21st Annual Conference on
PARAGRAPH IV DISPUTES
April 29 – 30, 2025 • The Altman Building, New York, NY
Where Leaders in IP Come to Learn, Network and Navigate the Intricacies of Paragraph IV Proceedings
Your 2025 Conference Chairs:
Jamie Leeds Vice President, and Chief Patent Counsel –Hatch Waxman Litigation Eli Lilly and Company
View from the Bench:
Honorable Joshua D. Wolson District Judge, United States District Court Eastern District of Pennsylvania (Visiting Judge, District of Delaware)
Honorable Stanley R. Chesler District Judge, United States District Court District of New Jersey
Honorable Tonianne J. Bongiovanni Magistrate Judge, United States District Court District of New Jersey
Cynthia Sun Director, Legal Counsel Meitheal Pharmaceuticals Inc.
Government Insights:
Hon. Grace K. Obermann Administrative Patent Judge, Patent Trial & Appeal Board U.S. Patent and Trademark Office
Hannah Lamb Attorney U.S. Federal Trade Commission (FTC)
Special Interview with a Hatch-Waxman Pioneer:
Alfred Engelberg Founder Engelberg Center on Innovation, Law and Policy (Former Patent Counsel to the Generic Pharmaceutical Association)
Kathi Vidal Partner Winston & Strawn LLP (Immediate past Under Secretary of Commerce for IP and Director of the U.S. Patent and Trademark Office (USPTO))
Network with In-House from Leading Brand Names and Generics
• Bristol Myers Squibb
• Daiichi Sankyo, Inc.
• Eli Lilly & Company
• Ferring Pharmaceuticals
• Genentech
• Johnson & Johnson
• Meitheal Pharmaceuticals
• Nordic Pharma Inc.
• Sanofi
The business of small molecule drugs is changing, and political tides have turned.
In the year ahead, Paragraph IV practitioners will need to be attuned to the rapidly changing legal, regulatory, and political environment if they hope to successfully navigate the highly competitive Hatch-Waxman litigation landscape.
For innovators, there is scrutiny over so-called patent thickets, allegations of improper Orange Book listings, and the Inflation Reduction Act’s pricing cliff-now left in limbo. For generics, competition is intensifying, with fewer high value small molecule drugs on the market. This has left both sides actively seeking new opportunities to maximize profits, in a fast-moving legal atmosphere that now finds itself under a new administration.
Prepare for this brave new world by joining us at American Conference Institute’s 21st Annual Paragraph IV Disputes conference. We will convene four months into ‘Trump 2.0.,’ bringing you timely analysis of shifts and shakeups at the three key agencies responsible for drug approvals, exclusivities, and patents.
This spring, examine the implications of landmark cases including the Supreme Court’s decision in Loper v. Bright, as well as recent Federal Circuit and district court decisions on skinny labeling, safe harbor, §112 and ODP.
As in years past, this forum will bring together the top legal minds in Hatch-Waxman litigation to parse through pressing legal concerns and provide insights on strategies that will serve both patent owners and challengers.
Prepare for every step of these high-stakes Paragraph IV proceedings through discussion, debate and networking with the A-list of ANDA litigators, and those influencing the latest policies and regulations with an impact on pharmaceutical IP.
Program Highlights:
Angle-Right Industry Leaders Talk TRUMP 2.0: Explore potential policy shifts and how they could impact pharmaceutical portfolios and Paragraph IV litigation
Angle-Right Fireside Chat with a Hatch-Waxman Pioneer: An insider's perspective on the creation of the Act, what could be changed and the future of patent litigation
Angle-Right Judicial Panel: Weave practical procedural tips and preferences from the Judiciary into your Paragraph IV practice
Plus! Fresh New Tracks Focused on Business Communication, Budgeting, and Career Advancement for the Hatch-Waxman Practitioner
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.
