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American Conference Institute’s 9th Annual
Paragraph IV Disputes
Expert Insights on Hatch-Waxman Litigation Strategies for Brand Names and Generics
Main Conference: April 27–28, 2015 | The Conrad – New York | New York City • PTAB Trial Workshop for Hatch-Waxman Litigators: April 29, 2015
Preeminent patent litigators representing brand name and generic drug
makers, leading in-house counsel, esteemed jurists and government
representatives will provide insights on recent developments impacting
Paragraph IV litigation, including:
• Teva v. Sandoz and the Impact of a New Claim Construction Standard
of Review
• Personal and General Jurisdiction Challenges Under Daimler and Mylan
• Myriad 101 Rejections and Nautilus 112 Indefiniteness Findings
• Barraclude and New Obviousness Considerations
• IPR, CBM, and PGR Utilization in ANDA Litigation
• Reissue Applications as a Cure for Invalidity Findings
• Akamai’s Effect on Method of Treatment Claims and Carve-Outs
• Settlement Strategies Post-Actavis
• At-Risk Launches and Damages
Judicial Insights from:
District Court
PTAB
Honorable Ruben Castillo, Chief Judge
United States District Court, Northern District of Illinois
Honorable Douglas Arpert, U.S.M.J.
United States District Court, District of New Jersey
Honorable Roy Payne, U.S.M.J.
United States District Court, Eastern District of Texas
Honorable Garrett E. Brown, U.S.D.J. (ret.)
Former Chief Judge, United States District Court
District of New Jersey
FTC Keynote on Commission Activity Post-Actavis:
Markus H. Meier
Assistant Director, Health Care Division
Bureau of Competition, Federal Trade Commission
Supporting Sponsors:
Cocktail Sponsor:
Luncheon Sponsor:
Breakfast Sponsor:
Honorable Brian P. Murphy (invited)
(Acting) Lead Administrative Patent Judge
Patent Trial and Appeal Board, USPTO
Honorable Jacqueline D. Wright Bonilla (invited)
Administrative Patent Judge
Patent Trial and Appeal Board, USPTO
Custom Sponsors:
Lanyard Sponsor:
Credits
Insights from Industry:
• Astellas US LLC
• Bristol-Myers
Squibb
• Depomed
• Eisai Inc.
• Gilead Sciences
•
•
•
•
GlaxoSmithKline
Merck & Company
Mylan
Novartis
Pharmaceuticals
Corporation
• Pfizer Inc
• Sandoz Inc.
• Sun Pharmaceutical
Industries, Inc.
Associate Sponsors:
Agenda Sponsor:
Earn
CLE
ETHICS
Private Function:
Exhibitors:
Register Now • 888-224-2480 • www.AmericanConference.com/PIVDisputesNYC
Advisory Board and Faculty List
ACI’s Hatch-Waxman Series Advisory Board:
Confirmed Faculty
Acting Members
Co-Chairs
Guy Donatiello
Senior Vice President, Intellectual Property
Endo Pharmaceuticals (Malvern, PA)
Guy Donatiello
Senior Vice President, Intellectual Property
Endo Pharmaceuticals (Malvern, PA)
Lisa A. Jakob
Legal Director, IP Litigation
Merck & Company (Rahway, NJ)
Timothy X. Witkowski, M.S., J.D.
Executive Director & Executive Counsel
Intellectual Property, Boehringer Ingelheim (Ridgefield, CT)
James P. Leeds
Assistant General Patent Counsel
Eli Lilly & Company (Indianapolis, IN)
Speakers
Lisa M. Ferri
Partner, Mayer Brown LLP (New York, NY)
Honorable Douglas Arpert, U.S.M.J.
United States District Court, District of New Jersey (Trenton, NJ)
Jeffrey N. Myers, Ph.D.
Vice President & Assistant General Counsel
Pfizer Inc (New York, NY)
Frank W. Forman
Senior Patent Counsel, Astellas US LLC (Farmingdale, NY)
Stephen R. Auten
Partner, Chair of Pharmaceutical & Life Sciences Litigation
Taft Stettinius & Hollister LLP (Chicago, IL)
(Former Vice President, IP, Sandoz, Inc.)
Ralph J. Gabric
Shareholder & Chair, Litigation Group
Brinks Gilson & Lione (Chicago, IL)
Mark Rachlin
Senior Patent Counsel-Litigation
GlaxoSmithKline (King of Prussia, PA)
John L. Dauer, Jr.
Chief Patent Counsel
Sun Pharmaceutical Industries, Inc. (Cranbury, NJ)
Bradford J. Badke
Partner, Ropes & Gray LLP (New York, NY)
Joseph Evall
Partner, Gibson Dunn & Crutcher LLP (New York, NY)
Steven E. Feldman
Partner, Husch Blackwell LLP (Chicago, IL)
Barry P. Golob
Partner, Cozen O’Connor (Washington, DC)
Carmen M. Shepard
Senior Vice President
Global Policy and Regulatory Counsel
Mylan (Washington, DC)
Nicolas Barzoukas
Partner, Baker Botts L.L.P. (Huston, TX)
Robert J. Gunther, Jr.
Partner
Wilmer Cutler Pickering Hale and Dorr LLP (New York, NY)
Matthew J. Becker
Partner, Axinn, Veltrop & Harkrider LLP (Hartford, CT)
Christopher J. Harnett
Partner, Ropes & Gray LLP (New York, NY)
Pearl T. L. Siew
Vice President & Head, IP US
Sandoz Inc. (Princeton, NJ)
Richard Berman
Partner, Arent Fox LLP (Washington, DC)
Elizabeth J. Holland
Partner, Goodwin Procter LLP (New York, NY)
Stephen P. Benson
Partner, Katten Muchin Rosenman LLP (Chicago, IL)
Beth D. Jacob
Partner, Kelley Drye & Warren LLP (New York, NY)
Honorable Jacqueline D. Wright Bonilla (invited)
Administrative Patent Judge
Patent Trial and Appeal Board
United States Patent and Trademark Office (Alexandria, VA)
Lisa A. Jakob
Legal Director, IP Litigation, Merck & Company (Rahway, NJ)
David H. Silverstein, M.S., J.D.
