Agenda
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Day 1 - Monday, April 23, 2018
7:00 |
Registration & Continental Breakfast
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8:00 |
Co-Chairs’ Opening Remarks |
8:15 |
Paragraph IV Litigation Year in Review: Present Developments and Future Forecasts |
9:00 |
The Evolving Principles of Venue and Jurisdiction in the Aftermath of TC Heartland |
10:00 |
Morning Coffee Break
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10:15 |
IPR UPDATEOil States, SAS and the Future of IPRs: An Assessment of Challenges to Inter Partes Review Presently before the Supreme Court |
11:15 |
IPR UPDATEThe Question of Sovereign Immunity: A Legitimate Means of Pharmaceutical Patent Protection? |
12:00 |
Networking Luncheon
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1:00 | |
1:05 | |
1:55 | |
2:45 | |
3:30 |
Afternoon Refreshment Break |
3:45 |
The Distinctive Roles of The Magistrate Judge and Local Counsel in Paragraph IV Proceedings |
4:45 |
VIEW FROM THE BENCHThe Federal Judges Speak on Paragraph IV Litigation |
6:00 |
Conference Adjourns for Cocktail Reception
|
Day 2 - Tuesday, April 24, 2018
7:00 |
Continental Breakfast |
8:00 |
Co-Chairs’ Opening Remarks and Recap of Day One |
8:15 |
The Impact of New FDA Leadership on Hatch-Waxman Practice |
9:00 |
PTAB UPDATEPTAB Update: Wins, Losses and Appeals |
10:00 |
Morning Coffee Break |
10:15 |
FIRESIDE CHAT WITH THE PTABThoughts on Practice, Procedure, IPRs and Other Meanderings in the World of Pharmaceutical Patent Validity Challenges |
11:00 |
Obviousness Update for PIV Litigation: Matters of Inherency, Anticipation and Secondary Considerations |
12:00 |
FTC KEYNOTEAntitrust Developments Concerning Brands & Generics |
12:45 |
Networking Luncheon |
1:45 |
The Devil in the Label Details: A New Test for Induced Infringement |
2:45 |
A Question of Damages: Lost Profits, Reasonable Royalties and Exceptional Findings |
3:45 |
Afternoon Refreshment Break |
4:00 |
ETHICSCase Studies in Ethical Developments Influencing Paragraph IV Practice |
5:00 |
Conference Adjourns |
Post-Conference Workshops
Workshops A | Jurisdiction and Venue Selection Master Class
Apr 25, 2018 8:30am – 12:00pm
Speakers

Wyley S. Proctor
Partner
McCarter & English, LLP (Boston, MA

Anne S. Toker
Partner
Quinn Emanuel Urquhart & Sullivan, LLP (New York, NY)
Workshops B | Biosimilar Litigation Boot Camp for the Hatch-Waxman Litigator
Apr 25, 2018 1:00pm – 4:00pm
Speakers

Patricia A. Carson
Partner
Kirkland & Ellis LLP(New York, NY)

