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  • 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

    ACIs

    Industry InsIghts from:

    and ACIs 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--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:

  • 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)

    MargaretPegM.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)

    2

    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)

    AcIs hatch-Waxman series Advisory Board chairman emeritus:

    Media Partners:

  • 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 Institutes (AcIs) maximizing pharmaceutical patent life cycles conference is the pharmaceutical industrys 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 anyones 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 years 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.

    Withallthatsatstake,youcannotaffordtomissthisconference.

    Dont 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

  • 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 companys 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 PTOs 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?

    - understandingthePTOs1444clock 14months:firstactionresponsetime 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- 37CFR1.7101.791

    Identifyingimportantbenchmarksinadrugsdevelopmentand 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

    4

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

    2:00PM5:30PM(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 ECs DG Competitions 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)?

    TheOrphanDrugsRegulationobtainingorphanmarketexclusivity

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

    EmergingMarketsBRIC* 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 LookingatBrazilianantitrustauthoritiesviewonpay-for-

    delay and how it is influencing patent life cycle strategies

    russia Exploringuncertaintiesinanemergingpatentsystem

    India OverviewtheIndianpatentsystemanditsrecognition

    of primary patents only

    china AnalysisofChinaspatentsystemanditstreatmentofU.S.

    pharmaceutical patents in particular

    * BRIC Brazil, Russia, India, China

    5

  • 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)

    6

    Main Conference Day One Tuesday, October 4, 2011

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

    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 FDAs 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 FDAs 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 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- PTOs 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

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

    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--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 Circuits 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 Intl, 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--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

    diagnosticclaimspatentableshouldtheybepatentable? patent drafting and claiming strategy to protect the

    genetic and diagnostic inventions. ExaminingSection112writtendescriptionandenablement

    vis--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 (contd) Tuesday, October 4, 2011

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

    - examining Abbotts 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

    ScopeofpatentInfringementexceptionunder271(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 FTCs position in these matters, including:

    TheFTCscurrentstanceonpay-for-delaysettlements- 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

    TheFTCsReportonFollow-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

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

    Examininginducementchallengestomethodsofuseclaimslisted in the Orange Book

    Defininginducementofinfringementanddividedinfringement under current law- how the Supreme Courts ruling in Global Tech v. SEB

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

    - the concept of divided and joint infringement vis--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

    anothersexclusivitymayoccur? DecipheringtheFDAsstanceonpreandpostMMA

    180-day exclusivity Interpretingtheearlierof,lateroflanguageinmaking

    a forfeiture determination Evaluatingthestrengthofthefailuretomarketprovision

    post-Lipitor Exploringsimultaneousqualificationforandforfeiture

    of exclusivity for failure to obtain tentative approval Evaluatingtheimpactofdelistingonforfeiture 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)

    Exploringtherelationshipbetweenadrugslabel,patentsand Orange Book listings

    DefiningSectionviiicarveoutsandunderstandingtheirsignificance 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--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 Generals 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 (contd)Wednesday, October 5, 2011

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

    American Conference Institute, 2011

    Evaluatingwhenthe180-dayexclusivityperiodcan be relinquished, and exploring the consequences

    Whencanabrandparkagenericsexclusivity? Definingsharedexclusivity 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 FDAs 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 agencys 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 FDAs 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 IdentifyingresearchtoolsunderProveris?

    ifapatentcanbeextendedunder156,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--visthesafeharbor? exploringtheapplicabilityofthesafeharborinITCactions?

    5:00 conference ends

    11

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    CLE Credits

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  • R E g i s t R a t i o n f o R m Registration feeThe fee includes the conference all program materials continental breakfasts lunches and refreshments.

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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

    ACIs

    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.seymourText BoxOn 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.