Skip to main content Skip to footer
HomeHome
 
  • Homepage
  • Searching for patents

    Patent knowledge

    Access our patent databases and search tools.

    Go to overview 

    • Overview
    • Technical information
      • Overview
      • Espacenet - patent search
      • European Publication Server
      • Searching Asian documents: patent search and monitoring services
      • EP full-text search
      • Bibliographic coverage in Espacenet and OPS
      • Full-text coverage in Espacenet and OPS
    • Legal information
      • Overview
      • European Patent Register
      • European Patent Bulletin
      • European Case Law Identifier sitemap
      • Searching Asian documents
      • Third-party observations
    • Business information
      • Overview
      • PATSTAT
      • IPscore
      • Patent insight reports
    • Data
      • Overview
      • Linked open EP data
      • Bulk data sets
      • Web services
      • Coverage, codes and statistics
    • Helpful resources
      • Overview
      • First time here?
      • Asian patent information
      • Patent information centres
      • Patent Translate
      • Patent Knowledge News
      • Business and statistics
      • Unitary Patent information in patent knowledge

    UP search

    Learn about the Unitary Patent in patent knowledge products and services

  • Applying for a patent

    Applying for a patent

    Practical information on filing and grant procedures.

    Go to overview 

    • Overview
    • European route
      • Overview
      • European Patent Guide
      • Oppositions
      • Oral proceedings
      • Appeals
      • Unitary Patent & Unified Patent Court
      • National validation
      • Request for extension/validation
    • International route (PCT)
      • Overview
      • Euro-PCT Guide – PCT procedure at the EPO
      • EPO decisions and notices
      • PCT provisions and resources
      • Extension/validation request
      • Reinforced partnership programme
      • Accelerating your PCT application
      • Patent Prosecution Highway (PPH)
      • Training and events
    • National route
    • MyEPO services
      • Overview
      • Understand our services
      • Get access
      • Find a professional representative
      • File with us
      • Interact on your files
      • Online Filing & fee payment outages
      • Tutorials
    • Forms
      • Overview
      • Request for examination
    • Fees
      • Overview
      • European fees (EPC)
      • International fees (PCT)
      • Unitary Patent fees (UP)
      • Fee payment and refunds
      • Warning

    UP

    Unitary Patent

  • Law & practice

    Law & practice

    European patent law, the Official Journal and other legal texts.

    Go to overview 

    • Overview
    • Legal texts
      • Overview
      • European Patent Convention
      • Official Journal
      • EPC Guidelines
      • PCT-EPO Guidelines
      • Guidelines revision cycle
      • Extension / validation system
      • London Agreement
      • National law relating to the EPC
      • Unitary patent system
      • National law relating to the UP
    • Court practices
      • Overview
      • European Patent Judges' Symposium
    • User consultations
      • Overview
      • Ongoing consultations
      • Completed consultations
    • Substantive patent law harmonisation
      • Overview
      • The Tegernsee process
      • Group B+
    • Convergence of practice
    • Options for professional representatives

    legal text

    Legal texts

  • News & events

    News & events

    Our latest news, podcasts and events, including the European Inventor Award.

    Go to overview 

     

    • Overview
    • News
    • Events
    • European Inventor Award
      • Overview
      • About the award
      • Categories and prizes
      • Meet the finalists
      • Nominations
      • Watch the 2022 ceremony
    • Press centre
      • Overview
      • Patent Index and statistics
      • Search in press centre
      • Background information
      • Copyright
      • Press contacts
      • Call back form
      • Email alert service
    • Innovation and patenting in focus
      • Overview
      • Firefighting technologies
      • Green tech in focus
      • CodeFest on Green Plastics
      • Clean energy technologies
      • IP and youth
      • Research institutes
      • Women inventors
      • Fighting coronavirus
      • Lifestyle
      • Space and satellites
      • The future of medicine
      • Materials science
      • Mobile communications
      • Biotechnology
      • Patent classification
      • Digital technologies
      • The future of manufacturing
      • Books by EPO experts
    • "Talk innovation" podcast

    Podcast

    Listen to our podcast

  • Learning

    Learning

    The e-Academy – the point of access to your learning

    Go to overview 

    • Overview
    • European Patent Academy
      • Overview
      • Learning activities
      • Learning paths
    • Professional hub
      • Overview
      • EQE - European qualifying examination
      • EPAC - European patent administration certification
    • Learning resources by area of interest
      • Overview
      • Patent granting
      • Technology transfer and dissemination
      • Patent enforcement and litigation
    • Learning resources by area by profile
      • Overview
      • Business and IP managers
      • EQE candidates
      • Judges, lawyers and prosecutors
      • National offices and IP authorities
      • Patent attorneys and paralegals
      • Universities, research centres and technology transfer centres (TTOs)

    European Patent Academy

    Boost your IP knowledge with (e-)training from the European Patent Academy

  • About us

    About us

    Find out more about our work, values, history and vision

    Go to overview 

    • Overview
    • The EPO at a glance
    • 50 years of the EPC
      • Overview
      • A glimpse of the planned activities
      • Kids’ collaborative art competition
      • 50 Leading Tech Voices
    • Legal foundations and member states
      • Overview
      • Legal foundations
      • Member states of the European Patent Organisation
      • Extension states
      • Validation states
    • Governance
      • Overview
      • Communiqués
      • Calendar
      • Select Committee documents
      • Administrative Council
    • Principles & strategy
      • Overview
      • Our mission, vision, values and corporate policy
      • Public consultation on the EPO's Strategic Plan 2028
      • Towards a New Normal
    • Leadership & management
      • Overview
      • President António Campinos
      • Management Advisory Committee
    • Social responsibility
      • Overview
      • Environment and sustainability
      • Art collection
    • Services & activities
      • Overview
      • Our services & structure
      • Consulting our users
      • European and international co-operation
      • European Patent Academy
      • Chief Economist
      • Ombuds Office
      • Reporting wrongdoing
    • Procurement
      • Overview
      • Procurement forecast
      • Doing business with the EPO
      • Procurement procedures
      • About eTendering and electronic signatures
      • Procurement portal
      • Invoicing
      • General conditions
      • Archived tenders
    • Transparency portal
      • Overview
      • General
      • Human
      • Environmental
      • Organisational
      • Social and relational
      • Economic
      • Governance
    • Statistics and trends
      • Overview
      • Statistics & Trends Centre
      • EPO Data Hub
      • Clarification on data sources
    • History
      • Overview
      • 1970s
      • 1980s
      • 1990s
      • 2000s
      • 2010s
      • 2020s

