aci maximizing pharmaceutical patent life cycles 2011 nyc

8/6/2019 ACI Maximizing Pharmaceutical Patent Life Cycles 2011 NYC

1/12

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

Earn

CLECredit

Maximizing

Pharmaceutical

Patent Life CyclesTe defnitive Hach-Waxman and BPCIA even for brand names and genericsOcober 4 5, 2011 | New York Marriot Downown | New York

12th

Annual

HATCH-WAXMANs e r i e s

ACIs

Industry InsIghts rom:

and ACIs Hatch-Waxman Series Advisory Board See P.2

Key AgencIes spotlIght

Hear rom the: ui sa pa a taak o :

pa r Teresa Stanek Rea(Invited)

Deputy Under Secretary o Commerce orIntellectual Property and Deputy Director, USPTO

ptA a pte Aai Mary C Till(Invited), Legal Advisor

Ofce o Patent Legal Administration, USPTO

rxa a riJean F. Vollano, Ph.D (Invited)Quality Assurance Specialist, USPTO

FederalTradeCommissionon:|ciiv Bavi Iaipaaia pa li c maa

Suzanne Munck, Counsel or Intellectual PropertyOfce o Policy and Planning, FTC

U.S.FoodandDrugAdministrationon:dA Aivii Ai paaia pali c sa a la m

Elizabeth Dickinson (Invited), Associate ChieCounsel, Ofce o the Chie Counsel, FDA

Homann-LaRoche

Apotex, Inc.

BIO

Eli Lilly & Company

Endo Pharmaceuticals

Lundbeck ResearchUSA, Inc.

Medicis PharmaceuticalCorporationMerck & Company

Pzer, Inc.PhRMARoche Diagnostics IndiaPvt Ltd.Sandoz, Inc.

Preeminent patent counsel and advisors to leading brand name and genericpharmaceutical companies, as well as representatives rom key government agenciesand industry associations will provide insights on the latest challenges aectingpharmaceutical patent lie cycles or small and large molecules and help you:

understAnd how the a iwill impact ivai and r&d

prepAre or the release o anticipated dA ai on biiiaand comprehend how iai BpcIAwill aectaaia a i aa ai

Assess how the combined evolution oi a bvi and bvi-b ai is infuencing the uture oa a

eVAluAte patent lie cycle strategies relative to aiz ii vi--vii 101 patentability and i 112 written description requirements

AnAlyZe the signicance oMicrosot,Myriadand Therasenseon patent liecycle strategies or a and a

eXAmIne the impact orems studies on i

decIpherthe relationship between vi and i/ivi ii actions relative to oa Bk ii

eXplorei rulings -Lipitor

nAVIgAte newa ab dilemmas or both a i and a patents

ob 3, 2011: Iaiv p-c taii a sa si

A.ptA- pte B ca: Bai taii i eia pa tAj a pa t rai pa law svi Biaaia I

B.Wki g gba paaia pa li cmaa sai eabi a ei mak:

A paia, ha-o gi t pa exi a exiviiAvaiab paaia p A W

si s: s b:Aias:

ckai rih b:


2/12Register now: 888-224-2480 Fax: 877-927-1563 AmericanConference.com/LifeCycles

sak:

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

AaronF.Barkoff,Ph.D.

PartnerMcAndrews, Held & Malloy, Ltd.(Chicago, IL)

NicolasG.BarzoukasPartner

Weil, Gotshal & Manges LLP(Huston, TX)

AllenR.BaumShareholder and Chair, ChemicalPractice GroupBrinks Hoer Gilson & Lione(Research Triangle Park, NC)

ScottBeeser,Ph.D.LLBPatent Attorney Biopharmaceuticals

Apotex Inc. (Toronto, ON)

MargaretPegM.BuckHead o Section,US Legal Aairs & PatentsLundbeck Research USA, Inc.(Paramus, NJ)

paiia caPartnerKaye Scholer LLP (New York, NY)

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

MichaelA.DavitzPartner

Axinn, Veltrop & Harkrider LLP(New York, NY)

eizab diki (Invited)Associate Chie Counsel, Oceo the Chie CounselU.S. Food and Drug Administration(Rockville, MD)

g daiVice President, Intellectual PropertyEndo Pharmaceuticals(Chadds Ford, PA )

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

TedJ.Ebersole,Ph.D.Assistant General Patent Counsel

Eli 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.Partner

Duane Morris LLP (Chicago, IL)

