Managing IP is part of the Delinian Group, Delinian Limited, 8 Bouverie Street, London, EC4Y 8AX, Registered in England & Wales, Company number 00954730
Copyright © Delinian Limited and its affiliated companies 2023

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 ros bottom lb

More from across our site

Chris Semerjian, MacNeal Darnley and Nicolas Charest provide an overview of trade secret law in Canada and reveal best measures to protect and enforce trade secrets.
Inspired by his former team at Pure Storage, Suvashis Bhattacharya wants to reward inventors with merchandise, he tells Managing IP in an exclusive interview
IP minister George Freeman said on Wednesday that plans for a broad text and data mining exception would not go ahead and that further consultation was needed
We provide a rundown of Managing IP’s news and analysis coverage from the week, and review what’s been happening elsewhere in IP
The trademark battle over ‘MetaBirkin’ NFTs could inform future legal strategies and will provide at least some answers, whichever way it turns, say sources
The EPO BoA says the choice of format now rests with individual boards, sparking outrage from attorneys who say in-person hearings are the ‘gold standard’
Counsel at SMEs and private practice advisers say funding schemes are useful but must be backed by wider changes
Counsel welcome the Delhi High Court’s clarity on claim amendment but worry that its interpretation of the Patents Act negates statutory law
Kitchin is to hear the DABUS case before stepping down on September 29 this year
Numerous studies show that lawyers are increasingly stressed at work and looking for a way out, but law firms are still in denial