Legal Director, Intellectual Property
Par Pharmaceutical Companies, Inc. (Woodcliff Lake, NJ)
Meg Snowden
VP, Intellectual Property
Impax Laboratories (Hayward, CA)
Peter Waibel
Head, US Patent Litigation
Novartis Pharmaceuticals Corporation (East Hanover, NJ)
Timothy X. Witkowski, M.S., J.D.
Executive Director & Executive Counsel
Intellectual Property
Boehringer Ingelheim (Ridgefield, CT)
Emeritus Members
Stephen R. Auten
Partner, Chair of Pharmaceutical & Life Sciences Litigation
Taft Stettinius & Hollister LLP (Chicago, IL)
(Former Vice President, IP, Sandoz, Inc.)
Mark Bowditch
Patent Attorney (Princeton, NJ)
(Former Executive Director, Head, US Patent Product Support
Sandoz Inc.)
George W. Johnston
Counsel, Gibbons P.C. (Newark, NJ)
(Former Vice President & Chief Patent Counsel,
Hoffmann-La Roche)
Shashank Upadhye
Partner, Amin Talati & Upadhye (Chicago, IL)
(Formerly Vice President – Global Intellectual Property, Apotex, Inc.)
Mark Bowditch
Patent Attorney (Princeton, NJ)
(Former Executive Director, Head, US Patent Product Support
Sandoz Inc.)
Honorable Garrett E. Brown, U.S.D.J. (ret.)
Former Chief Judge, United States District Court,
District of New Jersey (Trenton, NJ)
Neutral, JAMS, The Resolution Experts (New York, NY)
Kurt R. Karst
Director, Hyman, Phelps & McNamara, P.C. (Washington, DC)
Benjamin A. Katzenellenbogen
Partner, Knobbe, Martens, Olson & Bear, LLP (Irvine, CA)
Christopher J. Kelly
Partner, Mayer Brown LLP (Palo Alto, CA)
Thomas Krzeminski
Partner, Knobbe, Martens, Olson & Bear, LLP (Irvine, CA)
Michael F. Buchanan
Partner, Patterson Belknap Webb & Tyler LLP (New York, NY)
George C. Lombardi
Partner, Chair, Intellectual Property Practice
Winston & Strawn LLP (Chicago, IL)
Owen Byrd
Chief Evangelist & General Counsel
Lex Machina (Menlo Park, CA)
Laura A. Lydigsen
Shareholder and Co-Chair Appellate Practice Group
Brinks Gilson & Lione (Chicago, IL)
Vincent L. Capuano, PH.D.
Partner, Duane Morris LLP (Boston, MA)
David A. Manspeizer
Partner
Wilmer Cutler Pickering Hale and Dorr LLP (New York, NY)
Honorable Ruben Castillo
Chief Judge, United States District Court
Northern District of Illinois (Chicago, IL)
Dominick A. Conde
Partner, Fitzpatrick, Cella, Harper & Scinto (New York, NY)
Steven M. Coyle
Partner and Pharmaceutical Litigation Group Leader
Cantor Colburn LLP (Hartford, CT)
Neal K. Dahiya
Senior Counsel – Patent Litigation
Bristol-Myers Squibb (Princeton, NJ)
Ronald M. Daignault
Shareholder, Polsinelli (New York, NY)
2
Michael R. Dzwonczyk
Partner, Sughrue Mion, PLLC (Washington, DC)
Join the Conversation
Kerry B. McTigue
Member, Co-Chair, Intellectual Property Department
Cozen O’Conner (Washington, DC)
Markus H. Meier
Assistant Director, Health Care Division
Bureau of Competition
Federal Trade Commission (Washington, DC)
Gregory A. Morris
Of Counsel, Paul Hastings LLP (Chicago, IL)
Honorable Brian P. Murphy (invited)
(Acting) Lead Administrative Patent Judge
Patent Trial and Appeal Board
United States Patent and Trademark Office (Alexandria, VA)
Jeffrey N. Myers, Ph.D.
Vice President & Assistant General Counsel
Pfizer Inc (New York, NY)
Glenn Newman
Partner, Baker Tilly Virchow Krause, LLP (Philadelphia, PA)
Martin B. Pavane
Member and Vice Chair, Intellectual Property Department;
Co-Chair, ANDA and Biologics
Cozen O’Connor (New York, NY)
Honorable Roy Payne, U.S.M.J.
United States District Court, Eastern District of Texas
(Marshall, TX)
Mark Rachlin
Senior Patent Counsel-Litigation
GlaxoSmithKline (King of Prussia, PA)
Paul A. Ragusa
Partner, Baker Botts L.L.P. (New York, NY)
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)
Mark H. Remus
Partner, Katten Muchin Rosenman LLP (Chicago, IL)
Katharine R. Rice
Corporate Counsel, Gilead Sciences (Foster City, CA)
Irena Royzman
Partner, Patterson Belknap Webb & Tyler LLP (New York, NY)
Richard T. Ruzich
Partner, Taft Stettinius & Hollister LLP (Chicago, IL)
Carmen M. Shepard
Sr. Vice President, Global Policy and Regulatory Counsel
Mylan (Washington, DC)
Paul Simboli
Vice President, Intellectual Property & Asst. General Counsel
Depomed (Newark, CA)
Michael Sitzman
Partner, Gibson Dunn & Crutcher LLP (San Francisco, CA)
Jennifer C. Tempesta
Special Counsel, Baker Botts L.L.P. (New York, NY)
Shashank Upadhye
Partner, Amin Talati & Upadhye (Chicago, IL)
(Former Vice President – Global Intellectual Property, Apotex, Inc.)
Tedd W. Van Buskirk
Shareholder, Polsinelli (New York, NY)
Mark E. Waddell
Chair‚ Patent Litigation and Counseling
Loeb & Loeb LLP (New York, NY)
Donna M. Meuth
Associate General Counsel, Intellectual Property
Eisai Inc. (Andover, MA)
Peter Waibel
Head US Patent Litigation
Novartis Pharmaceuticals Corporation (East Hanover, NJ)
Don J. Mizerk
Partner, Husch Blackwell LLP (Chicago, IL)
Bruce M. Wexler
Partner, Paul Hastings LLP (New York, NY)
ACI’s Hatch-Waxman Series
@ACI_Pharma / #ACIPIV
BE PART OF THE ONLY EVENT WHICH SHAPES THE LAW,
POLICY AND PROCEEDINGS OF PARAGRAPH IV LITIGATION.
