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Register Now • 888-224-2480 • AmericanConference.com/LifeCycles Earn CLE Credits Maximizing Pharmaceutical Patent Life Cycles e definitive Hatch-Waxman and BPCIA event for brand names and generics October 4 – 5, 2011 | New York Marrio Downtown | New York 12 th Annual HATCH-WAXMAN s e r i e s ACI’s INDUSTRY INSIGHTS FROM: and ACI’s Hatch-Waxman Series Advisory Board – See P.2 KEY AGENCIES SPOTLIGHT Hear from the: United States Patent and Trademark Office on: Patent Reform Teresa Stanek Rea (Invited) Deputy Under Secretary of Commerce for Intellectual Property and Deputy Director, USPTO PTA and PTE Analysis Mary C Till (Invited), Legal Advisor Office of Patent Legal Administration, USPTO Reexam and Reissue Jean F. Vollano, Ph.D (Invited) Quality Assurance Specialist, USPTO • Federal Trade Commission on: | Competitive Behaviors Impacting Pharmaceutical Patent Life Cycle Management Suzanne Munck, Counsel for Intellectual Property Office of Policy and Planning, FTC • U.S. Food and Drug Administration on: FDA Activities Affecting Pharmaceutical Patent Life Cycles for Small and Large Molecules Elizabeth Dickinson (Invited), Associate Chief Counsel, Office of the Chief Counsel, FDA Hoffmann-LaRoche Apotex, Inc. BIO Eli Lilly & Company Endo Pharmaceuticals Lundbeck Research USA, Inc. Medicis Pharmaceutical Corporation Merck & Company Pfizer, Inc. PhRMA Roche Diagnostics India Pvt Ltd. Sandoz, Inc. Preeminent patent counsel and advisors to leading brand name and generic pharmaceutical companies, as well as representatives from key government agencies and industry associations will provide insights on the latest challenges affecting pharmaceutical patent life cycles for small and large molecules and help you: UNDERSTAND how the patent cliff will impact innovation and R&D PREPARE for the release of anticipated FDA regulations on biosimilars and COMPREHEND how the further implementation of BPCIA will affect pharmaceutical patent life cycle management strategies ASSESS how the combined evolution of prior art obvious and obvious-type double patenting is influencing the future of secondary patents EVALUATE patent life cycle strategies relative to personalized medicine vis-à-vis section 101 patentability and section 112 written description requirements ANALYZE the significance of Microsoft, Myriad and Therasense on patent life cycle strategies for small and large molecules EXAMINE the impact of REMS studies on generic entry DECIPHER the relationship between use code controversies and inducement/ divided infringement actions relative to Orange Book listings EXPLORE forfeiture rulings post-Lipitor NAVIGATE new safe harbor dilemmas for both general screening and research tool patents October 3, 2011: Interactive Pre-Conference Training and Strategy Sessions A. PTA- PTE Boot Camp: Basic Training in the Essentials of Patent Term Adjustment and Patent Term Restoration for Patent Lawyers Serving the Biopharmaceutical Industry B. Working Group on Global Pharmaceutical Patent Life Cycle Management Strategies for Established and Emerging Markets: A Practical, Hands-On Guide To Patent Extensions and Exclusivities Available to Pharmaceutical Products Around the World Supporting Sponsors: Sponsored by: Associate Sponsor: Cocktail Reception Hosted by:

Transcript of th Maximizing HATCH-WAXMAN ACI’s - brinksgilson.com · ACI’s Industry InsIghts from: and...

Page 1: th Maximizing HATCH-WAXMAN ACI’s - brinksgilson.com · ACI’s Industry InsIghts from: and ACI’s Hatch-Waxman Series Advisory Board – See P.2 Key AgencIes spotlIght ... Sun

Register Now • 888-224-2480 • AmericanConference.com/LifeCycles

Earn

CLE Credits

Maximizing Pharmaceutical Patent Life CyclesThe definitive Hatch-Waxman and BPCIA event for brand names and generics

October 4 – 5, 2011 | New York Marriott Downtown | New York

12th Annual

HATCH-WAXMANs e r i e s

ACI’s

Industry InsIghts from:

and ACI’s Hatch-Waxman Series Advisory Board – See P.2

Key AgencIes spotlIght

Hear from the:• united states patent and trademark office on:

patent reform Teresa Stanek Rea (Invited)

Deputy Under Secretary of Commerce for Intellectual Property and Deputy Director, USPTO

ptA and pte Analysis Mary C Till (Invited), Legal Advisor

Office of Patent Legal Administration, USPTO

reexam and reissue Jean F. Vollano, Ph.D (Invited)

Quality Assurance Specialist, USPTO

• FederalTradeCommissionon:| competitive Behaviors Impacting pharmaceutical patent life cycle management

Suzanne Munck, Counsel for Intellectual Property Office of Policy and Planning, FTC

• U.S.FoodandDrugAdministrationon: fdA Activities Affecting pharmaceutical patent life cycles for small and large molecules

Elizabeth Dickinson (Invited), Associate Chief Counsel, Office of the Chief Counsel, FDA

Hoffmann-LaRocheApotex, Inc.BIOEli Lilly & CompanyEndo PharmaceuticalsLundbeck Research USA, Inc.

Medicis Pharmaceutical CorporationMerck & CompanyPfizer, Inc.PhRMARoche Diagnostics India Pvt Ltd.Sandoz, Inc.

