C5’s 17th Annual Forum on Pharma & Biotech Patent Litigation in Europe - WEB

29–30 May 2024

Kimpton De Witt Amsterdam, Amsterdam

C5’s 17th Annual Forum on

&PHARMA BIOTECH PATENT LITIGATION IN EUROPE

Legal, Regulatory, and Commercial Strategies for the UP and UPC Era

2024 Conference Co-Chairs

Joel Coles Partner Powell Gilbert LLP

Rachel Mumby Partner Bristows LLP

Ruud van der Velden Partner Hogan Lovells

In-House Insights From

ç Adalvo

ç Confo Therapeutics

ç EconSight

ç Polpharma Group

ç Regeneron

ç Sandoz

ç Sanofi

ç UCB, Inc. and more!

Attend to Gain Insights, Global Perspectives and Develop Winning Strategies. Our Stellar Faculty will help you:

ɽ Master the UPC's Evolving Terrain: Obtain key judicial insights on the UPC’s initial impact, procedural details, and strategic influence on European patent litigation

ɽ Unravel Regulatory Transformations: Explore the EU's legislative transformation and see how new directives and regulations are reshaping pharma and biotech litigation strategies

ɽ Strategize Across Borders: Sharpen your cross-border litigation strategies with sessions on defending patent rights outside the UPC, navigating China's patent linkage system, and understanding crucial U.S. legal developments

ɽ Engage with Judges from the UPC: Featuring a judicial roundtable with Honorable Marije Knijff, András Kupecz, and Edger Brinkman, alongside leading Chief IP Counsel, this conference is a hub for high-level intellectual exchange within the European life sciences patent elite

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

Supporting Sponsor

Mr. Edger Brinkman Legally Qualified Judge, Local Division, The Hague Unified Patent Court

Honorable Marije Knijff District Court Judge The Hague

Associate Sponsors

After a transformative year since the UPC's inception and regulatory reform, life sciences IP lawyers are at a critical juncture to grasp the sweeping changes and implications of these developments.

C5's 17th Annual Forum on Pharma & Biotech Patent Litigation in Europe stands as a pivotal assembly for legal professionals and executives navigating the ever-evolving terrain of pharmaceutical and biotechnological patent law. In a year marked by significant legal shifts and regulatory transformations, this forum is designed to dissect, understand, and forecast the implications of these changes on the industry. From the groundbreaking establishment and operational nuances of the Unified Patent Court (UPC) to the intricacies of international patent litigation and the latest in EU regulatory reforms, the forum promises a comprehensive exploration of the current patent litigation landscape.

The forum also serves as a prime networking opportunity, bringing together the elite of the European life sciences patent bar to exchange ideas, share experiences, and forge connections that will drive the future of the field. Whether you're a litigator defending the interests of a pharma/biotech company, or in-house counsel navigating the patent challenges of a global pharma corporation, this event is poised to offer valuable perspectives and actionable insights.

Join us at C5's 17th Annual Forum to engage with the forefront of legal and regulatory developments in pharma and biotech patent litigation. Together, we will explore the latest challenges and opportunities, shaping the strategies that will define the future of the industry.

C5’s 2024 edition of the Pharma & Biotech Patent Litigation forum in Amsterdam marks the one year anniversary of the Unified Patent Court and will be a great opportunity to hear from in-house counsel, litigators and judges about the lessons learnt during these first 365 days as well as expectations going forward. Additionally, there will be engaging presentations about the most current topics in the pharma & biotech patent field today. I’m very much looking forward to co-chairing this event and facilitating some interesting debates!

Ruud van der Velden Partner, Hogan Lovells

The C5 Pharma & Biotech Patent Litigation forum is always a great couple of days with engaging discussions and insightful talks on current challenges faced by the Pharma & Biotech industry. I’m really looking forward to co-chairing what I’m sure will be another excellent event.

