C5's 16th Annual Forum on Pharma & Biotech Patent Litigation in Europe - DS

23 – 24 May 2023

DoubleTree by Hilton Amsterdam Centraal Station, Amsterdam

C5’s 16th Annual Forum on

&PHARMA BIOTECH PATENT LITIGATION IN EUROPE

Insights from Key Industry Stakeholders:

Alessandra Attavino

Senior Patent Attorney Chiesi Farmaceutici

Dr. Sabrina Duschner

VP Patent Litigation Strategy

Fresenius Kabi Deutschland GmbH

James Horgan

Assistant Managing Counsel

Merck Sharp & Dohme

Mathilde Rauline

Head of Greater Europe Patent Litigation, Global Intellectual Property Department

Sanofi

Karin Pramberger

Head of IP Polpharma Group

Ioana Ratescu

Head Legal, Regulatory Europe

Novartis Pharma AG

2023 Co-Chairs:

Angle-Right Tactical Training Session for UPC Litigators: Developing Offensive and Defensive Strategies for Success

Angle-Right ADR in the UPC: Preparing for the New UPC Patent Mediation and Arbitration Centre (PMAC)

Angle-Right Interview with Judges Rian Kalden and Margot Kokke from the UPC

Honorable Rian Kalden

Senior Judge Court of Appeal, The Hague

Honorable Margot Kokke

Senior Judge District Court, The Hague

Our Esteemed Faculty Comprised of the Best IP Minds in Europe Will Help You:

Check Devise Strategies for Enforcing and Defending Patent Rights in Non-UPC Jurisdictions

Check Forecast the Future of Plausibility and Priority in Light of the Latest EBA Referral Cases

Check Prepare for Anticipated Reform of the EU’s General Pharmaceutical Legislation

Check Develop Transnational Tactics for Avoiding and Defending Contributory and Induced Infringement Claims

Check Address Key Questions on the Future of Unitary SPCs

Check Formulate Winning Global Strategies for Biosimilars and Biologics Patent Litigation

Associate Sponsors

Dominic Adair Partner Bristows LLP

Dr. Penny Gilbert Partner Powell Gilabert LLP

Bert Oosting Partner Hogan Lovells

The Unitary Patent System and Unified Patent Court Will Commence on

1st June – ARE YOU READY?

C5 invites you to join us in Amsterdam on 23-24 May for Europe’s premier life sciences patent litigation conference. Spring 2023 marks the beginning of a new patent era for Europe – the UP will go into effect and UPC will be open for business. Join us and obtain up-to-the-minute information and strategic insights on utilizing this new patent system and optimizing your IP.

C5’s Annual Forum on Pharma & Biotech Patent Litigation in Europe has united the greatest minds of the European Life Sciences Patent Bar for over 15 years. This year is no different. We are all especially excited to welcome you to Amsterdam to mark the start of the UP and UPC paradigm.

Designed for networking, collaboration and masters-level strategy sharing, this flagship event will provide you with the comprehensive knowledge and skills you you need to navigate the newest challenges and opportunities ushered in by the long-awaited Unified Patent Court, as well as the forthcoming reform of the EU's General Pharmaceutical Legislation.

Our esteemed 2023 faculty will ensure that you understand how the latest case law and regulatory developments will impact your cases, as well as your clients’ bottom lines. Attend and learn to navigate the latest litigation battlegrounds facing today’s pharma and biotech products.

At a time when the industry is on the precipice of such significant transformation, you cannot afford to miss Europe’s original and best life science patents litigation forum. Register today. We look forward to seeing you in Amsterdam.

Caret-right

Meet Our Esteemed Speaking Faculty

CONFERENCE CO-CHAIRS

Dominic Adair Partner Bristows LLP

Dr. Penny Gilbert Partner Powell Gilbert LLP

Bert Oosting Partner

Hogan Lovells

DISTINGUISHED SPEAKERS

Boris Andrejaš

Case Handler Officer

European Commission DG COMPETITION

Alessandra Attavino Senior Patent Attorney Chiesi Farmaceutici

Koen Bijvank Partner Brinkhof

Gaëlle Bourout Counsel

Linklaters

Thierry Calame Partner

Lenz & Staehelin

Philippe Campolini Partner Stibbe

Grant Castle Partner

Covington & Burling LLP

Robert V. Cerwinski Partner Gemini Law LLP

Anthony Chen Partner Jones Day

Dr. Sabrina Duschner VP Patent Litigation Strategy

Fresenius Kabi Deutschland GmbH

Andrzej Gadkowski

Associate Legal Officer, IP Disputes Section

WIPO Arbitration and Mediation Center

Ida Gjessing Partner GjessingReimers

Philipp Groz Partner

Schellenberg Wittmer Ltd

James Horgan Assistant Managing Counsel

Merck Sharp & Dohme

Professor Willem Hoyng Partner

HOYNG ROKH MONEGIER Chairman, Advisory Committee of the UPC Member, Drafting Committee of the Rules of Proceedings of the UPC

Gordon Humphreys Chairperson of the 1st and 3rd Board of Appeals

European Union Intellectual Property Office (EUIPO)

Ian Jones Partner Gill Jennings & Every

Honorable Rian Kalden Senior Judge Court of Appeal, The Hague

Honorable Margot Kokke Senior Judge District Court, The Hague

Gregor König Partner

König Szynka Tilmann von Renesse

Daan de Lange Partner Brinkhof Advocaten

Daniel Lim Partner, Intellectual Property Kirkland & Ellis International LLP

Benjamin May Partner

Aramis Société d’Avocats

Miquel Montañá Partner

Clifford Chance LLP

Maarten Meulenbelt Partner Sidley Austin LLP

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

Karin Pramberger Head of IP Polpharma Group

Ioana Ratescu

Head Legal, Regulatory Europe Attorney at Law Novartis Pharma AG

Mathilde Rauline

Head of Greater Europe Patent Litigation, Global Intellectual Property Department Sanofi

