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A.53 EPC Exceptions to patentability

European patents shall not be granted in respect of:

(a)

inventions the commercial exploitation of which would be contrary to "ordre public" or morality; such exploitation shall not be deemed to be so contrary merely because it is prohibited by law or regulation in some or all of the Contracting States;

(b)

plant or animal varieties or essentially biological processes for the production of plants or animals; this provision shall not apply to microbiological processes or the products thereof;

(c)

methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body; this provision shall not apply to products, in particular substances or compositions, for use in any of these methods.

[ Art. 54 100 138 R. 28 29 ]

Amended by the Act revising the European Patent Convention of 29.11.2000.

See decisions/opinion of the Enlarged Board of Appeal G 3/95, G 1/98, G 1/03, G 2/03, G 1/04, G 2/06, G 1/07, G 2/07, G 1/08, G 2/08, G 1/16, G 3/19 (Annex I).

Source: http://www.epo.org/law-practice/legal-texts/html/epc/2016/e/ar53.html

Date retrieved: 17 May 2021

204 references found. Limiting display to 200 references.

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EPC Articles

X Chapter I Patentability

X A.54 EPC Novelty

X A.100 EPC Grounds for opposition

X A.138 EPC Revocation of European patents

EPC Implementing Rules

X R.26 EPC General and definitions

X R.28 EPC Exceptions to patentability

X R.29 EPC The human body and its elements

EPO Guidelines Foreword

X GL FOREWORD 2.1 Overview

EPO Guidelines - A Formalities Examination

X GL A III 8.1 Morality or " ordre public "

EPO Guidelines - B Search

X GL B IV 1.2 Formal deficiencies

X GL B VIII 1 General remarks

X GL B VIII 2.1 Methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body

X GL B X 8 Restriction of the subject of the search

X GL B XI 3 Analysis of the application and content of the search opinion

EPO Guidelines - C Procedureal Aspects of Substantive Examination

X GL C VIII 7 Enlargement of the examining division; consultation of a legally qualified examiner

EPO Guidelines - D Opposition and Limitation/Revocation Procedures

X GL D III 5 Grounds for opposition

EPO Guidelines - E General Procedural Matters

X GL E VI 3 Observations by third parties

EPO Guidelines - F The European Patent Application

X GL F IV 4.12 Product-by-process claim

EPO Guidelines - G Patentability

X GL G II 4.1 Matter contrary to " ordre public " or morality

X GL G II 4.1.1 Prohibited matter

X GL G II 4.1.2 Offensive and non-offensive use

X GL G II 4.1.3 Economic effects

X GL G II 4.2 Surgery, therapy and diagnostic methods

X GL G II 4.2.1 Limitations of exception under Art. 53(c)

X GL G II 4.2.1.1 Surgery

X GL G II 4.2.1.2 Therapy

X GL G II 4.2.1.3 Diagnostic methods

X GL G II 4.2.2 Methods for screening potential medicaments and clinical trials

X GL G II 5.2 Patentable biotechnological inventions

X GL G II 5.3 List of exceptions ( Rule 28 )

X GL G II 5.4 Plant and animal varieties or essentially biological processes for the production of plants or animals

X GL G II 5.4.1 Plant varieties

X GL G II 5.4.2 Essentially biological processes for the production of plants or animals

X GL G II 5.4.2.1 Examples

X GL G II 5.5.1 General remarks

X GL G VI 7.1 First or further medical use of known products

X GL G VI 7.1.2 Therapeutic uses pursuant to Art. 54(5)

X GL G VI 7.1.3 Diagnostic uses pursuant to Art. 54(5)

X GL G VI 7.1.4 Surgical uses pursuant to Art. 54(5)

EPO Guidelines - H Amendments and Corrections

X GL H IV 3.6 Conflicts between Art. 123(3) and other requirements of the EPC

X GL H IV 4.4.3 Points to be disregarded

X GL H V 4.1 The subject-matter to be excluded is not disclosed in the application as originally filed (so-called undisclosed disclaimers)

EPO PCT GL - B Search

X GL-PCT B VIII 2 Subject-matter which the ISA is not required to search and examine

X GL-PCT B VIII 2.1 Methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body

