Registration & Continental Breakfast
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Co-Chairs’ Opening Remarks

Guy Donatiello
Senior Vice President, Intellectual Property
Endo Pharmaceuticals, Inc. (Malvern, PA)

Timothy X. Witkowski M.S., J.D.
Global Head, Chemistry Patents for R&D IP
Novartis Institutes for BioMedical Research (Cambridge, MA)

Paragraph IV Litigation Year in Review: Present Developments and Future Forecasts

Owen Byrd
Chief Evangelist and General Counsel
Lex Machina (Menlo Park, CA)

Benjamin A. Katzenellenbogen
Partner
Knobbe Martens (Irvine, CA)

John J. Molenda, Ph.D.
Partner
Steptoe & Johnson LLP (New York, NY)

Irena Royzman Ph.D.
Partner
Patterson Belknap Webb & Tyler LLP (New York, NY)

Paul Simboli
Consultant
Depomed, Inc. (Newark, CA)

Jane M. Love
Partner
Gibson, Dunn & Crutcher LLP (New York, NY)

MODERATOR:

Mark E. Waddell
Co-Chair, Life Sciences; Patent Litigation and Counseling
Loeb & Loeb LLP (New York, NY)

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:

• Analyzing the developments leading to the Paragraph IV litigation decline over the past 12 months
• Understanding the correlation between Paragraph IV filings and the speed of ANDA approvals
• Exploring the relationship between PDUFA, GDUFA and Paragraph IV filings
• Examining ANDA filings in light of the patent cliff
• Probing how changes in judiciary and Judges shortages in key jurisdictions have impacted trends in Paragraph IV litigation

The Evolving Principles of Venue and Jurisdiction in the Aftermath of TC Heartland

Michael R. Dzwonczyk
Partner
Sughrue Mion, PLLC (Washington, DC)

D. Clay Holloway
Partner
Kilpatrick Townsend & Stockton LLP (Atlanta, GA)

Staci Julie
Senior Vice President and Chief Intellectual Property Counsel
Teva Pharmaceuticals (Horsham, PA)

Filko Prugo
Partner
Ropes & Gray LLP (New York, NY)

Robert D. Rhoad
Partner
Dechert LLP (Princeton, NJ)

Peter Waibel
Head US Patent Litigation
Novartis Pharmaceuticals Corporation (East Hanover, NJ)

MODERATOR:

Kathleen B. Carr
Member
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo PC (Boston, MA)

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:

• Understanding the repercussions of TC Heartland on Paragraph IV litigation
• Exploring the jurisdictions where the recent flurry of patent infringement complaints have been filed, and assessing how different jurisdictions are interpreting the decision
• Examining the Federal Circuit’s recent rulings on District Court interpretations of TC Heartland, as well as the various litmus tests, which some jurisdictions have devised, in the aftermath of this decision

Morning Coffee Break
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IPR UPDATE

Oil States, SAS and the Future of IPRs: An Assessment of Challenges to Inter Partes Review Presently before the Supreme Court

Lisa M. Ferri
Partner
Mayer Brown LLP (New York, NY)

Rekha Hanu Ph.D., Esq.
Executive Director, Chief IP Counsel
Akorn Pharmaceuticals (Lake Forest, IL)

Irene E. Hudson
Partner
Baker & Hostetler LLP (New York, NY)

Rudolf E. Hutz
Counsel
Reed Smith LLP (Wilmington, DE)

David Silverstein M.S., J.D.
Partner
Axinn, Veltrop & Harkrider LLP (New York, NY)(Former Senior Director, Intellectual Property, Par Pharmaceutical, Inc)

Andrea Tiglio
Assistant General Counsel, IP, Legal
Astellas US LLC (Northbrook, IL)

MODERATOR:

John T. Gutkoski
Partner
Barclay Damon LLP (Boston, MA)

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:

• Analyzing prior juris prudence as to why a judicial body must address every claim in a petition
• Anticipating the Court’s view in Oil States on whether an IPR represents an unconstitutional taking
• Exploring separation of powers in the seventh amendment arguments, brought forth under Oil States
• Developing interim jurisdictional strategies while these cases are pending
• Understanding how these decisions will impact ANDA litigation and your practice
  • Implementing brand name and generic strategies

IPR UPDATE

The Question of Sovereign Immunity: A Legitimate Means of Pharmaceutical Patent Protection?