    about us

    Patent Index 2022

 
en de fr
  • Language selection
  • English
  • Deutsch
  • Français
Main navigation
  • Homepage
  • New to patents
    • Go back
    • Overview
    • What's your big idea?
    • Are you ready?
    • What to expect
    • How to apply for a patent
    • Your business and patents
    • Is it patentable?
    • Are you first?
    • Why do we have patents?
    • Patent quiz
    • Unitary patent video
  • Searching for patents
    • Go back
    • Overview
    • Technical information
      • Go back
      • Overview
      • Espacenet - patent search
        • Go back
        • Overview
        • National patent office databases
        • Global Patent Index (GPI)
        • Release notes
      • European Publication Server
        • Go back
        • Overview
        • Cross-reference index for Euro-PCT applications
        • EP authority file
        • Help
      • Searching Asian documents
      • EP full-text search
      • Bibliographic coverage in Espacenet and OPS
      • Full-text coverage in Espacenet
    • Legal information
      • Go back
      • Overview
      • European Patent Register
        • Go back
        • Overview
        • Release notes archive
        • Register documentation
          • Go back
          • Overview
          • Deep link data coverage
          • Federated Register
            • Go back
            • Overview
            • BG - Federated Register Service
            • GB - Federated Register Service
            • NL - Federated Register Service
            • MK - Federated Register Service
            • ES - Federated Register Service
            • GR - Federated Register Service
            • SK - Federated Register Service
            • FR - Federated Register Service
            • MT - Federated Register Service
          • Register events
      • European Patent Bulletin
        • Go back
        • Overview
        • Download Bulletin
        • EP Bulletin search
        • Help
      • European Case Law Identifier sitemap
      • Searching Asian documents
      • Third-party observations
    • Business information
      • Go back
      • Overview
      • PATSTAT
      • IPscore
        • Go back
        • Release notes
      • Patent insight reports
    • Data
      • Go back
      • Overview
      • Linked open EP data
      • Bulk data sets
        • Go back
        • Overview
        • Manuals
        • Sequence listings
        • National full-text data
        • European Patent Register data
        • EPO worldwide bibliographic data (DOCDB)
        • EP full-text data
        • EPO worldwide legal event data (INPADOC)
        • EP bibliographic data (EBD)
          • Go back
          • EBD files (weekly download) - free of charge
            • Go back
            • Secure EBD ST.36 files (weekly download) - for national patent offices only
        • Boards of Appeal decisions
        • EP full-text data for text analytics
      • Web services
        • Go back
        • Overview
        • Open Patent Services (OPS)
        • European Publication Server
      • Coverage, codes and statistics
        • Go back
        • Weekly updates
        • Updated regularly
    • Helpful resources
      • Go back
      • Overview
      • First time here? Patent information explained.
        • Go back
        • Overview
        • Basic definitions
        • Patent classification
          • Go back
          • Overview
          • Cooperative Patent Classification (CPC)
        • Patent families
          • Go back
          • Overview
          • DOCDB simple patent family
          • INPADOC extended patent family
        • Legal event data
          • Go back
          • Overview
          • INPADOC classification scheme
      • Asian patent information
        • Go back
        • Overview
        • China (CN)
          • Go back
          • Overview
          • Facts and figures
          • Grant procedure
          • Numbering system
          • Useful terms
          • Searching in databases
        • Chinese Taipei (TW)
          • Go back
          • Overview
          • Grant procedure
          • Numbering system
          • Useful terms
          • Searching in databases
        • India (IN)
          • Go back
          • Overview
          • Facts and figures
          • Grant procedure
          • Numbering system
        • Japan (JP)
          • Go back
          • Overview
          • Facts and figures
          • Grant procedure
          • Numbering system
          • Useful terms
          • Searching in databases
        • Korea (KR)
          • Go back
          • Overview
          • Facts and figures
          • Grant procedure
          • Numbering system
          • Useful terms
          • Searching in databases
        • Russian Federation (RU)
          • Go back
          • Overview
          • Facts and figures
          • Numbering system
          • Searching in databases
        • Useful links
      • Patent information centres (PATLIB)
      • Patent Translate
      • Patent Knowledge News
      • Business and statistics
      • Unitary Patent information in patent knowledge
  • Applying for a patent
    • Go back
    • Overview
    • European route
      • Go back
      • Overview
      • European Patent Guide
      • Oppositions
      • Oral proceedings
        • Go back
        • Oral proceedings calendar
          • Go back
          • Calendar
          • Public access to appeal proceedings
          • Public access to opposition proceedings
          • Technical guidelines
      • Appeals
      • Unitary Patent & Unified Patent Court
        • Go back
        • Overview
        • Unitary Patent
          • Go back
          • Overview
          • Legal framework
          • Unitary Patent Guide
          • Main features
          • Applying for a Unitary Patent
          • Cost of a Unitary Patent
          • Translation and compensation
          • Start date
        • Unified Patent Court
      • National validation
      • Extension/validation request
    • International route
      • Go back
      • Overview
      • Euro-PCT Guide
      • Entry into the European phase
      • Decisions and notices
      • PCT provisions and resources
      • Extension/validation request
      • Reinforced partnership programme
      • Accelerating your PCT application
      • Patent Prosecution Highway (PPH)
        • Go back
        • Patent Prosecution Highway (PPH) programme outline
      • Training and events
    • National route
    • MyEPO services
      • Go back
      • Overview
      • Understand our services
        • Go back
        • Overview
        • Online Filing 2.0 pilot
        • MyEPO Portfolio - pilot phase
        • Online Filing 2.0 pilot continuation
        • Exchange data with us using an API
      • Get access
        • Go back
        • Overview
        • Installation and activation
      • Find a professional representative
      • File with us
        • Go back
        • Overview
        • What if our online filing services are down?
        • Release notes
      • Interact on your files
      • Online Filing & fee payment outages
      • Tutorials
    • Fees
      • Go back
      • Overview
      • European fees (EPC)
        • Go back
        • Overview
        • Decisions and notices
      • International fees (PCT)
        • Go back
        • Reduction in fees
        • Fees for international applications
        • Decisions and notices
        • Overview
      • Unitary Patent fees (UP)
        • Go back
        • Overview
        • Decisions and notices
      • Fee payment and refunds
        • Go back
        • Overview
        • Payment methods
        • Getting started
        • FAQs and other documentation
        • Technical information for batch payments
        • Decisions and notices
        • Release notes
      • Warning
    • Forms
      • Go back
      • Request for examination
  • Law & practice
    • Go back
    • Overview
    • Legal texts
      • Go back
      • Overview
      • European Patent Convention
        • Go back
        • Overview
        • Archive
          • Go back
          • Overview
          • Documentation on the EPC revision 2000
            • Go back
            • Overview
            • Diplomatic Conference for the revision of the EPC
            • Travaux préparatoires
            • New text
            • Transitional provisions
            • Implementing regulations to the EPC 2000
            • Rules relating to Fees
            • Ratifications and accessions
          • Travaux Préparatoires EPC 1973
      • Official Journal
      • EPC Guidelines