Rachel Mumby Partner, Bristows LLP

The C5 Pharma & Biotech Patent Litigation forum will mark the end of a fascinating year in which European patent litigation has entered a brave new era. The forum will provide an invaluable opportunity for attendees to take stock, share their experiences of the new landscape and look to exciting new developments that lie ahead. It promises to be an excellent event, which I am delighted to be co-chairing. I’m looking forward to another thought-provoking program, in the charming surroundings of Amsterdam.

Bethan Hopewell Partner, Powell Gilbert

Learn and Connect with C5’s Life Sciences IP Portfolio Advisory Board.

C5’s Global Life Sciences IP Advisory board was created as a part of C5’s ongoing effort to provide industry leading content and a world renowned speaker faculty. The board is composed of a selection of advisers from around the globe, including leading pharmaceutical and biotech companies. This ‘inner circle’ counsels C5 on the impact of litigation trends and emerging topics.

Advisory Board

Heidi Adler Director, Intellectual Property Rights Orion Corporation

Brigitte Carion-Taravella

Principal Patent Counsel, Lead Biologics IP EU

Global IP Department, Legal, Ethics & Business Integrity

Sanofi

Monika Dorda

SVP & General Counsel

Global Pharmaceuticals GSK

Emeritus Members

Dominic Adair Partner Bristows LLP (U.K)

Dr. Sabrina Duschner

VP Patent Litigation Strategy

Fresenius Kabi Deutschland GmbH

Julia Pike

Global IP Head Sandoz

Guido Pontremoli, Ph.D.

Global IP Head

Corp. Intellectual Property-Patents

Chiesi Farmaceutici S.p.A.

Karin Pramberger

Head of IP Polpharma Group

Bert Oosting Partner Hogan Lovells

Laura Reynolds

Associate General Counsel

European IP and Regulatory Litigation

Teva Pharmaceuticals

Jiri Slavik

Director, IP Adalvo

Shohta Ueno

Senior Director

Assistant General Counsel –

Dispute Resolution

Regeneron

Distinguished Speakers

2024 Conference Co-Chairs

Joel Coles Partner Powell Gilbert LLP

UPC Judges

Mr. András Kupecz

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

Government

Gabriele Venskaityte Case Handler European CommissionDG COMP

In-House Counsel

Sabrina Duschner VP Patent Litigation Fresenius Kabi

James Horgan

Assistant Managing Counsel Merck Sharp & Dohme (UK) Ltd.

Frank Landolt Chief Counsel, IP and Legal Confo Therapeutics

Outside Counsel

Stefania Bergia Partner

Simmons & Simmons LLP

Dr. Ulrich

Blumenröder Partner

Grünecker Patent

Thierry Calame Partner

Lenz & Staehelin

Michael Cottler Partner

Gemini Law

Ross Cummings Partner

Gill Jennings & Every LLP

Christoph de Coster

Partner

Taylor Wessing

Daan de Lange Partner Brinkhof

Rachel Mumby Partner Bristows LLP

Mr. Edger Brinkman

Legally Qualified Judge, Local Division, The Hague Unified Patent Court

Academics

Pr. Dr. Holger Gohlke Professor for Pharmaceutical and Medicinal Chemistry Heinrich Heine University Düsseldorf

Julia Pike Global IP Head Sandoz

Karin Pramberger Head of IP Polpharma Group

Jiri Slavik Director, IP Adalvo

Jochen Spuck Chief Technology Officer EconSight

Kirsty Dolphin Partner Venner Shipley

Hazel Ford Partner

Mathys & Squire

Mark van Gardingen Partner Brinkhof

Frits Gerritzen Partner

Allen & Overy

Willemijn Gommans Team Leader, Biotechnology NLO

Markus Grammel Partner Grünecker Patent

Eduardo Hallak

Founding Partner Licks Attorneys

Ruud van der Velden Partner Hogan Lovells

Honorable Marije Knijff

District Court Judge The Hague

Associations

Sergio Napolitano General Counsel and External Relations Director Medicines for Europe

Brigitte Carion-Taravella

Principal Patent Counsel, Lead Biologics IP EU Global IP Department, Legal, Ethics & Business Integrity Sanofi