Preeminent patent counsel and advisors to leading brand name and generic pharmaceutical companies, as well as representatives from key government agencies and industry associations will provide insights on the latest challenges affecting pharmaceutical patent life cycles for small and large molecules and help you:

• understAnd how the patent cliff will impact innovation and r&d

• prepAre for the release of anticipated fdA regulations on biosimilars and comprehend how the further implementation of BpcIA will affect pharmaceutical patent life cycle management strategies

• Assess how the combined evolution of prior art obvious and obvious-type double patenting is influencing the future of secondary patents

• eVAluAte patent life cycle strategies relative to personalized medicine vis-à-vis section 101 patentability and section 112 written description requirements

• AnAlyZe the significance of Microsoft, Myriad and Therasense on patent life cycle strategies for small and large molecules

• eXAmIne the impact of rems studies on generic entry

• decIpher the relationship between use code controversies and inducement/ divided infringement actions relative to orange Book listings

• eXplore forfeiture rulings post-Lipitor

• nAVIgAte new safe harbor dilemmas for both general screening and research tool patents

october 3, 2011: Interactive pre-conference training and strategy sessions

A.ptA- pte Boot camp: Basic training in the essentials of patent term Adjustment and patent term restoration for patent lawyers serving the Biopharmaceutical Industry

B.Working group on global pharmaceutical patent life cycle management strategies for established and emerging markets: A practical, hands-on guide to patent extensions and exclusivities Available to pharmaceutical products Around the World

supporting sponsors: sponsored by:Associate sponsor:

cocktail reception hosted by:

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

speakers:

StephenR.AutenVice President, IPSandoz, Inc. (Princeton, NJ)

AaronF.Barkoff,Ph.D.PartnerMcAndrews, Held & Malloy, Ltd.(Chicago, IL)

NicolasG.BarzoukasPartnerWeil, Gotshal & Manges LLP(Huston, TX)

AllenR.BaumShareholder and Chair, Chemical Practice GroupBrinks Hofer Gilson & Lione(Research Triangle Park, NC)

ScottBeeser,Ph.D.LLBPatent Attorney – BiopharmaceuticalsApotex Inc. (Toronto, ON)

Margaret“Peg”M.BuckHead of Section, US Legal Affairs & PatentsLundbeck Research USA, Inc.(Paramus, NJ)

patricia carsonPartnerKaye Scholer LLP (New York, NY)

BrianD.CoggioSenior PrincipalFish & Richardson, P.C. (New York)

MichaelA.DavitzPartnerAxinn, Veltrop & Harkrider LLP(New York, NY)

elizabeth dickinson (Invited)Associate Chief Counsel, Office of the Chief CounselU.S. Food and Drug Administration(Rockville, MD)

guy donatielloVice President, Intellectual PropertyEndo Pharmaceuticals(Chadds Ford, PA )

MichaelP.DoughertySpecial CounselCadwalader, Wickersham & Taft LLP(New York, NY)

TedJ.Ebersole,Ph.D.Assistant General Patent CounselEli Lilly and Company(Indianapolis, IN)

BartonW.Giddings,Ph.D PartnerStoel Rives LLP (Salt Lake City, UT)

GregoryJ.Glover,MD,JDPrincipalPharmaceutical Law Group PC(Washington, DC)

JamesM.GouldLegal Director – Intellectual Property LitigationMerck & Co., Inc. (Rahway, NY)

RobertM.Gould,Ph.D.PartnerDuane Morris LLP (Chicago, IL)

JohnM.Griem,Jr.PartnerLoeb & Loeb LLP (New York, NY)

nicholas groombridge Partner and Co-Chair Patent LitigationWeil, Gotshal & Manges LLP(New York, NY)

ThomasD.HoffmanConsultant – Patent CounselSandoz,Inc. (East Hanover, NJ )

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

gabriel KleimanAssistant General CounselPfizer Inc. (New York, NY)

david KornSenior Assistant General CounselPhRMA (Washington, DC)

ThomasJ.KowalskiShareholder Vedder Price P.C. (New York, NY)

StevenJ.LeePartnerKenyon & Kenyon (New York)

EdwardT.LentzPatent Attorney(New Lisbon, NY)

DeniseL.LoringPartnerRopes & Gray LLP (New York, NY)

BrianJ.MalkinPartner Frommer Lawrence & Haug LLP(New York, NY)

KevinW.McCabeDirectorSterne, Kessler, Goldstein & Fox P.L.L.C. (Washington, DC)

RashadL.MorganPatent AttorneyBrinks Hofer Gilson & Lione(Research Triangle Park, NC)

suzanne munckCounsel for Intellectual PropertyOffice of Policy and PlanningFederal Trade Commission (Washington DC)

BrianP.MurphyPartnerEdwards Angell Palmer and Dodge LLP (New York, NY)

JustinJ.OliverPartnerFitzpatrick, Cella, Harper & Scinto(Washington, DC)

Bert oostingPartnerHogan Lovells (Amsterdam, NE)

RichardS.ParrAssistant CounselMerck & Co., Inc. (Rahway, NJ)

BruceA.PokrasSenior Corporate Counsel, Intellectual PropertyPfizer Inc. (Madison, NJ)

RichardT.RuzichPartnerDuane Morris LLP (Chicago, IL)

teresa stanek rea (Invited)Deputy Under Secretary of Commerce for Intellectual Property and Deputy Director United States Patent and Trademark Office (Alexandria, VA)

HansSauer,Ph.D.,J.D.Deputy General Counsel for Intellectual PropertyBiotechnology Industry Organization(Washington, DC)

BrianV.SlaterPartnerFitzpatrick, Cella, Harper & Scinto(New York, NY)

LenS.SmithPrincipal Intellectual Property CounselMedicis Pharmaceutical Corporation(Scottsdale, AZ)

suja subramaniamHead of LegalRoche Diagnostics India Pvt Ltd.(Mumbai, India)

mary c till (Invited)Legal Advisor, Office of Patent Legal AdministrationUnited States Patent and Trademark Office (Alexandria, VA)

colleen tracyPartnerFitzpatrick, Cella, Harper & Scinto(New York, NY)

shashank upadhyeVice President – Global Intellectual PropertyApotex, Inc. (Toronto, ON)

ChristopherA.Vellturo,Ph.D., President, Quantitative Economic Solutions, LLC (Cambridge, MA)

JeanF.Vollano,Ph.D (Invited)Quality Assurance Specialist United States Patent and Trademark Office (Alexandria, VA)

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Advisory Board & Faculty List

StephenR.AutenVice President, IPSandoz, Inc.(Princeton, NJ)

MatthewP.BlischakVice President, Intellectual Property & Associate General CounselSunovion Pharmaceuticals Inc.(Marlborough, MA)

guy donatiello Vice President, Intellectual PropertyEndo Pharmaceuticals(Chadds Ford, PA )

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

GeorgeW.JohnstonVice President & Chief Patent CounselHoffmann-La Roche(Nutley, NJ)

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

meg snowden VP, Intellectual Property Impax Laboratories (Hayward, CA)

shashank upadhye Vice President – Global Intellectual PropertyApotex, Inc.(Toronto, ON)

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

JohnC.Vassil(Formerly Of Counsel to Morgan & Finnegan LLP)(New York)

chairmen:

GeorgeW.Johnston Vice President & Chief Patent CounselHoffmann-La Roche(Nutley, NJ)

MarkE.WaddellPartnerLoeb & Loeb LLP(New York, NY)

AcI’s hatch-Waxman series Advisory Board chairman emeritus:

Media Partners:

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unprecedented patent losses on small molecule pharmaceutical products having valuesinexcessof$130billionannuallywilloccurby2016.*

A pathway for biosimilars has been created, but accompanying regulations have yet tobepromulgated.

now is the time for brand name and generic pharmaceutical companies to rethink therulesofthepatentendgame.

get the information that you need to navigate the hatch-Waxman patent cliff andthepatentchallengesprecipitatedbyBPCIA.Attendtheoneeventwhich has remained “the industry constant” for shaping policies and strategies for both brandnamesandgenerics.

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

American conference Institute’s (AcI’s) maximizing pharmaceutical patent life cycles conference is the pharmaceutical industry’s leading source for information and analysis on patent life cycle management for both small and now, large molecule pharmaceutical products. It is the forum where lawyers, executives and policy makers for brand name and generic manufacturers gather each year to prepare for the life cycle challenges they currently face as well as those which they anticipate.

new Ip and industry dynamics coupled with evolving law and regulation have created new patent life cycle challenges

forbrandnamesandgenerics.The pharmaceutical industry now stands on the edge of the patent cliff. By 2016, patents on myriad block buster pharmaceutical products for treating ailments and conditions ranging from asthma to high cholesterol to psychosis and beyond will go off patent. This patent decline does not only pose problems for brand name drug manufacturers, but also proves troubling for generics; the ultimate Hatch-Waxman prize of 180-day exclusivity may be short-lived in the future as there will be few patented drug products worth coveting. Moreover, as the industry awaits FDA guidance on biosimilars, it remains anyone’s guess as to what effect, if any these new medicinal entities and therapies will have on the patent endgame.

prepare to meet these pharmaceutical life cycle challengeshead-on.

This 12th AcI conference on maximizing pharmaceutical patent life cycles will bring you the thoughtful and targeted commentary and in-depth analysis that you have come to expect from this industry-leading event. This year’s conference features:

• PresentationsfromkeyrepresentativesfromtheUSPTO(invited), FTC, and FDA (invited). They will provide you with direct insights and the logic of these agencies on some of most pressing life cycle management challenges that the industry is facing today, including the latest on:- Patent reform; PTE and PTA determinations; and reissue

and reexam proceedings- Pay-for-delay and the findings of the FTC Report on the

IP Market Place- Forfeiture determinations

• Anupdateonbiosimilarsandthefurtherdevelopmentofthese second generation biological products will influence pharmaceutical patent life cycle and portfolio strategies in view of the further implementation of BPCIA and the inevitability of the patent cliff

• In-depthdiscussionsonkeyregulatorydevelopmentsimpacting life cycle management including - REMS studies- Use codes, skinny labeling, and carve outs, and their

relationship to divided infringement and inducement theories- Regulatory bars to exclusivity

• Analysesofrecentcriticalcasesaffectingpatentlifecycleplanning including: Sun Pharma (double patenting); Microsoft (standard of invalidity); Ariad (patentability); Therasense (inequitable conduct) and strategies for using these cases to your advantage

Benefit from in-depth and practical training and strategy sessions that will address the essentials and emerging focus

of pharmaceutical patent life cycle management.In response to your requests, we have added the following pre-conference training and strategy sessions:

• ptA- pte Boot camp: Basic training in the essentials of patent term Adjustment and patent term restoration for patent lawyers serving the Biopharmaceutical Industry will offer critical instruction on the fundamentals and mechanics of PTA and PTE practice which help to ensure patent and profit longevity; and

• Working group on global pharmaceutical patent life cycle management strategies for established and emerging markets: A practical, hands-on guide to patent extensions and exclusivities Available to pharmaceutical products Around the World will offer in-depth and pragmatic advice for navigating patent systems in Europe and emerging BRIC markets

nearly 3,000 pharmaceutical patent professionals – for both brand names and generics – have made this conference their source of information for the legal issues surrounding life cycle management fornearlythelasttwelveyears.This updated event will bring you the latest legal strategies and tactics for successful maneuvering in the evolving patent endgame.

Withallthat’satstake,youcannotaffordtomissthisconference.

Don’t delay – register now by calling 888-224-2480, faxing your registration form to 877-927-1563 or registering on-line at www.americanconference/LifeCycles.

* Wall Street Journal, February 15, 2011

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

A 9:00 AM – 12:30 PM (Registration begins at 8:15 AM)

ptA- pte Boot camp: Basic training in the essentials of patent term Adjustment and patent term restoration for patent lawyers serving the Biopharmaceutical Industry

Scott Beeser, Ph.D. LLBPatent Attorney – BiopharmaceuticalsApotex Inc.(Toronto, ON)

Justin J. OliverPartnerFitzpatrick, Cella, Harper & Scinto(Washington, DC)

Richard S. Parr Assistant CounselMerck & Co., Inc.(Rahway, NJ)Patent Term Adjustment (PTA) and Patent Term Extensions (PTE) are essential to patent life cycle longevity – especially in the pharmaceutical and biotechnology industries. Biopharmaceutical companies invest numerous resources into preserving the patent life and the subsequent profits of products which take years to produce. Each day of patent life equals millions of dollars in profits. A loss of even one day can have substantial impact on a company’s profit margin.

Recent court decisions and the introduction of an abbreviated pathway for follow-on biological products have made knowing the “ins and outs” of PTE and PTA a critical competency for every patent practitioner servicing the pharmaceutical and biotechnology industries.

This intensive half-day workshop will help you master the skills you need to face your greatest PTA and PTE challenges head on. A faculty of PTA and PTE experts will offer practical solutions and in-depth instruction for everything from eligibility requirements to calculations to the application and reconsideration processes. They will also discuss to the interplay of these mechanisms. Points of discussion will include:

• OverviewofPatentTermAdjustment(PTA)andPatentTerm Extension (PTE)- statutory authorities Patent Act Hatch-Waxman Act

• UnderstandingtheuniqueroleofPTAandPTAinthelongevity of patent life cycles in the life sciences industries

• PTAvs.PTE- seeking redress for PTO delays- seeking redress for FDA delays

• Whichpointofpatentlifedoeseachofthesedevicesextend?- full scope of patent vs. full scope of patent life of patent

product

ptA

• Reviewof35U.SC.154(b)and37C.F.R.1.702-1.705• ComprehendingthecriteriaforPTAeligibility• ReconcilingdiscrepanciesincertainPTAandPTORules• SeekingPTA

- starting point and the Notice of Allowance- addressing dispute with PTO’s initial PTA calculation

request for Reconsideration /Application for Correction- when can PTA be corrected after the issuance of the patent

• PTOdelaysv.applicantdelays• A-Delays:whataretheyandwhenaretheygranted?

- understandingthePTO’s14–4–4clock 14months:firstactionresponsetime º howtomeasuretheinitial14monthdelay 4months:response/appeal 4months:patentissuance

- identifyingthepointintimewhenAdelaysaccumulate?• B-Delays:whataretheyandwhatarethecriteriafortheir

issuance?- triggers: PTO 3 year patent issuance deadline starting point for B-Delay accumulation howareB-Delaysmeasured?

• C-Delays:howaretheydifferentforAandB-Delays- triggering events: interferences secrecy orders notices of appeal

- whenaretheygranted?- howaretheycalculated?

• Identifyingeventswhichstopthe3yearB-Delayclock and their relation to C-Delays- other clock stoppers RCE- Request for Continued Examination

• AnalyzingandsolvingAandBDelayoverlapdilemmas- Wyeth v.Dudas- Japan Tobacco

pte

• OverviewofPTE- 35USC156- 37CFR1.710–1.791

• Identifyingimportantbenchmarksinadrug’sdevelopmentand patent timelines relative to seeking PTE- whatisthepatenttermrestoredandtowhatdoesitapply? defining “drug product” under PTE provisions of

Hatch-Waxman Act salts esters enantiomers

- regulatory review period determinations testing phase review phase

• UnderstandingwhyPTEprovisionsintheHatch-WaxmanAct extend to products outside the scope of Hatch-Waxman, i.e., biologics and certain medical devices- the importance of PTE in the newly ratified follow-on

biologic scenario- exploring PTE applicability relative to: antibiotics animal drugs food/color additives combination products

• Reviewingeligibilityrequirements/prerequisitesforpatentterm extension

• Calculatingthepatenttermrestored- FDA/ PTO interplay

• Criteriaandeligibilityforinterimextensions• ThePTEapplication

- strategies for preparation and submission

Interactive Training and Strategy Sessions Monday, October 3, 2011

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

2:00PM–5:30PM(Registration begins at 1:15 PM)B Working group on global pharmaceutical patent life cycle management strategies for established and emerging markets: A practical, hands-on guide to patent extensions and exclusivities Available to pharmaceutical products Around the World

James M. GouldLegal Director- Intellectual Property LitigationMerck & Co., Inc.(Rahway, NY)

Gabriel KleimanAssistant General CounselPfizer Inc.(New York, NY)

Bert OostingPartnerHogan Lovells(Amsterdam, NE)

Suja SubramaniamHead of LegalRoche Diagnostics India Pvt Ltd.(Mumbai, India)

Workshop objectives• Developingaglobalpharmaceuticalpatentlifecycle

management plan that responds to changes which impact intellectual property protection in established as well as emerging markets

• Learningtoextendpharmaceuticalpatentlifeinforeignjurisdictions

• Identifyingandseekingavailableinternationalpatentandnon-patent exclusivities

established markets• AssessingchangesinEuropeanpatentpracticeinlightof

the findings of the EC’s DG Competition’s Pharmaceutical Sector Inquiry

• Whatbearinghavethesechangeshadonpatentlifecyclestrategies in Europe- extensions of patent term - regulatory exclusivities

patent extensions in the eu• SupplementaryProtectionCertificates(SPCs)–extension

of patent life in the EU- scope of the protection-howdoyouapplyforit?- interaction between the Pharmaceutical Directive and

the SPC Regulation • MeetingtherequirementstoobtainanSPC

- tips for maximizing the patent extension obtained under an SPC for human medicinal products

- weighing the pros and cons of seeking a pediatric extension- obtaining a zero term or SPC or quasi patent term extension- determining what extension term is best for your

product based on an assessment of the type of rights you will be granted

• ContemplatingwhetherornotanewSPCcanbeobtainedfor new combinations, isomers, etc.

• Identifyingwhat(ifany)alternativesexistforobtaininganSPC when seeking to extend the patent term on your product

• EvaluatingdifferingstandardsforobtaininganSPConacountry-by-country basis

• ConsideringissuesuniquetoseekinganSPCwhentheoriginal Marketing Authorisation (MA) was granted in a country that is not part of the European Economic Area (EEA), i.e., Switzerland

• Obtainingaspringboardinjunctionformarketinganddistribution after patent expiry in case of offering and inclusion in pricelists before patent expiry

regulatory exclusivities – eu and elsewhere• RegulatoryDataProtection• ThePaediatricMedicinesRegulation

- scope and key obligations- what kind of reward/exclusivity are available (SPC

extension/patent protected products, orphan drugs, off-patentproducts)?