EPO PCT GL - F (not assigned)

X GL-PCT FOREWORD 3.1 Annex I: EPC-PCT concordance table

EPO PCT GL - G Patentability

X GL-PCT G II 1 General remarks

X GL-PCT G II 4.1 Matter contrary to public order or morality

X GL-PCT G II 4.2 Surgery, therapy and diagnostic methods

X GL-PCT G II 5.2 Biotechnological inventions

X GL-PCT G II 5.3 Exceptions

X GL-PCT G II 5.4 Plant and animal varieties, essentially biological processes for the production of plants or animals

Offical Journal of the EPO

X OJ EPO SE 2/2021, p133 - ANNEX 3

X OJ EPO SE 2/2021, p63 - V. PROCEEDINGS BEFORE THE BOARDS OF APPEAL

X OJ EPO SE 2/2021, p2 - I. PATENTABILITY

X OJ EPO SE 4/2020, p116 - ANNEX 3

X OJ EPO SE 4/2020, p2 - I. PATENTABILITY

X OJ EPO 2020, A119 - Opinion of the Enlarged Board of Appeal dated 14 May 2020 - G 3/19

X OJ EPO 2020, A79 - Notice from the European Patent Office dated 3 June 2020 concerning the resumption of proceedings following opinion G 3/19 of the Enlarged Board of Appeal

X OJ EPO 2019, A52 - Communication from the Enlarged Board of Appeal concerning case G 3/19

X OJ EPO 2019, A34 - Notice from the European Patent Office dated 9 April 2019 concerning the staying of proceedings due to the referral G 3/19 to the Enlarged Board of Appeal by the President of the European Patent Office

X OJ EPO SE 3/2018, p2 - BOARDS OF APPEAL AND ENLARGED BOARD OF APPEAL CASE LAW 2017

X OJ EPO 2018, A70 - Decision of the Enlarged Board of Appeal dated 18 December 2017 – G 1/16

X OJ EPO SE 6/2017, p134 - H. European patents subject to litigation in multiple jurisdictions

X OJ EPO SE 6/2017, p24 - B. Novelty

X OJ EPO SE 4/2017, p2 - BOARD OF APPEAL AND ENLARGED BOARD OF APPEAL CASE LAW 2015/2016

X OJ EPO 2017, A56 - Decision of the Administrative Council of 29 June 2017 amending Rules 27 and 28 of the Implementing Regulations to the European Patent Convention ( CA/D 6/17 )

X OJ EPO 2013, 412 - Communication from the Enlarged Board of Appeal concerning case G 2/13

X OJ EPO 2013, 42 - Decision of Technical Board of Appeal 3.3.04 dated 31 May 2012 T 1242/06 3.3.04

X OJ EPO 2012, 468 - Communication from the Enlarged Board of Appeal concerning case G 2/12

X OJ EPO 2012, 206 - Decision of the Enlarged Board of Appeal dated 9 December 2010 G 1/08 1

X OJ EPO 2012, 130 - Decision of the Enlarged Board of Appeal dated 9 December 2010 G 2/07

X OJ EPO 2011, 542 - Decision of Technical Board of Appeal 3.3.02 dated 27 October 2010 T 1635/09

X OJ EPO 2011, 134 - Decision of the Enlarged Board of Appeal dated 15 February 2010 G 1/07

X OJ EPO 2010, 456 - Decision of the Enlarged Board of Appeal dated 19 February 2010 G 2/08

Case Law Book: I Patentability

X CLR I B 1 Introduction

X CLR I B 1.1 Amendments made to Article 53 EPC as part of the EPC 2000 revision

X CLR I B 1.2 Basic principles

X CLR I B 2 Breaches of "ordre public" or morality

X CLR I B 2.1.1 Scope of exception under Rule 28(c) EPC

X CLR I B 2.1.2 Scope of exception under Rule 28(d) EPC

X CLR I B 2.2 ‍‍Article 53(a) EPC

X CLR I B 2.2.1 Test date

X CLR I B 2.2.2.C Donor consent

X CLR I B 3.1 Plants and plant varieties

X CLR I B 3.1.2 Limits to patentability

X CLR I B 3.2 Animals and animal varieties

X CLR I B 3.3.1 Essentially biological processes for the production of animals

X CLR I B 3.3.2.A ‍‍G 2/07 and G 1/08

X CLR I B 3.3.2.B Patentable technical processes

X CLR I B 3.3.3 Product claims for plants or plant material

X CLR I B 3.4 Microbiological processes and the products thereof

X CLR I B 3.4.1 The concept of "microbiological processes"

