chief judge northern district of illinois disputes iv disputes co… · paragraph iv disputes...

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

Guy Donatiello Sr. Vice President, Intellectual PropertyEndo Pharmaceuticals

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

Distinguished Co-Chairs

Paragraph IV Disputes

American Conference Institute’s 8th Annual

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

Supporting Sponsors:

Associate Sponsors: Sponsors:

April 30, 2014Master Class on Paragraph IV Dispute Settlements in the Aftermath of Actavis

Cocktail Sponsor: Private Dinner:Luncheon Sponsor:

On the 30th Anniversary of the Hatch-Waxman Act, join preeminent patent litigators representing brand name and generic pharmaceutical companies as they provide critical insights on:

• IPRUtilizationinHatch-WaxmanLitigation

• Akamai’s Anticipacted Impact on / Divided and Contributory Infringement

• TheGoodlatteBill’sProposedCodification ofObvious-TypeDoublePatenting

April 28-29, 2014 | The Conrad – New York | New York City

HATCH-WAXMANACI’s

s e r i e s

Earn CLE

ETHICS Credits

Industry Insights from:Boehringer Ingelheim

Bristol-MyersSquibb

Eisai Inc.

Endo Pharmaceuticals

ForestLaboratories

GileadSciences

ImpaxLaboratories

Merck&Company

Mylan

Novartis Pharmaceuticals CorporationPar Pharmaceutical Companies, Inc. PfizerIncSunPharma/CaracoPharmaceuticalLaboratories,Ltd.

FTC Keynote on ActavisMarkus H. Meier AssistantDirectoroftheHealthCareDivision, Bureau of Competition FederalTradeCommission

IPR Insights from: Hon. Brian P. Murphy (invited) Administrative Patent Judge PatentTrialandAppealBoard–USPTO

Judicial Insights from Chief Judges in Key Districts:Hon. Ruben Castillo, Chief Judge Northern District of Illinois

Hon. Leonard Davis, Chief Judge EasternDistrictofTexas

Hon. Gregory M. Sleet, Chief Judge District of Delaware

Hon. Garrett E. Brown, Chief Judge (ret.) District of New Jersey

Plus a Special Magistrates Panel on Local Rules featuring:Hon. Mary Pat Thynge ChiefMagistrateJudge District of Delaware

Hon. Tonianne Bongiovanni District of New Jersey

Hon. Roy Payne EasternDistrictofTexas

• Lighting BallastandInterimMarkmanStrategies

• RevisedSafeHarborExceptions

• GDUFA’sImpactonParagraphIVStrategies

• ExclusivitiesforCombinationProducts

• At-RiskLaunchesandDamages

Register now: 888-224-2480 • Fax: 877-927-1563 • www.AmericanConference.com/PIVDisputesNYC2.

Acting Members

Mark Bowditch ExecutiveDirector,Head,USPatentProductSupport SandozInc.(Princeton,NJ)

Guy Donatiello SeniorVicePresident,IntellectualProperty EndoPharmaceuticals(Malvern,PA)

Lisa A. Jakob LegalDirector,IPLitigation Merck&Company(Rahway,NJ)

James P. Leeds AssistantGeneralPatentCounsel EliLilly&Company(Indianapolis,IN)

Jeffrey N. Myers, Ph.D. VicePresident&AssistantGeneralCounsel PfizerInc(NewYork,NY)

Carmen M. Shepard SeniorVicePresident GlobalPolicyandRegulatoryCounsel Mylan(Washington,DC)

David H. Silverstein, M.S., J.D. LegalDirector,IntellectualProperty ParPharmaceuticalCompanies,Inc.(WoodcliffLake,NJ)

Meg Snowden VP,IntellectualProperty ImpaxLaboratories(Hayward,CA)

Peter Waibel Head,USPatentLitigation NovartisPharmaceuticalsCorporation(EastHanover,NJ)

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

Emeritus Members

Stephen R. Auten Partner,ChairofPharmaceutical&LifeSciencesLitigation TaftStettinius&HollisterLLP(Chicago,IL) (Former Vice President, IP, Sandoz, Inc.)

George W. Johnston Counsel,GibbonsP.C.(Newark,NJ) (Former Vice President & Chief Patent Counsel, Hoffmann-La Roche)

Shashank Upadhye Partner,SeyfarthShawLLP(Chicago,IL) (Formerly Vice President – Global Intellectual Property, Apotex, Inc.)

Co-Chairs

Guy Donatiello VicePresident,IntellectualProperty EndoPharmaceuticals(Malvern,PA)

Timothy X. Witkowski, M.S., J.D. Executive Director & Executive Counsel IntellectualProperty,BoehringerIngelheim(Ridgefield,CT)

Speakers

Eric I. Abraham, Partner,HillWallackLLP(Princeton,NJ)

Meredith Martin Addy Partner,Steptoe&JohnsonLLP(Chicago,IL)

Stephen R. Auten, Partner, Chair of Pharmaceutical &LifeSciencesLitigation,TaftStettinius&HollisterLLP(Chicago,IL)(Former Vice President, IP, Sandoz, Inc.)

Bradford J. Badke Partner,Ropes&GrayLLP(NewYork,NY)

Nicolas Barzoukas Partner,BakerBottsL.L.P.(Houston,TX)

Thomas H. Beck, Partner,SidleyAustinLLP(NewYork,NY)

Gregory K. Bell,GroupVicePresident,GlobalPracticeLeader–LifeSciences,CharlesRiverAssociates(Boston,MA)

Bob Billings, SpecialAdvisorytothePresidentandCEO GenericPharmaceuticalAssociation(Washington,DC)

Honorable Tonianne Bongiovanni, U.S.M.J. UnitedStatesDistrictCourt DistrictofNewJersey(Trenton,NJ)

Honorable Garrett E. Brown, U.S.D.J. (ret.) FormerChiefJudge,UnitedStatesDistrictCourt DistrictofNewJersey(Trenton,NJ) Neutral,JAMS,TheResolutionExperts(NewYork,NY)

Scott Brown, AssistantGeneralCounsel–PatentLitigation Bristol-MyersSquibb(Princeton,NJ)

Paul W. Browning Ph.D. Partner,Finnegan,Henderson,Farabow, Garrett&Dunner,LLP(Washington,DC)

Michael F. Buchanan Partner,PattersonBelknapWebb&TylerLLP(NewYork,NY)

Kathleen B. Carr PartnerandCo-ChairofitsIntellectualPropertyLitigationGroup,EdwardsWildmanPalmerLLP(Boston,MA)

Honorable Ruben Castillo ChiefJudge,UnitedStatesDistrictCourt NorthernDistrictofIllinois(Chicago,IL)

Greg Chopskie SeniorCounsel,GileadSciences(FosterCity,CA)

W. Blake Coblentz Member,CozenO’Connor(Washington,DC)

David G. Conlin Partner,EdwardsWildmanPalmerLLP(Boston,MA)

Bradley W. Crawford Shareholder,PolsinelliPC(Chicago,IL)

Meenakshi Datta, Partner,SidleyAustinLLP(Chicago,IL)

John L. Dauer, Jr., ChiefPatentCounsel,SunPharma/CaracoPharmaceuticalLaboratories,Ltd.(Cranbury,NJ)

Tracey B. Davies, Partner Gibson,Dunn&CrutcherLLP(Dallas,TX)

Bo Davis, Founder,TheDavisFirm(Longview,TX)

Honorable Leonard Davis ChiefJudge,UnitedStatesDistrictCourt EasternDistrictofTexas(Tyler,TX)

Anthony E. Dowell Attorney,TaftStettinius&HollisterLLP(Chicago,IL)

Kelly J. Eberspecher Shareholder,BrinksGilson&Lione(Chicago,IL)

Jeremy J. Edwards, Partner KnobbeMartensOlson&BearLLP(Washington,DC)

Brian Farnan, Partner,FarnanLLP(Wilmington,DE)