For more information on ACI’s CLE process, visit: www.AmericanConference.com/Accreditation/CLE EARN CLE/ETHICS CREDITS
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.
Supporting Sponsors
Cocktail Reception Sponsor
Lanyard & Luncheon Sponsor
Associate Sponsors
Premium Exhibitors
Media Partners
Speaker Faculty
DISTINGUISHED CHAIRS
Jamie Leeds
Vice President, and Chief Patent Counsel –Hatch Waxman Litigation Eli Lilly and Company
Honorable Joshua D. Wolson
District Judge, United States District Court Eastern District of Pennsylvania (Visiting Judge, District of Delaware)
Cynthia Sun Director, Legal Counsel
Meitheal Pharmaceuticals Inc.
MEMBERS OF THE JUDICIARY
Honorable Stanley R. Chesler
District Judge, United States District Court
District of New Jersey
Kathi Vidal Partner
Winston & Strawn LLP (Immediate past Under Secretary of Commerce for IP and Director of the U.S. Patent and Trademark Office (USPTO))
Honorable Tonianne J. Bongiovanni Magistrate Judge, United States District Court
District of New Jersey
Honorable Randall R., Rader (ret.)
Former Chief Judge
U.S. Court of Appeals for the Federal Circuit
GOVERNMENT REPRESENTATIVES
Hannah Lamb Attorney U.S. Federal Trade Commission (FTC)
THINK TANKS, ASSOCIATIONS AND ACADEMIA
Alfred Engelberg Founder Engelberg Center on Innovation, Law and Policy (Former Patent Counsel to the Generic Pharmaceutical Association)
Joshua Kresh Interim Executive Director of the Center for Intellectual Property x Innovation Policy George Mason University
Marta E. Wosińska, PhD Senior Fellow, Center on Health Policy The Brookings Institution
PATENT TRIAL AND APPEAL BOARD, USPTO
Ryan Daniel VP, Associate General Counsel, Corporate and Business Transactions Biopharmaceuticals Fresenius Kabi, LLC
Stephanie Donahue Head of Global Patent Litigation, Global Intellectual Property Department, Legal, Ethics & Business Integrity
Sanofi
Gloria Fuentes Vice President & Assistant General Counsel
Bristol Myers Squibb
Honorable Grace K. Obermann
Administrative Patent Judge, Patent Trial & Appeal Board U.S. Patent and Trademark Office
IN-HOUSE COUNSEL
Henry Hadad Vice President Bristol Myers Squibb
Colin Heitzmann Vice President, Intellectual Property and Business Development, Legal and Corporate Affairs
Daiichi Sankyo, Inc.
Mira Mulvaney
Associate VP –Assistant General Patent Counsel, IP Litigation
Eli Lilly and Company
Jenny Papatolis Johnson VP, Assistant General Counsel, IP Endo Pharmaceuticals
Aaron Pereira Senior Director of Patents Ferring Pharmaceuticals
Thomas Stoll Senior Director, Federal Government Affairs Genentech
Lars Taavola
Vice President, Chief Intellectual Property Counsel & General Counsel, Brands Mallinckrodt Pharmaceuticals
Maryll W. Toufanian Senior Vice President, Regulatory Strategy and Government Affairs Amneal Pharmaceuticals
Angie Verrecchio Senior Counsel, Patent Litigation Johnson & Johnson
Marina Volin VP, General Counsel and Corporate Secretary Nordic Pharma
David B. Abramowitz Shareholder Buchanan
Peter J. Armenio Partner
Cahill, Gordon & Reindel LLP
Isaac S. Ashkenazi Partner
Paul Hastings LLP
Jonathan Bachand Partner
Knobbe Martens
Aziz Burgy Partner
Axinn, Veltrop & Harkrider LLP
Lachlan S. Campbell-Verduyn Partner
Patterson Belknap Webb & Tyler LLP
Doug Carsten Partner
McDermott Will & Emery LLP
Arlene Chow Partner
Latham & Watkins LLP
Alan Clement Partner
Troutman Pepper Locke LLP
Andrew Cohen Partner
Patterson Belknap Webb & Tyler LLP
Bryce Cooper Partner
Winston & Strawn LLP
Jim Czaban Co-Chair, Life Sciences Loeb & Loeb LLP
Sam Deka Partner
DLA Piper LLP
Emily Greb Partner Perkins Coie LLP
Lora Green Partner
Gemini Law LLP
Vishal Gupta Partner
Steptoe LLP
Ryan Hagglund Partner
Loeb & Loeb LLP
Stephen Holland Senior Counsel
Crowell & Moring LLP
Tom Irving Senior Partner
The Marbury Law Group PLLC.
Colleen Tracy James Partner
Cahill, Gordon & Reindel LLP
Michael P. Kahn Partner
Akin Gump Strauss Hauer & Feld LLP
Kurt R. Karst Director
Hyman, Phelps & McNamara PC
Pilar G. Kraman Partner
Young Conaway Stargatt & Taylor, LLP
Chad Landmon Partner Polsinelli
Honorable Jose L. Linares Partner
McCarter & English LLP (Ret. Chief Judge, United States District Court, District of New Jersey)
Michael E. McCabe Jr. Managing Partner McCabe Ali LLP
Nicholas Mitrokostas Partner
A&O Shearman
John Molenda Partner
Steptoe LLP
Gregory A. Morris Partner
O'Melveny & Myers LLP
Deepro Mukerjee Partner
Katten Muchin Rosenman LLP
Mathew Murphy Partner
Axinn, Veltrop & Harkrider LLP
Kevin Noonan Partner
McDonnell Boehnen Hulbert & Berghoff LLP
Young J. Park Partner
Paul Hastings LLP
Matthew A. Pearson Partner
Akin Gump Strauss Hauer & Feld LLP
Honorable Teresa Rea Consultant
Rea Consulting LLC
(Former Acting Under Secretary of Commerce for IP and former Acting Director of the U.S. Patent and Trademark Office (USPTO))
Rob Rodrigues Partner
RNA Law
John Christopher "J.C." Rozendaal
Director and Chair – Trial & Appellate Practice Group
Sterne Kessler Goldstein & Fox LLC
Emer Simic Partner
Neal, Gerber & Eisenberg LLP
Michael Sitzman Partner
McDermott Will & Emery LLP
Brian Stone
Associate General Counsel, Global Legal-Regulatory Viatris
Rebecca Wood Partner
Sidley Austin LLP
Eric Alan Stone Partner
Groombridge, Wu, Baughman and Stone LLP
Dan Troy
Managing Director BRG
James R. Tyminski Partner
Venable LLP
Shashank Upadhye Partner
Upadhye Tang LLP
Jeanna Wacker Partner
Kirkland & Ellis LLP
7:15 Breakfast and Registration Opens
8:15 Opening Remarks from the Co-Chairs
Jamie Leeds Vice President, and Chief Patent Counsel –Hatch Waxman Litigation Eli Lilly and Company
Cynthia Sun Director, Legal Counsel Meitheal Pharmaceuticals Inc.
Kathi Vidal Partner Winston & Strawn LLP (Immediate past Under Secretary of Commerce for IP and Director of the U.S. Patent and Trademark Office (USPTO))
8:30 From ‘Patent Thickets’ to Pricing:
How Policies with an Impact on Small Molecule Drug Patents are Shaping Up Under the New Administration
Take a trip to the Hill with our session leaders, as they explore what a second Trump presidency could mean for policies impacting small molecule IP and the practice of Hatch-Waxman Litigation.
Topics of discussion will include:
• Exchanging perspectives on how the change in administration may affect the pharmaceutical industry and small molecule patents
• Forecasting the probability of previous proposals reemerging
» Examining proposed PTAB reform under the PREVAIL Act
» Anticipating potential reforms to the Inflation Reduction Act’s Medicare drug pricing negotiations
» Tracking the new administration's views on the use of "March-In Rights" as a tool to control "high-priced" federally funded drug prices
» Determining how the FDA proposal to create a safe harbor for skinny labeling will impact future Hatch-Waxman litigation
» Analyzing proposals requiring the FDA to disclose more information on Q1/Q2 sameness to ANDA applicants
• Monitoring legislative attempts to eliminate ‘thickets’ of patents for the same product
Stephen Holland
Senior Counsel
Crowell & Moring LLP
Thomas Stoll
Senior Director, Federal Government Affairs
Genentech
Maryll W. Toufanian
Senior Vice President, Regulatory Strategy and Government Affairs
Amneal Pharmaceuticals
MODERATOR:
Joshua Kresh
Interim Executive Director of the Center for Intellectual Property x Innovation Policy
George Mason University
9:30 Fireside Chat with a Hatch-Waxman Pioneer and a Prominent Leader in Innovation Law: Reflections on the Origins of the Hatch-Waxman Act and Perspectives on Life After 40
This session is designed to delve into the origins of the Hatch-Waxman Act in a way that will allow for a dynamic discussion and exchanging of views on the past, present and future of brand and generic competition.
Alfred Engelberg—a key contributor to the law—will be joined by Henry Hadad, a leading voice in innovation law, for a conversation led by the Honorable Judge Randall Rader.
Together they will delve into what the Hatch-Waxman Act set out to achieve-- as documented in Mr. Engelberg’s recently released book “Breaking the Medicine Monopolies: Reflections of a Generic Drug Pioneer”-- and how the system is working today.
10:00 Morning Break
Alfred Engelberg
Founder
Engelberg Center on Innovation, Law and Policy
(Former Patent Counsel to the Generic Pharmaceutical Association)
Henry Hadad
Vice President
Bristol Myers Squibb
INTERVIEWED BY:
Honorable Randall R., Rader (ret.)
Former Chief Judge
U.S. Court of Appeals for the Federal Circuit
10:30 Charting the Evolving Boundaries of the Safe Harbor 35 USC § 271 in View of Recent Case Law
• Determining what is and is not shielded by the safe harbor following the Federal Circuit decision on Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd.
» Analyzing the broad interpretation of the term ‘solely’ for regulatory purposes and the implications for patent enforcement
» Exploring Brand and Generic perspectives on the scope of conduct covered by the safe harbor
• Examining where safe harbor defenses are holding up and where they are being defeated
» Allel Biotechnology & Pharm v. Regeneron Pharm
» Protecting third party manufacturing activities for the purposes of filing an ANDA
» Comparing the US safe harbors for drug development with other key jurisdictions
11:30 Compounding Pharmacies: Examining Recent Litigation and Commercial Concerns from
Compounding pharmacies are increasingly being viewed as a threat to IP. Innovator concerns have snowballed over the past year, resulting in claims of patent infringement and calls for regulatory action over the compounded versions of blockbuster drugs known as GLP-1s.
This session will examine key questions that have arisen in the U.S. legal and regulatory landscape including, the FDA’s role in the absence of an approval process for these drugs, and whether there is an exemption from infringement. Panel leads will also explore global considerations, and how the prevalence of these practices will impact brand and generic manufacturers moving forward.
12:15 Networking Lunch
Antitrust Targets and Trends
The FTC has applied significant pressure on branded pharmaceutical companies to remove what it alleges are "junk" patent listings from the Orange Book. The FTC claims wrongfully listed patents can drive up prices by undermining fair competition.
In the past couple years numerous brand pharmaceutical companies have received letters from the agency urging them to delist hundreds of specific patents, many of which are drug device combinations. These challenges are starting to gain traction in the US District courts. Most recently the District Court of New Jersey ordered Teva to delist five patents in the Orange Book.
• Making sense of the the rise of FTC scrutiny of Orange Book patents
• Identifying the type of patents the FTC alleges are “improperly” listed
• Evaluating patent portfolios for potential FTC targets
• Assessing the consequences of withdrawing, amending the patent listing, or leaving it unchanged
• Anticipating potential litigation stemming from the FTC’s calls to delist certain patents
• Forecasting future guidance on how to comply with Orange Book listing requirements from the FDA
• Preparing for delisting as a strategy in the district courts following the decision in the
BREAKOUT TRACKS
Evaluating the Impact of Domestic and Global Polices, and Patent Regimes on Brand and Generic Strategies
3:00–3:45
TRACK 1: Inflation Reduction Act: Navigating New Unknowns for Patent Portfolios at the Precipice of a Pricing Cliff
Kevin Noonan Partner
McDonnell Boehnen Hulbert & Berghoff LLP
The Inflation Reduction Act hangs in the balance, and with it, the future of the drug pricing negotiation framework for Medicare. For innovator companies the IRA presents a threat to profits and future R&D in the life sciences industry. It is unclear if the new administration will repeal the IRA, partially or in full, as well as what reforms will be presented in the year ahead.
• Monitoring constitutional challenges and summary motions in different courts
• Examining safe harbor exemptions from the IRA negotiations
• Assessing the impact on the life sciences industry and the patents being pursued
» Anticipating the impact on clinical trial dates, (orphan) indications
• Considering how this will influence investments in small molecules drugs to move to the development of biologics
• Developing strategies to mitigate the impact of drug pricing negotiations
• How IRA implementation impacts business cases and settlements
• Modelling when the projected revenue threshold will be hit to trigger negotiations
• What happens when you are in Paragraph IV litigation when the drug is selected for IRA negotiations
• Brand and generic perspective on how this will influence litigation strategies and settlements that are expected before the negotiations
• Analyzing investment risks for the generics market in the absence of a set price
TRACK 2: Harkening Back to Helsinn: Reexamining On-Sale Bar and §102 Prior Art Exceptions
Isaac S. Ashkenazi Partner
Paul Hastings LLP
Bryce Cooper Partner
Winston & Strawn LLP
Tom Irving Senior Partner
The Marbury Law Group PLLC.
MODERATOR:
Emily Greb Partner
Perkins Coie LLP
In Sanho Corp. V. Kaijet Technology International Ltd., the Federal Circuit affirmed a PTAB finding that an inventor’s private but non-confidential sale does not qualify for a prior art exception under §102. Sanho raised the Supreme Court case Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc., where the finding was that a private sale could be a public disclosure. This session will delve into complexities of navigating disclosures and prior art exceptions as highlighted by these cases.
TRACK 3: Closed Door Meeting with Hatch-Waxman Advisory Board
Stephanie Donahue Head of Global Patent Litigation, Global Intellectual Property Department, Legal, Ethics & Business Integrity
Sanofi
Colin Heitzmann Vice President, Intellectual Property and Business Development, Legal and Corporate Affairs
Daiichi Sankyo, Inc.
Jenny Papatolis Johnson VP, Assistant General Counsel, IP Endo Pharmaceuticals
This closed-door session is being offered to in-house counsel from brand and generic pharmaceutical companies only and will be limited to 20 participants.
Network, benchmark and discuss emerging concerns for industry with members of ACI’s Hatch-Waxman Advisory Board. This year’s discussion will provide an opportunity to share insights on the evolution of the small molecule IP landscape, and early developments in this brave new world. Participants are encouraged to submit specific topics for discussion in advance.
To secure your seat, contact Sara Cain at S.Cain@AmericanConference.com
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BRAND AND GENERIC THINK TANKS
This is a unique opportunity for focused breakout discussions with peers about how the pharmaceutical industry is evolving, and the challenges facing brand and generic companies, respectively. A panel of discussion leads will start the conversation by presenting their perspectives on industry shaping forces, trends, and tactics before opening it up to the group.
