Agenda
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Day 1
December 4, 2024
Registration and Breakfast
Opening Remarks from the Co-Chairs
Navigating the Perfect Storm Year: Assessing the Impact of Monumental Legal and Regulatory Developments in the Life Sciences on Intellectual Property Due Diligence
Tom IrvingPartnerThe Marbury Law Group, PLLC
Forrester LiddleHead of IP and Legal, US R&DNovo Nordisk
Looking Ahead: Surveying the Changing Life Sciences Policy Landscape and its Effect on IP Due Diligence
Chris KatopisPrincipalAssociation Counsel
IP Consultant
American Bar Association
John NappiAssistant General CounselPhRMA
Lulu WangHead of Intellectual PropertyOrna Therapeutics
Mercedes Meyer, Ph.D.AttorneyBanner Witcoff
This session will provide insights on the shifting life sciences policy landscape as an introduction to themes discussed in more detail later in the program.
- Understanding the impact of the Supreme Court’s decision in Loper Bright Enterprises v. Raimondo on regulatory agency determinations from the Food and Drug Administration (FDA), the US Patent and Trademark Office (USPTO), and Federal Trade Commission (FTC)
- Analyzing the significance of the FTC’s position on Orange Book delistings and how this may affect diligence reviews
- Assessing the impact of the government’s potential use of march-in rights on life sciences intellectual property and how this would affect IP value
- Examining the impact of the PTO’s proposed rule on Terminal Disclaimers and the request for comments on the experimental use exception
- Revisiting the Inflation Reduction Act and the challenges it presents to patent value
- Analyzing recent reforms to patent eligibility following the introduction of the Patent Eligibility Restoration Act
- Anticipating the position of the next administration on life sciences IP rights, policies, and regulations
Networking Coffee Break
The Goldilocks Cases and Intellectual Property Due Diligence: Understanding Cellect and Xencor’s Influence on Patent Portfolios
Michael P. KahnPartnerAkin Gump Strauss Hauer & Feld LLP
Erica NoreySenior Counsel, Intellectual Property for Global Business Development and M&ASanofi
Alicia A. RussoPartnerVenable LLP
Cellect and Xencor, are among the most ground shifting life sciences patent cases in the last year—if not decade. They go to the very heart of patent claims through their holdings on obviousness-type double patenting and means-plus-function claims, adding another layer of consideration to life sciences IP due diligence review. These developments create new demand for a patent portfolio that’s not too big and not too little, but juuuust right.
- Analyzing the Federal Circuit’s decisions in Cellect and Xencor, and understanding their impact on obviousness considerations in IP due diligence reviews
- Obviousness type double patenting
- Means-plus-function claims
- Breaking down the impact of the Supreme Court denying certiorari for Cellect
- Mitigating double patenting concerns to ensure a robust IP portfolio
- Flagging potential means-plus-function claims to avoid pitfalls in IP valuation review
- How Goldilocks means-plus-function claims could lead to different results in cases like Amgen, and Baxalta.
- Understanding the use of means-plus-function limitations to claim antibodies
Terminal Disclaimers and Double Patenting Analysis and Think Tank Part 1
Understanding the Proposed Rules and their Implications for Life Sciences IP Due Diligence
Mary C. TillOf CounselFinnegan, Henderson, Farabow, Garrett & Dunner, LLP
In May of 2024 the USPTO released its proposed rule on Terminal Disclaimer Practice to Obviate Nonstatutory Double Patenting, with commenting closed in July.
Under the proposed rule, in an attempt to reduce patent thickets, all tied-together patents will be limited by each of the other’s terminal disclaimer claims. The rule’s intent is promoting competition and incentivizing innovation. The FTC has offered a comment in support of the proposed rule, but IPO and AIPLA have expressed concern.
Terminal Disclaimers and Double Patenting Analysis and Think Tank Part 2
Untangling the Thicket: Working Together to Develop Strategies for Terminal Disclaimers and Double Patenting Concerns
Robert N. Sahr, PhDShareholder | BiotechnologyWolf, Greenfield & Sacks, P.C.
Marsha Rose Gillentine, PhDDirectorSterne, Kessler, Goldstein & Fox PLLC
Robin WeatherheadV.P., Intellectual Property & LegalVentus Therapeutics
Networking Lunch
Focus on Europe: Revisiting the Significance of Unitary Patents, the Unified Patent Court, and Other Developments in Key European Jurisdictions for U.S. IP Due Diligence Strategies
Thorsten BauschPartnerHoffman Eitle
James Matthew GouldOf Counsel | Intellectual Property | Life SciencesBuchanan, Ingersoll & Rooney P.C.