        • Go back
        • Overview
        • Archive
      • PCT-EPO Guidelines
        • Go back
        • Overview
        • Archive
      • Guidelines revision cycle
      • Extension / validation system
      • London Agreement
      • National law relating to the EPC
        • Go back
        • Overview
        • Archive
      • Unitary Patent system
      • National measures relating to the Unitary Patent 
    • Court practices
      • Go back
      • Overview
      • European Patent Judges' Symposium
    • User consultations
      • Go back
      • Overview
      • Ongoing consultations
      • Completed consultations
    • Substantive patent law harmonisation
      • Go back
      • Overview
      • The Tegernsee process
      • Group B+
    • Convergence of practice
    • Options for professional representatives
  • News & events
    • Go back
    • Overview
    • News
    • Events
    • European Inventor Award
      • Go back
      • Overview
      • About the award
      • Categories and prizes
      • Meet the finalists
      • Nominations
      • Watch the 2023 ceremony
      • European Inventor Network
        • Go back
        • Activities granted in 2023
    • Press centre
      • Go back
      • Overview
      • Patent Index and statistics
      • Search in press centre
      • Background information
        • Go back
        • Overview
        • European Patent Office
        • Q&A on patents related to coronavirus
        • Q&A on plant patents
      • Copyright
      • Press contacts
      • Call back form
      • Email alert service
    • In focus
      • Go back
      • Overview
      • Firefighting technologies
        • Go back
        • Overview
        • Detection and prevention of fires
        • Fire extinguishing
        • Protective equipment
        • Post-fire restoration
      • Green tech in focus
        • Go back
        • Overview
        • About green tech
        • Renewable energies
        • Energy transition technologies
        • Building a greener future
      • CodeFest on Green Plastics
      • Clean energy technologies
        • Go back
        • Overview
        • Renewable energy
        • Carbon-intensive industries
        • Energy storage and other enabling technologies
      • IP and youth
      • Research institutes
      • Women inventors
      • Fighting coronavirus
        • Go back
        • Overview
        • Vaccines and therapeutics
          • Go back
          • Overview
          • Vaccines
          • Overview of candidate therapies for COVID-19
          • Candidate antiviral and symptomatic therapeutics
          • Nucleic acids and antibodies to fight coronavirus
        • Diagnostics and analytics
          • Go back
          • Overview
          • Protein and nucleic acid assays
          • Analytical protocols
        • Informatics
          • Go back
          • Overview
          • Bioinformatics
          • Healthcare informatics
        • Technologies for the new normal
          • Go back
          • Overview
          • Devices, materials and equipment
          • Procedures, actions and activities
          • Digital technologies
        • Inventors against coronavirus
      • Lifestyle
      • Space and satellites
        • Go back
        • Overview
        • Patents and space technologies
      • Healthcare
        • Go back
        • Overview
        • Medical technologies and cancer
        • Personalised medicine
      • Materials science
        • Go back
        • Overview
        • Nanotechnology
      • Mobile communications
      • Biotechnology
        • Go back
        • Overview
        • Red, white or green
        • The role of the EPO
        • What is patentable?
        • Biotech inventors
      • Classification
        • Go back
        • Overview
        • Nanotechnology
        • Climate change mitigation technologies
          • Go back
          • Overview
          • External partners
          • Updates on Y02 and Y04S
      • Digital technologies
        • Go back
        • Overview
        • About ICT
        • Hardware and software
        • Patents and standards
        • Artificial intelligence
        • Fourth Industrial Revolution
      • Additive manufacturing
        • Go back
        • Overview
        • About AM
        • AM innovation
      • Books by EPO experts
    • Podcast
  • Learning
    • Go back
    • Overview
    • European Patent Academy
      • Go back
      • Overview
      • Learning activities
      • Learning Paths
    • Professional hub
      • Go back
      • Overview
      • EPAC - European patent administration certification
      • EQE - European Qualifying Examination
        • Go back
        • Overview
        • Archive
        • Candidates successful in the European qualifying examination
        • Compendium
          • Go back
          • Overview
          • Pre-examination
          • Paper A
          • Paper B
          • Paper C
          • Paper D
    • Learning resources by area of interest
      • Go back
      • Overview
      • Patent granting
      • Technology transfer and dissemination
      • Patent enforcement and litigation
        • Go back
        • Overview
        • Patent enforcement in Europe
        • Patent litigation in Europe
    • Learning resources by profile
      • Go back
      • Overview
      • Business and IP managers
        • Go back
        • Overview
        • Innovation case studies
          • Go back
          • Overview
          • SME case studies
          • Technology transfer case studies
          • High-growth technology case studies
        • Inventors' handbook
          • Go back
          • Overview
          • Introduction
          • Disclosure and confidentiality
          • Novelty and prior art
            • Go back
            • Overview
            • Is the idea ‘obvious’?
            • Prior art searching
            • Professional patent searching
            • Simple Espacenet searching
            • What is prior art?
            • Why is novelty important?
          • Competition and market potential
            • Go back
            • Overview
            • Research guidelines
          • Assessing the risk ahead
            • Go back
            • Overview
            • Exploitation routes
            • Significant commercial potential
            • Significant novelty
            • What about you?
            • What if your idea is not novel but does have commercial potential?
          • Proving the invention
            • Go back
            • Overview
            • Help with design or redesign
            • Prototype strategy
          • Protecting your idea
            • Go back
            • Overview
            • Forms of IPR
            • Patenting strategy
            • The patenting process
          • Building a team and seeking funding
            • Go back
            • Overview
            • Building a team
            • Sources of funding
            • Sources of help for invention
          • Business planning
            • Go back
            • Overview
            • Constructing a business plan
            • Keep it short!
          • Finding and approaching companies
            • Go back
            • Overview
            • First contact
            • Meetings
          • Dealing with companies
            • Go back
            • Overview
            • Advance or guaranteed payment
            • Companies and your prototype
            • Full agreement – and beyond
            • Negotiating a licensing agreement
            • Reaching agreement
            • Royalties
        • Best of search matters
          • Go back
          • Overview
          • Tools and databases
          • EPO procedures and initiatives
          • Search strategies
          • Challenges and specific topics
        • Support for high-growth technology businesses
          • Go back
          • Overview
          • For IP professionals
          • For business decision-makers
          • For stakeholders of the innovation ecosystem
        • IP clinics
      • EQE Candidates
        • Go back
        • Overview
        • Coffee-break questions
        • Daily D questions
        • European qualifying examination - Guide for preparation
      • Judges, lawyers and prosecutors
        • Go back
        • Overview
        • Compulsory licensing in Europe
        • The jurisdiction of European courts in patent disputes
      • National offices and IP authorities
        • Go back
        • Overview
        • Learning material for examiners of national officers
        • Learning material for formalities officers and paralegals