• TheOrphanDrugsRegulation–obtainingorphanmarketexclusivity

exploring strategies to extend pharmaceutical patent life in:• Japan• SouthKorea• Taiwan• Singapore• Israel

EmergingMarkets–BRIC*• Examiningthetreatmentofpharmaceuticalpatentsin

BRIC* countries• Learningwhenandhowpatenttermcanbepreserved/

extended in these countries in the absence of a formal patent extension mechanism

• Assessingwhenfilinginthesejurisdictionsmakesensefroma global patent life cycle management perspective

• Navigatingtheparametersofregulatorydataprotectionthroughout these countries

Brazil• Examiningasystemthatprovidesaseparatereviewprotocol

for pharmaceutical patents• LookingatBrazilianantitrustauthoritiesviewon“pay-for-

delay” and how it is influencing patent life cycle strategies

russia• Exploringuncertaintiesinanemergingpatentsystem

India• OverviewtheIndianpatentsystemanditsrecognition

of primary patents only

china• AnalysisofChina’spatentsystemanditstreatmentofU.S.

pharmaceutical patents in particular

* BRIC – Brazil, Russia, India, China

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

7:15 registration and continental Breakfast

8:15 co-chairs’ opening remarks

Chairmen:

George W. Johnston Vice President & Chief Patent CounselHoffmann-La Roche(Nutley, NJ)

Mark E. Waddell PartnerLoeb & Loeb LLP(New York, NY)

Chairman Emeritus:

John C. Vassil (Formerly Of Counsel to Morgan & Finnegan LLP)(New York)

8:30 understanding how the patent cliff Will re-define the endgame

George W. Johnston Vice President & Chief Patent CounselHoffmann-La Roche(Nutley, NJ)

Christopher A. Vellturo, Ph.D., President, Quantitative Economic Solutions, LLC(Cambridge, MA)

Mark E. Waddell PartnerLoeb & Loeb LLP(New York, NY)

• Definingthepatentcliff

• Howwillthepatentcliffimpactthefutureofthepharmaceuticalindustry?- brand-name and generic perspectives

• Understandinghowthepatentcliffcouldunravelthebalance of power established by Hatch-Waxman between brand names and generics

• Exploringmodesofinnovationthatwillmakeupforpatentcliff losses- drug delivery modalities- combination products combined drugs combined drug and device therapies

- the future of gene patenting other section 101 controversies

• Identifyingtheroleofbiosimilarsintheeraofthesmallmolecule patent cliff

9:30 uspto Keynote: the Impending reality of patent reform and Its potential Impact on pharmaceutical patents

Teresa Stanek Rea (Invited)Deputy Under Secretary of Commerce for Intellectual Property and Deputy Director United States Patent and Trademark Office(Alexandria, VA)

On March 8, 2011, the Senate by a 95-5 vote passed S. 23,i.e., The America Invents Act or Patent Reform Act of 2011. A little more than a month later, the House Judiciary Committee voted to approve its own version of the Patent Reform Act, i.e., H.R.1249.ItisanticipatedthatthisbillwillgotoafullHousevote sometime in mid-June. If passed, proceedings would begin to reconcile both the Senate and House versions of this legislation.

In light of these developments, Patent Reform is now an impending reality of which the biopharmaceutical industry must become well acquainted.

Teresa Stanek Rea will address the provisions of the proposed Patent Reform legislation and its implications for the pharmaceutical and biotechnology industries. Points of discussion will include:

• Firsttofilevs.firsttoinvent

• ProposedchangesinPTOpractice

• Falsemarking

• Thefutureofreexaminationpractice

• PostGrantReviewproceedings

• TheGoodlatteSupplementalProceedingAmendments

10:30 morning coffee Break

10:45 potential life cycle management controversies posed By the Implementation of the Biosimilars Act

Stephen R. Auten Vice President, IPSandoz, Inc.(Princeton, NJ)

David KornSenior Assistant General CounselPhRMA(Washington, DC)

Hans Sauer, Ph.D., J.D.Deputy General Counsel for Intellectual PropertyBiotechnology Industry Organization(Washington, DC)

Moderator:

Gregory J. Glover, MD, JDPrincipalPharmaceutical Law Group PC(Washington, DC)

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Main Conference – Day One Tuesday, October 4, 2011

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It has been more than a year since the enactment of the Biologics Price Competition and Innovation Act (BPCIA) which established a pathway for biologics to be approved as biosimilars undersection351kofthePublicHealthServiceAct.Althoughthe FDA still has not issued regulations which would allow the industry to make critical determinations in pursuing the development of these products, the statutory structure suggests several life cycle management issues that are likely to arise from FDA’s regulations and the implementation of BPCIA.

In this session, our panelists will explore the regulatory, patent, and exclusivity issues raised by BPCIA as well as the status and anticipated content of FDA rulemaking in this area. Points of discussion will include:

• FDAregulatoryissuesintheimplementationofBPCIA- highly similar- interchangeability- user fees for expedited review- FDA waiver analytical studies animal studies human clinical studies

- what can we glean from FDA’s individual meetings with would-bebiosimilarmanufacturers?

- regulatory lessons learned from Europe• Marketprotectionissuesraisedbythepatentexchange

procedures- benefits and risks of the patent exchange procedures disclosure of the biosimilars application question of what constitutes infringement º perspective of the reference product sponsor list exchanges conundrum

- weighing economic and cost considerations of the biosimilars pathway and the full BLA

• Thepotentialimpactandpracticalimplicationsoftheexclusivity provisions- 12-year exclusivity nature of the exclusivity criteria for eligibility importance of “sameness” definitions

- interchangeability exclusivity uncertain duration potential need for “at-risk” launch

- pediatric exclusivity- orphan drug exclusivity

11:45 patent term Adjustment and patent term extensions update: strategies and considerations for small and large molecules

Barton W. Giddings, Ph.D PartnerStoel Rives LLP(Salt Lake City, UT)

Mary C Till (Invited)Legal Advisor, Office of Patent Legal AdministrationUnited States Patent and Trademark Office(Alexandria, VA)• AssessingtheimpactofevolvingPTAandPTEprecedents

in pharmaceutical patent life cycle management strategies

ptA

• Re-examiningAandBoverlapsinapost-Wyeth world - equitable tolling Schering v. Kappos (D.C. Cir.)

