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Paragraph IV Disputes

Register Now • 888-224-2480 • www.AmericanConference.com/PIVDisputesNYC

American Conference Institute’s 9th Annual

Supporting Sponsors: Associate Sponsors:

Exhibitors:Cocktail Sponsor: Luncheon Sponsor: Custom Sponsors: Lanyard Sponsor: Private Function:

Main Conference: April 27–28, 2015 | The Conrad – New York | New York City • PTAB Trial Workshop for Hatch-Waxman Litigators: April 29, 2015

Breakfast Sponsor:

Expert Insights on Hatch-Waxman Litigation Strategies for Brand Names and Generics

Agenda Sponsor:

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 Indefi niteness 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

District Court

Honorable Ruben Castillo, Chief JudgeUnited 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 CourtDistrict of New Jersey

Insights from Industry:• Astellas US LLC• Bristol-Myers

Squibb• Depomed• Eisai Inc.• Gilead Sciences

• GlaxoSmithKline• Merck & Company• Mylan• Novartis

Pharmaceuticals Corporation

• Pfi zer Inc• Sandoz Inc.• Sun Pharmaceutical

Industries, Inc.FTC Keynote on Commission Activity Post-Actavis:

Markus H. MeierAssistant Director, Health Care DivisionBureau of Competition, Federal Trade Commission

PTAB

Honorable Brian P. Murphy (invited)(Acting) Lead Administrative Patent JudgePatent Trial and Appeal Board, USPTO

Honorable Jacqueline D. Wright Bonilla (invited)Administrative Patent JudgePatent Trial and Appeal Board, USPTO

EarnCLE

ETHICSCredits

Judicial Insights from:

Join the Conversation ACI’s Hatch-Waxman Series @ACI_Pharma / #ACIPIV2

ACI’s Hatch-Waxman Series Advisory Board:

Acting Members

Guy Donatiello Senior Vice President, Intellectual PropertyEndo Pharmaceuticals (Malvern, PA)

Lisa A. JakobLegal Director, IP LitigationMerck & Company (Rahway, NJ)

James P. Leeds Assistant General Patent CounselEli Lilly & Company (Indianapolis, IN)

Jeffrey N. Myers, Ph.D.Vice President & Assistant General CounselPfi zer Inc (New York, NY)

Mark RachlinSenior Patent Counsel-LitigationGlaxoSmithKline (King of Prussia, PA)

Carmen M. ShepardSenior Vice PresidentGlobal Policy and Regulatory CounselMylan (Washington, DC)

Pearl T. L. SiewVice President & Head, IP USSandoz Inc. (Princeton, NJ)

David H. Silverstein, M.S., J.D. Legal Director, Intellectual PropertyPar Pharmaceutical Companies, Inc. (Woodcliff Lake, NJ)

Meg Snowden VP, Intellectual PropertyImpax Laboratories (Hayward, CA)

Peter WaibelHead, US Patent LitigationNovartis Pharmaceuticals Corporation (East Hanover, NJ)

Timothy X. Witkowski, M.S., J.D. Executive Director & Executive CounselIntellectual PropertyBoehringer Ingelheim (Ridgefield, CT)

Emeritus Members

Stephen R. Auten Partner, Chair of Pharmaceutical & Life Sciences LitigationTaft Stettinius & Hollister LLP (Chicago, IL)(Former Vice President, IP, Sandoz, Inc.)

Mark BowditchPatent Attorney (Princeton, NJ)(Former Executive Director, Head, US Patent Product Support Sandoz Inc.)

George W. JohnstonCounsel, 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.)

Confi rmed Faculty

Co-Chairs

Guy DonatielloSenior Vice President, Intellectual PropertyEndo Pharmaceuticals (Malvern, PA)

Timothy X. Witkowski, M.S., J.D.Executive Director & Executive CounselIntellectual Property, Boehringer Ingelheim (Ridgefi eld, CT)

Speakers

Honorable Douglas Arpert, U.S.M.J.United States District Court, District of New Jersey (Trenton, NJ)

Stephen R. AutenPartner, Chair of Pharmaceutical & Life Sciences LitigationTaft Stettinius & Hollister LLP (Chicago, IL)(Former Vice President, IP, Sandoz, Inc.)