      • Patent attorneys and paralegals
      • Universities, research centres and TTOs
        • Go back
        • Overview
        • Academic Research Programme
          • Go back
          • Overview
          • Completed research projects
          • Current research projects
        • Pan-European Seal Young Professionals Programme
          • Go back
          • Overview
          • For students
          • For universities
            • Go back
            • Overview
            • IP education resources
            • University memberships
          • Our young professionals
          • Professional development plan
        • IP Teaching Kit
          • Go back
          • Overview
          • Download modules
        • Intellectual property course design manual
  • About us
    • Go back
    • Overview
    • The EPO at a glance
    • 50 years of the EPC
      • Go back
      • Overview
      • 50 Leading Tech Voices
      • Kids’ collaborative art competition
    • Legal foundations and member states
      • Go back
      • Overview
      • Legal foundations
      • Member states
        • Go back
        • Overview
        • Member states by date of accession
      • Extension states
      • Validation states
    • Governance
      • Go back
      • Overview
      • Communiqués
        • Go back
        • Overview
        • 2022
        • 2021
        • 2020
        • 2019
        • 2018
        • 2017
        • 2016
        • 2015
        • 2014
        • 2013
      • Calendar
      • Documents and publications
        • Go back
        • Overview
        • Select Committee documents
      • Administrative Council
        • Go back
        • Overview
        • Composition
        • Representatives
        • Rules of Procedure
        • Board of Auditors
        • Secretariat
        • Council bodies
    • Principles & strategy
      • Go back
      • Overview
      • Mission, vision, values & corporate policy
      • Strategic Plan 2028
      • Towards a New Normal
      • Data protection & privacy notice
    • Leadership & management
      • Go back
      • Overview
      • About the President
      • Management Advisory Committee
    • Procurement
      • Go back
      • Overview
      • Procurement forecast
      • Doing business with the EPO
      • Procurement procedures
      • About eTendering
      • Procurement portal
        • Go back
        • Overview
        • e-Signing contracts
      • Invoicing
      • General conditions
      • Archived tenders
    • Services & activities
      • Go back
      • Overview
      • Our services & structure
      • Quality
        • Go back
        • Overview
        • Foundations
          • Go back
          • Overview
          • European Patent Convention
          • Guidelines for examination
          • Our staff
        • Enabling quality
          • Go back
          • Overview
          • Prior art
          • Classification
          • Tools
          • Processes
        • Products & services
          • Go back
          • Overview
          • Search
          • Examination
          • Opposition
          • Continuous improvement
        • Quality through networking
          • Go back
          • Overview
          • User engagement
          • Co-operation
          • User satisfaction survey
          • Stakeholder Quality Assurance Panels
        • Patent Quality Charter
        • Statistics
          • Go back
          • Overview
          • Search
          • Examination
          • Opposition
      • Consulting our users
        • Go back
        • Overview
        • Standing Advisory Committee before the EPO (SACEPO)
          • Go back
          • Overview
          • Objectives
          • SACEPO and its working parties
          • Meetings
          • Single Access Portal – SACEPO Area
      • Our user service charter
      • European and international co-operation
        • Go back
        • Overview
        • Co-operation with member states
          • Go back
          • Overview
        • Bilateral co-operation with non-member states
          • Go back
          • Overview
          • Validation system
          • Reinforced Partnership programme
        • Multilateral international co-operation with IP offices and organisations
        • Co-operation with international organisations outside the IP system
      • European Patent Academy
        • Go back
        • Overview
        • Partners
      • Chief Economist
        • Go back
        • Overview
        • Economic studies
      • Ombuds Office
      • Reporting wrongdoing
    • Statistics and trends
      • Go back
      • Overview
      • Statistics & Trends Centre
      • EPO Data Hub
      • Clarification on data sources
    • Social responsibility
      • Go back
      • Overview
      • Environment
      • Art collection
        • Go back
        • Overview
        • The collection
        • Let's talk about art
        • Artists
        • Media library
        • What's on
        • Publications
        • Contact
    • History
      • Go back
      • Overview
      • 1970s
      • 1980s
      • 1990s
      • 2000s
      • 2010s
      • 2020s
    • Transparency portal
      • Go back
      • Overview
      • General
        • Go back
        • Overview
        • Annual Review 2022
          • Go back
          • Overview
          • Foreword
          • Executive summary
          • Goal 1: Engaged and empowered
          • Goal 2: Digital transformation
          • Goal 3: Master quality
          • Goal 4: Partner for positive impact
          • Goal 5: Secure sustainability
      • Human
      • Environmental
      • Organisational
      • Social and relational
      • Economic
      • Governance
  • Boards of Appeal
    • Go back
    • Overview
    • Decisions of the Boards of Appeal
      • Go back
      • Overview
      • Recent decisions
      • Selected decisions
    • Procedure
    • Annual reports
      • Go back
      • Overview
    • Organisation
      • Go back
      • Overview
      • President of the Boards of Appeal
      • Enlarged Board of Appeal
        • Go back
        • Overview
        • Pending referrals (Art. 112 EPC)
        • Decisions sorted by number (Art. 112 EPC)
        • Pending petitions for review (Art. 112a EPC)
        • Decisions on petitions for review (Art. 112a EPC)
      • Technical Boards of Appeal
      • Legal Board of Appeal
      • Disciplinary Board of Appeal
      • Presidium
        • Go back
        • Overview
        • Composition of the Presidium
          • Go back
          • Overview
          • Archive
    • Code of Conduct
    • Business distribution scheme
      • Go back
      • Overview
      • Technical boards of appeal by IPC in 2023
      • Archive
    • Annual list of cases
    • Communications
    • Publications
    • Case Law of the Boards of Appeal
      • Go back
      • Overview
      • Archive
    • Case Law from the Contracting States to the EPC
    • Oral proceedings
  • Service & support
    • Go back
    • Overview
    • Website updates
    • Availability of online services
      • Go back
      • Overview
    • FAQ
      • Go back
      • Overview
    • Publications
    • Ordering
      • Go back
      • Overview
      • Terms and conditions
        • Go back
        • Overview
        • Patent information products
        • Bulk data sets
        • Open Patent Services (OPS)
        • Fair use charter
    • Procedural communications
    • Useful links
      • Go back
      • Overview
      • Patent offices of member states
      • Other patent offices
      • Legal resources
      • Directories of patent attorneys
      • Patent databases, registers and gazettes
      • Disclaimer
    • Contact us
      • Go back
      • Overview
      • Filing options
      • Locations
      • Specific contact
      • Surveys
        • Go back
        • Overview
        • Search services
        • Examination services, final actions and publication
        • Opposition services
        • Patent filings
          • Go back
          • Overview
          • Detailed methodology
          • Archive
        • Online Services
        • Patent information
          • Go back
          • Overview
          • Innovation process survey
        • Customer services
        • Filing services
        • Website
        • Survey on electronic invoicing
        • Companies innovating in clean and sustainable technologies
    • Subscription centre
      • Go back
      • Overview
      • Subscribe
      • Change preferences
      • Unsubscribe
    • Official holidays
    • Forums
    • Glossary
Board of Appeals
Decisions

