Co-Chairs Opening Remarks

Liz Cohen
Partner
Bristows

Dr. Andreas von Falck
Partner
Hogan Lovells

Preliminary Injunctions: Comparing and Contrasting How Injunctions are Being Handled in the UPC vs. National Courts and Key Considerations When Selecting a Forum

Liz Cohen
Partner
Bristows

Justice James Mellor
High Court Judge
Royal Courts of Justice, Chancery Division, UK

Roberto Rodriguez
Partner
Licks Attorneys

• Examining the nuances of how the UPC is dealing with injunctions
• Comparing and contrasting how preliminary injunctions are being handled in the UPC vs. national courts, including the UK courts
• What are the requirements and tests involved in obtaining a PI in both forums?
• How are proportionality factors applied in injunction decisions in both forums?
• Exploring key preliminary injunction considerations that pharma and biotech companies should take into account when selecting a forum for their litigation

Evidence, Damages, and Expert Witnesses: Understanding the Nuances of the UPC Approach

Gustavo Hirsch
Attorney at Law
Daniel Law

Ludvig Holm
Partner
Westerberg & Partners

Miriam Kiefer
Partner
Kather Augenstein Rechtsanwälte

Stefan Richter
Partner
Clifford Chance

• Understanding what means of evidence, and what means of obtaining evidence, are admissible before the UPC
• Taking a look at how the UPC is dealing with experts and witnesses
• How does the UPC approach differ from other key non-UPC member jurisdictions?
• Analyzing the damages principles that will apply when the UPC determines damages for patent infringement
• Navigating damages proceedings in the UPC
• What will the UPC take into account when determining and calculating damages?
• Assessing damages limitations in the UPC
• A comparative analysis of UPC vs. UK vs. U.S. – key distinctions in the handling of evidence, damages and witnesses that practitioners need to know

Morning Coffee Break

UPC Judge Keynote Interview

UPC Judicial Spotlight Interview: Critical Considerations for Practitioners in the Unified Patent Court

András Kupecz
Legally Qualified Judge, Central Division, Munich Section
Unified Patent Court

Interviewed by:

Professor Willem Hoyng
Partner
Hoyng Rokh Monegier
Chairman
Advisory Committee of the UPC
Member
Drafting Committee of the Rules of Proceedings of the UPC

Networking Luncheon

Analyzing The Impact of the UPC on Life Science Patent Prosecution Strategies

Simon Curtis
Partner
Potter Clarkson

Peter Klusmann
Partner
Hoffman Eitle

• Understanding what patent attorneys should be thinking about when drafting and filing patents that will to be enforced in the UPC
• Lessons on claim drafting that patent prosecutors can take from the latest UPC patent litigation trends
• Assessing how the UPC is impacting patent licensing agreements
• Examining how the UPC approach to revocation actions is impacting patent oppositions and other elements of patent prosecution

Navigating the Current Drug Exclusivity Landscape: Implementing Strategies for Effective Patent Lifecycle Management Amidst New Pharmaceutical Law Reform in Europe

Christian Fulda
Partner
Jones Day

Hiroshi Sheraton
Partner
Baker & McKenzie LLP

• Assessing the latest developments in loss of exclusivity and incorporating those developments into your patent lifecycle management strategy
• Strategies for managing data exclusivity, market protection, orphan drug exclusivity, pediatric extensions/pediatric rewards
• Analyzing how the new Pharma Law revisions by the European Commission will impact regulatory exclusivity protections available to innovator pharmaceutical companies operating in the EU
• Understanding how to effectively achieve market exclusivity and protection of clinical trial data to best safeguard your (or your client’s) investment

Afternoon Break

Avoiding the Top 10 Drafting Mistakes Impacting the Enforcement of Life Science Patents in Europe

Dr. Fabian Sokolowski
Partner
MAIKOWSKI & NINNEMANN

Ute Feldman
Partner
Prinz & Partner

This interactive session will test your patent drafting savvy through a series of hypothetical scenarios which highlight common patent drafting mistakes. Through live polling, discover how your approach to patent drafting compares to your colleagues and competitors. Benefit from a practical discussion of the polling results and walk away with patent drafting strategies that will ensure longstanding protection and enforceability of your IP.

