Protecting Antibody IP: Consider Regional Differences

Biotechnology developers should be aware of subtle differences between the way that European and United States patent authorities approach monoclonal antibodies.

Protecting intellectual capital is an imperative for every country that wants its biotech business to succeed. However, what works in one nation may not work in another, and applicants need to pay attention to regional differences to ensure that they will achieve desired results.As Monika Rai and Juliet Redhouse, attorneys with the law firm,Mathys & Squire LLP, describe some differences in practice between the United States and Europe as they concern monoclonal antibodies.

The European Patent Office’s (EPO) approach to patenting antibodies focuses on their being novel, inventive and “reproducible by a skilled person.”  These attributes are closely connected to antibody target, structure, or function. For instance, how the antibody binds to its target’s epitope; whether its structure might lead to greater affinity, or whether or not it is capable of blocking a particular type of receptor.  Ensuring that these points are made clear in an application will be essential for any developer.

On Oct. 9–11, 2018 in Madrid, CPhI’s BioLive program will explore many facets of biopharmaceutical development, manufacturing, and business. For more information on intellectual property issues, read the September 2018 article on the subject in BioPharm International (1).

References

1. M. Rai, J. Redhouse, BioPharm International, 31 (9) 2018.