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Day 1 - Wednesday, February 23, 2022

8:00
Registration & Networking Refreshments
9:00
Co-Chairs’ Opening Remarks
9:10
Preparing for the Unitary Patent and the Unified Patent Court: Thoughts on Ratification, Implementation, and Protocols for the Pharma and Biotech Industries
10:00
Proven Strategies for Life Sciences Patent Enforcement: Protecting Patent Rights and Mastering Enforcement Procedures
11:00
Networking Break
11:30
European Supplementary Protection Certificates (SPCs): Examining Current Scope, Duration, Requirements and Assessing the Viability of a Unitary SPC
1:00
Networking Luncheon
2:30
Plausibility, Sufficiency, and Inventive Step: Special Considerations for Formulation and Combination Patents in the Life Sciences Arena
3:30
Networking Break
4:30
Second Medical Use: Reconciling Infringement and Enforcement
5:30
Day One Concludes | Welcome Back Cocktail Reception

Day 2 - Thursday, February 24, 2022

8:00
Networking Breakfast
9:00
Co-Chairs’ Opening Remarks
9:10
Global Strategies for Biosimilars and Innovator Biologics: From Patent Protection to Cost and Market Access
10:10
Compulsory Licensing: Determining Access to Medicines in the Time of the Global Pandemic
11:10
Networking Break
11:30
Patent Enforcement Liability Towards Third Parties: What the Life Sciences Industry Needs to Know About Findings of Unjust Enrichment Due to the Invalidation of Previously Valid Patents
1:00
Networking Luncheon
2:00
IP Infringement Alert: Understanding How Accelerating Drug Discovery and Development Through AI and Data Mining May Lead to Patent Challenges
3:00
Remedies and Alternative Measures for Life Sciences Patent Challenges: New Considerations for Injunctions, Corrective Measures, and Rules on Procurement of Evidence
4:00
Alternative Dispute Resolution for Pharma and Biotech Patent Disputes: The Shift from Ordinary Proceedings Towards ADR
5:00
Conference Concludes

Day 1 - Wednesday, February 23, 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: Thoughts on Ratification, Implementation, and Protocols for the Pharma and Biotech Industries

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 achieve a simpler, and more cost-effective means of protecting and enforcing patents in Europe. In 2022, the UP and UPC will supplement and strengthen the existing centralised European patent granting system.

  • 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
Proven Strategies for Life Sciences Patent Enforcement: Protecting Patent Rights and Mastering Enforcement Procedures

António Andrade
Partner
Abreu Advogados

Laëtitia Bénard
Partner
Allen & Overy LLP

Dr Penny Gilbert
Partner
Powell Gilbert LLP

Current differences in legal systems across jurisdictions, as well as myriad strategies for enforcing IP rights must be considered to design a multi-jurisdictional plan for life sciences patent protection throughout Europe. Join us for a discussion on:

  • Developing full proof plan for multijurisdictional patent protection of life sciences inventions
  • Comparing the timelines of proceedings across jurisdictions
  • Reconciling the proportionality of defenses
  • Predicting cross-border injunctions in the region

11:00
Networking Break
11:30
European Supplementary Protection Certificates (SPCs): Examining Current Scope, Duration, Requirements and Assessing the Viability of a Unitary SPC

Robert Rodrigues
Partner
Licks Attorneys

Mikkel Vittrup
Partner
Plesner

Steven Baldwin
Partner
Kirkland & Ellis LLP

Parliament emphasizes the importance of SPCs, but criticises the varying procedures across jurisdictions. While the Commission explores measures to strengthen the EU SPC regime to address legal uncertainty. This session will consider the introduction of a unitary SPC, as an extension of the unitary patent. 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: Special Considerations for Formulation and Combination Patents in the Life Sciences Arena

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 is a contentious issue. On 11 October 2021, a Technical Board of Appeal referred “plausibility” and “inventive step” questions to the Enlarged Board of Appeal of the EPO. During the pendency of this Appeal, we will consider in what situations post-published evidence can be considered to support the effect of the invention and what this means for life sciences patents in particular. 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

  • 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 | Welcome Back Cocktail Reception

Day 2 - Thursday, February 24, 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

Over the next five years, some of the best-known biologic medicines will lose patent protection. Meanwhile, in 2022, the introduction of efficient regulatory pathways, competition law, and a novel court system in Europe will significantly impact the way in which biosimilar medicines will enter the marketplace, thus creating a perfect storm in the biologic-biosimilar ecosystem. 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: Determining Access to Medicines in the Time of the Global Pandemic

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: What the Life Sciences Industry Needs to Know About Findings of Unjust Enrichment Due to the Invalidation of Previously Valid 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

In Menzis / AstraZeneca, District Court of The Hague ruled that AstraZeneca was unjustifiably enriched at the expense of insurance company Menzis due to enforcement actions based on a patent that was later invalidated. While industry awaits the decision on appeal and prepares to see more cases like this in the future, this panel will debate the issue of liability toward third parties.

1:00
Networking Luncheon
2:00
IP Infringement Alert: Understanding How Accelerating Drug Discovery and Development Through AI and Data Mining May Lead to Patent Challenges

Dr. Ulrike Till
Director IP and Frontier Technologies Division
World Intellectual Property Organization (WIPO)

  • 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 for Life Sciences Patent Challenges: New Considerations for 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

In a recent referral to the CJEU, the Munich Regional Court opposed what it considered to be an overly restrictive practice of in proceedings for preliminary injunctions in patent matters. According to current practice, the patent must have survived nullity or opposition proceedings and hence a “second examination” of the patent (in addition to the granting procedure) as one of the conditions for a preliminary injunction (PI). This referral is astonishing (sensational?) as the Munich I Regional Court de facto lets the CJEU review a practice which originated from the Düsseldorf Court of Appeal. There is no decision of the CJEU yet but there is the chance that PIs may be obtained much easier in the future. There has, since long, been an exception to this rule of “second examination” in Generics-Originator proceedings, but this exception may be extended to further proceedings (originator-originator or Gx-Gx).

  • Predicting whether preliminary injunctions may be more easily obtained in the future due to a recent referral to the CJEU from the Munich Regional Court for perceived overly restrictive practices for granting preliminary injunctions in patent matters
  • Is public interest in ensuring continued availability sufficient justification to deviate from default position of simply ordering a preliminary or final injunction?
  • In light of the Boards of Appeal’s decision in Amgen v. Sanofi, how great an influence is potential invalidity when it comes to a preliminary injunction application?
  • Assessing when may preliminary injunctions be denied, regardless if a patent is valid or infringed upon
  • How important is the role of an infringement assessment in preliminary proceedings?
  • Analyzing Article 3(2) of the IP Enforcement Directive 2004/48

4:00
Alternative Dispute Resolution for Pharma and Biotech Patent Disputes: 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)

André Pohlmann
Member of the 5th Board of Appeal
European Union Intellectual Property Office

  • 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