Bradford J. BadkePartner, Ropes & Gray LLP (New York, NY)

Nicolas BarzoukasPartner, Baker Botts L.L.P. (Huston, TX)

Matthew J. BeckerPartner, Axinn, Veltrop & Harkrider LLP (Hartford, CT)

Richard BermanPartner, Arent Fox LLP (Washington, DC)

Stephen P. BensonPartner, Katten Muchin Rosenman LLP (Chicago, IL)

Honorable Jacqueline D. Wright Bonilla (invited)Administrative Patent JudgePatent Trial and Appeal BoardUnited States Patent and Trademark Offi ce (Alexandria, VA)


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)

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

Owen ByrdChief Evangelist & General CounselLex Machina (Menlo Park, CA)

Vincent L. Capuano, PH.D.Partner, Duane Morris LLP (Boston, MA)

Honorable Ruben CastilloChief Judge, United States District CourtNorthern District of Illinois (Chicago, IL)

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

Steven M. CoylePartner and Pharmaceutical Litigation Group LeaderCantor Colburn LLP (Hartford, CT)

Neal K. DahiyaSenior Counsel – Patent LitigationBristol-Myers Squibb (Princeton, NJ)

Ronald M. Daignault Shareholder, Polsinelli (New York, NY)

John L. Dauer, Jr.Chief Patent CounselSun Pharmaceutical Industries, Inc. (Cranbury, NJ)

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

Joseph EvallPartner, Gibson Dunn & Crutcher LLP (New York, NY)

Steven E. FeldmanPartner, Husch Blackwell LLP (Chicago, IL)

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

Frank W. FormanSenior Patent Counsel, Astellas US LLC (Farmingdale, NY)

Ralph J. GabricShareholder & Chair, Litigation GroupBrinks Gilson & Lione (Chicago, IL)

Barry P. GolobPartner, Cozen O’Connor (Washington, DC)

Robert J. Gunther, Jr.PartnerWilmer Cutler Pickering Hale and Dorr LLP (New York, NY)

Christopher J. HarnettPartner, Ropes & Gray LLP (New York, NY)

Elizabeth J. HollandPartner, Goodwin Procter LLP (New York, NY)

Beth D. JacobPartner, Kelley Drye & Warren LLP (New York, NY)

Lisa A. JakobLegal Director, IP Litigation, Merck & Company (Rahway, NJ)

Kurt R. KarstDirector, Hyman, Phelps & McNamara, P.C. (Washington, DC)

Benjamin A. KatzenellenbogenPartner, Knobbe, Martens, Olson & Bear, LLP (Irvine, CA)

Christopher J. KellyPartner, Mayer Brown LLP (Palo Alto, CA)

Thomas KrzeminskiPartner, Knobbe, Martens, Olson & Bear, LLP (Irvine, CA)

George C. LombardiPartner, Chair, Intellectual Property PracticeWinston & Strawn LLP (Chicago, IL)

Laura A. LydigsenShareholder and Co-Chair Appellate Practice GroupBrinks Gilson & Lione (Chicago, IL)

David A. ManspeizerPartnerWilmer Cutler Pickering Hale and Dorr LLP (New York, NY)

Kerry B. McTigueMember, Co-Chair, Intellectual Property DepartmentCozen O’Conner (Washington, DC)

Markus H. MeierAssistant Director, Health Care DivisionBureau of CompetitionFederal Trade Commission (Washington, DC)

Donna M. MeuthAssociate General Counsel, Intellectual PropertyEisai Inc. (Andover, MA)

Don J. MizerkPartner, Husch Blackwell LLP (Chicago, IL)

Gregory A. MorrisOf Counsel, Paul Hastings LLP (Chicago, IL)

Honorable Brian P. Murphy (invited)(Acting) Lead Administrative Patent JudgePatent Trial and Appeal Board United States Patent and Trademark Offi ce (Alexandria, VA)

Jeffrey N. Myers, Ph.D.Vice President & Assistant General CounselPfi zer Inc (New York, NY)

Glenn NewmanPartner, Baker Tilly Virchow Krause, LLP (Philadelphia, PA)

Martin B. PavaneMember 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)


Paul A. RagusaPartner, Baker Botts L.L.P. (New York, NY)

Teresa ReaPartner, 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 Offi ce)

Mark H. RemusPartner, Katten Muchin Rosenman LLP (Chicago, IL)

Katharine R. RiceCorporate Counsel, Gilead Sciences (Foster City, CA)

Irena RoyzmanPartner, Patterson Belknap Webb & Tyler LLP (New York, NY)

Richard T. RuzichPartner, Taft Stettinius & Hollister LLP (Chicago, IL)

Carmen M. ShepardSr. Vice President, Global Policy and Regulatory CounselMylan (Washington, DC)

Paul SimboliVice President, Intellectual Property & Asst. General CounselDepomed (Newark, CA)

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

Jennifer C. TempestaSpecial Counsel, Baker Botts L.L.P. (New York, NY)

Shashank UpadhyePartner, Amin Talati & Upadhye (Chicago, IL)(Former Vice President – Global Intellectual Property, Apotex, Inc.)

Tedd W. Van BuskirkShareholder, Polsinelli (New York, NY)

Mark E. WaddellChair‚ Patent Litigation and CounselingLoeb & Loeb LLP (New York, NY)

Peter WaibelHead US Patent LitigationNovartis Pharmaceuticals Corporation (East Hanover, NJ)

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

Advisory Board and Faculty List

Register now: 888-224-2480 • Fax: 877-927-1563 • www.AmericanConference.com/PIVDisputesNYC 3

Each 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 profi ts. 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 fi lings, fi nal adjudication and every step in between.

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.

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 fi nal disposition through a mock trial scenario.

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.

Very truly yours,

Lisa J. Piccolo, Esq.Senior Industry Manager, Life Sciences and Health CareAmerican Conference Institute

BE PART OF THE ONLY EVENT WHICH SHAPES THE LAW, POLICY AND PROCEEDINGS OF PARAGRAPH IV LITIGATION.

Media Partners:

Dear Colleague:


MONDAY, APRIL 27, 2015 Main Conference – Day 1

7:00 Registration and Continental Breakfast

Sponsored by:

8:15 Co-Chairs’ Opening Remarks

Guy DonatielloVice President, Intellectual PropertyEndo Pharmaceuticals (Malvern, PA)

Timothy X. Witkowski, M.S., J.D.Executive Director & Executive Counsel, Intellectual PropertyBoehringer Ingelheim (Ridgefield, CT)

8:30 The Role of Legal Analytics in the Paragraph IV Disputes Landscape: Playing Moneyball for Successful ANDA Litigation Strategy

Owen ByrdChief Evangelist & General CounselLex Machina (Menlo Park, CA)

Barry P. GolobPartnerCozen O’Connor (Washington, DC)


• 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

9:15 Questions of Personal and General Jurisdiction in A Paragraph IV Case: Exploring Daimler’s Applicability in a Hatch Waxman Scenario

Dominick A. CondePartnerFitzpatrick, Cella, Harper & Scinto (New York, NY)

Steven M. CoylePartner and Pharmaceutical Litigation Group LeaderCantor Colburn LLP (Hartford, CT)

Elizabeth J. HollandPartnerGoodwin Procter LLP (New York, NY)

Thomas KrzeminskiPartnerKnobbe, Martens, Olson & Bear, LLP (Irvine, CA)

Tedd W. Van BuskirkShareholderPolsinelli (New York, NY)

Peter WaibelHead US Patent LitigationNovartis 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

• 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

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. BeckerPartnerAxinn, Veltrop & Harkrider LLP (Hartford, CT)

Richard BermanPartnerArent Fox LLP (Washington, DC)

Robert J. Gunther, Jr.PartnerWilmer Cutler Pickering Hale and Dorr LLP(New York, NY)

Benjamin A. KatzenellenbogenPartnerKnobbe, Martens, Olson & Bear, LLP (Irvine, CA)

Paul SimboliVice President, Intellectual Property & Asst. General CounselDepomed (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


• 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

11:30 Defeating the Undefeatable: New Obvious Considerations for Paragraph IV Compound Patent Challenges in Light of Baraclude

Vincent L. Capuano, Ph.D.PartnerDuane Morris LLP (Boston, MA)

Lisa M. FerriPartnerMayer Brown LLP (New York, NY)

George C. LombardiPartner, Chair, Intellectual Property PracticeWinston & Strawn LLP (Chicago, IL)

Katharine R. RiceCorporate CounselGilead Sciences (Foster City, CA)

Bruce M. WexlerPartnerPaul Hastings LLP (New York, NY)

Moderator:

Michael R. DzwonczykPartnerSughrue Mion, PLLC (Washington, DC)

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

12:30 Networking Luncheon

Sponsored by:

1:45 PTO Proceedings Retrospect: Exploring the Growing Use of IPR, PGR and CBM Review in Hatch-Waxman Litigation

Lisa A. JakobLegal Director, IP LitigationMerck & Company (Rahway, NJ)

Laura A. LydigsenShareholder and Co-Chair Appellate Practice GroupBrinks Gilson & Lione (Chicago, IL)

Gregory A. MorrisOf CounselPaul Hastings LLP (Chicago, IL)

Martin B. PavaneMember and Vice Chair, Intellectual Property Department; Co-Chair, ANDA and BiologicsCozen O’Connor (New York, NY)

Paul A. RagusaPartnerBaker Botts L.L.P. (New York, NY)

Irena RoyzmanPartnerPatterson 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


- 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 Hatch-Waxman 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. AutenPartner, Chair of Pharmaceutical & Life Sciences LitigationTaft Stettinius & Hollister LLP (Chicago, IL)(Former Vice President, IP, Sandoz, Inc.)

Michael SitzmanPartnerGibson Dunn & Crutcher LLP (San Francisco, CA)

• 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 The Patent Trial and Appeals Board Live: A Conversation with Administrative Patent Judges on PTAB Practices and Protocols for Hatch-Waxman Practitioners

Honorable Brian P. Murphy (invited)(Acting) Lead Administrative Patent JudgePatent Trial and Appeal BoardUnited States Patent and Trademark Office(Alexandria, VA)

Honorable Jacqueline D. Wright Bonilla (invited)Administrative Patent JudgePatent Trial and Appeal BoardUnited States Patent and Trademark Office(Alexandria, VA)

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.

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.

4:45 A View From the Bench: The Federal Judges Speak

Honorable Ruben CastilloChief JudgeUnited States District Court Northern District of Illinois (Chicago, IL)

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)

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)

Moderator:

Ralph J. GabricShareholder & Chair, Litigation GroupBrinks Gilson & Lione (Chicago, IL)

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.

6:00 Conference Adjourns to Day Two

Cocktail Party Sponsored by:


TUESDAY, APRIL 28, 2015 Main Conference – Day 2

7:30 Continental Breakfast

Sponsored by:

8:30 Teva v. Sandoz — Claim Construction Redoux: De Novo vs. Deferential

Bradford J. BadkePartnerRopes & Gray LLP (New York, NY)

Ronald M. DaignaultShareholderPolsinelli (New York, NY)

Don J. MizerkPartnerHusch Blackwell LLP (Chicago, IL)

Jeffrey N. Myers, Ph.D.Vice President & Assistant General CounselPfizer Inc (New York, NY)

Moderator:


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.

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

9:30 Limelight v. Akamai: Assessing Its Impact on Method of Treatment Patents and Section viii Label Carve Outs

Neal K. DahiyaSenior Counsel – Patent LitigationBristol-Myers Squibb (Princeton, NJ)

Steven E. FeldmanPartnerHusch Blackwell LLP (Chicago, IL)

David A. ManspeizerPartnerWilmer Cutler Pickering Hale and Dorr LLP(New York, NY)

Mark H. RemusPartnerKatten Muchin Rosenman LLP (Chicago, IL)

Mark E. WaddellChair‚ Patent Litigation and CounselingLoeb & Loeb LLP (New York, NY)

Moderator:

Richard T. RuzichPartnerTaft 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. MeierAssistant Director, Health Care DivisionBureau of CompetitionFederal 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 Hatch-Waxman 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 Hatch-Waxman space.


11:30 Developing Practical Strategies for Settling A Paragraph IV Case Post-Actavis: A Litigator’s Perspective

John L. Dauer, Jr.Chief Patent CounselSun Pharmaceutical Industries, Inc. (Cranbury, NJ)

Beth D. JacobPartnerKelley Drye & Warren LLP (New York, NY)

Christopher J. KellyPartnerMayer Brown LLP (Palo Alto, CA)

Jennifer C. TempestaSpecial CounselBaker 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

• 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

12:30 Networking Luncheon

1:45 FDA Update: Survey of Agency Activity Impacting Paragraph IV Litigation

Joseph EvallPartnerGibson Dunn & Crutcher LLP (New York, NY)

Kurt R. KarstDirectorHyman, Phelps & McNamara, P.C.(Washington, DC)

Carmen M. ShepardSr. Vice President, Global Policy and Regulatory CounselMylan (Washington, DC)

Shashank UpadhyePartnerAmin Talati & Upadhye (Chicago, IL)(Former Vice President – Global Intellectual Property, Apotex, Inc.)