Dear Colleague:
E
ach spring for nearly a decade, the “who’s who” of Hatch-Waxman litigators
and industry decision makers, as well as members of the judiciary, and key
government representatives have gathered in New York City to attend American
Conference Institute’s (ACI’s) Paragraph IV Disputes conference. They come to this
industry-leading event to confer with each other and assess the implications and
imprimaturs of court cases, legislation, and industry behaviors which affect the patent
endgame and the pursuit of related profits. Leaders from both brand and generic drug
companies recognize that this event is the single forum which serves both sides of the
industry and is second to none in offering both legal and economic “take aways” for
every sphere of this costly, complex and evolving litigation. This is the only event on
market which not only addresses the hot topics, but also puts them within the context
of pre-suit considerations, case filings, final adjudication and every step in between.
Finally, in response to your requests, we are pleased to offer a workshop on the
Anatomy of a PTO PTAB Patent Trial in the Hatch-Waxman Arena. In this interactive
workshop, our panelists will guide you — step by step — through the anatomy of a
PTAB trial involving a patent for a small molecule drug from inception through final
disposition through a mock trial scenario.
ACI is pleased to present this year’s Paragraph IV Disputes conference. We welcome
you to join our exceptional faculty and your peers as we examine the consequences of
the 2015 patent cliff escarpments which will result in some $32 billion dollars in patent
losses for drugs such as Lantus, Abilify, Copaxone, Neulasta, and Androgel. Within
this context, we will explore the role of legal analytics in Hatch-Waxman litigation, the
impact of Teva on Markman hearings, questions of personal and general jurisdiction,
the effect of cases such as Myriad and Nautilus, new obvious considerations in light
of Baraclude, the increased utilization of PTO proceedings, the ongoing debate over
divided and induced infringement, the continuing controversy in settling these matters
in a post-Actavis era, damages assessment, as well as the importance of legal ethics.
This year’s event will also feature a keynote by the FTC and two Judicial Roundtables
— one with District Court Judges and the other with PTAB Judges.
Very truly yours,
Clearly, there is not a moment to lose in this ruthless endgame of no-holds bar
litigation. Do not be left behind. Register today by calling 1-888-224-2480,
faxing your registration form to 1-877-927-1563 or visiting our website at
www.AmericanConference.com/PIVDisputesNYC.
We look forward to seeing you in New York this April.
Lisa J. Piccolo, Esq.
Senior Industry Manager, Life Sciences and Health Care
American Conference Institute
Media Partners:
Register now: 888-224-2480 • Fax: 877-927-1563 • www.AmericanConference.com/PIVDisputesNYC
3
MONDAY, APRIL 27, 2015
Main Conference – Day 1
7:00
Registration and Continental Breakfast
Sponsored by:
8:15
8:30
Questions of Personal and General Jurisdiction
in A Paragraph IV Case: Exploring Daimler’s
Applicability in a Hatch Waxman Scenario
Dominick A. Conde
Partner
Fitzpatrick, Cella, Harper & Scinto (New York, NY)
Co-Chairs’ Opening Remarks
Steven M. Coyle
Partner and Pharmaceutical Litigation Group Leader
Cantor Colburn LLP (Hartford, CT)
Guy Donatiello
Vice President, Intellectual Property
Endo Pharmaceuticals (Malvern, PA)
Elizabeth J. Holland
Partner
Goodwin Procter LLP (New York, NY)
Timothy X. Witkowski, M.S., J.D.
Executive Director & Executive Counsel,
Intellectual Property
Boehringer Ingelheim (Ridgefield, CT)
Thomas Krzeminski
Partner
Knobbe, Martens, Olson & Bear, LLP (Irvine, CA)
The Role of Legal Analytics in the Paragraph
IV Disputes Landscape: Playing Moneyball
for Successful ANDA Litigation Strategy
Owen Byrd
Chief Evangelist & General Counsel
Lex Machina (Menlo Park, CA)
Barry P. Golob
Partner
Cozen O’Connor (Washington, DC)
Mark Rachlin
Senior Patent Counsel-Litigation
GlaxoSmithKline (King of Prussia, PA)
• Analyzing trends in ANDA litigation over the past 5 years
and understanding how can they help you with litigation
strategy
• Identifying qualified outside counsel for each new matter,
based on objective data
• Understanding how data-driven predictions about the
behavior of judges, attorneys and parties, as well as data
about prior asserted patents, can help you succeed in
ANDA litigation
4
9:15
Join the Conversation
10:15 Morning Coffee Break
Sponsored by:
10:30 Exploring Possible New Grounds Paragraph
IV Invalidity Challenges: How 101 Rejections
Under Myriad and Findings of 112 Indefiniteness
Under Nautilus May Alter Paragraph IV Litigation
Matthew J. Becker
Partner
Axinn, Veltrop & Harkrider LLP (Hartford, CT)
Tedd W. Van Buskirk
Shareholder
Polsinelli (New York, NY)
Richard Berman
Partner
Arent Fox LLP (Washington, DC)
Peter Waibel
Head US Patent Litigation
Novartis Pharmaceuticals Corporation
(East Hanover, NJ)
In January 2014, the Supreme Court issued its decision in
Daimler AG v. Bauman, 134 S. Ct. 746 (2014). At the time,
many industry watchers opined that because of Daimler’s
very specific parameters for general jurisdiction, the case
would have significant bearing on the forums in which a
Paragraph IV case could be heard, thus disrupting the very
active and established Paragraph IV dockets in such Districts
as New Jersey, Delaware, Eastern Texas, Northern Illinois,
Northern California and Southern New York. However,
this past November, the District of Delaware in AstraZeneca
AB v. Mylan Pharmaceuticals, Inc., C.A. No. 14-696-GMS
(D. Del. Nov. 5, 2014) found a basis for specific jurisdiction
in a Hatch-Waxman case consistent with Daimler. At time
of press, there are several other Paragraph IV cases pending
at the District Court level in which jurisdiction is also being
challenged. This panel will examine Mylan within the context
of Daimler and address the following points of discussion:
• Exploring grounds for findings of general jurisdiction
in Hatch-Waxman matters prior to Daimler and Mylan
• Analyzing the Supreme Court’s ruling in Daimler and its
holding on personal and general jurisdiction and how it
has altered prior jurisprudence on this subject
ACI’s Hatch-Waxman Series
• Examining Judge Sleet’s opinion in Mylan and the court’s
logic in determining how service of the Paragraph IV
Notice Letter satisfies the Daimler requirements for
personal jurisdiction
• Anticipating possible Federal Circuit review of Mylan
• Predicting outcomes for future jurisdictional challenges
in a Paragraph IV setting
Robert J. Gunther, Jr.
