-II, 220.127.116.11 and G-II, 5.6.2 have been amended to clarify the practice regarding antibodies.
General remarks (G-II, 5.6.1)
The “General remarks” (G-II, 5.6.1) have been mainly rewritten to acknowledge the “different formats” in which antibodies may exist. Whilst the 2021 Guidelines define “conventional antibodies” as “large, Y-shaped proteins naturally produced by plasma B-cells and composed of two identical light chains and two identical heavy chains, both containing variable and constant domains” and only refer to “camelid heavy chain only antibodies” as “new antibody formats”, the 2022 Guidelines now refer to antibodies more broadly. Specifically, the 2022 Guidelines state:
“Antibodies exist in a number of different formats. The most frequently used format is an immunoglobulin G (IgG), which is a large, Y-shaped protein composed of two identical light chains and two identical heavy chains, both containing variable and constant domains. Antibodies bind specifically to antigen targets via the antigen binding region which contains complementarity-determining regions (CDRs). In the case of an IgG, the antigen binding region consists of a heavy and light chain variable domain, each variable domain having three CDRs.
Other immunoglobulin structures are also known, such as heavy-chain-only antibodies that consist of only two identical heavy chains (with variable and constant domains) and the antigen-binding region consists of a single variable domain with only three CDRs.
Furthermore, knowledge of the structure-function relationships of parts of the antibody has allowed for the creation of antibody derivatives for a multitude of applications. These include antibody fragments, bispecific or multispecific antibodies and antibody fusion products.”
Definition by structure of the antibody (G-II, 18.104.22.168)
Section G-II, 5.6.1 of the 2022 Guidelines has been amended to refer to “IgG” instead of “convention antibody”. Whilst the wording in the 2022 Guidelines has been slightly modified, it is still the case that “in order to be uniquely defined by its structure only and have its characteristic binding specificity, [the IgG] needs to be defined by the number of CDRs required for its binding to fulfil the requirements of Art. 84. […] If an IgG is defined by fewer than the six sequences of its CDRs, the claim will be objected to under Art. 84 because it lacks an essential technical feature unless it is experimentally shown that one or more of the six CDRs do not interact with the target epitope or if it concerns a specific antibody format allowing for epitope recognition by fewer CDRs”.
Inventive step of antibodies (G-II, 5.6.2)
Section G-II, 5.6.2 of the 2022 Guidelines which relates to inventive step of antibody claims clarifies that “no reasonable expectation of success of obtaining antibodies having the required properties” is a valid test to acknowledge an inventive step for “subject matter of a claim defining a novel, further antibody binding to a known antigen”. This section of the 2022 Guidelines also now specifically states that arriving at “alternative antibodies”, which bind the same antigen as known antibodies but are structurally different from the known antibodies, “exclusively by applying techniques known in the art is considered to be obvious to the skilled person.” Whilst not explicitly stated, the 2022 Guidelines still allow for an inventive step to be acknowledged where the “alternative antibodies” are produced not exclusively using techniques known in the art.