Agenda
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Day 1
May 29, 2024
Registration and Breakfast
Amgen v. Sanofi One Year Later: Mastering the Art of Claim Balance and Disclosure in Life Sciences Patent Prosecution
Julie Wu, Ph.D.Supervisory Patent Examiner, Immunotherapy and Recombinant AntibodiesU.S. Patent and Trademark Office
Forrester Liddle, Ph.D.Head of IP and Legal R&D (US)Novo Nordisk
Sarah HoosonCounsel, PatentsMerck Sharp & Dohme LLC
Kevin Noonan, Ph.D.Partner | Co-Chair Biotechnology and Pharmaceuticals Practice GroupMcDonnell Boehnen Hulbert & Berghoff LLP
Thomas J. KowalskiPartner | Chair of Life Sciences, Pharmaceuticals and Biotechnology DivisionsDuane 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
The APJ’s Speak on Practice, Policy, and Procedure in Patent Validity Challenges: Key Developments and Strategies for Prosecutors
Honorable Susan MitchellLead Judge, Patent Trial and Appeal BoardU.S. Patent and Trademark Office
Honorable Jacqueline BonillaDeputy Chief Administrative Patent Judge Patent Trial & Appeal Board U.S. Patent and Trademark Office
Honorable Grace ObermannAdministrative Patent Judge Patent Trial & Appeal Board U.S. Patent and Trademark Office
Kevin GeorgekPartnerWhite & 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
- Expert declarations and the Xerox case
Networking Break
Federal Circuit and PTAB Yearly Review: Fortifying Patent Prosecution Strategies with Litigation Lessons
Rachel J. ElsbyPartnerAkin Gump Strauss Hauer & Feld LLP
Erin M. DunstonPartner | Co-Chair
PTABPanitech Schwarze Belisario & Nadel LLP
Jonathan S. CaplanPartner | Co-Chair, IPKramer Levin Naftalis & Frankel LLP
Once a patent prosecutor gets deposed or litigates a patent, they will never prosecute the same way again. In this session, topics of discussion will include:
- Exploring the latest PTAB statistics in the life sciences arena, as well as any recently designated precedential decisions
- Unpacking the implications of the CRISPR decisions on prosecution and licensing strategy as well as the Jepson-format and means-plus-function claims in biotechnology (Xencor’s appeal)
- Considering patent prosecution submissions to different jurisdictions and frankly assessing when deviation in submissions goes too far and opens up the door for litigation
- What amounts to inequitable conduct?
- Lessons learned from the Federal Circuit’s recent decision in Elektra Limited v. Zap Surgical Systems (Case 2023-1985, September 21, 2023) and clarifying the record to negate potential inferences being drawn based on citation of references
- Working backwards from litigation to distill best prosecution practices in terms of terminology, claims drafting, and/or how the portfolio was built
Networking Lunch
Decoding In Re Cellect for Prosecutors: Optimizing Patent Adjustments and Overcoming Double Patenting in Global Portfolio Management
Kery A. FriesSenior Legal Advisor, Office of Deputy Commissioner for Patent PolicyU.S. Patent and Trademark Office
Joanna T. BrougherCounsel, IP LeadIndivior
Thomas J. Campbell, Jr.PartnerNeal, Gerber & Eisenberg LLP
Thomas L. IrvingSenior PartnerThe 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
Networking Break
Mastering Subject Matter Eligibility (SME) Rejections: Innovative Strategies for Navigating the Morass of SME Jurisprudence in the U.S. and Abroad
Josephine ChangLegal Advisor, Office of Patent Legal AdministrationU.S. Patent and Trademark Office
Peter F. CorlessPartnerFox Rothschild LLP
Jason N. Mock, Ph.DPartnerFoley & Lardner LLP
Nicole WoodsVice President | Assistant General Patent CounselEli Lilly and Company
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
Balancing Innovation and Data Privacy: Navigating Global Regulatory Frontiers in Digital Health and Therapeutics
Abeba HabtemariamPartnerArnold & Porter Kaye Scholer LLP
Ksenia TakhistovaChief Legal OfficerLCM Biosensor Technologies LLC
Erin GeyganSenior Privacy Counsel, Data Protection LegalJohnson & Johnson
Sara ShantiPartnerSheppard 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 regulatory landscape in the United States and the EU on
digital health:
- Compiling FDA digital health guidance
- Digital Health Policy Navigator
- Understanding the regulatory landscape for medical devices
- Unpacking the FDA’s final CDS guidance
- Understanding the FDA’s new medical device cybersecurity guidelines
- Utilizing FDA’s list of devices that incorporate AI/ML
- Appreciating the essential role drug delivery plays in personalized medicine
- Considering technological advancements that allow for more user-friendly and accurate devices: the integration of microelectromechanical systems (MEMS) and smart devices and the integration of IoT into drug delivery devices (e.g., smart pills, smart auto injectors)
- Exploring the benefits and challenges of AI/ML technologies in medical
diagnostics
- Reflecting on the gaps identified by the Center for Devices and Radiological Health’s update on its AI Program
