Paragraph IV Disputes Conference

April 25 – 26, 2023

Agenda

Please Note: For those attending via livestream, Track 2 will be the only track available.

Day 1 - Tuesday, April 26, 2022

7:00	Breakfast and Registration
8:00	Co-Chairs’ Opening Remarks
8:15	60 Minutes on Patents, Politics, Policies, and Pricing: Patent Listing Statutes, “Buy America” Policies and Executive Orders, and Recent Hatch-Waxman and BPCIA Amendments Transforming PIV Disputes
9:15	Holistic Litigation Strategies for Strengthening or Defeating a Written Description Invalidity Defense
10:15	Networking Break
10:45	FTC Keynote
11:15	The Future of Inducement Claims in the Hatch-Waxman Context: Reconciling the Demarcation Between Describing an Infringing Use and Encouraging That Use in a Label
12:15	Networking Luncheon
1:45	The Costs and the Consequences of Determining Venue Post-Valeant v. Mylan: Coordinating Multiple ANDA Suits through MDLs
2:45	Networking Break
3:00	Breakout Sessions Track 1: The Business of PIV Disputes (available to in-person delegates only)Cross-Border Business Considerations in a Hatch-Waxman Scenario: Masterfully Managing Global Litigation Track 2: The Practice of PIV Disputes (available to in-person and livestream delegates)Advanced Pleadings Drafting: Choosing Claims and Defenses Wisely
3:45	Breakout Sessions Track 1: The Business of PIV Disputes (available to in-person delegates only)The Cost and Worth of a Patent: The Economics of a Paragraph IV Challenge Track 2: The Practice of PIV Disputes (available to in-person and livestream delegates)Mastering the Use of Experts in Parallel Proceedings
4:30	Networking Break
4:45	View from the Bench: The Federal Judges Speak on Paragraph IV Litigation
6:00	Cocktail Reception

Day 2 - Wednesday, April 27, 2022

7:15	Breakfast and Registration
8:00	Co-Chairs’ Opening Remarks
8:15	Brand and Generic Perspectives on the Latest FDA Initiatives Impacting Pharmaceutical Patents
9:30	Networking Break
10:00	Federal Circuit Fireside Chat
10:30	Breakout Sessions Track 1: The Business of PIV Disputes (available to in-person delegates only)Monitoring Legal Spend and Balancing the Budget Track 2: The Practice of PIV Disputes (available to in-person and livestream delegates)Seeking Damages and Assessing Value Calculations
11:15	Breakout Sessions Track 1: The Business of PIV Disputes (available to in-person delegates only)Communicating Value and Collaboration Between Corporate Legal and Outside Counsel Track 2: The Practice of PIV Disputes (available to in-person and livestream delegates)Joint Defense Groups: A Risk Benefit Analysis for the Hatch-Waxman Practitioner
12:00	Networking Luncheon
1:15	Restrictions on Reverse-Payment Settlements: Non-Monetary Settlements and Expert Testimony on the Merits
2:15	The APJs Speak on Practice, Policy, and Procedure in the World of Pharmaceutical Patent Validity Changes
3:15	Parallel Proceedings Think Tank: Winning Strategies for Navigating the District Court and Inter Parte Review (IPR)
4:15	Afternoon Break
4:30	The Ethical Practice of Paragraph IV Litigation: New Developments Impacting Professional Responsibility in the Hatch-Waxman Arena
5:30	Conference Concludes