Lisa M. Ferri, Partner,MayerBrownLLP(NewYork,NY)

Thomas J. Filarski Partner,Steptoe&JohnsonLLP(Chicago,IL)

David P. Frazier Ph.D. Partner,Finnegan,Henderson,Farabow, Garrett&Dunner,LLP(Washington,DC)

Michael J. Freno, Partner SeedIntellectualPropertyLawGroupPLLC(Seattle,WA)

Ralph J. Gabric, Shareholder&Chair,LitigationGroup BrinksGilson&Lione(Chicago,IL)

Keith J. Grady PracticeGroupChair,PolsinelliPC(St.Louis,MO)

Pablo D. Hendler Partner,Ropes&GrayLLP(NewYork,NY)

Gary E. Hood, Shareholder,PolsinelliPC(Chicago,IL)

Joseph A. Hynds, Partner Rothwell,Figg,Ernst&Manbeck,P.C.(Washington,DC)

Beth D. Jacob, Partner Kelley,Drye&Warren(NewYork,NY)

Lisa A. Jakob, LegalDirector,IPLitigation Merck&Company(Rahway,NJ)

Mark T. Jansen Partner,Crowell&MoringLLP(SanFrancisco,CA)

George W. Johnston, Counsel,GibbonsP.C.(Newark,NJ) (Former Vice President & Chief Patent Counsel, Hoffmann-La Roche)

Kurt Karst Director,Hyman,PhelpsandMcNamara(Washington,DC)

Benjamin A. Katzenellenbogen, Partner KnobbeMartensOlson&BearLLP(Irvine,CA)

Christopher J. Kelley Partner,MayerBrownLLP(PaloAlto,CA)

Sandra Lee, Partner,BakerBotts(NewYork,NY)

Steven Lieberman, Partner Rothwell,Figg,Ernst&Manbeck,P.C.(Washington,DC)

Steven A. Maddox, Partner Knobbe,Martens,Olson&Bear,LLP(Washington,DC)

David A. Manspeizer, Partner WilmerCutlerPickeringHaleandDorrLLP(NewYork,NY)

Donald R. McPhail Member,CozenO’Connor(Washington,DC)

Markus H. Meier AssistantDirector,HealthCareDivision,BureauofCompetition,FederalTradeCommission(Washington,DC)

Donna M. Meuth, AssociateGeneralCounsel IntellectualProperty,EisaiInc.(Andover,MA)

Don J. Mizerk, Partner,HuschBlackwellLLP(Chicago,IL)

Steven Moore Partner,Kelley,Drye&Warren(Stamford,CT)

Honorable Brian P. Murphy (invited) Administrative Patent Judge PatentTrialandAppealBoard–USPTO(Alexandria,VA)

Jeffrey N. Myers, Ph.D. VicePresident&AssistantGeneralCounsel PfizerInc(NewYork,NY)

Glenn S. Newman, CPA/ABV/CFF, MBA Partner,ForensicLitigation&ValuationServices ParenteBeardLLC(Philadelphia,PA)

Christopher R. Noyes, Partner WilmerCutlerPickeringHaleandDorrLLP(NewYork,NY)

Joseph M. O’Malley, Jr. PartnerandGlobalCo-Chair,IntellectualPropertyPractice PaulHastingsLLP(NewYork,NY)

Sailesh K. Patel, Partner,SchiffHardinLLP(Chicago,IL)

Martin B. Pavane Member,CozenO’Connor(NewYork,NY)

Honorable Roy Payne, U.S.M.J. UnitedStatesDistrictCourt EasternDistrictofTexas(Marshall,TX)

Lisa Barons Pensabene, Partner Fitzpatrick,Cella,Harper&Scinto(NewYork,NY)

Paul A. Ragusa, Partner,BakerBottsL.L.P.(NewYork,NY)

Irena Royzman, Partner PattersonBelknapWebb&TylerLLP(NewYork,NY)

Maureen L. Rurka Partner,WinstonStrawnLLP(Chicago,IL)

Richard T. Ruzich Partner,TaftStettinius&HollisterLLP(Chicago,IL)

Charles Ryan SeniorVicePresident,ChiefIntellectualPropertyCounsel ForestLaboratories(NewYork,NY)

Peter O. Safir, Partner Covington&BurlingLLP(Washington,DC)

Carmen M. Shepard Sr.VicePresident,GlobalPolicyandRegulatoryCounsel Mylan(Washington,DC)

David H. Silverstein, M.S., J.D. LegalDirector,IntellectualProperty ParPharmaceuticalCompanies,Inc.(WoodcliffLake,NJ)

Michael A. Sitzman Partner,Gibson,Dunn&CrutcherLLP(SanFrancisco,CA)

Honorable Gregory M. Sleet ChiefJudge,UnitedStatesDistrictCourt DistrictofDelaware(Wilmington,DE)

Meg Snowden VP,IntellectualProperty,ImpaxLaboratories(Hayward,CA)

James K. Stronski Partner,Crowell&MoringLLP(NewYork,NY)

Honorable Mary Pat Thynge ChiefMagistrateJudge UnitedStatesDistrictCourt,DistrictofDelaware (Wilmington,DE)

Shashank Upadhye, Partner,SeyfarthShawLLP (Chicago,IL)(Former Vice President – Global Intellectual Property, Apotex, Inc.)

Mark E. Waddell, Partner,Loeb&LoebLLP(NewYork,NY)

Peter Waibel, Head,USPatentLitigation NovartisPharmaceuticalsCorporation(EastHanover,NJ)

Bruce M. Wexler Partner,PaulHastingsLLP(NewYork,NY)

George Yu Counsel,SchiffHardinLLP(SanFrancisco,CA)

AdvisOrY BOArd ANd FACULTY L isT

ACI’s Hatch-Waxman Series Advisory Board:

Distinguished Faculty:

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

Dear Colleague:

Intheeightyearssince its inception,AmericanConferenceInstitute’s(ACI’s)ParagraphIVDisputes conference has become the pharmaceutical industry’s leading forum on Hatch-Waxmanlitigation.Eachspring, the“who’swho”ofHatch-Waxmanlitigatorsandindustrydecisionmakers,aswellasmembersofthejudiciaryandkeygovernmentrepresentativesgatherinNewYorkCityatthisconferencetoassesstheimplicationsandimprimatursofcourtcases,legislation, and industry behaviors which affect the patent endgame and the pursuit of related profits.This “must-attend” event serves the legal and business needs of both branded andgenericdrugmakersbyprovidinginvaluable“takeaways”forlegalstrategiesandcost-analysisforeveryfacetofthiscomplexlitigationfrompre-suitconsiderationstocasefilingsthroughfinaladjudication.

Inthis30thanniversaryyearoftheHatch-WaxmanAct,thetimeforthisconferencehasneverbeen more apropos. In the course of the next eighteen months, the industry will scale the next escarpments of the proverbial patent cliff which will bring an additional 90 billion dollars in patentlosseswhenblockbusterdrugssuchasNexium,Lunesta,Abilify,CrestorandRestasisallgooffpatent.ThiswillresultinincreasedANDAlitigationbetweenbrandsandgenerics,aswellasincreasedchallengesamonggenericsvyingtobethefirsttoobtainthehighlycovetedprizeof180-dayexclusivity.However,therewillalsobenewchallengestoface.BrandsandgenericsmustassessoftheimpactandutilizationofPTOproceedingswhichhaveprovidedalternativeandparallelforumstotheFederalCourts.Then,thereistheuncertaintyofthefalloutfromtheSupremeCourt’sdecisioninActavis, which may add to the already astronomical cost of these litigations as settlements may be both legally and economically infeasible.

