Day 1 - Wednesday, September 21, 2022

8:00
Opening Remarks
8:15

LIVE AUDIENCE POLLING

60 Minutes on Patents, Politics and Policy: An Analysis of Proposed Hatch- Waxman Reform Measures
9:15

§101 and §112

Skinny Labeling: The Future of Carveouts and the Analyzing the Influence of GSK v. Teva on Competition
10:15
Networking Coffee Break
10:45
The Relationship Between Written Description and Enablement Post-Biogen v. Mylan: Best Practices for Strengthening or Invalidating Patent Claims
11:45
Is Your Case Dead in the Water? Redefining What Is Patent-Eligible Subject Matter Post-American Axle v. Neapco
12:45
Networking Luncheon
2:00
VENUE WAR ROOM: Knowing, How, When, and Where to Plan Your Attack Based on Current Trends in MDL with Joint Defense Groups
3:00

Diversity, Equity & Inclusion

Implicit Bias in Life Sciences IP: How to Promote and Implement Bias-Reducing Strategies
4:00
Afternoon Refreshment Break
4:15

MAGISTRATE TOWN HALL

Understanding the Roles of the Magistrate Judges and Local Counsel in Paragraph IV Proceedings
5:15

VIEW FROM THE FEDERAL BENCH

District Court Judges on the Present State of Paragraph IV Litigation: Filing Trends, Counterclaims Settlements and Timings
6:15
Cocktail Reception

Day 2 - Thursday, September 22, 2022

8:00
Opening Remarks
8:15

REGULATORY THINK TANK

Analyzing the Impact of the Latest FDA Initiatives on Generic Drug Access and Hatch-Waxman Litigation
9:15

THE PTAB LIVE!

The APJs Speak on Practice, Policy, and Procedure in the World of Pharmaceutical Patent Validity Changes
10:15
Networking Coffee Break
10:45
The Interplay of Co-Pending IPR Proceedings: Winning Strategies for Navigating the District Court and Inter Partes Review
12:00
Networking Luncheon
1:00
Restrictions on Reverse-Payment Settlements: Non-Monetary Settlements and Provisions Relating to FTC/DOJ review
2:00

INTERNATIONAL

Cross-Border Business Considerations in a Hatch-Waxman Scenario: The Global Approach to Pharmaceutical Patent Litigation
3:00
Refreshment Break
3:15
OTDP and Patent Terms: The Interplay Between Obviousness-Type Double Patenting, Pattern Terms Extension and Patent Term Adjustment Post-Ex Parte Cellect
4:15
Revisiting Damages in an At-Risk Launch Scenario: Questions of Remedies and Valuation
5:15

ETHICS

Ethical Considerations for the Hatch-Waxman Practitioner: Discovery, Privilege, and Professional Responsibility
6:15
Conference Concludes

Day 1 - Wednesday, September 21, 2022

8:00
Opening Remarks

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

Linda Friedlieb
Division Counsel
AbbVie

8:15

LIVE AUDIENCE POLLING

60 Minutes on Patents, Politics and Policy: An Analysis of Proposed Hatch- Waxman Reform Measures

Anita Varma
Partner
White & Case LLP

Anna Brook
Partner
Culhane Meadows PLLC

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

This session will consider current and proposed legislation, as well as other potentially impactful measures which may influence on Paragraph IV litigation. Topics of discussion will include:

  • Pending bipartisan legislation to watch including:
    • S.2891 (Restoring the American Invents Acts)
    • S.3772 (Defend American Courts Act)
    • S.2076 (PASTEUR Act) / S.2209 (VALID Act)
  • Predicting what the Inflation Reduction Act means for ANDA litigators
  • “Buy American” policies and executive orders

9:15

§101 and §112

Skinny Labeling: The Future of Carveouts and the Analyzing the Influence of GSK v. Teva on Competition
David Abramowitz

David Abramowitz
Partner
Locke Lord LLP

Aziz Burgy
Partner
Axinn, Veltrop & Harkrider LLP

Gregory A. Morris
Partner
O’Melveny & Myers LLP

  • 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

10:15
Networking Coffee Break
10:45
The Relationship Between Written Description and Enablement Post-Biogen v. Mylan: Best Practices for Strengthening or Invalidating Patent Claims

John T. Bennett
Partner
Allen & Overy LLP

Mary C. Till
Senior Legal Advisor
Office of Patent Legal Administration

U.S. Patent and Trademark Office

Moderator:

William A. Rakoczy
Founding Partner
Rakoczy Molino Mazzochi Siwik LLP

As demonstrated by the Federal Circuit’s recent denial of Biogen’s petition for en banc review in Biogen International GmbH et al. v. Mylan Pharmaceuticals Inc., written description and enablement requirements have perplexed patent practitioners for years. The dissent demonstrates opposing views at the Federal Circuit and among the bar as to §112 and signals that the Supreme Court may grant cert.