X CLR I B 4.1 Introduction

X CLR I B 4.2.2 Uniform approach: no need for practitioner involvement

X CLR I B 4.3.1 One surgical step in a multi-step method

X CLR I B 4.3.2 Treatment by surgery not limited to surgery for a therapeutic purpose

X CLR I B 4.3.3 Towards a new concept of "treatment by surgery"

X CLR I B 4.3.4.A Surgical nature of a method step

X CLR I B 4.3.4.B Surgical step part of claimed method?

X CLR I B 4.3.4.C Apparatus claim – disguised method claim?

X CLR I B 4.3.5.A Claim cannot be left to encompass surgical step

X CLR I B 4.3.5.B Disclaimer

X CLR I B 4.3.5.C Methods only concerning the operation of a device

X CLR I B 4.3.6 Data obtained during surgery

X CLR I B 4.4.1.A Definition of the term

X CLR I B 4.4.1.B Application in the case law

X CLR I B 4.4.2 Methods with both therapeutic and non-therapeutic indications

X CLR I B 4.4.2.A Inevitable and inextricably linked therapeutic effect of the claimed method

X CLR I B 4.4.3 Avoiding the non‑patentability under Article 53(c) EPC of methods with therapeutic effect

X CLR I B 4.5 Diagnostic methods

X CLR I B 4.5.1.B Involvement of practitioner

X CLR I B 4.5.1.C The criterion "practised on the human or animal body"

X CLR I B 4.5.2 Case law applying the principles developed in G 1/04

X CLR I C 1 General

X CLR I C 7.1.1 Introduction

X CLR I C 7.1.2 Scope of a purpose-related product claim

X CLR I C 7.2.1 Introduction

X CLR I C 7.2.3 Purpose-limited product claims and Swiss-type claims – scope of protection

X CLR I C 7.2.4.E New dosage regimen

X CLR I C 7.2.4.G Interpretation of "substance or composition"

X CLR I C 7.2.4.J Whether there is a therapeutic method

X CLR I E 1.1 Invention and industrial application

Case Law Book: II Conditions to be met by an Application

X CLR II A 3.2 Indication of all essential features

X CLR II E 1.7.3.B Drafting of disclaimers – disclaimer shall not remove more than is necessary

X CLR II E 1.7.3.E Drafting of disclaimers – clarity

Case Law Book: III Amendments

X CLR III H 1.2 Application of the rules of interpretation

X CLR III H 1.2.4 Subsequent agreement or practice

X CLR III H 1.2.5 Secondary considerations

X CLR III H 5 Decisions of the Administrative Council: boards of appeal not formally bound