Partner
Wilmer Cutler Pickering Hale and Dorr LLP
(New York, NY)
Benjamin A. Katzenellenbogen
Partner
Knobbe, Martens, Olson & Bear, LLP (Irvine, CA)
Paul Simboli
Vice President,
Intellectual Property & Asst. General Counsel
Depomed (Newark, CA)
• Review of the Supreme Court’s decision in Association
For Molecular Pathology v. Myriad Genetics, Inc.
(Supreme Court Docket Number 12–398) (Myriad)
and understanding its implications for 101 subject matter
patentability in the small molecule space
• Examining 101 rejections by the PTO as per the agency’s
Myriad guidance
• Understanding how 101 prosecution rejections under
this guidance may translate to 101 invalidity challenges
of a small molecule drug in a Paragraph IV setting at the
District Court level
@ACI_Pharma / #ACIPIV
•Analyzing CLS Bank v. Alice Corp. (Supreme Court Docket
Number 13-298) and its relationship to Myriad vis-à-vis 101
- Covered Business Method patent review at the PTAB
and 101 applicability
 Amneal Pharmaceuticals, LLC, Par Pharmaceutical,
Inc., and Roxane Laboratories, Inc. (REMS relative
to Orange Book listed patent)
• Review of the Supreme Court’s new standard for
definiteness in Nautilus, Inc. v. Biosig Instruments, Inc.
(Supreme Court Docket Number 13-0369) under 112
• Evaluating possible impact of Nautilus‘s “reasonable
certainty” claim construction interpretation in a Paragraph
IV invalidity challenge
• Devising new due diligence strategies for patent protection
and patent challenges in light of this new jurisprudence
Compound patents also known as composition of matter
patents, lead patents and NCE patents were always considered
the IP stronghold of the branded pharmaceutical industry.
These were patents that were never defeated in a Paragraph
IV obviousness challenge — at least not until the District
of Delaware’s ruling in Bristol-Myers Squibb Company v. Teva
Pharmaceuticals USA, Inc. (Baraclude) which the Federal
Circuit affirmed last June. Some industry watchers have
dubbed this case the beginning of the end for pharmaceutical
compound patents, while other have been quick to say not so
fast as the case was very fact specific. Nevertheless, it is still
a pivotal decision in the world of Paragraph IV litigation.
This panel will explore the significance of Baraclude and
provide insights on:
• Review of obviousness criteria post-KSR and its unique
application to Baraclude
• Examining the Delaware court’s finding and Federal
Circuit’s subsequent affirmation for structural obviousness
rendering the Baraclude patent invalid
• Analyzing the criteria for lead compound analysis relative
to Baraclude
- lead compound selection
- rationale for lead compound modification
- reasonable expectation of success for lead compound
modification
• Understanding how Baraclude will impact both
prosecution and litigation under Hatch-Waxman
- preparation of patent application for lead compounds
- trial strategies
- expert testimony
• Predicting future obviousness rulings in light of Baraclude
• Devising strategies for obviousness challenges to lead
compounds: brand name and generic perspectives
11:30 Defeating the Undefeatable: New Obvious
Considerations for Paragraph IV Compound
Patent Challenges in Light of Baraclude
Vincent L. Capuano, Ph.D.
Partner
Duane Morris LLP (Boston, MA)
Lisa M. Ferri
Partner
Mayer Brown LLP (New York, NY)
George C. Lombardi
Partner, Chair, Intellectual Property Practice
Winston & Strawn LLP (Chicago, IL)
Katharine R. Rice
Corporate Counsel
Gilead Sciences (Foster City, CA)
Bruce M. Wexler
Partner
Paul Hastings LLP (New York, NY)
12:30 Networking Luncheon
Sponsored by:
1:45
Moderator:
Michael R. Dzwonczyk
Partner
Sughrue Mion, PLLC (Washington, DC)
PTO Proceedings Retrospect: Exploring the
Growing Use of IPR, PGR and CBM Review
in Hatch-Waxman Litigation
Lisa A. Jakob
Legal Director, IP Litigation
Merck & Company (Rahway, NJ)
Laura A. Lydigsen
Shareholder and Co-Chair Appellate Practice Group
Brinks Gilson & Lione (Chicago, IL)
Gregory A. Morris
Of Counsel
Paul Hastings LLP (Chicago, IL)
Martin B. Pavane
Member and Vice Chair, Intellectual Property
Department; Co-Chair, ANDA and Biologics
Cozen O’Connor (New York, NY)
Paul A. Ragusa
Partner
Baker Botts L.L.P. (New York, NY)
Irena Royzman
Partner
Patterson Belknap Webb & Tyler LLP
(New York, NY)
Petitions for Inter Partes Review (IPR), the most popular of
the PTO’s post grant proceedings are being filed in increasing
multitude in the life sciences space and are becoming an
integral part of Hatch-Waxman litigation. Post Grant
Review (PGR), and Covered Business Method Patent Review
(CBM) petitions have also been filed in conjunction with
Paragraph IV litigation. Other PTO proceedings such as
re-issue applications and supplemental re-exam are also being
incorporated into the Hatch-Waxman schematic. This panel
will explore the use and utility of these proceedings. Points of
Discussion will include:
IPR
• Evaluating when an IPR petition should be brought
in an ANDA setting
• Assessing strategic benefits that can be derived from such
proceedings as opposed to district court litigation in a
Hatch-Waxman scenario
• Understanding how brands are rethinking Paragraph IV
litigation strategies in light of this new proceeding and
its use by generics
• Analyzing the first IPR decisions in the Hatch-Waxman
sphere — what can we glean about the PTAB’s thought
processes through these initial decisions?
