Patentees generally want to encompass both their core invention and a small amount of white space around it. In some fields, this is relatively straightforward. However, in biologics, applicants at the EPO are often forced into claims that recite a specific sequence ID which, arguably, does not encompass similar sequences. This has been the case irrespective of whether the product is an antibody, other protein therapy, nucleic acid, or a combination of the above. In the recent Board of Appeal Decision T 0137/24, the Board has confirmed that functional language can be used as a tool for obtaining breadth in how sequences are defined.
Sequence Breadth is Commercially Valuable
Unlike small molecules, for which generics are typically looking to produce identical compounds to those approved, biosimilars – which, as the name suggests, are similar but not identical – represent a significant threat to market share. Therefore, claims reciting a single protein (e.g., antibody) or nucleic acid