2024 Agenda
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Day 1
April 25, 2024
Breakfast and Registration
Hon. Pauline NewmanCircuit JudgeU.S. Court of Appeals for the Federal Circuit
Hon. Randall R. Rader (ret.)Former Chief Judge U.S. Court of Appeals for the Federal Circuit
Andrei IancuPartnerSullivan & Cromwell LLP(Former Director of the USPTO)
ACI is honored to have this panel of distinguished jurists who were actively involved in Paragraph IV cases from the start to provide a retrospective look at the Hatch-Waxman Act. Join us as these legends detail the law’s original intents, pivotal milestones, and future trajectories. They will outline how this landmark legislation has shaped the pharmaceutical industry and patent litigation for brands and generics.
Gerald J. Flattman Jr.PartnerCahill Gordon & Reindel LLP
Chad LandmonPartnerAxinn, Veltrop & Harkrider LLP
Ashley RossPartnerKirkland & Ellis LLP
Dan TroyManaging DirectorBerkeley Research Group
Emer SimicPartnerNeal, Gerber & Eisenberg LLP
Join us for a look back at the past year’s most important developments impacting small molecule drugs, including groundbreaking court decisions, pivotal regulatory and policy changes, and major industry shifts.
Session leaders will offer insights how these developments are changing the practice of Hatch-Waxman Litigation. Topics of discussion will include:
- The Biden Administration’s new stance on drug pricing and march-in rights
- Analyzing recent actions to control prescription drug prices in the U.S., including the potential impact of using march-in rights under the Bayh-Dole Act
- FTC’s approach to drug listings in the orange book and the evolution of pay-for-delay
- Exploring the intensified scrutiny and investigations
- Examining recent listing and relisting of drugs in the Orange Book
- Understanding how this is influencing the dynamics of drug patenting and market exclusivity
- The evolution of USPTO-FDA Collaboration
- Taking stock of the evolving partnership and understanding the impact on patent prosecution and regulatory approvals
- §101 legislation and the impact on patent eligibility
- Assessing the latest legislative proposals regarding §101, focusing on the potential effects on the patentability of small molecules
- Global policy shifts
- Understanding the implications of the new TRIPS waiver and the WIPO’s disclosure proposals on international pharmaceutical patent protection and licensing
- Implications of GSK v. Teva on section viii carve-outs for small molecules
- Examining the current landscape for small molecule patent strategies and litigation
Morning Break
The Economics of Pharmaceutical Patents in 2024: Understanding How the Next Ledge of the Patent Cliff Will Reshape PIV Strategy
Alex BrillSenior FellowAmerican Enterprise Institute
John Christopher “J.C.” RozendaalDirectorSterne Kessler
Eric Alan StonePartnerGroombridge Wu Baughman & Stone
Brian MalkinAssociate General CounselTeva Pharmaceuticals
By 2026, nearly 400 small molecule drugs – including at least a half dozen of blockbuster status and blockbuster revenue are set to go off patent. This panel will explore the seismic economic implications of this latest patent cliff statistic as well as its effects on Hatch-Waxman litigation. Join us as we examine the current challenges and opportunities relative to the complexities of the looming patent cliff, pipeline replenishment, and the strategies brands and generics are employing to navigate these challenges. Points of discussion will include:
- It’s not 1984 anymore…
- Understanding why this latest patent cliff is different than others
- The economic impact of the patent cliff
- Potential revenue loss and market share shifts
- Strategies for scaling today’s patent cliff
- Extending patent life, managing patent portfolios, and navigating legal challenges in a competitive market
- Assessing the impact of the cliff on Paragraph IV practice: to sue or not to sue?
- The role of AI, automation, and digital transformation in creating new opportunities considering patent cliff challenges
- Understanding the influence of new and evolving regulation on pharma patenting strategies and the broader implications for access and pricing
- Predicting long-term shifts in pharma IP management based on cliff dynamics
- The evolving landscape of pharmaceutical innovation: recent trends and breakthroughs in research, advancements in obesity treatment and discoveries in Alzherimer’s disease
The Inflation Reduction Act’s Transformative Impact: Pharmaceutical Patent Dynamics, Drug Valuation and Pricing, ANDA Litigation and Settlements
David KornVP, IP and LawPhRMA
Jason LeonardPartnerMcDermott Will & Emery
Adam PerlmanPartnerLatham & Watkins LLP
Steven MaslowskiPartnerAkin Gump Strauss Hauer & Feld LLP
The IRA has far-reaching effects on big pharma. This session will detail the ripple effect of drug pricing reforms patent portfolio management, life cycle management and litigation
- Evaluating the potential impact of the IRA on pharmaceutical patent litigation
- Examining possible patent perils during IRA price negotiation
- What happens when a patent holder’s product is selected for negotiation before or during litigation?
- What is the impact on recoverable damages in an at-risk launch scenario?
- Assessing the impact on coordination and discovery
- Exploring how the IRA can encourage settlement of infringement litigation
- Practical strategies for safeguarding IP value when your drug is selected for negotiation
Networking Luncheon Sponsored by:
§112 Before the Supreme Court and Federal Circuit: Navigating Genus Claims and MPF Strategies Post Amgen and Xencor
Matthew J. BeckerPartnerAxinn, Veltrop & Harkrider LLP
Ryan HagglundPartnerLoeb & Loeb LLP
Colleen Tracy JamesPartnerCahill Gordon & Reindel LLP
Aaron PereiraSenior Director of PatentsFerring Pharmaceuticals
This session will outline the evolving landscape of §112 in Hatch-Waxman litigation, illustrated by the Supreme Court’s decision in Amgen v. Sanofi, and the Federal Circuit’s pending decision in In re: Xencor.
Session leaders will detail how these cases are shaping the future of patent drafting and Paragraph IV litigation strategies, particularly broad genus claims and mean-plus-function claims in.- Analyzing the impact of the Supreme Court’s decision in Amgen on the enablement requirement for broad genus claims and the resulting impact to patent portfolios
- Discussing potential outcomes of the Xencor case and how it could reshape the use and viability of MPF claims on antibody patents
- Exploring best practices in claim drafting relative to Amgen and Xencor
- Broad protection v. sufficient disclosure
- Assessing how these cases influence Hatch-Waxman strategies, especially for ANDA filers
Afternoon Break
Break Out 1
Track 1 – The Business of PIV Disputes
Communicating Value and Collaboration Between Corporate Legal and Outside Counsel
Donna MeuthAssociate General Counsel, IPEisai
Melanie R. RupertPartner, Global Co-Chair of Talent DevelopmentPaul Hastings LLP
David M. KnappAttorneyLocke Lord LLP
This session will enhance the synergy between in-house legal teams and their law firm counterparts. Session leaders will explore effective communication strategies, share best practices for aligning business goals, and provide you with actionable insights into building stronger partnerships, managing expectations, and fostering a collaborative environment that supports the unique legal needs of Hatch-Waxman practitioners.
Track 2 – The Practice of PIV Disputes
AI in Pharma: Transforming Life Sciences IP and Reshaping the Hatch Waxman Litigation Landscape
Erin J.D. AustinPartnerVenable LLP
Rama G. ElluruSenior DirectorSpecial Competitive Studies Project – SCSP
- Detailing the impact of AI on life sciences IP and Hatch-Waxman litigation
- Discovering how AI is revolutionizing drug discovery and development
- Understanding new challenges and opportunities for IP protection and litigation under Hatch-Waxman
- Predicting AI’s role in patentability matters, data protection, and its influence on future litigation
Stephanie DonahueHead of Global Patent Litigation
Global Intellectual Property Department
Legal, Ethics & Business IntegritySanofi
Colin HeitzmannVice President, IP and Business DevelopmentDaiichi Sankyo, Inc.
Neema KumarVice President, IP, North AmericaSandoz
Mary MorryCounsel, IP LitigationMerck & Company
Lars P. TaavolaVP, Chief IP Counsel & General Counsel, Specialty GenericsMallinckrodt Pharmaceuticals
Serena Farquharson TorresExecutive Director, Assistant General CounselBristol Myers Squibb
Contact Joe Gallagher to reserve your spot at this rare opportunity.
Email: [email protected]
Limited to 25 in-house attendees, this unique, interactive discussion will provide an exclusive and intimate networking and benchmarking opportunity that will shed light on the expectations of in-house counsel from their law firm partners.
It is also a vehicle for other in-house counsel to benchmark their current “3C’s” strategies with those of the Advisory Board.
- “Cost”, will offer insights on the monitoring of legal spend and balancing a budget
- “Competency”, will provide best practices for overcoming talent limitations with demonstrable advice
- “Communication”, will engage attendees in the art of communicating value and fostering collaboration between corporate legal counsel and outside
Break Out 2
Gloria FuentesVice President & Assistant General CounselBristol Myers Squibb
Colman RaganVice President & General Counsel, North America IPTeva Pharmaceuticals
Jennifer NockPartnerRothwell Figg
This session will provide you with effective strategies for managing and maximizing the value of your patent portfolio. Session leaders will provide insights into winning techniques for strategic patent management. Whether navigating patent lifecycles or exploring innovative expansion to your portfolio, you will be empowered with the tools required for successful portfolio optimization.
