T 0923/92 (human t-PA) of 8.11.1995 | XEPC: EPC and PCT resource

European Case Law Identifier:

ECLI:EP:BA:1995:T092392.19951108

Date of decision:

08 November 1995

Case number:

T 0923/92

Application number:

83302501.8

IPC class:

C12N 15/00

Language of proceedings:

Distribution:

Download and more information:

Decision text in EN (PDF, 2Â MB)
Documentation of the appeal procedure can be found in the Register
Bibliographic information is available in:	EN
Versions:	OJ \| Published

Title of application:

Human tissue plasminogen activator, pharmaceutical compositions containing it, processes for making it, and DNA and transformed cell intermediates therefor

Applicant name:

GENENTECH, INC.

Opponent name:

01 KabiVitrum AB
02 The Wellcome Foundation Limited
03 Celltech Limited
04 Toyo Boseki Kabushiki Kaisha
06 Behringwerke Aktiengesellschaft
07 Boehringer Mannheim GmbH

Board:

3.3.04

Headnote:

I. The skilled person considers a reference to a particular amino acid sequence in a claim as a true technical feature characterizing the invention. Such a claim is not under Article 87 entitled to priority from an earlier application in which that amino acid sequence was not disclosed (cf. points 8 and 16 of the Reasons).
II. A claim to a process which comprises the preparation of a protein which has human tissue plasminogen activator (t- PA) function, without further indication which of the many functions of human t-PA are meant, is not allowable under Articles 83 and 84 EPC. This is firstly because the skilled addressee would be left guessing whether or not a derivative which fulfils only one of the functions typical of this molecule falls under the scope of the claim. Moreover, the requirement of Article 83 EPC is not fulfilled if the claim, on the basis of the broadest possible meaning of the functional definition contained in it, relates to an invention which, having regard to the examples and the information given in the patent specification, cannot be performed in the whole area claimed by a person skilled in the art, using common general knowledge, without undue burden (cf. point 27 of the Reasons).
III. Given a description that contains adequate information how to produce human t-PA, and a claim directed to derivatives of human t-PA with an indication of the functions to test for, the skilled person can be expected to be able to prepare without application of inventive skill or undue burden, derivatives of human t-PA by way of amino acid deletion, substitution, insertion, addition or replacement and test which of the derivatives satisfy the functional requirements, so that the claimed invention is adequately described for the purpose of Article 83 EPC [cf. points 44 and 45 of the Reasons].

Relevant legal provisions:

European Patent Convention 1973 Art 123
European Patent Convention 1973 Art 87
European Patent Convention 1973 Art 88
European Patent Convention 1973 Art 54
European Patent Convention 1973 Art 56
European Patent Convention 1973 Art 83
European Patent Convention 1973 Art 84

Keywords:

Main request - entitlement to priority (no) - differences in sequences
Main request - novelty (no)
Subsidiary requests 1 and 2 - lack of clarity (yes)
Lack of sufficient disclosure (yes)
Subsidiary request 3 - formal admissibility (yes)
Subsidiary request 3 - reformatio in peius (no)
Entitlement to priority (yes)
Sufficiency of disclosure (yes)
Novelty (yes)
Inventive step (yes) - no reasonable expectation of success

Catchwords:

Cited decisions: