22nd Advanced Summit on Life Sciences Patents - DS

Perfect Your Patent Prosecution Strategies and Master the Patent Application Process in the U.S and Around the World

22 nd Advanced Summit on

LIFE SCIENCES PATENTS

May 29 – 30, 2024

Fairfield Inn & Suites Manhattan Times Square South New York, NY

Special Fireside Chat with the Unified Patent Court:

The Honorable Edger Brinkman Presiding Judge Unified Patent Court, the Hague Local Division

2024 Highlights Include:

CHEVRON-RIGHT PTAB and Federal Circuit Yearly Review of the Critical Cases Impacting Patent Prosecution

CHEVRON-RIGHT Decoding In Re Cellect to Overcome Double Patenting Challenges and Optimize Patent Terms

CHEVRON-RIGHT From Concept to Approval: IP and Regulatory Strategies for Digital Health and AI-Aided Drug Discoveries and Therapies

CHEVRON-RIGHT The Impact of Geopolitics and the Pricing Controls on Global Patent Portfolio Management and Life Sciences Investment Trends

Supporting Sponsor

Associate Sponsors

2024 Chairs

MJ Edwards Senior Associate General Counsel

Patent Prosecution Team Lead Gilead Sciences Inc.

Nicole Woods

Vice President | Assistant General Patent Counsel Eli Lilly and Company

Mercedes Meyer, Ph.D. Partner Banner Witcoff LLP

Attend and Gain Critical Insights From:

• Eisai Inc.

• Eli Lilly and Company

• Gilead Sciences Inc

• GlaxoSmithKline Inc.

• Indivior

• Kite Pharma

• LCM Biosensor Technologies LLC

• Memorial Sloan Kettering Cancer Center

• Novo Nordisk

• OrbiMed Healthcare Fund Management

• Valo Health

Conference Sponsor

This May, join the who’s who of the pharmaceutical, biotechnology and diagnostic industries, as they gather in person for ACI’s 22nd Advanced Summit on Life Science Patents

In response to the intensifying scrutiny on the interplay between patent protection and drug pricing worldwide, including U.S. price control measures like the Inflation Reduction Act, President Biden's move to enforce march-in rights, and FTC's evaluation of prosecution strategies, there's a growing knowledge gap among life sciences IP practitioners.

To bridge this gap, and to understand the real-world implications of these developments, the 2024 conference will host two focused sessions exploring the detailed effects of the political climate on patent practices and investment trends in the life sciences industry, offering crucial insights for professionals navigating these changes.

Through our sophisticated panel discussions and lectures, you will learn strategic solutions to fundamental prosecution and portfolio management matters relating to patent eligibility and claims drafting, maximizing patent terms and overcoming double patenting challenges, Unified Patent Court and global filing decision matrices, and so much more.

By bringing together the collective knowledge and practical experiences of leading in-house IP counsel, patent prosecutors, and litigators, from both sides of the Atlantic, as well as the USPTO, this event will provide you with comprehensive knowledge and benchmarking opportunities to ensure that you are leading the way in patent protection for your company and clients.

What an absolute thrill to be co-chairing ACI’S 22nd Advanced Summit on Life Sciences Patents. This conference brings together practitioners from across Life Sciences to have thoughtful discussion and debate about the issues that affect our profession. The cross-section of experience, from industry leaders, government agencies, and the judiciary creates an environment for exchange of thoughtful ideas and opinion that is truly inspiring. My co-chairs, Mercedes Meyer and Nicole Woods, and I are looking forward to learning from leading experts on mapping successful patent strategies to bring innovative treatments to patients.

MJ Edwards, Senior Associate General Counsel, Patent Prosecution Team Lead, Gilead Sciences Inc. 2024 Conference Chair

EARN CLE/ CREDITS

LEGAL ACCREDITATION

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/CLE

2024 FACULTY

2024 CONFERENCE CHAIRS

MJ Edwards

Senior Associate General Counsel Patent Prosecution Team Lead Gilead Sciences Inc.