Nicolas G. Barzoukas
Partner
Reed Smith LLP (Huston, TX)

Josephine Liu, Ph.D., J.D.
Head, US IP Litigation
Sandoz Inc. (Princeton, NJ)

Stephen B. Maebius
Partner
Foley & Lardner LLP (Washington, DC)

Don J. Mizerk
Partner
Husch Blackwell LLP (Chicago, IL)

Steven J. Moore
Partner
Withers Bergman LLP (Greenwich, CT)

Jason A. Wietjes
Shareholder
Polsinelli PC (Dallas, TX)

MODERATOR:

Steven M. Coyle
Partner and Litigation Department Co-Chair
Cantor Colburn LLP (Hartford, CT)

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.

• Reviewing the status of the Allergan, Inc. v. Teva Pharmaceuticals
  • Examining the PTAB’s opinion denying the St. Regis tribe’s invocation of the sovereign immunity defense
  • Anticipating the Federal Circuit’s review of this matter
• Analyzing the findings of the House Judiciary Committee’s Subcommittee on IP’s hearing on sovereign immunity and the intellectual property system
• Update on the status of S.1948
• Examining the investigations of other entities transferring patent rights to Native American tribes

Networking Luncheon
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Afternoon Refreshment Break

The Distinctive Roles of The Magistrate Judge and Local Counsel in Paragraph IV Proceedings

Honorable Mary Pat Thynge
Chief Magistrate Judge
United States Federal District Court, District of Delaware (Wilmington, DE)

Honorable Tonianne J. Bongiovanni
Magistrate Judge
United States District Court, District of New Jersey (Trenton, NJ)

Honorable Christopher J. Burke
Magistrate Judge
United States District Court, District of Delaware (Wilmington, DE)

Honorable Roy Payne
Magistrate Judge
United States District Court, Eastern District of Texas (Houston, TX)

Bo Davis
Founding Partner
The Davis Firm (Longview, TX)

Charles M. Lizza
Partner
Saul Ewing Arnstein & Lehr LLP (Newark, NJ)

MODERATOR:

Anne Shea Gaza
Partner
Young Conaway Stargatt & Taylor, LLP (Wilmington, DE)

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”.

VIEW FROM THE BENCH

The Federal Judges Speak on Paragraph IV Litigation

Honorable Ruben Castillo
Chief Judge
United States District Court Northern District of Illinois (Chicago, IL)

Honorable Leonard P. Stark
Chief Judge
United States District Court, District of Delaware (Wilmongton, DE)

Honorable Jose L. Linares, U.S.D.J.
Chief Judge
United States District Court, District of New Jersey (Newark, NJ)

MODERATORS:

Barry P. Golob
Co-Chair, Intellectual Property Litigation
Cozen O’Connor (Washington, DC)

Lisa B. Pensabene
Partner
O’Melveny & Myers LLP (New York, NY)

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.

