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

Gaëlle Bourout Counsel

Linklaters

Sara Burghart Lead IP Litigation Counsel Sandoz

Grant Castle Partner

Covington & Burling LLP

Dr. Sabrina Duschner VP Patent Litigation Strategy

Fresenius Kabi Deutschland GmbH

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 2nd Board of Appeal European Union Intellectual Property Office

Ian Jones Partner Gill Jennings & Every

Honorable Rian Kalden Senior Judge Court of Appeal, The Hague

Honorable Margot Kokke District Court Judge The Hague, Netherlands

Gregor König Partner

König Szynka Tilmann von Renesse

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

Director Intellectual Property Swiss Pharma International AG (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

Jiri Slavik

Senior Manager, Intellectual Property Adalvo

Rob Rodrigues Partner Licks Attorneys

Sture Rygaard Partner Plesner

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

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Media Partners

8:30 CO-CHAIRS’ OPENING REMARKS

Pharma & Biotech Patent Litigation Year in Review

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.

• After delays and detours, examining what UPC procedures will look like going forward

• How will UPC judges approach areas of law where there is inconsistency across jurisdictions?

• How will the UPC judges align on handling conundrums including preliminary injunctions, timing/urgency, evidence and the application of discretion?

12:45 Networking Luncheon

1:45 EU REGULATORY THINK TANK

SPOTLIGHT ON THE UP AND UPC PRACTICE Status Report on Unitary Patent Applications: Examining Filing Trends Three Months into The Sunrise Period

9:00

• Understanding how companies are evaluating and identifying which patents to opt-in and opt-out

• Evaluating the efficiency of the UP Case Management System

» What aspects of the system are running smoothly and what aspects are creating challenges?

• Requirements for registering an opt-out EP in a Sunrise register

• Understanding when and under what circumstances you can withdraw an opt-out

9:30

Developing Winning Patent Litigation Strategies for the Unified Patent Court

• 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

10:30

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

• 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

Weighing Risks and Rewards of Entering into the Unified

Patent

Court

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. Topics of discussion will include:

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

• 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

• 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

3:30 Afternoon Break

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

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

• 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

8:30

Co-Chairs’ Welcome Back and Recap of Day 1

9:00

Transnational Tactics for Avoiding and Defending Contributory and Induced Infringement Claims

• 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

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)

• 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

• How are brands and generics strategically using the SMW and how to best advise your clients regarding its use

5:30 Conference Adjourns

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

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.

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

• 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?

3:00 Afternoon Break

3:15

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

China

• Assessing how the recently amended patent law in China will impact global pharmaceutical companies

• Examining how the new law aims to strengthen protection for Chinese patents by establishing heightened standards with regard to:

» Double patenting

» Joint ownership

» Novelty bar

» Compulsory licensing

» Prior Art defense

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

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