• Post-Wyeth PTO procedures and calculations- PTO’s PTA computer program overhaul- proposed changes by the PTO to the PTA Rules- factoring-in BPAI appeals- holidays

• IdentifyingcircumstanceswhenfilingaDistrictCourtcomplaint before the DC Circuit is still your best option for PTA redress

pte

• ExaminingsubstantiveandproceduralPTEcontroversiesimpacting not only drugs but biological products as well

• The Medicines Company v. PTO (E.D. Va.)- denying PTE application filed on day 62- potential legislative solution to Medicines Company

dilemma under Patent Reform• Genetics & IVF Institute v. Kappos (E.D. Va.)

- interim PTE rejection• Schering Corp. v. Mylan Pharmaceuticals, Inc., (D.N.J. 2011)

- duty to disclose prior art

12:30 networking luncheon

1:45 exploring post-Issuance pto procedures in the era of the patent cliff: focus on reexam and reissue proceedings

Robert M. Gould, Ph.D.PartnerDuane Morris LLP (Chicago, IL)

Kevin W. McCabeDirectorSterne, Kessler, Goldstein & Fox P.L.L.C.(Washington, DC)

Len S. SmithPrincipal Intellectual Property CounselMedicis Pharmaceutical Corporation(Scottsdale, AZ)

Jean F. Vollano, Ph.D (Invited)Quality Assurance, Specialist United States Patent and Trademark Office (Alexandria, VA)

• Examiningtherecentupswinginreexamandreissueproceedings and what their implications are for patent life cycle strategies

• Understandinghowreexamproceedingsarebeingused by both patent challengers and patent holders - ex-parte and inter-partes proceedings- economics and efficiencies of reexam- what are the inherent risks for third party challengers- when does it make sense for a patent holder to file for

reexam?

7

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• Assessingthefuture of reexam proceedings in light of pending Patent Reform legislation

• Currentreexamproceedingvs.proposedpost-grantreviewunder Patent Reform

• Evaluatingtherisksandbenefitsofreissueproceedingsinpatent life cycle management

• ExploringthesignificanceofIn Re Tanaka on reissue filings in the pharmaceutical industry- addition of narrow claim- preservation of original claim

2:45 Afternoon refreshment Break

3:00 the combined Impact of prior Art obviousness and obvious-type double patenting on pharmaceutical patent life cycle strategies

Margaret “Peg” M. BuckHead of Section, US Legal Affairs & PatentsLundbeck Research USA, Inc.(Paramus, NJ)

Thomas J. Kowalski Shareholder Vedder Price P.C.(New York, NY)

Steven J. Lee PartnerKenyon & Kenyon(New York)

Brian P. MurphyPartnerEdwards Angell Palmer and Dodge LLP(New York, NY)

Brian V. SlaterPartnerFitzpatrick, Cella, Harper & Scinto(New York, NY)

• Comparingobviousnessbasedonpriorarttoobvious-typedouble patenting and understanding their collective impact on pharmaceutical patent and portfolio strategies

prior Art obviousness

• Priorartobviousnessrevisited:lessonslearnedfromKSR and its progeny and In Re Kubin relative to life cycle and portfolio strategies for large and small molecules

• ReaffirmationofKSR through In Re Kao (Fed. Cir. 2011)• UnderstandingtheimpactofKSR and its progeny on

primary compound and composition claims vis-à-vis generic challenge- impact on secondary patents enantiomers isomers new formulations new indications crystallizations salts

• Anticipatedobviousnesschallengestoproteinsandbiosimilars• ExaminingtheUSPTO2010Revisionstoitsobviousness

guidelines

obviousness-type double patenting

• Analyzingtheevolvingstateofthelawonobviousness-typedouble patenting

• Sun Pharm. Indus. v. Eli Lilly & Co.,No.2010-1105(Fed.Cir. 2010): how denial of both en banc review and certiorari by the Supreme Court has resulted in a culmination of a new double patenting standard- deciphering the Federal Circuit’s rationale regarding

an extension of a prior art analysis to a double patenting controversy

- exploring why the Federal Circuit strayed from prior Federal Circuit precedent holding that double-patenting is based upon that which is already claimed

- understanding the importance of the dissent in this opinion examining the heretofore used “obvious variant” standard

• Boehringer Ingleheim Int’l, et al. v. Barr Labs, Inc., et al., 592 F.3d 1340 (Fed. Cir. 2010) - exploring the respective roles of patent term extensions and

terminal disclaimers in the double patenting controversy• Brand-nameandgenericstrategiesfornavigatingthenew

double patenting landscape- examining the link between double patenting and

inequitable conduct• UnderstandingtheimpactoftheSun and Boehringer cases

on pharmaceutical patent life cycle strategies

4:15 personalized medicine and patent life cycle considerations Vis-à-Vis sections 101, 112, and Allowable research exceptions

Patricia CarsonPartnerKaye Scholer LLP(New York, NY)

Michael A. Davitz PartnerAxinn, Veltrop & Harkrider LLP(New York, NY)

Denise L. Loring PartnerRopes & Gray LLP(New York, NY)

• Patentcontroversiesrelativetoresearchongeneticmaterial- Section 101 Patentability exploring the patentability of genes and related

diagnosticclaimspatentable–shouldtheybepatentable? patent drafting and claiming strategy to protect the

genetic and diagnostic inventions.• ExaminingSection112writtendescriptionandenablement

vis-à-vis personalized medicine - recap of Ariad v. Lilly and its current application by the

Federal Circuit to Centocor Ortho Biotech Inc. v. Abbott Laboratories

- reaffirming the distinction between written description and enablement

- reviewing specification requirements understandability inventorship

8

Main Conference – Day One (cont’d) Tuesday, October 4, 2011

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- examining Abbott’s impact on future written description challenges regarding antibodies and other biological products anticipating written description challenges relative

to biosimilars- what level of description is required to satisfy the Patent

Office to meet the written description and enablement requirements?

