Pre-Conference Workshops

Morning Working Group A | How to successfully draft antibody filings

Oct 19, 2016 9:00am – 12:00pm

Speakers

Tom Leonard
Partner
Kilburn & Strode (United Kingdom)

Hilary van der Hoff
Director
Kymab (UK)

Morning Working Group B | Negotiating the difficulties of drafting claims for Algorithms

Oct 19, 2016 9:00am – 12:00pm

Speakers

Philip Cupit
Partner
Finnegan (United Kingdom)

Hazel Ford
Partner
Finnegan (United Kingdom)

Afternoon Working Group D | Prepare internally for Nagoya Protocol compliance

Oct 19, 2016 2:00pm – 5:00pm

Speakers

Philippe de Jong
Partner
Altius (Belgium)

Dominic Muyldermans
Senior Legal Advisor
ABS International (Belgium)

Day 1 - Thursday, October 20, 2016

8:00
Registration & Coffee
9:00
Opening Remarks from the Chair
9:15
Early Publishing of Clinical Trial Data
9:40
Panel Discussion:
Early Publishing of Clinical Trial Data Striking the Balance between Patent Protection & the Wider Public Interest
10:40
Morning Refreshments
11:00
Second Medical Use Patents – How Much is the Patentee Now Required to Do?
12:00
Is There Life (Sciences) After Brexit?
12:45
Lunch
2:00
Europe & Plausibility – How Much Data do you Really Need to Support your Patent?
3:00
5:30
Co-Chair’s Closing Remarks – End of Day 1
5:45
Cocktail Reception for Delegates & Speakers

Day 2 - Friday, October 21, 2016

8:30
Registration & Coffee
8:55
Opening Remarks from the Chair
9:00
Biosimilar Litigation in the US – How to Prepare & Participate Effectively
10:00
The Unitary Patent and the Unified Patent Court – Brexit and Beyond
11:00
Coffee Break
11:30
2:45
Is the Life Sciences Industry taking the Nagoya Protocol seriously?
3:30
Afternoon Coffee Break
3:40
What does TTIP hold for the Life Sciences community?
4:20
Closing Comments from the Chair
4:25
End of Summit

Day 1 - Thursday, October 20, 2016

8:00
Registration & Coffee
9:00
Opening Remarks from the Chair

Matthew Royle
Partner
Taylor Wessing

9:15
Early Publishing of Clinical Trial Data
9:40
Panel Discussion:
Early Publishing of Clinical Trial Data Striking the Balance between Patent Protection & the Wider Public Interest

Oliver Werner
Head SPC Working Group
German Patent and Trademark Office (Germany)

Timo Minssen
Professor of Biotechnology Law, Jur. Dr., LL.M., M.I.C.L.
Centre for Information and Innovation Law (CIIR) (Germany)

Moderator:

Simon Bradbury
Head of Life Sciences
Appleyard Lees (United Kingdom)

  • Success of recent changes
  • Is the industry complying in practise?
  • Outcome switching
  • Secondary filings
  • Second Medical Use Patents
  • Position of the key stakeholders
  • Real consequences of publishing data earlier
  • The perspective of innovators

10:40
Morning Refreshments
11:00
Second Medical Use Patents – How Much is the Patentee Now Required to Do?

Nicola Dagg
Partner
Allen & Overy (United Kingdom)

Ian Hiscock
Head IP Oncology
Novartis (United Kingdom)

  • Analysis of recent key cases
  • Lyrica Appeal Decision
    • Pricing & reimbursement
    • Regulatory issues
    • Stakeholder requirements
  • Actavis v Lilly
    • What are generics manufacturers free to do ?
    • How much work is the patentee required to do?
  • Approach of different jurisdictions (UK & Germany)

12:00
Is There Life (Sciences) After Brexit?