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

nia gbiPartner and Co-Chair Patent Litigation

Weil, Gotshal & Manges LLP(New York, NY)

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

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

gabi KiaAssistant General CounselPzer Inc. (New York, NY)

davi KSenior Assistant General CounselPhRMA (Washington, DC)

ThomasJ.KowalskiShareholderVedder 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.MalkinPartnerFrommer Lawrence & Haug LLP(New York, NY)

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

RashadL.MorganPatent AttorneyBrinks Hoer Gilson & Lione

(Research Triangle Park, NC)sza mkCounsel or Intellectual PropertyOce o Policy and PlanningFederal Trade Commission(Washington DC)

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

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

B oi

PartnerHogan Lovells (Amsterdam, NE)

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

BruceA.PokrasSenior Corporate Counsel, IntellectualPropertyPzer Inc. (Madison, NJ)

RichardT.RuzichPartnerDuane Morris LLP (Chicago, IL)

ta sak ra (Ivi)Deputy Under Secretary o Commeror Intellectual Property and Deputy

DirectorUnited States Patent andTrademark Oce (Alexandria, VA)

HansSauer,Ph.D.,J.D.Deputy General Counsel orIntellectual PropertyBiotechnology Industry Organizatio(Washington, DC)

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

LenS.SmithPrincipal Intellectual Property CounseMedicis Pharmaceutical Corporation

(Scottsdale, AZ)sja sbaaiaHead o LegalRoche Diagnostics India Pvt Ltd.(Mumbai, India)

ma c ti (Invited)Legal Advisor, Oce o Patent Legal

AdministrationUnited States Patent and TrademarkOce (Alexandria, VA)

c taPartnerFitzpatrick, Cella, Harper & Scinto(New York, NY)

saak ua

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

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

JeanF.Vollano,Ph.D (Invited)Quality Assurance SpecialistUnited States Patent and TrademarkOce (Alexandria, VA)

2

Advisory Board & Faculty List

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

MatthewP.BlischakVice President, Intellectual Property& Associate General Counsel

Sunovion Pharmaceuticals Inc.(Marlborough, MA)

g daiVice President, Intellectual PropertyEndo Pharmaceuticals(Chadds Ford, PA )

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

GeorgeW.JohnstonVice President & Chie PatentCounsel

Homann-La Roche(Nutley, NJ)

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

m swVP, Intellectual PropertyImpax Laboratories(Hayward, CA)

saak uaVice President Global Intellectual Property

Apotex, Inc.(Toronto, ON)

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

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

cai:

GeorgeW.Johnston

Vice President & Chie Patent CounHomann-La Roche(Nutley, NJ)

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

AcI ha-Waxa si Avi Ba caia ei:

Media Partners:


3/12

u a a aaia avivaluesinexcessof$130billionannuallywilloccurby2016.*

A awa biiia a b a, b aai ai av tobepromulgated.

nw i i ba a a i aaia ai iktherulesofthepatentendgame.

g iai a avia ha-Waxa a iandthepatentchallengesprecipitatedbyBPCIA.Attendtheoneeventwhich a ai i a ai ii a ai bbrandnamesandgenerics.

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

Aia c Ii (AcI) maxiizi paaiapa li c conerence is the pharmaceutical industrys leadingsource or inormation and analysis on patent lie cycle managementor both small and now, large molecule pharmaceutical products. It isthe orum where lawyers, executives and policy makers or brand nameand generic manuacturers gather each year to prepare or the lie cycle

challenges they currently ace as well as those which they anticipate.

nw Ip a i ai wi vvi awa ai av a w a i a

forbrandnamesandgenerics.

The pharmaceutical industry now stands on the edge o the patentcli. By 2016, patents on myriad block buster pharmaceuticalproducts or treating ailments and conditions ranging rom asthmato high cholesterol to psychosis and beyond will go o patent. Thispatent decline does not only pose problems or brand name drugmanuacturers, but also proves troubling or generics; the ultimateHatch-Waxman prize o 180-day exclusivity may be short-lived inthe uture as there will be ew patented drug products worth coveting.Moreover, as the industry awaits FDA guidance on biosimilars, it

remains anyones guess as to what eect, i any these new medicinalentities and therapies will have on the patent endgame.

pa aaia i challengeshead-on.

