Paragraph IV Disputes Conference

Co-Chairs’ Opening Remarks

Guy Donatiello
Senior Vice President, Intellectual Property
Endo Pharmaceuticals

Pearl Siew
Senior Vice President and Head, Intellectual Property
Design Therapeutics

Co-Chairs’ opening remarks.

Welcome Back Town Hall

Forecasting the Future of Pharmaceutical Patent Litigation: Trends, Legal Analyses and Business Prognoses Post-Covid

Andrei Iancu
Partner
Irell & Manella LLP
(Former Director, U.S. Patent and Trademark Office)

Jay R. Deshmukh
Partner
Kasowitz Benson Torres

Simon Roberts
Partner
Hogan Lovells

The global pandemic completely disrupted the pharmaceutical IP world with an exceptional challenge. Innovative companies reacted by collaborating and sharing intellectual property to introduce revolutionary vaccines and therapeutics. These efforts demonstrated the value of IP protections in encouraging innovation as well as highlighted the dilemmas of affordable market access.

This opening annual report will outline the key factors brands and generics need to consider to protect patents, products, and market share in the future.

• Analyzing recent federal and state executive actions and legislative initiatives and their potential impact on the pharmaceutical industry
  • Orange Book Transparency Act
  • “Buy America” policies and executive orders
  • California’s A824 patent settlement law and related federal and state legislative initiatives
  • Potential amendments to the Hatch-Waxman Act, and more
• Navigating state laws governing transparency in drug pricing
• Evaluating the factors impacting the pharmaceutical global supply chain
• Understanding the impact on pharma of patent enforcement trends in ex-U.S. jurisdictions, as well as ongoing international developments at the WTO

GSK v. Teva: Induced Infringement Liability the Fate of Section VIII Carve-Outs

Josephine Liu
Global Head of IP Litigation
Sandoz

James Peterka
Partner
Locke Lord LLP

Michael Sitzman
US Chair, Life Sciences Patent Litigation
DLA Piper

Vanessa Yen
Partner
King & Spalding LLP

Moderator:

William A. Rakoczy
Founding Partner
Rakoczy Molino Mazzochi Siwik LLP

On February 23, 2021, the Federal Circuit, on Teva’s petition, reheard a second oral argument in GSK v. Teva. The court had previously vacated its prior ruling finding in GSK’s favor that Teva induced infringement based on so-called skinny labeling. As we await the Federal Circuit’s new opinion, this panel will provide insights into strategies and tactics regarding section viii carve outs in view of the decision.

• Reevaluating claim and label language for optimal drafting
• Analyzing what types of evidence should be used to prove infringement
• Understanding second medical use patents and carve-out strategies
  • Clarifying the patentability of further medical use inventions
• Outlining the implications of the Federal Circuit decision striking down labeling carve-outs
• Determining whether post-filing evidence is admissible to show insufficient disclosure of further medical use
• Balancing competing interests in promoting innovation v. permitting generic drugs

Networking Break

The Current State of Patent Eligibility Jurisprudence: Redefining What Is Patent-Eligible Subject Matter Post-American Axle v. Neapco

Ryan M. Daniel
Chief Patent Counsel, Region North America
Fresenius Kabi USA, LLC

Steven M. Coyle
Partner
Cantor Colburn LLP

Alejandro Menchaca
Shareholder
McAndrews, Held & Malloy, Ltd.

Jonathan Davies
Partner
Cooley LLP

The saga continues. Competing interests have kept the reformation of patentable subject matter eligibility under 35 U.S.C. 101 from getting before has Congress. At the time of press, a petition for writ of cert has been filed and the Supreme Court invited the Acting Solicitor General to file a brief in the American Axle. At issue is what standard determines whether a patent claim is directed to a patent-ineligible concept and whether patent eligibility is a question of law.

This session will review the most impactful cases from the last 12 months in 101 jurisprudence and review the Court’s attempt to resolve the “bitter divide” in the application of §101:

• Examining the Biden administration’s views on patent law and eligibility
• Reviewing recent District Court cases tackling 101 at the motion to dismiss and summary judgment stages
• Taking stock of recent 101 cases applying the Supreme Court’s Alice/Mayo tests before the Federal Circuit
  • Boehringer Ingelheim Pharmaceuticals, Inc. v. Mylan Pharmaceuticals, Inc. (Fed. Cir. 2020)
  • Illumina, Inc. v. Ariosa Diagnostics, Inc. (Fed. Cir. 2020)
• Deciding whether a new application of an abstract idea is abstract
• Analyzing when courts will conclude that any claim at issue is deemed invalid as claiming ineligible subject matter
  • Whether there was direction to a natural phenomenon

Networking Luncheon

The Future of Obviousness: Objective Indicia of Nonobviousness and Obviousness-Type Double Patenting

Forrester Liddle
Senior Director, Head of IP
Jounce Therapeutics

David Blackburn
Director
NERA Economic Consulting

Elizabeth Holland
Partner
Goodwin Procter LLP

Robert C. Millonig
Director
Sterne, Kessler, Goldstein & Fox P.L.L.C.