New Developments Impacting Brand Name and Generic Exclusivities

• 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)

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

Generics

• Reviewing recent FDA decisions revoking 180-day exclusivity- Ranbaxy cGMP violations

Other Significant Regulatory Developments Affecting Hatch-Waxman

• 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

2:45 Afternoon Refreshment Break

3:00 Assessing the True Measure of Damages in At Risk Launch Scenario

Nicolas BarzoukasPartnerBaker Botts L.L.P. (Huston, TX)

Stephen P. BensonPartnerKatten Muchin Rosenman LLP (Chicago, IL)

Michael F. BuchananPartnerPatterson Belknap Webb & Tyler LLP (New York, NY)

Kerry B. McTigueMember, Co-Chair, Intellectual Property DepartmentCozen O’Conner (Washington, DC)

Glenn NewmanPartnerBaker Tilly Virchow Krause, LLP (Philadelphia, PA)

Moderator:

Christopher J. HarnettPartnerRopes & Gray LLP (New York, NY)


• Survey of recent at-risk launches, status and outcomes• Conducting a risk–benefi ts 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 quantifi cation of damages in an at risk-launch

• Lost profi ts- assessment of profi t as a true measure of damages questions of profi tability and sales

- when is it the only thing that you can seek?- circumstances under which lost profi ts can be denied- analysis of lost profi ts determination in Sanofi -Aventis v.

Glenmark, No. 2012-1489 (Fed. Cir., Apr. 21, 2014)- Exploring novel lost profi t determinations

does launch of an authorized generic defeat request for lost profi ts? if holder of patent to whom damages is awarded is

an off-shore entity — should lost profi ts 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. FormanSenior Patent CounselAstellas US LLC (Farmingdale, NY)

Donna M. MeuthAssociate General CounselIntellectual PropertyEisai Inc. (Andover, MA)

• 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 fi ndings- inequitable conduct and Patent Reform supplemental proceedings under the AIA:

an opportunity to cure inequitable conduct?

5:00 Conference Ends

© American Conference Institute, 2015

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 ReaPartnerCrowell & Moring LLP (Washington, DC)(Former Acting Under Secretary of Commerce for Intellectual Property and Former Acting Director of the United States Patent and Trademark Offi ce)

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 fi led in advance of traditional Paragraph IV litigation or in some instances stay or run parallel to such proceedings.

• 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

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 fi nal 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:

• Strategies for operating in an expedited time line• Best practices for petition and petition response drafting• Amending petition/response• Amending claims during petition process


Patent attorneys and litigators (in-house & law firm) who represent:

� Brand name pharmaceutical companies

� Generic pharmaceutical companies

� Biopharmaceutical companies

WHO YOU WILL MEET

With more than 300 conferences in the United States, Europe, Asia Pacifi c, 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 FleischhackerSenior Business Development Executive, Special Projects, American Conference Institute

Tel: 212-352-3220 [email protected]

Global Sponsorship Opportunities

Accreditation will be sought in those jurisdictions requested by the registrants which have continuing education requirements. This course is identifi ed as nontransitional for the purposes of CLE accreditation.

ACI certifi es that the activity has been approved for CLE credit by the New York State Continuing Legal Education Board.

ACI certifi es 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

EarnCLE

ETHICSCredits

Each year more than 15,000 in-house counsel, attorneys in private practice and other senior executives participate in ACI events — and the numbers keep growing.

Guaranteed Value Based on Comprehensive Research

ACI’s highly trained team of attorney-producers are dedicated, full-time, to developing the content and scope of our conferences based on comprehensive research with you and others facing similar challenges. We speak your language, ensuring that our programs 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.

American Conference Institute:The leading networking and information resource for counsel and senior executives.

Is your organization recruiting specialists with expertise in this area?

Many of our speakers and delegates use our conferences to recruit for new, expert talent to fi ll open positions at their fi rms.

Because ACI provides many niche conferences annually, our events are a great way to discover a rich pool of highly qualifi ed talent.

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 fi rm 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.


THANK YOU TO OUR SUPPORTING SPONSORS

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.

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.

Baker Botts is an international law firm with a global network of offices. Our Life Science lawyers are well-versed 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

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.

For Sponsorship Opportunities for this Event, Please Contact:

Esther Fleischhacker at 212-352-3220 ext. 5232 or [email protected]

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: Apr

il 29

, 201

5

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