Shohta Ueno

Senior Director Assistant General Counsel –Dispute Resolution Regeneron

Wendela Hårdemark Partner Westerberg & Partners

Martin Herzog Managing Partner Herzog IP Marleen van den Horst Patent Litigator/ UPC Representative La Gro Geelkerken Advocaten

Prof. Willem Hoyng Partner

Hoyng Rokh Monegier Chairman of the UPC Advisory Committee

Oliver Kingsbury Partner Elkington + Fife LLP

Gregor König Partner

König Szynka Tilmann von Renesse

Sanjeev Kumar Tiwari Partner & Litigation Practice Chair

K&S Partners | Intellectual Property Attorneys

Josep Montefusco Partner

Clifford Chance

Alexander Roussanov Partner

Arnold & Porter

Dr. Moritz Schroeder Counsel

Bird & Bird

Derk Visser Of Counsel

EIP Partnership LLP

Thomas Wolter Partner Mewburn Ellis LLP

Huiya Wu Partner Goodwin Procter LLP

7:30 Networking Breakfast and Registration

8:45

Co-Chairs’ Opening Remarks: Pharma & Biotech Patent Litigation Year in Review

Microphone-alt Joel Coles, Partner, Powell Gilbert LLP

Rachel Mumby, Partner, Bristows LLP

Ruud van der Velden, Partner Hogan Lovells

Over the past year, the landscape of pharmaceutical and biotech patent litigation in Europe has undergone notable transformation. The activation of the Unified Patent Court inaugurated a new chapter in European patent litigation. The landscape has also been shaped by key decisions from the European Board of Appeal and legislative reforms in the pharmaceutical sector, introducing fresh challenges and strategies for patent practitioners. In this conference opening assessment, our 2024 co-chairs will delve into these significant developments, offering a comprehensive analysis of the evolving trends and their implications for life science patent law in 2024.

C5's UPC Institute

9:15

Refining Life Sciences IP Litigation Strategies After the UPC’s Inaugural Year

Microphone-alt Christoph de Coster, Partner, Taylor Wessing

Dr. Moritz Schroeder, Counsel, Bird & Bird

Stefania Bergia, Partner, Simmons & Simmons LLP

Dr. Ulrich Blumenröder, Partner, Grünecker Patent

• Evaluating and refining litigation strategies to leverage the experiences and precedents set in the first year of the UPC

• Understanding how initial rulings and procedural nuances have shaped the litigation landscape

• Tailoring offensive and defensive strategies in the UPC context, incorporating lessons learned from the court's inaugural year

• Understanding which arguments and approaches have proven most effective in this new legal environment

• Analyzing the evolving relationship between EPO opposition proceedings and validity challenges within the UPC

• Assessing how decisions in one forum influence strategies and outcomes in the other

10:15

Adapting Approaches for Defending and Enforcing Patent Rights in Non-UPC Jurisdictions

Microphone-alt Josep Montefusco, Partner, Clifford Chance, S.L.P.

Eduardo Hallak, Founding Partner, Licks Attorneys

• Analyzing the impact of UPC developments on non-member states and how these jurisdictions are responding to the changing European patent landscape

• Exploring the specific challenges and opportunities in Brazil, highlighting its unique patent environment and implications for global patent strategies

• Strategic considerations for enforcing patents in non-UPC jurisdictions, including leveraging local laws and court systems to the patent owner’s advantage

• Defensive tactics for facing patent litigation in these countries, taking into account the differing procedural nuances and legal frameworks

• Examining case studies and rulings from key non-UPC jurisdictions to draw lessons and strategies for effective patent rights management.

