Paragraph IV Disputes

April 25 – 26, 2024

2023 Agenda

Day 1 - Wednesday, April 19, 2023

7:00	Breakfast and Registration
8:00	Chairs’ Opening Remarks
8:15	A View from Capitol Hill Patents, Politics and Policies: Understanding Impact of The Inflation Reduction Act on Hatch-Waxman Litigation
9:15	SUPREME COURT UPDATE Amgen v. Sanofi: Understanding How the Supreme Court May Re-Shape §112
10:30	FEDERAL CIRCUIT FIRESIDE CHAT A Conversation with the Federal Circuit
11:00	Morning Networking Break
11:15	Skinny Labeling and the Infringement of Repurposed Patents: Winning Strategies, New Approaches to Carve Outs, and Induced Infringement of Method Claims
12:15	Networking Luncheon Sponsored by:
1:45	§101 in the Balance: Comparing Current Requirements with Proposed Reforms for Patent Subject Matter Eligibility
2:45	Networking Break
3:00	The Practice of PIV Disputes Track 1 — International IP Risks: Effectively Managing a Global Pharmaceutical IP Litigation Strategy Track 2 — Joint Defense Groups: A Risk Benefit Analysis for the Hatch-Waxman Practitioner Track 3 — Closed Door Executive Meeting with ACI’S Hatch-Waxman Series Advisory Board
3:45	The Business of PIV Disputes Track 1 — The Cost and Worth of a Patent: The Economics of a Paragraph IV Challenge Track 2 — Best Practices for Utilizing FDA’s Citizen Petition Process to Achieve Market Exclusivity
4:30	Networking Break
4:45	View from the Bench: Spotlight on PIV Litigation in DE and NJ
6:00	Cocktail Reception Sponsored by:

Day 2 - Thursday, April 20, 2023

7:15	Breakfast and Registration
8:00	Chairs’ Opening Remarks
8:15	FOCUS ON FDA GDUFA III User Fees, Guidances, and MAPPs – User Fee Reauthorization Riders and New Litigation with FDA
9:00	Part II: What Every PIV Litigator Needs to Know about the USPTO- FDA Collaboration and the Efforts to Promote Competition
9:30	Morning Networking Break
10:00	The Business of PIV Disputes Track 1 — Legal Spend Management: Best Practices for Budgeting Pharmaceutical IP Litigation – Monitoring Legal Spend and Balancing the Budget Track 2 — Revisiting Damages in an At-Risk Launch Scenario: Questions of Remedies and Valuation
10:45	The Business of PIV Disputes Track 1 — The Essential Skills In-House Counsel Require: Communicating Value and Collaboration Track 2 — Patent Reissue and Reexamination: Strategies for Correcting Errors and Determining When to Pursue
11:30	ANTITRUST MATTERS IN THE SETTLEMENT OF PIV DISPUTES FTC KEYNOTE
12:00	Networking Luncheon
1:45	Reverse-Payment Settlements: Demystifying the Current State of Pharmaceutical Litigation Settlements in the Hatch-Waxman Context
2:45	THE PATENT TRIAL AND APPEAL BOARD THINK TANK The APJs Speak on Practice, Policy, and Procedure in the World of Pharmaceutical Patent Validity Changes
3:45	Networking Break
4:00	Preparing for Parallel Proceedings: Maneuvering through the District Court and Inter Partes Review
5:00	CYBERSECURITY Cybersecurity and Information Security Concerns for Hatch-Waxman Litigators: Practical and Ethical Considerations
6:00	Conference Concludes

