15th Annual Pharma & Biotech Patent Litigation in Europe - FULL - DS

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2007–2022

15 Years Celebrating

C5’s Annual Forum on

PHARMA& BIOTECH PATENT LITIGATION IN EUROPE Calendar-alt map-marker-alt

30–31 May 2022 Hotel NH Collection Amsterdam Barbizon Palace, Amsterdam (CET)

The original conference where the “Who’s Who” of the European Life Sciences Patent Bar gather each year to shape patent litigation policies and procedures throughout Europe!

Learn and Connect with C5’s Life Sciences IP Portfolio Advisory Board: Monika Dorda SVP & General Counsel Global Pharmaceuticals GSK Sabrina Duschner Head of Patent Litigation Strategy Fresenius Kabi Guido Pontremoli, Ph.D. Global IP Head Corp. Intellectual Property-Patents Chiesi Farmaceutici S.p.A. Laura Reynolds Associate General Counsel, European IP and Regulatory Litigation Teva Pharmaceuticals Shohta Ueno, PhD Director, Dispute Resolution Regeneron UK Ltd Dominic Adair Partner Bristows LLP Bert Oosting Partner Hogan Lovells

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Conference Co-Chairs: Dominic Adair Partner Bristows LLP

Bert Oosting Partner Hogan Lovells

Join Us for In-depth Analyses on the Most Significant Developments Impacting Life Sciences Patents in Europe: ĉ Status Report on the Unitary Patent and the Unified Patent Court: Ratification, Implementation, and Protocols

ĉ Focus Sessions on Patent Enforcement Strategies:

Protecting Patent Rights and the Procedures to Enforce Them

ĉ SPC Update: Current Protocols and Viability of a Unitary SPC ĉ Think Tank on Plausibility, Sufficiency, and Inventive Step: Considerations for Formulation and Combination Patents

ĉ Blueprints for Global IP Strategies for Biosimilars and

Innovator Biologics: From Patents to Commercialization to Market Access

ĉ Forecast on the Role of Artificial Intelligence in Drug Discovery and Development

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Associate Sponsors:

With a historic 2021 behind us, the European Life Sciences Patent Bar will convene in-person for a holistic view of pharmaceutical patent trends. Join us to network and discuss the unwritten lessons for the path forward.

C5 is pleased to release the agenda for the 15th Anniversary Forum on Pharma & Biotech Patent Litigation in Europe. We invite you to join us in-person in Amsterdam on 30-31 May 2022 (CET) and around the globe via live stream.

Life Sciences patent law is an ever-changing battleground. The past twenty months have only amplified existing struggles for control of increasingly competitive intellectual property rights.

There is a pervasive need to understand what new directions the courts are taking, and how to strategize for success when protecting against patent infringement or authorizing the distribution of products.

Europe’s premier pharmaceutical and biotechnology IP counsel and patent litigators have made C5’s Annual Forum on Pharma & Biotech Patent Litigation in Europe their home for acquiring information on the hottest disputes surrounding post-filing patent litigation challenges.

Attend and come away with the knowledge and skills you need to address postfiling patent litigation challenges, and optimise your patent litigation strategy to continuously deliver efficient patent protection in this extraordinarily competitive marketplace.

Registration is now open!

See why our 2022 Conference Co-Chairs are looking forward to the original and best industry shaping event.

Bert Oosting Partner Hogan Lovells

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Dominic Adair Partner Bristows LLP

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C5’S 15 YEAR IMPACT AT PHARMA & BIOTECH EUROPE

1000+

330+

60+

Speakers

Attendees

36

Sponsors

Countries in Attendance

DISTINGUISHED FACULT Y The best that the bar, the bench, and the industry have to offer.

MASTER LE VEL STR ATEGIES For litigators and in-house counsel.

UNPAR ALLELED CONNECTIONS With the “Who’s Who” of the European Life Sciences Patent Bar.

WHO AT TE NDS In-Housel Counsel and Executives from Pharmaceutical and Biotech Companies, including:

Law firm attorneys with practices in:

ĉ

Head of IP

ĉ

Principal Patent Examiner

ĉ

R&D Patent manager

ĉ

ĉ

Head of Patent Litigation

ĉ

Head of Global Strategy

ĉ

VP-Intellectual property

Life Sciences

ĉ

Scientific Director

ĉ

European Patent Law

ĉ

Director Innovation, IP and Portfolio Management

ĉ

ĉ

Associate VP & Director of Technology Licensing & Commercialization

Intellectual Property and Patent Law

Head of Legal / Legal Affairs

ĉ

U.S. Patent

ĉ

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ĉ

Patent Counsel

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DISTINGUISHED SPEAKERS Dominic Adair Partner Bristows LLP António Andrade Partner Abreu Advogados Steven Baldwin Partner Kirkland & Ellis LLP Eran Bareket Partner, Head of Legal Practice Gilat, Bareket & Co., Attorneys at Law Laëtitia Bénard Partner Allen & Overy LLP Koen Bijvank Partner Brinkhof Advocaten Richard Bonneau Executive Director Prescient Design, A Genentech Accelerator Sara Burghart Lead IP Litigation Counsel Global Litigation & Launch – Global IP Sandoz International GmbH (DEU) Daan de Lange Partner Brinkhof Advocaten Sabrina Duschner Head of Patent Litigation Strategy Fresenius Kabi Dr. Penny Gilbert Partner Powell Gilbert LLP