Robert V. Cerwinski
Partner
Goodwin Procter LLP
Day 1 - Monday, April 23, 2018
7:00 |
Registration & Continental Breakfast
|
8:00 |
Co-Chairs’ Opening Remarks![]() Guy Donatiello ![]() Timothy X. Witkowski M.S., J.D. |
8:15 |
Paragraph IV Litigation Year in Review: Present Developments and Future Forecasts![]() Owen Byrd ![]() Benjamin A. Katzenellenbogen ![]() John J. Molenda, Ph.D. ![]() Irena Royzman Ph.D. ![]() Paul Simboli ![]() Jane M. Love MODERATOR:![]() Mark E. Waddell For the first time in three years, ANDA filings are on the decline. However, industry watchers believe that this trend will soon reverse itself. ANDA litigation is a unique beast and is unlike anything else that the patent bar deals with. This panel will consider the drivers behind this decrease in filings, as well as provide insights on why stakeholders believe that this decline will only be a short-lived phenomenon. Our speakers will also discuss current developments in and future forecasts for this distinct category of litigation. Points of discussion will include:
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9:00 |
The Evolving Principles of Venue and Jurisdiction in the Aftermath of TC Heartland![]() Michael R. Dzwonczyk ![]() D. Clay Holloway ![]() Staci Julie ![]() Filko Prugo ![]() Robert D. Rhoad ![]() Peter Waibel MODERATOR:![]() Kathleen B. Carr Last spring, in TC Heartland, the Supreme Court reined in the previously broad interpretation of the venue statute, and held that the word “resides” describes a company’s place of incorporation. Now that the Court has addressed this first part of 28 U.S.C. §1400(b), pharmaceutical companies on both sides are struggling to interpret the second prong of the venue statute, which the Supreme Court did not address. As such, confusion abounds as to how courts and stakeholders alike should interpret the meaning of “where the defendant has committed acts of infringement and has a regular and established place of business. And so, the mad revels begin. This panel will examine this second prong of TC Heartland, as well as the consequences of the landmark decision. Points of discussion will include:
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10:00 |
Morning Coffee Break
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10:15 |
IPR UPDATEOil States, SAS and the Future of IPRs: An Assessment of Challenges to Inter Partes Review Presently before the Supreme Court![]() Lisa M. Ferri ![]() Rekha Hanu Ph.D., Esq. ![]() Irene E. Hudson ![]() Rudolf E. Hutz ![]() David Silverstein M.S., J.D. ![]() Andrea Tiglio MODERATOR:![]() John T. Gutkoski At time of press, the SAS and Oil States cases are still pending before the Supreme Court. Whether you are the patent holder or a patent challenger, these cases will have a tremendous impact on your approach to PTAB practice. In SAS, the Court will decide whether the PTAB must issue a written decision covering all claims challenged in an IPR. While in Oil States, the Court must decide on the question of the Constitutionality of these proceedings altogether. It just may be the end of the world, as we know it. This panel will explore the status and possible impact of these pending decisions. Points of discussion will include:
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11:15 |
IPR UPDATEThe Question of Sovereign Immunity: A Legitimate Means of Pharmaceutical Patent Protection?![]() Nicolas G. Barzoukas ![]() Josephine Liu, Ph.D., J.D. ![]() Stephen B. Maebius ![]() Don J. Mizerk ![]() Steven J. Moore ![]() Jason A. Wietjes MODERATOR:![]() Steven M. Coyle In an inspired attempt to “rent” sovereign immunity, a major pharmaceutical company, tried to avail itself of the auspices of this protection by assigning its patents to a lucrative drug to a Native American Indian tribe. Upon review of the assigned patent portfolio last fall, a U.S. District Court Judge found the patents invalid due to obviousness, and expressed trepidation about the validity of the use or misuse of sovereign immunity in this matter. In February 2018, the PTAB denied the St. Regis tribe’s motion to dismiss several IPRs challenging the validity of the Allergan Restasis patents it was assigned on the basis of the Sovereign Immunity Doctrine, thus opening the door for the Federal Circuit to act. This use of sovereign immunity as a means of patent protections is now at the center of a larger discussion, as more companies may try to avoid IPRs by assigning rights away while seeking the protections of sovereign immunity. Last fall, Sen. Claire McCaskill, D-Mo., introduced S.1948 which seeks to prevent Native American tribes from avowing sovereign immunity in these types of cases. Pending the passage of such a bill, patent holders will continue to wonder whether this strategy is a sustainable means of patent protection meant to evade invalidation.
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12:00 |
Networking Luncheon
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1:00 | |
1:05 | |
1:55 | |
2:45 | |
3:30 |
Afternoon Refreshment Break |
3:45 |
The Distinctive Roles of The Magistrate Judge and Local Counsel in Paragraph IV Proceedings![]() Honorable Mary Pat Thynge ![]() Honorable Tonianne J. Bongiovanni ![]() Honorable Christopher J. Burke ![]() Honorable Roy Payne ![]() Bo Davis ![]() Charles M. Lizza MODERATOR:![]() Anne Shea Gaza Magistrate Judges have a unique role in ANDA cases. They hear key motions and resolve the disputes which the parties encounter throughout the course of litigation. Many jurisdictions where Paragraph IV disputes are heard have their own local patent rules, with some jurisdictions exhibiting subsets of local patent rules for Hatch-Waxman matters, which dictate everything from scheduling, to discovery to dispositive motions. Recently, several jurisdictions have modified their local rules, calling for the patent bar to significantly adjust their practices. With these unfamiliar local rules in mind, the importance of retaining local counsel becomes paramount. This panel will explore the intricacies of the local rules and how Magistrate Judges effectively working with local counsel can help the parties reach an amicable “yes”. |