- how much information is sufficient for diagnostic claims to an expert in the field, i.e., one skilled in the art

- revisiting the role of written description in patent life cycle strategies for the biopharmaceutical industry

- assessing how written description will be used as a means of invalidity challenges in light of this jurisprudence

• ScopeofpatentInfringementexceptionunder§271(e)(1)as it applies to genetic research and development

5:15 cAfc and supreme court Watch: three cases that may have radical Impact on pharmaceutical patent life cycle strategies

John M. (Jack) Griem, Jr.PartnerLoeb & Loeb LLP(New York, NY)

Edward T. LentzPatent Attorney(New Lisbon, NY)

Rashad L. MorganPatent AttorneyBrinks Hofer Gilson & Lione(Research Triangle Park, NC)

Colleen TracyPartnerFitzpatrick, Cella, Harper & Scinto(New York, NY)

There are currently three matters before the Federal Circuit and U.S. Supreme Court that may greatly impact patent life cycle strategies in the biopharmaceutical industry. These matters go to the very heart of patent validity, the subject matter of that which is patentable, and the ethical considerations affecting the manner in which patents are obtained. Our panel will address the legal and strategic implications raised by these matters as they discuss:

• Microsoft Corporation v. i4i Limited Partnership (Supreme Court ___)

• Association for Molecular Pathology v. Myriad (Fed. Cir. __)• Therasense, Inc. v. Becton, Dickinson and Co. (Fed. Cir. ___)

6:15 conference Adjourns to day two

cocktail reception hosted by

9

7:15 continental Breakfast

8:15 co-chairs’ opening remarks and recap of day one

8:30 ftc Keynote: Analysis of competitive Behaviors in pharmaceutical patent life-cycle management strategies

Suzanne MunckCounsel for Intellectual PropertyFederal Trade Commission (Washington DC)

The FTC continues to vigorously use its enforcement and policy tools to prevent anticompetitive business practices in the pharmaceutical industry. The Commission remains steadfast in its position that certain industry behaviors concerning patent settlements are anticompetitive. In this session, Suzanne Munck will discuss the FTC’s position in these matters, including:

• TheFTC’scurrentstanceon“pay-for-delay”settlements- enforcement of MMA reporting requirements- FTC and DOJ alignment on “pay-for-delay”- status of pending legislation regarding settlements

• Analysisofthecompetitiveimplicationsofotherpharmaceutical life cycle management strategies

• FTCReportontheIPMarketPlace

• TheFTC’sReportonFollow-OnBiologicDrugCompetition

9:15 morning coffee Break

9:30 rems studies and generic entry: exploring the latest regulatory conundrum Affecting pharmaceutical patent life cycle strategies

Guy DonatielloVice President, Intellectual PropertyEndo Pharmaceuticals(Chadds Ford, PA )

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

• UnderstandinghowREMS(RiskEvaluationand Mitigation Strategies) studies are impacting the generic entry of certain drugs- cost of REMS study- obligation of generic to continue or mimic REMS study

• TheFDAprohibitionagainstusingREMSasablockingstrategy: fact vs. reality

• ExploringthepatentabilityofaREMSstudy- the incorporation of certain REMS elements in Orange

Book listings

• Exploringthepotentialuseofa505(b)(2)application as a design around REMS obligations by the generic

• NovelquestionsofsamplerequestunderandANDA as posed by Thalidomide

Main Conference – Day TwoWednesday, October 5, 2011

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• Examininginducementchallengestomethodsofuseclaimslisted in the Orange Book

• Defininginducementofinfringementanddividedinfringement under current law- how the Supreme Court’s ruling in Global Tech v. SEB

has altered the standard for inducement findings mens rea requirements º willful blindness vs. deliberate indifference indirect vs. direct infringement

- the concept of divided and joint infringement vis-à-vis Akamai Technologies, Inc. v. Limelight Networks, Inc., (Fed. Cir. 2011)

• Exploringtherelationshipbetweeninducementactionsanddivided infringement and how they apply to methods of use claims in pharmaceutical patents

• AstraZeneca LP v. Apotex, Inc.: the role of Section viii carve-outs and the inducement controversy- Orange Book listed methods of use patents vs. that which

is actually listed in the label- Indentifying the indirect infringer in these circumstances- how might a similar rationale be used in a matter of

dividedinfringement?

12:30 networking luncheon

1:45 exclusivities and forfeitures: new developments, controversies and concerns

Allen R. BaumShareholder and Chair, Chemical Practice GroupBrinks Hofer Gilson & Lione(Research Triangle Park, NC)

Thomas D. HoffmanConsultant – Patent Counsel Sandoz,Inc.(East Hanover, NJ )

Brian J. MalkinPartner Frommer Lawrence & Haug LLP(New York, NY)

Shashank UpadhyeVice President – Global Intellectual PropertyApotex, Inc.(Toronto, ON)• Forfeitureprovisions:circumstancesunderwhichexclusivity

is forfeited- identifying circumstances under which forfeiture of

another’sexclusivitymayoccur?• DecipheringtheFDA’sstanceonpreandpost–MMA

180-day exclusivity• Interpretingthe“earlierof”,laterof”languageinmaking

a forfeiture determination• Evaluatingthestrengthof“thefailuretomarket”provision

post-Lipitor• Exploringsimultaneousqualificationforandforfeiture

of exclusivity for failure to obtain tentative approval• Evaluatingtheimpactof“delisting”onforfeiture• Forfeiturerelativetopatentexpiration• Whencanthe180-dayexclusivityperiodbetransferred

toanotherANDAapplicant?

