BIOTECHNOLOGY PATENT LITIGATION - Semantic Scholar · 2016-01-29 · In a nutshell, biotechnology...

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Chapter 8a

BIOTECHNOLOGY PATENT LITIGATION*

Main Supple- Edition ment

I. Introduction ........................................................................... — 36 II. Patentable Subject Matter: How Much is Enough? ............... — 36

A. Patentability of Products of Nature ................................. — 37B. Patentability of Mental Processes and Methods ............. — 40C. Section 101 Strategies ..................................................... — 41

III. DefiningtheClaimedInvention ............................................ — 41A. TheDoctrineofSimultaneousConceptionand

ReductiontoPractice:TheSpecialCaseof Nucleic Acids .................................................................. — 421. ConceptionandPriorityofDNA-BasedClaims ....... — 432. JointInventorshipandDNA-BasedClaims .............. — 433. StrategiesforConception,Priority,and

Inventorship .............................................................. — 44B. ClaimScopeandtheDoctrineofEquivalents ................ — 44

IV. Section112-BasedDefenses:WrittenDescriptionand Enablement ............................................................................ — 46A. WrittenDescriptionChallenges ...................................... — 46B. EnablementChallenges .................................................. — 48

V. InjunctiveRelief .................................................................... — 52A. eBayv.MercExchange: The New Standard for

Patent Cases .................................................................... — 52B. IrreparableHarmPost-eBay ........................................... — 53C. ImportanceofthePublicInterestFactor ........................ — 54D. Injunction Strategies ....................................................... — 55

VI. EvidentiaryConsiderations:ExperimentalEvidence ............ — 56A. TheExpert’sCredibilityandExpertise ........................... — 57B. DesignandExecutionofExperiments ........................... — 58C. AdmittingExperimentalDataIntoEvidence ................. — 59

*DeborahFishmanandKristaCarter,DicksteinShapiroLLP,PaloAlto,California.

sae1

Text Box

Copyright © 2011 American Bar Association, reprinted with permission of the publisher BNA Books. For more information on Patent Litigation Strategies Handbook, Third Edition, please visit bna.com/bnabooks or call 1-800-960-1220.

36 patent Litigation StrategieS handbook—2011 Supp.

i. introduCtion

Whatsetsbiotechnology1patentlitigationapartfromothertypesofpatentlitigation?Inanutshell,biotechnologypatentlitigationischaracterizedbytherecurringthemethatsmallchangescanhavebigconsequences.Whilethisprin-cipleoperatesinmanyareasandgoesbymanynames—an“unpredictableart,”a“pioneeringinvention,”orsimplythechallengeofenablingthefullscopeofone’sclaims—thecommonthreadinthebiotechnologycontextisthatasmallchangeinaDNAsequence,proteinsequence,orlivingorganismcanhavepro-foundandunchartedimplications.Apatenteereliesonthisunpredictabilitywhenheraldingaclaimedinventionasagreatachievementthat,oncedemonstrated,willprovidearoadmapforallwhochoosetofollow.Onechallengingapatentmayusethisunpredictabilitywhendisputingpriorityorconception,ortotestthesufficiencyofthepatent’steachinganddisclosureasmeasuredagainstthefullscopeoftheclaims.

Whilebiotechnologypatent litigation sharesmany strategic and tacticalattributeswithpatentlitigationinothertechnicalareas,inthischapterwefocusontheaspectsofpatentlitigationuniquetothisfieldandsharesomeinsightsonhowtoharnessthepowerofsmallchanges.

ii. patentabLe SubjeCt Matter: how MuCh iS enough?

In the process of researching and developing biotechnology products,researchersmayinnovatenewandbettermethodsofmanufacturingandusingthoseproducts.Forthisreason,innovationinthebiotechindustrycanresultinavarietyofinventionsthatcovermultipleaspectsoftheprocessofmakinganewproductandmethodsofusingthedevice,inadditiontothenewandusefulproductitself.Forexample,thedevelopmentofanewtherapeuticmayresultinpatentscoveringtheisolatedDNA,aprocessformakingaproteinorantibody,therecombinantly-producedproteinorantibodyitself,andmethodsofusingthatproductasatherapeutic.Similarly,thedevelopmentofanewmedicaldevicemayleadtopatentscoveringthedevice,componentsofthedevice,andmethodsforusingthem.Whilepursuingseparatepatentprotectionformultipleinven-tionsmaybetime-consumingandcostly—notinsignificantconsiderationsforearly-stagecompanies—obtainingpatentsoneachoftheseseparateinventionsprovides thebroadestpatentprotectionand the long-termability tomaintainmarketexclusivity(andstrategicflexibility)forthegreatestduration(sinceeachpatentisprosecutedseparately,eachoftenissuesatadifferenttimeandcarriesadistinctpatentterm).

Thequestionthenbecomes:Whatdiscoveriesalongthepathofresearchanddevelopmentarelegallysufficienttoqualifyaspatent-eligiblesubjectmatter?Conversely,wheredoesaninventorinvitechallengebasedonhisorherclaiming

1“Biotechnology”isoftenusedtorefertotechnologythatdependsinsomeimportantwayontheuseoflivingorganisms,cells,orcell-derivedmaterials.PatentsinthebiotechnologyindustryaredirectedtoproductssuchasisolatedDNA,recombinantly-producedproteins,andmonoclonalantibodies,aswellastheprocessesformakingthemandmethodsordeliverysystemsforusingthem.

8A.I.

bioteChnoLogy patent Litigation 37

strategy?Thissectionexploressomeofthebenefitsandpitfallsofseekingandobtainingbroadcoverageforbiotechinventionsthroughapanoplyofclaims.

Section101ofthePatentActprovides:“Whoeverinventsordiscoversanynewandusefulprocess,machine,manufacture,orcompositionofmatter,oranynewandusefulimprovementthereof,mayobtainapatenttherefor,subjecttotheconditionsandrequirementsofthistitle.”2AlthoughtheSupremeCourthasidentifiedlawsofnature,naturalphenomena,andabstractideasascategoricalexceptionsthatarenoteligibleforpatentprotection,3patenteligibilityhashis-toricallypresentedarelativelylowbar,withotherrequirementsofpatentability,suchasthosesetoutin35U.S.C.§§102,103,and112,havingmoreteeth.TheSupremeCourtinDiamondv.Chakrabarty,forexample,interpretedthePatentAct broadly and opened the door to the patenting of living organisms.4 The Courtexplainedthat“[i]nchoosingsuchexpansivetermsas‘manufacture’and‘compositionofmatter,’modifiedbythecomprehensive‘any,’Congressplainlycontemplatedthatthepatentlawswouldbegivenwidescope.”5Asfurthersup-port,theCourtquotedThomasJefferson,theauthorofthePatentActof1793,to theeffect that“ingenuityshouldreceivea liberalencouragement”;6 it also pointed to theCommitteeReportsaccompanying the1952Act,whichstatedthatCongressintendedpatentablesubjectmatterto“includeanythingunderthesunthatismadebyman.”7

Recentdevelopmentsinthecaselawseemtohaveraisedthebar—oratleastmuddiedthewaters—astowhatconstitutespatent-eligiblesubjectmatter,thusmakinga§101patentchallengeamoreappealingdefense.Thetwoareasthathavebeenthemostinflux,andwhichthereforeprovidethemostopportunityforpatentchallengers,are(1)patentclaimsdirectedtoproductsofnatureand(2)patentclaimsdirectedtomethodsofuse(whichcanbeattackedasmentalprocesses).

