Pharma & Biotech Patent Litigation in Europe

CO-CHAIRS' OPENING REMARKS

Pharma & Biotech Patent Litigation Year in Review

Dominic Adair
Partner
Bristows LLP (U.K)

Dr. Penny Gilbert
Partner
Powell Gilbert LLP

Bert Oosting
Partner
Hogan Lovells

In the year since we last met, there have been numerous developments influencing the pharmaceutical and biotech patent litigation landscape in Europe. New pharmaceutical legislative reform and significant EBoA decisions are currently on the horizon, and of course – Germany’s ratification of the UPC Agreement has finally launched the countdown to the beginning of the Unitary Patent and Unified Patent Court on 1st June. In this opening session, our esteemed co-chairs will set the stage for the conference with a high-level exploration of the most significant developments impacting European life science patent practitioners in 2023.

Developing Winning Patent Litigation Strategies for the Unified Patent Court

Gaëlle Bourout
Counsel
Linklaters

Philippe Campolini
Partner
Stibbe

Mathilde Rauline
Counsel, European Patent Attorney
August Debouzy (FRA)

• Navigating the new opportunities and challenges of the new streamlined patent system
• Developing offensive litigation strategies for the UPC, as well as defensive strategies if you believe you will be sued in the UPC
• Understanding the interplay between opposition proceedings at the EPO and validity challenges in the UPC
• What preemptive strikes can be taken when the UPC court opens: strategies for the use of preliminary injunctions, seizure of evidence and ex-parte measures

Devising Tactics for Defending and Enforcing Patent Rights in Non-UPC Member Jurisdictions

Thierry Calame
Partner
Lenz & Staehelin

Dr. Penny Gilbert
Partner
Powell Gilbert LLP

Ida Gjessing
Partner
GjessingReimers

Miquel Montañá
Partner
Clifford Chance LLP

• Identifying key strategies for litigating pharmaceutical and biotech patent rights in jurisdictions outside of the UPC
• Navigating the challenges of defending patent rights within the UPC while concurrently stopping competitors in non-member states such as Switzerland, UK, Spain and Norway

Morning Coffee Break

UPC JUDICIAL ROUNDTABLE

Critical Considerations for Practitioners Entering Into the Unified Patent Court

Honorable Rian Kalden
Senior Judge
Court of Appeal, The Hague

Honorable Margot Kokke
Senior Judge
District Court, 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

Tune in for an exclusive opportunity to hear from a panel of “in the know” UPC judges on the most important considerations for practitioners entering into the new court system. With the UPC set to open its doors on 1st June, this is a session you cannot afford to miss. Topics of discussion will include:

• Examining what UPC procedures will look like going forward
• Breaking down the UPC Code of Conduct
• Understanding who can act as a Technical Judge and the role of the Standing Appeal Judge
• How will UPC judges plan to approach areas of law where there is not consistency across jurisdictions?
• The standard of inventivity
• Plausibility
• Doctrine of Equivalence
• How will the UPC judges align on handling key aspects of Preliminary Injunction proceedings including:
• Timing/Urgency
• Balance of convenience
• Application of discretion
• Application of security
• What role will decisions of the Enlarged Boards of Appeal have in the UPC?

Networking Luncheon

EU REGULATORY THINK TANK

Anticipating the Impact of EU Regulatory Transformation on Pharmaceutical and Biotech Companies

Grant Castle
Partner
Covington & Burling LLP

Daan de Lange
Partner
Brinkhof Advocaten

Sergio Napolitano LL.M.
General Counsel and External Relations Director
Medicines for Europe

Ioana Ratescu
Head Legal, Regulatory Europe
Attorney at Law
Novartis Pharma AG

• Assessing the latest plans to reform the European Union’s general pharmaceutical legislation: What can we anticipate from the proposed revisions expected in 2023?
• What can be gleaned from the recently leaked draft of the Commissions proposed policies?
• Examining the biggest concerns and surprises contained in the leaked draft of the reform
• What impact will the new revisions have on current regulatory exclusivity rules, and the balancing of innovation and market competition?
• Analyzing recent developments to the EU regulatory framework governing clinical trial development and management of data sources and health data
• Navigating challenges of transitioning to the new clinical trials framework under Regulation (EU) 536/2014
• Examining the latest strides of key global regions in developing regulatory policies to facilitate decentralized clinical trials (“DCTs”)
• Exploring the latest developments in EU and UK regulation of Artificial Intelligence and medical devices
• Examining current legislative proposals amending Directive 83/2001: how will this proposal impact the sale, production, labelling, classification, distribution and advertising of medicinal products in the EU?

