EPO’s new examination guidelines: what you need to know
A new edition of the European Patent Office (EPO) Guidelines for Examination came into force on March 1, 2021. Relevant to life sciences, this edition includes a new subsection detailing EPO practice with respect to the interpretation of terms relating to amino or nucleic acid sequences, as well as a new section on the examination of claims to antibodies.
Terms in relation to amino or nucleic acid sequences (F-IV, 4.24)
In the field of biotechnology, claims often include nucleotide or amino acid sequences that are defined in terms of their percentage identity or percentage similarity (amino acid sequences only) to a specified reference sequence. The new guidelines provide written guidance on how these different terms are interpreted.
First, they confirm that when an amino acid or nucleic acid sequence is defined by using percentage sequence identity language, this is determined by the number of identical residues over a defined length in a given alignment. If no algorithm or calculation method for determining the percentage of identity is defined, the broadest interpretation will be applied using any reasonable method known at the relevant filing date.
In addition, it is confirmed that amino acid sequences can also be defined by a degree of similarity, expressed as a percentage of similarity. Similarity is considered broader than identity, as it allows conservative substitutions of amino acid residues having similar physicochemical properties over a defined length of a given alignment.