X CLR III H 6 Implementing Regulations

Case Law Book: V Priority

X CLR V B 2.5.1 Question already decided by the Enlarged Board

Case Law of the Enlarged Board

X G 0003/95 (Inadmissible referral) of 27.11.1995

X G 0001/98 (Transgenic plant/NOVARTIS II) of 20.12.1999

X G 0001/03 (Disclaimer/PPG) of 8.4.2004

X G 0002/03 (Disclaimer/GENETIC SYSTEMS) of 8.4.2004

X G 0001/04 (Diagnostic methods) of 16.12.2005

X G 0002/06 (Use of embryos/WARF) of 25.11.2008

X G 0001/07 (Treatment by surgery/MEDI-PHYSICS) of 15.2.2010

X G 0002/07 (Broccoli/PLANT BIOSCIENCE) of 9.12.2010

X G 0001/08 (Tomatoes/STATE OF ISRAEL) of 9.12.2010

X G 0002/08 (Dosage regime/ABBOTT RESPIRATORY) of 19.2.2010

X G 0002/12 () of 25.3.2015

X G 0002/13 () of 25.3.2015

X G 0001/16 (Disclaimer III) of 18.12.2017

X G 0003/19 (Pepper (follow-up to ÂTomatoes IIÂ and ÂBroccoli IIÂ)) of 14.5.2020

General Case Law

X T 0663/02 () of 17.3.2011

X T 0992/03 () of 4.11.2010

X T 0522/04 (Stem cells/CALIFORNIA) of 28.5.2009

X T 1319/04 (Dosage regimen/KOS LIFE SCIENCES, INC.) of 22.4.2008

X T 0080/05 (Method of diagnosis/UNIVERSITY OF UTAH) of 19.11.2008

X T 0250/05 (Use of nitric oxide for systemic treatment/THE BRIGHAM AND WOMEN' … of 4.3.2008

X T 1314/05 (Schweizer Anspruchsfassung fÃ¼r Vorrichtung zur medizinischen … of 15.4.2008

X T 1075/06 () of 17.5.2011

X T 1242/06 (Tomatoes II/STATE OF ISRAEL) of 31.5.2012

X T 1729/06 (Seedless watermelon/SYNGENTA) of 17.9.2014

X T 1855/06 () of 18.6.2009

X T 0266/07 () of 25.6.2010

X T 0788/07 (Brassica/PIONEER) of 7.1.2008

X T 1695/07 () of 28.9.2011

X T 1814/07 (Index disorder/CARDIAC INTELLIGENCE CORP.) of 2.9.2008

X T 1854/07 (Oil from seeds/CONSEJO SUPERIOR) of 12.5.2010

X T 0836/08 () of 12.5.2011

X T 0923/08 () of 2.8.2011

X T 1199/08 (Selected sperm/XY) of 3.5.2012

X T 1407/08 () of 20.3.2013

X T 1680/08 () of 8.6.2011

X T 1798/08 () of 21.8.2012

X T 1859/08 (Anti-ErbB2 antibodies/GENENTECH, INC.) of 5.6.2012

X T 2003/08 (Dilated cardiomyopathy/EDWARDS) of 31.10.2012

X T 0189/09 () of 27.7.2011

X T 0385/09 () of 25.11.2010

X T 1099/09 () of 12.1.2012

X T 1487/09 () of 24.9.2013

X T 1570/09 (Alpha-ketoglutaric acid and pharmaceutically acceptable salts thereof … of 16.5.2014

X T 1635/09 (Zusammensetzung fÃ¼r EmpfÃ¤ngnisverhÃ¼tung/BAYER SCHERING PHARMA AG) of 27.10.2010

X T 0495/10 () of 3.7.2012

X T 0547/10 (Transgenic cotton plants/BAYER CROPSCIENCE) of 13.7.2016

X T 0773/10 () of 24.10.2014

X T 0915/10 (Soybean event/MONSANTO) of 11.6.2015

X T 1016/10 () of 11.4.2014

X T 1836/10 (Gewinnung von embryonalen Stammzellen/WÃRFEL) of 9.4.2013

X T 2221/10 (Culturing stem cells/TECHNION) of 4.2.2014

X T 2369/10 () of 13.11.2015

X T 2323/11 (Sequence excision/BASF) of 24.1.2017

X T 2438/11 () of 7.10.2015

X T 0044/12 () of 11.1.2017

X T 0475/12 () of 11.11.2015

X T 1208/12 (Oilseed/PIONEER HI-BRED) of 7.2.2017

X T 0158/13 () of 17.11.2016

X T 1441/13 (Embryonic stem cells, disclaimer /ASTERIAS) of 9.9.2014

X T 1808/13 (Neurale VorlÃ¤uferzellen/BRÃSTLE) of 26.2.2015

X T 1819/13 () of 21.2.2018

X T 2420/13 () of 8.12.2016

X T 2451/13 () of 14.1.2016

X T 0013/14 (Agent for treatment of schizophrenia/SUMITOMO DAINIPPON) of 15.10.2015

X T 0015/14 (Immunemodulating oligosaccharides for use in medical treatment/ … of 6.10.2015

X T 0385/14 (In vitro differentiated cardiomyocytes/AXIOGENESIS) of 11.9.2019

X T 1758/15 () of 11.7.2017

X T 1063/18 (Extreme dark green, blocky peppers/SYNGENTA) of 5.12.2018