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Day 1 - Monday, May 30, 2022

8:00
Registration & Networking Refreshments
9:00
Co-Chairs’ Opening Remarks

Dominic Adair
Partner
Bristows LLP (U.K)

Bert Oosting
Partner
Hogan Lovells

9:10
Preparing for the Unitary Patent and the Unified Patent Court: Ratification, Implementation, and Protocols

Domien Op de Beeck
Partner
Bird & Bird

Jochen Herr
Partner
Finnegan, Henderson, Farabow, Garrett & Dunner, LLP

The Unitary Patent and the Unified Patent Court have been designed to bring forth a simpler, cost-effective means of protecting and enforcing patents in Europe. The introduction of the UP and the UPC will impact all applicants and patentees seeking protection in Europe through the EPO. This session will analyze the changes and provide attendees with a handbook for the future.

  • Considering the costs and benefits of the system for patent applications
  • Understanding the territorial scope of protection
  • Predicting the impact to litigation and legal certainty
  • Detailing the non-exclusive jurisdiction for all national validations of European patents

10:00
Strategies for Patent Enforcement: Protecting Patent Rights and the Procedures to Enforce Them

António Andrade
Partner
Abreu Advogados

Laëtitia Bénard
Partner
Allen & Overy LLP

Dr Penny Gilbert
Partner
Powell Gilbert LLP

The European patent system is experiencing a major reformation centered on the idea of unifying the European patent system. For decades, patent enforcement decisions across jurisdictions within Europe have produced contradictory enforcement decisions across jurisdictions within Europe. There are important differences and particularities in the legal systems across the jurisdictions, and the strategies for practicing, protecting and enforcing must take these differences into account.

Topics of discussion will include:

  • Comparing the timelines of proceedings across jurisdictions
  • Analyzing the particularities of patent enforcement in some jurisdictions
  • Considering the differences between the case law of some jurisdictions

11:00
Networking Break
11:30
European Supplementary Protection Certificates (SPCs): Scope, Duration and Requirements

Steven Baldwin
Partner
Kirkland & Ellis LLP

Sture Rygaard
Partner
Pleasner

The United Kingdom has become a fully independent third country to the European Union. Implementing the trade agreement the UK has made with the EU represents a formidable challenge facing the pharmaceutical industry. Intellectual property and the pharmaceutical and biotech sectors are significant considerations for both the UK and the EU following Brexit. This session will shine a spotlight on the impact of Brexit on the pharmaceutical industry, focusing on the challenges ahead as well as areas of opportunity for the UK.

Topics of discussion will include:

  • Outlining the implications of the rules of origin on the pharmaceutical and biotech industries
  • Detailing the scope, relevant marketing authorization, and which patents can be used to obtain an SPC
  • Considering areas where clarification from CJEU may still be required

1:00
Networking Luncheon
2:30
Plausibility, Sufficiency, and Inventive Step: Considerations for Formulation and Combination Patents in Europe

Bert Oosting
Partner
Hogan Lovells

Sabrina Duschner
Head of Patent Litigation Strategy
Fresenius Kabi

Plausibility in the context of the inventive step and sufficiency requirements can be a contentious issue. To discern whether an invention is purely speculative, the Boards of Appeal of the EPO have developed the doctrine of “plausibility” in the context of sufficiency of disclosure as well as inventive step. On 11 October 2021, a Technical Board of Appeal referred questions to the Enlarged Board of Appeal of the EPO on plausibility and inventive step. As we await the Board of Appeal to issue the written decision, this session will consider in what situations post-published evidence can be considered to support the effect of the invention. Topics of discussion will include:

  • Considering the benefits of new formulations and combinations
  • Interpreting second medical use claims during enforcement proceedings
  • Striking the balance between securing an early filing date and overcoming the plausibility hurdle

3:30
Networking Break
4:30
Second Medical Use: Reconciling Infringement and Enforcement

Sara Burghart
Lead IP Litigation Counsel
Global Litigation & Launch – Global IP

Sandoz International GmbH (DEU)

Miquel Montañá
Partner
Clifford Chance S.l.

Jonas Westerberg
Partner
Westerberg & Partners Advokatbyrå AB

Patents that cover new uses for previously known medicines are called “second medical use patents”. This form of patent protection has drawn much attention in recent years as courts around the world continue to adjudicate the complex questions that underlie them. Topics of discussion will include:

  • Understanding second medical use patents & carve out strategies
    • Clarifying the patentability of further medical use inventions
  • Assessing the implications of second use patents for:
    • Regulatory
    • Market Access
    • Legal
  • Outlining the implications
  • What form can second medical use claims take?
  • What must be established for a second medical use patent to be infringed?
  • How do you enforce a second medical use patent?
  • Can you prevent off-label use?