Inresponse to thesechallenges,ACI ispleasedtopresent thisyear’sParagraphIVDisputesconference.We welcome you to join our exceptional faculty and your peers as we explore

notonlythelatestlegalnuancesaffectingtheessentialsofHatch-Waxmanlitigation,but also new dilemmas affecting patent sustainability and vulnerability, the impact of IPRandPGR,theGoodlatteBill’sproposedstatutorydefinitionofdouble-patentingtype obviousness, and the probable outcome of Lighting Ballast on claim construction controversies.Thisyear’seventwillfeatureadiscussiononlocalpatentruleswithbothlocalcounselandleadingMagistrates.Also,backbypopulardemandaretheJudges’RoundtableandFTCkeynotespeakersessions.Finally,inresponse,toyourrequests,weareofferingadaylongworkinggrouponpatentsettlementswhichshallnotonlyaddress predictions for how the courts may interpret Actavis, but also provide practical advice on how to structure and draft a settlement agreement with which the parties canliveandthatthecourtsandFTCwillbless.

Clearly,thereisnotamomenttoloseinthisruthlessendgameofno-holdsbarlitigation. Do not be left behind. Register today by calling 1-888-224-2480, faxing your registration form to 1-877-927-1563orvisitinguson-lineat www.AmericanConference.com/PIVDisputesNYC.

WelookforwardtoseeingyouinNewYorkthisApril.

Verytrulyyours,

Lisa J. Piccolo, Esq.SeniorIndustryManager,LifeSciencesandHealthCareAmerican Conference Institute

Network With the “Who’s Who” of Hatch-Waxman Litigators and stakeholders.

Prepare for the Next Wave of ANdA Litigation and Patent Challenges at the Courts and PTO.

Attend the industry’s Premier Paragraph iv disputes Conference.

Media Partners:


Monday, April 28, 2014Main Conference – day 1

7:00 Registration and Continental Breakfast

Continental Breakfast Sponsored by:

8:15 Co-Chairs’ Opening Remarks On the 30th Anniversary of the Drug Price Competition and Patent Term Restoration Act: Understanding Hatch-Waxman’s Transformative Impact on the Pharmaceutical Industry

Co-Chairs

Guy Donatiello VicePresident,IntellectualPropertyEndoPharmaceuticals(Malvern,PA)

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

With Commentary from:

Bob Billings SpecialAdvisorytothePresidentandCEOGenericPharmaceuticalAssociation(Washington,DC)

Brand Name Industry Representative, TBA

September 2014 will mark the 30 year passage of theDrug Price Competition and Patent Term RestorationAct, i.e., theHatch-WaxmanAct.This lawestablishedabalance of power between the brand name and generic pharmaceutical sectors by setting IP timelines and procedures which changed the dynamics of both patent litigationandprofits.Section505(j)(2)(A)(vii)(IV),i.e., theParagraphIVprovisionisthecornerstoneoftheAct’slitigation schematic – as well as the cornerstone of thisconference.

Pleasejoinourco-chairsandrepresentativesforboththebrand name and generic sectors as they will explore this transformative law and other related matters. Points of discussion will include:

• TheevolutionandchangingdynamicsofbothindustrysectorsinviewofHatch-Waxman

• Theinterplayofnewandproposedlegislation andtheHatch-Waxmanschematic- TheAmericaInventsAct- H.R.3309,TheGoodlatte“InnovationAct”,

i.e.,PatentReformII anti-trollprovisionsandpossibleimpact

onHatch-Waxmansuits- H.R.3091,TheMODDERNCuresActof2013

9:00 Assessing Pharmaceutical Patent Sustainability and Vulnerability: Strategies and Considerations for Brand Names and Generics in Anticipating, Identifying and Determining Which Patents Will Be Ripe for Challenges of Invalidity and Non-Infringement

Stephen R. AutenPartner,ChairofPharmaceutical&LifeSciencesLitigationTaftStettinius&HollisterLLP(Chicago,IL)(Former Vice President, IP, Sandoz, Inc.)

Joseph M. O’Malley, Jr.PartnerandGlobalCo-Chair Intellectual Property PracticePaulHastingsLLP(NewYork,NY)

Irena RoyzmanPartnerPattersonBelknapWebb&TylerLLP(NewYork,NY)

Charles RyanSeniorVicePresident,ChiefIntellectualPropertyCounselForestLaboratories(NewYork,NY)

• RevisitingtheANDAapplicant’sassertionunderParagraphIV,i.e.,“suchpatentisinvalidorwillnot be infringed by… the new drug for which the applicationissubmitted”fromtheperspectiveofbothbrand name and generic manufacturers- reviewingthepresumptionofvalidity Sciele Pharma Inc. v. Lupin Ltd.(Fed.Cir.2012) reaffirmation of Microsoft v. i4i

(131S.Ct.2238(2011))

- overcomingthepresumptionby“clearandconvincing”evidencetothecontrary

- questionsoflawvs.questionsoffact- understandingcircumstancesinwhichtheburden

may shift from patent holder to alleged infringer• Applyingthepresumptionofvalidityto101subject

matterquestions- CLS Bank Int’l v. Alice,717F.3d1269

(Fed.Cir.2013),cert. granted Dec.6,2013- impacton101validitychallengestoAPIs- potentialuptickin101utilitychallenges

• Analyzingthequestionofwhobearstheburdenofproofinalicensee’schallengetopharmaceuticalpatent validity- Medtronic, Inc. v. Boston Scientific Corporation,

(SupremeCourtdocketnumber12-1128) MedImmune, Inc. v. Genentech, Inc.

549U.S.118(2007)• Newquestionsofinfringement

- Sunovion Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc.,No.13-1335 (Fed.Cir.Sept.26,2013) understanding when a promise not to infringe

is an act of infringement scopeofinfringementvis-à-vis271(e)(2)(a)

PATeNTS RIPe FOR PARAGRAPH IV CHALLeNGe

Brand Side Considerations:

• Evaluatingthestrengthofthepatentsinyourcurrentportfolio - blockbustersvs.smallerproducts determining vulnerabilities IP and economics

- smallmoleculesvs.smallproteins- smallproteinspost-BPCIA

• Non-OrangeBookpatents

Generic Considerations:

• ChoosingwhichOrangeBookpatentstochallenge• Understandingtheroleofnon-OrangeBookpatents

inyourPIVANDAstrategies- innovator/non-innovator- API


STRATeGIeS FOR BOTH SIDeS TO AVOID LITIGATION

• Licensingandauthorizedgenericsagreements- newconsiderationsinlightofamendments

toHartScottRodinoandEffexor amicus brief• Claimingthelabel• Useofcitizens’petitions• OTCswitching

10:00 Morning Coffee Break

Morning Coffee Break Sponsored by:

10:15 Use of IPR and Other PTO Proceedings in A Paragraph IV Challenge: Strategies For Brand Names and Generics in Navigating PTO Proceedings in ANDA Litigation

Lisa M. FerriPartnerMayerBrownLLP(NewYork,NY)

Thomas J. FilarskiPartnerSteptoe&JohnsonLLP(Chicago,IL)

Joseph A. HyndsPartnerRothwell,Figg,Ernst&Manbeck,P.C.(Washington,DC)

Honorable Brian P. Murphy (invited)Administrative Patent JudgePatentTrialandAppealBoard–USPTO(Alexandria,VA)

Christopher R. NoyesPartnerWilmerCutlerPickeringHaleandDorrLLP(NewYork,NY)

Moderator:

Kelly J. EberspecherShareholderBrinksGilson&Lione(Chicago,IL)

NewandamendedPTOproceedingsinitiatedundertheAIA are now in full effect and have garnered a great deal ofattention in theHatch-Waxmanspace in lightof therecent decisions and petitions.This session will provideinsightsonhowtheseproceduresmayalterParagraphIVlitigation strategies by providing a means for alternate redress or incorporation of parallel proceedings into District Court actions. Points of discussion will include:

Actual and Anticipated Uses of Inter Partes Review in a Paragraph IV Scenario

• UnderstandingwhenitisstrategicallyprudenttofileanIPR

• SurveyofrecentIPRfilingsanddispositions- Garmin v. Cuozzo Speed Tech,IPR2012-00001

(PTAB2013):firstIPRdecision what can pharmaceutical companies learn from

this decision?- exploringhowrecentwritofmandamusfilings

are being used as a means to bypass the statutory bartoappealsofPTO’sIPRdenials In re MCM Portfolios LLC(Fed.Cir.2013)

• ExaminingtheApotex and Ranbaxy petitions, subsequentsettlementsandtheirsignificance- howmightthesefilingschangethedynamics

ofParagraphIVlitigation?• UnderstandingwhythePTABmayexerciseits

discretion to hear the Teva(Moxifloxin)petitiondespite settlement of that matter

• WillDistrictCourtParagraphIVcasesbestayed inlightofIPRfilings?

• HowarebrandsrethinkingParagraphIVlitigationstrategies in light of this new proceeding and its use by generics?

• AnalyzingconcernsthatIPRandotherproceedingsmaybeusedtogeta“secondbiteattheapple”- Fresenius USA v. Baxter Int’l. (Fed.Cir.2013)

• ExploringusesofIPRforsecond,thirdandothersubsequentANDAfliers- forfeituretriggers- exploringtacticsbyothergenericstoavoidthis

scenario• Query:ifanOrangeBook-listedpatentisfound

invalidinanIPRproceeding–doesitneedtobedelisted?

• Questionofvaluation–whichpatentsonbrandname products are worth challenging? - changingdynamics

Re-evaluating Orange Book Listed Patents and Orange Book Patent Challenges in View of New Legal and Regulatory Developments:

• Compoundpatentsvs.methodsvs.polymorphs- utilizationofusecodesintheaftermathofCaraco- smallproteinspost-BPCIA

• PTAandPTEconsiderations- possibleimpactofExelixis v. Kappos (E.D.Va2013)

• Analyzingnewcontroversiesinbrandnameexclusivities that may affect your due diligence analysis

PRePARING FOR LITIGATION

Brand Side Considerations:

• Developingdiscoverycheck-lists- implementationofdocumentretentionpolicy- whenisalitigationholdputonalldocuments

which may be discoverable• e-Discovery

- possiblee-discoveryrestraintsinvariousjurisdictions

- “callback”ruleforinadvertentdisclosure

Generic Considerations:

• Procuringlegalopinionsoninvalidityandnon-infringement- assessingwhenopinionsareneeded- opinionofin-housev.outsidecounsel- questionsofprivilege Rule26(b)(4)

• FilingtheANDA- fulfillingrequirementsforFDAapproval: pharmaceuticallyequivalent bioequivalent identifying triggers which may necessitate new

bioequivalencestudies


GeNeRIC SIDe

Procedural requirements

• PerfectingtheParagraphIVCertification- contents- delivery/service- avoiding“prematurenotice” “latenotice”

• PerfectingtheParagraphIVNoticeLetter• MakingnecessaryamendmentstotheANDA

Substantive requirements

• IdentifyingtheproposedproductcoveredbytheANDA- findingthepatentofthecorrespondingbranded

productwhichisthesubjectoftheParagraphIVletter

• LegalandfactualbasisoftheCertification• Examiningthedetailedstatementandquestions

ofconfidentiality• Exploringtheuseofopinionlettersinrelation

totheNoticeLetter- aretheystillneededinviewofPatentReform?- detailsandotherrequirements- sanctions

BRANDeD SIDe

The response

• Makingproductiveuseofthe45dayperiod• Informationgatheringtechniquesstrategies

- confidentialityagreementsanddocumentrequests obtaining the ANDA terms scope of information that can reasonably expected negotiations

• Extendingthe45dayperiod- 21CFR314.95(f )

• Whenshouldapatentownerfilesuit?- otheroptionstoexplore

• StrategiestoconsiderwithmultipleANDAfilers

Questions for both sides to consider

• Optionstoexploreifsuitisnotcommencedin45days- pros,consandconsequencesof: forfeiture of 30 month stay suing for damages declaratoryjudgmentactions no contest letter

12:15 Networking Luncheon

Networking Luncheon Sponsored by:

1:30 Of Prior Art and Double Patenting: exploring the Dichotomy Between the Federal Circuit and PTO on Obvious Findings and the Potential Impact of the Goodlatte Bill on Double-Patenting Type Obviousness

Jeremy J. EdwardsPartnerKnobbeMartensOlson&BearLLP(Washington,DC)

Lisa A. JakobLegalDirector,IPLitigationMerck&Company(Rahway,NJ)

Steven J. Moore PartnerKelley,Drye&Warren(Stamford,CT)

Bruce M. Wexler PartnerPaulHastingsLLP(NewYork,NY)

Moderator:

Mark T. JansenPartnerCrowell&MoringLLP(SanFrancisco,CA)

Prior Art

• ExaminingthecontrastbetweentheFederalCourtsandPTOonpriorartobviousnessfindings

• AnalyzingFederalCircuit’sreversalsofPTOobviousdeterminations

Other PTO Proceedings to Watch

• SpecificconcernsforjoinderrelativetoDistrictCourtandPTOProceduresundertheAIA

• Possiblescenariosinwhichthefollowingprocedureswould run parallel to district court proceedings- thirdpartyre-issuancesubmissions- supplementalexamination- post-grantreview

• ExaminingcircumstancesinwhichredressisonlysoughtbeforethePTO

11:15 The Gauntlet Rethrown: The Paragraph IV Certification and Notice Letter

For the Brand Name Side

George W. JohnstonCounselGibbonsP.C.(Newark,NJ)(Former Vice President & Chief Patent Counsel, Hoffmann-La Roche)

Peter WaibelHead,USPatentLitigationNovartis Pharmaceuticals Corporation(EastHanover,NJ)

For the Generic Side

Michael J. FrenoPartnerSeedIntellectualPropertyLawGroupPLLC(Seattle,WA)

David H. Silverstein, M.S., J.D.LegalDirector,IntellectualPropertyPar Pharmaceutical Companies, Inc. (WoodcliffLake,NJ)

Moderators:

Gary E. HoodShareholderPolsinelliPC(Chicago,IL)

Sandra Lee PartnerBakerBotts(NewYork,NY)


- Rambus Inc. v. Rea (Fed.Cir.2013)- Leo Pharmaceutical Products v. Rea

(August12,2013)(inter partes reexamination) exploring these decisions and the Federal

Circuit’semphasistoalljudiciaryinthefederalcourtsandPTABontheimportanceofobjectiveevidence in an obviousness determination

• AssessingtheimpactoftheAIA’spriorartprovisionsinParagraphIVrelatedobviouschallenges- examiningsecondaryconsiderationsbefore

thePTOundercurrentprocedures undernewIPRandPGRProcedures

• ExploringhowPTOproceduresmaybeusedtobypassfindingsofnon-obviousnessinthefederalcourts- howthedifferentburdensofproofinobviousness

challengesbeforethefederalcourtsandPTOmayimpact litigation strategies questionsofcollateralestoppel questionsoffederalcourtauthority

vs. administrative authority possibleSupremeCourtreview impactontacticsoffirstandsecondfilers

inParagraphIVdisputes• Teva v. Sandoz (Fed.Cir.2013)

- methodsofmeasureandobviousness• Allergan, Inc. v. Sandoz Inc., (Fed.Cir2013)

- combiningobviousnessandinherency• Bristol-Myers Squibb v. Teva Pharms.,

No.10-805-CJB(D.Del.)- structuralobviousness- findingsofinvalidityaftertrial

• Novo Nordisk A/S v. Caraco Pharmaceutical Laboratories, Ltd. (Fed.Cir.2013)- combinationproducts

• Decipheringnewjurisprudencerelativetoobviousness determinations in primary compound andcompositionclaimsvis-à-visaParagraphIVchallenge- impactonmethodsandcompositions- impactonsecondarypatents

Obvious-Type Double Patenting

• UnderstandinghowtheGoodlatteBill,i.e., Innovation Actmaybothcodifyanddrasticallyalterthejudicialdoctrineofobvious-typedoublepatenting