A. PatentabilityofProductsofNature

In Diamondv.Chakrabarty,8theSupremeCourtbegantodrawnuanceddistinctionsbetweenwhat isandwhat isnotpatentablesubjectmatter in thebiotechnologyindustry.TheSupremeCourtthereconsideredwhetherproductsofnaturecouldconstitutepatentablesubjectmatter,andheldthatChakrabarty’sinventionofaman-madebacteriumcapableofbreakingdowncrudeoilconsti-tutedapatentable“manufacture”or“compositionofmatter.”9Theinventionwasdeterminedtobenotonlydistinctfromwhatisfoundinnature,butalsotohavepotentiallysignificantutility:

[T]hepatenteehasproducedanewbacteriumwithmarkedlydifferentcharacter-isticsfromanyfoundinnatureandonehavingthepotentialforsignificantutility.

235 U.S.C. §101. 3Diamondv.Chakrabarty,447U.S.303,309(1980).4Id. at 308.5Id.6Id.at308–09(quoting5writingS of thoMaS jefferSon75–76(Washingtoned.,1871)).7Id.at309(quotingS. rep. no.82-1979,at5(1952);H.R.Rep.No.82-1923,at6(1952)).8447U.S.303(1980).9Id. at 309–10.

8A.II.A.


Hisdiscoveryisnotnature’shandiwork,buthisown;accordinglyitispatentablesubjectmatterunder101.10

Insoholding,theCourtdistinguishedother,earliercaseswhere,despiteclearactsofhumaningenuityandcreativity,theresultsnonethelessfailedtorisetothelevelofpatentablesubjectmatter.Forinstance,thedisputedclaimsintheearlycase of FunkBros.SeedCo.v.KaloInoculantCo. were directed to an inoculant forplantsproducedbyselectingnon-inhibitingstrainsofdifferentspeciesofbacteria.11 The FunkCourtarticulatedtherulethatphenomenaofnature—suchasthequalitiesofthesebacteria,theheatofthesun,electricity,andthequalitiesofmetals—“aremanifestationsoflawsofnature,freetoallmenandreservedexclusively to none.”12While therewas an advantage to the selectionof thebacteria,theclaimedproductwasnonethelessfoundtobeunpatentablebecause“[t]hecombinationofspeciesproducesnonewbacteria,nochangeinthesixspeciesofbacteria,andnoenlargementrangeoftheirutility....Theyservetheendsnatureoriginallyprovidedandactquiteindependentlyofanyeffortofthepatentee.”13Therefore,thesubjectmatterofthepatentclaimswasdeterminedtobeunpatentablephenomenaofnature.14

For purposes of patentability, between the genetically-engineered livingorganismandtheproductseeminglypluckedas-isfromnatureliepurifiedandisolatedproductsofnature.Thepurificationandisolationoftheseproductscanrenderthemnewlyusefulas,forexample,therapeuticsortestingmaterialforuse in scientific research.While patentability depends onwhether a claimedcomposition“possessesanewordistinctiveform,quality,orproperty”com-paredtothenaturally-occurringproduct,15courtshavehistoricallymaintainedthevalidityofpatentsonpurifiedandisolatedproductsofnature.Bywayofexample,JudgeLearnedHandinParke-Davis&Co.v.H.K.MulfordCo. rejected avaliditychallengetopatentclaimsdirectedtoanadrenalinecompoundthathadbeenisolatedandpurifiedfromanimalsuprarenalglands.16Unliketheclaimedinvention,adrenaliningrossformasfoundinnaturecouldnotbeusedforthetherapeuticpropertiesitpossessed,norcoulditbeadministeredtohumansfortreatment.Similarly,inInreBergstrom,theCourtofCustomsandPatentAppealsupheldthevalidityofpatentsdirectedtopurifiedprostaglandinsthathadbeenextractedfromprostateglands.17TheC.C.P.A.notedthatthesenaturally-occur-ringproducts“donotexist innatureinpureform,”makingsuchcompoundspatent-eligible.18

Thus,thecaselawdistinguishesbetween,ontheonehand,theunpatent-ableproductofnatureinanunmodified(albeituseful)formand,ontheother,thepatentable,man-madeproductorimprovement(eventhroughpurification)

10Id. at 310.11FunkBros.SeedCo.v.KaloInoculantCo.,333U.S.127(1948).12Id.at 130.13Id.at 131.14Seealso ExParteGrayson,51USPQ413(Pat.Off.Bd.App.1941)(denyingapatentonabeheaded

andcleanedshrimpstillinitsshellbecausetheshrimp,eventhoughmanipulated,wasnonethelessanunpat-entableproductofnature).

15AmericanFruitGrowersv.BrodgexCo.,283U.S.1,11(1931).16Parke-Davis&Co.v.H.K.MulfordCo.,189F.95(S.D.N.Y.1911).17InreBergstrom,57C.C.P.A.1240(C.C.P.A.1970).18Id.at 1249.

8A.II.A.


uponnature.Thislong-standingdivisionbetweenpatentableandunpatentablesubjectmatterwasrecentlychallengedinAssociationforMolecularPathologyv. U.S. Patent & Trademark Office.19Inthatcase,adistrictcourt(forthefirsttime)invalidatedpatentsdirectedtoisolatedDNAandmethodsofanalyzinggenesequencesbasedontheconclusionthatDNA(even“isolatedDNA”)isanunpat-entableproductofnature,therebyintroducingnewvulnerabilityanduncertaintyregardingclaimsdirectedtoisolatedand/orpurifiedproductsofnature.20

Thedistrictcourt’srulinginAssociationofMolecularPathology,holdingthatclaimstoisolatedDNAencodingbreastcancersusceptibilitygeneswereunpatentable,wascontrarytoPatentOfficepracticeofgrantingpatentsoniso-latedDNAandcaselawupholdingtheirvalidity.ThecourtfocusedonwhethertheclaimedDNAhadstructuralorfunctionaldifferencesthatmadeit“markedlydistinct”fromthenativeDNAfoundinnatureanddeterminedthat“[t]hepropercomparisonisbetweentheclaimedisolatedDNAandthecorrespondingnativeDNA,andthepresenceorabsenceofchromosomalproteinsmerelyconstitutesadifferenceinpurity thatcannotservetoestablishsubjectmatterpatentabil-ity.”21Onappeal,theFederalCircuitreversedandheldthattheclaimsdrawntoisolatedDNA“aredrawntopatentablesubjectmatterbecausetheclaimscovermoleculesthataremarkedlydifferent—haveadistinctivechemicalidentityandnature—frommoleculesthatexistinnature.”22Thecourtexplainedthathumaninterventionincleavingorsynthesizingresultsin“adistinctivechemicalidentity”fromnativeDNA,andthattheformerisnotjustapurifiedformofnativeDNA.23 Moregenerally,theFederalCircuitrejectedthedistrictcourt’sattempttocreateacategoricalruleexcludingisolatedDNAfrompatenteligibility,notingthatsuchachangeinthelawwouldhavetocomefromCongress.24

TheFederalCircuit’sdecisioninAssociationforMolecularPathologycon-firmedthepatentabilityofisolatedDNAandhasbeenaverypositivedevelopmentforinnovatorbiotechnologycompaniesaswellasthepublic,whichbenefitsfromthegreatadvancestheseinventionscontributetothemedicalcommunity.Hadthedistrictcourt’sdecisionbeenupheld,itwouldhavecausedsignificantdisruptiontotheincentivesforcompaniesandscientiststoinvestsignificanttimeandeffortinthediscoveryofnewtherapeutics,amongotherthings.Asthischaptergoestopress,theuncertaintysurroundingthepatentabilityofisolatedDNAseems,atleastfornow,tohaveabated.

19AssociationforMolecularPathologyv.U.S.Patent&TrademarkOffice,702F.Supp.2d181(S.D.N.Y.2010).

20Id.at 232.21Id.at229–30.Thedistrictcourtalsoheldthatthepatentsdirectedtomethodsofanalyzingandcom-

paringgenesequencesandmethodsofusingtheDNAtoscreenforcancerrisksbycomparinggrowthratesofcellswereinvalidasmentalprocessesthatfailedtomeetthe“machine-or-transformation”test.Id.at 236–37. Thepatentabilityofmentalprocessesandmethodsisdiscussedin§II.B.,infra.

