Recent updates to the EPO’s Guidelines for Examination of Inventions in the Field of Biotechnology

An amended version of the Guidelines for Examination in the EPO entered into force on 1 March 2022, replacing the March 2021 edition. Here we review the updates relating to inventions in the field of biotechnology , in particular with regard to inventions relating to the genetic modification of animals and in connection with inventions relating to antibodies.

Overall, particular emphasis has been placed on updating the Guidelines to reflect well-established but important case law regarding matters contrary to “public order” or morality. Additionally, following the introduction of the new antibody guidelines in the 2021 edition, this section has also been updated to reflect a wider range of antibody formats and also to provide additional comments on the inventive step for antibody claims; referring specifically to the “no reasonable expectation of success” test for obtaining antibodies with the required properties as being a valid test for recognizing inventive step. It is also suggested that if the argument that an antibody is an inventive “alternative” antibody, an applicant may expect to have to demonstrate that the antibody was not obtained exclusively by applying techniques known in the art. , even if the antibody is structurally different from known antibodies.

Inventions relating to the genetic modification of animals

Exception to patentability – Object contrary to public order or morality (G-II, 4.1)

The section on exceptions to patentability, and in particular matters contrary to public order or morality (G-II, 4.1) has been amended to make specific reference to decision G 1/03 of the Enlarged Board of appeal.

As already stated in the 2021 Guidelines, “[a]Any invention whose commercial exploitation would be contrary to public order or morality is specifically excluded from patentability. The purpose is to deny protection to inventions likely to cause a riot or public disorder, or lead to criminal or other generally offensive behavior”. The Guidelines further state that “[t]this provision is likely to be invoked only in rare and extreme cases. […] The mere possibility of abuse of an invention is not sufficient to refuse patent protection according to Art. 53(a) EPC if the invention can also be exploited in a way which does not and would not infringe public order and morality”.

Enlarged Board decision G 1/03 dates from 2004 and its findings are already well established in EPO practice in that it set out the conditions for the admissibility of an undisclosed disclaimer. In this decision, the Enlarged Board dealt with situations where the subject matter to be excluded falls within the 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 within the meaning of Article 53(a) EPC and gave a “concrete example” where it would be necessary to exclude human beings from living beings for example by reciting non-human beings. This “practical example” has now been incorporated into the 2022 guidelines which state:

“G 1/03 explains that the practical examples under Art. 53(a) stem 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 unwanted offspring due to certain properties (sex, color, health) and for economic reasons may be perfectly legitimate for domestic animals, but applied to human beings it would be contrary to public order or good morals. ”

Therefore, the 2022 guidelines make it clear that “pets” and “humans” should be treated differently. In practice this means that where an application defines animals as including humans, the subject matter may need to be restricted to non-human animals where it would otherwise be “contrary to” public order “or morality” to refer also in UK – 664739952.1 2 humans. This is not new practice at the EPO and the example is based on a decision almost 20 years old. However, this amendment to the Guidelines can be seen as reflecting the EPO’s rigorous approach to ensuring that the claims do not involve the application of a teaching to a human being, to which, although theoretically feasible, 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 the exclusions and exceptions for biotechnological inventions under Rule 28 EPC and has been updated to include references to decisions of the Technical Boards of Appeal T 315/03, T 19/90 and T 1553 /15. In particular, decisions T 315/03 and T 19/90 are already cited in the Case Law of the Board of Appeal (2019 edition) and therefore form part of established case law according to 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]under art. 53(a) list [of exceptions to patentability laid down in Rule 28 EPC] is illustrative and not exhaustive and should be considered as embodying the notions of “public order” and “morality” in this technical field”.

The 2021 Guidelines list the following biotechnological inventions for which patents should not be granted:

(i) Processes for cloning human beings

(ii) Methods of modifying the germline genetic identity of human beings

(iii) Uses of human embryos for industrial or commercial purposes

iv) Processes for modifying the genetic identity of animals likely to cause them suffering without substantial medical benefit for humans or animals, as well as 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 conclusions are already well established in EPO practice. Specifically, the 2022 Guidelines clarify the test for establishing whether the requirements of Rule 28(1)(d) EPC are met and state that “the following must be established:

a) that the object in question concerns a process for modifying the genetic identity of animals or animals resulting from this process,

(b) the likelihood of animal suffering,

(c) the likelihood of substantial medical benefit and

d) the necessary correspondence between the suffering and the substantial medical benefit with regard to the claimed animals. »

The 2022 Guidelines also state that “[t]The level or standard of proof for establishing animal suffering and substantial medical benefit is probability. The correspondence must be established according to the approach of the balance of probabilities (E-IV, 4.3)”. The 2022 Guidelines further state that “[f]or of Article 53(a), a careful balancing of the suffering of the animals and the possible risks for the environment, on the one hand, and the usefulness of the invention for humanity, on the other hand. on the other hand, are used insofar as these two aspects are supported by evidence (see T 19/90 and T 315/03)”.

The 2022 Guidelines further refer to 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 for the environment are involved, the provisions of Article 53(a) must be assessed taking into account the usefulness of the invention for humanity”.

Clarified Practice Regarding Antibodies

In the 2022 Guidelines, sections G-II, 5.6.1, G-II, 5.6.1.1 and G-II, 5.6.2 have been amended to clarify practice regarding antibodies.

General remarks (G-II, 5.6.1)

The “General Notes” (G-II, 5.6.1) have been rewritten primarily to account for the “different formats” in which antibodies may exist. While 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 domains and constants” and only refer to “heavy chain antibody only camelids” as “new antibody formats”, the 2022 guidelines now refer to antibodies more broadly. Specifically, the 2022 guidelines state:

“Antibodies come 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 specifically bind to antigenic targets via the antigen binding region which contains complementarity determining regions (CDRs). In the case of 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 which 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.

Additionally, knowledge of the structure-function relationships of antibody parts has allowed 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, 5.6.1.1)

Section G-II, 5.6.1 of the 2022 Guidelines has been amended to refer to “IgG” instead of “conventional antibody”. Although the wording of the 2022 guidelines has been slightly modified, the fact remains that “to be uniquely defined solely by its structure and to have its characteristic binding specificity, [the IgG] must be defined by the number of CDRs required for its link to satisfy the requirements of Art. 84. […] If an IgG is defined by less than six sequences of its CDRs, the claim will be challenged under Art. 84 because it lacks an essential technical characteristic unless it is experimentally demonstrated that one or more of the six CDRs do not interact with the target epitope or if it is a specific antibody format allowing recognition of the epitope 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 the inventive step of antibody claims, states that “no reasonable expectation of success in obtaining antibodies having the required properties” is not a valid test to recognize inventive step for “the subject matter of a claim defining a new additional antibody that binds to a known antigen”. This section of the 2022 Guidelines also now specifically states that arriving at “antibody alternatives”, which bind to the same antigen as known antibodies but are structurally different from known antibodies, “exclusively by applying techniques known in the art is considered obvious to those skilled in the art. Although not explicitly stated, the 2022 Guidelines still permit recognition of inventive step when “alternative antibodies” are not produced exclusively using techniques known in the art.

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