New Orange Book Strategies and Controversies

10:15 part A: carve-outs, skinny labeling and use codes: understanding their role in orange Book listing strategies and life cycle management

Nicolas G. BarzoukasPartnerWeil, Gotshal & Manges LLP(Huston, TX)

Bruce A. PokrasSenior Corporate Counsel, Intellectual PropertyPfizer Inc.(Madison, NJ)

Richard T. Ruzich PartnerDuane Morris LLP(Chicago, IL)

• Exploringtherelationshipbetweenadrug’slabel,patentsand Orange Book listings

• DefiningSectionviiicarve–outsandunderstandingtheirsignificance to Orange Book listings- skinny labeling off-label uses

• Therapeuticequivalenceevaluationcodes- the role of AB ratings and OB use codes in the Orange

Book and how they impact pharmaceutical patent life cycle strategies

• Examiningdelistingstrategiesbasedonusecodesandlabeling controversies vis-à-vis Novo Nordisk A/S v. Caraco Pharmaceutical Laboratories, Ltd. (Fed. Cir. 2010)- whencanusecodesbealtered?- will seeking permission from the FDA to carve-out patent

protectedlanguageallowforgenericentry?- significance of Solicitor General’s filing of an invitation

brief in this matter

11:15 part B: Inducement Actions and divided Infringement: how method of use claims controversies Are Influencing orange Book listings

Aaron F. Barkoff, Ph.D.PartnerMcAndrews, Held & Malloy, Ltd.(Chicago, IL)

Michael P. Dougherty Special CounselCadwalader, Wickersham & Taft LLP(New York)

Ted J. Ebersole, Ph.D.Assistant General Patent CounselEli Lilly and Company(Indianapolis, IN)

Nicholas Groombridge Partner and Co-Chair, Patent LitigationWeil, Gotshal & Manges LLP(New York, NY)

10

Main Conference – Day Two (cont’d)Wednesday, October 5, 2011

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© American Conference Institute, 2011

• Evaluatingwhenthe180-dayexclusivityperiodcan be relinquished, and exploring the consequences

• Whencanabrand“park”ageneric’sexclusivity?• Defining“sharedexclusivity”• Howhaveauthorizedgenericschangedtheplayingfield

relativeto180-dayexclusivity?• Exploringregulatorybarstoexclusivity

- GMP violations- SEC

• Revisitingtherelationshipbetweenexclusivity,forfeitureand the 30 month stay- circumstances under which a second stay may be granted

impact on grant of exclusivity

3:00 Afternoon refreshment Break

3:15 fdA Keynote: update on fdA Activities Impacting pharmaceutical patent life cycles for small and large molecules

Elizabeth Dickinson (Invited)Associate Chief Counsel, Office of the Chief CounselU.S. Food and Drug Administration(Rockville, MD)The FDA’s jurisdiction over the Orange Book and listed patents; its decision-making powers concerning the consequences of de-listing patent; and its recent determinations regarding forfeitures are indicative of the agency’s critical role in the patent endgame. The discretionary Rule Making authority allowed to the agency over follow-on biologics under BPCIA further enhances this role. This session will cover the present state of the FDA’s authority in Orange Book listings, forfeiture decisions and other Hatch-Waxman and biosimilar-related matters.

4:15 safe harbor or stormy port?: calming the legal tempest left by Proveris

Brian D. CoggioSenior PrincipalFish & Richardson, P.C.(New York)• AnalyzingthepivotalrolethattheHatch-Waxmansafeharbor

plays in patent portfolio management and life cycle management • Overviewofthesafeharborexemptiontopatentinfringement• Identifying“researchtools”underProveris?

− ifapatentcanbeextendedunder§156,doesProveris stillapply?

− does Proveris control “compounds” used as research tools (e.g.,comparators)?

• Underwhichcircumstancesdoesthesafeharborprotectgeneralscreening(highthrough-putscreening)?− if not, where is the dividing line between unprotected

screeningandprotectedresearch?− what is a “reasonable basis for believing” a compound

or compounds “may work” for their intended purposes under Merck v. Integra

− whenispost-approvaltestingprotectedunderthesafeharbor?− can aspects of the research be “farmed-out” and still

beprotected?− specialconsiderationsforantibodiesvis-à-visthesafeharbor?− exploringtheapplicabilityofthesafeharborinITCactions?

5:00 conference ends

11

Continuing Legal Education Credits

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 Boardintheamountof15.0hours.Anadditional4.0credithourswill apply to workshop A/B participation.

AcI certifies that this activity has been approved for CLE credit by the StateBarofCaliforniaintheamountof12.75hours.Anadditional3.5credithourswillapplytoworkshopA/Bparticipation.

You are required to bring your state bar number to complete the appropriate state forms during the conference. CLE credits are processedin4-8weeksafteraconferenceisheld.

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.

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CLE Credits

Withmorethan500conferencesintheUnitedStates,Europe,AsiaPacific, 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.

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Who You Will Meet:

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• Brandnamepharmaceuticalcompanies

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Maximizing Pharmaceutical Patent Life CyclesThe definitive Hatch-Waxman and BPCIA event for brand names and generics

October 4 – 5, 2011 | New York Marriott Downtown | New York

12th Annual

HATCH-WAXMANs e r i e s

ACI’s

SPECIAL DISCOUNT

october 3, 2011: Interactive pre-conference training and strategy sessions

A. PTA- PTE Boot Camp: Basic Training in the Essentials of Patent Term Adjustment and Patent Term Restoration for Patent Lawyers Serving the Biopharmaceutical Industry

B. Working Group on Global Pharmaceutical Patent Life Cycle Management Strategies for Established and Emerging Markets: A Practical, Hands-On Guide To Patent Extensions and Exclusivities Available to Pharmaceutical Products Around the World

a.seymour
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On behalf of Brinks Hofer Gilson & Lione, you will receive $300 off registration for this event. Please mention "BRINKS-300" at the time of registration to utilize this discount.