815L17_12pg_WEB

Register Now | 888 224 2480 | AmericanConference.com/PIVDisputesChicago
a C5 Group Company
Business Information in a Global Context
ACIAmerican Conference Institute
C5 Group is celebrating 30 years!
It is time for a brand that reflects
the dynamic strides we have made.
See inside for details…
EARN CLE/ETHICS
CREDITS
The Advanced Forum for Brand Name and Generic Counsel
on the Intricacies of Extreme Hatch-Waxman Litigation
Pre-suit Considerations | Commencement of Suit
Discovery | Motion Practice | Final Adjudication
Paragraph IV Disputes
Master Symposium
4th
Annual
From American Conference Institute, the creator of the industry-leading and original Paragraph IV Disputes,
comes a conference designed for the new era of extreme Hatch-Waxman litigation
September 19 – 20, 2016 | InterContinental Chicago Magnificent Mile | Chicago, IL
September 19, 2016: Hatch-Waxman Boot Camp | September 21, 2016: Post-Conference Workshops
Preeminent patent litigators representing brand name and generic drug makers,
leading in-house counsel, esteemed jurists, and government representatives will
gather in Chicago at this “meeting of the minds” to discuss, analyze, and interpret
the latest controversies impacting Paragraph IV litigation. Join us as they provide
insights on such matters as:
• Budgeting and Cost-Management Strategies
for Paragraph IV cases
• Personal and General Jurisdiction Challenges
under Daimler and Mylan
• Parallel Proceedings — Reviewing Invalidity
Hearings in District Courts and PTAB after Cuozzo
• 101 Rejections Post Prometheus, Myriad, Ariosa,
and Their Progeny
• Evaluation of On-Sale Bar — The Medicines Co.
v. Hospira and Helsinn v. Teva
• Obviousness and Obvious-Type Double Patenting
Considerations
• Divided and Induced Infringement Post Limelight
• Settlement Strategies Post Actavis
• At-Risk Launches and Damages
• Impact of Use Codes on Hatch-Waxman Cases
• Safe Harbor Provision of 271(e)
• FDA Processes and Regulatory Exclusivities
for Paragraph IV filers
• Ethical considerations in view of Halo v. Pulse
and Stryker v. Zimmer
Insights from Judiciary:
District Court
Honorable Rubén Castillo,
Chief Judge
United States District Court
Northern District of Illinois
Honorable Stanley Chesler,
Senior Judge
District of New Jersey
Honorable Joseph Dickson,
U.S.M.J.
District of New Jersey
Honorable Beverly Reid
O’Connell, U.S.D.J.
Central District of California
Honorable Roy Payne, U.S.M.J.
Eastern District of Texas
Honorable Gail Standish,
U.S.M.J.
Central District of California
Patent Trial and Appeal Board
Honorable Jackie Wright Bonilla
Lead Administrative Patent Judge
United States Patent and
Trademark Office
Honorable Brian P. Murphy
Trademark Office
Honorable Rama Elluru
Administrative Patent Judge
Trademark Office
In-House Insights from:
Akorn Pharmaceuticals, Inc.
Depomed, Inc.
Eli Lilly and Co.
Fresenius Kabi USA, LLC
GlaxoSmithKline
Ironwood Pharmaceuticals, Inc.
Merrimack Pharmaceuticals, Inc.
Sorrento Therapeutics, Inc.
Takeda Pharmaceuticals, U.S.A., Inc.
Xellia Pharmaceuticals, Inc.
Supporting
Sponsors:
Associate
Sponsors:
Sponsored By:

ADVISORY BOARD AND FACULTY LIST
ACI HATCH-WAXMAN ADVISORY BOARD
Acting Members
Mark Bowditch
Vice President – Intellectual Property and Litigation
Coherus BioSciences (Redwood City, CA)
Debra Condino
Senior Vice President, Chief Intellectual Property Counsel
Allergan, Inc. (Irvine, CA)
Guy Donatiello
Senior Vice President, Intellectual Property
Endo Pharmaceuticals (Malvern, PA)
Brian Hirsch
Vice President Global IP and Legal Head North America
Glenmark Pharmaceuticals (Mahwah, NJ)
Lisa A. Jakob
Legal Director, IP Litigation
Merck & Company (Rahway, NJ)
Staci Julie
SVP and Chief IP Counsel
Teva Pharmaceuticals (Dresher, PA)
James P. Leeds
Assistant General Patent Counsel
Eli Lilly & Company (Indianapolis, IN)
Jeffrey N. Myers, Ph.D.
Vice President & Assistant General Counsel
Pfizer Inc (New York, NY)
Mark Rachlin
Senior Patent Counsel-Litigation
GlaxoSmithKline (King of Prussia, PA)
Carmen M. Shepard
Senior Vice President
Global Policy and Regulatory Counsel
Mylan (Washington, DC)
Pearl T. L. Siew
Senior Vice President and Head Intellectual Property
Eagle Pharmaceuticals, 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.)
George W. Johnston
Counsel
Gibbons P.C. (Newark, NJ)
(Former Vice President & Chief Patent Counsel,
Hoffmann-La Roche)
David H. Silverstein, M.S., J.D.
Partner
Axinn, Veltrop & Harkrider LLP (New York, NY)
(Former Senior Director, Intellectual Property,
Par Pharmaceutical, Inc)
Shashank Upadhye
Partner
Amin Talati & Upadhye (Chicago, IL)
(Former Vice President – Global Intellectual Property, Apotex, Inc.)
CONFIRMED FACULTY
Co-Chairs
Rekha Hanu, Ph.D., J.D.
Director, Intellectual Property
Akorn Pharmaceuticals (Lake Forest, IL)
James P. Leeds
Speakers
John L. Abramic
Partner
Steptoe & Johnson LLP (Chicago, IL)
David B. Abramowitz
Partner
Locke Lord LLP (Chicago, IL)
David G. Adams
Partner
Venable LLP (Washington, DC)
Ali I. Ahmed
Chief Intellectual Property Counsel, Region North America
Fresenius Kabi USA, LLC (Lake Zurich, IL)
Stephen R. Auten
Partner
(Former Vice President IP, Sandoz, Inc.)
Aaron F. Barkoff, Ph.D.
Shareholder
McAndrews, Held & Malloy, Ltd. (Chicago, IL)
Richard Berman
Partner
Arent Fox LLP (Washington, DC)
Nicholas M. Boivin
Head of Intellectual Property
Merrimack Pharmaceuticals, Inc. (Cambridge, MA)
Honorable Jackie Wright Bonilla, Lead Administrative
Patent Judge
United States Patent and Trademark Office (Alexandria, VA)
Daniel G. Brown
Partner
Latham & Watkins (New York, NY)
Honorable Garrett E. Brown, Jr. (Ret.)
Retired U.S. District Chief Judge
ADR Neutral, Mediator, and Arbitrator
JAMS (New York, NY)
Karen E. Brown, Ph.D., J.D.
Vice President and Chief Intellectual Property Counsel
Ironwood Pharmaceuticals (Cambridge, MA)
Kathleen B. Carr
Member
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo P.C.
(Boston, MA)
Patricia A. Carson
Partner
Kirkland & Ellis LLP (New York, NY)
Honorable Rubén Castillo, Chief Judge
United States District Court, Northern District of Illinois
(Chicago, IL)
Honorable Stanley Chesler, Senior Judge
United States District Court, District of New Jersey
(Newark, NJ)
David G. Conlin
Member
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo P.C.
(Boston, MA)
Honorable Joseph Dickson, U.S.M.J.
United States District Court, District of New Jersey
(Newark, NJ)
Stephen J. Elliott
Special Counsel
Sullivan & Cromwell LLP (New York, NY)
Honorable Rama G. Elluru, Administrative Patent Judge
Thomas J. Filarski
Partner
Louis E. Fogel
Partner
Jenner & Block (Chicago, IL)
David M. Fox
Partner
Hogan Lovells US LLP (Washington, DC)
Jennifer Fox
Shareholder
Brinks Gilson & Lione (Research Triangle Park, NC)
Jeffrey R. Gargano
Partner
McDermott Will & Emery LLP (Chicago, IL)
Janet Gongola
Patent Reform Coordinator
Keith J. Grady
Practice Chair and Shareholder
Polsinelli, PC (St. Louis, MO)
John M. Griem, Jr.
Partner
Carter Ledyard & Milburn LLP (New York, NY)
Honorable James M. Holderman (Ret.)
JAMS (Chicago, IL)
Jake M. Holdreith
Partner and Leader of the Health
and Life Sciences Industry Practice
Robins Kaplan LLP (New York, NY and Minneapolis, MN)
Gary E. Hood
Shareholder/Hatch-Waxman and Biosimilars Practice Leader
Polsinelli, PC (Chicago, IL)
Sara Tonnies Horton
Partner
Andrei Iancu
Partner
Irell & Manella LLP (Los Angeles, CA)
Derek E. Johnson
Senior Counsel – Intellectual Property
Takeda Pharmaceuticals U.S.A., Inc. (Deerfield, IL)
Michael P. Kahn
Partner
Akin Gump Strauss Hauer & Feld LLP (New York, NY)
Scott E. Kamholz, M.D., Ph.D.
Partner
Foley Hoag LLP (Washington, DC)
Kurt R. Karst
Director
Hyman, Phelps, & McNamara, P.C. (Washington, DC)
Laura A. Lydigsen
Shareholder
Brinks Gilson & Lione (Chicago, IL)
Bradford P. Lyerla
Partner, Jenner & Block (Chicago, IL)
Michael E. McCabe, Jr.
Member, Funk & Bolton P.A. (Baltimore, MD)
Alejandro Menchaca
Shareholder, McAndrews, Held & Malloy, Ltd. (Chicago, IL)
Daniel J. Minion
Partner, Fitzpatrick, Cella, Harper & Scinto (New York, NY)
Don J. Mizerk
Partner
Husch Blackwell LLP (Chicago, IL)
Gregory A. Morris, Ph.D.
Partner and Leader, Life Sciences Litigation
Honigman Miller Schwartz and Cohn LLP (Chicago, IL)
Honorable Brian P. Murphy,
Steven A. Nash
Senior Patent Counsel
Xellia Pharmaceuticals, Inc. (Grayslake, IL)
Michael C. Newell
Managing Director, Epsilon Economics (Chicago, IL)
George K. Ng
Executive Vice President, Chief Administrative Officer
& Chief Legal Officer
Sorrento Therapeutics, Inc. (San Diego, CA)
Honorable Beverly Reid O’Connell, U.S.D.J.
United States District Court, Central District of California
(Los Angeles, CA)
United States District Court, Eastern District of Texas
(Marshall, TX)
James T. Peterka
Partner, Locke Lord LLP (Chicago, IL)
Mark Rachlin
Senior Patent Counsel-Litigation
Richard B. Racine
Partner
Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
(Washington, DC)
William B. Raich, Ph.D.
Partner
Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
(Washington, DC)
Sasha G. Rao
Partner, Maynard Cooper & Gale (San Francisco, CA)
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)
Stuart D. Sender
Shareholder, Budd Larner, P.C. (Short Hills, NJ)
Laura Shores
Partner, Kaye Scholer LLP (Washington, DC)
Paul Simboli
Vice President, Intellectual Property & Asst. General Counsel
Depomed, Inc. (Newark, CA)
Honorable Gail Standish, U.S.M.J.
United States District Court, Central District of California
(Los Angeles, CA)
Lynn M. Terrebonne, Ph.D.
Partner
Caesar Rivise, PC (Philadelphia, PA)
Shashank Upadhye
Member
(Former Vice President – Global Intellectual Property, Apotex, Inc.)
Eric H. Weisblatt
Partner, Hunton & Williams LLP (Washington, DC)

