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Day 1 - Monday, October 17, 2022

7:45
Registration and Continental Breakfast
8:45
Co-Chairs’ Opening Remarks
9:00
Examining the Current Status of the UP and UPC: Final Steps to Implementation and Practical Considerations for Patent Practitioners
10:00
Devising Successful Strategies for Procuring and Maintaining Patents in the New Unitary Patent Era
11:00
Morning Coffee Break
11:30
Developing Key Offensive and Defensive Patent Litigation Strategies to Bring Into the UPC
12:30
Networking Luncheon for Speakers and Delegates
1:30

Focus on Formulations. Combination Patents and Second Medical Uses

Part I — Plausibility, Sufficiency, and Inventive Step: The Latest Considerations for Substances, Formulations, Combination Patents and Second Medical Use Patents in Europe
2:30

Focus on Formulations. Combination Patents and Second Medical Uses

Part II — Global Strategy Session: Interactive Roundtable on Transnational Tactics for Claiming and Enforcing Formulation, Combination and Second Medical Use Patents
3:45
Afternoon Break
4:00
Maximizing the Chances of Success in a Bet-the-Company Pharmaceutical Litigation
5:00
Conference Adjourns to Day 2

Day 2 - Tuesday, October 18, 2022

8:00
Continental Breakfast
8:45
Co-Chairs’ Opening Remarks & Recap of Day 1
9:00
Entitlement to Priority: Incorporating the Latest EPO and National Jurisprudence into Your Patent Prosecution and Enforcement Strategies
9:45
A Tactical Tool-Kit for Antibody and Epitope Claims: The Latest Strategies for Successfully Claiming Antibody Patents and Epitopes in Europe and the U.S.
10:45
Morning Break
11:15
Key Considerations Regarding Patenting & Artificial Intelligence in Europe and Abroad
12:15
Networking Luncheon
1:30
Clinical Trial Disclosures and IP Rights – Overcoming the Obstacles to Patentability in Europe
2:15

U.S. Focus Session

What’s the Skinny on Skinny Labels in the U.S.?: What Every Life Science IP Lawyer in Europe Needs to Know
3:00
Afternoon Break
3:15
Life Sciences Litigator Think Tank: “What I Wish the Patent Prosecutor Would Have Done”
4:15
Conference Concludes

Post-Conference Workshop

Patent Terms Extension Masterclass

Oct 19, 2022 7:45am – 3:45pm

Speakers

2022 Co-Chairs

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

Oswin Ridderbusch
Partner
Vossius & Partner

Day 1 - Monday, October 17, 2022

7:45
Registration and Continental Breakfast
8:45
Co-Chairs’ Opening Remarks

Gregory Bacon
Partner
Bristows LLP

Dr. Andreas von Falck
Partner
Hogan Lovells

Co-Chairs’ opening remarks.

9:00
Examining the Current Status of the UP and UPC: Final Steps to Implementation and Practical Considerations for Patent Practitioners

Professor Willem Hoyng
Partner
Hoyng Rokh Monegier
Chairman, Advisory Committee of the UPC Member, Drafting Committee of the Rules of Proceedings of the UPC

Judge Edger F. Brinkman
Senior Judge Civil Law Division
IP Court of The Hague, The Netherlands

Preparing for the Unitary Patent and the Unified Patent Court

With Europe’s new Unitary Patent and Unified Patent Court now upon us, the time to ensure you are prepared is now. During our morning sessions, our esteemed panelists will shed light on both the risks and opportunities of the new European patent system. Tune in to understand what you should be doing now to protect your (or your client’s) business from the impact of the new patent system, and to take advantage of what it has to offer in both the procurement and litigation of your patents.

  • Status report on preparatory activities and deadlines for the start of operations, sunrise period and opt in / opt out
  • How were the judges selected?  
  • To what extent will there be training programs?
  • Should life science companies opt out, choose UP’s etc.?
  • Examining last minute changes to the Rules of Proceedings and their significance
  • Assessing the extra territorial possibilities of the UPC – Do they exist?

