2022 Agenda

Pre-Conference Workshops

Workshop A — UPC Mock Trial Exercise

Sep 26, 2023 9:00am – 12:30 PM

Speakers

Peter Meyer
Partner
Simmons & Simmons

Jan van Dieck
Counsel
Bird & Bird

Dr. Christian Paul
Partner
Jones Day

Workshop B — Patent Term Extension Master Class

Sep 26, 2023 1:30pm – 05:00 PM

Speakers

Garreth Duncan
Partner
D Young & Co LLP

Dr. Graham Lewis
Partner
J A Kemp

Sebastian Moore
Partner
Herbert, Smith Freehills

Muriel Morel-Pecheux
Vice President, Synthetic Molecules Patents, Global Intellectual Property Department
Sanofi

Oswin Ridderbusch
Partner
Vossius & Partner

Takanori Abe
Managing Partner
Abe & Partners

Day 1 - Wednesday, September 27, 2023

8:45	Co-Chairs Opening Remarks
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
10:00	Evidence, Damages, and Expert Witnesses: Understanding the Nuances of the UPC Approach
11:15	Morning Coffee Break
11:45	UPC Judge Keynote Interview UPC Judicial Spotlight Interview: Critical Considerations for Practitioners in the Unified Patent Court
12:45	Networking Luncheon
1:45	Analyzing The Impact of the UPC on Life Science Patent Prosecution Strategies
2:15	Navigating the Current Drug Exclusivity Landscape: Implementing Strategies for Effective Patent Lifecycle Management Amidst New Pharmaceutical Law Reform in Europe
3:15	Afternoon Break
3:30	Avoiding the Top 10 Drafting Mistakes Impacting the Enforcement of Life Science Patents in Europe
4:30	Conference Adjourns to Day Two

Day 2 - Thursday, September 28, 2023

8:00	Registration and Continental Breakfast
8:45	Co-Chair Opening Remarks & Recap of Day 1
9:00	Focus Session on Plausibility: Applying the Latest EBA Decisions and National Jurisprudence to Your Litigation Strategy
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
11:30	Spotlight on the Bolar Exemption: What Will Proposed Changes to the Scope of the Exemption Mean for Life Science Patent Practitioners in Europe?
12:15	Networking Luncheon
1:15	Analyzing the Latest Strategies for Procuring and Enforcing Antibody Claims in Europe and the U.S.
2:00	Navigating the Unique Challenges of Patenting and Protecting Personalized Medicine
2:45	AI and Life Science Patents: Strategies for Patenting AI-Driven Innovations and Predicting the Impact of the New EU Artificial Intelligence Act on Patent Strategies in Europe
3:30	Conference Ends

Day 1 - Wednesday, September 27, 2023

8:45	Co-Chairs Opening Remarks Liz Cohen Partner Bristows Dr. Andreas von Falck Partner Hogan Lovells
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 Liz Cohen Partner Bristows Justice James Mellor High Court Judge Royal Courts of Justice, Chancery Division, UK Roberto Rodriguez Partner Licks Attorneys 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 Gustavo Hirsch Attorney at Law Daniel Law Ludvig Holm Partner Westerberg & Partners Miriam Kiefer Partner Kather Augenstein Rechtsanwälte Stefan Richter Partner Clifford Chance 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
11:45	UPC Judge Keynote Interview UPC Judicial Spotlight Interview: Critical Considerations for Practitioners in the Unified Patent Court András Kupecz Legally Qualified Judge, Central Division, Munich Section Unified Patent Court Interviewed by: Professor Willem Hoyng Partner Hoyng Rokh Monegier Chairman Advisory Committee of the UPC Member Drafting Committee of the Rules of Proceedings of the UPC
12:45	Networking Luncheon
1:45	Analyzing The Impact of the UPC on Life Science Patent Prosecution Strategies Simon Curtis Partner Potter Clarkson Peter Klusmann Partner Hoffman Eitle 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 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 the Enforcement of Life Science Patents in Europe Dr. Fabian Sokolowski Partner MAIKOWSKI & NINNEMANN Ute Feldman Partner Prinz & 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 Two

Day 2 - Thursday, September 28, 2023

8:00	Registration and Continental Breakfast
8:45	Co-Chair Opening Remarks & Recap of Day 1 Liz Cohen Partner Bristows Dr. Andreas von Falck Partner Hogan Lovells
9:00	Focus Session on Plausibility: Applying the Latest EBA Decisions and National Jurisprudence to Your Litigation Strategy Hans-Rainer Jaenichen Partner Vossius & Partner Dr. 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 Ioana Ratescu Head of Legal Regulatory, Europe Novartis Pharma Jiri Slavik Senior Manager Intellectual Property Adalvo Dr. Andreas von Falck Partner Hogan Lovells 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 Mean for Life Science Patent Practitioners in Europe? Takanori Abe Managing Partner Abe & Partners Rais Amils Arnal Partner Pérez-Llorca Markus Grammel Partner Grünecker 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. 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 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 on Patent Strategies in Europe Eileen Brandenburger Head of IP \| Patent Attorney Exscientia David Sanker Partner Morgan, Lewis & Bockius LLP 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

Workshop A — UPC Mock Trial Exercise

Sep 26, 2023 9:00am – 12:30 PM

Peter Meyer
Partner
Simmons & Simmons

Jan van Dieck
Counsel
Bird & Bird

Dr. Christian Paul
Partner
Jones Day

What is it about?