22AssociationforMolecularPathologyv.U.S.Patent&TrademarkOffice,No.2010-1406,2011WL3211513,at*17,99USPQ2d1398(Fed.Cir.July29,2011).TheFederalCircuitalsoreversedthedistrictcourt’s holding that themethodofusing theDNA to screen for cancer risks failed to rise to the levelofpatent-eligiblesubjectmatter,rulinginsteadthat thismethodispatentablebecausetheclaimcontainedan“inherentlytransformativestepinvolvingthemanipulationofthecellsandtheirgrowthinthemedium.”Id. at*23.However,theFederalCircuitaffirmedthelowercourt’srulingthatthemethodclaimstocomparingoranalyzingDNAsequenceswithouta“transformative”stepwerenotpatent-eligible“becausetheyclaimonlyabstractmentalprocesses.”Id. at *21.

23Id.at *17.24Id.at *18.

8A.II.A.


B. PatentabilityofMentalProcessesandMethods

Inanotherrecent§101development,theSupremeCourtinBilskiv.Kappos addressedthepatentabilityofmethodclaimsand,inparticular,claimsdirectedtoamethodofhedgingriskinthefieldofcommoditiestrading.25Whilethetech-nology at issue in Bilksiwasunrelatedtothelifesciencesindustry,thedecisionhasimportantimplicationsforthefieldofmedicaltechnologyandmethodsoftreatment.Aspartofanoverallpatentstrategy,medicaltechnologycompanieswillpursuepatentsnotonlyonthemedicaldeviceortherapeuticproductitselfbutalsoonnovelmethodsofusingthedeviceorproduct.

The BilskiCourt rejected a categorical rule that business methods arenotpatentable,butnonethelessaffirmedtheFederalCircuit’sholdingthattheconceptofhedgingriskandtheapplicationofthatconcepttoenergymarketsareunpatentableabstractideas.26Significantly,theCourtendorsedthemachine-or-transformationtestasoneapplicable test,butheld that itwasnot the sole orexclusivetestforpatent-eligiblesubjectmatter.27TheCourtrecognizedthetestasa“usefulandimportantclue,aninvestigativetool,fordetermining”thepatentabilityofprocessclaims;28then,insteadofprovidingmoreconcreteguid-anceonwhatothertestscouldbeapplied,itdirectedcourtssimplytolooktotheSupremeCourt’sprecedenttodeterminewhatwouldconstituteanunpatentableabstract idea.29Attheendoftheday,theBilskidecisioncautionedtheFederalCircuitandlowercourtstoavoidbright-linedeterminationsandaffordedthemgreaterflexibilityinassessingpatentablesubjectmatter.

Inoneofthefirstpost-Bilskidecisionsaddressing§101patentability,theFederalCircuitinPrometheusLaboratories,Inc.v.MayoCollaborativeServicesupheld(forthesecondtime)thevalidityofmethodclaimsdirectedtoadmin-isteringadrugandthendeterminingthelevelofthedrug’smetabolitesinthesubject.30SincetheSupremeCourtdidnotrejectthemachine-or-transformationtest,itisnotsurprisingthattheFederalCircuitappliedthissametestagainonremandtoreachthesameconclusion.TheFederalCircuitagaindisagreedwiththedistrictcourtthatthestepsoftheclaimedprocessweresimplyunpatentablecorrelationsofnaturalphenomena,andalsodisagreedthatthestepsweremerelyunpatentabledata-gatheringandmentalsteps.Rather,theFederalCircuitfoundthattheclaimsweredirected“nottoalawofnature,buttoaparticularapplicationofnaturallyoccurringcorrelations,andaccordinglydonotpreemptallusesoftherecitedcorrelations.”31Theclaimedmethodsthussatisfiedthetransformationprongofthemachine-or-transformationtestbecausethey“‘transformanarticle

25Bilskiv.Kappos,130S.Ct.3218(2010).26Id.at3228,3231.27Id.at3227.Themachine-or-transformationtestprovidesthataclaimedmethodorprocessispatent-

ableifitistiedtoaparticularmachineorapparatusortransformsaparticulararticleintoadifferentstateorthing.

28Id.at 3227.29Id. at 3231.30PrometheusLabs,Inc.v.MayoCollaborativeServs.,628F.3d1347(Fed.Cir.2010).TheFederal

Circuithadoncebeforereachedthesameconclusionunderthemachine-or-transformationtest(seePrometheusLabs.,Inc.v.MayoCollaborativeServs.,581F.3d1336(Fed.Cir.2009)),buttheSupremeCourtgrantedMayoCollaborative’spetitionforawritofcertiorariandvacatedandremandedthecaseinlightoftheBilski decision.MayoCollaborativeServs.v.PrometheusLabs,Inc.,130S.Ct.3543(2010).

31PrometheusLabs,628F.3dat1354.

8A.II.B.


intoadifferentstateorthing,’andthistransformationis‘centraltothepurposeof theclaimedprocess.’”32Thecourt elaboratedon this lastpointandstatedthat“methodoftreatment[claims]...arealwaystransformativewhenoneofadefinedgroupofdrugsisadministeredtothebodytoamelioratetheeffectsofanundesiredcondition.”33Followingthisdecision,theSupremeCourtagaingrantedcertiorarionJune20,2011;theoutcomeofthatreviewremainstobeseen.

C. Section101Strategies

Itmaybeprematuretoalterone’spatentlitigationstrategybasedonthenon-final decisions inPrometheusand Association forMolecularPathology,butsomeguidepostsareemergingthatmaybeinstructivetopatenteesandpat-ent challengers.While not dispositive, themachine-or-transformation test isinstructiveandsuggeststhatthestrongestbiotechnologyclaimswillbethosedirected toproducts thathavebeenaltered fromtheirnatural stateand thosedirectedtomethodsoftreatmentinwhichthebodyis“transformed”asaresultofthetreatment.

Forapatentee,astraightforwardpre-litigationstrategymaybetodraftpatentclaimstosatisfyatleastthemachine-or-transformationtestbytyingamethodorprocesstoaparticulardeviceinbroadtermsorclaimingisolatedDNAinavector,thusreinforcingpatentabilityinexchangefornarrowerclaimscope.Oncethepatenteehasemergedfromprosecutionwith issuedpatents, itcandecidewhenfacinganinfringingcompetitorwhethertoassertitsentirepatentportfolioor,instead,toselectonlythestrongestpatentclaimsfroma§101perspectiveinordertoavoidthechallengeofpatentablesubjectmatteraltogether.

Forapatentchallenger,newopportunitiesemergetousetheambiguityinthelaw,thelackofbright-linerules,andtherecentheightened§101scrutinytogainstrategicadvantage.Apatentchallengermayraisea§101issueearlyinacaseforthematicreasonsaswell:tominimizethesignificanceoftheclaimedinventionbycharacterizingitasaproductthatexistsinnatureorasamereabstractidea.Moreover,achallengetothepatentabilityofassertedclaimsinthisunknownenvironment—especiallyafteradistrictcourtdecisionlikethatinAssociationofMolecularPathology—posesconcernforthepatenteeandprovidesmoreofanincentivetosettleratherthantakethechancethatitspatentclaimswillbeinvalidated.Nowthat theSupremeCourthaseliminatedBilski’smachine-or-transformationtestasabright-linerule,issuesofpatentablesubjectmatteraremuchlesslikelytobedecidedonsummaryjudgment.Theywillneverthelessremainaviabledefenseandasourceofpatentvulnerabilityuntilthelawismoreclearlydefined.

iii. defining the CLaiMed invention

Abiotechnologypatentcase,likemanyothertypesofpatentcases,beginsandendswiththedefinitionoftheclaimedinvention.Inthebiotechfield,how-ever,definingtheclaimedinventionisasmuchanartasitisascience.Whatmay

32Id.at1355(quotingInreBilski,545F.3d943,962(Fed.Cir.2008)).33Id. at 1356.