10:00
Devising Successful Strategies for Procuring and Maintaining Patents in the New Unitary Patent Era
Antje Brambrink

Antje Brambrink
Counsel
Finnegan

Dr. Heike Vogelsang-Wenke
Patent Attorney
Grünecker

  • Exploring patent drafting and filing considerations amidst the new UP landscape
  • Evaluating the European Patent and Unitary Patent alternatives
    • When should you apply for a patent nationally and opt out of playing in the UPC playground?
  • Re-assessing your patent prosecution strategies in light of the relative benefits and risks of applying for Unitary Patents, European Patents and National Patents
  • Reviewing your patent portfolio together with your litigation risks and strategies to identify which patents you want to opt-in and opt-out during the sunrise period
    • What are the benefits of opting out or opting in? When should you opt in / opt out?
    • Requirements for registering an opt-out EP in a Sunrise register
    • Understanding when and under what circumstances you can withdraw an opt-out
    • Considering the impact of the jurisdictional scope of the UPC and the ongoing potential for parallel proceedings in countries that are not participating in the UPC
  • Considering the potential impact of the UPC/UP on patent license agreements
    • Determining whether licensed patents should be opted out
    • Making amendments to jurisdiction and enforcement clauses that may be affected by the new UPC structure
  • Assessing the costs of obtaining and maintaining a UP vs. classic European Patent vs. national patent
    • Comparing validation costs and renewal fees and factoring that into your patent prosecution strategy

11:00
Morning Coffee Break
11:30
Developing Key Offensive and Defensive Patent Litigation Strategies to Bring Into the UPC

Domien Op de Beeck
Partner
Bird & Bird

Sarah Burghart
Lead IP Litigation Counsel
Sandoz

Dr. Andreas von Falck
Partner
Hogan Lovells

Dr. Stephan Neuhaus
Partner
Allen & Overy LLP

  • Preparing your litigation strategies for the new opportunities and challenges of the UPC
  • Understanding the interplay between opposition proceedings at the EPO and validity challenges in the UPC
  • How do you prepare to bring a lawsuit in the UPC? How do you prepare for defensive litigation if you know you’re going to be sued in the UPC?
  • Identifying preemptive strikes that can be taken when the court opens
  • Strategies for the use of preliminary injunctions, seizure of evidence and ex-parte measures
  • Understanding how the Unified Patent Court will handle bifurcation of cases, stays and speed of proceedings

12:30
Networking Luncheon for Speakers and Delegates
1:30

Focus on Formulations. Combination Patents and Second Medical Uses

Part I — Plausibility, Sufficiency, and Inventive Step: The Latest Considerations for Substances, Formulations, Combination Patents and Second Medical Use Patents in Europe

Mike Gilbert
Partner
Marks & Clerk

Dr. Corinna Sundermann
Senior Vice President
Intellectual Property Management
Business Center COO

Fresenius Kabi Deutschland GmbH

  • 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 post-published evidence?
    • Assessing the anticipated implications of this ruling on future patent prosecution strategies
  • As we await the written decision of the Board of Appeal – understanding in what situations post-published evidence can be considered to support the effect of the invention
  • Overcoming the key challenges and hurdles currently being faced in obtaining formulation, combination and second medical use patents in Europe (as related to showing plausibility, sufficiency and inventive step)
  • Incorporating the latest EPO and national case law into your strategies for procuring, maintaining and enforcing these types of patents

2:30

Focus on Formulations. Combination Patents and Second Medical Uses

Part II — Global Strategy Session: Interactive Roundtable on Transnational Tactics for Claiming and Enforcing Formulation, Combination and Second Medical Use Patents

Guido Pontremoli, Ph.D.
Global IP Head
Chiesi Farmaceutici S.p.A.

Roberto Rodriguez
Partner
Licks Attorneys

Ningling Wang
Partner
Finnegan (China)

  • Analyzing different approaches you can take to writing these claims which may yield success in the US, UK, EU, Asia, South America, etc.
  • What do you have to show in different countries in order to procure and protect formulation, combination and second medical use patents?
  • Engaging in strategic decision making regarding whether to pursue a second medical use patent – examining their value and the cost of procurement across international jurisdictions
  • What does the prosecution and litigation landscape look like internationally with regard to these types of patents?
  • Incorporating the latest international developments into your global patent prosecution and enforcement strategy

3:45
Afternoon Break
4:00
Maximizing the Chances of Success in a Bet-the-Company Pharmaceutical Litigation
Caroline Haas

Caroline Haas
Patent Attorney
Finnegan

Ha Kung Wong
Partner
Venable (U.S.)

