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15 Years Celebrating
C5’s Annual Forum on
PHARMA& BIOTECH PATENT LITIGATION IN EUROPE Calendar-alt map-marker-alt
23–24 February, 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
C5-Online.com/PPLitigation • +44 20 4532 2313
Part of C5 Group’s LIFE SCIENCES GLOBAL SERIES
With a historic 2021 behind us, the European Life Sciences Patent Bar will convene in-person to gain a holistic view of pharmaceutical patent trends in Europe. Join us to network, and discuss the unwritten lessons for the path forward. C5 is pleased to release the preview agenda for the 15th Anniversary Forum on Pharma & Biotech Patent Litigation in Europe. We invite you to join us inperson in Amsterdam on 23-24 February 2022 (CET) and around the globe via live stream.
Associate Sponsors:
Media Partners:
Global pharmaceutical and biotechnology patent law is an ever-changing battleground. The past twenty months 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 the only event that makes distance irrelevant and come away with the knowledge and skills you need to address post-filing 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
2 | #PatentLitigation
Dominic Adair Partner Bristows LLP
twitter: @C5Live linkedin: Life Science, Pharma & Biotech: Legal, IP, Regulatory and Compliance Professionals in Europe
C5’S 15 YEAR IMPACT AT PHARMA & BIOTECH EUROPE
1000+
330+
Attendees
60+
Speakers
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: ĉ
Head of IP
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Principal Patent Examiner
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Head of Patent Litigation
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Head of Global Strategy
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ĉ
VP-Intellectual property
ĉ
Scientific Director
Director Innovation, IP and Portfolio Management
ĉ
ĉ
R&D Patent manager
Associate VP & Director of Technology Licensing & Commercialization Patent Counsel
Head of Legal / Legal Affairs ĉ
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C5-Online.com/PPLitigation • +44 20 4532 2313
Law firm attorneys with practices in: Intellectual Property and Patent Law
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ĉ
Life Sciences
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European Patent Law
ĉ
U.S. Patent
Part of C5 Group’s LIFE SCIENCES GLOBAL SERIES
DAY ONE 23rd February 2022 (CET) 8:00
HANDSHAKE Registration &
Networking Refreshments
9:00
Co-Chairs’ Opening Remarks Dominic Adair Partner Bristows LLP Bert Oosting Partner Hogan Lovells 9:10
Preparing for the Unitary Patent and the Unified Patent Court: Thoughts on Ratification, Implementation, and Protocols for the Pharma and Biotech Industries The Unitary Patent and the Unified Patent Court have been designed to achieve a simpler, and more cost-effective means of protecting and enforcing patents in Europe. In 2022, the UP and UPC will supplement and strengthen the existing centralised European patent granting system. • Considering the costs and benefits of the system for patent applications • Understanding the territorial scope of protection • Predicting the impact to litigation and legal certainty • Detailing the non-exclusive jurisdiction for all national validations of European patents 10:00
Proven Strategies for Life Sciences Patent Enforcement: Protecting Patent Rights and Mastering Enforcement Procedures Current differences in legal systems across jurisdictions, as well as myriad strategies for enforcing IP rights must be considered to design a multi-jurisdictional plan for life sciences patent protection throughout Europe. Join us for a discussion on:
• Developing full proof plan for multijurisdictional patent protection of life sciences inventions • Comparing the timelines of proceedings across jurisdictions • Reconciling the proportionality of defenses • Predicting cross-border injunctions in the region 11:00
HANDSHAKE Networking Break 4 | #PatentLitigation
11:30
European Supplementary Protection Certificates (SPCs): Examining Current Scope, Duration, Requirements and Assessing the Viability of a Unitary SPC Parliament emphasizes the importance of SPCs, but criticises the varying procedures across jurisdictions. While the Commission explores measures to strengthen the EU SPC regime to address legal uncertainty. This session will consider the introduction of a unitary SPC, as an extension of the unitary patent. 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
• 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? 17:30
Day One Concludes — Welcome Back wine-glass-alt Cocktail Reception
DAY TWO 24th February 2022 (CET)
13:00
HANDSHAKE Networking Luncheon 14:30
Plausibility, Sufficiency, and Inventive Step: Special Considerations for Formulation and Combination Patents in the Life Sciences Arena Plausibility in the context of the inventive step and sufficiency requirements is a contentious issue. On 11 October 2021, a Technical Board of Appeal referred “plausibility” and “inventive step” questions to the Enlarged Board of Appeal of the EPO. During the pendency of this Appeal, we will consider in what situations post-published evidence can be considered to support the effect of the invention and what this means for life sciences patents in particular. 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
