“Important changes have been made to the biotech section of the new European Patent Office Guidelines for Examination concerning the patentability of plants and animals, human embryonic stem cells, second medical indications and antibodies.”
As discussed in Part I of this article, the European Patent Office (EPO) recently published its Guidelines for Examination 2021, which came into force on March 1. In the previous article, we detailed changes affecting computer-implemented inventions and with respect to procedural matters. Here, we will address the Guidelines’ changes for biotech.
In addition to some specifications regarding the interpretation of terms relating to amino and nucleic acid sequences and the definition of the concept of “therapy” and of the products that can be claimed in view of their new medical use, the main additions that have been made to the part of the Guidelines relating to biotechnological inventions concern the exclusions from patentability, and in particular the ineligibility of inventions relating to plants or animals and human embryos. A full section has also been added relating to the patentability of antibodies.
Interpretation of terms such as identity and similarity in relation to amino and nucleic acid sequences (F-IV 4.24)
This section is concerned with the interpretation of claims where an amino or nucleic acid sequence is defined through a percentage of identity. The percentage of identity defines the number of identical residues along a certain length in a certain alignment. If the algorithm to be used for determining the percentage of identity is not stated, the examiner will adopt the broadest possible interpretation of the claim, including all sequences that fulfil the percentage of identity as calculated by any algorithm known as of the relevant filing date. The same applies to claims where an amino acid sequence is defined by the degree of similarity.
Definition of “therapy” (G-II 22.214.171.124)
This section specifies that the concept of “therapeutic method” excluded from patentability under Art. 53(c) EPC does not include treatments performed on a human or animal body that is in its normal, healthy state, even if subject to some discomfort that nevertheless is not likely to result in a pathological state.
Exclusions regarding plants and animals exclusively obtained by means of an essentially biological process (G-II 5.2 and 5.4)
The eligibility of inventions relating to groups of plants and animals that are broader than plant or animal varieties is well-established in the EPO jurisprudence, which also reflects the provisions of Directive 98/44/EC on the protection of biotechnological inventions. On the other hand, the patentability of essentially biological processes for the production of plants and animals is expressly excluded by Art. 53(b) EPC.
Over the past 10 years or so, the jurisprudence of the EPO has extensively dealt with the interpretation of the concept of “essentially biological processes” and whether or not the non-eligibility of essentially biological processes for the production of plants and animals places limitations on the patentability of plants and animals that are not varieties.
The Guidelines already incorporated the recent EPO case law in this area, in particular, the definition of “essentially biological process” developed in decisions G2/07 and G1/08 (Broccoli I and Tomatoes I) as well as the ineligibility of inventions relating to plants and animals exclusively obtained by essentially biological processes established in decision G 3/19 (Pepper) which had overturned the previous decisions G 2/13 and G 2/12 (Broccoli II and Tomatoes II).
The new version of the Guidelines specifies that the exclusion relating to plants and animals exclusively obtained by essentially biologically processes only applies to patent applications with a filing date and/or a priority date after July 1, 2017 and that it does not apply to patents granted before that date or to pending patent applications with a filing date and/or a priority date before July 1, 2017 (G 3/19). Accordingly, a disclaimer to exclude plants and animals produced by an essentially biological process is needed only for the applications or patents having the aforementioned relevant dates.
Exclusions regarding human embryos (G-II 5.3)
The Guidelines have been updated to reflect the case law developed by the EPO in recent years in this area. The new Guidelines specify that a patent application pertaining to human pluripotent stem cells, including human embryonic stem cells, their uses and products derived therefrom, does not fall under the exclusions from patentability of Art. 53(a) and Rule 28(1) EPC if it has an effective date (i.e., a valid priority date or filing date) after June 5, 2003, and if it can be made using human embryonic stem cells derived from parthenogenetically activated human oocytes (i.e., by a technique that does not involve destruction of the human embryo).
The Guidelines have also been updated to clarify that fetal and post-natal human cells are in principle not excluded from patentability, and that culture media, supports and apparatuses “suitable for” use with human embryonic stem cells are not per se excluded from patentability.
Antibodies (G-II 5.6)
In the new version of the Guidelines, a whole new section has been introduced where the patentability of antibodies is discussed depending on how the antibody is defined in the claims. An antibody may be defined by its structure (i.e. amino acid or nucleic acid sequences), by reference to the target antigen or epitope, by one or more functional features, by its production process, or by the producing hybridoma.
When an antibody is defined by its amino acid or nucleic acid sequences, in principle the claim should specify the six CDRs, otherwise a clarity objection under Art. 84 EPC may arise. Definition by fewer that the six CDRs is permissible only if it is experimentally demonstrated that one or more CDRs do not interact with the antigen or if the antibody is in a format allowing for epitope recognition by fewer CDRs.
Definition of an antibody through its target antigen is permissible, provided that the antigen is clearly defined. Care should be taken not to use an open language to define the antigen. Accepted language is, for example, “antibody binding to X”, “anti-X antibody”, “antibody reacting with X”, “antibody specific for X”, antibody binding to X consisting of SEQ ID NO:y”.
In case an antibody is defined by the epitope it recognizes on the antigen, the burden of proving that the antibody is different from the prior art antibodies that bind to the same antigen but on a different epitope resides with the applicant. The epitope may either be a linear epitope or a discontinuous epitope (i.e. a conformational epitope). In the latter case, the claim must specify the method for determining the discontinuous epitope.
An antibody may alternatively or additionally be defined by functional features, such as the binding affinity, the neutralizing properties, induction of apoptosis, the internalization of receptors, the inhibition or activation of receptors, etc. In that case, particular care should be taken to provide an enabling description, i.e. a description that is sufficiently clear and complete to enable reproduction of the claims over their full scope, i.e., to provide further antibodies having the same functional features.
Usually, it is not permitted to broaden the scope of claims where an antibody is structurally defined by amino acid or nucleic acid sequences having percentages of identity lower than 100%. However, this may be permissible if the variable domains or CDRs with less than 100% sequence identity are combined with one or more clear functional features.
The criteria for evaluating the inventive step of a claim pertaining to an antibody are essentially the same as for other types of biotechnological inventions, and in particular the presence of one or more surprising technical features over the enabled antibodies of the prior art.
Products that may be claimed for a further medical use (G-VI 7.1.1)
Art. 53 (c) EPC excludes from patentability methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practiced on the human or animal body; however, it also specifies that the exclusion does not apply to “products, in particular substances or compositions” for use in any of these methods (see also Art. 54(5) EPC).
The Guidelines already specified that the possibility of patenting a product in view of its new medical use only applies to substances or compositions and does not apply to devices. The new version of the Guidelines further clarifies what is meant by “substances and compositions”. A product qualifies as a “substance or composition” and is therefore not excluded from patentability a priori if it is the active ingredient in the specified medical use and if its therapeutic effect can be ascribed to its chemical properties.
In summary, the new version of the Guidelines defines the temporal limitations of the exclusions from patentability of inventions relating to plants and animals exclusively obtained by essentially biological processes and to human pluripotent stem cells, which include, inter alia, human embryonic stem cells.
The new Guidelines also provide detailed guidance for the definition of antibodies by their structural and functional features, (i.e., the nucleotide and amino acid sequences of their distinctive portions, the antigen or epitope they recognize, the binding properties, the method of production, the antibody-producing hybridoma), providing some useful practical examples to avoid lack of novelty, clarity or enablement objections.
Finally, the Guidelines clarify that a “substance or composition” which may be patented for its new medical use is an active ingredient whose therapeutic effect is attributable to its chemical properties.