4:45 |
VIEW FROM THE BENCHThe Federal Judges Speak on Paragraph IV Litigation![]() Honorable Ruben Castillo ![]() Honorable Leonard P. Stark ![]() Honorable Jose L. Linares, U.S.D.J. MODERATORS:![]() Barry P. Golob ![]() Lisa B. Pensabene 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. |
6:00 |
Conference Adjourns for Cocktail Reception
|
Day 2 - Tuesday, April 24, 2018
7:00 |
Continental Breakfast |
8:00 |
Co-Chairs’ Opening Remarks and Recap of Day One |
8:15 |
The Impact of New FDA Leadership on Hatch-Waxman Practice![]() Kurt R. Karst ![]() Michael Sitzman ![]() Maryll W. Toufanian, J.D. Dr. Scott Gottlieb was sworn in as the 23rd Commissioner of the U.S. Food and Drug Administration in May of 2017. Many industry watchers believe that Dr. Gottlieb’s appointment heralds the beginning of new era at FDA which includes recommendations for the future of Hatch-Waxman. Only time will reveal the FDA’s agenda in this area and how various components of Hatch-Waxman such as exclusivity periods, regulatory review timelines, shared exclusivity and the timing of generic entry. Our panel will address all of this and more. Discussion points will include:
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9:00 |
PTAB UPDATEPTAB Update: Wins, Losses and Appeals![]() Dominick A. Conde ![]() Stephen M. Hash ![]() Joseph A. Hynds ![]() Laura A. Lydigsen ![]() Lars Taavola ![]() Dennies Varughese MODERATOR:![]() Honorable Teresa Rea
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10:00 |
Morning Coffee Break |
10:15 |
FIRESIDE CHAT WITH THE PTABThoughts on Practice, Procedure, IPRs and Other Meanderings in the World of Pharmaceutical Patent Validity Challenges![]() Honorable Jacqueline D. Wright Bonilla ![]() Honorable Brian P. Murphy ![]() Honorable Michelle Nerozzi-Ankenbrand Since its formation in 2012, the PTAB has become an established alternate forum in the pharmaceutical patent dispute arena. IPRs are now a standard and established parallel procedure in Paragraph IV litigation. The IPR proceeding presents an option frequently built-in and often considered by the parties. PGRs and CMB challenges have also been used in these high stakes pharmaceutical patent challenges. As such, knowing the ‘ins and outs’ of PTAB practice is a critical competency for today’s Hatch-Waxman petitioner. To help you better understand these procedures, as well as their governing forum, a current and a former Administrative Patent Judge from the PTAB will explore potential rule changes, the use of expert declarations and other evidence, oral hearing demonstratives, and the use of reheating procedures, in an intimate fireside chat. |
11:00 |
Obviousness Update for PIV Litigation: Matters of Inherency, Anticipation and Secondary Considerations![]() Tony V. Pezzano ![]() John Snow ![]() Stephen R. Smerek ![]() Bruce M. Wexler MODERATOR:![]() Donna M. Meuth
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12:00 |
FTC KEYNOTEAntitrust Developments Concerning Brands & Generics![]() Markus H. Meier The Supreme Court’s decision in the Actavis case established the antitrust “rule of reason” as the standard for evaluating reverse-payment agreements. The precise meaning and reach of the Supreme Court’s 2013 decision is now becoming clearer as district courts and courts of appeal grapple with its application. The FTC continues to review Hatch-Waxman settlements filed under the MMA and issue periodic reports with its findings. And the agency is currently challenging a number of reverse-payment agreements both in federal court and in administrative adjudication. Private plaintiffs also have stepped up their game, with more than fifteen reverse-payment cases currently in some stage of litigation around the country. In this session, the FTC will address these matters, as well as other anticompetitive concerns involving brand and generic pharmaceuticals. |
12:45 |
Networking Luncheon |
1:45 |
The Devil in the Label Details: A New Test for Induced Infringement![]() Emily Greb ![]() Michael P. Dougherty ![]() Robert C. Millonig, Jr., Ph.D. ![]() Joseph O’Malley ![]() Wendy Petka, Ph.D., J.D. The Federal Circuit recently issued new guidance for evaluating divided and contributory infringement of pharmaceutical method-of-use patents. In Sanofi v. Watson, the Federal Circuit held that drug product labeling “as a whole” may be used to support a claim of induced infringement, thus providing guidance for enforcing method-of-use patents, as new uses for drugs are revealed. This panel will explore this finding. Points of discussion will include:
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2:45 |
A Question of Damages: Lost Profits, Reasonable Royalties and Exceptional Findings![]() Michael F. Buchanan ![]() Christopher Gerardi ![]() Vishal C. Gupta ![]() Rachael P. McClure ![]() Hany W. Rizkalla, Ph.D. MODERATOR:![]() Martin B. Pavane
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3:45 |
Afternoon Refreshment Break |
4:00 |
ETHICSCase Studies in Ethical Developments Influencing Paragraph IV Practice![]() David G. Conlin ![]() Michael V. O’Shaughnessy This session will identify common ethical dilemmas in Hatch-Waxman litigation and teach you how to incorporate protocols to avoid them. Points of discussion will include:
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5:00 |
Conference Adjourns |
Workshops A | Jurisdiction and Venue Selection Master Class