• Analyzing the impact of Immunex v. Sandoz (Fed. Cir. 2020) on the standard for determining common ownership in applying obviousness-type double patenting (OTDP)
• Outlining recent federal circuit and district court trends related to OTDP
  • Evaluating activity on OTDP as it applies to PTA
• Reviewing the status of proposed OTDP legislation
• Developing strategies for overcoming OTDP rejections
• Evaluating circumstances in which a terminal disclaimer must be made

BREAKOUT SESSIONS (CHOOSE A OR B)

Track A | The Business of Hatch-Waxman Litigation: A Global Approach

Track B | The Practice of Hatch-Waxman Litigation: Town Hall with the Magistrate Judges

Track A

Donna Meuth
Associate General Counsel, IP
Eisai

Henry H. Gu
VP, Head of Intellectual Property
Morphic Therapeutics

Melanie R. Rupert
Partner, Global Co-Chair of Talent Development
Paul Hastings LLP

Track B

Honorable Christopher J. Burke
Magistrate Judge
District of Delaware

Michael K. Nutter
Partner
Winston & Strawn LLP

Adam Poff
Partner
Young Conaway Stargatt & Taylor, LLP

Track A | The Business of Hatch-Waxman Litigation: A Global Approach

Managing Global Pharmaceutical Patent Litigation: International and Domestic Considerations.

• 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 B | The Practice of Hatch-Waxman Litigation: Town Hall with the Magistrate Judges

When to Reduce Claims and Defenses to a Manageable Level in Paragraph IV Litigation.

• Utilizing claim reduction during scheduling negotiations to avoid excessive patent claims
• Deciding when to oppose consolidation of new actions in litigation based on patents issuing from new applications
• Determining when to demand that claims to be tried are representative of all asserted claims and give ride to estoppel

BREAKOUT SESSIONS (CHOOSE A OR B)

Track A | Understanding the Importance of Aligning Legal and Business Functions for Patent Litigation Planning

Track B | Practical Strategies and Tactics for Effective Settlement Negotiation

Track A

Stephanie Donahue
Senior Director, Patent Litigation
Sanofi- Aventis

Lars Taavola
VP, Chief Intellectual Property Counsel
Mallinckrodt Pharmaceuticals

Noah M. Leibowitz
Partner
Dechert LLP

Alyson Wooten
Director
Berkeley Research Group LLC

Track B

Honorable Mary Pat Thynge
Chief Magistrate Judge
District of Delaware

Vishal C. Gupta
Partner
Steptoe & Johnson LLP

Adam L. Perlman
Partner
Latham & Watkins LLP

Track A | Understanding the Importance of Aligning Legal and Business Functions for Patent Litigation Planning

• Utilizing business functions such as operations, business development and life cycle management to advance product portfolio acquisitions and IP protections
• Understanding the importance of global portfolio planning from the get-go
• Responding in kind to continued growth on a global scale by building a team structure that is sustainable on a long-term basis to address IP litigation around the world
• 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
• Considering FDA warning letters relative to foreign manufacturing sites and reviewing related manufacturer liability
  • 180-day exclusivity forfeiture

Track B | Practical Strategies and Tactics for Effective Settlement Negotiation

• Developing timelines for business and legal milestones relative to the terms of the settlement
• Understanding the application of antitrust law’s “rule of reason” on pharmaceutical patent settlement practice
• Examining recent decisions concerning pharmaceutical patent settlements in the PIV context
• Analyzing practical strategies and tactics for effective settlement negotiation

Networking Break

Spotlight on Delaware: District Court Judges Address Brand and Generic Concerns

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

Moderator:

Elizabeth S. Weiswasser
Partner
Weil, Gotshal & Manges 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 discuss best practices for both patent holders and patent challengers. These federal judges will identify the impediments to resolving such multifaceted contests and provide you with a rare opportunity to find solutions to your most unyielding Paragraph IV predicaments.

Welcome Back Cocktail Reception

Co-Chairs’ Opening Remarks

Guy Donatiello
Senior Vice President, Intellectual Property
Endo Pharmaceuticals

Pearl Siew
Senior Vice President and Head, Intellectual Property
Design Therapeutics

Co-Chairs’ opening remarks.

Regulatory Think Tank

Analyzing the Effect of the Latest FDA Initiatives on Generic Drug Access and PIV Disputes

Maryll Toufanian
Director, Office of Generic Drug Policy
U.S. FDA

Brian Stone
Associate General Counsel, Global Legal-Regulatory
Viatris

Kurt Karst
Director
Hyman, Phelps & McNamara PC

• 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

The PTAB Live! Practice, Policy, and Procedure in the New World of Pharmaceutical Patent Validity Challenges

Honorable Jacqueline Wright Bonilla
Deputy Chief Administrative Patent Judge
Patent Trial & Appeal Board
USPTO

Honorable Michelle N. Ankenbrand
Lead Administrative Patent Judge

Honorable Kristi Rupert Sawert
Administrative Patent Judge

Moderated by:

John J. Molenda
Partner
Steptoe & Johnson LLP

Gregory A. Morris
Partner
Honigman LLP

• Taking stock of the latest developments related to the PTAB’s expanded use of discretionary denials
• Examining the impact of the Supreme Court’s decision in Arthrex Inc. v. Smith & Nephew
• Reviewing the latest stats at PTAB, highlighting bio/pharma cases
• Analyzing the status of PTAB in a COVID environment
  • Oral hearings
• 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

Networking Break

To Stay or Not to Stay: Winning Strategies for Addressing Parallel Proceedings at the District Court and IPR

Dominick A. Conde
Partner
Venable LLP

Gerald J. Flattmann, Jr.
Partner
King & Spalding LLP

Edward D. Pergament
Partner
Pergament & Cepeda LLP

Brian Anderson
Counsel
Polsinelli PC

• 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
• Ensuring all RPIs are properly named
• Assessing split petition strategies
• Understanding when requests for joinder can be made and when they should be made
• Analyzing secondary considerations
• 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
• Identifying best practices for simultaneous trials
• Appealing decisions in both forums

SPOTLIGHT ON DEI

Diversity, Equity, and Inclusion: Implementing Change and Expanding Innovation

Valencia Martin Wallace
Deputy Commissioner for Patents
U.S. Patent and Trademark Office

Huong T. Nguyen
General Counsel
Fosun Pharma USA Inc.

Neal Dahiya
SVP, Head of Litigation
Moderna

The Director of the National Institute of Health (NIH) recently announced that the agency plans “new ways to support diversity, equity, and inclusion,” and will also correct policies within the agency “that may harm our workforce and our science”. The growing call to action seems clear: the pharmaceutical IP community must support equity-mindedness and conscious inclusion if they are to realize the full benefits of a diverse workforce. This session will consider best practices for implementing change and expanding innovation by advocating for diversity, equity and inclusion in IP.

Networking Luncheon

Think Tank on State and Federal Antitrust Initiatives: Commercial Considerations for Patent Settlements, Reverse Payments, and Emerging Legislation

Dr. Christine Siegwarth Meyer
Managing Director, Chair of IP
NERA Economic Consulting

Michael A. Carrier
Distinguished Professor of Law
Rutgers Law

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 reverse payment litigation, the competitive effects, and economic consequences.

Topics of discussion will include:

• Understanding settlement strategies between innovator biologic companies and biosimilar 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

Written Description and Enablement: Defensive Strategies and Offensive Moves for §112 Rejections and Attacks

David L. Anstaett
Partner
Perkins Coie LLP

Andrew J. Allen
Senior Director, Legal Counsel
Dr. Reddy’s Laboratories

Kevin S. Prussia
Partner
Wilmer Cutler Pickering Hale and Dorr LLP

Jeanna M. Wacker
Partner
Kirkland & Ellis LLP

Moderator:

Emily Savas
Partner
Locke Lord LLP

In one of the most important patent stories of the year, the Federal Circuit issued a groundbreaking decision concerning the validity of antibody epitome claims covering a reference product. In Amgen Inc. v. Sanofi, No. 20-1074 (Fed. Cir. 2021), the court held that “a genus of antibodies claimed only by specific functional properties are invalid for lack of enablement.” The Federal Circuit invalidated all claims for lack of enablement, holding that “the binding limitation itself was sufficient for the claims to require undue experimentation.” In view of this precedential decision, this panel will consider the new requirements for creating a valid patent and how best to leverage recent decisions.

• Identifying best practices for meeting the written description and enablement requirements
  • How to survive invalidity and unpatentability challenges
• Evaluating the enablement and written description of claims directed to a genus of antibodies
• Examining the Federal Circuit’s recent approach and interpretation of written description under §112 as it applies to small molecules
• Assessing current patents for written description vulnerabilities under these Federal Circuit opinions
• Examining patent challenges and defenses in ANDA proceedings under this new §112 jurisprudence

SCOTUS Weighs In: The Future and Scope of the Equitable Doctrine of Assignor Estoppel

Shashank Upadhye
Partner
Upadhye Tang LLP

Last year, in Minerva Surgical, Inc. v. Hologic, Inc. the Federal Circuit held that the doctrine of assignor estoppel does not prevent an assignor from lodging a validity challenge of an assigned patent in an IPR proceeding. The doctrine precludes inventors from assigning a patent to someone and then challenging the validity of the patent. In reviewing the Federal Court’s decision, The Supreme Court vacated the Federal Circuit’s decision in a 5-4 decision, holding that the appeals court gave an overly broad interpretation of assignor estoppel. This session will consider the now limited doctrine and contemplate its future as an equitable matter.

Points of discussion will include:

• Reviewing recent approaches to assignors in patent invalidation
  • Taking stock of the impact to patent sale and assignment agreements
• Assessing considerations for contract provisions
• Examining how the decision could impact pharmaceutical patent law and related transactions

ETHICS LAB

The Ethical Practice of Paragraph IV Litigation: New Developments Impacting Professional Responsibility in the Hatch-Waxman Arena

Jonathan D.J. Loeb Ph.D.
Partner
Dechert 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

Conference Concludes