Day 1 - Tuesday, April 26, 2022

7:00	Breakfast and Registration
8:00	Co-Chairs’ Opening Remarks Lars Taavola VP, Chief IP Counsel & General Counsel, Specialty Generics Mallinckrodt Pharmaceuticals Stephanie Donahue Principal Counsel – Global Patent Litigation Global Intellectual Property Department Legal, Ethics & Business Integrity Sanofi- Aventis Co-Chairs’ opening remarks.
8:15	60 Minutes on Patents, Politics, Policies, and Pricing: Patent Listing Statutes, “Buy America” Policies and Executive Orders, and Recent Hatch-Waxman and BPCIA Amendments Transforming PIV Disputes Jay R. Deshmukh Partner Kasowitz Benson Torres Andrei Iancu Partner Irell & Manella LLP (Former Director, U.S. Patent and Trademark Office) Nicholas Groombridge Partner Paul, Weiss, Rifkind, Wharton & Garrison LLP Joseph Reisman, Ph.D. Partner Knobbe Martens Analyzing recent federal and state executive actions and legislation Anticipating the impact on the pharmaceutical industry Patent listing statutes “Buy America” policies and Executive Orders State legislative initiatives Recent Hatch-Waxman and BPCIA amendments Navigating state laws governing transparency in drug pricing Reviewing which states proposed or enacted drug pricing laws Detailing the scope and applicability Appreciating the impact of pharmaceutical patent enforcement trends in the U.S. and around the world Forecasting the impact of the WTO TRIPS waiver for COVID-19 technologies
9:15	Holistic Litigation Strategies for Strengthening or Defeating a Written Description Invalidity Defense John Haberman Senior Director, IP Sarepta Therapeutics Steven M. Coyle Partner Cantor Colburn LLP Matthew Pearson Partner Akin Gump Strauss Hauer & Feld LLP Kevin S. Prussia Partner Wilmer Cutler Pickering Hale and Dorr LLP Moderator: Vanessa Yen Partner King & Spalding LLP Reviewing Biogen International GMBH v. Mylan Pharmaceuticals Inc. Appeal No. 20-1933, where the Federal Circuit affirmed invalidity of a method of treatment patent for lack of written description Appreciating the importance of inventor testimony and the impact of post-filing clinical data When can witness admissions strengthen a written description invalidity defense? Identifying when to divide your opponent’s testimony between IPR proceedings and district court litigation Considering the dissent and determining whether the district court erred in applying judicial estoppel
10:15	Networking Break
10:45	FTC Keynote Beckey Egeland Attorney, Health Care Division Federal Trade Commission FTC keynote.
11:15	The Future of Inducement Claims in the Hatch-Waxman Context: Reconciling the Demarcation Between Describing an Infringing Use and Encouraging That Use in a Label Huong T. Nguyen General Counsel & Compliance Officer Fosun Pharma USA Inc. Abigail Struthers Partner Arnold & Porter Kaye Scholer LLP April Abele Isaacson Partner Kilpatrick Townsend & Stockton LLP Sanya Sukduang Partner Cooley LLP Moderator: Aaron S. Lukas Co-Chair, Hatch-Waxman & Biologics Practice Cozen O’Connor Analyzing whether a skinny label alone is enough to preclude induced infringement allegations Reviewing the implications of recent decisions for induced infringement Anticipating the impact of recent decisions on claim drafting and the availability of generic drugs Devising strategic considerations of label language for inducement infringement What considerations should patent owners keep in mind when labeling drugs? Reviewing the approval of generic drug labeling On what basis will FDA determine the scope of an appropriate carve-out? Must FDA review the patent to ensure the only information carved out is covered by the patent? Is the interpretation of the patent claims subject only to a jury’s interpretation? Assessing the flurry of follow-on cases in the courts
12:15	Networking Luncheon
1:45	The Costs and the Consequences of Determining Venue Post-Valeant v. Mylan: Coordinating Multiple ANDA Suits through MDLs David L. Anstaett Partner Perkins Coie LLP Steven Maslowski Partner Akin Gump Strauss Hauer & Feld LLP Mark Rubinshtein, Ph.D. Attorney Knobbe Martens Moderated by: Jeanna M. Wacker Partner Kirkland & Ellis LLP Reviewing the Federal Circuit’s holding in Celgene v. Mylan from November 2021 where Celgene’s argument that a branded drug company should be able to file suit where it receives notice was rejected Anticipating circumstances when brands can file suit where generics reside toward using multidistrict litigation for the consolidation of discovery Coordinating MDLs “to promote the just and efficient conduct of the patent infringement actions” Identifying when parties may agree to proceed in one jurisdiction to streamline litigation Reconciling when Maryland (where U.S. FDA is located) may be a proper venue for Hatch-Waxman litigation
2:45	Networking Break
