Day 1 - Tuesday, February 26, 2019

8:00
Registration & Networking Morning Refreshments
9:00
Chair’s Opening Remarks
9:10

STAKEHOLDER THINK TANK

The Unitary Patent Court and Brexit – Devising Patent Strategies Which Adapt to the Variables of the Unknown
10:00
Latest Updates: Arrow Declaration from UK
10:45
Networking Break
11:15

FOCUS GROUP

The Economics of Cross Border Patent Litigation Strategies: Effectively Utilizing Different Patent Systems to Protect IP and Ensure Product Value
12:00
Networking Lunch
1:00

FOCUS ON SPCs

Analysing Recent SPC Decisions Which Will Shape the Future of IP Protection
2:00
Analysing the Influence of The Trade Secret Directive (EU Directive (2016/43) on Future Patent Strategies
3:00
Networking Break
3:30

DEBATE

Warner-Lambert vs. Generics: an Examination of the Proper Utilization of Secondary Medical Use Patents for Innovators and Generics
4:30
Chair’s Closing Remarks & Introduction to Day 2

Day 2 - Wednesday, February 27, 2019

8:00
Registration & Networking Morning Refreshments
9:00
Chair Opening Remarks
9:10
Patent Legalities and Practicalities in the U.S.: Takeaways from the Latest U.S. District Court and Patent Trial and Appeals Board Decisions
10:00
The Doctrine Of Equivalence: Where are we now?
10:45
Networking Break
11:30
Digital Concerns for the Quality of Patents
12:30
Networking Lunch
1:30
European Patent Convention: Exploring Questions of Claim Construction and Burdens of Proof
2:30
CRISPR and Broad Institute vs. University of California: Contrasting Current Developments in U.S. and Their Opposition from the EPO
3:30
Networking Break
4:00
Review of the latest developments in English law
4:30
Chair’s Closing Remarks & End of Conference

Day 1 - Tuesday, February 26, 2019

8:00
Registration & Networking Morning Refreshments
9:00
Chair’s Opening Remarks

Judith Krens
Partner
Taylor Wessing

9:10

STAKEHOLDER THINK TANK

The Unitary Patent Court and Brexit – Devising Patent Strategies Which Adapt to the Variables of the Unknown

Francesco Macchetta
Director Intellectual Property
Bracco Group

Paul Inman
Partner
Gowling WLG

Pierre Veron
Honorary President
EPLAW
Member, Drafting Committee of the Rules of Procedure of the Unified Patent Court
Member, Expert Panel group

Dean Thomas
Head of Intellectual Property
Glenmark Pharmaceuticals

The Unitary Patent Court (UPC) which will cover 25 countries is expected to come into full force in Spring 2019. This unified system will streamline the patent approval process through the use of both legal and technical experts and as such will likely provide cost savings in the long-term for Pharmaceutical and Biotech firms. The UK ratified the UPC system prior to its announcement that it would leave the EU, so it is anyone’s guess as to what will happen to the UPC.

  • Determining whether the UK can still participate in the UPC after its exit from EU
  • What are the expected outcomes of Brexit to the UPC and how will this impact pharma and biotech organisations?
  • Assessing the impact of Brexit on the European Court of Justice
  • How will IP case law develop as a result of Brexit?

10:00
Latest Updates: Arrow Declaration from UK

Paul Inman
Partner
Gowling WLG

10:45
Networking Break
11:15

FOCUS GROUP

The Economics of Cross Border Patent Litigation Strategies: Effectively Utilizing Different Patent Systems to Protect IP and Ensure Product Value

Arvid van Oorschot
Partner
Vondst

Dr. Claudia Milbradt
Partner
Clifford Chance

Brian Cordery
Partner
Bristows

This session will provide a detailed analysis of landmark Pharmaceutical and Biotech patent cases that will help improve your understanding of the enforceability and value of of patent rights across significant jurisdictions.

  • UK: How will Brexit affect cross boarder patent litigation strategies?
  • Spain: Being outside of the UPC, how will this impact decisions and implementation of patent litigation?
  • Germany: What are the current scenarios and developments for the future?

12:00
Networking Lunch
1:00

FOCUS ON SPCs

Analysing Recent SPC Decisions Which Will Shape the Future of IP Protection

Adrian Spillmann
Head of Corporate IP
Valneva

Ricardo Dijkstra
Advocaat
Vondst

Marco Blei
Counsel
Portolano Cavallo

SPCs are a vital tool for innovator companies to extend the product lifecycle. Recently, there has been conflict between the legal and technical interpretation of SPC regulation and the application of decisions from European Court of Justice to ensure that the timeline of an SPC is fully satisfied by both innovators and generics. This panel will examine this conflict and its repercussions.

  • Examining the most recent SPC decisions and how they are applicable to innovators vs. generics
  • Considering advances in technology in pharmaceutical and biotechnology: Which areas can the courts improve to ensure the pragmatic nature of SPC decisions
  • What are the new proposals for SPC regulations?
  • In light of Brexit, should SPC applications apply under existing EU laws or be held in abeyance until new UK laws are enforced?