Recent decisions

Overview
  • 2023 decisions
  • 2022 decisions
  • 2021 decisions
https://www.epo.org/en/node/t150259eu1
  1. Home
  2. T 0259/15 (Buprenorphine patch/EURO-CELTIQUE) 25-07-2017
Facebook Twitter Linkedin Email

T 0259/15 (Buprenorphine patch/EURO-CELTIQUE) 25-07-2017

European Case Law Identifier
ECLI:EP:BA:2017:T025915.20170725
Date of decision
25 July 2017
Case number
T 0259/15
Petition for review of
-
Application number
10185240.8
IPC class
A61F 13/00
A61K 31/485
A61K 9/70
A61P 25/04
Language of proceedings
EN
Distribution
NO DISTRIBUTION (D)

Download and more information:

Decision in EN 446.69 KB
Documentation of the appeal procedure can be found in the European Patent Register
Bibliographic information is available in:
EN
Versions
Unpublished
Application title

A buprenorphine transdermal patch for use in the treatment of pain for a dosing interval of at least 7 days

Applicant name

EURO-CELTIQUE S.A.

Mundipharma Laboratories GmbH

Napp Pharmaceutical Holdings Limited

Mundipharma Pharmaceuticals B.V.

Mundipharma AB

Mundipharma Pharmaceuticals Limited

Norpharma A/S

Mundipharma OY

Opponent name

Gallafent, Alison

Hexal AG

Murray, Adrian D'Coligny

tesa Labtec GmbH

Board
3.3.07
Headnote
-
Relevant legal provisions
European Patent Convention Art 56
Keywords
Inventive step - (no)
Catchword
-
Cited decisions
T 1742/12
T 0293/07
T 0091/98
T 0847/07
T 1545/08
Citing decisions
T 0489/20

I. European patent No. 2 305 194, based on European patent application No. 10185240.8, was granted on the basis of 6 claims.

Independent claim 1 read as follows:

"1. A buprenorphine transdermal delivery device comprising a polymer matrix layer containing buprenorphine or a pharmaceutically acceptable salt thereof, for use in treating pain in humans for a dosing interval of at least 7 days, wherein the transdermal delivery device comprises 10 %-wt buprenorphine base, 10 to 15 %-wt levulinic acid, about 10 %-wt oleyloleate, 55 to 70 %-wt polyacrylate and 0 to 10 %-wt polyvinylpyrrolidone".

Three oppositions were filed against the patent on the grounds that its subject-matter lacked novelty and inventive step, was not sufficiently disclosed and extended beyond the content of the application as filed and of the parent and grandparent applications.

The following documents were among those cited during the opposition proceedings:

D1: WO 96/19975

D2: Journal of pharmaceutical sciences, 83, 2 (1994), pages 126-130

D5: US 5,240,711

D6: US 5,225,199

D8: US 5,026,556

D9: Therapeutische Systeme, 1984, 4th Edition, pages 26, 27 and 48-53

D11: US 4,956,171

II. By decision posted on 22 December 2014, the opposition division rejected the oppositions.

Concerning the requirement of inventive step, the opposition division held that both document D1 and document D11, relating to transdermal devices for the administration of buprenorphine, represented reasonable starting points for the assessment of inventive step. These documents failed to disclose the use of the transdermal devices in the treatment of pain for a dosing interval of at least 7 days. The technical problem to be solved in the light of these documents was to be seen in the provision of convenient and effective pain treatment with buprenorphine from a transdermal delivery device. Some prior art documents indicated that for certain active agents, a dosing interval of 7 days was feasible. However, as explained in D9, a large amount of active ingredient was required. Furthermore, problems of skin irritation could limit the use of transdermal devices. Hence, the skilled person would have had no reasonable expectation of success when attempting to use the buprenorphine devices of D1 and D11 over a dosing interval of 7 days.