This 12 AcI maxiizi paaia pali c will bring you the thoughtul and targeted commentaryand in-depth analysis that you have come to expect rom thisindustry-leading event. This years conerence eatures:

PresentationsfromkeyrepresentativesfromtheUSPTO(invited), FTC, and FDA (invited). They will provide youwith direct insights and the logic o these agencies on someo most pressing lie cycle management challenges that theindustry is acing today, including the latest on:- Patent reorm; PTE and PTA determinations; and reissue

and reexam proceedings- Pay-or-delay and the ndings o the FTC Report on the

IP Market Place- Foreiture determinations

Anupdateonbiosimilarsandthefurtherdevelopmentofthese second generation biological products will infuencepharmaceutical patent lie cycle and portolio strategies in viewo the urther implementation o BPCIA and the inevitabilityo the patent cli

In-depthdiscussionsonkeyregulatorydevelopmentsimpacting lie cycle management including

- REMS studies

- Use codes, skinny labeling, and carve outs, and theirrelationship to divided inringement and inducement theories

- Regulatory bars to exclusivity Analysesofrecentcriticalcasesaffectingpatentlifecycle

planning including: Sun Pharma (double patenting);Microsoft(standard o invalidity);Ariad(patentability); Therasense(inequitable conduct) and strategies or using these casesto your advantage

B i- a aia aii a ai a wi a ia a i

aaia a i management.

In response to your requests, we have added the ollowingpre-conerence training and strategy sessions:

ptA- pte B ca: Bai taii i eia

pa t Aj a pa t rai pa law svi Biaaia Iwilloer critical instruction on the undamentals and mechanicso PTA and PTE practice which help to ensure patent andprot longevity; and

Wki g gba paaia pa li cmaa sai eabi a ei mak:

A paia, ha-o gi t pa exi aexivii Avaiab paaia p A

W will oer in-depth and pragmatic advice or navigatingpatent systems in Europe and emerging BRIC markets

na 3,000 aaia a ia b ba

a a i av a i i iai a i i i aafornearlythelasttwelveyears.This updated event will bring youthe latest legal strategies and tactics or successul maneuvering inthe evolving patent endgame.

Withallthatsatstake,youcannotaffordtomissthisconference.

Dont delay register now by calling 888-224-2480, axing youregistration orm to 877-927-1563 or registering on-line awww.americanconference/LifeCycles .

* Wall Street Journal, February 15, 2011



A9:00 AM 12:30 PM (Registration begins at 8:15 AM)

ptA- pte B ca: Bai taii i eia pa t Aj a pat rai pa law svi Biaaia I

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

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

Richard S. ParrAssistant CounselMerck & Co., Inc.(Rahway, NJ)

Patent Term Adjustment (PTA) and Patent Term Extensions

(PTE) are essential to patent lie cycle longevity especiallyin the pharmaceutical and biotechnology industries.Biopharmaceutical companies invest numerous resources intopreserving the patent lie and the subsequent prots o products which take years to produce. Each day o patent lie equalsmillions o dollars in prots. A loss o even one day can havesubstantial impact on a companys prot margin.

Recent court decisions and the introduction o an abbreviatedpathway or ollow-on biological products have made knowingthe ins and outs o PTE and PTA a critical competency orevery patent practitioner servicing the pharmaceutical andbiotechnology industries.

This intensive hal-day workshop will help you master theskills you need to ace your greatest PTA and PTE challenges

head on. A aculty o PTA and PTE experts will oer practicalsolutions and in-depth instruction or everything romeligibility requirements to calculations to the application andreconsideration processes. They will also discuss to the interplayo these mechanisms. Points o discussion will include:

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

UnderstandingtheuniqueroleofPTAandPTAinthelongevity o patent lie cycles in the lie sciences industries

PTAvs.PTE- seeking redress or PTO delays

- seeking redress or FDA delays Whichpointofpatentlifedoeseachofthesedevicesextend?

- ull scope o patent vs. ull scope o patent lie o patentproduct

ptA

Reviewof35U.SC.154(b)and37C.F.R.1.702-1.705

ComprehendingthecriteriaforPTAeligibility

ReconcilingdiscrepanciesincertainPTAandPTORules

SeekingPTA- starting point and the Notice o Allowance- addressing dispute with PTOs initial PTA calculation

request or Reconsideration /Application or Corre- when can PTA be corrected ater the issuance o the p

PTOdelaysv.applicantdelays

A-Delays:whataretheyandwhenaretheygranted?- understandingthePTOs1444clock 14months:rstactionresponsetime howtomeasuretheinitial14monthdelay 4months:response/appeal 4months:patentissuance

- identifyingthepointintimewhenAdelaysaccumul

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

C-Delays:howaretheydifferentforAandB-Delays- triggering events: intererences secrecy orders notices o appeal

- whenaretheygranted?

