Inventive step assessment of antibody claims

Resolution of the World Congress and Executive Committee, Naples, Italy
13 to 17 October 2025

“Inventive step assessment of antibody claims”

FICPI, the International Federation of Intellectual Property Attorneys, broadly representative of the free profession throughout the world, assembled at its World Congress and Executive Committee held in Naples, Italy, 13 to 17 October 2025, passed the following resolution:

NOTING that Art 27.1 of TRIPS, states that “… patents shall be available … without discrimination as to the … field of technology”, and no specialised standard for the assessment of inventive step of antibodies is included in national laws;

RECOGNISING that certain Patent Offices have adopted a prima facie presumption of obviousness in the assessment of the inventive step of claims to antibodies per se that bind to a known antigen; 

UNDERSTANDING that if the applicant cannot prove that the claimed antibody meets an exception, commonly a surprising technical effect, it is presumed to lack an inventive step because antibody generation is considered to involve “routine methods”;

BELIEVING that the adoption of a negative presumption that antibody products are the products of routine methods and not patentable, unless proven otherwise, obscures the analysis of the actual invention and undervalues the complexity of engineered antibody products, and may discourage innovation in this vital class of products used to diagnose or treat disease;

URGES Patent Offices to eliminate from, or refrain from including in, their Rules, Guidelines and internal practices:

• the presumption of prima facie obviousness of antibodies; and
• the assumption that all antibodies are produced by “routine methods”. 
   

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