• DissectingthecontroversyoverSection9(d)§106 of the proposed Innovation Act, i.e., prior art in cases of double patenting- potentialcodificationofobvious-typedouble

patentinginto§103• ExploringthepotentialexpansionofIPRtoinclude

doublepatenting-typeobviousnessasacauseofaction- consequencesofthisexpansion

2:30 Afternoon Refreshment Break

2:45 Let the Games Begin: Advanced Strategies for Drafting and Perfecting Pleadings and effectively Using Dispositive Motions in Paragraph IV Disputes

For the Brand Name Side

Scott BrownAssistantGeneralCounsel–PatentLitigationBristol-MyersSquibb(Princeton,NJ)

Michael F. BuchananPartnerPattersonBelknapWebb&TylerLLP(NewYork,NY)

For the Generic Side

John L. Dauer, Jr. Chief Patent CounselSunPharma/ CaracoPharmaceuticalLaboratories,Ltd.(Cranbury, NJ)

Don J. MizerkPartnerHuschBlackwellLLP(Chicago,IL)

Moderators:

Benjamin A. Katzenellenbogen PartnerKnobbeMartensOlson&BearLLP(Irvine,CA)

Paul A. Ragusa PartnerBakerBottsL.L.P.(NewYork,NY)

Initial considerations

• Whereshouldsuitbefiled?- attemptingtoinfluencewhereandwhenthesuit

will occur- evaluatingtransfermotionsandwritsofmandamus

relativetovenue/jurisdiction- examiningjoinderprovisionsandHatch-Waxman

exceptions under AIA relative to venue• Assessingsubjectmatterjurisdiction

- Merck Sharp & Dohme Corp. v. Sandoz Inc., No.12-3289(D.N.J.2013)

• Questionsofstanding- considerationsformultinationalsandsubsidiaries- weighingprobabilityformotionstodismiss

• Handicappingofjudgesandjurisdiction- localpatentrules

• Questionofjurytrial:exploringcircumstances thatmayputyouinfrontofajury

• ExaminingparallelproceedingsbeforethePTO inviewofPatentReform

Crafting the initial pleadings

• Thecomplaint- challengingtheParagraphIVcertification:alleging

the patent is valid and infringed what claims are made in the ANDA?

- avoidingRule11sanctions- assessingwhetherattorney’sfeescanbeproperly

sought?- considerationswithmultipleANDAfliers whendoesitmakesensetoonlysuethefirstfiler

orafewasopposedtoallANDAfilers? whataretheconsequencesofnotsuingall

ANDAfilers?• Theanswerandcounterclaims

- de-listingimproperlylistedpatents- antitrustandunfaircompetitionclaims- assertionsofinequitableconduct- thegenericpointofview: attorneys fees Rule11


Factoring – in the 30 month stay

• Commencementofthestatutory30monthstay- understandingthescopeandlimitsofthe30

monthstayundertheMMA• The30-monthstayinthecourseoflitigation

- optionsandstrategiesforthepatentholderifthestay expires during the course of litigation early termination of the stay

Generic Generic Law Suits

• Exploringcircumstancesinwhichthegeneric behaves as an innovator

• Pleadingprotectionofmarketexclusivity

Declaratory Judgment Motions

• WhenisitappropriatetomoveforaDJ• UnderstandingtheMMAdeclaratoryjudgment

provisionsandtheCAFC’sinterpretationoftheseprovisions- twoprongtest

• CircumstanceswhenaDJwillbegranted• ShouldDJbesoughtonallpatents–listed

and not listed?

Summary Judgment Motions

• IdentifyingcircumstancesinaParagraphIVlitigationwhenfilingamotionforsummaryjudgmentmakessense- whenisitadvantageousforthegenericside

to do so? on grounds of invalidity or infringement?

- doesitevermakesenseforthebrand?

3:45 Working With Local Counsel and within Local Rules: Magistrate and Local Counsel Roundtable

Honorable Mary Pat ThyngeChiefMagistrateJudgeUnitedStatesDistrictCourt,DistrictofDelaware(Wilmington,DE)

Honorable Tonianne Bongiovanni, U.S.M.J. UnitedStatesDistrictCourtDistrictofNewJersey(Trenton,NJ)

Honorable Roy Payne, U.S.M.J.UnitedStatesDistrictCourtEasternDistrictofTexas(Marshall,TX)

Eric I. AbrahamPartnerHillWallackLLP(Princeton,NJ)

Bo DavisFounderTheDavisFirm(Longview,TX)

Brian FarnanPartnerFarnanLLP(Wilmington,DE)

Moderators:

W. Blake CoblentzMemberCozenO’Connor(Washington,DC)

Ralph J. GabricShareholder&Chair,LitigationGroupBrinksGilson&Lione(Chicago,IL)

ManykeyjurisdictionsinwhichParagraphIVdisputesareheardhavetheirownlocalpatentrules.Somejurisdictionseven go as far as having a subset of local patent rules for Hatch-Waxmanmatters.Thisiswhytheassistanceoflocalcounselisoftencrucialinnavigatingthe“insandouts”oftheserulesandjurisdictions.Thispanelofmagistratesandlocal andnational counselwill explore the requirementsand nuances of these rules as well as the importance of working with local counsel. Points of discussion willinclude:

• Choosingandworkingwithlocalcounsel• Surveyinglocalpatentrulesinkeyjurisdictions

- NewJersey- E.D.Texas- Delaware- NorthernDistrictofIllinois

• Schedulesettingrules• Applicablediscoveryrules• Localpatentrulesanddispositivemotions• LocalpatentrulesandMarkmanhearings• Trialproceduresunderlocalrules

4:45 A View from the Bench

Honorable Ruben CastilloChief Judge UnitedStatesDistrictCourt NorthernDistrictofIllinois(Chicago,IL)

Honorable Leonard DavisChief JudgeUnitedStatesDistrictCourt EasternDistrictofTexas(Tyler,TX)

Honorable Gregory M. SleetChief JudgeUnitedStatesDistrictCourt,DistrictofDelaware(Wilmington,DE)

Honorable Garrett E. Brown, U.S.D.J. (ret.) FormerChiefJudge,UnitedStatesDistrictCourtDistrictofNewJersey(Trenton,NJ)Neutral,JAMS,TheResolutionExperts(NewYork,NY)

Moderators:

Meredith Martin AddyPartnerSteptoe&JohnsonLLP(Chicago,IL)

Michael A. SitzmanPartnerGibson,Dunn&CrutcherLLP(SanFrancisco,CA)

RenownedjuristswithsomeofthemostactiveParagraphIV litigation dockets in the country will share theirthoughts and insights on the most important issues facing both patent holders and patent challengers. Come preparedwithyourmostpressingquestions.

6:00 Conference Adjourns to Day Two

Cocktail Reception immediately following Judges’ Panel

Cockail Reception Sponsored By:


Tuesday, April 29, 2014Main Conference – day 2

7:30 Co-Chairs’ Opening Remarks and Recap of Day 1

Continental Breakfast Sponsored by:

8:15 Claim Construction and Markman Hearings: Standards, Jurisprudential Splits and Strategies for Paragraph IV Litigation

Keith J. GradyPracticeGroupChairPolsinelliPC(St.Louis,MO)

Pablo D. HendlerPartnerRopes&GrayLLP(NewYork,NY)

Beth D. JacobPartnerKelley,Drye&Warren(NewYork,NY)

Jeffrey N. Myers, Ph.D.VicePresident&AssistantGeneralCounselPfizerInc(NewYork,NY)

Moderator:

Martin B. Pavane MemberCozenO’Connor(NewYork,NY)

Claim construction has been described as the most important event in the course of patent litigation – letalone Paragraph IV litigation. The Supreme Court inMarkman described claim construction as a “mongrelpractice.” This is evident through the considerable splitinFederalCircuitclaimconstructionjurisprudencewhichhas caused considerable uncertainty in the planning of Markman strategies. As the Supreme Court did notgrant certiorari in Retractable Technologies, Inc. v. Becton, Dickinson and Company (Fed. Cir. 2011), any hopes forconsistent guidance in these matters were dashed. All eyes are now on the Federal Circuit’s Lighting Ballast Control LLC v. Philips Electronics North America Corp., 500Fed.

