Key takeaways
Inventive step (Art. 56 EPC) exists if scientific uncertainty at the priority date prevented a ‘reasonable expectation of success’, even if there was a ‘hope to succeed’.
The Court found that uncertainty about the relative contribution of a protein’s intracellular versus extracellular pathways in vivo was a critical factor preventing a reasonable expectation of success.
Prior art showing only marginal effects at physiological concentrations undermined any rational prediction that an antibody therapy, which only acts extracellularly, would be therapeutically effective.
Contemporaneous research by competitors indicated the field was interesting to explore but did not establish that success was predictable, thus not negating inventive step.
Medical use claims inherently require a ‘meaningful’ therapeutic effect, meaning a noticeable improvement in the patient’s condition, not just any measurable biological activity.
This requirement stems directly from the ‘medical use’ claim format itself and is not dependent on specific wording in the claim or the patent’s description.
A main claim’s scope is not interpreted by dependent claims that add distinct features; such claims cannot be used to dilute the requirements of the main claim.
The Court of First Instance had wrongly used dependent claims on combination therapy to lower the efficacy standard required for the monotherapy protected by the main claim.
No added matter (Art. 138(1)(c) EPC) exists if the application as a whole clearly points to the claimed combination, even without literal support for that specific combination.
The Court rejected the patent challenger’s “arbitrary mosaic” argument, finding that the application contained clear pointers and links making the claimed combination the preferred, non-arbitrary embodiment.
Sufficiency (Art. 138(1)(b) EPC) is met if the patent enables obtaining suitable embodiments without undue burden; enabling every conceivable embodiment is not required.
The patent challenger bears the burden of proof and failed to provide evidence of failed attempts. The Court noted that laborious methods are not automatically an “undue burden.”
The unsuccessful party bears the costs (Art. 69 UPCA), and the Court can order payment within a set timeframe (R. 118.8 RoP) and determine the value.
The Court ordered each of the two unsuccessful parties to pay the successful party EUR 1.375 million for first instance costs and set the value per appeal at EUR 100 million.
Division
Court of Appeal
UPC number
UPC_CoA_528/2024, UPC_CoA_529/2024
Type of proceedings
Appeal against a decision in a revocation action and a counterclaim for revocation
Parties
Appellant / Defendant (First Instance): Amgen, Inc.
Respondents / Claimants & Counter-Claimant (First Instance): Sanofi-Aventis Deutschland GmbH, Sanofi-Aventis Groupe S.A., Sanofi Winthrop Industrie S.A. (“Sanofi”); Regeneron Pharmaceuticals Inc. (“Regeneron”)
Patent(s)
EP 3 666 797
Jurisdictions
UPC
Body of legislation / Rules
Art. 56 European Patent Convention (EPC)
Art. 138(1)(b) EPC
Art. 138(1)(c) EPC
Art. 69 Agreement on a Unified Patent Court (UPCA)
Rule 118.8 Rules of Procedure of the UPC (RoP)