3:45–4:30
TRACK 1: Brand Pharma Roundtable and Breakout
Colleen Tracy James Partner
Cahill, Gordon & Reindel LLP
Sam Deka Partner
DLA Piper LLP
• Strengthening internal collaboration and communication to help navigate IP decisions and support Hatch-Waxman litigation down the line
• Enabling effective collaboration between R&D, clinical, IP with in house and outside counsel to capture, launch and protect innovation
• Exploring perspectives on securing and asserting secondary patents amid heightened scrutiny of ‘patent thickets’
• Factoring public perception about the commercial success of brand pharmaceutical companies into how you present your case
4:30 Refreshment Break
TRACK 2: Generic Pharma Roundtable and Breakout
David B. Abramowitz Shareholder Buchanan
Cynthia Sun Director, Legal Counsel Meitheal Pharmaceuticals Inc.
• Exploring perspectives on how generic companies can ensure portfolio sustainability
• Examining where generics are expanding to remain profitable
• Assessing how traditionally generic companies are managing new identities as they move into the branded and large molecule market through acquisitions
» Anticipating the potential for more litigation as companies evolve
• Examining how serial assertion of patents by brand pharma following the initial Paragraph IV litigation impacts generic decisions product launch and resources
4:45 View from the Bench: Integrating Insights, Perspectives and Preferences from the Judiciary into Your Paragraph IV Practice
Honorable Joshua D. Wolson
District Judge, United States District Court Eastern District of Pennsylvania (Visiting Judge, District of Delaware)
MODERATOR:
Honorable Jose L. Linares
Partner McCarter & English LLP
Honorable Stanley R. Chesler
District Judge, United States District Court District of New Jersey
(Ret. Chief Judge, United States District Court, District of New Jersey)
Honorable Tonianne J. Bongiovanni
Magistrate Judge, United States District Court District of New Jersey
Our highly anticipated ‘view from the bench’ roundtable returns. Our distinguished panel of District Court Judges will provide a closer look at the Paragraph IV litigation dockets during this dynamic discussion. Both patent holders and challengers will gain valuable insights on trends and trial advocacy.
5:45 Cocktail Reception
7:15 Registration Opens and Breakfast Served
8:15 Opening Remarks from the Co-Chairs
Jamie Leeds Vice President, and Chief Patent Counsel –Hatch Waxman Litigation Eli Lilly and Company Cynthia Sun
& Strawn
(Immediate past Under Secretary of Commerce for IP and Director of the U.S. Patent and Trademark Office (USPTO)) 8:30
• Identifying how AI can assist with drug discovery and across the life sciences sector
• Unpacking USPTO inventorship guidance on AI-assisted inventions
• Assessing the potential impact of Algorithmic prior art on eligibility and litigation
• Considering how AI could be used to support arguments of enablement and undue experimentation
• Exploring Brand and Generic In-House uses, concerns and strategies for AI
• Monitoring positions on the use of AI in the IP life sciences in Europe 9:30
• Examining how §112 is being applied in the District Courts post Amgen v. Sanofi
» Analyzing patent validity decisions pre and post Amgen
• Exploring opportunities to recapture breadth of scope for brand innovation
• Genus versus species claims
» Assessing whether Jepson and means plus function claims are still viable routes
• Exploring how the Federal Circuit discussion on §112 in Teva v. Amneal could impact future Hatch-Waxman litigation for both brands and generics
» Anticipating increased scrutiny of claims
• Developing strategies for patent drafting through to litigation
Burgy
Axinn, Veltrop & Harkrider LLP
Michael P. Kahn Partner Akin Gump Strauss Hauer & Feld LLP James R. Tyminski
MODERATOR: Kathi Vidal
Winston & Strawn LLP (Immediate past Under Secretary of Commerce for IP and Director of the U.S. Patent and Trademark Office (USPTO))
Arlene Chow Partner Latham & Watkins LLP
