The development of hybridoma technology in the 1970s revolutionized the field of antibody technology, leading to a fundamental transformation in our realisation of the potential of antibodies as a tool for research and for prevention, detection and treatment of diseases. In the past few decades in particular, monoclonal antibodies have found important applications in therapeutics, drug targeting and diagnostics. Since the approval of the first therapeutic monoclonal antibody in the 1980s, therapeutic monoclonal antibodies and antibody-related products such as Fc-fusion proteins, antibody fragments, bi-specifics, and antibody-drug conjugates have become a major class within the biopharmaceutical market. Today, antibody-based therapeutics are fast advancing through clinical development and approval numbers are growing.
The success of the antibody field has naturally been accompanied by vigorous patenting activity, both in terms of obtaining patents for antibodies even where a particular target may already be known and in terms of disputes at both national court and European Patent Office (EPO) opposition and appeal level. This has led to a sizeable body of case law, which increases year on year as patentees seek to maximise their protection or clear the way in increasingly crowded spaces. A comprehensive understanding of this case law, as well as extensive practical experience of the antibody patenting area is required in order to be able to provide useful, commercial advice on patenting strategies. Case law and practice has established a unique set of guidelines around acceptable structural and functional claim features for defining antibodies, as well as breadth of claim and support from Examples, particularly for claiming specific therapeutic applications. Case law and practice has established a unique set of guidelines around acceptable structural and functional claim features for defining antibodies, as well as breadth of claim and support from Examples, particularly for claiming specific therapeutic applications. From 1 March 2021, the EPO has introduced a new section in the Guidelines for Examination which is dedicated to antibody practice.
Attorneys at CMS have the relevant experience, having worked in the antibody patenting field for more than 20 years, with a particular focus on EPO prosecution, opposition and appeal. As a snapshot of this long standing and varied experience, our attorneys were involved in:
- The successful defence at first instance and appeal level of a claim directed to any antibody binding to a novel target in T1902/11, Human IL-23/MERCK SHARP & DOHME
- The successful prosecution of a claim to new immunoglobulin format DVD-Ig™ molecules for dual-specific targeting
- The successful defence at first instance in Anti-angiopoietin-2 antibodies/MEDIMMUNE of a claim to a proprietary antibody where the target was already known, based on the identification of an unexpected technical effect
- The successful opposition at appeal level of the clarity of a claim defining a disease in functional terms in T 2321/13 in Hyperproliferative diseases/MAX-PLANCK-GESELLSCHAFT
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