8A.III.


berequiredforapatenteetoconceiveofanisolatedDNAsequence,ageneticmarker,atherapeuticallyeffectiverecombinantprotein,oramethodofscreen-ingforadiseaseorconditionpushestheboundariesofpatentlawaswellasthestateoftherelevantart.

Pioneersareoftenentitledtobroadclaimscope,34 but those who follow in the footstepsofpath-breakinginventorsmustnavigatethepriorartandtakecareincraftingclaimsandmakingrepresentationsduringprosecutioninordertosecurewhat they canwithout unnecessarily surrendering claim scope. Claim scopeisinherentlyfact-boundandwilldependon,amongotherthings,theintrinsicrecord:theclaims,thespecification,andthefilehistory.Additionally,boththepatenteeandtheallegedinfringermustplaythehandthattheyhavebeendealtandeitherembraceorreconcilethosefactswhenconstructingtheirarguments.

Whileneitherthepatenteenortheallegedinfringerisentirelyfreetowriteonablankslate,drawingthemetesandboundsofaclaimedinventionprovidesopportunities to introduce (or resolve)possibledisputes regarding, interalia,priority,conception,inventorship,writtendescription,enablementandscopeofequivalents.

A. TheDoctrineofSimultaneousConceptionandReductiontoPractice:TheSpecialCaseofNucleicAcids

What is theclaimed inventionandwhatwasrequired toconceiveof it?Conceptionisthecompletionofthementalactofinventionandthetouchstoneofinventorship.35Itiswell-settledlawthatconceptionofaclaimedinventionrequiresboththeideaofaninvention’sstructureandpossessionofanoperativemethod formaking it.36 In thecaseofDNAandother chemical compounds,“conceptiondoesnotoccurunlessonehasamentalpictureofthestructureofthechemical.”37

Intheearly1990s,whenconsideringclaimstoanisolatedDNAsequence,theFederalCircuitappliedthedoctrineofsimultaneousconceptionandreductiontopractice.38Borrowingfromalineofcasesdatingbacktothe1940s,theCourtdeterminedthatwhenaninventorisunabletoenvisionthedetailedstructureofaDNAsequence,aswellasamethodforobtainingit,“conceptionhasnotbeenachieveduntilreductiontopracticehasoccurred,i.e.,untilafterthegenehasbeenisolated.”39Whilenotentirelylimitedtoisolatednucleicacidclaims,thedoctrinehasbeenusedinthemainintheconsiderationofDNAclaimsand,forgoodorill,haspersistedintheanalysisoftheseclaimstothepresentday.

34See,e.g.,AugustineMed.,Inc.v.GaymarIndus.,Inc.,181F.3d.1291,1301(Fed.Cir.1999)(“Withoutextensivepriorarttoconfineandcabintheirclaims,pioneersacquirebroaderclaimsthannon-pioneerswhomustcraftclaimstoevadethestricturesofacrowdedartfield.”).

35BurroughsWellcomeCo.v.BarrLaboratories,Inc.,40F.3d1223,1227–28(Fed.Cir.1994)(citingSewallv.Walters,21F.3d411,415(Fed.Cir.1994)).

36SeeOkav.Youssefyeh,849F.2d581,583(Fed.Cir.1988);seealsoHybritechInc.v.MonoclonalAntibodies,Inc.,802F.2d1367,1376(Fed.Cir.1986).

37AmgenInc.v.ChugaiPharmaceuticals,Inc.,927F.2d1200,1206(Fed.Cir.1991).38Id. SeealsoFiersv.Revelv.Sugano,984F.2d1164(Fed.Cir.1993).39AmgenInc.,927F.2dat1206.SeealsoFiers,984F.2d1164(Fed.Cir.1993);accordSmithv.Bousquet,

111F.2d157(C.C.P.A.1940).

8A.III.


1. ConceptionandPriorityofDNA-BasedClaims

Oneconsequenceofapplyingthedoctrinetobiotechnologicalinventionsisthatthemomentofcompletedconceptionispushedforwardintimetothemomentofreductiontopracticeorevenlater.Becauseconceptionrequiresthataninventorappreciatewhatheorshehasinvented,40apatentchallengermayarguethatreductiontopracticeofthestructureisnecessarybutnotsufficientforfullconceptionoftheclaimedinvention.Forexample,iftheclaimedinventionincludesarecombinantproteinthatpossessescertainproperties,oraparticularuseofanisolatedDNAsequence,completeconceptionmayrequirebothidenti-ficationoftheunderlyingstructure(DNAorproteinsequence)andconfirmationoftheclaimedfunctionality.

Foronechallengingthevalidityofapatent,extendingthetimeforconcep-tion(andsimultaneousreductiontopractice)opensthewayforprioritychal-lenges,interveningart,orevencontributionbyotherpotentialputativeinventors.Conversely,definingearlywhatisrequiredtoconceiveoftheclaimedinventionallowsapatentee toanticipateandstaveoff invaliditychallenges,aswellasmarshalevidencetocorroborateconceptionandreductiontopractice.

2. JointInventorshipandDNA-BasedClaims

Wherethecompletedactofconceptionispushedforwardintime,thecon-tributionsofothers—eveninthecontextofsimultaneousconceptionandreduc-tiontopractice—openthewayforclaimsofjointinventorship(oradefenseofmisjoinderornon-joinder)and/orobviousness.

Whileajointinventormustcontributeinsomesignificantwaytotheconcep-tionoftheinvention,thereisnorequirementthatajointinventorindependentlyhaveacontemporaneouspictureofthefinalclaimedinventioninordertoqualifyasajointinventor.41TheFederalCircuithasheldthatthedoctrineofsimultane-ousconceptionandreductiontopracticecannotbeusedtoshowthat“becausethefirstpersondidnotconceiveorreducetopracticetheentireclaimedinven-tion,heorshedidnotatleastcontributeinsomesignificantwaytotheultimateconception.”42Therefore,thecontributionsofcollaboratorsorco-workersmayqualifyasinventiveevenwherethecollaboratordidnothave“anindependentmentalpictureofthecompletecompoundclaimed.”43Forapatentchallenger,aprolongedtimelinetocompletedconceptionmayopenthedoortocontributionsbyothersthatmaybefoundtobeinventive.Wherethosecontributionsweremadeoutsideofcommonemploymentoranobligationtoassign,theymayalsoprovideachallengerwiththebasisforanobviousnessdefense.44Asseveralcourtshavenoted,jointinventorshipisoneofthe“muddiest”conceptswithinpatentlaw,45 providingamplefodderforapatentchallengerinthelifesciencesfield.

40InvitrogenCorp.v.ClontechLabs,Inc.,429F.3d1052,1063(Fed.Cir.2005)(citingSilvestriv.Grant,496F.2d593,597(C.C.P.A.1974)).

41VanderbiltUniv.v.ICOSCorp.,601F.3d1297,1303(Fed.Cir.2010).42FinaOilv.Ewenv.Razavi,123F.3d1466,1474(Fed.Cir.1997);seealsoVanderbiltUniv.v.ICOS

Corp.,601F.3d1297,1308(Fed.Cir.2010).43VanderbiltUniv.v.ICOSCorp.,601F.3d1297,1307(Fed.Cir.2010).44See35U.S.C.§103(c).45SeeBrownv.RegentsofUniv.ofCal.,866F.Supp.439,442(N.D.Cal.1994)(citing Mueller Brass

Co.v.ReadingIndus.,Inc.,352F.Supp.1357,1372(E.D.Pa.1972),aff’d, 487F.2d1395(3dCir.1973)).

8A.III.A.2.


Apatenteemaycharacterizethecontributionsofothersastherotelabworkofatechnicianorapairoflabhandsactingundertheguidanceandsupervisionofthepatentee.Evenwherethecontributorisaco-workerorunderacommonobligation of assignment, a patenteemaywish tomaintain the contributor’snon-inventivestatusnotonlytoavoiddisruptingthedesignationofthenamedinventor/inventors,butalsosothatthecontributormayserveasanon-inventorcorroboratoroftheinvention.46

3. StrategiesforConception,Priority,andInventorship

WhilebothpatenteesandpatentchallengerstendtoapplythedoctrinebyrotetoDNA-basedclaims,itisworthconsideringwhetherdoingsomakessenseinlightofthefactsofthecaseathandandthenatureoftheclaimedinvention.Forbothpatenteesandchallengers,itisimportanttorememberthatthedecisionsfirstapplyingthedoctrineofsimultaneousconceptionandreductiontopracticetoDNA-based inventions areundeniablyproductsof their time.Theearliestcasesreflectthestateoftheartin1983–84,whenadetailedmethodforisolatingaDNAsequence,byitself,didnotensuresuccessorcertaintyinobtainingthedesiredsequence.

TheFederalCircuithasconsistentlydeclinedtoholdthataninventorcanneverconceiveofaninventionuntilreductiontopracticebecauseoftheinherentunpredictabilityofthescience.47Rather,ineachoftheDNAorbiotechconceptioncases,thecourtultimatelyreliedonthedateofreductiontopracticebecauseit,ineffect,providedthefirstevidencetocorroborateconceptionoftheinvention.48 Today,morethan25yearsaftertheseearlyDNAcases,polymerasechainreaction(PCR),DNAscreeninglibraries,andthehumangenomeprojecthavemadetheisolationandcharacterizationofDNAsequencesmuchmorepredictable,andapatenteeorpatentchallengermayfindroomtodistinguishtheapplicationofthedoctrineandre-settheclocktoanearlierdateforcompletedconception.

B. ClaimScopeandtheDoctrineofEquivalents

Notwithstandingapatentee’sefforttodefinethemetesandboundsoftheclaimedinvention,heorshecannotconceiveoforenableeverypossibleper-mutationandmayneedtorelyonascopeofequivalentstocaptureanaccusedinfringer’sactivities.Thedoctrineofequivalentsholdsaspecialchallengeforpatenteesintheunpredictableartofbiotechnology.

Ontheonehand,apatenteewantstomaintainhisorherpositionthattheclaimedinventionwasabreakthroughthatprovedaprinciple,clearingthewaypastpriorartthatmightotherwiseberelevant.Atthesametime,however,argu-

46SeeProcter&GambleCo.v.TevaPharm.USA,Inc.,566F.3d989,999(Fed.Cir.2009)(citing Hahn v.Wong,892F.2d1028,1032(Fed.Cir.1989)(Aninventor“mustprovideindependentcorroboratingevidenceinadditiontohisownstatementsanddocuments.”).SeealsoShu-HuiChenv.Bouchard,347F.3d1299,1309(Fed.Cir.2003)(“Itiswellestablishedthatwhenapartyseekstoproveconceptionviatheoraltestimonyofaputativeinventor,thepartymustprofferevidencecorroboratingthattestimony.”).

47SeeSmithv.Bousquet,111F.2d157,162(C.C.P.A.1940);AmgenInc.v.ChugaiPharm.Co.,927F.2d1200,1206–07(Fed.Cir.1991);Fiersv.Revelv.Sugano,984F.2d1164,1171(Fed.Cir.1993);BurroughsWellcomeCo.v.BarrLabs.,40F.3d1223,1229(Fed.Cir.1994);seealsoBoardofEducationv.AmericanBioscienceInc.,333F.3d1330,1340(Fed.Cir.2003).

48Id.

8A.III.A.2.


ing thata smalldifference—insequence, in structure, inmethod—mayhaveprofoundconsequencesandconstituteapatentable inventionmakes itall themoredifficulttoarguethatsimilarsmalldifferencesareproperlycapturedbythescopeofequivalents.Forexample,patentedproteinsmayhavehundredsorthousandsofanalogs(e.g.,bysingleaminoacidsubstitution)thatarenotliterallycoveredbytheclaims.Whenmorethanoneaminoacidissubstituted,added,and/ordeleted,thenumberofanalogsincreasesexponentially.Theonlyavenueforcapturingthesesmallchangestotheclaimedproductmaybethroughthedoctrineofequivalents.Patentees,then,areconfrontedwithaHobson’schoice:Loseascopeofequivalentsoropenthedoortoobviousness.

Insomecases,dependingonwhatpositionsitwasforcedtostakeoutdur-ingprosecution,apatenteewillhavelessflexibilityinchoosinghowtoframeitsclaimsandscopeofequivalents.Wherethepatenteehassubmittedanarrow-ingamendmenttoitspendingclaimsinordertoovercomearejectionrelatedtopatentability,thepatenteemaybeestoppedfromassertingthoseclaimstocoverclaimscopethatisdeemedsurrendered,regardlessofhowminortheamendmentorhowclosetheaccusedproductistomeetingtheclaimlimitation.TheFederalCircuit in GlaxoWellcome,Inc.v.ImpaxLaboratories,Inc. considered a case wherethepatenteeamendeditsclaimsinresponsetoanenablementrejectiontoaddaspecificmechanismofaction.49Thecourtheldthatprosecutionhistoryestoppelattachedtothatamendment,andthatthedoctrineofequivalentscouldnotbeusedtoproveinfringementbyanotheragentthathadanequivalentmecha-nismofactiontotheoneclaimed.50

Sometimes,though,apatenteecancarefullythreadtheneedletomaintainbotharguments.InAbbottLaboratoriesv.Dey,Inc.,forexample,theFederalCircuitconsideredwhetherthedoctrineofequivalentscouldbeappliedwhereclaimsdirectedtoalungsurfactantcompositionwith68.6–90.7%phospholipidwereassertedagainstanaccusedproductcontaining94.5%phospholipid.51 To determinewhetherthedoctrineofequivalentscouldbeappliedtocapturethisincreaseinphospholipid,thecourtconsideredwhethera“hypotheticalclaim”thatliterallyencompassedtheaccusedproductwouldbeallowableoverthepriorart.52Thecourtdeterminedthat,eventhoughtheclaimrecitedaspecificnumericrangeandthepriorartoverlappedwiththatrange,thedoctrineofequivalentscould be applied because other limitations rendered the hypothetical claimnonobvious.53Thus,thedoctrineofequivalentsmaybeappliedtocapturetheslightchangesmadebyanaccusedinfringerifthepriorartdoesnotprecludesuchapplication.

Whileapatenteewillbemoresuccessfulassertingapioneeringpatentwherethepriorarthasnotforcedextensivenarrowingamendmentsornoveltyargu-ments,thereremainstheformidabletaskofdecidinghowtoframetheclaimed

49356F.3d1348,1351–56(Fed.Cir.2004).50Id. at 1354–56. SeealsoAmgenInc.v.HoechstMarionRoussel,Inc.,457F.3d1293,1308–16(Fed.

Cir.2006) (prosecutionhistoryestoppelprecluded infringementbyequivalentswhere theaccusedproteindifferedfromtheclaimedproteinbyoneaminoacid).

51AbbottLabs.v.Dey,L.P.,287F.3d1097,1107–08(Fed.Cir.2002).52Id.at1105(citingWilsonSportingGoodsCo.v.DavidGeoffrey&Assocs.,904F.2d677,684(Fed.

Cir.1990)(“ThepertinentquestionthenbecomeswhetherthathypotheticalclaimcouldhavebeenallowedbythePTOoverthepriorart.”)).

53Id. at 1106–07.