5:30
Day One Concludes

Day 2 - Tuesday, May 31, 2022

8:00
Networking Breakfast
9:00
Co-Chairs’ Opening Remarks

Dominic Adair
Partner
Bristows LLP (U.K)

Bert Oosting
Partner
Hogan Lovells

9:10
Global Strategies for Biosimilars and Innovator Biologics: From Patent Protection to Cost and Market Access

Rieke Kaup
Case Handler
European Commission

Shohta Ueno, PhD
Director, Dispute Resolution
Regeneron UK Ltd

Otto Licks
Partner
Licks Attorneys

Peter van Schijndel
Partner
Hoyng Rokh Monegier

Heli Pihlajamaa
Director
European Patent Office

In 2022, the introduction of efficient regulatory pathways, the application of competition law and a novel court system in Europe will significantly impact the way in which biosimilar medicines will enter the marketplace. Further, some of the best-known biologic medicines will lose patent protection over the next five years. During this session, topics of discussion will include:

  • Understanding the regulatory framework and legislative developments impacting the global pharmaceutical industry
    • Reviewing the potential adaptation of competition law
    • Taking stock of the impact of the Unified Patent Court
  • Understanding the economics of biosimilars
    • Considerations for market access, sustainable pricing and reimbursement policies
    • Market uptake of biosimilar products
    • Biosimilar v. biosimilar litigation in a crowded market
  • Are biobetters a viable alternative?
  • Innovator v. Innovator litigation
    • Proportionality/appropriateness of injunctive relief
    • Whether the claims of a patent are too broad
    • Increasingly bringing innovator companies with competing pipeline candidates into disputes

10:10
Compulsory Licensing: Access to Medicines, The TRIPS Agreement and Vaccines

Peter Ling
Partner
Lenz & Staehelin

Daan de Lange
Partner
Brinkhof Advocaten

  • Anticipating the potential impact of COVID-19 on IP legal matters, including patent protection for new uses and diagnostics
    • How will IP protection work?
    • Can the distribution of a vaccine await licensing and agreement on pricing?
  • What is the impact to IP licensing and enforcement?
    • Compulsory licenses in Europe
  • Assessing COVID-19 related antibody litigation
  • Developing strategies for evolving to succeed in a post-COVID marketplace

11:10
Networking Break
11:30
Patent Enforcement Liability Towards Third Parties: Liability and Unjust Enrichment on Retrospectively Invalid Patents

Jean-Hyacinthe de Mitry
Partner
Gide Loyrette Nouel A.A.R.P.I

Eran Bareket
Partner, Head of Legal Practice
Gilat, Bareket & Co., Attorneys at Law

Ruud van der Velden
Partner
Hogan Lovells

On October 14, 2020 the decision in Menzis/AstraZeneca was issued by the District Court of The Hague. The District Court considered AstraZeneca liable for damages vis-à-vis health insurer Menzis because of AstraZeneca’s enforcement of a patent against a generic manufacturer. AstaZeneca was initially awarded an injunction which AstraZeneca enforced, but the patent was later revoked. The District Court held that AstraZeneca had been unjustifiably enriched at the expense of health insurer Menzis by enforcing the preliminary injunction based on the patent against the generic manufacturer. The District Court considered that the enforcement precluded Menzis from designating a generic quetiapine product as ‘preferred product’ under its preference policy, so that Menzis had to reimburse the price of the originator product instead of a cheaper generic product.

1:00
Networking Luncheon
2:00
Artificial Intelligence, Data and Drug Development: Accelerating Drug Discovery and Development

Peter Silverman
EVP, General Counsel and Head of Utrecht
Merus N.V.

  • Analyzing the extent to which data might be mined from previous clinical trials toward finding new uses for known drugs
  • Taking stock of the role of artificial intelligence in this process
  • Preparing for the challenges that exist for patents

3:00
Remedies and Alternative Measures: Injunctions, Corrective Measures and Rules on Procurement of Evidence

Dominic Adair
Partner
Bristows LLP (U.K)

Dr. Kai Rüting
Partner
Vossius & Partner

Selma Ünlü
Senior Partner
NSN Law Firm

Benjamin May
Partner
ARAMIS Société d'Avocats

4:00
Alternative Dispute Resolution: The Shift from Ordinary Proceedings Towards ADR

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

  • Understanding how BoA and the EUIPO helps with ADR
    • ADRs in the EUIPO Boards of Appeal
    • Assisted Negotiation and Expert Determination
    • Effective Dispute Resolution (EDR)
    • Co-mediation mechanisms
    • ADR Cooperation Initiatives
  • Detailing why parties should consider using EUIPO ADR mechanisms
    • Combining parallel disputes at national and international levels into one resolution
    • Avoiding complex litigation proceedings
    • Achieving quicker, more efficient outcomes in a cost-effective way

5:00
Conference Concludes