Wyley S. Proctor
Partner
McCarter & English, LLP (Boston, MA

Anne S. Toker
Partner
Quinn Emanuel Urquhart & Sullivan, LLP (New York, NY)
What is it about?
(Registration begins at 8:00 AM – continental breakfast will be served)* Historically, the lions-share of Paragraph IV litigation has been filed in three main districts: the District of Delaware, the District of New Jersey, and the Eastern District of Texas. However, the Supreme Court’s groundbreaking decision in TC Heartland, LLC v. Kraft Foods Group Brands LLC is remodeling “venue” in patent litigation and may alter the status of the three traditional Hatch-Waxman stronghold venues. Pharmaceutical patent infringement cases are being filed in nontraditional jurisdictions. There is a testing of the waters so to speak as hundreds of venue transfer motions have been filed in the time since TC Heartland was decided. However, is the devil that you know better than the one you don’t? This workshop will help you make that determination and devise proper venue and jurisdiction strategies in wake of TC Heartland and lower courts’ struggles to interpret the decision. Points of discussion will include:- Reviewing the latest Federal Circuit and District Court decisions regarding venue determination in pharmaceutical patent infringement cases
- Determining where a corporate defendant be sued
- Options for foreign defendants
- Deciding where you should file your case
- Developing new strategies to move to transfer for improper venue in the wake of TC Heartland
- Weighing the chances for success or defeat of a venue transfer motion
- Understanding whether this may or may not be the right move
Workshops B | Biosimilar Litigation Boot Camp for the Hatch-Waxman Litigator

Patricia A. Carson
Partner
Kirkland & Ellis LLP(New York, NY)

Robert V. Cerwinski
Partner
Goodwin Procter LLP
What is it about?
(Registration begins at 12:30 PM) In the landmark Amgen v. Sandoz decision, the Supreme Court 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 essential analysis of biosimilar litigation as well as the approval process and other key points of regulation for the benefit of Hatch-Waxman practitioners. Points of discussion will include:LEGAL AND REGULATORY BACKGROUND:
- Comparing and contrasting the biosimilar pathway to 505(b)(2) and BLA pathways
- Determining whether research and development resources are best spent pursuing a biosimilar pathway or going the traditional BLA route
- Breakdown of relevant considerations with each route including timing, costs, and IP litigation considerations, and exclusivity
- Overview of the 2010 Biologics Price Competition and Innovation Act (BPCIA)
- Exclusivity provisions
- Criteria for biosimilarity and interchangeability
- Clinical trials and safety studies
- Patent litigation and exchange provisions: Understanding the major differences between
- Hatch-Waxman and biosimilars litigation as outlined in the statute
LITIGATION UPDATE:
- Review of Amgen v. Sandoz and its impact on other biosimilar cases currently being litigated
- Exploring new strategies to engage in the patent dance in wake of the Supreme Court’s decision
- Timing of patent filings: making the decision to file pre-suit, waiting out the lengthy legal process, or launching without the benefit of having discovery of the other party’s patents and legal positions
- Evaluating the use of IPRs with biosimilars
- Developing patent certainty
- Factoring decisions in recent BPCIA cases into your overall patent validity analysis
- BLA versus biosimilar application
- Choosing between District Court, PTAB, and the ITC