Agenda
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Day 1 - Monday, April 29, 2019
7:00 |
Registration and Continental Breakfast |
8:00 |
Co-Chairs’ Opening Remarks |
8:15 |
An Executive DiscussionThe 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 |
11:00 |
Helsinn v. TevaThe 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 RoundtableThe 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 |
Latest FDA Initiatives Affecting Generic Drug Access and Pricing |
9:00 |
Networking Coffee Break |
9:15 |
Day Two Morning Tracks D, E or F |
11:30 |
FTC KeynoteAntitrust 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 StudyAssessing Secondary Considerations in Light of Blocking Patents Post-Acorda |
3:00 |
Refreshment Break |
3:15 |
“Skinny Labeling” RevisitedThe 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 |
Post-Conference Workshops
Working Group on Biosimilars for the Hatch-Waxman Practitioner
May 1, 2019 8:30am – 12:00pm
Speakers
Kevin E. Noonan
Partner
McDonnell Boehnen Hulbert & Berghoff LLP (Chicago, IL)
Parallel Proceedings Master Class
May 1, 2019 1:00pm – 4:30pm
Speakers
Jeffrey R. Gargano
Partner
Morgan, Lewis & Bockius LLP (Chicago, IL)
Day 1 - Monday, April 29, 2019
7:00 |
Registration and Continental Breakfast |
8:00 |
Co-Chairs’ Opening RemarksGuy Donatiello Pearl T.L. Siew |
8:15 |
An Executive DiscussionThe Present State of Paragraph IV Litigation and Its Impact on the Pharmaceutical Industry: Legal Analyses and Business PrognosesCharlotte Jacobsen Christina Schwarz Lisa B. Pensabene Taras A. Gracey
|
9:15 |
Addressing the Impact of a Uniform Claims Construction Standard: Panacea or Peril?Michael P. Kahn Steven M. Coyle Aaron Lukas
|
10:15 |
Networking Coffee Break |
10:30 |
VIEW FROM THE FEDERAL CIRCUITHonorable Kathleen M. O’Malley Interviewed By:Honorable Mary Pat Thynge 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. TevaThe Supreme Court Weighs in on the On- Sale Bar and the State of Secret Prior ArtColman Ragan Joseph O’Malley Stephen S. Rabinowitz Ben Katzenellenbogen Jovial Wong 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.
|
12:00 |
Networking Luncheon |
1:00 |
The Costs and the Consequences of Determining Venue Post-TC HeartlandRichard J. Berman Gregory A. Morris Lars Taavola 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.
|
1:45 |
Afternoon Refreshment Break |
2:00 |
Day One Afternoon Tracks A, B or CTRACK AThe Business of Pharmaceutical Patent Litigation: A Global ApproachTrack Moderator: George Johnston Counsel Intellectual Property, Gibbons P.C.(Newark, NJ)TRACK BThe Practice of Pharmaceutical Patent Litigation: Part ITrack Moderator: Shashank Upadhye Partner Amin Talati Upadhye (Chicago, IL)TRACK CThe Hatch-Waxman Series Advisory Board on “The Three C’s”Track Moderator: Pearl T.L. Siew Senior Vice President and Head, Intellectual Property Eagle Pharmaceuticals, Inc. |
4:15 |
Subject Matter Patentability and Written Description Reconsidered: Understanding the New §101 and §112 ConundrumAndrew Allen Bruce M. Wexler Gerald J. Flattmann Jr. Matthew A. Pearson Mark E. Waddell
|
5:15 |
Judicial RoundtableThe Great Debate with District JudgesHonorable Ruben Castillo Honorable Renee M. Bumb Honorable Stanley R. Chesler Moderators:Kathleen B. Carr Barry P. Golob 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 OneGuy Donatiello Pearl T.L. Siew |
8:15 |
Latest FDA Initiatives Affecting Generic Drug Access and PricingGrail Sipes Maryll Toufanian ModeratorKurt R. Karst
|
9:00 |
Networking Coffee Break |
9:15 |
Day Two Morning Tracks D, E or FTRACK DA Town Hall with the Magistrate JudgesTrack Moderator: Honorable Mary Pat Thynge Chief Magistrate Judge District of Delaware (Wilmington, DE)(Newark, NJ)TRACK EThe Practice of Pharmaceutical Patent Litigation: Part IITrack Moderator: Guy Donatiello Senior Vice President, Intellectual Property Endo PharmaceuticalsTRACK FNew Developments in Market Access and ExclusivitiesTrack Moderator: Hon. Teresa Rea Partner Crowell & Moring LLP(Former Acting Under Secretary of Commerce for IP and Former Acting Director of the U.S. Patent and Trademark Office) (Washington, DC) |
11:30 |
FTC KeynoteAntitrust Developments Concerning Brands & GenericsMarkus H. Meier |
12:00 |
Networking Luncheon |
1:00 |
THE PTAB LIVE!The APJs Speak on Practice, Policy, and Procedure in the World of Pharmaceutical Patent Validity ChallengesHonorable Jacqueline Wright Bonilla Honorable Michelle N. Ankenbrand Honorable Rama G. Elluru ModeratorScott E. Kamholz
|
2:00 |
Obviousness Case StudyAssessing Secondary Considerations in Light of Blocking Patents Post-AcordaAlan B. Clement Liane M. Peterson Dennies Varughese
|
3:00 |
Refreshment Break |
3:15 |
“Skinny Labeling” RevisitedThe Evolving Induced Infringement AnalysisSam Park Daniel J. Minion Michael Dougherty Filko Prugo
|
4:00 |
The Ethical Practice of Paragraph IV Litigation: New Developments Impacting Professional Responsibility in the Hatch-Waxman ArenaDavid G. Conlin Marck Rachlin This session will identify common ethical dilemmas in Hatch-Waxman litigation and help you incorporate practices to avoid them. Points of discussion will include:
|
5:00 |
Conference Concludes |
Working Group on Biosimilars for the Hatch-Waxman Practitioner
Kevin E. Noonan
Partner
McDonnell Boehnen Hulbert & Berghoff LLP (Chicago, IL)
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
Jeffrey R. Gargano
Partner
Morgan, Lewis & Bockius LLP (Chicago, IL)
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