The requirement of Article 56 EPC was therefore met.

III. The opponents (hereinafter: appellant-opponent I, appellant-opponent II and appellant-opponent III) lodged an appeal against that decision.

IV. With their reply to the appeals dated 21 September 2015 the patent proprietors (hereinafter: the respondents) requested that the appeals be dismissed and submitted five auxiliary requests.

Auxiliary request 1 consisted of a single claim identical to claim 1 as granted.

Claim 1 of auxiliary requests 2 and 3 differed from claim 1 as granted in the deletion of the words "at least" before the feature "7 days".

Claim 1 of auxiliary requests 4 and 5 differed from claim 1 of auxiliary requests 2 and 3 in the deletion of the word "about" before the feature "10 %-wt oleyloleate".

V. A request of intervention pursuant to Article 105 EPC, was submitted on 3 January 2017 by tesa Labotech GmbH (hereinafter: the intervener). In a communication dated 2 June 2017, the Board expressed its opinion that the intervention was admissible.

VI. Oral proceedings were held on 25 July 2017. For information on the course of the oral proceedings, reference is made to the minutes.

VII. The appellant-opponents and the intervener argued on inventive step starting from document D1 as the closest prior art. They considered that the subject-matter of claim 1 of the patent differed from the disclosure of D1 mainly in the indication that the transdermal delivery device was used for a dosing interval of at least 7 days. In their view, it was evident to a skilled person that using a transdermal device over a long dosing period was advantageous for patients in terms of comfort and convenience. The transdermal device disclosed in D1 was a promising candidate for a convenient method of treating pain with a buprenorphine patch. It would have been obvious therefore to carry out clinical tests with this device in order to establish for how long it could be applied. This would have led the skilled person to the observation that the patch of D1 could effectively be used over a dosing period of at least 7 days as claimed in the patent. Such clinical tests were relatively simple and could be made with healthy persons. Considerations of reasonable expectation of success were not relevant in the present case since it was easy for the skilled person to carry out tests in order to verify whether the patch of D1 was suitable for a long dosing period. Thus, claim 1 of the patent was not inventive. The same considerations applied to the subject-matter of the auxiliary requests.

VIII. The respondents arguments on inventive step can be summarised as follows.

The main purpose of the invention underlying document D1 was to provide a better penetration enhancer. However, this document did not disclose any clinical data and did not provide any information about e.g. the dosing interval or the effective plasma concentration. In that respect, documents D2 or D11 were more appropriate starting points for the assessment of inventive step. Selecting document D1 as the closest prior art because it described the same patch as the patent in suit was based on hindsight.

The subject-matter of claim 1 was nonetheless inventive, even starting from document D1 as the closest prior art. The main distinguishing feature was the dosing interval of at least 7 days. The skilled person knew, for instance from D9, that the amount of active ingredient contained in a patch was much higher than the amount actually delivered to the patient. He was also aware that buprenorphine does not penetrates human skin well, as reported in D5, and that it may cause irritation, as indicated in D6 and D8. Thus, when considering the possibility of using the patch of D1 over a dosing period of at least seven days, the skilled person would have very low expectations of success. There was no indication in this document to apply the patch on humans for such a long period. There was no way to calculate the absorption rate in humans from the data of D1, relating to experiments carried out using mouse skin. Thus, the skilled person would not have tested the device of D1. Furthermore, to determine the dosing interval of a patch, it was necessary to perform clinical tests. The case law of the boards of appeal clearly excluded a "try-and-see" approach to situations in which clinical tests were involved.

IX. The appellants and the intervener requested that the decision under appeal be set aside and that the patent be revoked.

X. The respondents requested that the appeal be dismissed, or alternatively that the patent be maintained on the basis of one of auxiliary requests 1 to 5 as filed with letter dated 21 September 2015.

MAIN REQUEST (PATENT AS GRANTED)

1. Inventive step

The invention underlying the patent in suit relates to a transdermal delivery device for the administration of buprenorphine, an opioid analgesic agent.

1.1 Closest prior art

1.1.1 The Board agrees with the opposition division's conclusion that document D1 is the closest prior art. This document relates to transdermal devices for the administration of active ingredients. In particular, it addresses the problem of enhancing the absorption of the active ingredient through the skin (see page 1, third paragraph and page 2, fourth paragraph). Document D5, discussed in paragraph [0007] of the patent in suit, explains that one of the major problems with the transdermal administration of buprenorphine is that this substance only badly penetrates through the human skin (column 2, lines 32 to 34). This would have directed the skilled person to consider document D1. Moreover, the teaching of this document is focused on transdermal formulations of buprenorphine. Indeed, all the five examples of D1 concern devices containing this analgesic opioid as active ingredient. Lastly, the transdermal device of example 3 is the same device as that of the purpose-limited product claim 1 of the patent in suit.

1.1.2 Documents D2 and D11, proposed by the respondent as alternative closest prior-art documents, are in the Board's view less promising starting points for the assessment of inventive step.

D2, as pointed out by the respondent, provides more experimental data than D1 about the absorption of the active ingredient (see table 2 to 8). However, it is less instructive regarding the transdermal device used: there is only a general indication of the adhesive used ("amine resistance silicone") and the amounts in which buprenorphine and the excipients are included in the device are not clear (see page 127 paragraph "Preparation of matrix device"). Moreover, D2 does not specifically address the problem of enhancing the penetration of buprenorphine.

Document D11 relates to drug delivery systems with increased drug permeability (column 2, lines 41 to 50). Example 3 describes a matrix-type transdermal delivery device comprising buprenorphine as active ingredient and discloses the in vitro flux of the active ingredient through human cadaver skin. The Board notes that whereas D1 describes the same buprenorphine device as that referred to in claim 1 of the patent in suit, example 11 concerns a different type of transdermal device. Thus, whilst both documents appear to be equally relevant when the purpose or the effect of the inventions is considered, D1 comes closer to the subject-matter of the patent in suit when the structure of the devices is considered.