- howaretheycalculated? Identifyingeventswhichstopthe3yearB-Delayclockand their relation to C-Delays- other clock stoppers RCE- Request or Continued Examination

AnalyzingandsolvingAandBDelayoverlapdilemma- Wyeth v.Dudas- Japan Tobacco

pte

OverviewofPTE- 35USC156- 37CFR1.7101.791

Identifyingimportantbenchmarksinadrugsdevelopm

and patent timelines relative to seeking PTE- whatisthepatenttermrestoredandtowhatdoesita dening drug product under PTE provisions o

Hatch-Waxman Act salts esters enantiomers

- regulatory review period determinations testing phase review phase

UnderstandingwhyPTEprovisionsintheHatch-WaxmAct extend to products outside the scope o Hatch-Waxman, i.e., biologics and certain medical devices- the importance o PTE in the newly ratied ollow-o

biologic scenario

- exploring PTE applicability relative to: antibiotics animal drugs ood/color additives combination products

Reviewingeligibilityrequirements/prerequisitesforpatterm extension

Calculatingthepatenttermrestored- FDA/ PTO interplay

Criteriaandeligibilityforinterimextensions

ThePTEapplication- strategies or preparation and submission

Interactive Training and Strategy Session

Monday, October 3, 2011

4



2:00PM5:30PM(Registration begins at 1:15 PM)

B Wki g gba paaia pali c maa sai eabia ei mak: A paia, ha-o git pa exi a exivii Avaiab paaia p A W

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

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

Bert OostingPartnerHogan Lovells(Amsterdam, NE)

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

Wk objiv

Developingaglobalpharmaceuticalpatentlifecyclemanagement plan that responds to changes which impactintellectual property protection in established as well asemerging markets

Learningtoextendpharmaceuticalpatentlifeinforeignjurisdictions

Identifyingandseekingavailableinternationalpatentandnon-patent exclusivities

eabi mak

AssessingchangesinEuropeanpatentpracticeinlightofthe ndings o the ECs DG Competitions PharmaceuticalSector Inquiry

Whatbearinghavethesechangeshadonpatentlifecyclestrategies in Europe- extensions o patent term- regulatory exclusivities

pa exi i eu

SupplementaryProtectionCerticates(SPCs)extensiono patent lie in the EU

- scope o the protection-howdoyouapplyforit?- interaction between the Pharmaceutical Directive and

the SPC Regulation

MeetingtherequirementstoobtainanSPC- tips or maximizing the patent extension obtained under

an SPC or human medicinal products- weighing the pros and cons o seeking a pediatric extension- obtaining a zero term or SPC or quasi patent term extension- determining what extension term is best or your

product based on an assessment o the type o rightsyou will be granted

ContemplatingwhetherornotanewSPCcanbeobtaior new combinations, isomers, etc.

Identifyingwhat(ifany)alternativesexistforobtainingaSPC when seeking to extend the patent term on your pro

EvaluatingdifferingstandardsforobtaininganSPConcountry-by-country basis

ConsideringissuesuniquetoseekinganSPCwhenthe

original Marketing Authorisation (MA) was granted in country that is not part o the European Economic Are(EEA), i.e., Switzerland

Obtainingaspringboardinjunctionformarketinganddistribution ater patent expiry in case o oering andinclusion in pricelists beore patent expiry

ra exivii eu a ew

RegulatoryDataProtection

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

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

TheOrphanDrugsRegulationobtainingorphanmaexclusivity

exi ai x aaia a i

Japan

SouthKorea

Taiwan

Singapore

Israel

EmergingMarketsBRIC* Examiningthetreatmentofpharmaceuticalpatentsin

BRIC* countries

Learningwhenandhowpatenttermcanbepreserved/extended in these countries in the absence o a ormalpatent extension mechanism

Assessingwhenlinginthesejurisdictionsmakesensea global patent lie cycle management perspective