a C5 Group Company
Master the Necessary Skills
to Rise to the Newfound
Challenges of the Pharmaceutical
Patent Endgame
Dear Colleague:
American Conference Institute (ACI) is
very excited to return to Chicago for our
fourth annual Paragraph IV Disputes
Master Symposium. This conference,
along with its sister New York conference
presented in the spring, is the “place to
be” for the “who’s who” of litigators in the
brand-name and generic pharmaceutical
space. We are proud to provide you with
a forum where you can hear from industry
leaders on the hottest areas, while
connecting with your peers to discuss
the challenges that arise in the various
regions of the Hatch Waxman arena.
Fresh for this year, we have added several
new panels which will discuss: strategies
and best practices for balancing your
Hatch Waxman litigation budget, how to
best prepare for at-risk launch scenarios
while taking potential damages into
account, and a mock parallel proceeding
featuring live audience polling.
Our exceptional faculty — including several
new judges, past and current USPTO
representatives, and your peers — will
explore new on-sale bar considerations
in light of The Medicines Co. v. Hospira
and Helsinn v. Teva, the increased use
of parallel proceedings and the impact
of the Supreme Court’s recent decision
in Cuozzo, questions of personal and
general jurisdiction under Daimler and
Mylan, the evolving world of section 101
post Prometheus, Myriad, and Ariosa,
legal ethics, and more. This year’s event
will also feature two Judicial Roundtables
— one with District Court Judges and the
other with PTAB Judges.
ACIAmerican Conference Institute
This year marks 30 years since the inception of C5 Group.
30 years
expanding
across
the globe
30 years
building a
network of
industry leaders
30 years
hosting more
than 6,000
conferences
It is time for a brand, logo and language in keeping with the dynamic
strides we have made as a company. It is time for a brand that will
take us forward for the next 30 years.
C5 Group, comprising American Conference Institute, The Canadian
Institute and C5 in Europe, will unite under one central brand image,
appropriately a globe. See how bringing together the power of
people and the power of information can accelerate your growth
and success.
Our new brand look and language will be fully revealed soon.
Stay tuned for more exciting changes.
Finally, in response to your requests, we are pleased to offer two post-conference
workshops: the ﬁrst on Mastering the Hatch Waxman IPR Process, and the second
on the essentials of Biosimilars and BPCIA litigation. Also new this year we are
introducing a special Hatch Waxman Boot Camp session for new associates as well
as industry attorneys who are new to this space.
Don’t sit back while your competition gains this valuable knowledge. Register now by
calling 1-888-224-2480, faxing your registration form to 1-888-927-1563 or logging
onto www.AmericanConference.com/PIVDisputesChicago.
We look forward to seeing you in Chicago this fall.
Very truly yours,
Julie E. Kurzrok, Esq.
Legal Analyst and Program Director
American Conference Institute

Join the Conversation @ACI_Pharma #ACIPIV ACI’s Hatch-Waxman Series
MONDAY, SEPTEMBER 19, 2016
Main Conference Day One
7:00 Registration and Continental Breakfast
8:00 Co-Chairs’ Opening Remarks
James P. Leeds
8:15 Balancing the Budget: Keeping
Hatch-Waxman Litigation Costs
in Check
Jake M. Holdreith
Partner and Leader of the Health
and Life Sciences Industry Practice
Robins Kaplan LLP
(New York, NY and Minneapolis, MN)
Gary E. Hood
Shareholder/Hatch-Waxman
and Biosimilars Practice Leader
Polsinelli, PC (Chicago, IL)
George K. Ng
Executive Vice President, Chief Administrative
Officer & Chief Legal Officer
Sorrento Therapeutics, Inc. (San Diego, CA)
• Crafting creative ways to reduce the monetary burden
- Alternative billing structures
- Stakes in the outcome
- Success fees
- Evaluating potential cost-reducing strategies
 ANDA disclosure “no strings attached”
 Using admissions to minimize litigation costs
• Budgeting, forecasting, and aligning litigation costs to
business goals
• Demystifying funding agreements with outside sources
• Analyzing revisions to FRCP 26 which may impact
budgeting strategies
- Scope of discovery proportionate to scope of the case
- Implementation of amended FRCP 26
• Preparing for discovery
• Balancing cost savings with ensuring negotiation
of a favorable agreement
9:15 Evaluating Personal Jurisdiction in
the Wake of Mylan (and the possible
death of Daimler)
Patricia A. Carson
Partner
Kirkland & Ellis LLP (New York, NY)
Laura A. Lydigsen
Shareholder
Brinks Gilson & Lione (Chicago, IL)
Steven A. Nash
Senior Patent Counsel
Xellia Pharmaceuticals, Inc. (Grayslake, IL)
Eric H. Weisblatt
Partner
Hunton & Williams LLP (Washington, DC)
• Reviewing Hatch-Waxman venue and jurisdiction
under Daimler
- Consent vs. personal jurisdiction
• Overview of related Hatch-Waxman case law
- Astrazeneca AB v. Mylan Pharms. Inc., 72 F. Supp. 3d 549
(D. Del. 2014)
- Acorda Therapeutics v. Mylan Pharms. Inc., 78 F. Supp.
3d 572 (D. Del. 2015)
- In Re TC Heartland LLC (Fed. Cir. 2016)
• Venue, personal jurisdiction, ANDA filing, Oh My!
- If venue and personal jurisdiction are one and the same —
how does the artificial act of infringement come into play?
 Are the courts over-reaching?
- If a company can be sued wherever they “may”
sell drugs, then does this follow through to general
and specific jurisdiction?
10:15 Morning Coffee Break
10:30 Untangling the Changing World of
Section 101 — Solving the Patentable
Subject Matter Conundrum
Keith J. Grady
Practice Chair and Shareholder
Polsinelli, PC (St. Louis, MO)
Andrei Iancu
Partner
Irell & Manella LLP (Los Angeles, CA)
Shashank Upadhye
Member
(Former Vice President – Global Intellectual Property,
Apotex, Inc.)
• Struggling with court and PTO decisions — interpreting
differing views of patentability
• Protecting against 101 challenges
• Parsing patentability in the aftermath of Myriad and Ariosa
• Utilizing trade secret protection in view of evolving
101 jurisprudence
- Predicting effects of widespread trade secret protection
on Hatch-Waxman cases and the public overall
- Pondering a possible regulatory exclusivity for
non-patentable subject matter such as diagnostics
11:30 Deciphering the On-Sale Bar:
Clarifying “Public Use” Under
Section 102
John L. Abramic
Partner
Ali I. Ahmed
Chief Intellectual Property Counsel,
Region North America
Fresenius Kabi USA, LLC (Lake Zurich, IL)
Richard Berman
Partner
Arent Fox LLP (Washington, DC)