• Survey of the types of Hatch-Waxman patents and success
rates for IPR petitions brought so far
-compound
-composition
- method of treatment
• Exploring how IPR may be used to bypass findings
of non-obviousness in the federal courts
Register now: 888-224-2480 • Fax: 877-927-1563 • www.AmericanConference.com/PIVDisputesNYC
5
- how the different burdens of proof in obviousness
challenges before the federal courts and PTO may
impact litigation strategies
• Deciphering the Federal Circuit’s decisions regarding
PTO obvious determinations
- Federal Circuit’s objective evidence advisory
• Examining uses of IPR for second, third and other
subsequent ANDA fliers
- forfeiture triggers
- query: if an Orange Book-listed patent is found invalid
in an IPR proceeding — does it need to be delisted?
• Taking a closer look at discovery in IPR proceedings
- learning the art of economy, restraint and efficiency
in your discovery strategy
• Evaluating requests for joinder and or ex partes
re-examination in an IPR proceeding in the HatchWaxman space
• Settlements, final dispositions and appeals
- what happens when the PTAB insists on hearing
a case even after the parties agree to settle?
PGR
• Accord Healthcare, Inc. v. Helsinn Healthcare S.A.,
et al., IPR2014-00010
CBM
• Amneal Pharmaceuticals, LLC, Par Pharmaceutical, Inc.,
and Roxane Laboratories, Inc. (REMS relative to Orange
Book listed patent)
Other points to consider
• Questions of estoppel and whether IPR and other
proceedings may be used to get a “second bite at the apple”
• Identifying criteria for stays of district court litigation
and strategies for parallel proceedings
3:00
Afternoon Refreshment Break
3:15
Exploring the Utilization of Reissue Applications
to Cure Invalidity Findings at the PTAB and
District Courts
Stephen R. Auten
Partner,
Chair of Pharmaceutical & Life Sciences Litigation
Taft Stettinius & Hollister LLP (Chicago, IL)
(Former Vice President, IP, Sandoz, Inc.)
6
Join the Conversation
Michael Sitzman
Partner
Gibson Dunn & Crutcher LLP (San Francisco, CA)
4:45
Honorable Ruben Castillo
Chief Judge
United States District Court
Northern District of Illinois (Chicago, IL)
• Exploring how and when a pharmaceutical patent holder
can file a reissue application at the PTO after a finding
of invalidity in the District Court or PTAB
- prior art
- section 112
• Patent portfolio audits: is there an opportunity to use
reissue to ‘correct’ patents that may be most vulnerable
• Understanding when reissue is estopped through the
doctrine of res adjudicata/claim preclusion
- Senju v. Apotex (Fed. Cir. 2014)
3:45
A View From the Bench:
The Federal Judges Speak
Honorable Douglas Arpert, U.S.M.J.
United States District Court, District of New Jersey
(Trenton, NJ)
Honorable Roy Payne, U.S.M.J.
United States District Court, Eastern District of Texas
(Marshall, TX)
The Patent Trial and Appeals Board Live:
A Conversation with Administrative Patent
Judges on PTAB Practices and Protocols
for Hatch-Waxman Practitioners
Honorable Garrett E. Brown, U.S.D.J. (ret.)
Former Chief Judge, United States District Court
District of New Jersey (Trenton, NJ)
Neutral, JAMS, The Resolution Experts
(New York, NY)
Honorable Brian P. Murphy (invited)
(Acting) Lead Administrative Patent Judge
Patent Trial and Appeal Board
United States Patent and Trademark Office
(Alexandria, VA)
Moderator:
Honorable Jacqueline D. Wright Bonilla (invited)
Administrative Patent Judge
Patent Trial and Appeal Board
United States Patent and Trademark Office
(Alexandria, VA)
Renowned jurists with some of the most active Paragraph IV
litigation dockets in the country will share their thoughts and
insights on complex challenges facing both patent holders
and patent challengers. Come prepared with your most
pressing questions.
Ralph J. Gabric
Shareholder & Chair, Litigation Group
Brinks Gilson & Lione (Chicago, IL)
The Patent Trial and Appeal Board is one of the most watched
administrative courts since the creation of the ITC. Given the
popularity of proceedings such as IPR in the Hatch-Waxman
arena, it is absolutely essential that Paragraph IV litigators
have a strong working knowledge of this administrative forum.
6:00
Conference Adjourns to Day Two
Cocktail Party Sponsored by:
Unlike Article III Courts, the Patent Trial and Appeal Board
is an administrative body formed through a statute. While,
the PTAB is more informal in some respects, it is more
intense in others due to the speed by which matters are
heard. The PTAB has its own rules of engagement and its
own protocols — in addition to substantive and procedural
standards that differ greatly from those of the District Courts.
In this session, Judges from the PTAB will discuss protocols
and the art of appearance before this administrative body.
ACI’s Hatch-Waxman Series
@ACI_Pharma / #ACIPIV
TUESDAY, APRIL 28, 2015
Main Conference – Day 2
7:30
Points of discussion will include:
• Debating the merits of de novo review vs. deferential review
• Review and comparison of the Federal Circuit’s holding
in Lighting Ballast Control LLC v. Philips Electronics North
America Corp., 500 Fed. App’x 951, 951-52 (Fed. Cir. 2013)
to Teva
• Analyses of the Teva v. Sandoz briefings
• Predicting how the Court’s decision will impact
Paragraph IV challenges and Markman hearings
Continental Breakfast
Sponsored by:
8:30
Teva v. Sandoz — Claim Construction Redoux:
De Novo vs. Deferential
Bradford J. Badke
Partner
Ropes & Gray LLP (New York, NY)
Ronald M. Daignault
Shareholder
Polsinelli (New York, NY)
Don J. Mizerk
Partner
Husch Blackwell LLP (Chicago, IL)
Jeffrey N. Myers, Ph.D.
Vice President & Assistant General Counsel
Pfizer Inc (New York, NY)
Moderator:
Mark Bowditch
Patent Attorney (Princeton, NJ)
(Former Executive Director, Head, US Patent Product
Support Sandoz Inc.)