Navigatingtheparametersofregulatorydataprotectionthroughout these countries

Bazi

Examiningasystemthatprovidesaseparatereviewproor pharmaceutical patents

LookingatBrazilianantitrustauthoritiesviewonpay-delay and how it is infuencing patent lie cycle strateg

ria

Exploringuncertaintiesinanemergingpatentsystem

Iia

OverviewtheIndianpatentsystemanditsrecognitiono primary patents only

cia

AnalysisofChinaspatentsystemanditstreatmentofUpharmaceutical patents in particular

* BRIC Brazil, Russia, India, China



:15 riai a cia Baka

:15 c-cai oi rak

Chairmen:

George W. Johnston

Vice President & Chie Patent CounselHomann-La Roche(Nutley, NJ)

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

Chairman Emeritus:

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

:30 uai hw pa ci Wir-d ea

George W. JohnstonVice President & Chie Patent CounselHomann-La Roche(Nutley, NJ)

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

Mark E. WaddellPartner

Loeb & Loeb LLP(New York, NY)

Deningthepatentcliff

Howwillthepatentcliffimpactthefutureofthepharmaceuticalindustry?- brand-name and generic perspectives

Understandinghowthepatentcliffcouldunravelthebalance o power established by Hatch-Waxman betweenbrand names and generics

Exploringmodesofinnovationthatwillmakeupforpatentcli losses- drug delivery modalities

- combination products combined drugs combined drug and device therapies

- the uture o gene patenting other section 101 controversies

Identifyingtheroleofbiosimilarsintheeraofthesmallmolecule patent cli

9:30 uspto K: t Ii rai pa r a I pia Ia paaia pa

Teresa Stanek Rea (Invited)Deputy Under Secretary o Commerce or IntellectuaProperty and Deputy DirectorUnited States Patent and Trademark Oce(Alexandria, VA)

OnMarch8,2011, the Senate bya 95-5votepassedSi.e., The America Invents Act or Patent Reorm Act o 201little more than a month later, the House Judiciary Commvoted to approve its own version o the Patent Reorm ActH.R.1249.ItisanticipatedthatthisbillwillgotoafullHvote sometime in mid-June. I passed, proceedings wbegin to reconcile both the Senate and House versions olegislation.

In light o these developments, Patent Reorm is nowimpending reality o which the biopharmaceutical indmust become well acquainted.

Teresa Stanek Rea will address the provisions o the proposed PReorm legislation and its implications or the pharmaceuand biotechnology industries. Points o discussion will inclu

Firsttolevs.rsttoinvent

ProposedchangesinPTOpractice

Falsemarking

Thefutureofreexaminationpractice

PostGrantReviewproceedings

TheGoodlatteSupplementalProceedingAmendments

10:30 mi c Bak

10:45 pia li c maa cvip B Iai Biiia

Stephen R. AutenVice President, IPSandoz, Inc.(Princeton, NJ)

David KornSenior Assistant General CounselPhRMA(Washington, DC)

Hans Sauer, Ph.D., J.D.Deputy General Counsel or 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



It has been more than a year since the enactment o the BiologicsPrice Competition and Innovation Act (BPCIA) whichestablished a pathway or biologics to be approved as biosimilarsundersection351kofthePublicHealthServiceAct.Althoughthe FDA still has not issued regulations which would allowthe industry to make critical determinations in pursuing thedevelopment o these products, the statutory structure suggestsseveral lie cycle management issues that are likely to arise romFDAs regulations and the implementation o BPCIA.

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

FDAregulatoryissuesintheimplementationofBPCIA- highly similar- interchangeability- user ees or expedited review- FDA waiver analytical studies animal studies

human clinical studies- what can we glean rom FDAs individual meetings withwould-bebiosimilarmanufacturers?

- regulatory lessons learned rom Europe

Marketprotectionissuesraisedbythepatentexchangeprocedures- benets and risks o the patent exchange procedures disclosure o the biosimilars application question o what constitutes inringement

perspective o the reerence product sponsor list exchanges conundrum

- weighing economic and cost considerations o thebiosimilars pathway and the ull BLA

Thepotentialimpactandpracticalimplicationsoftheexclusivity provisions- 12-year exclusivity nature o the exclusivity criteria or eligibility importance o sameness denitions

- interchangeability exclusivity uncertain duration potential need or at-risk launch

- pediatric exclusivity- orphan drug exclusivity

1:45 pa t Aj a pa t

exi ua: sai a ciai sa a la m

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

Mary C Till (Invited)Legal Advisor, Oce o Patent Legal AdministrationUnited States Patent and Trademark Oce(Alexandria, VA)