Day 1 - Wednesday, April 19, 2023

7:00	Breakfast and Registration
8:00	Chairs’ Opening Remarks Honorable Kathleen M. O’Malley (Ret.) Of Counsel Irell & Manella LLP (Former United States Circuit Judge U.S. Court of Appeals for the Federal Circuit) Neema Kumar Vice President, IP, North America Sandoz Serena Farquharson Torres Executive Director, Assistant General Counsel, Innovation Law Bristol Myers Squibb
8:15	A View from Capitol Hill Patents, Politics and Policies: Understanding Impact of The Inflation Reduction Act on Hatch-Waxman Litigation Michael P. Kahn Partner Akin Gump Strauss Hauer & Feld LLP David J. Kappos Partner Cravath, Swaine & Moore LLP David Korn Vice President, IP and Law PhRMA Moderator: William James Partner Allen & Overy LLP Analyzing the impact of the Inflation Reduction Act (IRA) on Hatch-Waxman patent protections, exclusivities, and market entry Examining the key provisions designed to lower prescription drug prices Evaluating which drugs will be negotiated and strategies to get your product outside of the four corners of the statute How will the IRA impact the ability to secure investments, partnerships, and acquisitions? How will the Biden EO support industry, R&D, and workforce development? Understanding the efforts to support the development of critical medicines The PASTEUR Act Taking stock of the Biden Executive Orders promoting competition in the American Economy
9:15	SUPREME COURT UPDATE Amgen v. Sanofi: Understanding How the Supreme Court May Re-Shape §112 Matthew A. Pearson Partner Akin Gump Strauss Hauer & Feld LLP Emily J. Greb Partner Perkins Coie LLP Eric Stone Partner Groombridge, Wu, Baughman & Stone LLP Richard C. Pettus Shareholder Greenberg Traurig LLP Moderator: Vishal C. Gupta Partner Steptoe & Johnson LLP In November of 2022, The U.S. Supreme Court granted cert. in Amgen v. Sanofi, but strangely denied cert. in Juno v. Kite, a case with remarkably similar questions presented. At the time of press, Juno petitioned the Court for rehearing, arguing that the grant of cert. in Amgen warrants reconsideration. The fate of §112 hangs in the balance leaving Hatch-Waxman practitioners wondering how this will impact litigation strategies. Topics of discussion will include: Analyzing why SCOTUS granted cert only in Amgen v. Sanofi despite the presentation of the same single issue of the proper interpretation of §112 in Juno v. Kite Assessing the current state of 112 jurisprudence and predicting how the law may evolve in the future Preparing for the impact to existing patents with functional claims Evaluating the impact on patent prosecution practice in the future Best practices for strengthening or invalidating patent claims What is the true test for enablement? What is the relevant inquiry for written description post-Biogen v. Mylan?
10:30	FEDERAL CIRCUIT FIRESIDE CHAT A Conversation with the Federal Circuit Honorable Leonard P. Stark United States Judge U.S. Court of Appeals for the Federal Circuit (Former Chief Judge, United States District Court, District of Delaware) Interviewed by: Honorable Kathleen M. O’Malley (Ret.) Of Counsel Irell & Manella LLP (Former United States Circuit Judge U.S. Court of Appeals for the Federal Circuit)
11:00	Morning Networking Break
11:15	Skinny Labeling and the Infringement of Repurposed Patents: Winning Strategies, New Approaches to Carve Outs, and Induced Infringement of Method Claims Chad A. Landmon Partner Axinn, Veltrop & Harkrider LLP Jason Leonard Partner McDermott Will & Emery Kevin S. Prussia Partner Wilmer Cutler Pickering Hale and Dorr LLP Jeanna M. Wacker Partner Kirkland & Ellis LLP Moderator: Michael Sitzman Partner DLA Piper The battle over the common generic carve-out has made its way to the White House. The Supreme Court has asked the Solicitor General to weigh in on the matter of carve outs. The industry ponders the implications of the pending opinion on pharmaceutical patents as well as the practice of patent law. In this session, points of discussion will include: Evaluating the impact of GSK v. Teva, Amarin v. Hikma and their progeny on proving induced infringement Analyzing recent court treatment Types of evidence to demonstrate inducement Pre-launch v. post-launch Distinguishing between skinny labels and partial labels Explaining the patentability of further medical use inventions Strategies for claim drafting in view of these decisions Reevaluating claim and label language Detailing what every patent owner needs to consider when labeling FDA-approved products Best practices for aligning patent claims with the label Considerations for multiple approved indications
12:15	Networking Luncheon Sponsored by:
1:45	§101 in the Balance: Comparing Current Requirements with Proposed Reforms for Patent Subject Matter Eligibility Ryan Hagglund Partner Loeb & Loeb LLP John Kirkland Executive Director, IP and Litigation Counsel Alkermes Noah M. Leibowitz Partner Dechert LLP Rashad Morgan Partner Crowell & Moring LLP Whitney Meier Howard Partner Venable LLP The Supreme Court’s denial of cert. in American Axle & Manufacturing, Inc. v. Neapco Holdings LLC, 967 F.3d 1285 (Fed. Cir. 2020) contributes to the history of uncertainty surrounding patent eligible subject matter determinations. The case has also spurred debate over whether the current state of play advances or harms innovation. The Federal Courts, the USPTO, and Congress have responded to this the uncertainty in several ways, including proposed legislation. In this session, points of discussion will include: Evaluating the Supreme Court’s denial to grant cert. in American Axle & Manufacturing v. Neapco Holdings after the Solicitor General’s support for a partial grant Examining the Second Tillis-Coons proposal to reform §101 Understanding the rationale behind the Patent Eligibility Restoration Act of 2022 (PERA) Analyzing the impact of the Deferred Subject Matter Eligibility Project on U.S. patent drafting Devising strategies for overcoming ineligibility rejections from the USPTO Discussing the future statutory and jurisprudential landscape of §101 Predicting the impact on investment and innovation
2:45	Networking Break
3:00	The Practice of PIV Disputes Track 1 — International IP Risks: Effectively Managing a Global Pharmaceutical IP Litigation Strategy Track 2 — Joint Defense Groups: A Risk Benefit Analysis for the Hatch-Waxman Practitioner Track 3 — Closed Door Executive Meeting with ACI’S Hatch-Waxman Series Advisory Board Track 1 Deepro R. Mukerjee Partner and Chair, IP Katten Muchin Rosenman LLP Kevin Zive Vice President - General Counsel, and Head of Global Intellectual Property Apotex Inc. Track 2 Honorable Christopher J. Burke Magistrate Judge District of Delaware Pilar G. Kraman Partner Young Conaway Stargatt & Taylor, LLP Track 3 Ryan M. Daniel AGC, Corporate and Business Transactions Fresenius Kabi Stephanie Donahue Principal Counsel, Patent Litigation Sanofi James P. Leeds Assistant General Patent Counsel Eli Lilly & Company Aaron Pereira Senior Director of Patents Ferring Pharmaceuticals Track 1 — International IP Risks: Effectively Managing a Global Pharmaceutical IP Litigation Strategy Assessing common international business scenarios encountered by both brand name and generic manufacturers which lead to patent disputes Identifying potential safe-harbor concerns related to foreign manufacturers and finishers Building and managing a winning global litigation team Understanding the importance of aligning legal and business functions for global patent litigation planning Exploring matters of international trade and impacting the value of pharmaceutical patents Track 2 — Joint Defense Groups: A Risk Benefit Analysis for the Hatch-Waxman Practitioner Evaluating the benefits and detriments of joint defense groups in PIV disputes Maximizing efficiency and minimizing risk by protecting joint legal interests resourcefully Devising brand name strategies for addressing litigation with joint defense groups Establishing clear leadership at the outset to simplify future occurrences Understanding when and how many consulting firms to utilize toward avoiding too many cooks in the kitchen Track 3 — Closed Door Executive Meeting with ACI’S Hatch-Waxman Series Advisory Board Limited to 24 participants (12 brand; 12 generic) by invitation- only, 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 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 counsel.
3:45	The Business of PIV Disputes Track 1 — The Cost and Worth of a Patent: The Economics of a Paragraph IV Challenge Track 2 — Best Practices for Utilizing FDA’s Citizen Petition Process to Achieve Market Exclusivity Track 1 Jonathan Davies Partner Cooley LLP Isaac S. Ashkenazi Partner Paul Hastings LLP Track 2 Kathleen Gersh Partner Loeb & Loeb LLP Kurt Karst Director Hyman, Phelps & McNamara PC Track 1 — The Cost and Worth of a Patent: The Economics of a Paragraph IV Challenge IP and economic assessments on product selection and defense Factoring-in R&D considerations and market trends Analyzing available exclusivities, both regulatory and patent Assessing key litigation considerations and related costs Considering the likelihood of victory depending on patent type Budgeting, forecasting, and aligning litigation costs to business goals Exploring cost saving options in litigation Examining value of licensing deals and structures Track 2 — Best Practices for Utilizing FDA’s Citizen Petition Process to Achieve Market Exclusivity Reviewing FDA’s citizen petition processes and protocols Understanding the criteria FDA considers when evaluating a petition How does FDA determine the petition’s primary purpose was to delay? Analyzing market exclusivities to be addressed in the petition Detailing what should be included and what the process entails Taking stock of recent decisions involving Citizens Petitions Best practices for the reconsideration process and litigation
4:30	Networking Break
4:45	View from the Bench: Spotlight on PIV Litigation in DE and NJ Honorable Stanley R. Chesler District Judge United States District Court, District of New Jersey Honorable Mitchell Goldberg District Judge United States District Court, Eastern District of Pennsylvania (Visiting Judge, District of Delaware) Honorable Maryellen Noreika District Judge United States District Court, District of Delaware Honorable Joshua Wolson District Judge United States District Court Eastern District of Pennsylvania (Visiting Judge, District of Delaware) Moderator: Jonathan B. Turpin Attorney Locke Lord LLP
6:00	Cocktail Reception Sponsored by:

Day 2 - Thursday, April 20, 2023

7:15	Breakfast and Registration
8:00	Chairs’ Opening Remarks Honorable Kathleen M. O’Malley (Ret.) Of Counsel Irell & Manella LLP (Former United States Circuit Judge U.S. Court of Appeals for the Federal Circuit) Neema Kumar Vice President, IP, North America Sandoz Serena Farquharson Torres Executive Director, Assistant General Counsel, Innovation Law Bristol Myers Squibb
8:15	FOCUS ON FDA GDUFA III User Fees, Guidances, and MAPPs – User Fee Reauthorization Riders and New Litigation with FDA Christopher Pruitt Deputy Director, Office of Generic Policy U.S. FDA Brian Stone Associate General Counsel Global Legal-Regulatory Viatris Maryll W. Toufanian Senior Vice President, Regulatory Strategy and Policy Amneal Pharmaceuticals Moderator: David B. Abramowitz Partner Locke Lord LLP Examining the areas of focus in GDUFA III Complex drugs Facility inspections and re-inspections Understanding the GDUFA III commitment letter Analyzing user fee reauthorization riders Taking stock of recent litigations with FDA Avadel v. FDA Melinta v. FDA
9:00	Part II: What Every PIV Litigator Needs to Know about the USPTO- FDA Collaboration and the Efforts to Promote Competition Christopher Pruitt Deputy Director, Office of Generic Policy U.S. FDA Brian Stone Associate General Counsel Global Legal-Regulatory Viatris Maryll W. Toufanian Senior Vice President, Regulatory Strategy and Policy Amneal Pharmaceuticals Moderator: Daniel G. Brown Partner Latham & Watkins LLP President Biden and Congress have applied pressure on USPTO and FDA to change patent policies to keep drug prices down and promote competition. The two agencies are exploring initiatives, as the Order required USPTO and FDA to identify inter-agency goals for collaboration. Areas of collaboration to be discussed will include: Reconciling how the two agencies can collaborate on PTE determinations Policy considerations for method of use patents, use codes and skinny labeling Considerations regarding risk evaluation and mitigation strategies (REMS) Avadel CNS Pharmaceuticals v. Jazz Pharmaceuticals Efforts to thwart the misuse of patents to delay completion
9:30	Morning Networking Break
10:00	The Business of PIV Disputes Track 1 — Legal Spend Management: Best Practices for Budgeting Pharmaceutical IP Litigation – Monitoring Legal Spend and Balancing the Budget Track 2 — Revisiting Damages in an At-Risk Launch Scenario: Questions of Remedies and Valuation Track 1 Peter Waibel Head, Patent Litigation (US) Novartis Pharmaceuticals Corporation Douglas H. Carsten Partner McDermott Will & Emery Track 2 Andrew Cochran Attorney Cahill Gordon & Reindel LLP Vikram Mathrani Partner Honigman LLP Ted Mathias Partner Axinn, Veltrop & Harkrider LLP Track 1 — Legal Spend Management: Best Practices for Budgeting Pharmaceutical IP Litigation – Monitoring Legal Spend and Balancing the Budget Accounting for inflation and implementing practices to minimize surprises and increase predictability Forecasting the budget by phase and quarter Strategies for reevaluating the use of task codes Deciding what components should be incorporated into the budget Vendors Experts Understanding the source of error when unforeseen events or overages occur Evaluating the appropriateness of alternative fee arrangements Track 2 — Revisiting Damages in an At-Risk Launch Scenario: Questions of Remedies and Valuation Exploring questions of royalties, lost profits, and exceptional findings Market reconstruction considerations Alternatives for noninfringement Examining the value of the use of the patented technology Examining grounds for mitigation Considering the practical consequences of the Supreme Court’s WesternGeco decision on Hatch- Waxman damages awards Exploring when U.S. patent owners may recover foreign lost profits tied to domestic acts of infringement under § 271(f)(2) Examining cases where the relevant infringing conduct occurred in the United States
10:45	The Business of PIV Disputes Track 1 — The Essential Skills In-House Counsel Require: Communicating Value and Collaboration Track 2 — Patent Reissue and Reexamination: Strategies for Correcting Errors and Determining When to Pursue Track 1 Donna Meuth Associate General Counsel IP Eisai Kevin M. Nelson Partner ArentFox Schiff LLP Track 2 Mira A. Mulvaney Associate VP, Assistant General Patent Counsel, IP Litigation Eli Lilly and Company Mary Morry Counsel, IP Litigation Merck & Company Preston K. Ratliff II Partner Paul Hastings LLP Track 1 — The Essential Skills In-House Counsel Require: Communicating Value and Collaboration Establishing early-on in the relationship the desired level of commitment, availability and responsiveness Succinctly focusing on shared, pragmatic business goals Determining preferences for formality of correspondence and practical verse academic guidance Track 2 — Patent Reissue and Reexamination: Strategies for Correcting Errors and Determining When to Pursue Evaluating the benefits and detriments of joint defense groups in PIV disputes Maximizing efficiency and minimizing risk by protecting joint legal interests resourcefully Devising brand name strategies for addressing litigation with joint defense groups Establishing clear leadership at the outset to simplify future occurrences Understanding when and how many consulting firms to utilize toward avoiding too many cooks in the kitchen