Paul Reeskamp
Partner
DLA Piper (Netherlands)

James Horgan
Assistant Managing Counsel
Merck Sharpe & Dohme (UK)

Dr. Peter Feldschreiber
Counsel
Four New Square (United Kingdom)

Moderator:

Bonella Ramsay
Partner
DLA Piper (United Kingdom)

Following the surprising vote by the UK to leave the European Union, this session will look at the range of implications for the Life Sciences community:

  • The practical consequences
    • EMEA moving out of London
    • Free flow of goods
  • Extra layer of regulatory requirements in the pharma industry?
  • Alignment of UK courts & other national patent courts within the EU
  • Cross border injunctions
  • The complications of enforcement
  • Is Brexit a good thing for the UK & its relationship with SPC’s? 12:45

12:45
Lunch
2:00
Europe & Plausibility – How Much Data do you Really Need to Support your Patent?

Christoph de Costa
Partner
Taylor Wessing (Germany)

Matthew Royle
Partner
Taylor Wessing

  • Has plausibility been re-defined?
  • What is driving the push to raise the expected standard of plausibility?
  • Impact of Lyrica and other Second Medical Use Patents cases
  • Priority filings as prior art?
    • G1/15 case
    • Impact on filing strategies
  • “Poisonous priorities”
    • Divergent interpretations of G2/98
    • Referral to Enlarged Board of Appeal

3:00
5:30
Co-Chair’s Closing Remarks – End of Day 1
5:45
Cocktail Reception for Delegates & Speakers

Day 2 - Friday, October 21, 2016

8:30
Registration & Coffee
8:55
Opening Remarks from the Chair

Roberto Valenti
Partner
DLA Piper (Italy)

9:00
Biosimilar Litigation in the US – How to Prepare & Participate Effectively

Brian Coggio
Partner
Fish & Richardson (United States)

  • Overview of the Biologics Price Completion & Innovation Act of 2009 (“BPCIA”)
  • Comparison to the Hatch-Waxman Act
  • Key Definitions – “Biosimilarity”/ “Interchangeability”/“Extrapolation”
  • Litigation Procedure – The First Wave
  • The “Patent Dance”
  • The 180-Day Notice Requirement
  • Key Decisions
  • Use of IPRs In Biosimilar Litigation
  • Preparation for Biosimilar Filing & Litigation

10:00
The Unitary Patent and the Unified Patent Court – Brexit and Beyond

Christoph Rehfuess
Head of IP
Sotio

Pierre Véron
Véron & Associés, Paris Honorary President
EPLAW (European Patent Lawyers Association) Member of the Expert Panel group of the Unified Patent Court Member of the Drafting Committee of the Rules of Procedure

Sam Granata
Judge
Antwerp Court of Appeal (Belgium)

Moderator:

Gualtiero Dragotti
Partner
DLA Piper

  • What will be the impact of Brexit on the UPC?
  • How are clients and advisors approaching the revised landscape?
  • Analysis of some significant outstanding uncertainties before commencement
    • Bolar Exemption
    • SPC’s
    • Co-invention issues
  • What kind of strategies have companies finally chosen to adopt?
  • What are the next steps after choosing your initial patent strategy?
  • How to prepare for litigation under the UPC
  • The challenges of litigating in an untried system

11:00
Coffee Break
11:30
2:45
Is the Life Sciences Industry taking the Nagoya Protocol seriously?

Katie Beckett
ABS Project Manager
Department for Business Innovation and Skills (UK)

Stephen Inglis
Director
National Institute for Biological Standards & Control (United Kingdom)

Philippe de Jong
Partner
Altius (Belgium)

Natalie Voruz
Assistant General Counsel
Monsanto (Switzerland)

  • Extent of preparations for Nagoya
  • Expectations of the authorities
  • Official guidance
    • Reason for the delay
    • Guidance sufficient?
  • Key areas
  • Sanctions for non-compliance
  • How to prepare & establish internal processes
  *To be confirmed

3:30
Afternoon Coffee Break
3:40
What does TTIP hold for the Life Sciences community?

Doris Schernhammer
Senior Manager for Corporate Affairs
Eli Lilly (Belgium)

  • What do we need to be aware of?
  • What will be the impact on European healthcare provision
  • Consequences for pharma & biotech companies
  • IP Rights under TTIP
    • Will court proceedings disappear?
    • The impact on litigation strategies

4:20
Closing Comments from the Chair
4:25
End of Summit