Day 1 - Thursday, October 3, 2019

7:00
Registration and Continental Breakfast
8:00
Opening Remarks
8:15

SUBMIT YOUR QUESTIONS

Town Hall Q&A Session with ACI’s Hatch-Waxman Series Advisory Board: Insights from the Eyes of the Client
9:15

LIVE AUDIENCE POLLING

60 Minutes on Patents, Politics and Policy: An Analysis of Proposed Hatch-Waxman Reform Measures
10:30
Networking Coffee Break
10:45

REGULATORY THINK TANK

Analyzing The Effect of the Latest FDA Initiatives on Generic Drug Access and ANDA Litigation
11:45

§101 and §112

Written Description and Subject Matter Patentability: The Impact of New §112 and §101 Challenges on Paragraph IV Litigation
12:30
Networking Luncheon hosted by
1:30
Interpretations of Evolving Doctrine of Equivalents Jurisprudence and its Effect on Hatch-Waxman Litigation
2:30
Afternoon Refreshment Break
2:45

MAGISTRATE TOWN HALL

Understanding the Roles of the Magistrate Judges and Local Counsel in Paragraph IV Proceedings
4:00

VIEW FROM THE FEDERAL BENCH

District Court Judges on the Present State of Paragraph IV Litigation: Filing Trends, Settlements and Timings
5:15
Drinks Reception hosted by

Day 2 - Friday, October 4, 2019

7:30
Registration and Continental Breakfast
8:00
Opening Remarks
8:15

BREAKFAST WITH THE PTAB

The APJs Speak on Practices, Policy and Procedure
9:15
Networking Coffee Break
9:30

A WAR ON TWO FRONTS

The Interplay of Co-Pending District Court and IPR Proceedings
10:30

FTC KEYNOTE

SPOTLIGHT ON PHARMACEUTICAL ANTITRUST IN AMERICAAntitrust Developments Concerning Brands & Generics
11:00
Practical Strategies and Tactics for Effective Settlement Negotiation
12:00
Networking Luncheon
1:00

INTERNATIONAL

The Global Approach to Pharmaceutical Patent Litigation
2:00

THE FUTURE OF OBVIOUSNESS

Understanding the Federal Circuit’s Application of the Blocking-Patent Doctrine Post Acorda
3:00
Refreshment Break
3:15

MOTION PRACTICE MAKES PERFECT

12(b) and 12(c) Motions: Analyzing the “Unique” Pleading Requirements in Hatch-Waxman Actions
4:15

ETHICS

The Ethical Practice of Paragraph IV Litigation: New Developments Impacting Professional Responsibility in the Hatch-Waxman Arena
5:15
Conference Concludes

Day 1 - Thursday, October 3, 2019

7:00
Registration and Continental Breakfast
8:00
Opening Remarks

Ryan M. Daniel
Acting Chief Patent Counsel
Fresenius Kabi USA, LLC (Lake Zurich, IL)

Andrea Hutchison
Associate General Counsel, IP Litigation
Gilead Sciences (Foster City, CA)

8:15

SUBMIT YOUR QUESTIONS

Town Hall Q&A Session with ACI’s Hatch-Waxman Series Advisory Board: Insights from the Eyes of the Client

Brian Hirsch
Vice President Global IP and Legal Head North America
Glenmark Pharmaceuticals (Mahwah, NJ)

James Leeds

James P. Leeds
Assistant General Patent Counsel
Eli Lilly & Company (Indianapolis, IN)

Pearl T. L. Siew
Senior Vice President and Head Intellectual Property
Eagle Pharmaceuticals, Inc. (Woodcliff Lake, NJ)

MODERATOR:

Shashank Upadhye

Shashank Upadhye
Partner
Upadhye Cwik LLP
(Former Vice President – Global Intellectual Property, Apotex, Inc.)

In this session, members of ACI’s Hatch-Waxman Advisory Board will provide you with insights from in-house counsel on what they want most from their outside counsel partners in terms of skills and knowledge, information, communication, and of course cost.

This exclusive panel will help you enhance the attorney-client relationship by running through real-life scenarios calling for real-time rejoinders. 10 attendees question will be answered in real time in this town-hall exchange. Please submit questions for consideration to [email protected]

9:15

LIVE AUDIENCE POLLING

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

David Korn
Vice President, IP and Law
PhRMA (Washington, DC)

Colin Heitzman

Colin C. Heitzmann
Senior Corporate Attorney
Otsuka Pharmaceutical Development & Commercialization, Inc. (Rockville, MD)

Lars Taavola

Lars P. Taavola
Senior Director / Senior Patent Counsel – Global Intellectual Property | Head of Patent Litigation
Amneal Pharmaceuticals (Bridgewater, NJ)

MODERATOR:

Mark T. Deming
Shareholder
Polsinelli PC (Chicago, IL)

In the current political climate fueled by the President’s Drug Pricing Blue Print, Hatch-Waxman reform is being proposed as vehicle to lower the high cost of drugs. This session will consider the current and proposed legislation and other potentially impactful measures and their influence on Paragraph IV litigation.