Track 2 – The Practice of PIV Disputes
Litigation Funding and Transparency in Hatch-Waxman Litigation
Lauren RabinovicPrincipalGLS capital
Amy Lange MillerAttorneyLocke Lord LLP
This session will explore the evolving landscape of litigation funding and alternative fee arrangements in Hatch-Waxman litigation, especially considering recent judicial scrutiny on hidden funding sources. Session leaders will discuss how these developments impact Hatch-Waxman litigation strategies and the importance of transparency in funding arrangements.
Refreshment Break and 20/40 Toast
Honorable Stanley R. CheslerDistrict JudgeUnited States District Court, District of New Jersey
Honorable Tonianne J. BongiovanniMagistrate JudgeUnited States District Court, District of New Jersey
Hon. Sherry R. FallonMagistrate JudgeUnited States District Court, District of Delaware
Anne Shea GazaPartnerYoung Conaway Stargatt & Taylor, LLP
District Court Judges are at the forefront of shaping the landscape of pharmaceutical IP law. During this can’t-miss roundtable, distinguished District Court Judges will share their unique perspectives, illuminating the delicate balance between patent holders, generic drug manufacturers, and public interest.
Cocktail Reception
Sponsored by
Day 2
April 26, 2024
Neema KumarVice President, IP, North AmericaSandoz
Kathryn JonesVP, Chief Counsel IPNovo Nordisk
Vishal C. GuptaPartnerSteptoe LLP
Gregory A. MorrisPartnerO'Melveny & Myers LLP
Leading Chief IP counsel from brands and generics will share insights and strategies for navigating the complexities of pharmaceutical intellectual property. Topics of discussion will include:
Brand Perspectives
- Appreciating the importance of patents for innovation
- Understanding the keys to growing a strong portfolio
- Orange Book listing strategies
- Gauging when to expect a Paragraph IV lawsuit
Generic Perspectives
- Determining which patents are ripe to challenge in today’s environment
- What makes one patent more attractive than another?
- Evaluating invalidity and non-infringement for the patent target
- Formulating your ANDA strategy
Considerations for Both Sides
- Deciding when to refer to outside counsel and detailing which matters typically remain in-house
- Taking stock of significantly challenging situations and predicting the challenges in-house lawyers will face in the future
Morning Break
Break Out 1
Track 1 – The Business of PIV Disputes
GLOBAL IP Risks: Effectively Managing an International Pharmaceutical IP Litigation Strategy
Andrea TiglioExecutive Director
Assistant General Counsel, IPJazz Pharmaceuticals
Kevin ZiveVice President, Global General Counsel,
Head of IPApotex Inc.
Deepro R. MukerjeePartnerKatten Muchin Rosenman LLP
This session will equip you with the tools and knowledge needed to navigate the complex landscape of international IP litigation in the Hatch-Waxman context. Session leaders will share strategies for managing cross-border IP risks, key considerations for global litigation, and aligning your global strategy with business objectives.
Track 2 – The Practice of PIV Disputes
Best Practices for Utilizing FDA’s Citizen Petition Process: Brand and Generic Recommendations for Achieving Market Access and Petitions for Reconsideration
Maarika L. KimbrellPartnerMorgan, Lewis & Bockius LLP
Brian McCormickVice President, Chief Regulatory CounselTeva Pharmaceuticals
Rob BerlinHead – US. Regulatory Policy GSK
This session, designed for both brands and generics, will provide proven strategies to navigate market access challenges. Session leaders will share insights on leveraging citizen petitions for market entry and addressing petitions for reconsideration, while offering practical recommendations to fortify your regulatory strategies.
Break Out 2
Raj GandeshaPartnerWhite & Case LLP
Nicholas MitrokostasPartnerAllen & Overy LLP
Focused on the intersection of pharma IP law and FDA regulations, session leaders will address how to balance patent protection strategies with regulatory compliance.
Douglas H. CarstenPartnerMcDermott Will & Emery
Ivan PoullaosPartnerWinston & Strawn LLP
With an increasing number of Hatch-Waxman disputes being decided by juries, it is crucial for practitioners to master the nuances of presenting complex scientific and legal arguments in a jury-friendly manner. Best practices training is essential for attorneys to effectively communicate the intricacies of pharmaceutical patent cases to a lay audience, ensuring the right balance between technical accuracy and persuasive storytelling.