Conference Adjourns to Day Two

Registration and Continental Breakfast

Co-Chair Opening Remarks & Recap of Day 1

Liz Cohen
Partner
Bristows

Dr. Andreas von Falck
Partner
Hogan Lovells

Focus Session on Plausibility: Applying the Latest EBA Decisions and National Jurisprudence to Your Litigation Strategy

Hans-Rainer Jaenichen
Partner
Vossius & Partner

Dr. Natalie Kirchhofer
Partner
Cohausz & Florack

• Analyzing the implications of the long awaited EBA plausibility decision allowing post filed data to prove technical effect
• Understanding how this ruling should be applied in your patent prosecution and litigation strategies
• How can this case be relied upon to get existing patents revoked based on plausibility?

Morning Coffee Break

Examining the Implications of EU Regulatory Reformation: Analyzing the Latest Pharma Law Revisions and the EC’s New Proposed Regulation on Compulsory Licensing of Patents

Ioana Ratescu
Head of Legal Regulatory, Europe
Novartis Pharma

Jiri Slavik
Senior Manager Intellectual Property
Adalvo

Dr. Andreas von Falck
Partner
Hogan Lovells

• Understanding the impact of the EU’s New Pharma Legislation reforms on:
• Incentives for research and innovation for orphan and paediatric drugs
• The regulatory regime for generics and biosimilars
• Rules on repurposing
• Restrictions on comparative advertising
• Unitary SPCs
• Analyzing key takeaways of the European Commission’s Proposed Compulsory Licensing Regulation
• Understanding what the implications will be for pharmaceutical and biotech companies
• Anticipating next steps and challenges for practitioners

Spotlight on the Bolar Exemption: What Will Proposed Changes to the Scope of the Exemption Mean for Life Science Patent Practitioners in Europe?

Takanori Abe
Managing Partner
Abe & Partners

Rais Amils Arnal
Partner
Pérez-Llorca

Markus Grammel
Partner
Grünecker

• An overview of how the Bolar Exemption has been interpreted and applied across different jurisdictions in Europe
• Understanding how to navigate the particularities of the Bolar provisions in key jurisdictions
• Analyzing the proposed changes to the bolar exemption in the new EU Pharma Package
• How does the new law broaden the scope of the exemption and what will the implications be for patent practitioners?

Networking Luncheon

Analyzing the Latest Strategies for Procuring and Enforcing Antibody Claims in Europe and the U.S.

Hazel Ford
Partner
Mathys & Squire

Rebecca Tollervey
Partner, Patent Attorney
MEWBURN ELLIS

• Identifying sound solutions for successfully patenting antibodies amidst developing case law in Europe and the U.S.
• Tactical tools for global commercialization
• Drafting claims to secure protection across different jurisdictions
• Understanding different patent office interpretations of antibody claims
• Examining principals of the EPO Boards on assessing inventive step and sufficiency of antibody claims

Navigating the Unique Challenges of Patenting and Protecting Personalized Medicine

Paul Calvo
Director
Sterne, Kessler, Goldstein & Fox P.L.L.C.

Peter Corless
Partner
Fox Rothschild LLP

While precision medicine is expanding and transforming treatment opportunities for patients, it comes with a number of intellectual property challenges that must be overcome to ensure that the inherent technologies can continue to evolve. This panel will analyze the host of IP hurdles faced by claimants of personalized medicine patents and strategies for overcoming them. Topics of discussion include:

• Understanding the unique challenges of asserting IP of personalized medicine
• Best practices for tackling IP hurdles of precision medicine, including subject matter eligibility, proving infringement and software licensing

AI and Life Science Patents: Strategies for Patenting AI-Driven Innovations and Predicting the Impact of the New EU Artificial Intelligence Act on Patent Strategies in Europe

Eileen Brandenburger
Head of IP | Patent Attorney
Exscientia

David Sanker
Partner
Morgan, Lewis & Bockius LLP

• Assessing the latest ways that AI is being used in drug development
• Analyzing how patent registries and courts are interpreting the existing law in Europe and the U.S. regarding patenting and protecting AI-driven innovations
• Understanding how companies are navigating patenting challenges surrounding:
• Eligibility disputes surrounding unpatentable subject matter
• Satisfaction of the written description and enablement requirements
• Issues of inventorship and conception
• Examining the EU Artificial Intelligence Act which is expected to come into force near the end of 2023
• What will the implications be on AI patenting?
• How will provisions of the new Act potentially open up a growing area of infringement litigation in the life sciences space?

Conference Ends