Nicole Woods Vice President | Assistant General Patent Counsel Eli Lilly and Company

Mercedes Meyer, Ph.D. Partner Banner Witcoff LLP

GOVERNMENT SPEAKERS

Honorable Edger Brinkman

Presiding Judge Unified Patent Court, the Hague Local Division

Honorable Susan Mitchell

Lead Judge, Patent Trial and Appeal Board

U.S. Patent and Trademark Office

Sharon A. Israel

Chief Policy Officer and Director for International Affairs

U.S. Patent and Trademark Office

Honorable Jacqueline Bonilla

Deputy Chief Administrative Patent Judge, Patent Trial & Appeal Board

U.S. Patent and Trademark Office

Honorable Grace Obermann

Administrative Patent Judge Patent Trial & Appeal Board

U.S. Patent and Trademark Office

Kery A. Fries

Senior Legal Advisor, Office of Deputy Commissioner for Patent Policy

U.S. Patent and Trademark Office

Josephine Chang

Legal Advisor, Office of Patent Legal Administration

U.S. Patent and Trademark Office

Karlheinz Skowronek

Supervisory Patent Examiner in Bioinformatics

U.S. Patent and Trademark Office

Julie Wu, Ph.D.

Supervisory Patent Examiner, Immunotherapy and Recombinant Antibodies

U.S. Patent and Trademark Office

IN-HOUSE COUNSEL

Jennifer Burdman

VP, Chief Counsel, Technology & Therapeutics, Chief IP Officer, Deputy General Counsel Valo Health

Erin Geygan

Senior Privacy Counsel, Data Protection Legal Johnson & Johnson

Sarah Hooson

Counsel, Patents

Merck Sharp & Dohme LLC

Hilary J. Libka

Vice President, Associate General Counsel & Chief IP Counsel

Memorial Sloan Kettering Cancer Center

Forrester Liddle

HeadofIPandLegalforUSR&D Novo Nordisk

Toby Mak, Ph.D.

Vice-Chair, Asian Practice Committee Intellectual Property Owner’s Association

Cynthia Martin

Assistant General Counsel, Patents GSK

Donna Meuth

Associate General Counsel Eisai

Mario Riojas, Ph.D.

Patent Counsel Genentech

Michael M. Shih Vice-President, Corporate Development Kite Pharma

Ksenia Takhistova Chief Legal Officer LCM Biosensor Technologies LLC

ESTEEMED SPEAKERS

Sandip Argawala Managing Director Blue Owl Capital

Dina Blikshteyn Partner | AI Practice Co Chair Haynes & Boone LLP

Earl “Eb” Bright President ExploraMed

Thomas J. Campbell, Jr. Partner Neal, Gerber & Eisenberg LLP

Jonathan S. Caplan Partner | Co-Chair, IP Kramer Levin Naftalis & Frankel LLP

Marcus A. Colucci

Special Counsel

Kramer Levin Naftalis & Frankel LLP

Peter F. Corless Partner Fox Rothschild LLP

Erin M. Dunston

Partner

Panitch Schwarze Belisario & Nadel LLP

Rachel J. Elsby Partner

Akin Gump Strauss Hauer & Feld LLP

Andreas von Falck, Ph.D.

Partner

Hogan Lovells International LLP

Kevin Georgek Partner

White & Case LLP

Emmanuel Gougé Partner

Pinsent Masons France LLP

Abeba Habtemariam Partner

Arnold & Porter Kaye Scholer LLP

Bethan Hopewell Partner

Powell Gilbert

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

Thomas L. Irving Senior Partner

The Marbury Law Group, PLLC

Yeon Jae Ko, Ph.D. Counsel Venable LLP

Thomas J. Kowalski Partner | Chair of Life Sciences, Pharmaceuticals and Biotechnology Divisions Duane Morris LLP

Monal Mehta Managing Director, Private Investment Team Avidity Partners

Jason N. Mock, Ph.D Partner Foley & Lardner LLP

Adam Mossoff Professor of Law

Antonin Scalia Law School, George Mason University

Kevin Noonan, Ph.D. Partner | Co-Chair Biotechnology and Pharmaceuticals Practice Group McDonnell Boehnen Hulbert & Berghoff LLP