11:15 Morning Coffee Break

11:45

The UPC One Year Later: Judicial Insights on Year One

Microphone-alt Honorable András Kupecz, Legally Qualified Judge, Central Division, Munich Section, Unified Patent Court

Honorable Edger Brinkman, Legally Qualified Judge, Local Division, The Hague, Unified Patent Court

Marije Knijff, District Court Judge, The Hague

Moderator:

Professor Willem Hoyng, Partner, HOYNG ROKH MONEGIER, Chairman, Advisory Committee of the UPC, Member, Drafting Committee of the Rules of Proceedings of the UPC

This judicial roundtable offers a unique opportunity to gain insights from the judiciary's viewpoint on the UPC's operations and its impacts over the past year. The judges will share their experiences, challenges, and triumphs in navigating this new legal landscape. Attendees will benefit from a firsthand account of how the UPC has influenced patent litigation in Europe, including changes in procedural dynamics, case management, and decision-making trends. This engaging conversation will not only provide a retrospective look at the UPC's inaugural year, but also offer foresight into future developments and ongoing evolution in European patent law.

12:45 Networking Luncheon

1:45

Navigating the New Landscape: Assessing the Impact of EU Pharmaceutical Legislation Reforms on Pharma and Biotech Litigation

Microphone-alt Sergio Napolitano, General Counsel and External Relations Director, Medicines for Europe

Wendela Hårdemark, Partner, Westerberg & Partners

Alexander Roussanov, Partner, Arnold & Porter

This session focuses on the transformative impact of the latest EU pharmaceutical legislation reforms on the pharma and biotech industries. Panelists will detail the implications of these changes, following the European Commission’s comprehensive overhaul, marked by the adoption of a new Directive and Regulation. Topics will include:

• Examining how the new Directive and Regulation, replacing existing pharmaceutical legislation (Regulation 726/2004 and Directive 2001/83/EC), influence market access strategies and innovation within the pharmaceutical industry

• Devising strategies for adapting to new requirements under the revised legislation, focusing on authorization, monitoring, labeling, and marketing of medicinal products, as laid out in the new Directive and Regulation proposals

• Assessing the implications of these reforms on clinical trial frameworks and data management, particularly the transition to the new clinical trials framework under Regulation (EU) 536/2014 and the management of health data sources

• Understanding the new legislation's impact on Advanced Therapy Medicinal Products (ATMPs) and other innovative therapies, including the European Commission's focus on the development and regulation of these treatments

2:45

Deciphering Plausibility: Post-Publication Evidence in Inventive Step and the EPO’s G2/21 Decision

Microphone-alt Oliver Kingsbury, Partner, Elkington + Fife LLP

Thomas Wolter, Partner, Mewburn Ellis LLP

This session will outline the nuances of the EPO Enlarged Board of Appeal's G 2/21 decision, focusing on its implications for plausibility and inventive step in patent law. Discussion points include:

• Outlining the guiding principles set by the Enlarged Board for using post-published evidence in inventive step assessment

• Detailing the impact of the decision on determining inventive step and drafting patent applications

• Implementing a case-by-case application of the guidelines and their influence on different technical fields

• Devising strategies for effectively incorporating post-published evidence in light of the G 2/21 decision

3:45 Afternoon Break

C5's SPC Think Tank

4:00

Advancing SPC Strategies in the NEW EU SPC Landscape

Microphone-alt Jiri Slavik, Director, IP, Adalvo

Brigitt Carion-Taravella, Principal Patent Counsel, Lead Biologics IP EU, Global IP Department – Legal, Ethics & Business Integrity, Sanofi

• Discussing the Unitary SPC Framework

» Understanding how the proposed unitary SPC integrate with the unitary patent system

» Appreciating the expected benefits and challenges of a centralized SPC application procedure

• Impact on Filing Strategies and Implementation

» How will the new unitary SPC system affect current SPC filing strategies under the Unified Patent Court?

» What are the key considerations for implementing a unitary SPC, and which institution might be best suited for this role?

• Debating the Coexistence of Unitary and National SPCs

» How should the industry navigate the coexistence of unitary and national SPCs?

» What could be the implications of a unified examination and grant procedure for both types of SPCs?

• Addressing Legal Uncertainties and Solutions

» What potential legal uncertainties could arise from the new SPC reforms?

» How can these uncertainties be addressed to ensure a smooth transition and effective implementation?

• Exploring Practical Challenges and Solutions

» What are the practical challenges in implementing the unitary SPC, especially regarding examination, granting, and appeals?