a C5 Group Company
Nicholas M. Boivin
Head of Intellectual Property
Merrimack Pharmaceuticals, Inc.
(Cambridge, MA)
• Analyzing non-public sales pre- and post-AIA
- Review of The Medicines Company v. Hospira (“i.e. the
Angiomax case”) and the applicability of the “no supplier
exception rule”
 Understanding the implications of this ruling in a
Hatch-Waxman scenario
 Experimental use exception
 Interpreting the en banc ruling, “bears the general
hallmarks of a sale”
- Helsinn Healthcare SA v. Teva Pharmaceuticals USA Inc.,
No. 16-1284 (Fed. Cir. 2016): Non-public sales post-AIA
• Examining the effects of contract-manufactured pharmaceutical
products on timing and validity of future patent filings
12:15 Networking Luncheon
Sponsored by:
1:30 Overcoming Obviousness in the
Hatch Waxman Space: Prior Art,
Obviousness, and Obvious-Type
Double Patenting
Karen E. Brown, Ph.D., J.D.
Vice President and Chief Intellectual
Property Counsel
Ironwood Pharmaceuticals (Cambridge, MA)
Kathleen B. Carr
Member
Mintz, Levin, Cohn, Ferris, Glovsky
and Popeo P.C. (Boston, MA)
Alejandro Menchaca
Shareholder
McAndrews, Held, & Malloy Ltd. (Chicago, IL)
William B. Raich, Ph.D.
Partner
Finnegan, Henderson, Farabow,
Garrett & Dunner, LLP (Washington, DC)
• Addressing obviousness of pharmaceutical patents at the PTAB
• Evaluating recent case law: interplay between prior art,
obviousness, secondary considerations, and obvious-type
double patenting
- Prometheus Laboratories, Inc. v. Roxane Laboratories, Inc.
et al., No. 14-1634, -1635, slip op. (Fed. Cir. 2015)
 Intertwining obviousness and obvious-type double
patenting
- Spectrum Pharmaceuticals Inc. v. Sandoz Inc. (Fed. Cir. 2015)
 Achieving a finding of obviousness utilizing conventional
knowledge in the field and secondary considerations
• Re-examining the Federal Circuit’s stance on obvious-type
double patenting: G.D. Searle LLC v. Lupin Pharmaceuticals,
Inc. (Fed. Cir. 2015)
• Deciphering the discord between the PTAB and District
Courts’ obvious-type double patenting findings
2:15 Mock Parallel Proceeding:
Pharmaceutical Patent Invalidity
Hearing in the District Court
and the PTAB
Lawyers for Mock Patent Challenger
Lynn M. Terrebonne, Ph.D.
Partner
Caesar Rivise, PC (Philadelphia, PA)
Lawyers for Mock Patent Holder
Sasha G. Rao
Partner
Maynard Cooper & Gale (San Francisco, CA)
Mock District Court Judge
Hon. Garrett E. Brown, Jr. (Ret.)
JAMS (New York, NY)
Mock PTAB Judges
Scott E. Kamholz, M.D., Ph.D.
Partner
Foley Hoag LLP (Washington, DC)
Partner
(Former Acting Under Secretary of Commerce for
Intellectual Property and Former Acting Director
of the United States Patent and Trademark Office)
Moderator
Sara Tonnies Horton
Partner
Setting
The increased use of parallel litigations in the Hatch-Waxman
arena adds yet another fun twist to the “boxing-gloves-on”
atmosphere of this type of high-stakes litigation. Attempting
to navigate the proceedings between these two forums has been
described as “walking a tightrope.” In this interactive session,
the panelists will illustrate the tricks and techniques of this
balancing act through a mock parallel invalidity hearing in both
a “District Court” and “the PTAB.”
We will provide the audience with a fact pattern, and our
“patent challenger” and “patent holder” will duke it out before a
“District Court” and a “PTAB panel.”
Deliberations and Polling
At the end of the mock hearing and motion, delegates will
deliberate and use polling devices to cast their votes as to the
outcome in each forum.
3:30 Afternoon Refreshment Break
Media Partners