Jennifer Raoul, Ph.D. Senior Counsel | Patent Attorney Borden Ladner Gervais LLP (Canada)

Matthew S. Rizzo General Partner OrbiMed

Roberto Rodrigues Partner Licks Attorney

Sara Shanti Partner

Sheppard Mullin LLP

Mary Till Of Counsel

Finnegan, Henderson, Farabow, Garrett & Dunner, LLP

7:45am Registration and Breakfast

8:45am

Opening Remarks from the Chairs

microphone-alt MJ Edwards, Senior Associate General Counsel, IP, Gilead Sciences Inc

Nicole Woods, VP, Assistant General Patent Counsel, Eli Lilly and Company

Mercedes Meyer, Ph.D., Partner, Banner Witcoff LLP

9:00am

Amgen v. Sanofi One Year Later: Mastering the Art of Claim Balance and Disclosure in Life Sciences Patent Prosecution

microphone-alt Julie Wu, Ph.D., Supervisory Patent Examiner, Immunotherapy and Recombinant Antibodies, U.S. Patent and Trademark Office

Forrester Liddle, Head of IP and Legal for US R&D, Novo Nordisk

Sarah Hooson, Counsel, Patents, Merck

Kevin Noonan, Ph.D., Partner, McDonnell Boehnen Hulbert & Bergofff LLP

Thomas J. Kowalski, Partner | Chair of Life Sciences, Pharmaceuticals and Biotechnology Divisions, Duane Morris LLP

This landmark Supreme Court decision emphasizing the necessity of sufficient enablement in patent claims, particularly for broad, functionallydefined patents, has reshaped the landscape of patent strategy and application in the life sciences. One year after the decision, this session will highlight how the outcome impacts the approach to patent drafting. Topics of discussion will include:

• Unpacking the USPTO recently released guidance on written description and enablement

• Lessons learned from recent enablement and/or written description cases

» Evaluating the risk of providing more detailed disclosure to obtain broader claims, both towards obtaining the patent and also enforcing the patent later

• Reconsidering filing date strategy

• Addressing the heightened difficulty of complying with the Amgen ruling for antibodies

» Determining the optimal level of specification to surpass the enablement threshold and also allows for a reasonable amount of experimentation on all of what is claimed, not merely a subset.

» Assessing what type of data (e.g., in vitro, pre-clinical) and how much data is needed to surpass the thresholds

» Reconsidering the doctrine of equivalents

10:00am

The APJ’s Speak on Practice, Policy, and Procedure in Patent Validity Challenges: Key Developments and Strategies for Prosecutors

microphone-alt Honorable Jacqueline Bonilla, Deputy Chief Administrative Patent Judge, Patent Trial & Appeal Board, U.S. Patent and Trademark Office

Honorable Susan Mitchell, Lead Judge, Patent Trial and Appeal Board, U.S. Patent and Trademark Office

Honorable Grace Obermann, Administrative Patent Judge, Patent Trial & Appeal Board, U.S. Patent and Trademark Office

INTERVIEWED BY: Kevin Georgek, Partner, White & Case LLP

In this exclusive interview, the APJs will answer questions touching on:

• Fintiv and the current policy relating to discretionary denials of institution

» How the Judges consider denials (e.g., serial petitions, parallel petitions, 325(b))

» Recent Director Review decisions relevant to discretionary denials

• The new Guidance on obviousness and the new Guidance on written description and enablement, post-Amgen v. Sanofi

• The latest statistics for types of challenges brought and types of patents challenged

• Best practice tips, i.e., what judges find helpful, unhelpful, the secondary considerations

• Exper t declarations and the Xerox case

11:00am Networking Break

11:15am

Federal Circuit, District Court, and PTAB Yearly Review: Key Insights for Prosecutors and Litigators

microphone-alt Rachel J. Elsby, Partner, Akin Gump Strauss Hauer & Feld LLP

Erin Dunston, Partner | Co-Chair PTAB Practice Group, Panitch Schwarze Belisario & Nadel LLP

Jonathan S. Caplan, Partner | Co-Chair, IP, Kramer Levin Naftalis & Frankel LLP

• Considering precedential and other critical cases from the PTAB

» Analyzing the PTAB affirmation rates and other statistics

» Fleshing out the nuances of how much emphasis to place on prior art in the Information Disclosure Statement

• Reviewing key cases from the federal and district courts

» Considering best practices for Markman hearings

» Revisiting the public accessibility standard (for a printed publication to qualify as prior art) following the Federal Circuit's precedential decision in Weber, Inc. v. Provisur Technologies, Inc.