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Professor Dr. Maximilian Haedicke, LL.M. Professor of Intellectual Property Law Freiburg University (Former Judge at Higher Regional Court of Duesseldorf)

Domien Op de Beeck Partner Bird & Bird Heli Pihlajamaa Director European Patent Office

Jochen Herr Partner Finnegan, Henderson, Farabow, Garrett & Dunner, LLP

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

Rieke Kaup Case Handler European Commission

Dr. Kai Rüting Partner Vossius & Partner

Otto Licks Partner Licks Attorneys

Sture Rygaard Partner Plesner

Peter Ling Partner Lenz & Staehelin

Peter Silverman EVP, General Counsel and Head of Utrecht Merus N.V.

Dr. Philipp Marchand Partner Vossius & Partner Benjamin May Partner Aramis Société d’Avocats Jean-Hyacinthe de Mitry Partner Gide Loyrette Nouel A.A.R.P.I Miquel Montañá Partner Clifford Chance S.l.

Bert Oosting Partner Hogan Lovells

Shohta Ueno, PhD Director, Dispute Resolution Regeneron UK Ltd Selma Ünlü Senior Partner NSN Law Firm Ruud van der Velden Partner Hogan Lovells Mikkel Vittrup Partner Plesner Jonas Westerberg Partner Westerberg & Partners Advokatbyrå AB

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DAY ONE 30 May 2022 8:00

HANDSHAKE Registration &

Networking Refreshments

9:00

Co-Chairs’ Opening Remarks Microphone Dominic Adair, Partner, Bristows LLP Bert Oosting, Partner, Hogan Lovells 9:10

Preparing for the Unitary Patent and the Unified Patent Court: Ratification, Implementation, and Protocols Microphone 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 bring forth a simpler, cost-effective means of protecting and enforcing patents in Europe. The introduction of the UP and the UPC will impact all applicants and patentees seeking protection in Europe through the EPO. This session will analyze the changes and provide attendees with a handbook for the future.

Topics of discussion will include: • Considering the costs and benefits of the system for patent applications • Understanding the territorial scope of protection and the role protocols play • Predicting the impact to litigation and legal certainty • Detailing the non-exclusive jurisdiction for all national validations of European patents 10:00

Strategies for Patent Enforcement: Protecting Patent Rights and the Procedures to Enforce Them Microphone António Andrade, Partner, Abreu Advogados

Laëtitia Bénard, Partner, Allen & Overy LLP Dr. Penny Gilbert, Partner, Powell Gilbert LLP The European patent system is experiencing a major reformation centered on the idea of unifying the European patent system. For decades, patent enforcement decisions across jurisdictions within Europe have produced contradictory enforcement decisions across jurisdictions within Europe. There are important differences and particularities in the legal systems across the jurisdictions, and the strategies for practicing, protecting and enforcing must take these differences into account.

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Topics of discussion will include: • Comparing the timelines of proceedings across jurisdictions • Analyzing the particularities of patent enforcement in some jurisdictions • Considering the differences between the case law of some jurisdictions 11:00

HANDSHAKE Networking Break 11:30

European Supplementary Protection Certificates (SPCs): Scope, Duration and Requirements Microphone Steven Baldwin, Partner, Kirkland & Ellis LLP

Sture Rygaard, Partner, Plesner The United Kingdom has become a fully independent third country to the European Union. Implementing the trade agreement the UK has made with the EU represents a formidable challenge facing the pharmaceutical industry.

Intellectual property and the pharmaceutical and biotech sectors are significant considerations for both the UK and the EU following Brexit.