8A.III.B.


inventionanditsscopeofequivalentsinawaythatavoidsobviousnesschallengesbasedontheassertionthatsmallchangesaresimilarinstructure,function,andresult.Aswiththe§112defensesdiscussedbelow,apatenteemaytakerefugeinthepatent’sowndisclosure.Forinstance,asmallchangewhoseaffectisunknownorunprovenpresentsauniverseofunpredictability.However,onceapatenteehastestedthesmallchange,andthusprovenaprinciple,otherspracticingintheartwiththebenefitofthatknowledgeanddisclosure(thepatent’steaching)maybeabletoapplythatchangerotely,ortoextrapolatefromtheprinciplemorebroadlyandmorepredictably.Insomecases,thesetensionswillbeeasiertonavigate,butinallcases,navigatingthisconflictanddecidingearlyinthecasehowtoframetheinventionareboththornyandcriticallyimportant.

Forapatentchallenger,itisimportanttominetheprosecutionhistorytothefullestextent,includingparentandsiblinghistories,tolookforevidenceofsurrenderedclaimscope.At thesame time, thechallengershouldexploit thetensionbetweennonobviousnessandnoveltyintheclaimedinventionandthepatentee’sattempttocaptureabroaderscopeofequivalentsinitsargumentsandindevelopingitsfactualrecord.

iv. SeCtion 112-baSed defenSeS: written deSCription and enabLeMent

Oneofthemostuniquehallmarksofbiotechnologypatentlitigationisthat§112invaliditydefensesareoftenmoresuccessfulthanthetraditionalantici-pationandobviousnessdefensescommoninothertypesofpatentlitigation.54 Becauseoftheunpredictabilityinherentinthebiotechnologyfield,biotechnol-ogypatentsareoftenmorepronetoattackasfailingtosatisfytheirdisclosurerequirementsthanforhavingbeenpracticedorsuggestedbythepriorart.Infact,somestatisticssuggestthat§112defensesarenearlytwiceaslikelyasSection102andSection103defensestoprevailinlifesciencespatentdisputes—nearlythecompleteinverseoftheresultsseeninITpatentlitigation.55

A. WrittenDescriptionChallenges

Amongthevarious§112defenses,writtendescriptionisoneofthemostfruitfulareasforapatentchallengertoexplore.Thisislargelybecausethedis-closure requirement inabiotechnologypatentapplication isheld toahigherstandardthanitsITcounterparts.AstheFederalCircuithasmadeclear,the“levelofdetailrequiredtosatisfythewrittendescriptionrequirementvariesdependingonthenatureandscopeoftheclaimsandonthecomplexityandpredictabilityoftherelevanttechnology.”56

Tosatisfythewrittendescriptionrequirement,apatenteemustdescribetheinventioninsufficientdetailso“thatoneskilledintheartcanclearlyconclude

54SeedatafromtheUniversityofHoustonLawCenteratwww.patstats.org.55Id.56AriadPharm.,Inc.v.EliLilly&Co.,598F.3d1336,1351(Fed.Cir.2010)(enbanc)(citing Capon

v.Eshhar,418F.3d1349,1357–58(Fed.Cir.2005)).

8A.III.B.


thattheinventorinventedtheclaimedinventionasofthefilingdatesought.”57 Patentchallengesinthelifesciencesbasedonwrittendescriptioncomeintwodistinctflavors.Thefirstmirrorsachallengetoconception—i.e.,anallegationthatthepatenteehasfailedtoconveytoanordinarilyskilledartisanthatheorshewasinpossessionof(orfullyappreciated)theclaimedinventionatthetimeoffiling.Thesecondtypeofattack,oftenreferredtoasa“genus/species”attack,allegesthatthepatenteehasnotadequatelydescribedthefullscopeoftheclaimssuchthatoneskilledintheartwouldhavebeenabletovisualizethefullcomple-mentofclaimedembodiments.Thissecondavenueofattackisverysimilartoascopeofenablementattackthatcanbemountedagainstgeneric(or“genus”)claims,asdiscussedbelow.

Thefirsttypeofwrittendescriptionchallengeisstrikinglysimilartotheconceptioncasesdiscussedabove.Inpractice,theFederalCircuithasrequiredapatentee todisclose the isolatedDNAsequenceforanyDNA-based inven-tion:“[A]nadequatewrittendescriptionofaDNArequiresmorethanamerestatementthatitispartoftheinventionandreferencetoapotentialmethodforisolatingit;whatisrequiredisadescriptionoftheDNAitself.”58Intheseminalwrittendescriptioncase,RegentsoftheUniversityofCaliforniav.EliLilly&Co.,theFederalCircuitfoundthataclaimdirectedtocDNAencodinghumaninsulinwasnotadequatelydescribedbythedisclosureofratinsulincDNAandageneralmethodforobtaininghumancDNA.59

Whilemorerecentcaseshavesuggestedthatfunctionallanguagemaysatisfythewrittendescriptionrequirementwherethereexistsanestablishedcorrelationbetweenstructureandfunctionthatissufficientlydisclosedorknownintheart,60 asapracticalmattertheFederalCircuithascontinuedtorequireasequenceorstructure-baseddisclosureinallbutacoupleofoutliercases.61Infact,apatentee’sinclusionofafunctionallimitationmayactuallyintroduceadditionaldescriptiondefectsifacourtfindsthatthereisinsufficientsupportforthegenusofclaimedstructuresactuallypossessingtherecitedfunction.62

Forapatenteedefendingagainstthistypeofwrittendescriptionattack,itiscriticaltodevelopevidenceshowingtheinventor’scontemporaryappreciationandpossessionoftheclaimedinvention.Evidenceofpossessioncanbebolsteredbydevelopingarecordshowingthatcorrelatedstructureswerewellknownorcouldberoutinelyselectedin theart.Apatentchallenger,ontheotherhand,mayexploittheprolongedtimelinetocompleteconception,andthusacomplete

57Lockwoodv.AmericanAirlinesInc.,107F.3d1565,1572(Fed.Cir.1997).58RegentsoftheUniv.ofCal.v.EliLilly&Co.,119F.3d1559,1566–67(Fed.Cir.1997)(internal

citationsomitted).59Seeid.at1567(“Whiletheexampleprovidesaprocessforobtaininghumaninsulin-encodingcDNA,

thereisnofurtherinformationinthepatentpertainingtothatcDNA’srelevantstructuralorphysicalcharac-teristics;inotherwords,itthusdoesnotdescribehumaninsulincDNA.DescribingamethodofpreparingacDNAorevendescribingtheproteinthat thecDNAencodes,astheexampledoes,doesnotnecessarilydescribethecDNAitself.”).

60EnzoBiochem,Inc.v.Gen-Probe,Inc.,323F.3d956,964(Fed.Cir.2002)(writtendescriptionrequire-mentmaybesatisfiedifthefunctionalcharacteristiciscorrelatedtoaparticularstructurethatissufficientlydisclosedorknownintheart);seealso Caponv.Eshhar,418F.3d1349(Fed.Cir.2005).

61Ariad Pharm., Inc. v. Eli Lilly&Co., 598 F.3d 1336, 1351 (Fed.Cir. 2010) (en banc); see alsoBillups-Rothenberg,Inc.v.AssociatedRegional&Univ.Pathologists,Inc.,642F.3d.1031,1036–37(Fed.Cir.2011).

62CentocorOrthoBiotechv.AbbottLabs.,636F.3d1341,1352(Fed.Cir.2011);see InreKubin,561F.3d1351,1353–54(Fed.Cir.2009).

8A.IV.A.


description, inorder to introduceuncertaintyregardingpriority, inventorship,andultimatelypossession,asdiscussedinmoredetailbelow.

Thesecondtypeofwrittendescriptionattackisbasedonachallengetothebreadthoftheclaimedinvention.Anadequatewrittendescriptionofaclaimedgenusrequires“morethanagenericstatementofaninvention’sboundaries.”63 A patenteemust set forth “either a representative number of species fallingwithinthescopeofthegenusorstructuralfeaturescommontothemembersofthegenus.”64Whatconstitutesa“representativenumberofspecies”isinverselyrelatedtothepredictabilityintheart,suchthattheFederalCircuithasnotedthatasinglespecieswillrarelybesufficienttoadequatelydescribeabroadclaiminanunpredictableart.65Nonetheless,theultimatedeterminationofwhatconstitutesdisclosuresufficienttodemonstratethataninventorpossessed(orconceived)oftheclaimedgenuswillbeinherentlyfact-bound.