  • Best practices for utilizing a mock trial in advance of litigation
  • Identifying the processes and criteria for selecting the absolute best expert witnesses
  • Tools for success in direct examinations and cross examinations
  • Partnering with inside counsel to make critical strategic decisions

5:00
Conference Adjourns to Day 2

Day 2 - Tuesday, October 18, 2022

8:00
Continental Breakfast
8:45
Co-Chairs’ Opening Remarks & Recap of Day 1

Gregory Bacon
Partner
Bristows LLP

Dr. Andreas von Falck
Partner
Hogan Lovells

Co-Chairs’ opening remarks and recap of Day 1.

9:00
Entitlement to Priority: Incorporating the Latest EPO and National Jurisprudence into Your Patent Prosecution and Enforcement Strategies

Maria Nichol
Head of IP
Agomab Therapeutics

Charlotte Teall
Partner, Life Sciences & Chemistry
Forresters

  • Understanding the potential consequences and pitfalls of claiming priority at the European Patent Office
  • Crafting bullet-proof strategies for avoiding invalid priority claims that could jeopardize the protection of your patent
  • Examining the recent referral before the EPO Enlarged Board of Appeal on the issue of priority entitlement (consolidated cases T 1513/17 and T 2719/19)
    • What might the potential implications of this BoA decision be on the “joint applicants” approach to claiming priority?

9:45
A Tactical Tool-Kit for Antibody and Epitope Claims: The Latest Strategies for Successfully Claiming Antibody Patents and Epitopes in Europe and the U.S.

Dr. Holger Dulat
VP, Intellectual Property
Affimed

James Velema
Partner
Lathrop GPM LLP

Dr. Jörk Zwicker
Partner
Zwicker Schnappauf & Partner Patentanwälte

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 drafting and 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 the U.S. Federal Circuit decision in Amgen v. Sanofi (Fed. Cir. 2021)
    • How has this case raised the enablement bar for antibody patents and what are the implications for practitioners?
  • Assessing the recent EPO Board of Appeal decision maintaining a functional epitope antibody genus claim (T 1964/18)
    • How will this decision impact antibody claim prosecution strategies going forward?
    • How does this outcome compare and contrast to the U.S. and its written description requirement?

10:45
Morning Break
11:15
Key Considerations Regarding Patenting & Artificial Intelligence in Europe and Abroad

Martin Herzog
Patent Attorney
Herzog IP Patentanwalts GmbH

Dr. Philipp Marchand

Dr. Philipp Marchand
European Patent Attorney
Partner

Jochen Spuck
Chief Technology Officer
EconSight

Inventions generated by AI are challenging the global patent system in a whole new way, as the key question often becomes “who” did the inventing, rather than “what” was invented. In the absence of clear laws setting out how to assess AI-generated inventions, patent registries and judges currently have to interpret and apply existing law as best they can – and this creates significant uncertainty amongst patent practitioners.

Tune in as this panel delves into topics including:

  • Exploring how AI is currently disrupting the patent strategies of life sciences companies
    • AI & patent propelled identification of “hot” fields in life science industry
    • AI application for “inventing” in a hot technical field
    • AI & patent propelled grant prediction of “inventions”
    • AI & patents
      • Legal framework
      • Case law principles relating to AI being an “inventor”: UK, US, EP, DE, AU, ZA
      • Legislative initiatives impacting this in the UK
  • Considerations and strategies for getting AI-related patents past the EPO (technical contribution, etc.)
  • How does procurement of such patents differ in Europe vs. the U.S.?
  • How might AI shift the bar on obviousness and inventive step in the future?

12:15
Networking Luncheon
1:30
Clinical Trial Disclosures and IP Rights – Overcoming the Obstacles to Patentability in Europe

Jan Carl Zillies
Partner
Dr., Pharmacist, German and European Patent Attorney

Hoffmann Eitle

  • Under what circumstances can the mere publication of the fact that a trial is ongoing be detrimental to the patentability of a corresponding patent due to lack of inventive step?
    • What is the latest EPO and national case law saying about this?
  • Understanding the risk of prior art disclosures: at what point are you disclosing a patentable finding to the public?
  • Recommendations for avoiding clinical trials becoming an obstacle to patentability in Europe
    • What steps can companies take to reduce the risk of clinical trials becoming prior art?
  • Examining the new EU Clinical Trials Regulation (EU No. 536/2014) which will increase transparency of information on clinical trials (effective 31 January, 2022): what are the implications and considerations for IP filing strategies?