App’x951,951-52(Fed.Cir.2013)caseinhopesthatitwillfinallyestablishthestandardofreviewforsuchmatters.

ThispanelwillprovidepracticalstrategiesforformulatingMarkman hearing strategies in view of the still existingintra-circuit split and possible new standard of review.Points of discussion will include:

• Understandinghow Lighting Ballast Control LLC v. Philips Electronics North America Corp.,500Fed.App’x951,951-52(Fed.Cir.2013)maymendtheintracircuitsplitinclaimconstructionjurisprudence- whattheadoptionofadeferentialstandardofreview

maymeanforMarkmanstrategiesgoingforward• HowthesplitintheFederalCircuitonclaim

constructionhasimpactedParagraphIVchallengesandrelatedMarkmanhearings- morenarrowreadingofclaimsvs.broaderreading findingsoffactvs.questionsoflaw

- Cybor and Phillips- RetractableTechnologies

• Revisiting112writtendescriptionandenablementdistinctionrequirementsrelativetoclarityofclaims- reviewingspecificationrequirements understandability inventorship

• Strategiesforworkingaroundtheseinconsistencies atParagraphIVMarkmanhearings

9:15 FTC Keynote: Reverse Payment Settlements and Other Antitrust Concerns Impacting Paragraph IV Litigation in the Wake of Actavis

Markus H. MeierAssistantDirector,HealthCareDivisionBureau of CompetitionFederalTradeCommission(Washington,DC)

On June 17, 2013, the U.S. Supreme Court issued itsdecision in the Actavis case and finally addressed thematterofreversepaymentsettlementsinHatch-Waxmancases. The Court’s 5-3 decision clearly establishes theantitrust “rule of reason” as the standard for evaluatingreversepaymentsettlementcases.ThesignificanceoftheSupreme Court’s decision, however, will only becomeclear as the lower courts grapple with its application to challenged reverse payment settlements.

As per the MMA, the FTC is required to continue toreview Hatch-Waxman settlements, and it has publiclyannounced that it will continue challenging reverse payment settlement agreements, possibly including settlementagreementsfiledpriortotheActavis decision. Private plaintiffs certainly have stepped up their challenges,andtherearecurrentlyfifteenreversepaymentcases in litigation. Additionally, the FTC recently hasquestionedthelegalityunderActavisofaHatch-Waxmansettlementbasedonthebrand’sagreementnottolaunchanauthorizedgeneric.Itisnowanyone’sguessastohowfartheFTCandprivateplaintiffswillgo.

Inthissession,MarkusMeierwilladdressthesematters,inadditiontootheranticompetitiveconcernsintheHatch-Waxmanspace.

10:00 Morning Coffee Break

Morning Coffee Break Sponsored by:

10:15 Perils of the Safe Harbor: Understanding How the Resetting of the Boundaries of 271 (e)(1) In the Aftermath of Classen and Momenta is Impacting Paragraph IV Litigation Strategies

Kathleen B. CarrPartnerandCo-ChairofitsIntellectualPropertyLitigationGroupEdwardsWildmanPalmerLLP(Boston,MA)

Donna M. MeuthAssociateGeneralCounselIntellectual PropertyEisaiInc.(Andover,MA)

Sailesh K. PatelPartnerSchiffHardinLLP(Chicago,IL)

Maureen L. RurkaPartnerWinstonStrawnLLP(Chicago,IL)

Moderator:

Tracey B. DaviesPartner Gibson,Dunn&CrutcherLLP(Dallas,TX)


Moderator:

Mark E. WaddellPartnerLoeb&LoebLLP(NewYork,NY)

• UnderstandingthesignificanceoftheSupreme Court granting cert. in Limelight v. Akamai, S.Ct.No.12-786- examiningtheSolicitorGeneral’srecommendation

thattheCourt“holdthatapartycannotbeliableforinducementunder35U.S.C.271(b)ifnopartyhas directly infringed the patent

- revisitingtheFederalCircuit’senbancrulingon inducement of infringement and divided infringement in Akamai Technologies, Inc. v. Limelight Networks, Inc.(Fed.Cir.2012) Global Tech v. SEB,563U.S.______

(May31,2011), mens rearequirements willful blindness vs. deliberate indifference indirect vs. direct infringement

• Commil USA, LLC v. Cisco Sys., Inc., No.2012-1042(Fed.Cir.2013)- questionofreasonablebeliefofinvalidityatthe

timeoftheinducingactandconsequences• Exploringtherelationshipbetweeninducement

actions and divided and contributory infringement and how they apply to methods of treatment claims in pharmaceutical patents- applicabilitytomethodsoftreatmentclaimslisted

intheOrangeBook• ExamininghownewproposedFDARulemakingon

GenericLabelingmayimpactcarveoutsandskinnylabeling relative to method of treatment claims

12:15 Networking Luncheon

Networking Luncheon Sponsored by:

1:30 Assessing GDUFA Implementation and Additional Regulatory Developments at FDA Which Impact Paragraph IV Litigation

Bradley W. CrawfordShareholderPolsinelliPC(Chicago,IL)

Kurt KarstDirectorHyman,PhelpsandMcNamara(Washington,DC)

Peter O. SafirPartnerCovington&BurlingLLP(Washington,DC)

Carmen M. ShepardSr.VicePresidentGlobalPolicyandRegulatoryCounselMylan(Washington,DC)

• EvaluatingthesuccessofFDA’simplementationoftheGenericDrugUserFeeAmendmentsof2012(“GDUFA”)- GDUFAsteeringcommittee–purposeandintent- re-visitingFDA’sANDAbackloginlightGDUFA

implementation possible end of multiple review cycles

- addressingconcernsoverhowacontinuingbacklogmay impact not only generic approvals, but the 30 monthstayallowedunderHatch-Waxman

- exploringpossiblerepercussionsforfirstfilerstatus• ExploringproposedlegislationtoremedyGDUFA

hardship for small generic manufacturers- H.R.3631,theSmallManufacturerProtectionAct

of2013• AnticipatingGDUFArepercussionsbasedonAgency

goalsthatmayimpactANDAfliersbeyonduserfeecosts - forfeitures- inspectionsandcGMPviolations

• UnderstandinghowFDAregulatoryredressunderFDASIAmayimpactthefutureofParagraphIVlitigation

• Citizenspetitionsrevisited- examiningtheuptickincitizen’spetitionsfilings

inHatch-Waxmanmatters- whenshouldtheybefiled- avoidingaccusationsthecitizenpetitionisbeing

filedasadelayingtactic- FDAresponsetime/505(q)- CitizensPetitionsrelativetoREMSandgenericdrugs

• LawsuitsagainstFDA• WhenshouldyouconsidersuingtheFDArelative

toaHatch-Waxmandetermination?

• UnderstandingwhytheSupremeCourt’sdenialofcert. in Classen v. Biogen(Fed.Cir.2011)isnotanaffirmationofClassen or Momenta v. Amphastar’s (Fed.Cir.2012)safeharborholdings- dismissalwithoutprejudiceaspremature- reviewoftheSolicitorGeneral’sfindingsand

significanceforfurtherSupremeCourtreview• DecipheringhowtheSupremeCourt’spresentdenial

of cert. and the present state of the law concerning safeharborexceptionswillimpactANDAfilings- whenandtowhatactivitiesdoesthesafeharbor

exception apply? pre-marketvs.post-marketactivity

- infringingvs.non-infringingactivity “developmentandsubmissioninformation

underofaFederallaw”vs.“informationthatmay be routinely reported to the FDA, long after marketingapprovalhasbeenobtained”

- positionofbrandsvs.thatofgenericsrelativetoParagraphIVchallenges

- howmaythisjurisprudenceimpacttherelationshipbetween brands and generics as established by the Hatch-WaxmanAct?