11:30	ANTITRUST MATTERS IN THE SETTLEMENT OF PIV DISPUTES FTC KEYNOTE Beckey Egeland Attorney, Health Care Division Federal Trade Commission
12:00	Networking Luncheon
1:45	Reverse-Payment Settlements: Demystifying the Current State of Pharmaceutical Litigation Settlements in the Hatch-Waxman Context Julia Chapman Partner Dechert LLP Benjamin M. Greenblum Partner Williams & Connolly LLP Kurt Mathas Partner Winston & Strawn LLP Robert Milne Partner White & Case LLP Alyson Wooten Managing Director Berkeley Research Group LLC Understanding settlement strategies between brands and generics Structuring agreements and identifying antitrust concerns Understanding investigation and liability risks Highlighting the state legislation directly addressing “reverse payment” patent settlements Presumption of unlawfulness – California AB 824 Reviewing the proper standards of antitrust review and the rising call for a legislative response Analyzing the current legislative and regulatory framework Mergers, acquisitions, and exclusive licenses Anticompetitive agreements Abuse of dominance Life cycle management and contracting Pricing strategies Avoiding costly litigation and associated penalties by effectively complying with the law At-Risk Launch considerations
2:45	THE PATENT TRIAL AND APPEAL BOARD THINK TANK The APJs Speak on Practice, Policy, and Procedure in the World of Pharmaceutical Patent Validity Changes 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 & Appeal Board U.S. Patent and Trademark Office Honorable Grace Obermann Administrative Patent Judge, Patent Trial & Appeal Board U.S. Patent and Trademark Office Co-Moderators: John J. Molenda Partner Steptoe & Johnson LLP Gregory A. Morris Partner O'Melveny & Myers LLP Reviewing the provisions and consequences of the Patent Trial and Appeal Board Reform Act (2022) Detailing the key provisions and critical takeaways from pending legislation Taking stock of the latest developments related to the PTAB’s expanded use of discretionary denials in view of parallel litigation Analyzing recent IPR estoppel decisions Reviewing trends before the PTAB involving §112 Interpreting the duty of reasonable inquiry Confidentiality concerns Reviewing the latest stats at PTAB, highlighting bio/pharma cases Detailing recent rules at PTAB New rule relating to institution of trials (as it relates to SAS, expert testimony, and sur-replies) New rule relating to burdens of persuasion in MTAs Interpreting PTAB precedent and other information Newly designated precedent at PTAB
3:45	Networking Break
4:00	Preparing for Parallel Proceedings: Maneuvering through the District Court and Inter Partes Review Angie Verrecchio Senior Counsel, Patent Litigation Johnson & Johnson Andrew D. Cohen Partner Patterson Belknap Webb & Tyler LLP Gerald J. Flattmann, Jr. Partner Cahill Gordon & Reindel LLP Moderator: Daniel J. Minion Partner Venable LLP Developing new strategies for parallel proceedings in the District Courts and PTAB in view of a single standard Weighing the future of parallel proceedings in view of a single standard adoption Considering the takeaways from the patent challenger’s perspective in addition to the patentee perspective Devising strategies relative to the filing of an IPR or similar proceeding during the pendency of District Court litigation Formulating strategies based on type of pharmaceutical patent Establishing jurisdiction at the PTAB Special considerations for ex-U.S. parties Developing sound discovery strategies relative to dual proceedings Evaluating chances of getting a stay granted in the District Court Managing experts and use of experts in both forums Appealing decisions in both forums
5:00	CYBERSECURITY Cybersecurity and Information Security Concerns for Hatch-Waxman Litigators: Practical and Ethical Considerations Shashank Upadhye Partner Upadhye 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.
6:00	Conference Concludes

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