2:15

U.S. Focus Session

What’s the Skinny on Skinny Labels in the U.S.?: What Every Life Science IP Lawyer in Europe Needs to Know

James M. Gould
Co-Chair of the Pharmaceutical, Biopharma and Life Sciences Industry Group and Counsel
RatnerPrestia

Sarah Hooson
Counsel, Patents
Merck

This panel will analyze GSK v. Teva – a case potentially impacting the future use of skinny label carve-outs in the U.S. Topics of discussion will include:

  • Understanding the implications of the Federal Circuit opinion affirming a jury’s finding of infringement despite Teva’s skinny label carve-outs
  • Analysis of Teva’s Petition to the Supreme Court requesting review of the Federal Circuit’s opinion
  • Evaluation of the potential risks generic companies face—in view of the Federal Circuit’s opinion— when launching with a skinny label
  • What impact will GSK v. Teva have on prosecution strategies and tactics for drafting claim language and label language?
  • Incorporating skinny labeling considerations into your patent prosecution strategy in light of GSK v. Teva
    • When to start thinking about these issues in the early stages of planning your patent protection

3:00
Afternoon Break
3:15
Life Sciences Litigator Think Tank: “What I Wish the Patent Prosecutor Would Have Done”
Matthew Jones

Matthew Jones
Partner
EIP

Kristof Roox
Partner
Crowell & Moring LLP

This unique session will feature a panel of patent litigators who will share personal accounts of challenges they have faced in litigation and reflect on what they wished the prosecutor of the patent would have done in the early stages to prevent or mitigate the issues that developed down the road. The panelists will talk through scenarios where a more favorable outcome could have been achieved in litigation had the prosecutor:

  • Changed certain language in the claim
  • Argued or negotiated something differently during prosecution
  • Built or strategized the portfolio in a different way overall

4:15
Conference Concludes

Patent Terms Extension Masterclass

Oct 19, 2022 7:45am – 3:45pm

2022 Co-Chairs

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

Oswin Ridderbusch
Partner
Vossius & Partner

What is it about?

Join leading SPC authorities as they address crucial developments impacting the application and enforcement of patent term extensions in Europe and throughout the world.

Be part of an exclusive gathering of leading in-house IP counsel, patent attorneys, representatives from multi-jurisdiction patent offices and policy authorities from around the globe who will share their insights on how to navigate the complexities of SPCs and other types of patent extensions. They will provide you with comprehensive knowledge on:

  • Devising a pan-European SPC prosecution strategy which takes into consideration the diverging views of national patent offices
  • 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
  • Assessing the latest developments in loss of exclusivity and incorporating those developments into your patent lifecycle management strategy
  • Understanding how the latest SPC referral cases are interpretating Article 3(a) and 3(c) of the SPC Regulation as related to combination drug products

Join us and take advantage of opportunities for networking and benchmarking with a “who’s who” of the life sciences SPC community.

Add the Masterclass to your registration or have a colleague attend. Savings is available for an organization that registers within one transaction for both events!

View Full Agenda
8:00
Registration and Continental Breakfast
8:45
Co-Chairs’ Opening Remarks

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

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

Emilie Rochet
Patent Examiner
French Patent and Trademark Office (INPI)

Dr. Imke Salmon
Patent Examiner
German Patent and Trade Mark Office

Moderator:

José Manuel González
European Patent Attorney
MIA Patents

10:00
Developing a Practical Checklist for Preparing and Prosecuting SPC and PTE Applications in Europe, the U.S. and Beyond
  • 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

11:00
Morning Coffee Break
11:30
Unitary SPCs: Addressing Key Questions as to How, Where and When They Would Work
  • 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

12:15
Networking Luncheon
1:15
An Overview of the Latest Case Law Impacting the Litigation of PTE/SPC Rights
  • A survey of recent court decisions which are impacting how practitioners defend and oppose PTE/SPC rights
  • Navigating case law on third-party rights, the scope and validity of other parties’ SPCs, and determining your freedom to operate in global markets
  • Developing a PTE/SPC litigation strategy that aligns with your commercial objectives

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

2:00
Examining the Current Drug Exclusivity Landscape in Europe: Implementing the Latest Strategies for Effective Patent Lifecycle Management
  • 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

2:45
Afternoon Break
3:00
Interpreting Findings from Recent Case Law on Drug Combination SPCs
  • 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

3:40
Assessing the Implications and Strategic Uses of the SPC Manufacturing Waiver
  • What is the data showing?
    • 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
  • How are brands and generics strategically using the SMW and how to best advise your clients regarding its use
4:10
Conference Ends