Short Summary
1. In the case of a second medical use claim, a substance or composition within the mean- ing of Art. 54(4) EPC is used for any specific use which is not comprised in the state of the art. Such a therapeutic use can be a new indication, e.g. a disease not yet treated by the claimed substance, or an indication for a new group of patients. 2. For a finding of infringement of a second medical use claim, the alleged infringer must offer or place the medical product on the market in such way
Detailed Summary
1
Düsseldorf Local Division
UPC_CFI_505/2024
of the Court of First Instance of the Unified Patent Court
delivered on 13 May 2025
concerning EP 3 536 712 B1
Headnotes:
1.
In the case of a second medical use claim, a substance or composition within the mean-
ing of Art. 54(4) EPC is used for any specific use which is not comprised in the state of
the art. Such a therapeutic use can be a new indication, e.g. a disease not yet treated
by the claimed substance, or an indication for a new group of patients.
2.
For a finding of infringement of a second medical use claim, the alleged infringer must
offer or place the medical product on the market in such way that it leads or may lead
to the claimed therapeutic use of which the alleged infringer knows or reasonably
should have known that it does. The requirements of such behaviour cannot be defined
in an abstract manner but require an analysis of all relevant facts and circumstances of
the patent claim in question.
3.
In order to benefit from the notional novelty afforded by Art. 54(5) EPC, second medical
use claims must relate to a specific use in a method according to Art. 53(c) EPC. The
sole reason why such claims can still be patented is the novelty (and inventiveness) of
the new use.
4.
In terms of inventive step, the subject matter of the claim may be obvious if the skilled
person would have been motivated to implement it as the next step in the view of the
problem. A motivation to implement may be absent or negated if the skilled person is
faced with many uncertainties or expected difficulties. If there is no motivation at all
or a negated motivation, the subject matter of the claim is not obvious and involves an
inventive step.
5.
Objections based on pleading ignorance are in principle disregarded. The Rules of Pro-
cedure of the Unified Patent Court do not acknowledge this type of pleading.
Keywords:
Second medical use claim; infringement; novelty; pleading ignorance; inventive step; obviousness
2
CLAIMANT:
1.
Sanofi Biotechnology SAS, represented by its chairman, Laurent Gilhodes, 82 avenue Raspail,
94250 Gentily, France
2.
Regeneron Pharmaceuticals Inc., represented by its CEO Leonard Schleifer, 777 Old Saw Mill
River Road, Tarrytown, New York 10591, United States of America
all Claimants represented by:
Attorneys-at-law Dr Niels Hölder, Mike Gruber, Dr Michael
Pfeifer and all other UPC Represenatives of HOFFMANN EITLE
PartmbB, Arabellastraße 30, 81825 Munich, Germany
European Patent Attorney Daniel Wise, Attorney-at-law
Agathe Michel-de Cazotte and all other UPC Representatives
of Carpmeals & Ransford LLP, One Southhampton Row, Lon-
don WC1B 5HA, United Kingdom
electronic address for service:
nhoelder@hoffmanneitle.com
DEFENDANTS:
1.
Amgen Inc., represented by its CEO Robert Bradway, One Amgen Center Drive, Mail Stop 2-
28-C, 91320 1799 Thousand Oaks, California, USA
2.
Amgen Europe B.V., represented by its managing directors Jan Arie Bouman, Paulus Johan-
nes Dekkers and Daniëlle Christine IJkema, Minervum 7061, 4817 ZK Breda, The Netherlands
3.
Amgen N.V., represented by its Directors Gwenaël Caesens, Paraskevi Florou and Gabor
Sztaniszlav, Telecomlaan 5-7 1831 Diegem, Belgium
4.
Amgen GmbH, represented by its managing directors Manfred Heinzer, Adam Stewart Elinoff
and Andreas Wolfgang Bierl, Riesstraße 24, 80992 Munich, Germany
5.
Amgen B.V., represented by its directors Johannes Jacobus Michel Maria Rijnierse, Maria
Carolina Correa and Paraskevi Florou, Minervum 7061 Breda, 4817 DH, The Netherlands
6.
Amgen S.A.S., represented by its president Corinne Buffet, 18-20 Quai du Point du Jour, Bou-
logne-Billancourt, 92100 France
7.
Amgen S.R.L., represented by its directors Corrado Napolitano and Paraskevi Florou, Via En-
rico Tazzoli 6, Milano (Mi), 20154 Milano, Italy
all Defendants represented by:
Johannes Heselberger and Nadine Westermey
Practitioner Note
This case demonstrates the evidentiary and procedural standards applied in patent matters before Düsseldorf (DE) Local Division. Understanding the court's reasoning in Sanofi Biotechnologies SAS, Regeneron Pharmaceuticals Inc. vs Amgen Inc. , Amgen GmbH, Amgen Europe B.V., Amgen NV, Amgen S.R.L., Amgen B.V., Amgen S.A.S. is valuable context for structuring arguments or assessing risk in similar proceedings.
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