10:30
Networking Coffee Break
10:45

REGULATORY THINK TANK

Analyzing The Effect of the Latest FDA Initiatives on Generic Drug Access and ANDA Litigation
Kurt Karst

Kurt Karst
Director
Hyman, Phelps & McNamara PC (Washington, DC)

Carmen Shepard

Carmen M. Shepard
Senior Vice President, Global Policy and Regulatory Counsel
Mylan (Washington, DC)

  • Analyzing recent FDA activity affecting market access and exclusivities
  • Evaluating brand and generic insights into the relationship between pricing and patents in the current Hatch-Waxman landscape
  • Clarifying the breadth of orphan drug exclusivity
  • Determining 180-Day exclusivity
    • Deciphering the FDA’s First Applicant Interpretation

11:45

§101 and §112

Written Description and Subject Matter Patentability: The Impact of New §112 and §101 Challenges on Paragraph IV Litigation
Jonathan Bachand

Jonathan Bachand
Partner
Knobbe Martens Olson & Bear LLP (Washington, DC)

Karen E. Brown
Vice President & Chief IP Counsel
Ironwood Pharmaceuticals (Cambridge, MA)

Ryan M. Daniel
Acting Chief Patent Counsel
Fresenius Kabi USA, LLC (Lake Zurich, IL)

Nathan (Nate) Kelley
Partner
Perkins Coie LLP (Washington, DC)

MODERATOR:

James Peterla

James T. Peterka
Partner
Locke Lord LLP (Chicago, IL)

  • Reviewing recent litigation statistics and outcomes
  • Enabling the “full scope” of the claims
  • Examining the §112 written description requirement in pharmaceutical cases
  • Understanding §101 patent eligibility
    • Method of treatment claims v. diagnostic claims

12:30
Networking Luncheon hosted by
1:30
Interpretations of Evolving Doctrine of Equivalents Jurisprudence and its Effect on Hatch-Waxman Litigation
Andrew Allen

Andrew Allen
Director, Legal Counsel – IP
Dr. Reddy’s Laboratories

John T. Bennett
Partner
Goodwin Procter LLP (Boston, MA)

Jamie Lucia
Attorney
Steptoe & Johnson LLP (San Francisco, CA)

  • Analyzing the Federal Circuit’s limitation of the doctrine of equivalents to “exceptional cases” in Amgen Inc. v. Sandoz Inc.
  • Understanding how to use the doctrine of equivalents to prevent patent infringement
  • Evaluating when the doctrine of ensnarement precludes a patent owner from asserting infringement

2:30
Afternoon Refreshment Break
2:45

MAGISTRATE TOWN HALL

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

Honorable Tonianne J. Bongiovanni
Magistrate Judge
District of New Jersey (Newark, NJ)

Honorable Roy Payne
Magistrate Judge
Eastern District of Texas (Marshall, TX)

Honorable Sidney I. Schenkier
Magistrate Judge
Northern District of Illinois (Chicago, IL)

MODERATOR:

Paul J. Molino
Managing Partner
Rakoczy Molino Mazzochi Siwik LLP (Chicago, IL)

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

4:00

VIEW FROM THE FEDERAL BENCH

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

Honorable Rebecca R. Pallmeyer
Chief Judge
Northern District of Illinois (Chicago, IL)

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.

5:15
Drinks Reception hosted by

Day 2 - Friday, October 4, 2019

7:30
Registration and Continental Breakfast
8:00
Opening Remarks
8:15

BREAKFAST WITH THE PTAB

The APJs Speak on Practices, Policy and Procedure

Honorable Jacqueline Wright Bonilla
Vice Chief Administrative Patent Judge
Patent Trial and Appeal Board
US Patent and Trademark Office (Alexandria, VA)

Honorable Michelle N. Ankenbrand
Lead Administrative Patent Judge
Patent Trial and Appeal Board
US Patent and Trademark Office (Alexandria, VA)

Honorable Rama G. Elluru
Administrative Patent Judge
Patent Trial and Appeal Board
US Patent and Trademark Office (Alexandria, VA)

MODERATOR:

Gregory A. Morris
Partner
Honigman LLP (Chicago, IL)

  • Surveying notable pharmaceutical patent wins and losses
  • Reviewing IPR, PGR and CBM filings involving pharmaceutical patents
  • Examining the latest statistics for types of challenges brought and types of patents challenged
  • Examining when the PTAB will issue a “good cause” extension of trial
  • Considering emerging case law shaping the role of prior art in the PTAB’s discretionary denial of inter partes review
  • Evaluating when petitioners may rely on prior art previously considered by the PTAB