AssessingtheimpactofevolvingPTAandPTEprecedentsin pharmaceutical patent lie 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- actoring-in BPAI appeals- holidays

IdentifyingcircumstanceswhenlingaDistrictCourtcomplaint beore the DC Circuit is still your best optioor PTA redress

pte

ExaminingsubstantiveandproceduralPTEcontroversiimpacting not only drugs but biological products as we

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

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

- interim PTE rejection

Schering Corp. v. Mylan Pharmaceuticals, Inc., (D.N.J. 2- duty to disclose prior art

12:30 nwki l

1:45 exi p-Ia pto p i ea pa ci: rxaa ri pi

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, SpecialistUnited States Patent and Trademark Oce(Alexandria, VA)

Examiningtherecentupswinginreexamandreissueproceedings and what their implications are or patent cycle strategies

Understandinghowreexamproceedingsarebeingusedby both patent challengers and patent holders- ex-parte and inter-partes proceedings- economics and eciencies o reexam- what are the inherent risks or third party challengers- when does it make sense or a patent holder to le oreexam?



Assessingtheuture o reexam proceedings in light opending Patent Reorm legislation

Currentreexamproceedingvs.proposedpost-grantreviewunder Patent Reorm

Evaluatingtherisksandbenetsofreissueproceedingsinpatent lie cycle management

ExploringthesignicanceofIn Re Tanaka on reissue lingsin the pharmaceutical industry- addition o narrow claim- preservation o original claim

:45 A r Bak

:00 t cbi Ia pi A obvia obvi-t db pai paaia pa li c sai

Margaret Peg M. BuckHead o Section, US Legal Aairs & PatentsLundbeck Research USA, Inc.

(Paramus, NJ)Thomas J. KowalskiShareholderVedder Price P.C.(New York, NY)

Steven J. LeePartnerKenyon & 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 impacton pharmaceutical patent and portolio strategies

pi A obvi

Priorartobviousnessrevisited:lessonslearnedfromKSRand its progeny and In Re Kubin relative to lie cycle andportolio strategies or large and small molecules

ReafrmationofKSRthrough In Re Kao (Fed. Cir. 2011) UnderstandingtheimpactofKSRand its progeny onprimary compound and composition claims vis--visgeneric challenge- impact on secondary patents enantiomers isomers new ormulations new indications crystallizations salts

Anticipatedobviousnesschallengestoproteinsandbiosimilars ExaminingtheUSPTO2010Revisionstoitsobviousness

guidelines

obvi-t db pai

Analyzingtheevolvingstateofthelawonobviousness-double patenting

Sun Pharm. Indus. v. Eli Lilly & Co. ,No.2010-1105(FCir. 2010): how denial o both en bancreview and certiby the Supreme Court has resulted in a culmination o new double patenting standard- deciphering the Federal Circuits rationale regarding

an extension o a prior art analysis to a double patentcontroversy

- exploring why the Federal Circuit strayed rom priorFederal Circuit precedent holding that double-patenis based upon that which is already claimed

- understanding the importance o the dissent in this op examining the heretoore used obvious variant stan

Boehringer Ingleheim Intl, et al. v. Barr Labs, Inc., et al., F.3d 1340(Fed. Cir. 2010)- exploring the respective roles o patent term extension

terminal disclaimers in the double patenting controver

Brand-nameandgenericstrategiesfornavigatingthen

double patenting landscape- examining the link between double patenting andinequitable conduct

UnderstandingtheimpactoftheSun and Boehringercaon pharmaceutical patent lie cycle strategies

4:15 paiz mii a pa li cciai Vi--Vi si 101, 112,a Awab ra exi

Patricia CarsonPartnerKaye Scholer LLP(New York, NY)

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

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

Patentcontroversiesrelativetoresearchongeneticmate- Section 101 Patentability exploring the patentability o genes and relateddiagnosticclaimspatentableshouldtheybepatent

patent drating and claiming strategy to protect thegenetic and diagnostic inventions.