Conference Adjourns for Cocktail Reception
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Continental Breakfast

Co-Chairs’ Opening Remarks and Recap of Day One

The Impact of New FDA Leadership on Hatch-Waxman Practice

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

Michael Sitzman
Partner
Gibson, Dunn & Crutcher LLP (San Francisco, CA)

Maryll W. Toufanian, J.D.
Acting Director, Office of Generic Drug Policy Office of Generic Drugs, CDER
U.S. Food and Drug Administration (Silver Spring, MD)

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:

• Status and findings of the FDA’s internal working group on Hatch-Waxman
• Seeking guidance for the MMA’s Final Rule in determining whether to submit an ANDA or a 505(b)(2) application
  • Analyzing different pathways, regulatory and scientific considerations when determining which application to file
• Understanding the new priority ANDA review category
• Examining Commissioner Gottlieb’s efforts to encourage generic approval
• Assessing GDUFA II negotiations and the effort to assist potential ANDA applicants for complex products
• Explaining user fee changes in PDUFA VI

PTAB UPDATE

PTAB Update: Wins, Losses and Appeals

Dominick A. Conde
Partner
Fitzpatrick, Cella, Harper & Scinto (New York, NY)

Stephen M. Hash
Partner
Baker Botts LLP (Austin, TX)

Joseph A. Hynds
Member
Rothwell, Figg, Ernst & Manbeck, P.C. (Washington, DC)

Laura A. Lydigsen
Shareholder
Brinks Gilson & Lione (Chicago, IL)

Lars Taavola
Senior Director / Senior Patent Counsel - Global Intellectual Property, Head of Patent Litigation
Amneal Pharmaceuticals LLC (Bridgewater, NJ)

Dennies Varughese
Director
Sterne, Kessler, Goldstein & Fox P.L.L.C. (Washington, DC)

MODERATOR:

Honorable Teresa Rea
Partner
Crowell & Moring LLP (Washington, DC) (Former Acting Under Secretary of Commerce for Intellectual Property and Former Acting Director of the United States Patent and Trademark Office)

• Survey of notable pharmaceutical patent wins and losses
• Overview of IPR, PGR and CBM filings involving pharmaceutical patents
• Examining the latest statistics for types of challenges brought and types of patents challenged
• Investigating the Aqua Products decision
• Understanding the Final Rule establishing patent agent privilege and its impact
• 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
• Update on activity of reverse patent trolls
• Status of pending patent reform legislation and its possible impact on the PTAB

Morning Coffee Break

FIRESIDE CHAT WITH THE PTAB

Thoughts on Practice, Procedure, IPRs and Other Meanderings in the World of Pharmaceutical Patent Validity Challenges

Honorable Jacqueline D. Wright Bonilla
Vice Chief Administrative Patent Judge
Patent Trial and Appeal Board, USPTO (Alexandria, VA)

Honorable Brian P. Murphy
Partner
Haug Partners (New York, NY)
(Former Lead Administrative Patent Judge, Patent Trial and Appeal Board, USPTO)

Honorable Michelle Nerozzi-Ankenbrand
Lead Administrative Patent Judge
Patent Trial and Appeal Board, USPTO (Alexandria, VA)

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.

Obviousness Update for PIV Litigation: Matters of Inherency, Anticipation and Secondary Considerations

Tony V. Pezzano
Partner
Hogan Lovells LLP (New York, NY)

John Snow
Shareholder
Polsinelli PC (Chicago, IL)

Stephen R. Smerek
Partner
Winston & Strawn LLP (Los Angeles, CA)

Bruce M. Wexler
Partner
Paul Hastings LLP (New York, NY)

MODERATOR:

Donna M. Meuth
Associate General Counsel, Intellectual Property
Eisai (Andover, MA)

• Deciphering recent Federal Circuit opinions addressing inherency and anticipation in an ANDA setting
  • Millennium Pharm. v. Sandoz, Inc., Appeal no. 2015-2066 (Fed. Cir., July 17, 2017)
• Dissecting the concept of inherent obviousness and establishing the correct standard
  • Honeywell International, Inc. v. Mexichem Amanco
  • Requirements for rejections based on inherency and burden of proof determinations
  • Understanding how ‘that which may be inherent is not necessarily known’ and that which is unknown cannot be obvious’
• Examining inherency rejections
• Survey of recent cases at the District Courts highlighting the importance of secondary considerations in an obviousness determination
• Examining trends at the District Court and PTAB indicating a receptiveness to the use of secondary considerations
• Applying these findings to ANDA litigation
  • Analyzing factors of commercial success, unmet need, licensing
  • Exploring the ongoing debate on copying and its relevance or irrelevance to Hatch-Waxman litigation

FTC KEYNOTE

Antitrust Developments Concerning Brands & Generics

Markus H. Meier
Assistant Director of the Health Care Division
Bureau of Competition, Federal Trade Commission (Washington, DC)

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.