» How can these challenges be overcome, and what solutions can be proposed for a seamless integration?

5:00

Evolving Dynamics of the SPC Manufacturing Waiver: Use, Impact, and Litigation Trends

Microphone-alt Sabrina Duschner, VP Patent Litigation, Fresenius Kabi Frits Gerritzen, Partner, Allen & Overy

This session will explore the latest developments in the application and impact of the SPC Manufacturing Waiver. Since its implementation, the waiver has shown a significant influence on the pharmaceutical industry, particularly in terms of manufacturing within the EU. Points of discussion will include:

• Analyzing who is utilizing the SPC Manufacturing Waiver, how it's being used, and if there's any evidence of misuse

• Addressing the practicality of the waiver, especially the stockpiling exception, and the mixed feedback from industry participants

• Discussing potential areas of emerging litigation arising from the waiver's use and examining the disputes related to the waiver regulation

• Analyzing how different entities in the pharmaceutical sector are strategically using the SPC Manufacturing Waiver, and what best practices can be advised to clients in light of recent experiences and legal challenges

• Assessing the case for reforming the SPC manufacturing waiver regime during its upcoming 2024 review period

5:30

Conference Adjourns for Cocktail Reception

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DAY 2

30 MAY 2024

8:00 Networking Breakfast

8:50

Co-Chairs’ Welcome Back and Recap of Day 1

9:00

Strategic IP Management in Pharma & Biotech Litigation: Insights from Chief IP Counsel

Microphone-alt Frank Landolt, Chief Counsel, IP and Legal, Confo Therapeutics

Julia Pike, Global IP Head, Sandoz

Shohta Ueno, Senior Director, Assistant General Counsel –Dispute Resolution, Regeneron

Moderator:

Daan de Lange, Partner, Brinkhof

This opening session brings together leading Chief IP Counsel from both innovative and generic companies to share their insights and strategies for navigating the complexities of pharmaceutical and biotech IP in the European context. Points of discussion will cover:

Innovator Perspectives:

• Emphasizing the role of patents in driving innovation within the European pharmaceutical landscape

• Key strategies for building a robust patent portfolio in a changing European IP environment

• Navigating patent listing and protection strategies in line with European regulations

• Anticipating litigation under the new UPC regime, including the strategic timing for patent defense

Generic Perspectives:

• Identifying viable patents for challenge under European laws and the UPC framework

• Criteria for targeting specific patents for opposition or invalidation

• Approaches to assessing patent invalidity and non-infringement in the European context

Considerations for Both Sides:

• Decision-making on when to engage outside counsel versus handling matters in-house in the European context

• Addressing complex legal challenges and anticipating future trends in European pharma IP law

10:00

Emerging Trends and Litigation Strategies for the Global Biologic and Biosimilar Landscape

Microphone-alt

Marleen van den Horst, Patent Litigator/UPC Representative, La Gro Geelkerken Advocaten

James Horgan, Assistant Managing Counsel, Merck Sharp & Dohme (UK) Ltd.

Sanjeev Kumar Tiwari, Partner & Litigation Practice Chair, K&S Partners | Intellectual Property Attorneys

This session focuses on the dynamic global landscape of biosimilars and biologics, highlighting the latest trends, challenges, and strategies in patent litigation. Topics of discussion include:

• European insights on global cases

» Analyzing key global cases such as Amgen v Sanofi, focusing on their implications within the European legal framework and the necessity for jurisdiction-specific strategies

• Assessing the impact of international decisions on EU practices

» Examining how significant rulings, like those from the U.S. Supreme Court and the Japanese IP High Court, affect patent litigation strategies and outcomes in Europe

• Tracking trends affecting the European market

» Exploring emerging trends on biosimilar entry, assessing their impact on market competition and innovation within the EU

• Understanding the role of Patents and Biosimilars in Europe

» Considering how European regulations and practices around biosimilar approval pathways, such as the 'patent dance', influence litigation timing and strategic decisions

• Discussing the resolution of biologic and biosimilar patent disputes in Europe, considering the influence of global practices

