Day 1 - Monday, April 29, 2019

7:00
Registration and Continental Breakfast
8:00
Co-Chairs’ Opening Remarks
8:15

An Executive Discussion

The Present State of Paragraph IV Litigation and Its Impact on the Pharmaceutical Industry: Legal Analyses and Business Prognoses
9:15
Addressing the Impact of a Uniform Claims Construction Standard: Panacea or Peril?
10:15
Networking Coffee Break
10:30

View from the Federal Circuit

An Interview with:
11:00

Helsinn v. Teva

The Supreme Court Weighs in on the On- Sale Bar and the State of Secret Prior Art
12:00
Networking Luncheon
1:00
The Costs and the Consequences of Determining Venue Post-TC Heartland
1:45
Afternoon Refreshment Break
2:00
Day One Afternoon Tracks A, B or C
4:15
Subject Matter Patentability and Written Description Reconsidered: Understanding the New §101 and §112 Conundrum
5:15

Judicial Roundtable

The Great Debate with District Judges
6:15
Conference Adjourns for Cocktail Reception

Day 2 - Tuesday, April 30, 2019

7:15
Continental Breakfast
8:00
Co-Chairs’ Opening Remarks and Recap of Day One
8:15
Brand and Generic Perspectives on the Latest FDA Initiatives Impacting Pharmaceutical Patents
9:00
Networking Coffee Break
9:15
Day Two Morning Tracks D, E or F
11:30

FTC Keynote

Antitrust Developments Concerning Brands & Generics
12:00
Networking Luncheon
1:00

THE PTAB LIVE!

The APJs Speak on Practice, Policy, and Procedure in the World of Pharmaceutical Patent Validity Challenges
2:00

Obviousness Case Study

Assessing Secondary Considerations in Light of Blocking Patents Post-Acorda
3:00
Refreshment Break
3:15

“Skinny Labeling” Revisited

The Evolving Induced Infringement Analysis
4:00
The Ethical Practice of Paragraph IV Litigation: New Developments Impacting Professional Responsibility in the Hatch-Waxman Arena
5:00
Conference Concludes

Parallel Proceedings Master Class

May 1, 2019 1:00pm - 4:30pm

Day 1 - Monday, April 29, 2019

7:00
Registration and Continental Breakfast
8:00
Co-Chairs’ Opening Remarks

Guy Donatiello
Senior Vice President, Intellectual Property
Endo Pharmaceuticals

Pearl T.L. Siew
Senior Vice President and Head, Intellectual Property
Eagle Pharmaceuticals, Inc.

8:15

An Executive Discussion

The Present State of Paragraph IV Litigation and Its Impact on the Pharmaceutical Industry: Legal Analyses and Business Prognoses

  • Investigating the most popular districts, filing trends, settlements and timings
    • Examining how judicial shortages in key districts are impacting ANDA litigation and venue selection
    • Understanding how this is influencing PTAB filings
  • Analyzing the connection between recent Paragraph IV filings and the speed of ANDA approvals
  • Studying IPR outcomes of Orange Book patents and appreciating the correlation with District Court litigation
  • Exploring when settlement is considered as a favorable outcome in an IPR and its consequences for related District Court litigation
  • Understanding how ANDA litigation outcomes affect business forecasts in this next era of the patent cliff
  • Appreciating how Paragraph IV outcomes impact business decisions from, R&D to licensing, to M&A activity and beyond

9:15
Addressing the Impact of a Uniform Claims Construction Standard: Panacea or Peril?

  • Analyzing how the PTAB’s adoption of the Phillips standard is impacting Hatch-Waxman practice
  • 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

10:15
Networking Coffee Break
10:30

View from the Federal Circuit

An Interview with:

Honorable Kathleen M. O’Malley
United States Circuit Judge
United States Court of Appeals for the Federal Circuit (Washington, DC)

Join us for a conversation with Judge O’Malley as she will provides exceptional insights into working at the Appellate Court tasked with reviewing the country’s patent cases.