On January 20, 2015, the Supreme Court issued its
iconoclast decision in Teva v, Sandoz, which established a new
standard of review for claim construction. In this case which
arose from an obscure issue concerning molecular weight in
a Paragraph IV scenario, the Court held that a deferential
standard of review should be applied to findings of fact in a
claim construction matter. The Court also held that the de
novo standard still applied to all other components of claim
construction that were of a non-factual nature.
In this session our panelists will engage in a lively discussion
on what may be the patent case of the century.
9:30
Limelight v. Akamai: Assessing Its Impact on
Method of Treatment Patents and Section viii
Label Carve Outs
Neal K. Dahiya
Senior Counsel – Patent Litigation
Bristol-Myers Squibb (Princeton, NJ)
Steven E. Feldman
Partner
Husch Blackwell LLP (Chicago, IL)
David A. Manspeizer
Partner
Wilmer Cutler Pickering Hale and Dorr LLP
(New York, NY)
Mark H. Remus
Partner
Katten Muchin Rosenman LLP (Chicago, IL)
Mark E. Waddell
Chair‚ Patent Litigation and Counseling
Loeb & Loeb LLP (New York, NY)
Moderator:
Richard T. Ruzich
Partner
Taft Stettinius & Hollister LLP (Chicago, IL)
Last June, the Supreme Court issued its opinion in Limelight
v. Akamai and concluded that induced infringement cannot
exist without direct infringement. Many pharmaceutical
industry watchers are troubled by this ruling and its
implications for method of treatment patents as well as label
carve outs. This panel will explore these concerns in addition
to the repercussions for Paragraph IV litigation. Points of
discussion will include:
• Analyzing the Supreme Court’s ruling in Akamai,
S. Ct. No. 12-786
• Exploring the relationship between inducement actions
and divided and contributory infringement
- examining inducement and divided infringement
challenges to methods of treatment claims listed
in the Orange Book
 Commil USA, LLC v. Cisco Sys., Inc., No. 2012-1042
(Fed. Cir.2013), cert. granted
• Understanding how new proposed FDA Rulemaking
on Generic Labeling may impact carve outs and skinny
labeling relative to method of treatment claims
10:30 Morning Coffee Break
Sponsored by:
10:45 FTC Keynote: Reverse Payment Settlements
and Other Antitrust Concerns Impacting
Paragraph IV Litigation in the Wake of Actavis
Markus H. Meier
Assistant Director, 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 settlement cases. The significance of the
Supreme Court’s decision, however, will only become clear
as the lower courts grapple with its application to challenged
reverse payment settlements.
As per the MMA, the FTC is required to continue to review
Hatch-Waxman settlements, and it has publicly announced
that it will continue challenging reverse payment settlement
agreements, possibly including settlement agreements filed
prior to the Actavis decision. Private plaintiffs certainly have
stepped up their challenges, and there are currently fifteen
reverse payment cases in litigation. Additionally, the FTC
recently has questioned the legality under Actavis of a HatchWaxman settlement based on the brand’s agreement not to
launch an authorized generic. It is now anyone’s guess as to
how far the FTC and private plaintiffs will go.
In this session, the FTC will address these matters, in
addition to other anticompetitive concerns in the HatchWaxman space.
Register now: 888-224-2480 • Fax: 877-927-1563 • www.AmericanConference.com/PIVDisputesNYC
7
11:30 Developing Practical Strategies for Settling
A Paragraph IV Case Post-Actavis: A Litigator’s
Perspective
John L. Dauer, Jr.
Chief Patent Counsel
Sun Pharmaceutical Industries, Inc. (Cranbury, NJ)
Beth D. Jacob
Partner
Kelley Drye & Warren LLP (New York, NY)
Christopher J. Kelly
Partner
Mayer Brown LLP (Palo Alto, CA)
Jennifer C. Tempesta
Special Counsel
Baker Botts L.L.P. (New York, NY)
• Understanding the application of antitrust law’s
“Rule of Reason” to pharmaceutical patent settlements
• Examining decisions concerning pharmaceutical patent
settlements in the District Courts since Actavis
- In re Nexium (Esomerprazole) Antitrust Litigation
(D. Mass. 2014)
 large and unjustified payment — but agreement
found to not be anticompetitive
- In re Lipitor Antitrust Litigation (D.N.J. 2014)
- In re Effexor XR Antitrust Litigation (D.N.J. 2014)
 “reliable cash value of the non-monetary payment”
• Analyzing allegations in pending notable litigation
in this area
- Federal Trade Commission v. AbbVie et al, 2:14-cv-05151
(E.D. PA 2014)
 sham litigation
• Drafting and structuring an agreement in accord with new
jurisprudence and pending actions in this area and that
will also pass FTC review
• Identifying and avoiding red flags that could trigger
FTC scrutiny
• Incorporating elements that emphasize the procompetitive
nature of the agreement
• Assessing the role of commitments as to authorized
generics and licensing in view of the FTC’s views on
these topic
• Understanding how concepts such as valuation, pricing,
government contracting and managed markets, royalties
and lost profits as they apply to these agreements
8
Join the Conversation
Generics
• Developing timelines for business and legal milestones
relative to the terms of the settlement
• Devising strategies to employ pending completion
of the FTC’s review
• Reviewing recent FDA decisions revoking 180-day
exclusivity
-Ranbaxy
 cGMP violations
12:30 Networking Luncheon
1:45
Other Significant Regulatory Developments Affecting
Hatch-Waxman
FDA Update: Survey of Agency Activity
Impacting Paragraph IV Litigation
• Exploring the impact of new RTR guidance by FDA
and its impact on first generic filers
- new data stability requirements
• Determining ‘first generic’ status under GDUFA
- priority treatment
• Deciphering Revised ANDA Bioequivalence Guidance
and its effect on TE ratings
- Mallinckrodt downgrade for generic version of Concerta
and subsequent lawsuit against FDA
• Review of FDA’s REMs guidance relative to ANDA litigation
• Examining FDA’s guidance on premature notice filing
Joseph Evall
Partner
Gibson Dunn & Crutcher LLP (New York, NY)
Kurt R. Karst
Director
Hyman, Phelps & McNamara, P.C.
(Washington, DC)
Carmen M. Shepard
Sr. Vice President,
Global Policy and Regulatory Counsel
Mylan (Washington, DC)
Shashank Upadhye
Partner
Amin Talati & Upadhye (Chicago, IL)
(Former Vice President – Global Intellectual Property,
Apotex, Inc.)