• Extrapolating key insights and best practices from these cases towards "bullet-proofing" prosecution from future litigation

12:15pm Networking Lunch 1:15pm

Decoding In Re Cellect for Prosecutors: Optimizing Patent Adjustments and Overcoming Double Patenting in Global Portfolio Management

microphone-alt MODERATED BY: Mary Till, Of Counsel, Finnegan, Henderson, Farabow, Garrett & Dunner, LLP

Kery A. Fries, Senior Legal Advisor, Office of Deputy Commissioner for Patent Policy, U.S. Patent and Trademark Office

Thomas J. Campbell, Jr., Partner, Neal, Gerber & Eisenberg LLP

Tom Irving, Partner, the Marbury Law Group, PLLC

This session will provide invaluable insights into the recent In Re Cellect case, offering a deep dive into the intricacies of patent term adjustment (PTA), patent term extension (PTE), and obviousness-type double patenting (OTDP) and equipping life sciences IP professionals with the knowledge they need to strategically manage patent portfolios in light of these critical considerations.

• Unpacking Cellect’s arguments in the en banc petition of In re Cellect, LLC, 81 F. 4th 1216 (Fed. Cir. 2023) and the USPTO’s response

• Exploring the equitable purpose of the OTDP doctrine

• Assessing the strategy of putting more eggs in the PTE basket than reliance on PTA

• Emphasizing strategies in drafting claims for first filed and subsequent continuation applications to avoid OTDP concerns

» Maintaining safe harbour of a divisional all the way through versus filing all at once and re-dividing down the line?

• Outlining measures to audit patent portfolios to safeguard against OTDP challenges

2:15pm USPTO Keynote

Sharon A. Israel Chief Policy Officer and Director for International Affairs U.S. Patent and Trademark Office

2:45pm Networking Break

3:00pm

Mastering Subject Matter Eligibility (SME) Rejections: Innovative Strategies for Navigating the Morass of SME Jurisprudence in the U.S. and Abroad

microphone-alt

MODERATED BY: Nicole Woods, Vice President | Assistant General Patent Counsel, Eli Lilly and Company

Josephine Chang, Legal Advisor, Office of Patent Legal Administration, U.S. Patent and Trademark Office

Peter F. Corless, Partner, Fox Rothschild LLP

Jason N. Mock, Ph.D, Partner, Foley & Lardner LLP

Under the Alice/Mayo and Myriad framework, life sciences IP practitioners continue to face the challenging interplay between innovation and protection, as patentable subject matter fails to match innovation within life sciences IP. Topics of discussion will include:

• Dissecting the USPTO’s Patent Subject Matter Eligibility Guidance (PEG)

» What if any deference is given by the Federal Circuit to the USPTO’s PEG

» Lessons learned from patent application allowance rates, PTAB affirmance rates, and patentability decisions from the courts, since Myriad

• Exploring recent cases on subject matter eligibility challenges, especially challenges to gene-therapy, diagnostics, and combination products

» E.g., the REGENXBIO v Sarepta cases; the Realtime Data, LLC case; CareDX Inc., cases,

• Contrasting to the legal landscape of SME in the US to the EU and Asia

• Exploring the subject matter eligibility challenges to gene-therapy related inventions (REGENXBIO v. Sarepta)

• Reviewing the possibility and likelihood of divided infringement and tailoring prosecution strategy to avoid divided infringement

I’m super excited to Co-Chair ACI’s 22nd Advanced Summit on Life Science Patents as this conference provides a forum for professionals in life sciences to learn and discuss challenges facing the life sciences industry especially on how to enhance profitability, new medicines, use of artificial intelligence (AI) with the use of medicines and appropriate REM coverage, ROI for global filing given geopolitics, life post-Amgen, and compulsory licensing in its many guises around the world. I look forward to hearing from the field leaders scheduled to present and attend this conference and I guarantee no one will go to sleep as all discussions will be passionate and engaging.