This session will shine a spotlight on the impact of Brexit on the pharmaceutical industry, focusing on the challenges ahead as well as areas of opportunity for the UK. 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 13:00

HANDSHAKE Networking Luncheon 14:30

Plausibility, Sufficiency, and Inventive Step: Considerations for Formulation and Combination Patents in Europe Microphone Sabrina Duschner, Head of Patent

Litigation Strategy, Fresenius Kabi Bert Oosting, Partner, Hogan Lovells

Plausibility in the context of the inventive step and sufficiency requirements can be a contentious issue. To discern whether an invention is purely speculative, the Boards of Appeal of the EPO have developed the doctrine of “plausibility” in the context of sufficiency of disclosure as well as inventive step. On 11 October 2021, a Technical Board of Appeal referred questions to the Enlarged Board of Appeal of the EPO on

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plausibility and inventive step. As we await the Board of Appeal to issue the written decision, this session will consider in what situations postpublished evidence can be considered to support the effect of the invention. 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 15:30

Networking Break 16:30

HANDSHAKE Second Medical Use:

Reconciling Infringement and Enforcement Microphone 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 Koen Bijvank, Partner, Brinkhof Advocaten

Patents that cover new uses for previously known medicines are called “second medical use patents”. This form of patent protection has drawn much attention in recent years as courts around the world continue to adjudicate the complex questions that underlie them.

Topics of discussion will include: • 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?

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17:30

Day One Concludes — Cocktail Reception Begins Part of C5 Group’s LIFE SCIENCES GLOBAL SERIES

DAY TWO 31 May 2022 8:00

HANDSHAKE Networking Breakfast 9:00

Co-Chairs’ Opening Remarks Microphone Dominic Adair, Partner, Bristows LLP Bert Oosting, Partner, Hogan Lovells 9:10

Global Strategies for Biosimilars and Innovator Biologics: From Patent Protection to Cost and Market Access Microphone Rieke Kaup, Case Handler, European Commission

Shohta Ueno, PhD, Director, Dispute Resolution, Regeneron UK Ltd Otto Licks, Partner, Licks Attorneys Peter van Schijndel, Partner, Hoyng Rokh Monegier Heli Pihlajamaa, Director, European Patent Office In 2022, the introduction of efficient regulatory pathways, the application of competition law and a novel court system in Europe will significantly impact the way in which biosimilar medicines will enter the marketplace. Further, some of the best-known biologic medicines will lose patent protection over the next five years. During this session, topics of discussion will include: • Understanding the regulatory framework and legislative developments impacting the biopharmaceutical 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: Access to Medicines, The TRIPS Agreement and Vaccines Microphone Daan de Lange, Partner, Brinkhof Advocaten

Peter Ling, Partner, Lenz & Staehelin • 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

HANDSHAKE Networking Break

Artificial Intelligence, Data and Drug Development: Accelerating Drug Discovery and Development Microphone Peter Silverman, EVP, General Counsel and Head of Utrecht, Merus N.V. Dr. Philipp Marchand, Partner, Vossius & Partner Richard Bonneau, Executive Director, Prescient Design, A Genentech Accelerator • 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 15:00

Remedies and Alternative Measures: Injunctions, Corrective Measures and Rules on Procurement of Evidence Microphone Dominic Adair, Partner, Bristows LLP

11:30

Patent Enforcement Liability Towards Third Parties: Liability and Unjust Enrichment on Retrospectively Invalid Patents Microphone Eran Bareket, Partner, Head of

Legal Practice, Gilat, Bareket & Co., Attorneys at Law Jean-Hyacinthe de Mitry, Partner, Gide Loyrette Nouel A.A.R.P.I Ruud van der Velden, Partner, Hogan Lovells

On October 14, 2020 the decision in Menzis/ AstraZeneca was issued by the District Court of The Hague. The District Court considered AstraZeneca liable for damages vis-à-vis health insurer Menzis because of AstraZeneca’s enforcement of a patent against a generic manufacturer. AstaZeneca was initially awarded an injunction which AstraZeneca enforced, but the patent was later revoked. The District Court held that AstraZeneca had been unjustifiably enriched at the expense of health insurer Menzis by enforcing the preliminary injunction based on the patent against the generic manufacturer. The District Court considered that the enforcement precluded Menzis from designating a generic quetiapine product as ‘preferred product’ under its preference policy, so that Menzis had to reimburse the price of the originator product instead of a cheaper generic product.

13:00

HANDSHAKE Networking Luncheon 6 | #PatentLitigation

14:00

Dr. Kai Rüting, Partner, Vossius & Partner Selma Ünlü, Senior Partner, NSN Law Firm Benjamin May, Partner, Aramis Société d’Avocats 16:00

Alternative Dispute Resolution: The Shift from Ordinary Proceedings Towards ADR Microphone Professor Dr. Maximilian Haedicke,

LL.M., Professor of Intellectual Property Law, Freiburg University (Former Judge at Higher Regional Court of Duesseldorf)

• 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 17:00

Conference Concludes

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WATCH OUR RECORDED WEBINAR: European Pharma & Biotech Patent Litigation Year in Review: The Top 5 Most Critical Developments from 2021 Global pharmaceutical and biotech patent law is an ever-changing battleground, and the past twenty months only amplified existing struggles for control of increasingly competitive intellectual property rights. With a historic 2021 behind us, renowned thought leaders from the European life sciences patent bar will take stock of the most important developments from the past year, and offer best practices on how to manage increasing, overlapping, and uncertain risk factors.