In the respondent's view, the skilled person would attach more weight to D11 since it discloses data on the flux of the active ingredient, whereas D1 only provides data on the percentage of buprenorphine that penetrates mouse skin in an in vitro experiment. However, in the Board's view, the fact that D1 does not disclose data on the flux of the active ingredient would not lead the skilled person to disregard it. After all, D1 specifically addresses the problem of providing transdermal buprenorphine devices with increased absorption. Moreover, the fact that in 1992, when document D5 was filed, the poor penetration of buprenorphine was still regarded as a major problem (see point 1.1.1 above) could have led the skilled person to conclude that the devices of D11, described in 1989, were unsatisfactory. In this respect he would have possibly regarded the device described in document D1, which was filed more than six years after D11, as more promising.

1.1.3 In any case the Board notes that according to the established case law of the boards of appeal, when two or more prior-art documents could reasonably be used as the starting point for the assessment of inventive step, a conclusion that the subject-matter claimed is inventive can only be reached after assessing this requirement starting from all the possible closest prior art (see for instance T 1742/12, reasons 5 to 6.6). Hence, in the present case, the respondent cannot argue against assessing inventive step starting from D1 as the closest prior art as well.

1.1.4 As mentioned above, the transdermal device of example 3 of D1 has the same features as the device of claim 1 of the patent in suit. This device was tested in an in vitro experiment in which it was applied to mouse skin for 24 hours. Document D1 fails to disclose the use of the transdermal device of example 3 in humans for a dosing interval of at least 7 days.

1.2 Technical problem

1.2.1 The opposition division defined the technical problem as the provision of convenient and effective pain treatment with buprenorphine from a transdermal delivery device. The Board agrees with this formulation of the technical problem. The "convenience" of the treatment is due to the possibility of using the transdermal device for a dosing interval of at least 7 days.

1.3 Obviousness

1.3.1 The skilled person approaching the problem of providing a method of pain treatment based on the use of a buprenorphine-containing transdermal device would have regarded the patch of example 3 of D1 as a promising candidate to be tested in experimental trials. Indeed, as explained above, the poor penetration of buprenorphine through human skin constituted a major hurdle in the development of methods of pain treatment using a buprenorphine patch. Document D1, however, addresses this problem and discloses in example 3 a device that in an in vitro test provides the best results in terms of the percentage of buprenorphine that penetrates mouse skin. Although the skilled person would have been aware that positive results obtained in experimental models are not necessarily confirmed in clinical tests, the Board sees no reason why he should have been sceptical about the possibility of using the device of example 3 of D1 effectively on humans. On a fair reading, it is apparent that the purpose of D1 is to provide useful transdermal devices for the treatment of pain in humans.

1.3.2 Also the concern about any possible problem of skin irritation caused by the use of the patch of D1 would not have discouraged the skilled person from testing it. After all, the experiments described in D6 (examples 5 and 11) indicate that the applying a buprenorphine patch to the shaved back of rats does not cause any skin rash. In line with these results, D8 describes compositions for the transdermal delivery of buprenorphine that do not cause major problems of skin irritation (column 3, lines 5 to 11). Moreover, any possible problem of skin irritation in a patient during a clinical test could possibly be handled by discontinuing the application of the patch.

Hence, the skilled person would not have considered the potential problems of skin irritation as a major hurdle.

1.3.3 Thus, in the Board's view, the skilled person would have been encouraged to test the device of example 3 of D1 on human subjects. Furthermore, considering that the therapeutic application of buprenorphine (pain treatment) was well known, the main objective of these tests would have been to determine whether the active ingredient does indeed penetrate through human skin and for which dosing interval the device can be used. Concerning this second aspect, the Board agrees with the respondents that for reasons of comfort and convenience a user would normally prefer transdermal devices that can be applied to the skin over longer periods. Thus, a skilled person would be obviously interested in determining the maximum duration of effective application of a transdermal device.

Valuable data in relation to the above objectives could be obtained by applying the patch to human subjects and monitoring the levels of buprenorphine in the plasma, bearing in mind that the minimal effective concentration is 100 pg/ml (paragraph [0128]). This is what has been done in the test described in example 1 of the patent.

The data reported in Table 1 indicate that the level of 100 pg/ml is reached between 36 and 42 hours after patch application. Thereafter, the buprenorphine concentration remains above 100 pg/ml until the end of the seventh day. In the Board's view the observation that the levels of buprenorphine in the plasma were still above the minimum effective concentration for the treatment of pain after e.g. 2, 3 or 4 days would have encouraged the skilled person to test the patch over longer periods.

Thus, in the Board's opinion, the skilled person would have observed that the device of example 3 of D1 could be used for a dosing interval of at least 7 days by performing tests which simply require applying the patch of D1 and monitoring the level of buprenorphine in the blood.

1.3.4 In line with the appealed decision, the main argument of the respondent in support of the presence of inventive step was that the skilled person would not have started such clinical tests in the absence of a reasonable expectation of success.

The Board concurs with the respondent that on the basis of the experimental data disclosed in D1 it would not have been possible to predict whether the device of example 3 could be used to treat pain in humans for a dosing period of at least seven days. Indeed, D1 does not provide any data on the penetration of the active ingredient through human skin. Furthermore, as explained for instance in D9 (page 51, third paragraph), the amount of active ingredient contained in a transdermal device is usually higher than the amount actually released. The excess amount depends inter alia on the type of active ingredient, and the prior art does not provide any clear data in relation to buprenorphine. Thus, the skilled person would not have been able to estimate the maximum dosing interval of the device of example 3 on the basis of the amount of buprenorphine it contained.

Despite this, the Board considers that the skilled person would have had no reason to be pessimistic and therefore to abandon the idea of testing a promising device.

1.3.5 According to the established case law of the boards of appeal, the general idea behind the concept of "reasonable expectation of success", which has been developed in particular in the field of biotechnology, is that in certain circumstances the person skilled in the art, on the basis of his common general knowledge or the teaching of the prior art, may be able to theoretically conceive a straightforward approach to solve a given technical problem. However, the practical implementation of that approach and/or the experimentation required to verify whether it does indeed work, may involve, for instance, overcoming technical difficulties (Case Law of the Boards of Appeal of the EPO, 8th edition (2016), I.D.7.1). In such circumstances, the skilled person would possibly avoid embarking on a troublesome experimentation if he did not have a reasonable expectation of success. On that basis, inventive step may be acknowledged even if the prior art contains a teaching to follow that approach.