Mercedes Meyer, Partner, Banner Witcoff LLP 2024 Conference Chair

4:00pm

Balancing Innovation and Data Privacy: Navigating Regulatory Frontiers in Digital Health and Therapeutics

microphone-alt Ksenia Takhistova, Chief Legal Officer, LCM Biosensor Technologies LLC

Erin Geygan, Senior Privacy Counsel, Data Protection Legal, Johnson & Johnson

Abeba Habtemariam, Partner, Arnold & Porter Kaye Scholer LLP

Sara Shanti, Partner, Sheppard Mullin LLP

In this panel discussion, speakers will dive deep into the evolving landscape surrounding digital health data privacy, a central pillar in the journey from concept to regulatory approval for digital health technologies and digital therapies. The speakers will dissect recent global data updates that attendees cannot afford to overlook and provide strategies for navigating the complex intersection of digital health, data, and IP rights.

• Exploring the digital health and therapies regulatory landscape

» Compiling FDA digital health guidance and Digital Health Policy Navigator

• Considering the nuances of the regulatory landscape for medical devices that incorporate AI or digital technology

» Unpacking the FDA’s final Clinical Decision Support Software Guidance

» Understanding the FDA’s new medical device cybersecurity guidelines

• Appreciating the advancements in the digital health industry:

» Reviewing FDA's approved list of devices that incorporate AI/ML

» The integration of microelectromechanical systems (MEMS), smart devices and the integration of Internet of Things into drug delivery devices (e.g., smart pills, smart

• Getting ahead of the complex intersection of privacy and digital health technology or therapeutics

» E.g., compliance with federal, state, and international regulations in the collection of data

» Considering privacy laws not directly tied to health, such as the new Protecting American's Data from Foreign Adversaries Act and the changes required with respect to info blocking, info sharing, and web tracking

• Exploring the impact these regulations have on innovation within digital health industries

5:00pm Conference Adjourns

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7:30am Registration and Breakfast

8:30am

Opening Remarks from the Chairs

microphone-alt MJ Edwards, Senior Associate General Counsel, IP, Gilead Sciences Inc

Nicole Woods, VP, Assistant General Patent Counsel, Eli Lilly and Company

Mercedes Meyer, Ph.D., Partner, Banner Witcoff LLP

8:45am

Securing IP Rights in AI-Driven Discoveries: Overcoming Patent Challenges in the U.S. and EU

microphone-alt MODERATOR: Mario Riojas, Ph.D., Patent Counsel, Genentech

Karlheinz Skowronek, Supervisory Patent Examiner in Bioinformatics, U.S. Patent and Trademark Office

Jennifer Burdman, VP , Chief Counsel, Technology & Therapeutics, Chief IP Officer, Deputy General Counsel, Valo Health

Dina Blikshteyn, Partner AI Practice Co Chair, Haynes & Boone LLP

Artificial intelligence (AI) has the potential to revolutionize the drug discovery process, offering improved efficiency, accuracy, and speed. However, the successful application of AI is dependent on the availability of high-quality data, the addressing of ethical concerns, and the recognition of the limitations – operational and legal - of AI-based approaches. Topics of discussion will include:

• Preparing and prosecuting AI/ML based applications around the world:

» Considering the USPTO’s renewed exploration of the contours of inventorship law with respect to AI generated inventions

» Subject matter eligibility strategies for when the patent examiner treats the application as a software patent

» UK’s IPO guidance on patent applications for AI inventions

» Considering the FDA’s discussion paper on the use of AI/ML in the development of drug & biologic products

• Unpacking the limitations of the current AI methods in drug discovery

» The suitability of the data, and exploring the implications of data bias

» Navigating the black box model for datasets

• Best practices for electronic lab notebooks and other documentation methods towards clearly delineating the AI versus human input towards inventorship and inventorship analyses