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HOTEL 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 Patent Litigation”.

Hotel:

Hotel NH Collection Amsterdam Barbizon Palace

Address:

Prins Hendrikkade 59-72, 1012 AD Amsterdam, Netherlands

Reservations:

+1 212 219 7607

Please note that the guest room block cut-off date is 13 May 2022. After that date OR when the room block fills, guestroom availability and rate can no longer be guaranteed.

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

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.

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The Sessions area contains the majority of the conference programming and networking events.

The 1:1 Networking is a fast-paced opportunity to meet new people and expand your professional network.

Plan to visit the Expo often.

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CHEVRON-DOUBLE-RIGHT Attend live sessions, ask questions, comment in the chat function, and take part in live polling.

Enter this area to be paired up at random with other attendees for a quick video meet-up.

Use this opportunity to explore new products and services from leading providers, and meet with new and existing partners over video chat.

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Weigh in and seize the opportunity to benchmark with industry peers in real-time.

Use the Chat feature to engage with fellow attendees, speakers and sponsors.

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for roundtable sessions, networking events and video chats for a more engaging virtual connection.

Make Connections Join scheduled “1:1 Networking” sessions. They are an interactive way to expand your network of peers.

Engage with solution providers of all kinds by visiting the “Expo” to watch videos and live demonstrations, and for face-to-face conversations.

Use the “People” tab to create new relationships and strengthen existing ones within your industry.

Planning Ahead for Live Conferences: C5’s All Secure Safety Plan We look forward to the time when we are able to welcome you back to our live conferences.

When you are ready to attend one of our conferences, you will see that a lot has changed.

Social distancing and cleaning procedures that have now become a way of life for all of us are now the standard for how we will run our conferences. Our events will continue to offer unparalleled access to market leading intelligence and to the facilitation of a global exchange of expertise and now with a greater focus on the safety, health and well-being of all our guests.

As C5 Communications and our partners begin to look forward to live events, we are committed to building and enhancing the planning and preparation with a view to offering our guests a safe place for live conference delivery.

In addition, to ensure your safety, our event staff is fully vaccinated.

All our events will adhere to official government and local authority guidance in addition to venue or locationspecific regulations. Our live events will follow the commitments below.

In-person Conference Participation Requirements For the protection and wellbeing of all event attendees, we have implemented a vaccination requirement for entry into the conference. All attendees and staff are required to provide proof of being fully vaccinated with a COVID-19 vaccine. A negative COVID-19 test result will not qualify for entry into the conference. Vaccination proof must be accompanied with a government-issued ID. In addition, as per the guidance of the CDC, we encourage all attendees to wear a mask or face covering at all times while at the conference and its social functions, except in limited settings such as during meals.

We reserve the right to deny entry to anyone not following the requirements above. Please note our entry policy is subject to change at any time based on changing local regulations.

Attendance Screening All attendees will need to assert that at the time that they first attend the conference and for the 14 days prior: y They are not experiencing COVID-19 symptoms. y Have not traveled from an area under a travel health advisory. y Have not provided care for or had close contact with any person with or reasonably suspected of having COVID-19, or with any person who traveled outside of your home country or to an area under a travel health advisory. y Have not been advised by any health authority, government agency or regulation to self-isolate due to possible exposure to COVID-19.

Link to COVID-19 symptoms: https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/ symptoms.html We are closely monitoring industry best practices and will be evaluating further additional measures pertaining to vaccinations and on-site screening based on the advice of health authorities.

Safety and Physical Distancing y Physical distancing protocols such as limiting attendance, directional signage and markers throughout the conference. y A conference room layout with planned seating for appropriate physical distancing. y We continue to work closely with our venue partners to ensure the safety of our attendees. Please check back frequently as we monitor and evolve our plan in the weeks ahead.

Enhanced Communication y Advance communication to all attendees on what to expect and prepare for at the conference: from registration to conference materials to room layout to food and beverage options and more. y Education and training for the team to ensure we provide a safe and secure conference experience. y Distribution of local health-resource information in advance of the event. y Ongoing communication and advance planning with the venue regarding enhanced cleaning and sanitizing measures, response strategies and other onsite protocols.

Increased Cleaning and Sanitation y Placement of hygiene stations throughout the conference including the registration area, meeting spaces and high frequency areas. y Availability of personal hygiene and safety products including facial coverings where available.

Reduced Touchpoints y Reduction of the physical distribution of onsite materials. y Food and beverage options that ensure minimal handling and exposure.

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