ExaminingSection112writtendescriptionandenablevis--vis personalized medicine- recap oAriad v. Lillyand its current application by t

Federal Circuit to Centocor Ortho Biotech Inc. v. AbboLaboratories

- rearming the distinction between written descriptioand enablement

- reviewing specication requirements understandability inventorship

8

Main Conference Day One (contd)

Tuesday, October 4, 2011



- examiningAbbottsimpact on uture written descriptionchallenges regarding antibodies and other biological products anticipating written description challenges relative

to biosimilars- what level o description is required to satisy the Patent

Oce to meet the written description and enablementrequirements?

- how much inormation is sucient or diagnostic claimsto an expert in the eld, i.e., one skilled in the art

- revisiting the role o written description in patent liecycle strategies or the biopharmaceutical industry

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

ScopeofpatentInfringementexceptionunder271(e)(1)as it applies to genetic research and development

:15 cAc a s c Wa: t caa ma hav raia Ia paaiapa li c sai

John M. (Jack) Griem, Jr.PartnerMilbank, Tweed, Hadley & McCloy LLP(New York, NY)

Edward T. LentzPatent Attorney(New Lisbon, NY)

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

Colleen Tracy

PartnerFitzpatrick, Cella, Harper & Scinto(New York, NY)

There are currently three matters beore the Federal Circuit andU.S. Supreme Court that may greatly impact patent lie cyclestrategies in the biopharmaceutical industry. These matters goto the very heart o patent validity, the subject matter o thatwhich is patentable, and the ethical considerations aecting themanner in which patents are obtained. Our panel will addressthe legal and strategic implications raised by these matters asthey discuss:

Microsoft Corporation v. i4i Limited Partnership (SupremeCourt ___)

Association for Molecular Pathology v. Myriad(Fed. Cir. __)

Therasense, Inc. v. Becton, Dickinson and Co. (Fed. Cir. ___)

:15 c Aj da tw

ckai rih b

7:15 cia Baka

8:15 c-cai oi rak a ra da o

8:30 tc K: Aai ciiv Bavii paaia pa li-c maa

sai

Suzanne MunckCounsel or Intellectual PropertyFederal Trade Commission(Washington DC)

The FTC continues to vigorously use its enorcement policy tools to prevent anticompetitive business practices inpharmaceutical industry. The Commission remains steadaits position that certain industry behaviors concerning pasettlements are anticompetitive. In this session, Suzanne Muwill discuss the FTCs position in these matters, including:

TheFTCscurrentstanceonpay-for-delaysettlements

- enorcement o MMA reporting requirements- FTC and DOJ alignment on pay-or-delay- status o pending legislation regarding settlements

Analysisofthecompetitiveimplicationsofotherpharmaceutical lie cycle management strategies

FTCReportontheIPMarketPlace

TheFTCsReportonFollow-OnBiologicDrugCompetition

9:15 mi c Bak

9:30 rems si a gi e: exi

la ra c Aipaaia pa li c sai

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

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

UnderstandinghowREMS(RiskEvaluationandMitigation Strategies) studies are impacting the generic

entry o certain drugs- cost o REMS study- obligation o generic to continue or mimic REMS stu

TheFDAprohibitionagainstusingREMSasablockingstrategy: act vs. reality

ExploringthepatentabilityofaREMSstudy- the incorporation o certain REMS elements in Orang

Book listings

Exploringthepotentialuseofa505(b)(2)applicationas a design around REMS obligations by the generic

NovelquestionsofsamplerequestunderandANDAas posed by Thalidomide

Main Conference Day T wo

Wednesday, October 5, 2011



Examininginducementchallengestomethodsofusecllisted in the Orange Book

Deninginducementofinfringementanddividedinringement under current law- how the Supreme Courtsruling in Global Tech v. SEB

has altered the standard or inducement ndings mens rea requirements

willul blindness vs. deliberate indierence indirect vs. direct inringement

- the concept o divided and joint inringement vis--vAkamai Technologies, Inc. v. Limelight Networks, Inc.,(Fed. Cir. 2011)

Exploringtherelationshipbetweeninducementactiondivided inringement and how they apply to methods oclaims in pharmaceutical patents

AstraZeneca LP v. Apotex, Inc.: the role o Section viii caouts and the inducement controversy- Orange Book listed methods o use patents vs. that w

is actually listed in the label- Indentiying the indirect inringer in these circumsta- how might a similar rationale be used in a matter odividedinfringement?

