A Practical Guide to Drafting and Enforcing SPC Claims Across Various Jurisdictions

Jun 18, 2018 2:00pm - 5:00pm

Speakers

Dr. Ulrike Herr
Partner
Isenbruck Bösl Hörschler LLP

Dr. Dietrich Kamlah
Lawyer
Taylor Wessing Partnerschaftsgesellschaft mbB

Day 1 - Tuesday, June 19, 2018

8:00
Registration, Refreshments and Networking
8:50
Opening remarks from the Chair
9:00
Supplementary Protection Certificates: SPC Availability in Europe in Light of the Latest Case Law
10:15
Networking Refreshments
10:45
SPCs around Europe: A View from the Patent Offices
12:00
Networking lunch
1:00
Update on the latest development at EPO both internationally and internally
2:00
Second Medical Use and SPCs: What is the Challenge and How Can you Get It Right?
2:45
The SPC Manufacturing Waiver: Current Status and Potential Scope
3:30
Networking Break
4:00
Practical Considerations for Preparing and Prosecuting SPC Applications in Europe
4:30
UK – Brexit: Options for SPC Protection in the UK after the UK leaves the EU
5:30
Chair’s Closing Remarks – End of Day 1
5:45
Evening Networking Drinks

Day 2 - Wednesday, June 20, 2018

8:30
Registration, Refreshments and Networking
9:00
Opening Remarks from the Chair
9:10
The Unitary (EU) SPC: Understanding the Status – Towards a Unified System
10:10
Amendments to the SPC Regulation: Breaking News from the European Commission
11:10
Networking Break
11:40
Latest Information from South Korea
12:40
Networking Lunch
2:00
An Overview of the Status of Pharmaceutical Patent Protection in India
2:45
Update on Patent Term Extension and Patent Eligible Subject Matter in the United States
3:30
Networking Break
4:00
Israel: Understanding the Specific Requirements
4:45
Switzerland: An Overview of the New Paediatric Supplement Protection Certificate
5:30
Chairman’s Remarks and Conference Ends

Day 1 - Tuesday, June 19, 2018

8:00
Registration, Refreshments and Networking
8:50
Opening remarks from the Chair

Keith Withers
Patent Attorney
df-mp

9:00
Supplementary Protection Certificates: SPC Availability in Europe in Light of the Latest Case Law

Frank Landolt
V.P. Intellectual Property and Legal Counsel
Ablynx N.V.

Keith Withers
Patent Attorney
df-mp

  • Understanding the most recent CJEU case law development on SPCs
  • An update on the Abraxus case: a focus on Article 3(b) and new indications
  • The Seattle Genetics Ruling on duration
  • Article 3d in focus
  • Other case law impacting SPCs over the last year
Case Study:

  • SPC Regulation Article 3(a): protection of the product by the basic patent – where should the line be drawn?
  • Which tests are under consideration (now)?
    • What needs to be (or to have been) written into
      the claims?
    • What can be relied upon from ‘elsewhere’?
  • How much ‘structure’ does a structural feature require?
    • What requirements are imposed on Markush claims
      by the test(s)?
  • Do ‘functional features’ really function?
    • (C-493/12 [Lilly v HGS]): the ‘do the claims “relate, implicitly but necessarily and specifically”?’ test
  • Where do ‘antibodies’ fit on this scale of structural and functional tests?
    • Do the tests provide realistic and/or useful SPC protection for antibody inventions?
      • If ‘antibodies’, what about protection of ‘minibodies’, ‘diabodies’ and other ‘busybodies’?
    • Where should biosimilars be placed on the scale and is there still concern
  • Are ‘combination products’ really so different or should there be ‘one test for all’?
    • Or are ‘single molecule products’ the ‘exceptions that prove the rule’
  • How are the national courts reacting, and what are the stakes?
    • How might C-443/17 [[Abraxus] affect one Patentee’s rights using another’s MA?

10:15
Networking Refreshments
10:45
SPCs around Europe: A View from the Patent Offices

Dr. Martijn deLange
Patent Examiner
Dutch Patent Office

Dr. Oliver Werner
Head of SPC Working Group
German Patent & Trade Mark Office

This multi-jurisdictional panel will discuss how SPCs are examined by leading European patent offices. How will recent case law influence the legal framework and decisions in key European markets? This panel bridges the complex interaction between patent and regulatory law authorities.

  • A discussion on recent case law above and interpretations of Article 3
  • Towards harmonisation: the complexities involved in ECJ and local interpretations
  • A view from decisions and developments in each jurisdiction represented
  • Understanding recent changes and how this impacts SPC approval

12:00
Networking lunch
1:00
Update on the latest development at EPO both internationally and internally

Dieter Tzschoppe
Director Operations Biotechnology
European Patent Office

  • Certainty initiative for the core procedures Search, Examination and Opposition
  • Overall Unitary Patent update
  • Latest results and findings
  • New central opposition procures
  • Quality initiative at the EPO
  • Overview of patentable inventions in the field of pharmaceutical and biotechnology
  • Change of the Implementing Regulations regarding plant and Animal patenting

2:00
Second Medical Use and SPCs: What is the Challenge and How Can you Get It Right?

Ms. Dorte Petersen
Senior Examiner
Danish Patent & Trademark Office

  • Neurim C-130/11 and second medical use patents
  • When is a second medical use a new indication?
  • Article 3 (b): what constitutes the first marketing authorisation?
  • Product definition: what is needed?
  • How is substitution with generic drugs handled?

