21st Annual Global Life Sciences IP Summit - DS

Esteemed Co-Chairs:

Liz Cohen Partner

Bristows LLP

Dr. Andreas von Falck Partner

Hogan Lovells International LLP

Spotlight UPC Judicial Interview:

András Kupecz

Legally Qualified Judge

Central Division, Munich Section Unified Patent Court

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

CHEVRON-RIGHT Understand the UPC Approach for Handling Evidence, Expert Witnesses, and Damages

CHEVRON-RIGHT Compare and Contrast How Preliminary Injunctions are Managed in the UPC vs. National Courts

CHEVRON-RIGHT Strategize on Effective Patent Lifecycle Management Amidst New EU Pharma Law Reform

CHEVRON-RIGHT Avoid the Top 10 Drafting Mistakes Impacting Life Science Patent Enforcement in Europe

CHEVRON-RIGHT Apply the Latest EBA Decisions on Plausibility and Priority to Your Litigation Strategy

CHEVRON-RIGHT Comprehend the Implications of Proposed Changes to the Scope of the Bolar Exemption

CHEVRON-RIGHT Navigate the Unique Challenges of Patenting and Protecting Personalized Medicine

Associate Sponsors Conference Sponsors Media Partners

It is a new dawn for European patents.The creation of a new Unified Patent Court and a new patent with unitary effect will fundamentally change the international patent prosecution and litigation landscape for years to come. To be competitive in an already competitive market, you must be ready for these changes.

C5 invites you to Munich to attend our 21st Annual Life Sciences IP Summit at a time when the life sciences industry is on the precipice of such significant change. Our speakers from the pharma, biotech and medical device industries will provide practical insights on procuring and maintaining patents in the Unitary Patent era, as well as provide you with offensive and defensive patent litigation strategies for the new Unified Patent Court.

Our esteemed 2023 faculty will also help you strategize with effective patent lifecycle management amidst new EU Pharm Law revisions. They will also show you how to avoid the top 10 drafting mistakes which are impacting the enforcement of life science patents in Europe. Attend and learn to maneuver the new litigation battlegrounds facing today’s pharma and biotech products. Walk away with a keen understanding of how to incorporate the latest EBA decisions and national jurisprudence into your IP litigation strategy.

Be part of the premier forum for the European Life Sciences Patent Bar and obtain critical solutions you need for Europe's dynamic and evolving IP environment.

Registration is now open. We look forward to seeing you in Munich!

EARN CLE CREDITS

Accreditation will be sought in those jurisdictions requested by the registrants which have continuing education requirements. This course is identified as nontransitional for the purposes of CLE accreditation.

ACI certifies this activity has been approved for CLE credit by the New York State Continuing Legal Education Board.

ACI certifies this activity has been approved for CLE credit by the State Bar of California.

ACI has a dedicated team which processes requests for state approval. Please note that event accreditation varies by state and ACI will make every effort to process your request.

For more information on ACI’s CLE process visit: www.AmericanConference.com/Accreditation/

The Unitary Patent is Transforming the Calculus of Patenting in Europe – and the Unified Patent Court is Open for Business. Obtain the Tools you Need to Navigate Europe's New Life Sciences IP Landscape.

MEET OUR ESTEEMED SPEAKING FACULTY

CONFERENCE CO-CHAIRS

Liz Cohen Partner

Bristows LLP

Dr. Andreas von Falck Partner

Hogan Lovells International LLP

DISTINGUISHED SPEAKERS

Takanori Abe Managing Partner

Abe & Partners

Rais Amils Arnal Partner

Pérez-Llorca

Eileen Brandenburger

Head of IP | Patent Attorney Exscientia

Paul Calvo Director

Sterne, Kessler, Goldstein & Fox P.L.L.C.

Peter Corless Partner

Fox Rothschild LLP

Simon Curtis Partner

Potter Clarkson LLP

Garreth Duncan Partner

D Young & Co.

Ute Feldman Partner

Frinz & Partner

Hazel Ford Partner

Mathys & Squire

Christian Fulda Partner

Jones Day

Markus Grammel Partner

Grünecker

Gustavo Hirsch Partner

Daniel Law

Ludvig Holm Partner

Westerberg & Partners

Professor Willem Hoyng Partner, HOYNG ROKH MONEGIER Chairman, Advisory Committee of the UPC Member, Drafting Committee of the Rules of Proceedings of the UPC

Hans-Rainer Jaenichen Partner

VOSSIUS & PARTNER

Miriam Kiefer

Partner

Kather Augenstein Rechtsanwälte

Natalie Kirchhofer Partner

Cohausz-Florack

Peter Klusmann Partner

Hoffman Eitle

András Kupecz Legally Qualified Judge Central Division, Munich Section Unified Patent Court