The Future of Plausibility: Managing the Implications of the EPO’s Decisions in BOA Referral G 2/21

Alessandra Attavino
Senior Patent Attorney
Chiesi Farmaceutici

Koen Bijvank
Partner
Brinkhof

Dr. Sabrina Duschner
VP Patent Litigation Strategy
Fresenius Kabi Deutschland GmbH

Eleanor Root
Partner
Bird & Bird

Moderator:

Bert Oosting
Partner
Hogan Lovells

• Analyzing the current status of the EPO Enlarged Board of Appeals Referral G 2/21: will plausibility close or open the door for relying on post- published evidence?
• Examining the Board of Appeal’s recently released preliminary opinion: what does this intimate about their anticipated final decision and the future of plausibility and inventive step?
• Assessing the potential implications of this ruling on future patent prosecution and litigation strategies
• As we await the final written decision of the Board of Appeal – understanding in what situations post-published evidence can be considered to support the effect of the invention

Afternoon Break

Let’s Talk SPCs

Examining the Impact of Recent SPC Referral Cases and Addressing Key Questions on the Future of Unitary SPCs

Karin Pramberger
Head of IP
Polpharma Group

Oswin Ridderbusch
Partner
VOSSIUS & PARTNER

SPC Case Law and Referrals

• Examining the impact of recent SPC case law and latest referrals for preliminary rulings on the interpretation of Article 3(c) of the SPC Regulation

• Examining how existing SPCs will operate under the Unified Patent Court, and how the new Unitary Patent will affect SPC filing strategies
• Exploring the current status of reforms and the plans of the European Commission regarding the introduction of a Unitary SPC
• Addressing key practical questions surrounding the implementation of a Unitary SPC:
• Which institution is best equipped to examine and grant them?
• What potential problems could arise with using the European Patent Office (EPO) or the European Union Intellectual Property Office (EUIPO) as the granting authority for Unitary SPCs?
• Understanding how an appeal system would work for a Unitary SPC
• How would individual country marketing authorizations play out in the face of a Unitary SPC?
• Exploring the possible creation of a single unified examination and grant procedure for national SPCs – as an alternative or as a complementary measure to the introduction of a Unitary SPC
• Could the same institution be entrusted with granting Unitary SPCs and national SPCs?
• Understanding how appeals against the rejection of national SPCs by a centralized granting authority could be handled
• Practical challenges including language-related issues
• What could be the potential drawbacks of a Unitary SPC and/or a single unified grant procedure for national SPCs

Assessing the Uptake of the SPC Manufacturing Waiver and Making Sense of Disputes Arising from Manufacturing Waiver Regulations

Jiri Slavik
Senior Manager, Intellectual Property
Adalvo

• What is the latest data showing about:
• Who is using the SPC Manufacturing Waiver?
• How is it being used?
• Are we seeing any evidence of it being abused?
• Addressing perceived downsides of use of the SMW
• How well is the waiver working in practice, particularly for the stockpiling exception?
• Exploring potential areas of emerging litigation coming out of the waiver’s use, as well as disputes arising from the waiver regulation
• How are brands and generics strategically using the SMW and how to best advise your clients regarding its use

Conference Adjourns for Cocktail Reception

Co-Chairs’ Welcome Back and Recap of Day 1

Transnational Tactics for Avoiding and Defending Contributory and Induced Infringement Claims

Dominic Adair
Partner
Bristows LLP (U.K)

Ruud van der Velden
Partner
Hogan Lovells International LLP

• Analyzing trends in contributory and induced infringement litigation across various nations in Europe
• What practices are triggering liability for contributory infringement across different countries?
• What ways are companies being caught under different sections of the patent law for unintended infringement?
• How can companies avoid or minimize liability risks of this?

The Emerging Battleground: Global Strategies for Biosimilars and Biologics Patent Litigation

Rob Rodrigues
Partner
Licks Attorneys

Daniel Lim
Partner, Intellectual Property
Kirkland & Ellis International LLP

Biologics and biosimilars are a rising patent battleground across the globe. As innovation and the biologics market grows, litigation is certain to keep pace with that growth. This panel will examine global strategies for biosimilars and innovator biologics patent litigation, with topics of discussion to include:

• Identifying cases where litigation should be your first option
• Understanding whether you should look to litigate in a single jurisdiction first and try to leverage the result elsewhere
• Examining the pros and cons of entering into global ADR agreements vs. handling things jurisdiction by jurisdiction
• Examining the rise in innovator vs. innovator litigation as companies compete over work on the same target: assessing issues of proportionality and appropriateness of injunctive relief in these actions
• Strategies for avoiding biosimilar litigation down the line:
• Using “clear the path” strategies for proactive litigation
• Securing a declaration of non-infringement up front
• Utilizing “skinny labeling” to carve out particular patented indications for the biosimilar