12:30 nwki l

1:45 exivii a i: nw dvcvi a c

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

Thomas D. HomanConsultant Patent Counsel

Sandoz,Inc.(East Hanover, NJ )

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

Shashank UpadhyeVice President Global Intellectual PropertyApotex, Inc.(Toronto, ON)

Forfeitureprovisions:circumstancesunderwhichexcluis oreited- identiying circumstances under which oreiture o

anothersexclusivitymayoccur? DecipheringtheFDAsstanceonpreandpostMMA

180-day exclusivity Interpretingtheearlierof,lateroflanguageinmaki

a oreiture determination Evaluatingthestrengthofthefailuretomarketprovi

post-Lipitor Exploringsimultaneousqualicationforandforfeiture

o exclusivity or ailure to obtain tentative approval Evaluatingtheimpactofdelistingonforfeiture Forfeiturerelativetopatentexpiration Whencanthe180-dayexclusivityperiodbetransferredtoanotherANDAapplicant?

New Orange Book Strategiesand Controversies

10:15 pa A: cav-o, ski labi a uc: uai ti r i oa Bklii sai a li c maa

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

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

Richard T. RuzichPartnerDuane Morris LLP(Chicago, IL)

Exploringtherelationshipbetweenadrugslabel,patentsand Orange Book listings

DeningSectionviiicarveoutsandunderstandingtheirsignicance to Orange Book listings- skinny labeling o-label uses

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

Book and how they impact pharmaceutical patent liecycle strategies

Examiningdelistingstrategiesbasedonusecodesandlabeling controversies vis--vis Novo Nordisk A/S v. CaracoPharmaceutical Laboratories, Ltd. (Fed. Cir. 2010)- whencanusecodesbealtered?

- will seeking permission rom the FDA to carve-out patentprotectedlanguageallowforgenericentry?- signicance o Solicitor Generals ling o an invitation

brie in this matter

11:15 pa B: I Ai a diviIi: hw m u caicvi A Ifi oa Bk lii

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

Michael P. DoughertySpecial CounselCadwalader, Wickersham & Tat LLP(New York)

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

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

10

Main Conference Day Two (contd)

Wednesday, October 5, 2011



American Conference Institute,

Evaluatingwhenthe180-dayexclusivityperiodcanbe relinquished, and exploring the consequences

Whencanabrandparkagenericsexclusivity? Deningsharedexclusivity Howhaveauthorizedgenericschangedtheplayingeldrelativeto180-dayexclusivity?

Exploringregulatorybarstoexclusivity

- GMP violations- SEC

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

impact on grant o exclusivity

3:00 A r Bak

3:15 dA K: ua dA AiviiIai paaia pa li c sa a la m

Elizabeth Dickinson (Invited)

Associate Chie Counsel, Oce o the Chie 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 ode-listing patent; and its recent determinations regardingoreitures are indicative o the agencys critical role in the patentendgame. The discretionary Rule Making authority allowedto the agency over ollow-on biologics under BPCIA urtherenhances this role. This session will cover the present state o theFDAs authority in Orange Book listings, oreiture decisionsand other Hatch-Waxman and biosimilar-related matters.

4:15 sa hab s p?: cai la

t l bProverisBrian D. CoggioSenior PrincipalFish & Richardson, P.C.(New York)

AnalyzingthepivotalrolethattheHatch-Waxmansafeharborplays in patent portolio management and lie cycle management

Overviewofthesafeharborexemptiontopatentinfringement IdentifyingresearchtoolsunderProveris? ifapatentcanbeextendedunder156,doesProverisstillapply?

does Proveriscontrol compounds used as research tools(e.g.,comparators)?

Underwhichcircumstancesdoesthesafeharborprotectgeneralscreening(highthrough-putscreening)? i not, where is the dividing line between unprotectedscreeningandprotectedresearch?

what is a reasonable basis or believing a compoundor compounds may work or their intended purposesunderMerck v. Integra

whenispost-approvaltestingprotectedunderthesafeharbor? can aspects o the research be armed-out and stillbeprotected?

specialconsiderationsforantibodiesvis--visthesafeharbor? exploringtheapplicabilityofthesafeharborinITCactions?

5:00 c e

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Maximizing

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ob 3, 2011: Iaiv p-ctaii a sa si

A. PTA- PTE Boot Camp: Basic Trainin the Essentials o Patent Term

Adjustment and Patent TermRestoration or Patent Lawyers Servthe Biopharmaceutical Industry

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and Emerging Markets: A Practical,Hands-On Guide To Patent Extensand Exclusivities Available toPharmaceutical Products Aroundthe World

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