Graham Lewis Partner

J A Kemp LLP

Justice James Mellor High Court Judge Royal Courts of Justice, Chancery Division

Peter Meyer Partner Simmons & Simmons

Sebastian Moore Partner

Herbert Smith Freehills

Muriel Morel-Pecheux

Vice President, Synthetic Molecules Patents, Global Intellectual Property Department

Sanofi

Maria Nichol

Head of IP Agomab Therapeutics

Dr. Christian Paul Partner

Jones Day

Ioana Ratescu

Head of Legal Regulatory, Europe Novartis Pharma

Oswin Ridderbusch Partner VOSSIUS & PARTNER

Stefan Richter Partner

Clifford Chance

Roberto Rodriguez Partner Licks Attorneys

David Sanker Partner

Morgan, Lewis & Bockius LLP

Hiroshi Sheraton Partner

Baker & McKenzie LLP

Jiri Slavik

Senior Manager Intellectual Property Adalvo

Dr. Fabian Sokolowski Partner

MAIKOWSKI & NINNEMANN

Charlotte Teall Partner, Life Sciences & Chemistry Forresters

Rebecca Tollervey

Partner, Patent Attorney

MEWBURN ELLIS

Jan van Dieck Partner

Bird & Bird

Good meeting; I enjoyed it a lot, including both the talks and the social side. Andrew Bentham, Patent Attorney, JA Kemp

PRE-CONFERENCE WORKSHOP A

Tuesday, 26 September, 2023

9:00 – 12:30

UPC Mock Trial Exercise

microphone-alt Peter Meyer, Partner, Simmons & Simmons

Jan van Dieck, Partner, Bird & Bird

Dr. Christian Paul, Partner, Jones Day

With the doors of the UPC finally opened, patent practitioners must ensure they are prepared for the distinctive nuances of UPC proceedings. Through this carefully crafted UPC Mock Trial exercise, attendees will be able to observe and participate in a dress rehearsal which demonstrates the tactical and strategic considerations required for practicing within the new system.

Our mock trial, led by a UPC qualified judge, a UPC technical judge, and two experienced patent litigators, will exhibit how to prepare for and tackle UPC proceedings, while also displaying how the UPC will treat legal areas such as jurisdiction, plausibility, indirect infringement, doctrine of equivalents, remedies, damages and more.

PRE-CONFERENCE WORKSHOP B

Tuesday, 26 September, 2023

1:30 – 5:00

Patent Term Extension Master Class

microphone-alt Muriel Morel-Pecheux, Vice President, Synthetic Molecules

Patents, Global Intellectual Property Department, Sanofi

Oswin Ridderbusch, Partner, VOSSIUS & PARTNER

Graham Lewis, Partner, J A Kemp

Sebastian Moore, Partner, Herbert Smith Freehills

Garreth Duncan, Partner, D Young & Co.

Takanori Abe, Managing Partner, Abe & Partners

Maximizing your patent lifecycle is essential to maximizing your profit. And in today’s highly competitive life science patent landscape – every day counts. Being equipped with the latest strategies for prosecuting SPCs, litigating Patent Term Extension rights and effectively utilizing available exclusivities is paramount to the success of your patent portfolio and company.

Join this in-depth workshop and gain strategic solutions to tackle your greatest patent extension challenges and insights on how to prepare for the potential sweeping changes that a Unitary SPC could bring to the industry.

Topics of discussion will include:

• Analyzing recent trends in SPC case law and how they are impacting SPC approvals

• Developing a practical checklist for preparing and prosecuting SPC and PTE applications in Europe, the U.S. and beyond

• Unitary SPCs: Addressing key questions as to how, where and when they would work

• A discussion of recent case law with implications for the litigation of SPC rights in Europe

About us:

C5 celebrates 40 years of excellence! We are thrilled to have provided exceptional conference experiences globally with our outstanding team, speakers, sponsors, partners, and attendees. To mark this milestone, we’re launching a new logo which represents our commitment to innovation, growth, and excellence, represented by the five Cs of C5: Current, Connected, Customer-Centric, Conscientious, and Committed

Looking back on 40 years, we are grateful for our achievements—hosting global conferences, uniting industry leaders, and supporting business growth. However, we are not done yet! We are committed to pushing boundaries and creating impactful experiences and we’re excited for the next 40 years of success.