3:00	Breakout Sessions Track 1: The Business of PIV Disputes (available to in-person delegates only)Cross-Border Business Considerations in a Hatch-Waxman Scenario: Masterfully Managing Global Litigation Track 2: The Practice of PIV Disputes (available to in-person and livestream delegates)Advanced Pleadings Drafting: Choosing Claims and Defenses Wisely Track 1 - Speakers Henry H. Gu VP, Head of Intellectual Property Morphic Therapeutics Deepro R. Mukerjee Partner Katten Muchin Rosenman LLP Kevin Zive Vice President, General Counsel Apotex Inc. Track 2 - Speakers Honorable Christopher J. Burke Magistrate Judge United States District Court, District of Delaware Chad Landmon Partner Axinn, Veltrop & Harkrider, LLP Carolyn Blessing Partner Locke Lord LLP Track 1: The Business of PIV Disputes — Cross-Border Business Considerations in a Hatch-Waxman Scenario: Masterfully Managing Global Litigation Assessing common international business scenarios encountered by both brand name and generic manufacturers which may lead to patent and/or exclusivity loss Identifying potential safe-harbor violation liabilities related to foreign manufacturers and finishers Building a winning global litigation team Selecting the right foreign counsel Coordinating multi-jurisdictional proceedings Assessing the impact and dangers of applicable international treaties on the PIV landscape Track 2: The Practice of PIV Disputes — Advanced Pleadings Drafting: Choosing Claims and Defenses Wisely Complaint Ensuring that all counts of the complaint are plead with specificity Avoiding Rule 11 sanctions Devising strategies for situations with multiple ANDA filers Assessing damages prayer and request for jury trial Considerations relative to willfulness Answer and Counterclaims Choosing your defenses with prudence Understanding the advantages of not pleading every defense Knowing which patents to ask to delist; assessing allegations of improper Orange book listing
3:45	Breakout Sessions Track 1: The Business of PIV Disputes (available to in-person delegates only)The Cost and Worth of a Patent: The Economics of a Paragraph IV Challenge Track 2: The Practice of PIV Disputes (available to in-person and livestream delegates)Mastering the Use of Experts in Parallel Proceedings Track 1 - Speakers Donna Meuth Associate General Counsel, IP Eisai Inc. Bruce M. Wexler Partner and Global Co-Chair, Intellectual Property Paul Hastings LLP Richard J. Berman Partner ArentFox Schiff LLP Track 2 - Speakers Jovial Wong Partner Winston & Strawn LLP Alyson Wooten Director Berkeley Research Group LLC Track 1: The Business of PIV Disputes — The Cost and Worth of a Patent: The Economics of a Paragraph IV Challenge Conducting IP and economic due diligence assessments for brand name and generic manufacturers relative to such matters as NCE exclusivity, patent positions, screenings and alleged product hopping Factoring-in R&D considerations and market trends Analyzing available exclusivities, both regulatory and patent Assessing key litigation considerations and related costs for pharmaceutical patent challenges Considering the likelihood of victory at the District Court level and the PTAB on patent type and review of recent decisions Mastering the art of budgeting, forecasting, and aligning litigation costs to business goals Exploring cost saving options in litigation, including alternate billing, contingency clauses and outside funding Examining value of licensing deals and structures Track 2: The Practice of PIV Disputes — Mastering the Use of Experts in Parallel Proceedings Developing strategies to use expert testimony to your advantage at both the District Court and the PTAB in a dual proceedings scenario Understanding the scope and limitations of expert testimony at the PTAB, and how this may impact the District Court proceeding Appreciating the nuances of expert depositions for PTAB and District Court proceedings Ensuring that your expert communicates properly for the requisite forum
4:30	Networking Break
4:45	View from the Bench: The Federal Judges Speak on Paragraph IV Litigation Honorable Julien Xavier Neals District Judge United States District Court, District of New Jersey Honorable Joshua Wolson District Judge United States District Court Eastern District of Pennsylvania (Visiting Judge, District of Delaware) Moderated by: Rachel L. Pernic Waldron Partner Rakoczy Molino Mazzochi Siwik LLP Gregory A. Morris Partner Honigman LLP Distinguished jurists with some of the liveliest Paragraph IV litigation dockets in the country will examine decision-making practices employed by the judicial system and provide sage advice for both patent holders and patent challengers. These federal judges will identify the impediments to resolving such multifaceted contests and provide you with solutions to your most unyielding Paragraph IV predicaments.
6:00	Cocktail Reception