• DevisingstrategiesforHatch-Waxmanlitigationrelativetotheboundariesof271(e)(1)inviewofthelaw’spresentstate- brandnameandgenericperspectives

11:15 In the Limelight: Strategies and Theories of Inducement, Contributory and Divided Infringement in Paragraph IV Litigation Concerning Method of Treatment Patents

Nicolas BarzoukasPartnerBakerBottsL.L.P.(Houston,TX)

Steven LiebermanPartnerRothwell,Figg,Ernst&Manbeck,P.C.(Washington,DC)

David A. ManspeizerPartnerWilmerCutlerPickeringHaleandDorrLLP(NewYork,NY)

Shashank UpadhyePartnerSeyfarthShawLLP(Chicago,IL)(Former Vice President – Global Intellectual Property, Apotex, Inc.)


2:30 Looking Beyond 180 Days: New exclusivity Challenges for Brand Names and Generics and Related Implications for Paragraph IV Challenges

David P. Frazier Ph.D.PartnerFinnegan,Henderson,Farabow, Garrett&Dunner,LLP(Washington,DC)

Lisa Barons Pensabene PartnerFitzpatrick,Cella,Harper&Scinto(NewYork,NY)

Richard T. RuzichPartnerTaftStettinius&HollisterLLP(Chicago,IL)

Meg SnowdenVP,IntellectualPropertyImpaxLaboratories(Hayward,CA)

Brand Name Exclusivity Challenges

• AnalyzingnewNCEexclusivityconcerns- Eisai(Belviq)andUCB(Vimpat)citizenspetitions can the NCE exclusivity start date begin for a

controlled substance prior to DEA scheduling?• Exploringnew3-yearnewclinicalinvestigation

exclusivity matters- Covis(Lanoxin)- AstraZeneca(Seroquel)

• StatusoflawsuitsagainstFDAinregulatoryexclusivity denials- CenterforDrugEvaluationandResearch’s

(“CDER’s)ExclusivityBoard reviewofNCEexclusivity,3-yearnewclinical

trial exclusivity, and exclusivity for biological products

Exclusivity for Combination Products

• StatusandreviewofCombinationDrugDevelopmentIncentiveActof2013(H.R.2985)

• ExploringexclusivitiesforcombinationproductscomprisedoftwonewOrangeBooklisteddrugs- reviewofnecessarycriteriaforeachofthe

componentdrugstoreceive5yearNCEexclusivity

Gilead(Stribild)Ferring(Prepopik)andBayer(Natazia)CitizensPetitions

• WhataretheavailableexclusivitiesforacombinationproductcomprisedoftwooldOrangeBooklisteddrugs?

• Whatexclusivityprotectionsareafforded to a combination product comprised of a new andoldOrangeBooklisteddrug?

• Whatofavailableexclusivitiesforcombinationproducts comprised of :- anOrangeBooklisteddruganddevice?- anOrangeBooklisteddrugandbiologicalproduct?

180-Day Exclusivity Challenges for Generic Small Molecules

• DecipheringtheFDA’sstanceonpreandpost–MMA180-dayexclusivity

• Interpretingthe“earlierof”,“laterof”languageinmakingaforfeituredetermination

• Evaluatingthestrengthof“thefailuretomarket”provision

• Forfeitureprovisions:circumstancesunderwhichexclusivityisforfeitedunderFDCAct§505(j)(5)(D)(i)- Caraco:questionof180-dayexclusivityforfeiture

for an ANDA product that receives tentative approvalonthe30-monthANDAsubmissionanniversary date

• AssessingtheuseofIPRasaforfeituretriggeringevent• Evaluatingtheimpactof“delisting”onforfeiture• Forfeiturerelativetopatentexpiration• Evaluatingwhenthe180-dayexclusivityperiod

canberelinquishedortransferred,andexploring theconsequences

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

fieldrelativeto180-dayexclusivity?• Exploringregulatorybarstoexclusivity

- GMPviolations- SECactions

• Revisitingtherelationshipbetweenexclusivity,forfeiture and the 30 month stay- circumstancesunderwhichasecondstaymay

be granted- impactongrantofexclusivity

3:15 Afternoon Refreshment Break

3:30 A Pros and Cons Analysis of Launching At Risk and Survey of New Developments in Seeking Injunctive Relief and Damages

Thomas H. BeckPartnerSidleyAustinLLP(NewYork,NY)

Gregory K. Bell GroupVicePresident GlobalPracticeLeader–LifeSciencesCharlesRiverAssociates(Boston,MA)

Greg Chopskie SeniorCounselGileadSciences(FosterCity,CA)

Glenn S. Newman, CPA/ABV/CFF, MBAPartner,ForensicLitigation&ValuationServicesParenteBeardLLC(Philadelphia,PA)

James K. Stronski PartnerCrowell&MoringLLP(NewYork,NY)

George Yu CounselSchiffHardinLLP(SanFrancisco,CA)

Moderator:

Paul W. Browning Ph.D.Partner Finnegan,Henderson,Farabow, Garrett&Dunner,LLP(Washington,DC)

OnJune12,2013, theparties intheProtonix litigationreached an agreement in the amount of $2.15 Billionfor lost profit damages. This number is astronomical.However, as the damages portion did not go to trial, itis anyone’s guess as to how great an amount may haveultimately been awarded in court. Brand names and generics are still in thedarkas towhatmay transpire ifa trial for an at risk launch of the generic version of abrandedproductwereevertoreachfinaladjudicationatthe damages phase.


Thispanelwillexplore lessons learnedfromProtonix interms of new considerations for damages estimation and award in an at-risk launch and the continuing debateover divergent standards for injunctive relief. Points ofdiscussion will include:

The At-Risk Launch

• Launchingatriskduringlitigationortheappealperiod- takingacloserlookatProtonix- benefitsandrisksanalysis- assessingwhetherthemagnitudeoftheProtonix

litigationwilldeterfuturelaunchesatrisk- evaluatingtheoveralldeclineinatrisklaunches

over the last few years linkagetoFTC“pay–for-delay”activity impact of Actavisonsuchfilings

Injunctions

• ExamininghowDistrictCourtdeterminationsregardingpreliminaryinjunctionsarebeingmadein view of the inconsistencies between the Federal CircuitandtheSupremeCourtrelativetothegrantingofapreliminaryinjunction- Winter v. Natural Resources Defense Counsel, Inc.,

555 U.S. 7 (2008) eBay Inc. v. MercExchange, LLC,

547U.S.388(2006)- intra-CircuitsplitattheFederalCircuit- takingtheFederalCircuittotaskfornotfollowing

theSupremeCourt’sstandardforpreliminaryinjunctions

- Kimberly-Clark Worldwide, Inc. v. First Quality Baby Products, LLC,CaseNo.10-1382 (Fed.Cir.,Sept.29,2011)

• ReviewofrecentHatch-Waxmanmattersconcerningpreliminaryinjunctions- AstraZeneca LP v. Breath Ltd.(Fed.Cir.2013)

• Practicalstrategiesforbrandnamesandgenericsindealing with this discord before the District Courts and Federal Circuit

• Seekingapreliminaryinjunctionintheeventthat the stay ends in the course of the litigation - postingofbondbythebrandedside

• Strategiesforopposinginjunctiverelief

• Exploringthepossibilityofastipulatedinjunction- whyastipulatedinjunctionmaybeofbenefit

to both sides

Damages Analysis

• WhathastheProtonixsettlementtaughtusaboutdamages assessment?