HANDSHAKE Networking Break 16:30
Second Medical Use Revisited: Reconciling Infringement and Enforcement • 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
8:00
HANDSHAKE Networking Breakfast 9:00
Co-Chairs’ Opening Remarks Dominic Adair Partner Bristows LLP Bert Oosting Partner Hogan Lovells 9:10
Global IP Strategies for Biosimilars and Innovator Biologics: From Patent Protection to Commercialization to Market Access Over the next five years, some of the best-known biologic medicines will lose patent protection. Meanwhile, in 2022, the introduction of efficient regulatory pathways, competition law, and a novel court system in Europe will significantly impact the way in which biosimilar medicines will enter the marketplace, thus creating a perfect storm in the biologic- biosimilar ecosystem. During this session, topics of discussion will include: • Understanding the regulatory framework and legislative developments impacting the global pharmaceutical 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?
twitter: @C5Live linkedin: Life Science, Pharma & Biotech: Legal, IP, Regulatory and Compliance Professionals in Europe
• 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: Determining Access to Medicines in the Time of the Global Pandemic
• 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 11:30
Patent Enforcement Liability Towards Third Parties: What the Life Sciences Industry Needs to Know About Findings of Unjust Enrichment Due to Invalidating Previously Valid Patents In Menzis / AstraZeneca, District Court of The Hague ruled that AstraZeneca was unjustifiably enriched at the expense of insurance company Menzis due to enforcement actions based on a patent that was later invalidated. While industry awaits the decision on appeal and prepares to see more cases like this in the future, this panel will debate the issue of liability toward third parties.
13:00
HANDSHAKE Networking Luncheon 14:00
Artificial Intelligence, Data, and Drug Development: Accelerating Drug Discovery and Development • 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 for Life Sciences Patents: New Considerations for Injunctions, Corrective Measures, and Rules on Procurement of Evidence
• Predicting whether preliminary injunctions may be more easily obtained in the future due to a recent referral to the CJEU from the Munich Regional Court for perceived overly restrictive practices for granting preliminary injunctions in patent matters • Is public interest in ensuring continued availability sufficient justification to deviate from default position of simply ordering a preliminary or final injunction? • In light of the Boards of Appeal’s decision in Amgen v. Sanofi, how great an influence is potential invalidity when it comes to a preliminary injunction application? • Assessing when may preliminary injunctions be denied, regardless if a patent is valid or infringed upon • How important is the role of an infringement assessment in preliminary proceedings? • Analyzing Article 3(2) of the IP Enforcement Directive 2004/48
16:00
Alternative Dispute Resolution for Pharma and Biotech Patent Disputes: The Shift from Ordinary Proceedings Towards ADR • 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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HOTEL ACCOMMODATIONS: Hotel:
Hotel NH Collection Amsterdam Barbizon Palace
Address:
Prins Hendrikkade 59-72, 1012 AD Amsterdam, Netherlands
Reservations:
+1 212 219 7607
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”. Please note that the guest room block cut-off date is February 7, 2022. After that date OR when the room block fills, guestroom availability and rate can no longer be guaranteed.
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C5-Online.com/PPLitigation • +44 20 4532 2313
Part of C5 Group’s LIFE SCIENCES GLOBAL SERIES
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CALENDAR-ALT Mark Your Calendars! C5’s renowned life science IP events return in-person for 2022.
May 2022
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. 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.
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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 American Conference Institute 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.
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.
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.
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.
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Reduced Touchpoints y Reduction of the physical distribution of onsite materials. y Food and beverage options that ensure minimal handling and exposure.
C5-Online.com/PPLitigation • +44 20 4532 2313
Part of C5 Group’s LIFE SCIENCES GLOBAL SERIES