Hon. András KupeczLegally Qualified Judge
Central Division (Section Munich)UPC Court of First Instance
Join UPC practitioners to review the UPC´s first full year in operation.
Topics of discussion include:
- Analyzing the latest trends and statistics from the UPC
- Identifying the most important developments in the case law
- Providing hands-on feedback and tips for navigating the new system
- Understanding the strategic implications of the UPC
Networking Break
Jason DerryLife Sciences Intellectual Property CounselFormer Associate General Counsel, Intellectual Property, Synthego
Jeffrey Morton, Ph.D.PartnerHaynes and Boone, LLP
Kevin Noonan, Ph.D.Partner | Co-Chair Biotechnology and Pharmaceuticals Practice GroupMcDonell Boehnen Hulbert & Berghoff LLP
In July of 2023 the Supreme Court issued its decision in Amgen v. Sanofi, unanimously holding that several of Amgen’s patent claims were invalid for lack of enablement. A year and a half later, the lower courts and Federal Circuit have begun to rely on this decision in their own case analyses.
- Understanding how the lower courts and Federal Circuit are interpreting Amgen and how this will affect your IP due diligence review
- Determining whether the claims in your patents are narrow enough to survive while remaining broad enough to protect your IP
- Comparing US enablement and European plausibility assessments to inform patent strategy
- Developing claims both offensively and defensively
Ensuring Freedom-to-Operate in the Current IP Landscape: Defusing Landmines and Avoiding Pitfalls to Get the “All-Clear” for the Deal
Tashica Williams Amirgholizadeh, Ph.D.Senior Associate General Counsel, IP,
IP Alliance and Due Diligence (IPADD), Team LeadGilead Sciences, Inc.
Richard B. EmmonsPartnerWithersworldwide
Thomas J. Campbell, Jr.PartnerNeal, Gerber & Eisenberg LLP
Keisha Hylton-RodicManaging PrincipalHylton-Rodic Law (Washington, DC)
- Examining how new case law, as well as new legal and regulatory developments, are influencing Freedom to Operate (FTO) reviews in the life sciences
- Exploring different approaches to FTO analysis based on these developments
- Finding solutions to potential areas of infringement
- Assessing the scope of FTO potential FTO impediments to products and technologies with or without patent protection
Business Leader’s Roundtable
Life Sciences Business Development Leaders Roundtable: Investigating How Deal Makers Rely on IP Due Diligence Findings When Preparing for a Deal
Anna L. CocuzzoManaging Counsel, Patents, BostonMerck
Debbie Drazen, Ph.D., J.D.Assistant General Counsel – Patents Johnson & Johnson
William VickeryDirector of Due DiligenceServier
Hear from leading life sciences Business Development professionals on pressing IP concerns and critical patent portfolio considerations for successful life sciences deals.
Inform due diligence reviews by identifying focus-points and prioritizing value-indicators while remaining on the lookout for potential red flags. Gain key understanding on best methods to value intellectual property rights.
End of Day 1
Day 2
December 5, 2024
Registration and Breakfast
Co-Chairs Opening Remarks
Margaret Bolce Brivanlou, Ph.D.PartnerBallard Spahr LLP
Kathleen GershCo-Chair, Life SciencesLoeb & Loeb LLP
Hilary LibkaChief IP Counsel, Associate General CounselMemorial Sloan-Kettering Cancer Center
Ownership and Inventorship determinations are key to a thorough life sciences IP due diligence review, but the systems are becoming more complicated. Considering patent application process changes, the impact of the Bayh-Dole Act, and system searches, confirming ownership of rights is critical to finalization of a deal.
- Identifying ownership and inventorship concerns that are unique to the life sciences in the current IP atmosphere
- Demystifying ownership systems and developing review processes to determine proper licensing and assignment of rights
- Determining if inventors and owners are properly listed, named, and identified on patent applications and issued patents
- Addressing federal ownership questions rooted in the Bayh-Dole Act
Networking Coffee Break
The Intersection of Life Sciences and AI: Analyzing Life Sciences IP Diligence in the Age of Artificial Intelligence
Michael L. FullerPartnerKnobbe Martens
Charles KimDeputy Commissioner for PatentsUnited States Patent and Trademark Office
Jocelyn D. RamIntellectual Property CounselBroad Institute of MIT and Harvard
Following the ever-growing prevalence of AI in research and development, clinical trials, and other pre- and post-commercialization stages for life sciences inventions, understanding the impact of AI on the Life Sciences has become significantly more important to the IP due diligence process. This session will examine evolving policy and protections for your IP due diligence review.