3:45 A Hatch-Waxman Practitioner’s
Guide to The Patent Trial and
Appeals Board:The PTAB Live
Honorable Jackie Wright Bonilla,
United States Patent and Trademark Office
Honorable Brian P. Murphy,
Honorable Rama G. Elluru,
Administrative Patent Judge
Moderator
Jennifer Fox
Shareholder
Brinks Gilson & Lione
(Research Triangle Park, NC)
IPRs have become an important component in the Hatch-
Waxman arsenal. As such, knowing the “ins and outs” of PTAB
practice is a critical competency for today’s Hatch-Waxman
practitioner. Take advantage of this unique opportunity to hear
directly from PTAB Judges regarding protocols and the art of
appearing before this administrative body.
4:30 A View from the U.S. District Court
Bench:The Judges Speak
Honorable Rubén Castillo, Chief Judge
United States District Court, Northern District
of Illinois (Chicago, IL)
Honorable Stanley Chesler, Senior Judge
United States District Court, District of New
Jersey (Newark, NJ)
Honorable Joseph Dickson, U.S.M.J.
United States District Court, District of New
Jersey (Newark, NJ)
Honorable Beverly Reid O’Connell, U.S.D.J.
United States District Court, Central District
of California (Los Angeles, CA)
United States District Court, Eastern District
of Texas (Marshall, TX)
Honorable Gail Standish, U.S.M.J.
United States District Court, Central District
of California (Los Angeles, CA)
Moderator
Thomas J. Filarski
Partner
Renowned jurists with some of the most active Paragraph IV
litigation dockets in the country will share their thoughts and
insights on the latest hot-button issues facing both patentees and
patent challengers. What Paragraph IV issues keep you up at
night? Come prepared with your most pressing questions.
6:00 Conference Adjourns to Day Two
TUESDAY, SEPTEMBER 20, 2016
Main Conference Day Two
7:00 Continental Breakfast
8:00 Co-Chairs Opening Remarks
and Recap of Day One
8:15 Placing the Blame: Analyzing Divided
and Induced Infringement in the
“Limelight” of Lilly
Jeffrey R. Gargano
Partner
McDermott Will & Emery LLP (Chicago, IL)
Derek E. Johnson
Senior Counsel – Intellectual Property
Takeda Pharmaceuticals U.S.A., Inc.
(Deerfield, IL)
Michael P. Kahn
Partner
Akin Gump Strauss Hauer & Feld LLP
(New York, NY)
James T. Peterka
Partner
• Reviewing case law in the aftermath of Akamai
- Eli Lilly and Co. v. Teva Parenteral Medicines, Inc. et al.,
No. 10:1376 (S.D. Ill. 2015): role of physician
and patient as infringers
 Evaluating the impact of Lilly on future direct
and induced infringement allegations
• Delving into the criticality of the label in determining
divided and induced infringement
- Summarizing skinny labeling, carve out, and other tactics
resulting from the latest jurisprudence in this area
9:15 Understanding the Impact of
Use Codes on Hatch-Waxman
Challenges
Stuart D. Sender
Shareholder
Budd Larner, P.C. (Short Hills, NJ)
Paul Simboli
Vice President, Intellectual Property
& Asst. General Counsel
Depomed, Inc. (Newark, CA)
• Exploring the significance of section viii carve outs
to Orange Book listings and Paragraph IV challenges
- Deciphering Depomed’s citizen petition re: Nucynta’s
use code
 Evaluating the consequences of Depomed’s attempt
to broaden its use code
• Analyzing skinny labeling
- Section viii carve outs and trying to avoid infringement
- Off-label uses and section viii carve outs
• Changing use codes during litigation or in anticipation
of litigation
10:00 Morning Coffee Break

a C5 Group Company
10:15 Streamlining Section 271(e)
and Safe Harbor
Stephen R. Auten
Partner
(Former Vice President IP, Sandoz, Inc.)
Mark Rachlin
Senior Patent Counsel – Litigation
Richard B. Racine
Partner
Finnegan, Henderson, Farabow,
Garrett & Dunner LLP (Washington, DC)
• Comparing the Federal Circuit’s latest ruling in Momenta
Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc., Nos.
2014-1274, 2014-1277 (Fed. Cir. 2015) (“Momenta II”)
with Momenta I: Identifying the boundaries of the safe
harbor provision
• Reviewing the applicability of the safe harbor provision
to research tool patents
- Determining who owns the intellectual property
• Posturing when you need a license vs. when you fall within
the safe harbor
• Evaluating who to ask for a license in multiple-inventor
situations
11:00 Interpreting FDA’s Interplay with
Paragraph IV Filings
David B. Abramowitz
Partner
David M. Fox
Partner
Hogan Lovells US LLP (Washington, DC)
• Examining the status of FDA’s proposed MMA rules
• Updating GDUFA and pre-GDUFA filing status
- Determining first generic status under GDUFA
• Deciphering FDA’s ANDA Bioequivalence Guidance
• Reviewing FDA’s REMs guidance relative to Hatch-Waxman
litigation
12:00 Networking Luncheon
1:15 Understanding the Impact
of Regulatory Exclusivities
on Hatch-Waxman Litigation
David G. Adams
Partner
Venable LLP (Washington, DC)
Kurt R. Karst
Director
Hyman, Phelps, & McNamara, P.C.
(Washington, DC)
• Observing orphan drug exclusivity disputes
- Eagle Pharmaceuticals Inc. v. Sylvia Burwell, et al.,
No. 16-790, (D. D.C. 2016)
• Exploring 3-year and 5-year exclusivity issues
• Addressing ANDA exclusivity disputes
• Clarifying pediatric labeling carve-outs: ANDA vs. 505(b)(2)
2:15 Assessing the True Measure
of Damages in an At-Risk
Launch Scenario
Daniel G. Brown
Partner
Latham & Watkins (New York, NY)
John M. Griem, Jr.
Partner
Carter Ledyard & Milburn LLP (New York, NY)
Michael C. Newell
Managing Director
Epsilon Economics (Chicago, IL)
Setting
The decision whether or not to launch a generic product
“at risk” brings with it many potential dangers, as well as very
lucrative benefits. Each drug product presents a unique risk-
benefit analysis, including assessment of profit, calculation of
lost profits/damages, determining royalties, and more. In this
interactive case study, the parties will take part in a hypothetical
multi-party litigation, and will demonstrate some valuable
strategies from both the generic and branded viewpoint. Come
prepared with your most complex damages-related inquiries.
3:15 Afternoon Refreshment Break
3:30 Revisiting Reverse-Payment
Settlements and Antitrust Concerns
Impacting Paragraph IV Litigation
Stephen J. Elliott
Special Counsel
Sullivan & Cromwell LLP (New York, NY)
Bradford P. Lyerla
Partner
Don J. Mizerk
Partner
Husch Blackwell LLP (Chicago, IL)
Laura Shores
Partner
Kaye Scholer LLP (Washington, DC)
• Developing jurisprudence regarding patent settlements
post-Actavis
- What constitutes a payment
- Differing judicial interpretations of the “Rule of Reason Test”
- Weighing anticompetitive harm and procompetitive benefits
• Authorized Generics
• Structuring settlements in light of developing jurisprudence
• The resurgence of purchaser sham litigation claims
• The impact of cGMPs and 483s on leverage and settlements
• Best strategies to communicate risks and rewards of settlement
to clients