2:00
Analysing the Influence of The Trade Secret Directive (EU Directive (2016/43) on Future Patent Strategies

Dr. Sven Bostyn
Associate Professor of Biomedical Innovation Law
University of Copenhagen

Benjamin May
Partner
ARAMIS Société d'Avocats

  • Analysing the most recent implementation of UK Trade Secrets Regulation 2018 into the European directive on unlawful acquisition, use and disclosure of know-how, and business information
  • How do pharmaceutical companies put the changes in the EU directive into effect?
  • Will the trade secret directive amendments create a new and separate IP right?
  • How to find evidence relating to the Trade Secret Directive?

3:00
Networking Break
3:30

DEBATE

Warner-Lambert vs. Generics: an Examination of the Proper Utilization of Secondary Medical Use Patents for Innovators and Generics

Judith Krens
Partner
Taylor Wessing

Dr. Lorenz Kallenbach
Corporate Patent Counsel
Merck Group

Hubert Witte
Head of Patents Basel
Roche

Professor Dr. Maximilian Haedicke, LL.M.
Professor of Intellectual Property Law
Freiburg University
(Former Judge at Higher Regional Court of Duesseldorf)

  • Evaluating how the latest Secondary Medical Use cases are impacting innovators and generics
  • What are the immediate and long-term effects of Warner-Lambert vs. Generics (UK) on Secondary Medical Use patents
  • Discovering best timing strategy for Secondary Medical Use enforcement?
  • Cost/benefit analysis for the originator’s position to litigate weaker patents in the portfolio following expired product patents.
    • Consideration for generics/biosimilars manufacturers who have already attempted to launch products with specific labelling strategies

4:30
Chair’s Closing Remarks & Introduction to Day 2

Day 2 - Wednesday, February 27, 2019

8:00
Registration & Networking Morning Refreshments
9:00
Chair Opening Remarks

Paul Inman
Partner
Gowling WLG

9:10
Patent Legalities and Practicalities in the U.S.: Takeaways from the Latest U.S. District Court and Patent Trial and Appeals Board Decisions

Jon Singer
Principal
Fish & Richardson

  • Understanding the different proceedings at the U.S. District Courts and PTAB
  • Discovering the constantly evolving political and economic factors associated with filing for patents in the U.S.
  • Developing the best practice strategy for filing patents in the U.S. and mitigating the cost of litigation

10:00
The Doctrine Of Equivalence: Where are we now?

Paul Reeskamp
Partner
DLA Piper

  • A little history: what was the idea behind part 2 Protocol?
  • Protection of equivalence and legal certainty
  • Actavis v Lilly; Neuberger’s Kirin-Amgen revenge?
  • Recent developments in case law

10:45
Networking Break
11:30
Digital Concerns for the Quality of Patents

Dominic Adair
Partner
Bristows

The digital era has brought a considerable amount of data to the field of patenting. This poses a real concern to innovators as how to best protect their products. Join us for a fireside chat with distinguished outside and in-house counsel as they discuss:

  • How the digital age is affecting the quality of patent
  • More data: can this create different types of claim?
  • Whether an increase data can provide better claims?
  • Creating insights for new ways in producing different results
  • What are the consequences with access to more data.

12:30
Networking Lunch
1:30
European Patent Convention: Exploring Questions of Claim Construction and Burdens of Proof

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

Rene Wagner
Examiner JC Biotechnology
European Patent Office

Daan de Lange
Partner
Brinkhof

Through progressive technological advances in the areas of anti-bodies and therapeutics, function claims are being reexplored and questioned. This panel will explore these controversies

  • How does the EPO assess patentability of broad claims?
  • Exploration of recent EPO decision cases
  • What legal provisions are infringed?
  • Is there a lack of inventive step? (Art 56 EPC) or is there a lack of sufficiency disclosure? (Art 83 EPC)
  • What can be considered as different standard of proof?
  • What type of evidences are available and correct? What are the plausibility of national courts regarding establishing their own standard?

2:30
CRISPR and Broad Institute vs. University of California: Contrasting Current Developments in U.S. and Their Opposition from the EPO

Brian Coggio
Of Counsel
Fish & Richardson

Dean Thomas
Head of Intellectual Property
Glenmark Pharmaceuticals

  • Discovering patentability requirements in the U.S. for natural sequencing to ensure a valid and correct patent application via Broad Institute vs. University of California
  • What are the procedures and requirements to make a claim a priority?
  • How does the recent decision from the EPO impact the future of CRISPR technology- influenced patents in Europe?

3:30
Networking Break
4:00
Review of the latest developments in English law

Jane Lambert
Barrister
4-5 Gray’s Inn Square

Anna Lopez
Head of IP
Esteve

  • How far did Eli Lily v Actavis really change the law? A review of the cases in which the Supreme Court’s judgment has been considered and applied such as Icescape Ltd v Ice-World International BV and Regen Lab v Estar;
  • Clinical commissioning and licensing: the Administrative Court’s decision in Bayer Plc v NHS Darlington CCG and others;
  • The Implementation of the Trade Secrets Directive in the UK;
  • Proposals for supplementary protection certificates after Brexit

4:30
Chair’s Closing Remarks & End of Conference