• Understanding the place of oppositions, national litigation, the UPC and dispute resolution within the EU context

10:45 Morning Coffee Break

11:00

The

Vaccine Patent Wars: Analysing the COVID-19 Litigation and the Implications for Life Sciences IP

Microphone-alt Thierry Calame, Partner, Lenz & Staehelin

Kirsty Dolphin, Partner, Venner Shipley

This session will detail the complex and pivotal patent litigations surrounding COVID-19 vaccines, offering life sciences IP lawyers in Europe critical insights into this rapidly evolving landscape. Session leaders will dissect the intersection of patent law, public health policy, and global access, highlighting strategic considerations and broader implications for the life sciences IP community. Topics of discussion will include:

• Analyzing key cases like Moderna vs. Pfizer/BioNTech mRNA vaccine dispute, assessing their legal arguments, impact on the pharma industry, and implications for biotech patent law

• Examining how top pharmaceutical companies protect their COVID-19 vaccine IP and the impact of these strategies on vaccine innovation

• Detailing the interplay between public health policies, emergency use authorizations, and patent rights during the pandemic

• Assessing the impact of voluntary patent pledges, such as AstraZeneca’s non-profit vaccine pledge, on IP management in health crises

• Exploring key takeaways from the COVID-19 vaccine patent disputes to inform future IP management strategies in health emergencies

• Debating the ethical and legal challenges of balancing global vaccine access with the need to protect innovation through patents

11:45

EU Competition Law in the Life Sciences: New Developments, Enforcement Trends, and Economic Impacts

Microphone-alt Gabriele Venskaityte, Case Handler, European Commission - DG COMP

Karin Pramberger, Head of IP, Polpharma Group

As competition law continues to evolve, it is vital for life sciences IP practitioners in the pharmaceutical and biotech industries to stay informed about enforcement trends, litigation outcomes, and settlements, as well as the broader economic considerations that shape these laws. Points of discussion will include:

• Analyzing key enforcement actions taken by European competition authorities, focusing on cases involving pharmaceutical and biotech companies

• Exploring the influence of EU policies and regulations on competition law, including recent directives and guidelines specific to the life sciences sector

• Reviewing recent high-profile litigation and settlement cases within the EU, assessing their implications for market dynamics and legal strategies

• Understanding how market dynamics, such as pricing strategies and market consolidation, are influencing competition law enforcement and compliance in the EU

• Offering insights into how life sciences companies can adapt their strategies to comply with the changing EU competition law landscape and effectively advocate for their interests

12:30 Networking Luncheon

1:30

Advancements in Antibody Patent Litigation: Integrating 2023’s Key Rulings into 2024 Strategies

Microphone-alt Ross Cummings, Partner, Gill Jennings & Every LLP

Hazel Ford, Partner, Mathys & Squire

Mark van Gardingen, Partner, Brinkhof

This session addresses the continually evolving landscape of antibody patenting in Europe and the U.S., incorporating crucial case law developments from 2023 into effective prosecution strategies for 2024. Session leaders will dissect recent influential decisions and explore their implications for drafting and litigating antibody patents in different jurisdictions. Topics of discussion will include:

• Analyzing the Supreme Court's decision, which deemed claims of two Amgen patents invalid due to insufficient enablement for a genus of antibodies

• Examining how recent EPO decisions, like T 0499/18, influence the acceptability of claims where a combination of antigen plus function is used to define an antibody

• Reviewing effective strategies for claiming antibodies, considering different patent office interpretations and how to draft claims that secure protection across jurisdictions

• Understanding the nuances of epitope-based claims and functional antibody claims

• Assessing recent trends and develop best practices for antibody patent applications, ensuring broad and robust protection

2:15

Priority Claims in Focus: Adapting to EPO’s New Stance in G 1/22 and G 2/22

Microphone-alt Willemijn Gommans, Team Leader, Biotechnology, NLO

Markus Grammel, Partner, Grünecker Patent

Gregor König, Partner, König Szynka Tilmann von Renesse

Derk Visser, Of Counsel, EIP Partnership LLP

This session will help you make sense of the recent landmark decisions by the EPO's Enlarged Board of Appeal in G 1/22 and G 2/22, which have softened the approach to assessing entitlement to priority in patent applications. Topics of discussion include:

• Discussing the EPO's established competence to assess whether a party is entitled to claim priority, as affirmed in G 1/22 and G 2/22

• Analyzing the Enlarged Board's introduction of a "rebuttable presumption" that a priority claim is valid, significantly altering the burden of proof dynamics in priority entitlement challenges

• Exploring how this shift impacts both patent applicants and opponents in opposition proceedings, including strategies for leveraging or countering priority claims

• Examining the decision's perspective on transfers of priority rights, especially in scenarios involving joint filings of PCT applications by different parties

• Providing insights into how patent practitioners can adjust their approaches to claiming priority in light of these decisions, ensuring more robust and defensible patent applications

3:00 Afternoon Break

3:15

Global Shifts in Life Sciences IP: Patent Linkage in China

and Developments in the U.S.

Microphone-alt Michael Cottler, Partner, Gemini Law

Huiya Wu, Partner, Goodwin Procter LLP

This session will examine the evolving landscape of patent linkage litigation in China and recent developments in the U.S., providing critical insights for European companies. Points of discussion will include: China

• Reviewing significant cases like Chugai v. Haihe and Novartis v. Thery, which highlight the practical application of China’s patent linkage system

• Assessing how the courts' rulings, predominantly favoring generics, shape litigation strategies for both innovators and generics

• Exploring implications for biologic products and how China's system is expected to evolve

United States

• Analyzing the impact of changes to FDA’s accelerated approval process under FDORA

• Discussing recent shifts in FDA policies regarding clinical trial diversity and their impact on drug development and patent prosecution strategies

• Discussing how recent U.S. legal decisions, particularly concerning written description requirements, influence global patent strategies

• Exploring how these developments impact European companies involved in life sciences patent disputes

4:15

Navigating the Future of AI and IP in Europe

Microphone-alt Jochen Spuck, Chief Technology Officer, EconoSight

Martin Herzog, Patent Attorney, Herzog IP

Pr. Dr. Holger Gohlke, Professor for Pharmaceutical and Medicinal Chemistry, Heinrich Heine University Düsseldorf

Discover the future of life sciences in our essential session on the evolving world of IP and its interplay with technological advancements. We'll cover AI's impact on pharmaceuticals, future inventions, and the scenarios reshaping IP rights, underscoring their significance on the legal and economic aspects of the industry. Points of discussion will include:

The AI Revolution in Pharmaceutical Research

• Examining how artificial intelligence is transforming drug discovery and development

• Discussing the integration of AI in identifying novel molecules and their medical applications, alongside the legal and technical nuances of IP ownership and invention enablement

Predictive Analytics and Patent Potential

• Understanding the prediction of patent grant likelihood, the assessment of uniqueness, disruptiveness, and the economic impact on the valuation of entities owning such patents

• Considering the implications for litigation risk and the strategic management of IP portfolios

Reimagining Patentability and Prior Art

• Discussing the challenges and opportunities in patent application drafting enhanced by AI, and the evolving criteria for patentability, especially in terms of inventive step and novelty

Early-stage High-value Patents

• Analyzing strategies to secure high-value patents at an early stage and the acceleration of patent processes

• Evaluating the implications for startups and established companies in gaining a competitive edge in the market

5:15 Conference Concludes

Building VENUE INFORMATION

Kimpton De Witt Amsterdam Nieuwezijds Voorburgwal 5, 1012 RC Amsterdam, The Netherlands

ACCOMMODATIONS

C5 Communications Ltd. is pleased to offer our delegates a limited number of hotel rooms at a negotiated rate. To take advantage of these rates, please contact the hotel directly and quote “C5’s Pharma & Biotech EU”. Reservations: meetings@kimptondewitthotel.com

Please note that the guest room block cut-off date is April 29, 2024. After that date OR when the room block fills, guestroom availability and rate can no longer be guaranteed.

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