European Patent Office

T 0670/20 (Pharmaceutcial composition/SANKYO) of 02.12.2022

European Case Law Identifier
ECLI:EP:BA:2022:T067020.20221202
Date of decision
2 December 2022
Case number
T 0670/20
Petition for review of
-
Application number
08720658.7
Language of proceedings
English
Distribution
Distributed to board chairmen (C)
OJ versions
No OJ links found
Other decisions for this case
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Abstracts for this decision
Abstract on EPC2000 Art 054
Application title
PHARMACEUTICAL COMPOSITION
Applicant name
Daiichi Sankyo Company, Limited
Opponent name
Hexal AG
Generics [UK] Ltd
Board
3.3.07
Headnote
-
Relevant legal provisions
European Patent Convention Art 123(2)European Patent Convention Art 54European Patent Convention Art 56Rules of procedure of the Boards of Appeal 2020 Art 013(1)
Keywords
Amendments - allowable (yes)
Novelty - public prior use (no)
Inventive step - bonus effect (no)
Amendment to appeal case - justification by party (yes)
Catchword
The clinical trials were carried out in accordance with the EMEA Guidelines for Good Clinical Practice. These guidelines explicitly require adherence to the prescribed protocol and assurance of drug accountability. This set-up of the trials implies that the patients who decided to participate in the trials agreed, following their informed consent, to use the provided medication according to instruction or to return the unused medication. Accordingly, the participating patients who were provided with the tablets under investigation entered into a special relationship with the investigators of the trials and were with regard to the provided tablets not members of the public that could freely dispose over these tablets. (see section 4.3)
Citing cases
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Order

For these reasons it is decided that:

The appeals are dismissed.