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