» Considering the best approach for first to file versus first to invent, and the EPO versus the UK’s IPO

9:45am

Fireside Chat with a Unified Patent Court Judge

microphone-alt The Honorable Edger Brinkman, Judge, Unified Patent Court

INTERVIEWED BY: Professor Willem Hoyng, Chairman, Advisory Committee of the UPC, Member, Drafting Committee of the UPC, Hoyng Rokh Monegier

10:30am Morning Networking Break

10:45am

Navigating the Unified Patent Court (UPC) Landscape: Insights, Strategies, and Best Practices One Year In

microphone-alt

Andreas von Falck, Ph.D., Partner, Hogan Lovells International LLP

Bethan Hopewell, Partner, Powell Gilbert

Emmanuel Gougé, Partner, Pinsent Masons France LLP

• Learning the statistics with respect to the first year of unitary patents at the UPC

» By subject matter, industry, and geography

• Unpacking choice of venue

» Considering domestic versus national courts

» Considering the technical expertise of the judges of the respective courts

• Adopting best practices for appearing before the UPC

» What to expect at a UPC hearing

» The use of exper ts

» Working with the cultural and linguistic background of the judges

• Analyzing the first preliminary injunctions grated through the UPC

» Addressing the preservation of evidence

» Understanding protective letters and how they are used

• Appreciating the reach of the UPC on global litigation, disputes, and settlements

» Strategizing parallel proceedings and utilizing comparative timelines

11:45am

The Interplay of Geopolitics and Patent Law for Enhanced Portfolio Management: Navigating Global Filing and Patent Term Strategy

microphone-alt MODERATED BY: Mercedes Meyer, Ph.D., Partner, Banner Witcoff LLP

Rober to Rodrigues, Partner, Licks Attorney

Toby Mak, Vice Chair IPO’s Asian Practice Committee, Patent Attorney, Tee & Howe

Jennifer Raoul, Ph.D., Senior Counsel | Patent Agent, Borden Ladner Gervais LLP

In this session, leading life sciences IP attorneys will unpack the most substantial patent law reformations from around the world in recent years and will candidly discuss how geopolitical factors have influenced portfolio management. Topics of discussion will include:

• Learning the key considerations for creating harmonized applications around the world

» Knowing what to include for Europe, China, and the US

» Understanding China’s divisional practice

» Maximizing global protection while balancing fees and excess claim fees

• Considering the major changes to patent terms in the U.S., China, Canada, and supplementary protection certificates (SPCs) in the EU

• Appreciating cultural and international factors influencing patent law

» The regulation of traditional knowledge in India and Brazil

» International treaties

• Putting a price on geopolitical instability, price controls and government cadence with respect to drug patents

» Considering changes in global prosecution strategy over the past 10 years

» South America, Africa, Russia, and the Middle East – to file or not to file?

12:45pm Networking Lunch

1:45pm T HE ECONOMICS OF LIFE SCIENCES INNOVATION PART I

The

Dollars and Sense

of Drug Price Controls and Policies: Understanding the Impact on R&D, Prosecution Strategy, and Portfolio Management

microphone-alt MODERATED BY: MJ Edwards, Senior Associate General Counsel, IP, Gilead Sciences Inc

Adam Mossoff, Professor of Law, Antonin Scalia Law School, George Mason University

Hilary J. Libka, VP, Associate General Counsel & Chief IP Counsel, Memorial Sloan Kettering Cancer Center

Donna Meuth, Associate General Counsel, Eisai

This session will explore how the interplay between policy and economics affects the biopharma landscape. Panelists will detail how the latest regulatory and legislative developments are affecting biopharma R&D and commercial strategies, and what the ramifications of these developments mean for bio pharma prosecution and portfolio management. Topics of discussion include:

• An analysis of the key Inflation Reduction Act price control provisions and march in-rights under the Bayh-Dole Act that pertain to price controls of biopharma therapies

» Understanding how recent policy changes reshape R&D priorities and patent prosecution strategy