- Evaluating existing portfolios for risks rooted in the utilization of AI in the research and development process
- Clarifying USPTO guidance on the use of AI tools by parties and practitioners
- The EU AI Act
- Determining licensing requirements and restrictions around AI generated data and AI training data
- Identifying inventorship and ownership red flags when reviewing AI generated products
- Mitigating obviousness concerns for AI generated inventions and products in patent filing and diligence reviews
Patents and Price Controls: Understanding the Continuing Impact of the Inflation Reduction Act on Life Sciences IP
Jennifer J. Chheda Ph.D.PartnerJones Day
Caitlin E. OlwellCounselAkin Gump Strauss Hauer & Feld LLP
- Revisiting the Inflation Reduction Act’s (IRA’s) impact on pharmaceutical pricing, patent value and the resulting effect on IP due diligence
- Analyzing the IP and due diligence implications of the dismissal of IRA challenges brought by AstraZeneca, Bristol Myers Squibb, and Johnson & Johnson
- Determining best practices for maximizing IP protection under this unyielding regulatory structure
- Assessing the impact on patent value determination and diligence review for drugs on the negotiation list
Networking Lunch
Rick AldridgeManaging Director, Healthcare Investment BankingLazard
JM LeeDirector, Business DevelopmentNovo Nordisk
IP Due Diligence is just one component in the swath of information taken into account during life sciences dealmaking. Hear from investment banker Rick Aldridge and Director of Business Development JM Lee as they discuss the state of life sciences deal-making today and anticipate potential shifts in the landscape.
Topics of discussion will include:
- The interaction between investment bankers and business leaders in the proliferation of new deals
- Key market concerns in life science investment
- The impact of due diligence on dealmaking
- What due diligence practitioners should consider when undertaking due diligence review
Getting Bounced: A Spotlight on the Repercussions of Orange Book Delisting on Patent Value Determination
Kurt R. KarstDirectorHyman, Phelps & McNamara, P.C
Andrew WassonPartnerHaug Partners
The FTC has focused in on Orange Book listings as a hindrance to competition from generics manufacturers for many years. Twice in the last year, the Commission has made announcements about improper Orange Book listings and its intentions to bring possible actions for delisting.
In June 2024 US District Judge Stanley Chesler of New York ordered Teva Pharmaceuticals to delist their asthma inhaler patents from the Orange Book, attracting the attention of the FTC.
Hear from our panel about the effect of the FTC’s push for delisting on patent portfolios, due diligence reviews, and deal strategies following the decision.
Networking Break
Cross Border Business: Understanding the BIOSECURE Act and Its Impact on Due Diligence and International Deal Making
Sherry M. Knowles, Esq.Owner/PrincipalKnowles Intellectual Property Strategies
Anne Elise Herold LiPartnerCrowell & Moring LLP
Jasbir Sagoo, Ph.D., J.D.Associate Vice President of Intellectual Property, LSAGAgilent Technologies, Inc.
In May 2024, the U.S. House Committee for Oversight and Accountability voted to approve the BIOSECURE Act. This bi-partisan act prohibits federal “executive agencies” from contracting with certain biotechnology companies, with a specific focus on Chinese companies, and prohibits government funding for any company that contracts with the named “compan[ies] of concern.” This Act has the potential to significantly disrupt business in the life sciences, limiting access to international manufacturers and data-providers. Understanding and anticipating these disruptions will be critical in diligence processes.
Topics of this panel will include:
- Identifying IP and other diligence concerns around utilizing Chinese manufacturers
- Understanding potential implications for current business structures
- Squaring IP rights and requirements across multiple regulatory landscapes
- Ensuring IP access and enforcement abilities when undertaking platform and product hybrid deals
Beyond Traditional Patents: Standing Out and Increasing Value by Expanding Your IP in a Shifting Policy and Regulatory Landscape
Julie Anne GillespieExecutive IP StrategistFormer Vice President, Head of Intellectual Property, BioNTech
Henry GuSVP, Head of Intellectual PropertyZentalis Pharmaceuticals
- Leveraging trade secrets and data exclusivity to strengthen your IP portfolio in anticipation of continuing shifts in life sciences IP regulation and policies in order to survive and thrive in a diligence review
- Traversing the current regulatory landscape to identify deal stumbling blocks before you reach them and prepare for potential pitfalls
- Ensuring long-term success and reducing risk through anticipatory action
- To whom is the duty of confidentiality owed in the transition period?