Day 2 - Wednesday, April 27, 2022

7:15	Breakfast and Registration
8:00	Co-Chairs’ Opening Remarks Lars Taavola VP, Chief IP Counsel & General Counsel, Specialty Generics Mallinckrodt Pharmaceuticals Stephanie Donahue Principal Counsel – Global Patent Litigation Global Intellectual Property Department Legal, Ethics & Business Integrity Sanofi- Aventis Co-Chairs’ opening remarks.
8:15	Brand and Generic Perspectives on the Latest FDA Initiatives Impacting Pharmaceutical Patents Maryll Toufanian Director, Office of Generic Drug Policy U.S. FDA David B. Abramowitz Partner Locke Lord LLP Kurt Karst Director Hyman, Phelps & McNamara PC Christopher Pruitt Director, Division of Legal and Regulatory Support Office of Generic Drug Policy U.S. FDA John Bennett Partner Allen & Overy LLP Understanding the significance of the conversion of certain Orange Book NDAs to BLAs under the BPCIA and how this may influence Hatch-Waxman litigation strategies Teva’s Copaxone citizen’s petition Exploring branded and generic interests in GDUFA and PDUFA renewals Examining new attacks on 180-day exclusivity per the propose Blocking Act Assessing status of FDA activity concerning Hatch-Waxman reform
9:30	Networking Break
10:00	Federal Circuit Fireside Chat Honorable Kathleen M. O’Malley (Ret.) United States Circuit Judge United States Court of Appeals for the Federal Circuit Interviewed by: Honorable Mary Pat Thynge Chief Magistrate Judge United States District Court, District of Delaware
10:30	Breakout Sessions Track 1: The Business of PIV Disputes (available to in-person delegates only)Monitoring Legal Spend and Balancing the Budget Track 2: The Practice of PIV Disputes (available to in-person and livestream delegates)Seeking Damages and Assessing Value Calculations Track 1 - Speakers Serge Ilin-Schneider Sr. Vice President, Corporate Development & General Counsel Cosette Pharmaceuticals, Inc. David Silverstein Partner Axinn, Veltrop & Harkrider LLP Martin Wilson General Counsel and Chief Compliance Officer Rocket Pharmaceuticals Track 2 - Speaker Shashank Upadhye Partner Upadhye Tang LLP Robert McSorley Managing Director Ocean Tomo, LLC Track 1: The Business of PIV Disputes — Monitoring Legal Spend and Balancing the Budget Implementing practices to minimize surprises and increase predictability Forecasting the budget by phase and quarter Knowing when to reevaluate use of task codes Deciding what components go into the budget Vendors Experts Understanding the source of error when surprises and overages occur Evaluating the appropriateness of alternative fee arrangements Track 2: The Practice of PIV Disputes — Seeking Damages and Assessing Value Calculations Revisiting damages in an at- risk-launch scenario Exploring questions of royalties, lost profits and exceptional findings 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
11:15	Breakout Sessions Track 1: The Business of PIV Disputes (available to in-person delegates only)Communicating Value and Collaboration Between Corporate Legal and Outside Counsel Track 2: The Practice of PIV Disputes (available to in-person and livestream delegates)Joint Defense Groups: A Risk Benefit Analysis for the Hatch-Waxman Practitioner Track 1 - Speakers Stephanie Donahue Principal Counsel – Global Patent Litigation Global Intellectual Property Department Legal, Ethics & Business Integrity Sanofi- Aventis Colin Heitzmann Vice President, Head of Intellectual Property Sumitovant Biopharma, Inc Sam Deka Partner DLA Piper Jeffrey Martin Senior Director, Legal Counsel IP Dr. Reddy’s Laboratories Inc. Track 2 - Speakers Honorable Tonianne J. Bongiovanni Magistrate Judge United States District Court, District of New Jersey Ryan M. Daniel Chief Patent Counsel, Region North America Fresenius Kabi USA, LLC Robert M. Vrana Partner Young Conaway Stargatt & Taylor LLP Luke T. Shannon Shareholder Polsinelli Track 1: The Business of PIV Disputes — Communicating Value and Collaboration Between Corporate Legal and Outside Counsel 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 versus academic guidance Track 2: The Practice of PIV Disputes — Joint Defense Groups: A Risk Benefit Analysis for the Hatch-Waxman Practitioner Evaluating the benefits and detriments of joint defense groups in ANDA cases Maximizing efficiency and minimizing risk by protecting join legal interests resourcefully Devising brand name strategies for addressing litigation with joint defense groups Establishing clear leadership at the out-set to simplify future occurrences Understanding when and how many consulting firms to employ in order to avoid the “too many cooks” phenomenon