» Addressing continuations and the newly introduced fee structure for patent term extensions

• Considering Medicare drug price negotiation and the potential impact on the economic models for novel therapy development

• Exploring ownership and inventorship over therapies developed with federal funding

» Exploring the definitions of federal funding and what funding may trigger march-in rights

• Appreciating the drug pricing enforcement priorities of other agencies such as the Federal Trade Commission

» Considering the FTC's approach to listings in the Orange Book and how this may influence R&D, prosecution, and market exclusivity

3:00pm Afternoon Networking Break

3:15pm THE ECONOMICS OF LIFE SCIENCES INNOVATION PART II

Investors’ Roundtable: Understanding Investment Trends, the Value of the FTO, and the Impact of Governmental Price Controls on Life Sciences Investments

microphone-alt MODERATED BY: Michael M. Shih, Vice-President, Corporate Development, Kite Pharma

Matthew S. Rizzo, General Partner, OrbiMed Healthcare Fund Management

Sandip Argawala, Managing Director, Blue Owl Capital

Earl “Eb” Bright, President, ExploraMed

Monal Mehta, Managing Director, Private Investment Team, Avidity Partners

In this special roundtable, life sciences investors will dive deep into the current biopharma investment trends and what impact, if any, the governmental price controls have on patent and product value. Topics of discussion will include:

• Identifying areas of significant M&A activity and emerging investment opportunities in life sciences IP

» Demystifying investor risk assessment, preferences and their target areas for investment or acquisition

» How do investors value and use the freedom-to-operate analysis?

» What financial valuation methods do investors use?

» Considering strategic alliances and royalty monetization

• Examining the unique challenges faced by biotech and AI-aided companies in securing funding

» What value does the FTO create in light of increased reliance on trade secrets by the tech and AI industries?

• Appreciating how investors are considering the impact of the price control provisions on IP under Inflation Reduction Act and the potential of march-in rights under the Bayh-Dole Act in today’s deal-making.

» How are price controls, federal funding and patents linked?

• Outlining what investors wish inventors knew before coming to the table

» What do investors want to see in patents and IP strategy?

» When is the strength of the patent the bottom line and when do other factors (such as regulatory exclusivity or clinical trial results) prevail?

» How can IP counsel best present their FTO findings?

4:30pm

Synergizing Patent and Regulatory Strategies: Enhancing Profitability and Compliance in the Life Sciences

microphone-alt MODERATED BY: Erica Norey, Senior Counsel, Business Development and M&A, Sanofi

Cynthia Martin, Assistant General Counsel, Patents, GSK

Yeon Jae Ko, Ph.D., Counsel, Venable LLP

Marcus A. Colucci, Special Counsel, Kramer Levin Naftalis & Frankel LLP

This session will detail the strategic integration of patent prosecution and regulatory compliance – highlighting the benefits of collaboration between USPTO and FDA. This synergy, driven by USPTO’s duty to disclose, ensures compliance while enhancing profitability via smarter patent drafting. Topics of discussion will include:

• Appreciating the evolution of USPTO-FDA Collaboration

» Taking stock of the evolving partnership and understanding the impact on patent prosecution and regulatory approvals

» Lessons learned from duty of candour cases such as Belcher v Hospira

• Exploring the considerations and best strategies to align prosecution and regulatory strategy at specific phases:

» Early stage » Clinical

» Approval and commercial launch

» Pre-ANDA investigation and early litigation

» Expiration of regulatory exclusivity

» Litigation, IPRs and PGRs

• Considering the synergy of prosecution and regulatory from the due diligence perspective

5:30pm Conference Concludes

This year’s Summit will be an informative and engaging event. Capitalizing on the recent decisions and developments in IP, we will delve into key topics with a focus on insights for daily practice. In addition to these thought-provoking topics, I am delighted to have the opportunity to gain insights from (and network with) subject matter experts from an array of different perspectives including external and in-house counsel, USPTO personnel, and the judiciary. I look forward to this great event – Don’t miss it!

Nicole Woods, Vice President, Assistant General Patent Counsel, Eli Lilly and Company 2024 Conference Chair

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