This written description genus/species challenge goes to the heart of abiotechnologypatentcase:Havingmadeadiscoveryinanunpredictablefield,thepatenteewishes toclaimmorebroadlythanmerelythespecificdisclosedembodiments.Foranallegedinfringer, theunpredictability in theartandthepatentee’sallegationofnonobviousnesscanbepowerfuladmissionsforuseinunderminingthefullscopeoftheclaimedinvention.

Forthepatentee,therealchallengeindefendingagainstagenus/specieschallengeliesincharacterizingthebreadthoftheclaimasanon-novelfeatureoftheinvention.Forinstance,havingdiscoveredandisolatedtheDNAsequenceforhumanerythropoietin,apatenteemayarguethatappreciatingtherangeofvectorsorhostcellsthatcouldbeusedforrecombinantexpressionwasfairlyroutine.66Thepatenteewillcharacterizetheinventionasaparadigmshiftand,insodoing,mayarguethattheclaimedinventionopenedupanewfieldsuchthatotherscominglatercouldeasilyfollow,andthattheinventorwasthereforeentitledtoclaimhisorherinventionbroadly.Muchoftheevidentiaryrecordthatcanhelpdefendagainstawrittendescriptionchallengebasedonclaimbreadthwillbeusefulindefendingagainstasimilarbreadthchallengeonseparateenable-mentgrounds,asdiscussedbelow.

Fromtheperspectiveofapatentchallenger,muchofthepatentee’sevidenceofnonobviousnessandinventivenessmaybeparlayedintounpredictabilityinthescopeoftheclaimedinvention.Thecruxofthedefenseistotietheunpredict-abilityintheclaimeddiscoverytothebreadthorgenusaspectoftheclaim.

B. EnablementChallenges

Thesameunpredictabilitythatprovidesthebackdropforsignificantandpioneeringinventionsinthebiotechnologicalartcanposeproblemsforpatenteesattemptingtodiscloseandenablethefullscopeoftheirclaims.Theenablementdefense,likewrittendescription,providesmuchgristforpatentchallengers.

FromthefirstPatentActuptothepresent,Congresshasrequiredthat,inexchangefortheprivilegeoflimitedexclusivity,patenteesdiscloseandteach

63AriadPharm.,Inc.,598F.3dat1349.64Id. at 1350.65Id.66Amgenv.HoechstMarionRoussel,Inc.,314F.3d1313,1335(Fed.Cir.2003).

8A.IV.A.


ordinarilyskilledartisanshowtomakeandusetheclaimedinvention.67Today,Section112,paragraph1requiresthepatent’sspecificationtodisclose“theman-nerandprocessofmakingandusing[theclaimedinvention],insuchfull,clear,concise,andexacttermsastoenableanypersonskilledinthearttowhichitpertains,orwithwhichitismostnearlyconnected,tomakeandusethesame.”68 Overtime,caselawhaselaboratedonthestatutetorequirethatapatent’sspeci-ficationteachoneofordinaryskillinthearthowtomakeandusetheclaimedinventionwithoutundueexperimentation.69

Whileitisblack-letterlawthatapatenteeneednotdiscloseinhisorherpatentthatwhichiswellknownintheart,70thescopeofwhatiswellknownorwellunderstoodtoanordinarilyskilledartisaninarapidlyadvancingorunpre-dictableartwilloftenbenarrowandwillalmostcertainlybethesubjectofsomedebate.Andinanascentoremergingtechnology,onlythemostincidentalorminorfeaturesofthemethodofmakingorusingtheclaimedinventionmaybeinferredorprovidedbytheexistingknowledgeintheart.71

Whereapatentdisclosesasingleexampleoralimitednumberofexamples(or“species”)yetclaimsmorebroadly(asina“genus”),apatentchallengermayexploittheunpredictabilityoftheartandraiseanunduebreadthchallenge(simi-lartothatdiscussedaboveinthecontextofwrittendescription)totheclaimedinventionbasedontheseparateenablementrequirementofSection112.Inaseriesofcasesdecidedintheearly1990sarisingfromappealsbeforetheBPAI,theFederalCircuitrejectedbroadgenusclaimswhereonlyoneoralimitednumberofworkingexampleshadbeendisclosed.

In InreVaeck,theFederalCircuitheldthatclaimstotheuseofallbacte-rialhostcellswerenotenabledbyaspecificationthatprovidedtwoworkingexamples,bothusingasinglecyanobacteriastrainasthehost.72Twoyearslater,in InreWright,thecourtconcludedthatclaimstocertainpathogenicRNAvirusvaccineswerenotenabledbyasingleworkingexampletoaspecificRNAtumorvirus,andfurthersuggestedthatasingleworkingexampleisrarelysufficienttoenableaclaimtoabroadgenus.73Thatsameyear, in InreGoodman, theFederalCircuitagainconcludedthatapatenteefailedtoenablegenusclaimstogeneticallyalteredplants(bothmonocotsanddicots)wherethesingleworkingexampledisclosedonlyageneticallyaltereddicot(oneofthespeciesclaimed).74 Thesecasesstandforthepropositionthatapatenteemaynotbeabletosupportabroadgenusclaimbydisclosinghowtomakeanduseoneoronlyalimitednumberofspeciesfallingwithinthescopeofthegenus.Theassessmentof“how

67PatentActof1790,Ch.7,1Stat.109-112(Apr.10,1790).6835U.S.C.§112para.1.69InreWands,858F.2d731,736–37(Fed.Cir.1988)(“Enablementisnotprecludedbythenecessityfor

someexperimentationsuchasroutinescreening.However,experimentationneededtopracticetheinventionmustnotbeundueexperimentation.Thekeywordis‘undue,’not‘experimentation.’”);EnzoBiochem,Inc.v.Calgene,Inc.,188F.3d1362,1371–72(Fed.Cir.1999).

70Hybritechv.MonoclonalAntibodies,Inc.,802F.2d1367,1384(Fed.Cir.1986)(“[A]patentneednotteach,andpreferablyomits,whatiswellknownintheart”.);seealso ChironCorp.v.Genentech,363F.3d1247,1254(Fed.Cir.2004).

71Genentech,Inc.v.NovoNordisk,108F.3d1361,1366–67(Fed.Cir.1997),cert.denied,522US963(1997).

72InreVaeck,947F.2d488(Fed.Cir.1991).73InreWright,999F.2d1557(Fed.Cir.1993).74InreGoodman,11F.3d1046(Fed.Cir.1993).

8A.IV.B.


muchisenough”willbefact-specific,butingeneraltheamountofdisclosurecourtswillrequirewillbeinverselyproportionaltothepredictabilityintheartand,specifically,inthefieldoftheinvention.

Apatent challengerwill adduce the samekinds of evidence thatwouldsupportagenus/speciesattackonwrittendescription(asdiscussedabove)—thelimitednatureofthedisclosure,thelackofpredictabilityintheart,theexistenceofinoperativeembodiments—tomaintainitschallengeforlackofenablement.Apatenteewillagainmarshalevidenceandargumenttosupportitscontentionthatonceithadprovenanunpredictableorunknownprinciple,thatprinciplecouldbebroadlyandpredictablyapplied.Fromthepatentee’sperspective,however,anunduebreadthchallengemaybeeasiertocombatthanawrittendescriptionchallengebecauseapatenteeisbetterabletosupplementthepatent’sdisclosurewithwhatwasknowntoanordinarilyskilledartisanatthetime.75Forexample,apatenteecandevelopandrelyonevidenceoutsideofthepatent’sdisclosuretosupporttheenablementoftheclaims.76Apatenteemayalsointroducepost-filingevidenceofenablementtoshowthatthepatentwasenabledatthetimeoffiling.77Itispermissibleforanordinarilyskilledartisantoexperiment,andeventoencounterinoperativeembodimentswithinthescopeofaclaim,aslongastheexperimentationisnot“undue.”78Thus,apatenteecandevelopevidencethatoneofordinaryskillintheartwouldhaveknownhowtoselectortestforappropri-ateorworkablespeciesfromwithinthegenus,oreventhatheorshecouldhavefoundsuitablespecieswithsome(butnotundue)experimentation.

