EPO’s Guidelines for Examination 2021: Getting into the Field of Biotech

Recently through the publication of the Guidelines for Examination 2021, EPO tries to bring some changes in the field of Computer-implemented inventions and with respect to procedural matters. In this piece, we will try to discuss the changes that were bought in the field of Biotech. The guidelines tried to bring some changes with regards to few interpretations of terms such as amino acid and nucleic acid and defining the concept of “therapy”. The guidelines also deal in the exclusion of some biotechnological inventions from patentability and inventions relating to plants and animals.

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With regards to the interpretation of the terms of amino acid and nucleic acid sequence concerning the percentage of identity, this percentage of identity defines the number of identical residues along a certain length in a certain alignment. If this is not used then the examiner will adopt the broadest possible interpretation of the claim, including all sequences that fulfill the percentage of identity as calculated by an algorithm known as the relevant filing date. The same applies to claims where an amino acid sequence is defined by the degree of similarity. (F-IV 4.24)

While defining the concept of “therapeutic method”, it says that the method 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. (G-II 4.2.1.2)

While dealing with the exclusion of plants and animals exclusively obtained by means of an essentially biological process from being eligible for inventions, the EPO has a well-established jurisprudence reflecting the provision of Directive 98/44/EC on the protection of biotechnological inventions. As per Article 53(b) of EPC, the patentability of essentially biological processes for the production of plants and animals is expressly excluded.

The interpretation of the concept of “essentially biological processes” has been extensively dealt with by EPO. This interpretation has also questioned whether this non-eligibility as expressed under Art 53(b) limits the patentability of plants and animals that are not varieties. Incorporating decisions in the guidelines, such as, in 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), it tries to make the definition of “essentially biological process.”

This exclusion of plants and animals obtained by essentially biological processes, as specified by the guidelines 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). (G-II 5.2 and 5.4)

The exclusion from patentability as specified in Art. 53(a) and Rule 28(1) of EPC will not include patent application pertaining to human pluripotent stem cells, including human embryonic stem cells, their uses and products derived, if the effective date is 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 the destruction of the human embryo). (G-II 5.3)

The guidelines introduce a section discussing the patentability of antibodies. For defining the antibody by its amino acid and nucleic acid sequence and for not arising any clarity objection, the claim must specify the six CDRs. In case, if it can be experimentally proved that one or more CDR do not interact with the antigen or if the antibody is in a format allowing for epitope recognition by fewer CDRs, defining the fewer CDR can be permissible. Care should be taken not to use 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”. As compared to the evaluation of the inventive steps pertaining to the antibody, it is almost the same as that of the biological invention and also concerning one or more surprising technical features over the antibodies of the prior art.

Art. 53(c) EPC speaks about the exclusion of patentability methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practiced on the human or animal body while not applying this provision for “products, in particular substance or compositions.” The new guidelines also specify what is “substances and compositions” stating that the 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.

Author: Saransh Chaturvedi (an advocate) currently pursuing LLM from Rajiv Gandhi School of Intellectual Property Law (IIT Kharagpur).  In case of any queries please contact/write back to us at support@ipandlegalfilings.com.