Matthew A. Pearson Partner Akin Gump Strauss Hauer & Feld LLP
John Christopher "J.C." Rozendaal Director and Chair – Trial & Appellate Practice Group Sterne Kessler Goldstein & Fox LLC
Simic Partner Neal, Gerber & Eisenberg LLP MODERATOR: Ryan Hagglund Partner Loeb & Loeb LLP
BREAKOUT TRACKS
11:00–11:45
The Art of Internal and External Communication for PIV Practitioners Money Talks
TRACK 1: PIV Practitioner Perspectives on Confidentiality and Questions of Privilege
Doug Carsten Partner
McDermott Will & Emery LLP
Marina Volin
VP, General Counsel and Corporate Secretary Nordic Pharma
Aaron Pereira
Senior Director of Patents Ferring Pharmaceuticals
• Protecting communications concerning infringement and invalidity positions internally both in the US and with foreign affiliates/parent companies
• Managing attorney client privilege with foreign personnel
• Maintaining product confidentiality to avoid risk of follow-on patents
• Examining how patent cases could trigger the crime-fraud exemption to attorney-client privilege
11:45–12:30 Communications
TRACK 1: Section viii Carveouts and Inducement Analysis: Post Launch Considerations Following Amarin v. Hikma
Andrew Cohen
Partner
Patterson Belknap Webb & Tyler LLP
Chad Landmon Partner Polsinelli
Angie Verrecchio
Senior Counsel, Patent Litigation Johnson & Johnson
MODERATOR: Vishal Gupta Partner
Steptoe LLP
• Asserting induced infringement and defending against it post Amarin v. Hikma
» Supporting evidence beyond the label being generated by brands in skinny labeling cases
• Identifying where allegations of inducement could arise post launch
» Reviewing how the product is positioned in marketing and communications
» Examining unusual targets in litigation including PBMS and insurance plans
Strategies for Managing Budgets and Protecting the Business During PIV Litigation
TRACK 2: Strategies for Managing PIV Litigation Budgets More Effectively
John Molenda Partner
Steptoe LLP
Lars Taavola
Vice President, Chief Intellectual Property Counsel & General Counsel, Brands Mallinckrodt Pharmaceuticals
Glean insights on how in-house counsel is building and managing budgets and the strategic approaches that can be taken with outside counsel to ensure success. This session will highlight pain points, creative solutions, and alternative fee arrangements for the PIV practitioner.
• Exploring in-house perspectives on how they like to work with outside counsel to stay within budget
• Determining what cases are suitable for a fixed fee arrangement
• Evaluating opportunities for joint defense
Managing Budgets and Litigation Costs
TRACK 2: At-Risk Entry and Damages in Life Sciences IP
Pilar G. Kraman Partner
Young Conaway Stargatt & Taylor, LLP
Young J. Park Partner
Paul Hastings LLP
• Assessing what’s at stake in at-risk launch scenario
» Estimating lost profits versus reasonable royalties
• Tracking damages trends in IP life sciences
• Analyzing recent case studies
» In re Entresto
» Nivagen v. Amneal
• Challenging the use of damages experts
» Examining the use of experts in Ecofactor Inc., v. Google, LLC
» Comparative case analysis for damages
• Exploring how the Inflation Reduction Act could influence brand and generic decisions
TRACK 3: IP Life Sciences Leaders on the Rise: Wisdom, War Stories, and Perspectives on Pitfalls to Avoid as You Continue to Climb
Ryan Daniels VP, Associate General Counsel, Corporate and Business Transactions
Biopharmaceuticals Fresenius Kabi, LLC
Limited to 20 participants, this structured networking opportunity is designed to bring together IP Life Sciences leaders on the rise for conversations about career building and the current Hatch-Waxman landscape. Join an esteemed panel of experienced Hatch-Waxman leaders for a candid discussion on how they charted their career path, some of the stumbling blocks they encountered and the strategies that led them to where they are today. In-House counsel at brand and generic pharmaceutical companies and law firm partners under 5 years are invited to apply to attend.
