France: EPO practice: monoclonal antibodies and sequence identity

Managing IP is part of Legal Benchmarking Limited, 1-2 Paris Gardens, London, SE1 8ND

Copyright © Legal Benchmarking Limited and its affiliated companies 2025

Accessibility | Terms of Use | Privacy Policy | Modern Slavery Statement

France: EPO practice: monoclonal antibodies and sequence identity

Since the first marketing authorisation for a monoclonal antibody (Mab) in the 1980s, the patent system has never stopped adding the fuel of interest to the fire of Mabs ingenuity.

In view of the ever-increasing pace of technological progress in this highly competitive field, patent applications are often filed at the stage of Mab prototypes. Patent claims have naturally adapted to this practice in order to attempt to protect not only the Mab prototypes but also downstream developments. In this context, claims based on sequence identity are often sought after by applicants.

However, the EPO practice concerning Mab sequence identity appears rather variable, all the more so given that there is no official guideline in this area. A journey through Board of Appeal decisions and examination files nonetheless enables certain conclusions to be drawn in order for applicants to be in a better position to handle examination proceedings.

Firstly, complementarity-determining regions (CDRs) are intangible for the EPO: a claim focused on a degree of identity of CDR sequences is generally not allowed in Europe. Secondly, two main forms of sequence identity claim seem to be accepted by the EPO. The first form consists of applying the degree of identity to a region broader than the CDRs while specifying that said degree of identity does not apply to CDR sequences. This type of claim has been accepted by the Board of Appeal in the decision T 0516/11. The second form consists of associating the degree of identity with at least one functional feature, which has been encouraged by the Board of Appeal in the decision T 2101/09. This strategy can be particularly useful when the functional characteristic is a reflection of an unexpected property that justifies inventive step.

Thus, it is recommended to define the degree of identity in different ways and to provide fallback positions to combine degree of identity with functional features. It is nevertheless necessary to ensure that all the combinations contemplated have direct and unambiguous support in the original application to satisfy the requirements of Article 123(2) EPC.

marro-nicolas.jpg
boudeau-berengere.jpg

Nicolas Marro

Bérengère

Boudeau


Cabinet Beau de Loménie158, rue de l’UniversitéF - 75340 Paris Cedex 07 FranceTel: +33 1 44 18 89 00Fax: +33 1 44 18 04 23contact@bdl-ip.comwww.bdl-ip.com

more from across site and SHARED ros bottom lb

More from across our site

Bradford Newman, who has joined the firm’s new Silicon Valley office as head of complex technology disputes, discusses plans to build the practice group and attract local talent
Managing IP summarises the highlights from the IP STARS rankings for copyright and IP transactions work, the final firm rankings release of the year
Developments included the first judgment from the Nordic Baltic division, an injunction covering the UK, and a new code of conduct
Alston & Bird acted for InterDigital, while Samsung was represented by Fish & Richardson, during the arbitration process
Powell Gilbert lawyers reveal how they navigated parallel EPO proceedings and collaborated with European peers to come out on top in the Nordic-Baltic Division’s first judgment
The firms posted increases in revenue and profit per equity partner, with both giving a nod to their IP expertise
EasyGroup, the owner of the easyJet airline, said in a press release that UK-based first-instance judges are “less experienced”, bringing a long-running debate back to the fore
A cross-practice team from Mayer Brown, which included members of the firm’s IP practice, advised on the deal
María Cecilia Romoleroux discusses the challenges she has faced in her career in IP and how she hopes to improve things for the next generation of women
Value-added services give in-house counsel the satisfaction that they are getting more value for money, while law firms get the opportunity to win more work
Gift this article