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 team of 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.

Workshops are offered in-person only.

Workshop B — Patent Term Extension Master Class

Sep 26, 2023 1:30pm – 05:00 PM

Garreth Duncan
Partner
D Young & Co LLP

Dr. Graham Lewis
Partner
J A Kemp

Sebastian Moore
Partner
Herbert, Smith Freehills

Muriel Morel-Pecheux
Vice President, Synthetic Molecules Patents, Global Intellectual Property Department
Sanofi

Oswin Ridderbusch
Partner
Vossius & Partner

Takanori Abe
Managing Partner
Abe & Partners

What is it about?

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

Workshops are offered in-person only.

8:00	Registration and Continental Breakfast
8:45	Co-Chairs’ Opening Remarks Show Co-Chairs’ opening remarks. Muriel Morel-Pecheux Vice President, Synthetic Molecules Patents, Global Intellectual Property Department Sanofi Oswin Ridderbusch Partner Vossius & Partner
9:00	Views from the European Patent Offices: Analyzing Recent Trends in SPC Case Law and How They Are Impacting SPC Approvals Show Analyzing recent trends in SPC case law and how they are impacting SPC approvals. Célia Benabou International Affairs Officer French Patent and Trademark Office (INPI) Dr. Martijn de Lange Patent Examiner Netherlands Patent Office Dr. Patrick Purcell Patent Examiner UK Intellectual Property Office Dr. Imke Salmon Patent Examiner German Patent and Trade Mark Office Romain Lorentz Patent & SPC Examiner French Patent Office (INPI) Moderator: José Manuel González European Patent Attorney MIA Patents
10:15	Developing a Practical Checklist for Preparing and Prosecuting SPC and PTE Applications in Europe, the U.S. and Beyond Show Devising a pan-European SPC prosecution strategy which takes into consideration the diverging views of national patent offices Selecting the most appropriate patents on which to base an SPC filing Devising the optimal product definition for your SPC/PTE application Tips for coordinating the filing and prosecution of SPCs/PTEs around the world UK: Understanding the post-Brexit SPC filing framework Jochen Beyermann European Patent Attorney F. Hoffmann-La Roche Michael Pears Partner, UK and European Patent Attorney Potter Clarkson Moderator: Muriel Morel-Pecheux Vice President, Synthetic Molecules Patents, Global Intellectual Property Department Sanofi
11:15	Morning Coffee Break
11:30	Unitary SPCs: Addressing Key Questions as to How, Where and When They Would Work Show 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? Oswin Ridderbusch Partner Vossius & Partner Lena Pauschenwein Directorate-General GROW – Internal Market, Industry, Entrepreneurship and SMEs European Commission
12:30	Networking Luncheon
1:30	A Discussion of Recent Case Law With Implications For the Litigation of SPC Rights in Europe Show A survey of recent CJEU decisions which are impacting scope and validity of SPC rights, A3(a), (b), (c), (d) A comparison of the national application of the case law in the panelists’ home countries Understanding how the latest case law may impact freedom to operate considerations and assessment of other parties’ SPCs (including squatter SPCs) Assessing how SPC prosecution strategy may influence a litigation strategy Dr. Johannes Freudenreich Judge German Federal Patent Court Dr. Graham Lewis Partner, European and UK Patent Attorney JA Kemp (UK) Rais Amils Arnal Partner Pérez-Llorca
2:15	Examining the Current Drug Exclusivity Landscape in Europe: Implementing the Latest Strategies for Effective Patent Lifecycle Management Show 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 Understanding how to effectively achieve market exclusivity and protection of clinical trial data to best safeguard your (or your client’s) investment Examining the recent trend of withdrawing orphan drug status to obtain a pediatric extension Exploring the latest case law on the validity of this practice and understanding the implications Xisca Borrás Partner Bristows Jonathan Roses Shareholder Wolf Greenfield & Sacks
3:00	Afternoon Break
3:15	Interpreting Findings from Recent Case Law on Drug Combination SPCs Show Understanding the latest case law on SPC eligibility of patents for combination products How are these latest SPC Referral cases interpretating Article 3(a) and 3(c) of the SPC Regulation? CJEU C-149/22: Merck Sharp & Dohme v. Clonmel Healthcare CJEU C-119/22: Teva v. Merck Sharp & Dohme Analyzing the persisting differences in the national practice and case law regarding SPCs for combination products Incorporating the latest case law into your SPC prosecution strategy Garreth Duncan Partner D Young & Co LLP Sebastian Moore Partner, Head of Intellectual Property Herbert Smith Freehill
4:00	Conference Ends