12:30 Lunch Break
1:30 PART I Chevron Overturned: Examining Challenges Against the FDA and How the Death of the Doctrine Could Impact Drug Approvals and Exclusivities
In a monumental move, the Supreme Court overturned the Chevron Doctrine in Loper v. Bright in June of 2024. Join our panelists as they examine the aftermath in the year since the decision. Analyze how the loss of deference is impacting federal agency decision-making, and where challenges to agency interpretations are arising in wake of the Supreme Court ruling.
Kurt R. Karst Director
Hyman, Phelps & McNamara PC
Rebecca Wood Partner Sidley Austin LLP
Dan Troy Managing Director BRG
PART II Anticipating the New Administration’s Impact on FDA Policies and Regulations
With President-Elect Trump’s nominations of Robert F. Kennedy, Jr. as HHS Secretary and Martin Makary, MD, MPH, FACS as FDA Commissioner there may be big changes coming for FDA. With a focus on cutting costs, how might generic drug and biosimilar manufacturers and brand-name pharma— and more broadly, the Hatch-Waxman Amendments and the BPCIA—fare in a brave new world?
2:15 Interactive Ethics Module: A Scenario Based Discussion on New and Emerging Ethical Quandaries for Hatch-Waxman Practitioners
Take part in an interactive ethics training module, designed to provide you with an understanding of ethical obligations as it relates to pharmaceutical patent prosecution and litigation. Our session leads will walk you through a roundup of key ethical considerations and grey areas using a scenario-based approach. Become an active participant through live polling at the end of each case study, followed by an open Q&A.
Michael E. McCabe Jr. Managing Partner McCabe Ali LLP
Eric Alan Stone Partner
Groombridge, Wu, Baughman and Stone LLP
3:15 Afternoon Networking Break
3:30 Challenging Patents at the PTAB: Examining Policies, Procedures, and Practice Protocols for PIV Practitioners
• Analyzing PTAB caseloads and outcomes by the numbers
» Tracking PGR, IPR filings
• Reviewing recent changes to policies and procedures at the PTAB
• Integrating practice tips
Honorable Grace K. Obermann
Administrative Patent Judge, Patent Trial & Appeal Board U.S. Patent and Trademark Office
• Examining what the Allergan v. MSN decision clarified about ODP references and what questions remain
• Identifying ODP risk and mitigation measures from prosecution through to litigation
» Auditing soon to expire patent families
• Reconsidering the use of continuations in view of recent case law
• Assessing USPTO proposal on terminal disclaimers that would apply a finding of invalidity on a single patent claim to an entire patent family
5:00 Conference Concludes
Brian Stone Associate General Counsel, Global Legal-Regulatory Viatris
Honorable Teresa Rea Consultant Rea Consulting LLC (Former Acting Under Secretary of Commerce for IP and former Acting Director of the U.S. Patent and Trademark Office (USPTO))
INTERVIEWED BY: Lora Green Partner Gemini Law LLP
4:15 Patent Family Dynamics: How to Address Obviousness Type Double Patenting Concerns Presented by Cellect in
Lachlan S. Campbell-Verduyn Partner Patterson Belknap Webb & Tyler LLP
Mira Mulvaney
Associate VP – Assistant General Patent Counsel, IP Litigation Eli Lilly and Company DAY TWO April
March 11 – 12, 2025 • Brussels
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March 19 – 20, 2025 • Boston, MA
June 2 – 3, 2025 • Boston, MA
July 30 – 31, 2025 • Boston, MA
Upcoming Events Driving Innovation and IP Strategy Across the Life Sciences Landscape
May 19 – 20, 2025 • New York, NY
June 4, 2025 • Boston, MA
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