MONDAY, SEPTEMBER 19, 2016
Special Session
2:15 p.m. – 5:45 p.m. (Registration begins at 1:30 p.m.)
Hatch-Waxman Boot Camp: A Primer on IP Basics and Regulatory
Fundamentals Relative to Small-Molecule Drugs
Honorable James M. Holderman (Ret.)
JAMS (Chicago, IL)
Daniel J. Minion
Partner
Fitzpatrick, Cella, Harper & Scinto
(New York, NY)
Gregory A. Morris, Ph.D.
Partner and Leader, Life Sciences Litigation
Honigman Miller Schwartz and Cohn LLP
(Chicago, IL)
A thorough understanding of the Hatch-Waxman space is
essential to anyone working in the biopharmaceutical area.
The highly regulated nature of pharmaceutical products dictates
that their patenting be closely tied to regulatory approval by
FDA. In this workshop, our top-notch authorities will outfit
associates and in-house attorneys who are new to this area
with all aspects of practicing in the Hatch-Waxman arena.
• Identifying and analyzing the application process
for the approval of a new drug
• IND (Investigational New Drug) Application
• NDA (New Drug Application)
• The Orange Book: origins and contents
- Listings and de-listings
• The role of Orange Book under Hatch-Waxman
vis-à-vis the MMA
• ANDA: overview and analysis of requirements
- Bioequivalence defined
• Paragraph IV certifications and notice letters
- Statutory acts of infringement
• Accelerated approvals
- Defining eligibility criteria for accelerated approval
and priority reviews
- Use of advisory committees in the approval process
• Seeking patent protection during the pre-approval process
• IP and regulatory redress for time lost during the
pre-approval process
• Identifying the respective roles of the FDA and the PTO
in the patenting of drugs
• Exploring various regulatory exclusivities
- 180-day generic market exclusivity
- NCE (new chemical entity)
 5-year marketing exclusivity
 5-year data exclusivity
- Indication (new indication or use)
 3-year marketing exclusivity
- NDF (new dosage formulation)
- ODE (orphan drug exclusivity)
- PED (pediatric exclusivity)
- New exclusivity challenges — brand name
and generic concerns
• FD&C 505b2, aka, ‘the paper ANDA” (an alternate
pathway to an ANDA)
• 30-month stay
• Patent extensions
• The safe harbor and new controversies surrounding
its application
• Understanding the role of the Patent Trials and Appeals
Board (“PTAB”) in prosecution of patents, post-issuance
challenges to patents, and interferences
A.
4:30 Ethics of Paragraph IV Practice:
New Developments Impacting
Professional Responsibility in
the Hatch-Waxman Arena
David G. Conlin
Member
Mintz, Levin, Cohn, Ferris,
Glovsky and Popeo P.C. (Boston, MA)
Michael E. McCabe, Jr.
Member
Funk & Bolton, P.A. (Baltimore, MD)
• Ethical implications of Halo v. Pulse and Stryker v. Zimmer
• Escaping a willfulness finding
- Does infringer need to have any of the defense(s) in mind
at the time of infringement or can an infringer rely on a
later-developed trial defense?
5:30 Conference Ends
If you missed the chance to attend an ACI event, you can
still benefit from the conference presentation materials.
To order the Conference Materials, please call +1-888-224-2480
or visit: www.americanconference.com/conference_papers
MISSED A
CONFERENCE?
Order The Conference Materials Now!

a C5 Group Company
WEDNESDAY, SEPTEMBER 21, 2016
Post-Conference Workshops
8:30 a.m. – 12:00 p.m. (Registration begins at 8:00 a.m. –
Continental Breakfast will be Served)
Mastering the IPR Process in a Hatch-Waxman Scenario
Janet Gongola
Patent Reform Coordinator
Partner
(Former Acting Under Secretary of Commerce for Intellectual Property
and Former Acting Director of the United States Patent and Trademark Office)
In the nearly four years since the inception of Inter Partes Review, most Hatch-Waxman
practitioners are still “getting their feet wet” in this unique type of litigation. The frequency
of IPRs in the life sciences sector has steadily increased, and practitioners need to be as well
prepared for these situations as possible. In this workshop, we will examine some best practice
tips and also pitfalls to be wary of in the pharmaceutical patent field.
• How ANDA applicants are using IPR in connection with Paragraph IV Litigation
• How to Institute an IPR and how to win
• Pros and cons of filing a stay
• Review of PTAB Decisions in pharmaceutical IPRs
• Do ANDA filers have standing to file an IPR, and do they work in Hatch Waxman cases?
• How to strategically get around a patent/shorten exclusivities
• Effect of IPR for first filers vs. later filers
- Pros and Cons for a first filer to file an IPR
• Mechanism between orange book listing issues and IPR
- If a filer wins an IPR, then files a Paragraph IV certification, what is the outcome
- When a second filer enters, how does this affect the case?
- If PTAB decision says claims are invalid, the patent is alive until a Federal Circuit
affirmance, so how does this impact the district court case? Does the PTAB decision
allow the stay to be lifted? Does the PTAB decision mean a judgement in the generic’s
favor? Both?
• Stats of IPR vs. District Court Decisions
• Rare PTAB Rehearing Granted — Mylan Pharmaceuticals Inc. v. AstraZeneca AB,
No. IPR2015-01340
• The aftermath of Cuozzo Speed Technologies, LLC v. Lee
B. 1:00 p.m. – 4:30 p.m. (Registration Begins at 12:30 p.m.)
Biosimilars Boot Camp for the Paragraph IV Litigator
Aaron F. Barkoff, Ph.D.
Shareholder
McAndrews, Held & Malloy,
Ltd. (Chicago, IL)
Louis E. Fogel
Partner
Despite the fact that several BPCIA litigations have been filed to date, this is still relatively new
and uncharted territory, and we are only at the beginning of beginning. This hands-on boot
camp will walk you through the first wave of biosimilars cases and will also take a look at the
approval process and other key points of regulation.
• Legal and Regulatory Background
- Biosimilar Pathway vs. 505(b)(2) and BLA Pathways
 Determining which path is most efficient for the allocation of research
and development resources
 Timing, costs, IP litigation, exclusivity, and other factors to take into consideration
- Overview of the 2010 Biologics Price Competition and Innovation Act (BPCIA)
 Exclusivity provisions
 Criteria for biosimilarity and interchangeability
 Clinical trials and safety studies
 Comparing the statutes: Differentiating between Hatch-Waxman and biosimilars
litigation processes
- FDA Draft Guidance, “Implementation of the ‘Deemed to be a License’ Provision
of the Biologics Price Competition and Innovation Act of 2009”
• Litigation Update:
- Reviewing BPCIA cases filed to date and analyze underlying arguments including:
 Sandoz v. Amgen
 Status of Supreme Court cert. petitions
 Jannsen v. Celltrion
 Amgen v. Sandoz
 Amgen v. Apotex
 Recent Federal Circuit ruling that 180-day notice is mandatory
 Amgen v. Hospira
 Immunex v. Sandoz
- Analyzing the use of PTO proceedings in biosimilars litigation
- Strategies for forum choice in light of pending BPCIA cases
*Luncheon will be served at 12:00 p.m. for Delegates Attending Both
Workshops A and B.
C.

