European Patent Office comes up with Guidelines for Examination 2021: Part II

European Patent Office comes up with Guidelines for Examination 2021: Part II

The Guidelines for Examination 2021, published by European Patent Office (EPO) came into force on March 1. In part I, we have discussed the changes being brought in the Computer-implemented inventions. In this part, we will see the changes being brought for Biotech.

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 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. (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)

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 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. The Guideline tries to make the concept of "essentially biological processes" more clear.

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 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.

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 "substances and compositions" are, 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 it's therapeutic effect can be ascribed to its chemical properties.