Main Conference Day 1

Wednesday, 27 September, 2023

8:45

Co-Chairs' Opening Remarks

microphone-alt Dr. Andreas von Falck, Partner, Hogan Lovells

Liz Cohen, Partner, Bristows LLP (UK)

9:00

Preliminary Injunctions: Comparing and Contrasting How Injunctions are Being Handled in the UPC vs. National Courts and Key Considerations When Selecting a Forum

microphone-alt Justice James Mellor, High Court Judge, Royal Courts of Justice, Chancery Division, UK

Liz Cohen, Partner, Bristows LLP (UK)

Roberto Rodriguez, Partner, Licks Attorneys (Brazil)

• Examining the nuances of how the UPC is dealing with injunctions

• Comparing and contrasting how preliminary injunctions are being handled in the UPC vs. national courts, including the UK courts

» What are the requirements and tests involved in obtaining a PI in both forums?

» How are proportionality factors applied in injunction decisions in both forums?

• Exploring key preliminary injunction considerations that pharma and biotech companies should take into account when selecting a forum for their litigation

10:00

Evidence, Damages, and Expert Witnesses: Understanding the Nuances of the UPC Approach

microphone-alt Stefan Richter, Partner, Clifford Chance (Germany)

Miriam Kiefer, Partner, Kather Augenstein Rechtsanwälte (Germany)

Gustavo Hirsch, Partner, Daniel Law (Brazil)

Ludvig Holm, Partner, Westerberg & Partners (Sweden)

• Understanding what means of evidence, and what means of obtaining evidence, are admissible before the UPC

• Taking a look at how the UPC is dealing with experts and witnesses

» How does the UPC approach differ from other key non-UPC member jurisdictions?

• Analyzing the damages principles that will apply when the UPC determines damages for patent infringement

» Navigating damages proceedings in the UPC

» What will the UPC take into account when determining and calculating damages?

» Assessing damages limitations in the UPC

• A comparative analysis of UPC vs. UK vs. U.S. – key distinctions in the handling of evidence, damages and witnesses that practitioners need to know

11:15 Morning Coffee Break

Another great C5 conference. Good variety of attendees and topics.

Robin Ellis, Head of IP Product, Sandoz

11:45

UPC Judge Keynote Interview: Critical Considerations for Practitioners in the Unified Patent Court

microphone-alt András Kupecz, Legally Qualified Judge, Central Division, Munich Section, Unified Patent Court

INTERVIEWED BY:

Willem Hoyng, Partner, HOYNG ROKH MONEGIER

12:45 Networking Luncheon

1:45

Analyzing The Impact of the UPC on Life Sciences Patent Prosecution Strategies

microphone-alt Peter Klusmann, Partner, Hoffman Eitle

Simon Curtis, Partner, Potter Clarkson LLP

• Understanding what patent attorneys should be thinking about when drafting and filing patents that will to be enforced in the UPC

• Lessons on claim drafting that patent prosecutors can take from the latest UPC patent litigation trends

• Assessing how the UPC is impacting patent licensing agreements

• Examining how the UPC approach to revocation actions is impacting patent oppositions and other elements of patent prosecution

2:15

Navigating the Current Drug Exclusivity Landscape: Implementing Strategies for Effective Patent Lifecycle Management Amidst New Pharmaceutical Law Reform in Europe

microphone-alt Christian Fulda, Partner, Jones Day

Hiroshi Sheraton, Partner, Baker & McKenzie LLP

• Assessing the latest developments in loss of exclusivity and incorporating those developments into your patent lifecycle management strategy

» Strategies for managing data exclusivity, market protection, orphan drug exclusivity, pediatric extensions/pediatric rewards

• Analyzing how the new Pharma Law revisions by the European Commission will impact regulatory exclusivity protections available to innovator pharmaceutical companies operating in the EU

• Understanding how to effectively achieve market exclusivity and protection of clinical trial data to best safeguard your (or your client’s) investment

3:15 Afternoon Break

3:30

Avoiding the Top 10 Drafting Mistakes Impacting Life Science Patent Enforcement in in Europe

microphone-alt Dr. Fabian Sokolowski, Partner, MAIKOWSKI & NINNEMANN

Ute Feldman, Partner, Frinz & Partner

This interactive session will test your patent drafting savvy through a series of hypothetical scenarios which highlight common patent drafting mistakes. Through live polling, discover how your approach to patent drafting compares to your colleagues and competitors. Benefit from a practical discussion of the polling results and walk away with patent drafting strategies that will ensure longstanding protection and enforceability of your IP.

4:30

Conference Adjourns to Day 2

Main Conference Day 2

Thursday, 28 September, 2023

8:00 Registration and Continental Breakfast

8:45

Co-Chairs' Opening Remarks & Recap of Day 1

9:00

Focus Session on Plausibility: Applying the Latest EBA Decisions and National Jurisprudence to Your Litigation Strategy

microphone-alt Hans-Rainer Jaenichen, Partner, VOSSIUS & PARTNER

Natalie Kirchhofer, Partner, Cohausz-Florack

• Analyzing the implications of the long awaited EBA plausibility decision allowing post filed data to prove technical effect

» Understanding how this ruling should be applied in your patent prosecution and litigation strategies

» How can this case be relied upon to get existing patents revoked based on plausibility?