However, the concept of "reasonable expectation of success" does not apply when the implementation and the testing of an approach suggested by the prior art do not involve any particular technical difficulties (see T 293/07 point 36 of the Reasons and T 91/98 point 8 of the Reasons). In such situations the skilled person would prefer to verify whether the potential solution that he has conceived works, rather than abandon the project because success is not certain.

The Board holds that this is the situation in the present case.

1.3.6 For the reasons explained above, the skilled person would regard the patch disclosed in example 3 of D1 as a potentially suitable candidate for solving the technical problem. He would furthermore consider that verifying the effectiveness of this potential solution would be unlikely to require particularly challenging experiments.

Indeed, buprenorphine is a well-known active ingredient used clinically for the relief of acute and chronic pain (D2, first paragraph). The minimum effective concentration for providing analgesia was known before the priority date of the patent (D2, page 139, right column). A preliminary assessment of the possibility of using the transdermal device of D1 for effective and convenient treatment of pain can be made by applying the device to volunteers and observing whether and for how long the plasma concentration of buprenorphine is above the minimum threshold. This is in the essence the experiment described in paragraphs [0103] and [0104] of the patent. In this context the Board notes that before the priority date of the patent buprenorphine was already administered by various routes, including intravenously (D2, page 126, right column, lines 1 to 5). This mode of administration provides peaks of plasma concentration which are much higher than those obtained with transdermal administration (see also Table 8 of the patent). Since the severity of the side effects of a drug is generally proportional to its plasma concentration, the skilled person evaluating the possibility of testing the patch of D1 on humans was in a position to make a realistic assessment of the potential risks for the volunteers. Furthermore, the tests can be carried out with healthy human subjects to reduce the dangers of potential side effects. It is also emphasised that in the present context the Board is not being asked to assess the difficulties involved in carrying out all the clinical trials required to obtain a pharmaceutical authorisation. Here the point is whether the skilled person would start the tests necessary to determine the maximum length of use of the patch of D1. For the reasons described above, the Board considers that these studies are based on routine experiments and do not involve a high level of risk to the health of the subjects.

1.3.7 The respondent has argued that a skilled person would not conduct tests on human subjects in the form of a try-and-see screening approach if he did not have a reasonable expectation of success.

In the Board's opinion this issue cannot be approached in abstract terms but it needs to be considered in relation to the circumstances of each specific case. It is agreed that trials involving experimentation in humans demand, in general terms, a cautious approach. Nevertheless, the technical difficulties involved in such experiments, the risks to the subjects and the ethical concerns are highly variable. In the present case, the experimentation required to verify whether the patch of D1 can be used effectively for convenient pain therapy is relatively simple and does not involve major risks for the volunteers. Furthermore, no relevant argument has been submitted regarding any possible ethical issue.

Thus, in the circumstances of the present case, the Board considers that the skilled person would test the device of D1 on human subjects despite the uncertainties as to the maximum duration of application.

1.3.8 The Board is aware of decisions T 293/07, T 847/07 and T 1545/08 in which a "try-and-see" approach was denied in circumstances in which experiments on human beings were involved.

The invention underlying case T 293/07 related to the use of erythropoietin (Epo) for producing a peripherally applied pharmaceutical for the treatment of stroke in humans. The deciding board came to the conclusion that the skilled person would not have adopted a "try-and-see" approach to verify whether Epo could indeed be used for the treatment of stroke. However, a key aspect of the Board's reasoning was the consideration that carrying out a study on humans, with the objective of developing therapeutic measures for the treatment of stroke, could not be regarded as a well-established routine activity. In addition, it was highly doubtful whether Epo could cross a compromised blood-brain barrier (see point 37 of the Reasons). The present case differs from that of decision T 293/07 at least because the effectiveness of the solution suggested in the prior art (i.e. the patch of D1), can be tested through routine experimentation.

In T 847/07, the Board held that it was "questionable whether the skilled person would adopt a "try and see" attitude at all in cases such as the present one where extensive in vivo animal and ultimately human testing would be necessary in order to determine whether or not a compound has a certain property." The case concerned formulations comprising highly purified recombinant coagulation factor VIII. The decision did not discuss which in vivo testing would have been required for determining the property of factor VIII. The Board notes that the present case concerns a clinically used active ingredient with therapeutic properties that are already known. The patch defined in claim 1 of the patent in suit is the same patch as that described in D1. For the reasons explained above, the Board considers that assessing whether this patch can solve the problem defined in point 1.2.1 above does not involve extensive testing on animals and humans.

In decision T 1545/07 the Board concluded that the skilled person was not in a "try-and-see" situation by referring to the principles discussed in T 293/07 and T 847/07 (see points 93 and 94 of the Reasons).

In the Board's view, the case law does not support the conclusion that the skilled person would systematically avoid a "try-and-see" approach whenever testing on human patients is involved, regardless of the specific circumstances of the case.

1.4 For the above reasons, the Board concludes that the subject-matter of claim 1 of the patent does not meet the requirements of Article 56 EPC.

AUXILIARY REQUESTS 1 to 5

2. The amendments made in the auxiliary requests (see point IV above) do not alter the above assessment of inventive step regarding the subject-matter of the main request. Indeed, the parties did not submit any inventive step arguments specific to the auxiliary requests. Therefore, the Board concludes that auxiliary requests 1 to 5 do not meet the requirements of Article 56 EPC.

Order

For these reasons it is decided that:

1. The decision under appeal is set aside.

2. The patent is revoked.

Footer - Service & support
  • Service & support
    • FAQ
    • Contact us
    • Subscription centre
    • Official holidays
    • Publications
    • Procedural communications
    • Ordering
    • Glossary
Footer - More links
  • Jobs & careers
  • Press centre
  • Single Access Portal
  • Procurement
  • Boards of Appeal
SoMe facebook 0
European Patent Office
EPO Jobs
SoMe instagram
EuropeanPatentOffice
SoMe linkedIn
European Patent Office
EPO Jobs
EPO Procurement
SoMe twitter
EPOorg
EPOjobs
SoMe youtube
TheEPO
Footer
  • Legal notice
  • Terms of use
  • Data protection and privacy
  • Accessibility