Patent attorneys and litigators
(in-house & law ﬁrm) who represent:
» Brand name pharmaceutical companies
» Generic pharmaceutical companies
» Biopharmaceutical companies
WHO YOU WILL MEET
American Conference Institute is pleased to offer our delegates a limited number of hotel rooms at a preferential rate.
Please contact the hotel directly and mention the “ACI’s Paragraph IV Disputes” conference.
Venue: InterContinental Chicago Magnificent Mile
Address: 505 N Michigan Ave, Chicago IL 60611
TEL: (800) 628-2112 or (312) 944-4100
Online: www.tinyurl.com/PIVDisputesChicago2016
EXCLUSIVE ROOM RATES!

a C5 Group Company
THANK YOU TO OUR
SUPPORTING SPONSORS
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
American Conference Institute
Tel: 212 325 3220 x 5232
ef@americanconference.com
Global Sponsorship Opportunities
Accreditation will be sought in those jurisdictions
requested by the registrants which have continuing
education requirements. This course is identified as nontransitional for the
purposes of CLE accreditation.
ACI certifies that the activity has been approved for CLE credit by the
New York State Continuing Legal Education Board.
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. CLE credits are processed in 4–8
weeks after a conference is held.
ACI has a dedicated team which processes requests for state approval.
Please note that event accreditation varies by state and ACI will make
every effort to process your request.
Questions about CLE credits for your state? Visit our online CLE Help
Center at www.AmericanConference.com/CLE
Continuing Legal Education Credits
EARN CLE/ETHICS
CREDITS
Brinks’ Hatch-Waxman is exclusively focused on intellectual property law. With a wealth
of experience in prosecution, counseling, litigation and licensing, Brinks boasts more than
135+ attorneys, patent agents and scientific advisors who can provide thoughtful, effective
legal strategies and creative insights to help clients realize their business and legal objectives.
Brinks is 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.
In the past 10 years alone, our attorneys have appeared in 550+ intellectual property cases throughout the
United States. Our litigators are experienced and respected in every forum where intellectual property rights are
contested, including the federal district and appellate courts, the International Trade Commission (ITC), the U.S.
Patent & Trademark Office (USPTO), and arbitration tribunals.
More information is available at www.brinksgilson.com.
Since being involved in the very first ANDA litigation, Finnegan has been a leading
firm representing innovative pharmaceutical companies before federal district courts
and the U.S. Court of Appeals for the Federal Circuit. Our lawyers understand the long-term plans of innovative
pharmaceutical companies as well as the nuances of pharmaceutical patent law and the legal particularities
of ANDA litigation under the Hatch-Waxman Act. Finnegan has a long history of working with innovative
pharmaceutical companies to protect and maximize their valuable IP rights and assets. The fast pace of new
discoveries and their commercial applications require a law firm that has a comprehensive grasp of the IP
legal issues and the experience and industry expertise to understand the science and strategic implications
of the advancements.
Finnegan is one of the largest law firms in the world focusing solely on intellectual property law. With offices in
the United States, Asia, and Europe, and more than 350 IP professionals, the firm practices all aspects of patent,
trademark, copyright and trade secret law. Finnegan also represents clients on IP issues related to international
trade, portfolio management, the internet, e-commerce, government contracts, antitrust, European patents
and trade marks, and unfair competition. Finnegan delivers sophisticated legal strategies to help chemical,
pharmaceutical, and biotech clients protect, advocate, and leverage their valuable IP assets. For more information,
please visit www.finnegan.com. Follow us on LinkedIn and Twitter.
The Patent Litigation and Counseling Practice at Jenner & Block
litigates patent cases in courts across the country with creativity,
strong technical credentials and unparalleled trial experience. We litigate those patent cases against both
competitors and non-practicing entities. Partners in our Chambers-recognized patent litigation practice have tried
a variety of matters, averaging more than 10 cases each to juries, courts or arbitrators.
From coast to coast, our attorneys serve national and international clients on matters around the world. We represent
clients in the high-stakes fields of biotechnology, pharmaceuticals, medical devices, chemical manufacturing,
petrochemicals, plastics, electronic hardware, microchips, computer software, cloud computing, LCDs, molding
and packaging, telecommunications, food services, automotive devices and energy production, among many
other technologies. Our clients include Dow Chemical, Nissan, American Power Conversion Corporation, Johnson
& Johnson, Pelco, Hospira, General Dynamics, Wolfram Research, Mitsubishi Electric and many others.
We handle complex patent cases efficiently and offer creative approaches to every engagement. We have a history
of creating opportunities for early, favorable results for clients through summary judgment and claim constructions.
In addition to litigation in the courts, our patent practice includes litigation before the USPTO, PTAB and ITC.
We regularly counsel and render opinions on patent rights involving issues of infringement, validity and freedom
to operate, and we conduct patent due diligence, negotiate and prepare patent licenses and other transaction
agreements. We are well-positioned to represent clients in all facets of PTAB trial proceedings, including inter
partes review, post-grant review and the transitional program for covered business method patents. © American Conference Institute, 2016

