Paris, March 15, 2021 – The new version of the Guidelines for Examination in the EPO, which came into force on March 1st, contains a new section that at last spells out the approach of the EPO concerning the examination of patent applications relating to antibodies.
Numerous patent applications relating to antibodies are filed each year with the EPO, which has defined a specific practice concerning these inventions.
Thus, a claim to an antibody defined only by its antigen is generally not considered to be inventive if the antigen is known, unless particular difficulties had to be overcome in order to successfully generate antibodies against the antigen. It is therefore almost always necessary to incorporate structural or functional features of the antibody.
As for all other inventions in the field of life sciences, functional features are little appreciated by EPO examiners, who highly prefer structural features. The EPO additionally requires that the antibody, even when defined by a specific unpredictable structure, further have an unexpected advantageous property.
This practice is based on the case law of the Boards of Appeal and has been established for some time. However, it has not yet been the subject of a dedicated section in the Guidelines for Examination in the EPO, which are relied upon by both examiners when formulating their objections, and applicants when challenging them.
This has now been accomplished, with the new version of the Guidelines coming into force on March 1, 2021 including a new section G-II.5.6 concerning antibodies in the part relating to exclusions and exceptions for biotechnological inventions.
This section is divided into two subsections. The first subsection summarizes the different ways in which antibodies may be defined and how each definition should be assessed in terms of novelty, clarity, support and sufficiency of disclosure. The second subsection details the approach to be followed when assessing the inventive step of antibody claims.
This new section should allow for an even more homogeneous and predictable treatment of patent applications concerning antibodies.
With its experience in defending claims directed to antibodies, REGIMBEAU’s “Immunology” team is at your disposal to advise you on which strategies to implement in order to best protect your antibodies.