Brand and Generic Insights on FDA Programs Impacting Pharmaceutical Patents: Regulatory Initiatives and Recent FDA Litigation Every PIV Practitioner Needs to Know About
Mary Alice HiattDivision Director, Division of Legal and Regulatory Support Office of Generic Drug Policy U.S. Food and Drug Administration
Kurt R. KarstDirectorHyman, Phelps & McNamara PC
Maryll W. ToufanianSenior Vice President, Regulatory Strategy and Government AffairsAmneal Pharmaceuticals
For Hatch-Waxman litigators, staying up to date with new FDA regulations impacting Orange Book listed patents is crucial. By monitoring these developments, Hatch-Waxman litigators can adapt their strategies, assess the potential impact on patent validity and infringement disputes, and navigate the evolving landscape of pharmaceutical patent litigation effectively. During this session, our panelists will help you understand the nuances of new regulations and initiatives, empowering you to provide valuable insights, and advocate for your clients’ interests.
Networking Luncheon
In re Cellect: Understanding the Implications for Obviousness – Type Double Patenting and Patent Term Adjustments
Mira MulvaneyAssistant General Patent Counsel, IP Litigation Eli Lilly and Company
Angie VerrecchioSenior Counsel, Patent LitigationJohnson & Johnson
Andrew CohenPartnerPatterson Belknap Webb & Tyler LLP
Mark H. RemusPartnerCrowell & Moring LLP
Michael P. KahnPartnerAkin Gump Strauss Hauer & Feld LLP
This panel will explore the Federal Circuit’s decision in In re Cellect and its implications for PTA in the context of ODP.
- Analzying how the Federal Circuit’s decision affects the interaction between PTA and ODP
- Outlining measures to audit patent portfolios and employ claim drafting techniques to safeguard against ODP challenges
- Exploring the contrasting treatment of PTA and PTE in the ODP analysis in the Cellect and Novartis decisions
- Emphasizing strategies in drafting claims for first filed and subsequent continuation applications to avoid ODP concerns
- Adapting patent prosecution and litigation strategies
The APJs Speak on Practice, Policy, and Procedure in the World of Pharmaceutical Patent Validity Changes
Honorable Jacqueline BonillaDeputy Chief Administrative Patent Judge, Patent Trial & Appeal BoardU.S. Patent and Trademark Office
Honorable Linda HornerAdministrative Patent Judge, Patent Trial & Appeal BoardU.S. Patent and Trademark Office
Honorable Grace ObermannAdministrative Patent Judge, Patent Trial & Appeal BoardU.S. Patent and Trademark Office
Brent BabcockPartnerLoeb & Loeb LLP
John MolendaPartnerSteptoe LLP
- Surveying notable pharmaceutical patent wins and losses
- Reviewing IPR, PGR and CBM filings involving pharmaceutical patents
- Examining the latest statistics for types of challenges brought and types of patents challenged
- Examining when the PTAB will issue a “good cause” extension of trial
- Considering emerging case law shaping the role of prior art in the PTAB’s discretionary denial of inter partes review
- Evaluating when petitioners may rely on prior art previously considered by the PTAB
Afternoon Break
Honorable Rian KaldenLegally Qualified Judge, Second Chamber of the Court of AppealUnified Patent Court
Professor Willem HoyngPartnerHOYNG ROKH MONEGIER(Chairman, Advisory Committee of the UPC)
Reflecting on the first year since the launch of the Unitary Patent (UP) and the Unified Patent Court (UPC), this session will examine their profound effects on the global pharma patent landscape. Session leaders will dissect the implications of the UP and UPC, emphasizing how they are reshaping strategies for global patent protection, and enforcement.
- Analyzing how the UP and UPC have transformed pharma patent portfolio management strategies since the UPC opened
- Detailing the cost implications of the UP and UPC, focusing on how they have impacted the financial aspects of patenting and litigation
- Exploring new avenues for enforcing pharma patent rights globally in the wake of the UP and UPC’s establishment
Kevin E. Noonan, Ph.DPartnerMcDonnell Boehnen Hulbert & Berghoff LLP
Hon. Teresa ReaConsultantRea Consulting LLC(Former Acting Director of the USPTO)
Shashank UpadhyePartnerUpadhye Tang LLP
(Former Vice President – Global Intellectual Property, Apotex, Inc.)
Attorneys oversee myriad of sensitive information daily, and confidentiality is a core tenet of the legal profession. Now, more than ever before, cybersecurity must be an ever-present priority for Hatch-Waxman practitioners. This session will offer best practices for protecting your clients’ information, identify the main risks specific to the life sciences and intellectual property, and provide proven strategies on optimizing your firm’s cybersecurity approach that you can immediately implement.