- Considering the US Government Accountability Office’s 2022 report
- Considering the EU-AI Act, and the UK’s MHRA roadmap on software and AI as a medical device
- Getting ahead of the complex intersection of digital health technologies
and data privacy and protection
- The UK’s Information Commissioner’s Office guidance on the relationship between AI and data protection
Cocktail Reception
Conference Adjourns
Day 2
May 30, 2024
Registration and Breakfast
Securing IP Rights in AI-Driven Discoveries: From Concept to Commercialization: Overcoming Patent Challenges in the U.S. and EU
Karlheinz SkowronekSupervisory Patent Examiner in BioinformaticsU.S. Patent and Trademark Office
Jennifer BurdmanVP, Chief Counsel Technology & Therapeutics
Chief IP Officer, Deputy General CounselValo Health
Dina BlikshteynPartner | AI Practice Co ChairHaynes & 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:
- Analyzing the biopharma market’s vigor post-March 2023, focusing on
significant drug approvals and their technological underpinnings
- Distilling successful patent prosecution strategies from AI-aided drug discovery
- 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
- Addressing ethical, legal, and practical challenges of using large datasets
in AI
- Data privacy, quality, and integration
- 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
Morning Networking Break
Unified Patent Court (UPC) Strategy, From Filing to Injunctions: The Ins and Outs for Effective Decision-Making in the Unitary Patent System
Andreas von Falck, Ph.D.PartnerHogan Lovells International LLP
- Extracting filing trends and best practices from the first year of statistics
and granted unitary patents:
- What products, industries, and countries are requesting Ups the most and when are Eps being granted
- Lessons learned from the first UPC injunction hearing and comparing injunctive relief from the UPC to the U.S (e.g., 10x Genomics)
- Navigating license agreements and the right to prosecute patent
applications
- Factors to consider when agreeing a license covering a EP or EU, as licensor and licensee
- Considering which applicant to name first for a patent application with joint owners from different nationalities
- Appreciating how supplemental protection certificates (SPCs) function in
tandem with unitary patents and the UPC and assessing the advantages and
disadvantages of the European Commission’s proposed changes to SPCs
- Learning the best practices for staying on top of annuities
The Interplay of Geopolitics and Patent Law for Enhanced Portfolio Management: Navigating Global Filing and Patent Term Strategy
Roberto RodriguesPartnerLicks Attorneys
Toby Mak, PhDVice-Chair, Asian Practice CommitteeIntellectual Property Owner’s Association
Jennifer Raoul, Ph.D.Senior Counsel | Patent AttorneyBorden Ladner Gervais LLP (Canada)
Mercedes Meyer, Ph.D.PartnerBanner Witcoff 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?
Networking Lunch
The 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
Adam MossoffProfessor of LawAntonin Scalia Law School, George Mason University
Hilary J. LibkaVice President, Associate General Counsel & Chief IP CounselMemorial Sloan Kettering Cancer Center
Donna MeuthAssociate General CounselEisai
MJ EdwardsSenior Associate General Counsel
Patent Prosecution Team LeadGilead Sciences Inc.
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
bipharma therapies
- Understanding how recent policy changes reshape R&D priorities and patent prosecution strategy are
- 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
- Predicting the impact of Florida’s FDA authorization to import prescription drugs from Canada
Afternoon Networking Break
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
Sandip ArgawalaManaging DirectorBlue Owl Capital
Earl “Eb” BrightPresidentExploraMed
Matthew S. RizzoGeneral PartnerOrbiMed
Aaron KantoffCo-Founder & Managing PartnerScion Life Sciences
Michael M. ShihVice-President, Corporate DevelopmentKite Pharma
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?
Synergizing Patent and Regulatory Strategies: Enhancing Profitability and Compliance in the Life Sciences
Marcus A. ColucciSpecial CounselKramer Levin Naftalis & Frankel LLP
Erica NoreySenior Counsel, Business Development and M&ASanofi
Cynthia MartinAssistant General Counsel, PatentsGlaxoSmithKline Inc.
Yeon Jae Ko, Ph.D.CounselVenable 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
- Considering the FTC’s approach to drug listings in the orange book and
the evolution of pay-for-delay
- Exploring the intensified scrutiny and investigations; recent listing and relisting of drugs in the Orange Book
- Understanding how this is influencing the dynamics of drug patenting and market exclusivity
- Aligning prosecution strategy and clinical work with regulatory strategy,
particularly with respect to labelling
- Appreciating the lesson’s learned for skinny labels from the Federal Circuit’s December 7, 2023 case H. Lundbeck A/S et al. v. Lupin et al., (22-1194)