REGISTRATIONCODE
oIwouldliketoreceiveCLEaccreditationforthefollowingstates:.SeeCLEdetailsinside.
CompletePaymentDetails4
BringingaTeam?
3-410%ConferenceDiscount
5-615%ConferenceDiscount
720%ConferenceDiscount
8ormoreCall888-224-2480
PaymentPolicy
Paymentmustbereceivedinfullbytheprogramdatetoensure
admittance.AlldiscountswillbeappliedtotheProgramOnlyfee
(excludingadd-ons),cannotbecombinedwithanyotheroffer,and
mustbepaidinfullattimeoforder.Groupdiscountsavailableto3or
moreindividualsemployedbythesameorganization,whoregisterat
thesametime.
DelegateSubstitutionsandCancellations
Youmustnotifyusbyemailatleast48hrsinadvanceoftheconference
ifyouwishtosendasubstituteparticipant.Ifyouareunabletofind
asubstitute,pleasenotifyusinwritingnolaterthan10daysprior
totheconferencedate.Allcancellationsreceivedwillbesubjecttoa
cancellationfeeof$350.Delegatesoptingtoreceiveacreditvoucher
willreceiveacreditforthefullamountpaid,redeemableagainst
anyotherAmericanConferenceInstituteconferenceinthenext
12months.
Nocreditsorrefundswillbegivenforcancellationsreceivedwithin10
daysoftheconferencestartdate.Delegatesmaynot“share”apass
betweenmultipleattendeeswithoutpriorauthorization.Noliabilityis
assumedbyAmericanConferenceInstituteforchangesinprogram
date,content,speakersorvenue.AmericanConferenceInstitute
reservestherighttocancelanyconferenceitdeemsnecessaryand
will,insuchevent,makeafullrefundofanyregistrationfee,butwillnot
beresponsibleforairfare,hotelorothercostsincurredbyregistrants.
TermsandConditions
FillinyourProfile
SALUTATIONNAME
JOBTITLEORGANIZATION
ADDRESSCITY
STATE/PROVINCEZIPCODECOUNTRYTEL.
FAXEMAIL
TYPEOFBUSINESSNO.OFEMPLOYEES
APPROVINGMANAGERJOBTITLE
3
SelectyourLevelofEngagementRegister&PaybyAugust12,2016Register&PayafterAugust12,2016
oConference$2095$2295
oConference+1WorkshopoBoroC$2695$2895
oELITEPASS*:Conference+BothWorkshops$3295$3495
oSpecialSession:Hatch-WaxmanBootCamp(WorkshopA)$600
Allprogramparticipantswillreceiveanonlinelinktoaccesstheconferencematerialsaspartoftheirregistrationfee.
oPleasereserve___additionalcopiesoftheConferenceMaterialsat$199percopy.
2
*ELITEPASSisrecommendedformaximumlearningandnetworkingvalue.
5AccepttheTermsandConditionstoRegister
IconfirmIhavereadandunderstoodtheterms
andconditionsofregisteringforthisevent
815L17-CHIConferenceCode
FeeIncludes
Theprogram,allprogrammaterials,refreshmentbreaks
andlunches.
PleasechargemyoVISAoMasterCardoAMEXoDiscoverCardoPleaseinvoiceme
NUMBEREXP.DATE
CARDHOLDER
o Ihaveenclosedmychequefor$________________includingapplicabletaxesmade
payabletoAmericanConferenceInstitute(T.I.N.—98-0116207)
oACHPAYMENT($USD)
Pleasequotethenameoftheattendee(s)and
theeventcode815L17asareference.
ForUSregistrants:
BankName:HSBCUSA
Address:8006thAvenue,NewYork,NY10001
AccountName:AmericanConferenceInstitute
UPICRoutingandTransitNumber:021-05205-3
UPICAccountNumber:74952405
Non-USresidentspleasecontactCustomerService
forWirePaymentinformation
SpecialDiscount
ACIoffersfinancialscholarshipsforgovernmentemployees,
judges,lawstudents,non-profitentitiesandothers.Formore
information,pleaseemailorcallcustomerservice.
VenueInformationataGlance
Venue:InterContinentalChicagoMagnificentMile
Address:505NMichiganAve,ChicagoIL60611
TEL.:(800)628-2112or(312)944-4100
Online:www.tinyurl.com/PIVDisputesChicago2016
BookyourAccommodation
AmericanConferenceInstituteispleasedtoofferour
delegatesalimitednumberofhotelroomsatapreferential
rate.Pleasecontactthehoteldirectlyandmentionthe
“ACI’sParagraphIVDisputes”conference.
815L17.WEB

AttentionMailroom
Ifundeliverabletoaddressee,pleaseforwardto:
PatentCounsel,IPCounsel,PatentLitigators
IncorrectMailingInformation
Ifyouwouldlikeustochangeanyofyourdetails,
pleaseemaildata@americanconference.com
orfaxthelabelonthisbrochureto1-877-927-1563.
AmericanConferenceInstitute
45West25th
Street,11th
Floor
NewYork,NY10010
PHONE:
1-888-224-2480
EMAIL:
CustomerService@AmericanConference.com
ONLINE:
www.AmericanConference.com/PIVDisputesChicago
FAX:
1-877-927-1563
MAIL:
AmericanConferenceInstitute
45West25thStreet,11thFloor
NewYork,NY10010
ƻ
1ChooseyourRegistrationMethod
ACIAmericanConferenceInstitute
BusinessInformationinaGlobalContext
ParagraphIVDisputesMasterSymposium
4th
Annual
September19–20,2016|InterContinentalChicagoMagnificentMile|Chicago,IL
TheAdvancedForumforBrandNameandGenericCounsel
ontheIntricaciesofExtremeHatch-WaxmanLitigation
Pre-suitConsiderations|CommencementofSuit
Discovery|MotionPractice|FinalAdjudication
EARNCLE/ETHICS
CREDITS

815L17_12pg_WEB

Recommended

Recommended

More Related Content

Similar to 815L17_12pg_WEB

Similar to 815L17_12pg_WEB (20)

815L17_12pg_WEB