2:45
The SPC Manufacturing Waiver: Current Status and Potential Scope

Dr. Christian Drescher
Head of Patent Affairs
Midas Pharma GmbH

Sergio Napolitano
Director
Medicine for Europe

  • Impact of the SPC manufacturing waiver
  • Benefits of the adoption of the SPC export waiver for the generics manufacturing market
  • The potential impact of the implementation of an SPC manufacturing waiver on the R&D-based pharmaceutical industry
  • How can the different opinions among the parties be harmonised?

3:30
Networking Break
4:00
Practical Considerations for Preparing and Prosecuting SPC Applications in Europe

Dr. Stephan Kutik
European Patent Attorney
Chiesi Farmaceutici S.P.A

  • Choice of basic patent: considering various factors including possible differences in claim interpretation across Europe
  • Navigating pan-European SPC prosecution even when national offices have diverging views on guidance given by the ECJ

4:30
UK – Brexit: Options for SPC Protection in the UK after the UK leaves the EU

Dr. Beatrice Stirner
Legal Adviser
Swiss Federal Institute of Intellectual Property

David Holland
Partner
Carpmaels & Ransford

  • What are the latest developments in this area?
  • Understanding the impact of Brexit on SPCs
  • How can companies plan strategy in an uncertain legislative environment?

5:30
Chair’s Closing Remarks – End of Day 1
5:45
Evening Networking Drinks

Day 2 - Wednesday, June 20, 2018

8:30
Registration, Refreshments and Networking
9:00
Opening Remarks from the Chair

Dr. Christian Drescher
Head of Patent Affairs
Midas Pharma GmbH

9:10
The Unitary (EU) SPC: Understanding the Status – Towards a Unified System

Dr. Bettina Wanner
Head IP Advocacy & Strategy
Bayer Intellectual Property GmbH

Dr. Christopher Brückner
European Patent Attorney
Brückner IP

  • The most recent discussions around the creation of a Unitary SPC
  • What will it look like?
  • Who will have the granting authority?
  • Will the existing system just be modified?

10:10
Amendments to the SPC Regulation: Breaking News from the European Commission

Elise Melon
Assoc. Director IP Policy Patent Operations Lead
Union Chimique Belge

Jean-Luc Gal
Directorate General Internal Market, Industry, Entrepreneurship and SMEs
European Commission

This is an exclusive panel session whereby the latest data, implementations and findings will be presented, discussed and debated across the legal and corporate sectors. It gives delegates the unique opportunity to address how the new amendments will impact the SPC landscape.

  • Overview of the current SPC framework and reasons
    behind the consultation
  • Current status of the consultation
  • Do we really need a patent term extension system on top of
    the regular patent system?

    • The impact of case law and current regulation on the
      complexity of cases
  • Potential consequences of the consultation on
    IP incentives
  • Impact of the consultations on industry and next steps

11:10
Networking Break
11:40
Latest Information from South Korea

Jeong Kim
General Counsel
Celltrion Healthcare Co. Ltd

  • What is the status of patent term extensions in South Korea?
  • Examination guidelines for Patent Term Extensions in South Korea

12:40
Networking Lunch
2:00
An Overview of the Status of Pharmaceutical Patent Protection in India

Mahendra Gunjal
Associate Manager
Global IP Department

Zydus Cadila

  • Understanding the patenting system in India
  • How to pass the test of Section 3d of the Indian Patents Act
  • What are the challenges for companies and how to overcome them

2:45
Update on Patent Term Extension and Patent Eligible Subject Matter in the United States

  • What is the status of pharmaceutical patent terms extensions in the US
  • Scope of protection during the extended period
  • How is the length of the patent extension calculated?

3:30
Networking Break
4:00
Israel: Understanding the Specific Requirements

Dr. Ronnie Benshafrut
Partner
Reinhold Cohn & Partners

  • Background
  • How did the Israel PTE evolve?
  • How does the Israel PTE differ from PTE in the US and Europe?
  • The requirements for obtaining a PTE in Israel
  • The dependency of patentee’s right for PTE on PTE/SPC granted in the US and Europe and on existing Patent Law in the US and Europe
  • The term of extension: how is it calculated? When is the term finally determined?
  • Pitfalls to consider when filing and prosecuting an application for PTE

4:45
Switzerland: An Overview of the New Paediatric Supplement Protection Certificate

Dr. Beatrice Stirner
Legal Adviser
Swiss Federal Institute of Intellectual Property

  • The new Paediatric Supplement Protection Certificate with reference to patent term extensions: what is this?
  • Implications for companies with regards to the new tool

5:30
Chairman’s Remarks and Conference Ends

A Practical Guide to Drafting and Enforcing SPC Claims Across Various Jurisdictions

Jun 18, 2018 2:00pm - 5:00pm

€350

Speakers

Dr. Ulrike Herr
Partner
Isenbruck Bösl Hörschler LLP

Dr. Dietrich Kamlah
Lawyer
Taylor Wessing Partnerschaftsgesellschaft mbB

What is it about?

13:45 – 14:00 Registration

14:00 – 14:45 Filing of SPC applications – Meeting expectations of the National Patent Offices

  • Which products may be eligible for SPCs?
  • Suitable basic patents facing the latest case law on Article 3 (a).
  • How may SPC applications be drafted to facilitate their grant?

14:45 – 15:00 Tea/coffee break

15:00 – 16:00 Enforcement of SPCs – Strategies in the National Courts

  • What are the practical implications of Article 3 (a)?
    • Typical steps before an imminent new product launch.
  • Which arguments may be successful in infringement cases?

16:00 – 17:00 Practical Roundtable to summarise what’s been learnt and practical application

€695