10:00 Morning Coffee Break

10:30

Examining the Implications of EU Regulatory Reformation: Analyzing the Latest Pharma Law Revisions and the EC’s New Proposed Regulation on Compulsory Licensing of Patents

microphone-alt Andreas von Falk, Partner, Hogan Lovells

Jiri Slavik, Senior Manager Intellectual Property, Adalvo

Ioana Ratescu, Head of Legal Regulatory, Europe, Novartis Pharma

• Understanding the impact of the EU’s New Pharma Legislation reforms on:

» Incentives for research and innovation for orphan and paediatric drugs

» The regulatory regime for generics and biosimilars

» Rules on repurposing

» Restrictions on comparative advertising

» Unitary SPCs

• Analyzing key takeaways of the European Commission’s Proposed Compulsory Licensing Regulation

» Understanding what the implications will be for pharmaceutical and biotech companies

» Anticipating next steps and challenges for practitioners

11:30

Spotlight on the Bolar Exemption: What Will Proposed Changes to the Scope of the Exemption Will Mean for Life Science Patent Practitioners in Europe

microphone-alt Markus Grammel, Partner, Grünecker

Rais Amils Arnal, Partner, Pérez-Llorca

Takanori Abe, Managing Partner, Abe & Partners

• An overview of how the Bolar Exemption has been interpreted and applied across different jurisdictions in Europe

» Understanding how to navigate the particularities of the Bolar provisions in key jurisdictions

• Analyzing the proposed changes to the bolar exemption in the new EU Pharma Package

» How does the new law broaden the scope of the exemption and what will the implications be for patent practitioners?

12:15 Networking Luncheon

1:15

Analyzing the Latest Strategies for Procuring and Enforcing Antibody Claims in Europe and the U.S.

microphone-alt Hazel Ford, Partner, Mathys & Squire

Rebecca Tollervey, Partner, Patent Attorney, MEWBURN ELLIS

• Identifying sound solutions for successfully patenting antibodies amidst developing case law in Europe and the U.S.

• Tactical tools for global commercialization

» Drafting claims to secure protection across different jurisdictions

• Understanding different patent office interpretations of antibody claims

• Examining principals of the EPO Boards on assessing inventive step and sufficiency of antibody claims

2:00

Navigating the Unique Challenges of Patenting and Protecting Personalized Medicine

microphone-alt Paul Calvo, Director, Sterne, Kessler, Goldstein & Fox P.L.L.C

Peter Corless, Partner, Fox Rothschild LLP

While precision medicine is expanding and transforming treatment opportunities for patients, it comes with a number of intellectual property challenges that must be overcome to ensure that the inherent technologies can continue to evolve. This panel will analyze the host of IP hurdles faced by claimants of personalized medicine patents and strategies for overcoming them. Topics of discussion include:

• Understanding the unique challenges of asserting IP of personalized medicine

• Best practices for tackling IP hurdles of precision medicine, including subject matter eligibility, proving infringement and software licensing

2:45

AI and Life Science Patents: Strategies for Patenting AI-Driven Innovations and Predicting the Impact of the New EU Artificial Intelligence Act

microphone-alt David Sanker, Partner, Morgan, Lewis & Bockius LLP

Eileen Brandenburger, Head of IP | Patent Attorney, Exscientia

• Assessing the latest ways that AI is being used in drug development

• Analyzing how patent registries and courts are interpreting the existing law in Europe and the U.S. regarding patenting and protecting AI-driven innovations

• Understanding how companies are navigating patenting challenges surrounding:

» Eligibility disputes surrounding unpatentable subject matter

» Satisfaction of the written description and enablement requirements

» Issues of inventorship and conception

• Examining the EU Artificial Intelligence Act which is expected to come into force near the end of 2023

» What will the implications be on AI patenting?

» How will provisions of the new Act potentially open up a growing area of infringement litigation in the life sciences space?

3:30 Conference Ends

Again, very good speakers from all over Europe and the US.

Chrisoph Rehfuss, Head of IP, Sotio

From Patents to Regulatory Challenges: C5's Life Sciences IP Events Empower Industry Leaders with Essential Knowledge!

September 20 – 21, 2023 Boston, MA

October 10–26, 2023 Virtual

October 24–25, 2023 Chicago, IL

November 28 – 29, 2023

Boston, MA

March 19 – 20, 2024

Boston, MA

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April 17–18, 2024

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

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CONFERENCE CODE: 636L24-MUN

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