11:00

Helsinn v. Teva

The Supreme Court Weighs in on the On- Sale Bar and the State of Secret Prior Art

On January 22, 2019, the Court released its opinion in Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA Inc., (Supreme Court No. No. 17-1229). This panel will explore the current state of on-sale bar jurisprudence as they engage in a lively point-counterpoint discussion in view of the monumental decision.

  • Reviewing the Supreme Court’s opinion and it its nuances relative to how a secret sale constitutes prior art
    • Understanding the Court’s interpretation of how the AIA altered the on-sale bar
  • Assessing whether prior art patents and printed publications will continue to play a central role in patent invalidations in a post-Helsinn world in light of the Court’s decision
  • Deciding whether an inventor’s sale of an invention to a third party that is required to keep the invention confidential qualifies as prior art for the purposes of determining patentability
  • Analyzing whether the phrase “available to the public” implies a distinct restraint on issuance or if it adjusts the two prior limitations that appear before it

12:00
Networking Luncheon
1:00
The Costs and the Consequences of Determining Venue Post-TC Heartland

At the time of this conference it will be nearly two years since the Supreme Court issued its ground-breaking decision on venue and jurisdiction in TC Heartland. However, confusion remains as to how the district courts and litigants should interpret the meaning of “where the defendant has committed acts of infringement and has a regular and established place of business.” As such, many district courts are allowing limited discovery to find the right place to file suit. This panel will explore the benefits, costs and consequences of this remaining and unsettled question.

 

  • Knowing when to seek discovery related to venue and jurisdiction in order to defeat a motion to dismiss based on improper venue under TC Heartland
  • Assessing the impact of TC Heartland on litigation costs for both plaintiffs and defendants relative to additional venue discovery

1:45
Afternoon Refreshment Break
2:00
Day One Afternoon Tracks A, B or C

4:15
Subject Matter Patentability and Written Description Reconsidered: Understanding the New §101 and §112 Conundrum

  • Exploring the §112 and §101 nexus illustrated in recent ANDA cases
    • Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals
  • Understanding how the Federal Circuit’s decision in Affinity Labs of Texas, LLC v. Amazon.com, Inc., may impact Paragraph IV litigation
  • Examining the resurgence of 101 applicability in an ANDA setting
  • Drafting claims to avoid §101 roadblocks relative to pharmaceutical patent applications
  • Reviewing court-determined “adequate written descriptions” under § 112
    • AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc.
  • Understanding the standard for determining the adequacy of the “written description” of the invention under this recent jurisprudence and how it applies in a Hatch-Waxman setting
    • Reviewing precedent where substantial evidence supports claims of adequate written description
  • Analyzing whether the true test of written description requirement is based on enablement versus possession

5:15

Judicial Roundtable

The Great Debate with District Judges

Honorable Ruben Castillo
United States District Court
Norther District of Illinois (Chicago, IL)

Honorable Jose L. Linares
Chief Judge
District of New Jersey

Honorable Renee M. Bumb
United States District Judge
District of New Jersey

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.

6:15
Conference Adjourns for Cocktail Reception

Day 2 - Tuesday, April 30, 2019

7:15
Continental Breakfast
8:00
Co-Chairs’ Opening Remarks and Recap of Day One

Guy Donatiello
Senior Vice President, Intellectual Property
Endo Pharmaceuticals

Pearl T.L. Siew
Senior Vice President and Head, Intellectual Property
Eagle Pharmaceuticals, Inc.

8:15
Brand and Generic Perspectives on the Latest FDA Initiatives Impacting Pharmaceutical Patents

Grail Sipes
Deputy Center Director, Regulatory Policy
CDER

Maryll Toufanian
Director Office of Generic Drug Policy, CDER
U.S. Food & Drug Administration (Silver Spring, MD)

  • Analyzing the status and findings of the FDA’s internal working group on Generic Competition
  • Understanding the new priority ANDA review category
  • Examining Commissioner Gottlieb’s efforts to encourage generic approval
    • Drug Competition Action Plan
  • Assessing GDUFA II negotiations and the effort to assist potential ANDA applicants for complex products
  • Explaining user fee changes in PDUFA VI

9:00
Networking Coffee Break
9:15
Day Two Morning Tracks D, E or F

11:30

FTC Keynote

Antitrust Developments Concerning Brands & Generics

Markus H. Meier
Acting Director, Bureau of Competition
Federal Trade Commission (Washington, DC)

12:00
Networking Luncheon
1:00

THE PTAB LIVE!