Afternoon Refreshment Break
3:00
Assessing the True Measure of Damages
in At Risk Launch Scenario
Nicolas Barzoukas
Partner
Baker Botts L.L.P. (Huston, TX)
New Developments Impacting Brand Name
and Generic Exclusivities
Stephen P. Benson
Partner
Katten Muchin Rosenman LLP (Chicago, IL)
• Assessing the impact of pending MMA guidance
impacting forfeiture and other MMA-amendments
to Hatch-Waxman Act
• Exploring exclusivity losses in Hospira, Inc. v. Sylvia
Mathews Burwell, et al (District of Md. 2014)
Michael F. Buchanan
Partner
Patterson Belknap Webb & Tyler LLP (New York, NY)
Brands
• Examining new NCE criteria by FDA
• Analyzing FDA NCE exclusivity guidance for certain
fixed combination drugs
- criteria and interpretations
• Status of the Cures Initiative and exclusivity for repurposing
- rare disease and condition
• Revisiting the concept of additional exclusivity for
antibiotic development
ACI’s Hatch-Waxman Series
2:45
Kerry B. McTigue
Member, Co-Chair, Intellectual Property Department
Cozen O’Conner (Washington, DC)
Glenn Newman
Partner
Baker Tilly Virchow Krause, LLP (Philadelphia, PA)
Moderator:
Christopher J. Harnett
Partner
Ropes & Gray LLP (New York, NY)
@ACI_Pharma / #ACIPIV
• Survey of recent at-risk launches, status and outcomes
• Conducting a risk–benefits analysis of launching at risk
during the trial or appeal period based on current at-risk
outcomes
• Review of recent preliminary injunction determination
in Hatch-Waxman matters
- examining inconsistencies in these determination
given discord between district courts, Federal Circuit
and Supreme court in these matters
• Asserting damages in an at-risk scenario
- Ferring v. Actavis (D.NV. 2014)
• Exploring recent damages award in an at-risk launch
scenario, post-Protonix
• Determining the quantification of damages in an at
risk-launch
• Lost profits
- assessment of profit as a true measure of damages
 questions of profitability and sales
- when is it the only thing that you can seek?
- circumstances under which lost profits can be denied
- analysis of lost profits determination in Sanofi-Aventis v.
Glenmark, No. 2012-1489 (Fed. Cir., Apr. 21, 2014)
- Exploring novel lost profit determinations
• Review of recent inequitable conduct cases impacting
Hatch-Waxman litigation post-Therasense
- Apotex Inc. v. UCB, Inc. (Fed. Cir. 2014)
- American Calcar v. American Honda (Fed. Cir. 2014)
 “but-for materiality” and withholding of information
• Understanding the ethics implications for Octane Fitness
v. Icon Health & Fitness (Supreme Court Docket Number
12-1184)
- how the Court’s lowering of the standard from clear
and convincing to preponderance theory for exceptional
case may impact ethics considerations in a Paragraph IV
setting
- Classen Immunotherapies Inc. v. Biogen Idec
(D. Md. May 14, 2014)
• Exploring the PTO’s adoption of the Therasense standard
in its proceedings with respect to inequitable conduct
findings
- inequitable conduct and Patent Reform
 supplemental proceedings under the AIA:
an opportunity to cure inequitable conduct?
 does launch of an authorized generic defeat request
for lost profits?
 if holder of patent to whom damages is awarded is
an off-shore entity — should lost profits assessment
be based on transfer pricing?
• Reasonable royalties:
- establishing the basis for royalty
- looking at market share
- the point where infringement began
• Mitigating factors impacting damage award
4:00
The Ethics of Paragraph IV Practice:
New Developments Impacting Professional
Responsibility in the Hatch-Waxman Arena
Frank W. Forman
Senior Patent Counsel
Astellas US LLC (Farmingdale, NY)
Donna M. Meuth
Associate General Counsel
Intellectual Property
Eisai Inc. (Andover, MA)
5:00
Conference Ends
Post Conference Workshop: WEDNESDAY, APRIL 29, 2015
8:30 AM – 12:30 PM (Registration opens at 8:00 AM. Continental Breakfast will be served.)
Anatomy of a PTO PTAB Patent Trial in the Hatch-Waxman Arena
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)
Post-Grant Proceedings, IPRs — in particular and to lesser
but still relevant extent, PGRs and CBMs — have become
and ancillary if not integral part of Hatch-Waxman litigation.
These petitions may be filed in advance of traditional
Paragraph IV litigation or in some instances stay or run
parallel to such proceedings.
In this interactive workshop, our panelists will guide you
— step by step — through the anatomy of a PTAB trial
involving a patent for a small molecule drug from inception
through final disposition and every step in between. Through
a mock trial scenario and fact pattern, they will go through
expedited scheduling, petition and response, oral argument,
adjudication and appeal. The workshop leaders will provide
mock documents. Points of discussion will include:
•
•
•
•
•
•
•
•
•
Discovery parameters
Preparing for argument
Criteria and assessment for requesting a stay
Strategies for parallel district court and PTAB proceedings
PTAB adjudication, settlements and appeal options
Strategies for operating in an expedited time line
Best practices for petition and petition response drafting
Amending petition/response
Amending claims during petition process
© American Conference Institute, 2015
Register now: 888-224-2480 • Fax: 877-927-1563 • www.AmericanConference.com/PIVDisputesNYC
9
WHO YOU WILL MEET
Patent attorneys and litigators (in-house & law firm) who represent:
➥ Brand name pharmaceutical companies
➥ Generic pharmaceutical companies
➥ Biopharmaceutical companies
Continuing Legal Education Credits
Earn
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education requirements. This course is identified as nontransitional for the purposes of CLE accreditation.
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in private practice and other senior executives participate
in ACI events — and the numbers keep growing.
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provide strategic, cutting edge guidance on practical issues.
Unparalleled Learning and Networking
ACI understands that gaining perspectives from — and building
relationships with — your fellow delegates during the breaks can be
just as valuable as the structured conference sessions. ACI strives to
make both the formal and informal aspects of your conference as
productive as possible.
ACI certifies that this activity has been approved for CLE credit by the State Bar of California.