  • 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
  • Analyzing litigation insights that inform patent drafting application strategies

11:45
Is Your Case Dead in the Water? Redefining What Is Patent-Eligible Subject Matter Post-American Axle v. Neapco

John L. Abramic
Partner
Steptoe & Johnson LLP

Paul Browning
Partner
Finnegan, Henderson, Farabow, Garret & Dunner LLP

Brian P. Murray
Partner
Holland & Knight LLP

This session will review the latest developments and e most impactful cases from the last 12 months in 101 jurisprudence and review the Court’s attempt to resolve the “bitter divide” of patent subject matter eligibility.

  • Analyzing the unique 101 questions posed by American Axel and assessing its chance of have cert. granted
    • Understanding the significance of the Court’s invitation to the Solicitor General to file a brief in this case
  • Considering 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 the 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
  • Assessing the competing interests keeping 101 reform at bay

12:45
Networking Luncheon
2:00
VENUE WAR ROOM: Knowing, How, When, and Where to Plan Your Attack Based on Current Trends in MDL with Joint Defense Groups

Caryn Borg-Breen
Partner
Ballard Spahr

Dan Hoang
Senior Counsel – Patent Litigation
AbbVie

With the latest rulings on venue, deciding where to file your case is mission critical.

In this session, our panelists will consider the proper venue for Hatch-Waxman cases and address the unanswered question of what constitutes “actions related to the ANDA submission”. Topics of discussion will include:

  • Reviewing Celgene Corp. v. Mylan Pharmaceuticals, Inc. 17 F.4th 1111 (Fed. Cir. 2021)
    • As in Valeant, the question of whether the location where ANDA submissions are sent (i.e., Maryland) might be a proper venue/where an “act of infringement” occurs, was not addressed by CAFC.
  • Determining whether “relevant acts involved in the preparation and submission of an ANDA” limited to submission of the ANDA after Celgene?
  • Analyzing if Valeant and Celgene have impacted where Hatch-Waxman suits are being filed
  • Outlining the pros and cons of joint defense groups
  • Recognizing when to contest venue

3:00

Diversity, Equity & Inclusion

Implicit Bias in Life Sciences IP: How to Promote and Implement Bias-Reducing Strategies

Robin Evans
Deputy Commissioner for Patents
United States Patent and Trademark Office

Jamie L. Lucia
Partner
Steptoe & Johnson LLP

Linda Friedlieb
Division Counsel
AbbVie

Implicit bias refers to the unconscious attitudes or stereotypes that affect our understanding, actions, and decisions. In this interactive session, our panelists will introduce the topic of implicit bias in pharmaceutical patent litigation, share bias-reducing strategies, and will invite attendees to share their thoughts and perceptions on implicit bias. Topics of discussion will include:

  • Analyzing both involuntary and voluntary behaviors that hinder diversity, recruiting, and retention efforts in life sciences IP careers
  • Understanding the economic and other costs of implicit bias, especially in areas of law, science, IP, and innovation
  • Recommending strategies for reducing or eliminating bias
    • Identifying tests designed to aid in determining where biases exist

4:00
Afternoon Refreshment Break
4:15

MAGISTRATE TOWN HALL

Understanding the Roles of the Magistrate Judges and Local Counsel in Paragraph IV Proceedings

Hon. Douglas E. Arpert
Magistrate Judge
United States District Court, District of New Jersey

Hon. Christopher J. Burke
Magistrate Judge
United States District Court, District of Delaware

Moderator:

Jeffrey R. Gargano
Partner
K&L Gates LLP

This panel will explore the intricacies of local rules and offer solutions to your most rigid Paragraph IV pickles.

  • Understanding when to reduce claims and defenses to a manageable level
  • How to masterfully manage protective order disputes
  • Analyzing practical strategies and tactics for effective settlement negotiation

5:15

VIEW FROM THE FEDERAL BENCH

District Court Judges on the Present State of Paragraph IV Litigation: Filing Trends, Counterclaims Settlements and Timings

Hon. Colm F. Connolly
Chief Judge
United States District Court, District of Delaware

Judge Stanley Chesler

Hon. Stanley R. Chesler
District Judge
United States District Court, District of New Jersey

Hon. Joshua Wolson
District Judge
United States District Court, Eastern District of Pennsylvania
(Visiting Judge, District of Delaware)

Moderator:

Anne Shea Gaza
Partner
Young Conaway Stargatt & Taylor, 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.