12:00	Networking Luncheon
1:15	Restrictions on Reverse-Payment Settlements: Non-Monetary Settlements and Expert Testimony on the Merits Adam L. Perlman Partner Latham & Watkins LLP Saami Zain Assistant Attorney General Antitrust Bureau Office of the New York State Attorney General Sailesh Patel Partner ArentFox Schiff LLP In April 2021, lawmakers from the House and Senate introduced legislation “targeting conduct that prevents competition.” Complicating matters further, several states have enacted laws meant to curb reverse-payment patent settlements – with no comparable statute at the federal level. This session will consider the economic implications of the resurgence of antitrust conundrums during drug development and launch, the competitive effects, and economic damages. Topics of discussion will include: Understanding settlement strategies between innovator companies and generic applicants Highlighting the state legislation directly addressing “reverse payment” patent settlements 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
2:15	The APJs Speak on Practice, Policy, and Procedure in the World of Pharmaceutical Patent Validity Changes Honorable Jacqueline Wright Bonilla Deputy Chief Administrative Patent Judge Patent Trial & Appeal Board USPTO Honorable Michelle N. Ankenbrand Senior Lead Administrative Patent Judge Patent Trial & Appeal Board USPTO Moderators: John J. Molenda Partner Steptoe & Johnson LLP Elizabeth S. Weiswasser Partner Weil, Gotshal & Manges LLP Taking stock of the latest developments related to the PTAB’s expanded use of discretionary denials Reviewing the latest stats at PTAB, highlighting bio/pharma cases Outlining the latest developments on pilot programs at PTAB Legal Experience and Advancement Program (LEAP) Fast-Track Appeals Motions to Amend (MTAs) in AIA proceedings 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 New memorandum regarding indefiniteness approach in AIA proceedings
3:15	Parallel Proceedings Think Tank: Winning Strategies for Navigating the District Court and Inter Parte Review (IPR) Peter Waibel Head, US Patent Litigation Novartis Pharmaceuticals Corporation Dan Minion Partner Venable Eric W. Dittmann Partner and Global Vice-Chair, Intellectual Property Paul Hastings LLP Kathleen B. Carr Partner McCarter & English, LLP Moderator: Gerald J. Flattmann, Jr. Partner King & Spalding 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
4:15	Afternoon Break
4:30	The Ethical Practice of Paragraph IV Litigation: New Developments Impacting Professional Responsibility in the Hatch-Waxman Arena Mary J. Morry Counsel, IP Litigation Office of the General Counsel Merck Sharp & Dohme Corp. Chris Borello Partner Venable LLP Mark E. Waddell Partner Loeb & Loeb LLP David G. Conlin Partner McCarter & English, LLP Moderated by: Vishal C. Gupta Partner Steptoe & Johnson LLP This interactive skills session will identify common ethical dilemmas in Hatch-Waxman litigation and help you incorporate practices to avoid them. Points of discussion will include: Drafting conflicts of interest waivers, whether actual or potential Identifying hidden dangers in joint defense arrangements What happens if the clients do not agree or a dispute between them arises? Do all parties have to seek new counsel? Analyzing the requirements for pleadings, whether in the complaint, the answer, or the counterclaim Interpreting Rule 11 and other standards
5:30	Conference Concludes

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