Oswin Ridderbusch Partner VOSSIUS & PARTNER

Pedro Roman Intellectual Property Lawyer Insud Pharma

Eleanor Root Partner

Bird & Bird

Pete Sadler Partner Reddie & Grose

Jiri Slavik Senior Manager, Intellectual Property Adalvo

Rob Rodrigues Partner Licks Attorneys

Peter B. Silverman

EVP, Chief Operating Officer and General Counsel Merus

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

Ruud van der Velden Partner

Hogan Lovells International LLP

Dr. Jörk Zwicker Partner Zwicker Schnappauf & Partner

For over 35 years, C5 Group has proVided the opportunities that bring together business leaders, professionals and international experts from around the world to learn, meet, network and make the contacts that create the opportunities.

Our conferences and related products connect the power of people with the power of information, a powerful combination for business growth and success.

About us:

The C5 Group, comprising American Conference Institute, The Canadian Institute and C5 in Europe, is a leading global events and business intelligence company.

8:30 CO-CHAIRS’ OPENING REMARKS

Pharma & Biotech Patent Litigation Year in Review

MICROPHONE Dominic Adair, Partner, Bristows LLP

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.

9:15

Developing Winning Patent Litigation Strategies for the Unified Patent Court

MICROPHONE Mathilde Rauline, Head of Greater Europe Patent Litigation, Global Intellectual Property Department, Sanofi

Gaëlle Bourout, Counsel, Linklaters

Philippe Campolini, Partner, Stibbe

• 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

10:15

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

MICROPHONE Dr. Penny Gilbert, Partner, Powell Gilbert LLP (UK)

Miquel Montañá, Partner, Clifford Chance LLP (Spain)

Ida Gjessing, Partner, GjessingReimers (Norway)

Thierry Calame, Partner, Lenz & Staehelin (Switzerland)

• 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

11:15 Morning Coffee Break

11:45 UPC JUDICIAL ROUNDTABLE Critical Considerations for Practitioners Entering into the Unified Patent Court

MICROPHONE 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?

12:45 Networking Luncheon

1:45

EU REGULATORY THINK TANK

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

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

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

Grant Castle, Partner, Covington & Burling LLP

Daan de Lange, Partner, Brinkhof Advocaten

• 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?

2:45

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

MICROPHONE Alessandra Attavino, Senior Patent Attorney, Chiesi Farmaceutici

Dr. Sabrina Duschner, Vice President Patent Litigation Strategy, Intellectual Property Management, Fresenius Kabi Deutschland GmbH

Eleanor Root, Partner, Bird & Bird

Koen Bijvank, Partner, Brinkhof

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 postpublished 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

3:45 Afternoon Break

LET’S TALK SPCs

4:00

Analyzing the Implications of Recent SPC Referral Cases and Key Questions on the Future of Unitary SPCs

MICROPHONE 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

Unitary SPCs

• 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

5:00

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

MICROPHONE 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

5:30 Conference Adjourns for Cocktail Reception

8:30

Co-Chairs’ Welcome Back and Recap of Day 1

9:00

Transnational Tactics for Avoiding and Defending Contributory and Induced Infringement Claims

MICROPHONE Dominic Adair, Partner, Bristows LLP

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?

9:45

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

MICROPHONE Daniel Lim, Partner, Intellectual Property, Kirkland & Ellis International LLP

Rob Rodrigues, Partner, Licks Attorneys

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

10:30 Morning Coffee Break

11:00

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

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

Philipp Groz, Partner, Schellenberg Wittmer Ltd

Gordon Humphreys, Chairperson of the 1st and 3rd 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 at national 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

11:45

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

MICROPHONE Boris Andrejaš, Case Handler Officer, European Commission, DG COMPETITION

Maarten Meulenbelt, Partner, Sidley Austin LLP

12:30 Networking Luncheon for Speakers and Delegates

1:30

Global Prosecution Strategy Session: Best Practices for Claiming Antibody Patents in Europe and the U.S.

MICROPHONE Peter B. Silverman, EVP, Chief Operating Officer and General Counsel, Merus

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

Dr. Jörk Zwicker, Partner, Zwicker Schnappauf & Partner

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

2:15

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

MICROPHONE 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?

3:15

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

MICROPHONE Robert V. Cerwinski, Partner, Gemini Law LLP

Anthony Chen, Partner, Jones Day (Shanghai)

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

4:15

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

MICROPHONE 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

5:00 Conference Concludes

Upcoming Events

Venue Information

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 Communications”.

Hotel: DoubleTree by Hilton Amsterdam Centraal Station

Address: Oosterdoksstraat 4, 1011 DK Amsterdam

Reservations: +31 20 530 0800

Please note that the guest room block cut-off date is May 8, 2023. After that date OR when the room block fills, guestroom availability and rate can no longer be guaranteed.

Book with Confidence!

Register and pay to lock in your early rate and be eligible for a full refund until 9 May 2023.

If you are unable to attend for any reason, you will have the following options:

y A full credit note for you, or a colleague to attend another event.

y A full refund.

All cancellations and changes must be submitted to CustomerService@AmericanConference.com by 9 May 2023.

Only

CONFERENCE CODE: 630L23.AMS

Bringing a Team?*

3–4 10% Conference Discount

5–6 15%

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*Team/group registrations must be from the same organization/firm and register together in one transaction.

Attendees are asked to self-screen in the days leading up to, before and after attending an C5 event and/or conference.

We will continue to monitor the health situation and relevant authorities. Changes to health and safety measures may be made by C5 at any time as required.