You are required to bring your state bar number to complete the appropriate state forms during the conference.
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and ACI will make every effort to process your request.
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With more than 300 conferences in the United States, Europe, Asia Pacific, and Latin America, American Conference
Institute (ACI) provides a diverse portfolio devoted to providing business intelligence to senior decision makers who
need to respond to challenges spanning various industries in the US and around the world.
As a member of our sponsorship faculty, your organization will be deemed as a partner. We will work closely with your
organization to create the perfect business development solution catered exclusively to the needs of your practice group,
business line or corporation.
For more information about this program or our global portfolio of events, please contact:
Esther Fleischhacker
Senior Business Development Executive, Special Projects, American Conference Institute
Tel: 212-352-3220 x5232
[email protected]
Join the Conversation
Many of our speakers and delegates use our conferences to recruit for
new, expert talent to fill open positions at their firms.
Because ACI provides many niche conferences annually, our events
are a great way to discover a rich pool of highly qualified talent.
Global Sponsorship Opportunities
10
Is your organization recruiting specialists with expertise
in this area?
ACI’s Hatch-Waxman Series
Announcing the ACI Job Board
Visit www.americanconference.com/blog and navigate to the ACI
Expert Jobs link.
It’s quick, easy and free for you, your in-house recruiters, or anyone
in your firm to post current open positions and take advantage of our
exclusive community of experts.
The newly posted jobs will appear on the relevant sections of
www.americanconference.com and our partner sites, ensuring that
your free job listing is visible to a large number of targeted individuals.
@ACI_Pharma / #ACIPIV
THANK YOU TO OUR SUPPORTING SPONSORS
Baker Botts is an international law firm with a global
network of offices. Our Life Science lawyers are wellversed in all facets of the law impacting the industry, and
our matters have included representation of proprietary
pharmaceutical companies over a range of Hatch-Waxman issues, including ANDA litigation, patent
portfolio review, product design and clearance, Orange Book inquiries, 505(b)(2) applications,
paragraph IV certifications and notice letters, exclusivity inquiries, pre-litigation assessments,
settlements and trial. BakerBotts.com
The attorneys, scientific advisors and patent agents at Brinks Gilson & Lione
focus their practice in the field of intellectual property, making Brinks one of the
largest intellectual property law firms in the U.S. Clients around the world rely
on Brinks to help them protect and enforce their intellectual property rights.
Brinks attorneys provide counseling in all aspects of patent, trademark, unfair
competition, trade secret and copyright law. More information is available at
www.brinksgilson.com.
Cozen O’Connor is an international law firm with more than 575
lawyers in 23 offices. Our intellectual property team is a national
leader in Hatch-Waxman litigation with an impressive track record.
In addition to top-tier patent litigation, we also counsel clients on a full range of regulatory issues
and advocate on their behalf before key regulatory authorities. Our attorneys hold advanced degrees
in the natural sciences and nearly all members have experience as research scientists in industry or
academia for small molecules, biosimilars and hybrid products, such as smaller polysaccharides and
peptides (http://www.cozen.com/practices/intellectual-property/biologics-biosimilars).
Katten is a full-service law firm with more than 600 attorneys in
locations across the United States and in London and Shanghai.
Clients seeking sophisticated, high-value legal services turn to us for
counsel locally, nationally and internationally in a wide range of areas.
Katten’s team represents both plaintiffs and defendants in patent infringement actions filed in federal
jurisdictions throughout the United States and before the US Patent and Trademark Office (USPTO)
and the US International Trade Commission. Our clients come from a variety of companies with
pharmaceutical products — both generic and brand-name — as well as companies with biologics.
Katten’s team pursues litigation with a mind toward our clients’ overall business goals. As a result,
we maximize the value of our clients’ intellectual property assets and set the stage for continuing
technological and business development and expansion.
Patterson Belknap is a 200-lawyer firm based in New York City. More than half of our attorneys are
litigators, many with a focus on patent disputes. We litigate “bet-the-company” matters on behalf
of major corporations in industries including pharmaceuticals, manufacturing and software. Many of
our attorneys have scientific and technical backgrounds and varied industry experience, including
in such diverse fields as chemistry, biochemistry, biology, biotechnology, statistics, mathematics,
and chemical, nuclear and electrical engineering. Our patent and biotechnology attorneys recently
launched BiologicsBlog.com, a source of insights, information and analysis related to Biologics.
Polsinelli’s Hatch-Waxman team has extensive experience leading Abbreviated New Drug
Application (ANDA) cases and has represented some of the world’s largest, best-known, and most
influential generic, brand, and specialty pharmaceutical companies. Our attorneys have litigated the
blockbuster products of the last three decades, many in first-to-file cases, as well as smaller market
drugs, and we understand that each case, and each client, requires its own approach. We partner
with our clients to develop a strategy to achieve favorable results in a cost-effective manner that
aligns with our clients’ business goals.
Our attorneys have first-chair experience litigating Hatch-Waxman cases in key venues. We are
skilled courtroom advocates, and we bring to bear our backgrounds in chemistry, organic chemistry,
biochemistry, biology, pharmacy, medicine, molecular biology, microbiology, neuroscience,
pharmacology, genetics, immunology, and molecular biophysics, among others.
Our knowledge of the pharmaceutical sciences includes compositions and APIs, formulations (oral
dosage forms, controlled release, ODTs, transdermal, topical, ophthalmic, transmucosal, parenteral,
etc.), methods of use, polymorphs, enantiomers, drug delivery devices, and methods of manufacture.
We assist clients every step of the way — from preparing and filing an ANDA or 505(b)(2) application
through trial, appeal, and/or settlement. Our multidisciplinary team includes trial attorneys, FDA and
antitrust counsel, patent attorneys, and agents.
For Sponsorship Opportunities for this Event, Please Contact:
Esther Fleischhacker at 212-352-3220 ext. 5232 or [email protected]
Register now: 888-224-2480 • Fax: 877-927-1563 • www.AmericanConference.com/PIVDisputesNYC
11
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5 Easy Ways to Register
PTAB Trial Workshop for Hatch-Waxman Litigators: April 29, 2015
Main Conference: April 27–28, 2015 | The Conrad – New York | New York City
Paragraph IV Disputes
American Conference Institute’s 9th Annual
✃