6:15
Cocktail Reception

Day 2 - Thursday, September 22, 2022

8:00
Opening Remarks
8:15

REGULATORY THINK TANK

Analyzing the Impact of the Latest FDA Initiatives on Generic Drug Access and Hatch-Waxman Litigation
Kurt Karst

Kurt Karst
Director
Hyman, Phelps & McNamara PC

Brian Stone
Vice President
Assistant Global General Counsel Regulatory

Mylan

  • Reconciling Hatch-Waxman exclusivity with CGT exclusivity
  • 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
  • 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

9:15

THE PTAB LIVE!

The APJs Speak on Practice, Policy, and Procedure in the World of Pharmaceutical Patent Validity Changes

Jacqueline Bonilla
Deputy Chief Administrative Patent Judge
Patent Trial & Appeal Board

U.S. Patent and Trademark Office

Hon. Susan Mitchell
Lead Judge, Patent Trial & Appeal Board
U.S. Patent and Trademark Office

Hon. Grace Obermann
Administrative Patent Judge, Patent Trial & Appeal Board
U.S. Patent and Trademark Office

Moderator:

Carolyn Blessing
Partner
Locke Lord 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

10:15
Networking Coffee Break
10:45
The Interplay of Co-Pending IPR Proceedings: Winning Strategies for Navigating the District Court and Inter Partes Review

Scott Weidenfeller
Partner
Covington & Burling LLP

Cary Miller
Partner
Jones Day

Hon. Teresa “Terry” Stanek Rea
Partner
Crowell & Moring LLP (Washington, DC)
(Former Deputy Director, U.S. Patent and Trademark Office)

Arlene Chow
Partner
Latham & Watkins 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

12:00
Networking Luncheon
1:00
Restrictions on Reverse-Payment Settlements: Non-Monetary Settlements and Provisions Relating to FTC/DOJ review

Huong Nguyen
General Counsel & Compliance Officer
Fosun Pharma USA Inc.

Andrew Berdon
Partner
Quinn Emanuel Urquhart & Sullivan LLP

Anil Patel
Partner
K&L Gates LLP

  • 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

2:00

INTERNATIONAL

Cross-Border Business Considerations in a Hatch-Waxman Scenario: The Global Approach to Pharmaceutical Patent Litigation

Mary Morry
Counsel
Merck & Company

Domnick A. Conde

Dominick A. Conde
Partner
Venable LLP

Andrea Tiglio
Associate General Counsel, IP Legal
Senior Director IP

Astellas Pharma US

When considering cross-border biopharmaceutical patent matters, there are multiple factors in play. It is critical to understand the patent landscape in the relevant countries, the differences in patent laws in various jurisdictions, and the timing of litigation. Topics of discussion will include:

  • Assessing common international business scenarios encountered by both brand name and generic manufacturers
  • 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
  • Managing global pharmaceutical patent litigation
  • Exploring matters of international trade and impacting the value of pharmaceutical patents

3:00
Refreshment Break
3:15
OTDP and Patent Terms: The Interplay Between Obviousness-Type Double Patenting, Pattern Terms Extension and Patent Term Adjustment Post-Ex Parte Cellect

Jeremy Lowe
Shareholder
Leydig, Voit & Mayer, Ltd.

Kevin E. Noonan
Partner
McDonnell Boehnen Hulbert & Berghoff LLP

Steven J. Horowitz
Partner
Sidley Austin LLP

In Ex Parte Cellect, the PTAB considered the appropriateness of an OTDP rejection of two related patents that had different expiration dates due to PTA. The patent whose term had been extended was found invalid – sending shivers down the spine of patent owners everywhere. With a contradictory decision delivered by the CAFC, practitioners are left with two opposing schools of thought. The present case will either expand or contract the Gilead precedent on this issue of first impression, and consider whether the doctrine is statutory or equitable.

4:15
Revisiting Damages in an At-Risk Launch Scenario: Questions of Remedies and Valuation

Alejandro Menchaca
Shareholder
McAndrews, Held & Malloy, Ltd.

Matt Murphy
Partner
Axinn, Veltrop & Harkrider LLP

Merritt D. Westcott
Partner
McGuireWoods

  • 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

5:15

ETHICS

Ethical Considerations for the Hatch-Waxman Practitioner: Discovery, Privilege, and Professional Responsibility

Tanzina Chowdhury
Senior Corporate Counsel
Nostrum Laboratories, Inc.

Shashank Upadhye
Partner
Upadhye Tang LLP
(Former Vice President – Global IP, Apotex, Inc.)

There is an ethical obligation as well as a fiduciary duty to protect the interest of your client – and Hatch-Waxman litigation has no exception to this general premise In this interactive session, our leaders will review common ethical challenges faced by Hatch-Waxman practitioners. Attendees will then reflect critically on hypothetical situations posed by the panelists, discuss in groups, and then review their conclusions.

  • Understanding how to maintain candid communication with the USPTO and fulfilling disclosure obligations
  • Exploring best practices to avoid inequitable conduct in the pharmaceutical patent litigation arena

6:15
Conference Concludes