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

Honorable Jacqueline Wright Bonilla
Vice Chief, Administrative
Patent Judge

Honorable Michelle N. Ankenbrand
Lead Administrative Patent Judge
Patent Trial and Appeal Board US Patent and Trademark Office

Honorable Rama G. Elluru
Administrative Patent Judge

  • 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

2:00

Obviousness Case Study

Assessing Secondary Considerations in Light of Blocking Patents Post-Acorda

  • Reviewing the expanding doctrine of blocking patents relative to secondary considerations
  • Exploring the difficulty of presenting evidence of “negative acts”
  • Considering which party bears the burden of proving the effect of the putative blocking patent
  • Determining how much proof is required to overcome the “solid premise of diminished incentive” when a blocking patent is invoked?
  • Analyzing how the Acorda decision effects the obviousness analysis

3:00
Refreshment Break
3:15

“Skinny Labeling” Revisited

The Evolving Induced Infringement Analysis

  • Examining precedent where Courts have found inducement to exist when there is an element of inevitability resulting in infringement
  • Surveying decisions on infringement based on drug labels for support of execution of the infringing acts
  • Identifying strategic considerations of labeling language based on this new jurisprudence

4:00
The Ethical Practice of Paragraph IV Litigation: New Developments Impacting Professional Responsibility in the Hatch-Waxman Arena

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

  • 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

5:00
Conference Concludes

Working Group on Biosimilars for the Hatch-Waxman Practitioner

May 1, 2019 8:30am - 12:00pm

$600

What is it about?

(Registration begins at 8:00 AM – Breakfast will be served)

 

The Supreme Court delivered its groundbreaking decision in Sandoz Inc. v. Amgen Inc. in June of 2017, memorializing the first time the Court analyzed the Biologics Price Competition and Innovation Act (BPCIA) for the approval of biosimilar drugs. When discussing the BPCIA, the Court noted that it was a “a carefully calibrated scheme for preparing to adjudicate, and then adjudicating, claims of infringement” related to biosimilar applications, and granted more flexibility to biosimilar companies and filers of abbreviated biologics license applications.

 

This intimate and interactive working group will examine the core components of the Court’s decision, and provide an analysis of biosimilar case law in the progeny that followed. Further, we will explore the approvalprocess and other key points of regulation for the benefit of Hatch-Waxman practitioners. Points of discussion will include:

 

  • An introduction to biologic drugs, biosimilars, the Biologics Price Competition and Innovation Act (BPCIA) abbreviated approval pathway, and statutory language
  • Discussing the FDA Draft Guidance documents on biosimilar product development
  • Making predictions for the future of biotech patents and biosimilar product development in the U.S.
  • Reviewing BPCIA cases at the Federal Circuit and District Court levels

Parallel Proceedings Master Class

May 1, 2019 1:00pm - 4:30pm

$600

What is it about?

(Registration begins at 12:30 PM)

 

Parallel litigation in the District Court and PTAB in a Hatch-Waxman setting has become standard practice and adds to the “no-holds barred” atmosphere of this high stakes type of litigation. The art of navigating proceedings between to these two forums has been described as akin to walking a tightrope. In navigating these dual forums, even the most seasoned of litigators has a new appreciation for the intricacies of parallel litigation. They are developing best practices and also becoming aware of certain things to avoid in these procedures. In this interactive session, we will illustrate the “ins and outs” of IPR practice and appearing in dual proceedings in both the District Court and PTAB.

 

  • Understanding claim construction dichotomy in both forums and devising tactics to address both simultaneously
  • Managing experts and use of experts in both forums
  • Best practices for simultaneous trials
  • Appealing decisions in both forums
  • Addressing settlement in both forums