• Thequantificationofdamages- brand–namevs.genericpointofview- smallv.largegenericcompanyconcerns

• Lostprofits:- assessmentofprofitasatruemeasureofdamages isthedrugprofitable? aquestionofsales

- whenisittheonlythingthatyoucanseek?- circumstancesunderwhichlostprofitscanbe

denied Sanofi v. Glenmark (D.N.J.2012) questionofauthorizedgeneric

• Reasonableroyalties:- basisforroyalty- lookingatmarketshare- thepointwhereinfringementbegan

• Mitigatingfactorsimpactingdamageaward

4:45 ethical Considerations for Paragraph IV Matters Before the PTO and District Courts: Inequitable Conduct and More

Bradford J. BadkePartnerRopes&GrayLLP(NewYork,NY)

David G. ConlinPartnerEdwardsWildmanPalmerLLP(Boston,MA)

Anthony E. DowellAttorneyTaftStettinius&HollisterLLP(Chicago,IL)

• AnalysisofthePTO’snewRulesofProfessionalConduct - relationshiptoABAmodelrulesandsignificance harmonizationwithmostethicsrulesadoptedby

most state bars

understanding how the adoption of these rules willimpactParagraphIVlitigation

• ExaminingtheFederalCircuit’stighteningoftheinequitableconductstandardinTherasense - intenttodeceive single most reasonable inference

- materiality ‘butfor’test

• Analyzingthedownwardtrendininequitableconductallegations since Therasense

• ExploringthePTO’sadoptionoftheTherasense standardinitsproceedingswithrespecttoinequitableconductfindings- inequitableconductandPatentReform supplemental proceedings under the AIA:

anopportunitytocureinequitableconduct?• Apotex, Inc., et al., v. UCB, Inc., et al.,

(S.D.Florida2013)- obtainingacompetitor’sproductbydeception

• Sony Computer v. 1st Media LLC (on petition for writ ofcertiorari2013)- possiblereturntopre-Therasense standard

• Rule11obligationstobringanethicssuitin aHatch-Waxmancase- exploringthedebateofwhetherstateorfederallaw

applies to IP malpractice actions

5:45 Conference ends


Workshop Objectives:

• Understandtheapplicationofantitrustlaw’s“RuleofReason”topharmaceuticalpatentsettlements

• DraftandstructureanagreementthatwillpassFTCreview• IdentifyandavoidredflagsthatcouldtriggerFTC

scrutiny• Incorporateelementsthatemphasizetheprocompetitive

nature of the agreement • Assesstheroleofcommitmentsastoauthorizedgenerics

andtheFTC’sviewonthistopic• Understandthesignificanceofotherbusiness

opportunitiesinmakingtheseagreementsviable• Provideaworkingknowledgeofconceptssuchas

valuation,pricing,royaltiesandlostprofitsastheyapplyto these agreements

• Developtimelinesforbusinessandlegalmilestonesrelative to the terms of the settlement

• DevisestrategiestoemploypendingcompletionoftheFTC’sreview

TheMMArequirespharmaceutical companies tonotify theFTC and the DOJ of settlements of pharmaceutical patentdisputes. This mandate has caused both brand names andgenerics alike great apprehension as it replaces patent-baseduncertainty with antitrust risk. Although the FTC haschallenged only two settlements out of the hundreds filedin recent years, its public statements condemning “reversepayments” have created uncertainty and frustration amongboth the branded and generic pharmaceutical industries.

AlleyeswereontheSupremeCourtlastspringwhenitruledinFTC v. Actavis (formerly Watson) in hopes that there would be some guidance as to what was fair or foul in these settlements.

However, the Court’s decision has still not broughtcertainty to the antitrust analysis of these settlements. While, theCourtestablished that theRuleofReason isthe controlling antitrust principle in these cases, it did not explainfullyhowtoapplyit.Moreover,theCommission’sinvocation of Actavis in pursuing agreements relating to itemssuchasauthorizedgenericsonlycontinuestocausethe industry anxiety.

Thishands-on,interactiveworkshopwillexaminehow,inthispost-Actavis environment,parties toaParagraphIVdispute can resolve their differences, reach an agreement thattheybothcanlivewith,andminimizethechancesofcostlyanddistractinggovernmentscrutiny.Theworkshopleaderswillwalk you through the antitrust implicationsof Actavis and provide practical pointers and strategies for the drafting and structuring of successful and sound settlement agreements within the parameters of the workshop’sobjectives.Pointsofdiscussionwillinclude:

• Overviewoftheantitrustlawandcompetitiveprinciples governing pharmaceutical patent settlements

• AnalyzingtheSupremeCourt’srulinginActavis• Reviewofthe“RuleofReason”anditsapplication

to pharmaceutical patent settlements• AnticipatingtheFTC’snextareaoffocusinwake

of the Actavis ruling • Creativesettlementstrategieswithinthescope

of what is permissible • Assessingrolesofin-houseandoutsidecounsel,

andthein-housebusinessteam,indeveloping and executing settlement strategies

• Analysisofantitrustimplicationsofpossibleagreement terms and conditions

• Riskallocationbetweentheparties- supplyagreementsandstrategiesforsuccessful

structuring and permissible terms - avoidanceoftheappearanceofhiddenpayments- carefuluseofdocumentationtopromote

transparency, clarify intent and avoid any allegation ofnon-disclosure

• Developinglegalandbusinesstimelinestodetermineoptimal settlement terms for both sides - keypointsforbusinessandlegaltimelines- assessingtheproduct’splaceinthemarketplacein

comparison to other therapeutic classes of drug - valuationofproductovercourseofpatentlifecycle- criteriafordeterminingvalue- stockvalueovercourseoflifecycle- returnoninvestmentovercourseoflifecycle

• Potentialroyaltystreamsfromlicensing• Assessinglikelihoodsandvaluesoflitigation

outcomes • The30monthstay• Reviewofpricingtermsrelativetosettlement

agreements - transferpricing- bestprice- MedicarePartDpricing- WAC- priceadjustments

• Effexoramicusbriefandauthorizedgenerics- examiningtheapplicabilityoftheScottHart

Rodinopremergernotificationrulesamendmentsconcerning exclusive patent licenses for pharmaceutical products to the settlement of cases broughtunderParagraphIV

Post Conference Workshop on Pharmaceutical Patent Settlements | Wednesday, April 30, 2014 • 9:00 AM to 4:00 PM

(Registration with Continental Breakfast opens at 8:15 AM. Luncheon will be served from 12:00 PM – 1:00 PM.)

The Master Class on Settling Paragraph IV Disputes: Drafting and Negotiating Strategies for Brand-Names and Generics – A Hands-On, Practical Approach in the Aftermath of Actavis

Gregory K. BellGroupVicePresident GlobalPracticeLeader–LifeSciences CharlesRiverAssociates(Boston,MA)

Meenakshi DattaPartnerSidleyAustinLLP(Chicago,IL)

Donald R. McPhailMemberCozenO’Connor(Washington,DC)

Glenn S. Newman, CPA/ABV/CFF, MBA Partner,ForensicLitigation&ValuationServicesParenteBeardLLC(Philadelphia,PA)

Moderators:

Christopher J. KelleyPartnerMayerBrownLLP(PaloAlto,CA)

Steven A. MaddoxPartnerKnobbe,Martens,Olson&Bear,LLP(Washington,DC)


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Baker Botts is an international law firmwithaglobalnetworkofoffices.OurLife

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Brinks Gilson & Lionehas160attorneys,scientificadvisors and patent agents who specialize inintellectual property, making it one of the largestintellectualproperty lawfirms in theU.S.ClientsaroundtheworlduseBrinkstohelpthemidentify,

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Patterson Belknap is a 200-lawyer firm based in NewYork City. More than half of our attorneys are litigators,many with a focus on patent disputes. We litigate “bet-the-company” matters on behalf of major corporations inindustries including pharmaceuticals, manufacturing and software.Manyofourattorneyshavescientificandtechnicalbackgrounds and varied industry experience, includingin such diverse fields as chemistry, biochemistry, biology,biotechnology, statistics, mathematics, and chemical, nuclear and electrical engineering.

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