9:15
Networking Coffee Break
9:30

A WAR ON TWO FRONTS

The Interplay of Co-Pending District Court and IPR Proceedings
Domnick A. Conde

Dominick A. Conde
Partner
Venable LLP

Jeremiah S. Helm
Of Counsel
Knobbe Martens Olson & Bear LLP (Washington, DC)

Derek Johnson
Senior Counsel, Intellectual Property
Takeda Pharmaceuticals (Deerfield, IL)

Moderator:

Irena Royzman
Partner
Kramer Levin Naftalis & Frankel LLP (New York, NY)

  • Investigating the effect that a narrower claim construction standard will have on patentability rulings in both forums as well as the Federal Circuit
  • 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
  • Understanding the impact that the uniform standard will have on efficiency and cost of litigation
  • Analyzing how the PTAB’s adoption of the Phillips standard is impacting Hatch-Waxman practice

10:30

FTC KEYNOTE

SPOTLIGHT ON PHARMACEUTICAL ANTITRUST IN AMERICAAntitrust Developments Concerning Brands & Generics
James Weingarten

James Weingarten
Attorney
Federal Trade Commission (Washington, DC)

11:00
Practical Strategies and Tactics for Effective Settlement Negotiation
David Abramowitz

David B. Abramowitz
Partner
Locke Lord LLP (Chicago, IL)

William F. Cavanaugh

William F. Cavanaugh, Jr.
Partner
Patterson Belknap Webb & Tyler LLP (New York, NY)

Monique Heyninck
Vice President, IP & Government Affairs
Avanir Pharmaceuticals, Inc. (Aliso Viejo, CA)

  • Developing timelines for business and legal milestones relatives to terms of the settlement
  • Understanding the application of antitrust law’s “rule of reason” to pharmaceutical patent settlements
  • Examining decisions concerning pharmaceutical patent settlements

12:00
Networking Luncheon
1:00

INTERNATIONAL

The Global Approach to Pharmaceutical Patent Litigation
Dan DiNapoli

Daniel P. DiNapoli
Partner
Arnold & Porter Kaye Scholer LLP (New York, NY)

Vanessa Yen
Partner
King & Spalding LLP

Andrea Hutchison
Associate General Counsel, IP Litigation
Gilead Sciences (Foster City, CA)

  • 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

2:00

THE FUTURE OF OBVIOUSNESS

Understanding the Federal Circuit’s Application of the Blocking-Patent Doctrine Post Acorda

John L. Abramic
Partner
Steptoe & Johnson LLP (Chicago, IL)

Forrester J. Liddle
Senior Director of IP
Jounce Therapeutics (Cambridge, MA)

Luke T. Shannon
Shareholder
Polsinelli PC (Chicago, IL)

Moderator:

Marc N. Zubick
Partner
Latham & Watkins LLP (Chicago, IL)

  • Deciding whether objective indicia of nonobviousness may be partially or entirely discounted where the development of an invention was allegedly “blocked” by the existence of a prior patent
  • Analyzing the concept of “blocking patents”
    • Understanding the role and rationale in obviousness
  • Considering the takeaways from the patent challenger perspective in addition to the patentee perspective

3:00
Refreshment Break
3:15

MOTION PRACTICE MAKES PERFECT

12(b) and 12(c) Motions: Analyzing the “Unique” Pleading Requirements in Hatch-Waxman Actions
Steve Auten

Stephen R. Auten
Partner, Chair of Pharmaceutical & Life Sciences Litigation
Taft Stettinius & Hollister LLP
(Former Vice President, IP, Sandoz, Inc.)
(Chicago, IL)

  • Understanding when to file a rule 12(b) motion v. 12(c)
  • Avoiding your motion being converted into a motion for summary judgment
  • Learning what facts are necessary to support your motion
  • Considering materials incorporated by reference in the pleadings
    • NDA, ANDA, prosecution history etc.
  • Determining issues suitable for resolution
    • Questions of law v. questions of fact
  • Analyzing statistics of recent Hatch-Waxman cases
    • Granted v. denied

4:15

ETHICS

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

Bradley C. Graveline
Partner
Sheppard Mullin Richter & Hampton LLP (Chicago, IL)

This session will identify common ethical dilemmas in Hatch-Waxman litigation and help you incorporate practices to avoid them. Points of discussion will include:

  • Reviewing the sufficiency of your notice letter
  • Establishing standards for determining when attorneys/firms should be disqualified based on conflict
  • Determining who is a client based on actual representation
  • Considering joint defense arrangements in the Hatch-Waxman setting and possible ethical predicaments

5:15
Conference Concludes