Networking Luncheon

The Devil in the Label Details: A New Test for Induced Infringement

Emily Greb
Counsel
Perkins Coie LLP (Madison, WI)

Michael P. Dougherty
Partner
Hogan Lovells (New York, NY)

Robert C. Millonig, Jr., Ph.D.
Director
Sterne, Kessler, Goldstein & Fox P.L.L.C. (Washington, DC)

Joseph O’Malley
Partner
Paul Hastings LLP (New York, NY)

Wendy Petka, Ph.D., J.D.
Senior Director and Senior Patent Counsel
Theravance Biopharma US, Inc. (South San Francisco, CA)

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:

• Reviewing the state of the law on induced infringement and its repercussions for Hatch-Waxman
• Understanding how extensive labeling information on a generic drug may encourage an act of inducement
  • Intent to induce vs. actual inducement
• Looking beyond indications and usage and dosage and administration to establish inducement
• Comprehending the importance of how the doctor’s reading of the label as a whole may lead to an act of induced infringement

A Question of Damages: Lost Profits, Reasonable Royalties and Exceptional Findings

Michael F. Buchanan
Partner
Patterson Belknap Webb & Tyler LLP (New York, NY)

Christopher Gerardi
Senior Managing Director
FTI Consulting, Inc. (New York, NY)

Vishal C. Gupta
Partner
Steptoe & Johnson LLP (New York, NY)

Rachael P. McClure
Attorney
Vinson & Elkins LLP(New York, NY)

Hany W. Rizkalla, Ph.D.
Executive Director – IP and Legal Affairs
Glenmark Pharmaceuticals (Mahwah, NJ)

MODERATOR:

Martin B. Pavane
Vice Chair, Intellectual Property Department Co-Chair, Hatch-Waxman & Biologics Litigation
Cozen O’Connor (New York, NY)

• Assessing damages in an at-risk launch scenario
  • Entire market value rule (AstraZeneca AB v. Apotex Corp. (Fed. Cir 2015))
• Determining reasonable royalties and establishing the basis for royalty
  • Looking at market share
  • Identifying the point in time when infringement began
  • Question of prior art relative to damages calculation
• Gauging lost profits
  • Assessment of profit as a true measure of damages
  • Questions of profitability and sales
  • Exploring circumstances under which lost profits can be denied
• Calculating damages for exceptional findings
  • Definition of exceptional case under Octane Fitness, LLC v. ICON Health & Fitness, Inc., 134 S. Ct. 1749, 1758 (2014)
• Understanding the rationale behind the District Court’s exceptional case findings in:
  • Roxane Laboratories Inc. v. Camber Pharmaceuticals Inc. et al., case number 14-cv-04042 (D.N.J. 2017)
  • Par Pharmaceutical, Inc. v. Luitpold Pharmaceuticals, Inc. (D.N.J. 2017)
• Examining mitigating factors impacting damages award

Afternoon Refreshment Break

ETHICS

Case Studies in Ethical Developments Influencing Paragraph IV Practice

David G. Conlin
Member
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo PC (Boston, MA)

Michael V. O’Shaughnessy
Partner
Baker Botts L.L.P. (Washington, DC)

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:

• Evaluating typical ethical predicaments that may arise in Paragraph IV litigation
• Examining the willfulness standard under Halo, and how it applies in a Paragraph IV scenario
• Update on the status of the USPTO’s proposed disclosure rule under Therasense

Conference Adjourns