Morning Coffee Break

Alternative Dispute Resolution: Preparing for the New UPC Patent Mediation and Arbitration Centre (PMAC)

Andrzej Gadkowski
Associate Legal Officer, IP Disputes Section
WIPO Arbitration and Mediation Center

Philipp Groz
Partner
Schellenberg Wittmer Ltd

Gordon Humphreys
Chairperson of the 1^st and 3^rd Board of Appeals
European Union Intellectual Property Office (EUIPO)

Benjamin May
Partner
ARAMIS Société d'Avocats

• Exploring the benefits and challenges of combining parallel disputes atnational and international levels into one resolution
• Avoiding complex litigation proceedings
• Achieving quicker, more efficient outcomes in a cost-effective way
• Examining the role of the new UPC Patent Mediation and Arbitration Centre (PMAC)
• Assessing the opportunities and challenges created by the UPC’s new mediation/arbitration function
• Understanding key considerations for practitioners entering into the new PMAC system

Tracking Changes in Competition Law: Enforcement, Litigation, Settlements and Economic Considerations

Boris Andrejaš
Case Handler Officer
European Commission
DG COMPETITION

Maarten Meulenbelt
Partner
Sidley Austin LLP

Fireside Chat with the European Commission, DG Competition

Networking Luncheon for Speakers and Delegates

Successfully Claiming Antibody Patents in Europe and the U.S.: Incorporating Takeaways from the Latest Case Law Into Your Prosecution Strategy

Deborah Sterling
Director, Chair, Biotechnology & Chemical Practice Group
Sterne, Kessler, Goldstein & Fox P.L.L.C.

Dr. Jörk Zwicker
Partner
Zwicker Schnappauf & Partner

Peter Silverman
Chief Operating Officer and General Counsel
Merus

Drafting antibody claims is a complex endeavor, and questions surrounding which claims are patentable in Europe and the U.S. remain increasingly difficult to navigate. This panel will offer solutions for successful patenting strategies and global commercialization. Points of discussion include:

• Tactical tools for claiming antibodies in view of developing case law in Europe and the U.S.
• Understanding different patent office interpretations of antibody claims
• Drafting claims to secure protection across different jurisdictions
• Examining how Amgen v Sanofi (U.S. Fed. Cir. 2021) has impacted the enablement bar for antibody patents
• Assessing the recent EPO Board of Appeal decision maintaining a functional epitope antibody genus claim (T 1964/18)
• How is this decision impacting antibody claim prosecution strategies going

Spotlight on Priority: Incorporating the Latest EPO and National Jurisprudence into Your Patent Enforcement Strategies

James Horgan
Assistant Managing Counsel
Merck Sharp & Dohme

Gregor König
Partner
König Szynka Tilmann von Renesse

• Crafting bullet-proof strategies for avoiding invalid priority claims that could jeopardize the protection of your patent
• Examining the recent referrals to the Enlarged Board of Appeal on the issue of priority entitlement (G 1/22 and G 2/22)
• What might the potential implications of this BoA decision be on the “joint applicants” approach to claiming priority?

Afternoon Break

Spotlight on the U.S. and China: Examining the Influence and Implications of Legal and Regulatory Advancements Abroad

Robert V. Cerwinski
Partner
Gemini Law LLP

Anthony Chen
Partner
Jones Day

China

• Analyzing the latest developments in patent linkage litigation in China
• Understanding how patent linkage litigation has evolved since the CN Orange Book was recently established by the fourth amendment of the Chinese patent law
• Examining the major impact that patent linkage litigation is having on European biopharma companies doing business in China

United States

• Examining cross-border impact of recent US legal developments
• Implications of recent Supreme Court hearing on written description
• The latest U.S. case law discerning whether evidence of ITC can be used in post-grant proceedings

Navigating the Patenting Challenges Of AI-Assisted Drug Discovery and Development

Ian Jones
Partner
Gill Jennings & Every

Pete Sadler
Partner
Reddie & Grose

While AI is having a tremendous impact on drug development, the lack of clarity in patent law for AI-driven innovations continues to create roadblocks to patenting inventions. This panel will discuss the latest ways that AI is being used in drug development, how patent registries and courts are interpreting the existing law in Europe and the U.S, and how companies are navigating patenting challenges surrounding:

• Eligibility disputes surrounding unpatentable subject matter/abstract ideas
• Understanding how much disclosure in a patent application is necessary to satisfy the written description and enablement requirements
• Issues of inventorship and conception

Conference Concludes