Inadditiontobreadthandscopechallengestotheenablementofaclaimedinvention,apatentchallengermayalsoattempttoundermineeithernoveltyorenablementbypointingtosomelater-developedtechnology(usuallythealleg-edlyinfringingtechnology)thatthepatenteehasfailedtodiscloseandenable.Patenteesarenotobligatedtoteachhowtomakeandusetheallegedinfringingtechnology;wheretheclaimsaretiedtoparticularmethods,however,newordifferentmethodsthatarenotdisclosedortaughtbythepatenteeexposeenable-mentvulnerabilityforthepatent.Atthesametime,fromathematicperspective,apatentchallengerwillalmostalwaysbemotivatedtoshowthatitsownaccusedproductortechnologyissignificantlydifferentfromtheclaimedinventionandnotenabledby thepatentdisclosure.Evenwhere thisshowing isnotstrictlyrelevanttotheissueofenablement,itbecomesanimportantequitablethemeinadefenseagainstinfringement.

Thedevelopmentofpost-filingtechnologythatfallswithinthescopeofaclaimedinventionhasspecialconsequencesforboththepatenteeandthepatentchallenger.Forcomposition-of-matterclaims,thelawisclearthat“thespecifica-tionneedteachonlyonemodeofmakingandusingaclaimedcomposition.”79

75SeeAmgenInc.v.HoechstMarionRoussel,Inc.,314F.3d1313,1336(Fed.Cir.2003)(“Thespeci-ficationneednotexplicitlyteachthoseinthearttomakeandusetheinvention;therequirementissatisfiedif,givenwhattheyalreadyknow,thespecificationteachesthoseintheartenoughthattheycanmakeandusetheinventionwithout“‘undueexperimentation.’”)(citingGenentech,Inc.v.NovoNordisk,A/S,108F.3d1361,1365,42USPQ2d1001,1004(Fed.Cir.1997);InreVaeck,947F.2d488,495,20USPQ2d1438,1444(Fed.Cir.1991)).

76SeeAmgenInc.v.HoechstMarionRoussel,Inc.,314F.3d1313,1336(Fed.Cir.2003).77Seeid.78InreWands,858F.2d731,736–37(Fed.Cir.1988).79JohnsHopkinsUniv.v.Cellpro,Inc.,152F.3d1342,1361(Fed.Cir.1998).

8A.IV.B.


Thus,wherethemethodofmanufactureisimmaterialtotheclaimedinvention,enablement does not require the patentee to describe and teachmethods bywhichthepatentedcompositionmaybemadethataredevelopedafterthepat-entisfiled.80

In InvitrogenCorp.v.ClontechLaboratories.,Inc.,forexample,thepatentedclaimsdescribedgeneticallyengineeredenzyme,reversetranscriptase(“RT”),RTwithoutregardforthemethodusedtomutatethegenes.81Thepartiesagreedthatwhenthepatentwasfiled,thoseskilledintheartknewseveraltechniquesforalteringgeneticsequences,includingdeletionandpointmutations.Thepat-entchallengerarguedthatthepatentonlytaughthowtoimplementtheinven-tionbypointmutation.TheFederalCircuitfocusedonthefactthattheclaimswerenotlimitedtothemethodusedtomutategenesandheldthatthepatenteehadfullydescribedanoperablemethodforachievingtheclaimedmutation.82 Similarly,inAmgenInc.v.HoechstMarionRoussel,Inc.,83thepatentclaimsatissueincludedcompositionclaimsdirectedtorecombinanthumanerythropoietin(EPO),anaturallyoccurringhormonethatcontrolstheformationofredbloodcellsinbonemarrow.ThepatentchallengerarguedthatbecausethespecificationfailedtoteachthemethodofhomologousrecombinationandendogenousgeneactivationfortheproductionofrecombinanthumanEPO,thespecificationdidnotenableoneofordinaryskillinthearttopracticethefullscopeoftheassertedclaimswithoutundueexperimentation.TheFederalCircuitheldthatbecausetheclaimsatissuedidnotreciteaparticularmethodfortheproductionofEPO,thespecification’sfailuretodisclosealater-developedendogenousgeneactivationtechnologycouldnotinvalidatethepatent.84

Whilecomposition-of-matterclaimsmaybeimmunetochallengesbasedonpost-filingdevelopments,othertypesofclaims,andspecificallymethodclaims,arenot.Whereapatenteeassertsbroadmethodclaims,post-filingdevelopmentsin theartmayprovideauniqueopportunityforpatentchallengers topresentthematicallyconsistentnoninfringementandnonenablementdefenses.Apatentchallengermaybuildonitsnoninfringementdefensetoarguethatnotonlyistheaccusedmethodsignificantlydifferentfromtheclaimedinvention,butalsoiftheclaimscopeisbroadenoughtoreadontheaccusedmethod,thenthepatenteefailed toadequatelyenablepost-filingdevelopments. Insupportof thisargu-ment,thechallengermayrelyonevidencefromthetimeoffiling,orevenlater,todemonstratethestateoftheartatthetimeoffiling,orthatlaterdevelopmentswerenotenabledevenafterthefilingdate.85

Inallitsvarieties,thedeterminationofenablementissofact-dependentthatitisrareforabiotechpatentchallengernottomountanenablementdefense.Almostinevitably,boththepatenteeandthepatentchallengermustdevotecon-siderableresourcestodevelopingafactualrecord(bothfromthetimeofpatent

80SeeAmgenInc.v.HoechstMarionRoussel,Inc.,314F.3d1313,1336(Fed.Cir.2003)(citing US SteelCorp.v.PhillipsPetroleumCo.,865F.2d1247,1251(Fed.Cir.1988);InreKoller,613F.2d819,824–25(C.C.P.A.1980));seealsoInreHogan,559F.2d595,606(C.C.P.A.1977).

81429F.3d1052,1071(Fed.Cir.2005).82Id. at 1070–72. 83AmgenInc.v.HoechstMarionRoussel,Inc.,314F.3d1313(Fed.Cir.2003).84Id.at1334–36.85Seeid. at 1336.

8A.IV.B.


filingandbeyond)fromwhichtheymaypresent,ordefendagainst,thebreadthofenablementchallenges.

v. injunCtive reLief

Thesignificanceof injunctive relief—both topatenteesandpatentchal-lengers—cannotbeoverstated.Forbiotechnologycompaniesseekingtoenforcetheirpatents,theavailabilityofinjunctivereliefprovidesanincentivetoinvestinthetime-consumingandcostlyendeavorofresearchinganddevelopingnewproducts,andtheawardordenialofaninjunctioncanforeverchangethecom-petitivelandscape.AftereBayv.MercExchange,itwashotlydebatedwhetherthebacklashagainstpermanentinjunctionswouldaffectbiotechnologycases.Whilepermanentinjunctionsarenolongerautomaticallygrantedafterafavorabledispositiononthemerits,thevarietyoffactorsthatcourtsconsidertodeterminewhetheraninjunctioniswarrantedstillfavorsinjunctionsinthosebiotechnol-ogycaseswherethepatentedinventionisavailableonthemarketandsatisfiesmarketdemand.Forbiotechnologycompaniesinparticular,thefourthprongoftheinjunctioninquiry—thepublicinterestprong—hasheightenedsignificanceand,posteBay,playsa special role incourts’assessmentof theproprietyofinjunctionsinbiotechnologypatentcases.

A. eBay v. MercExchange:TheNewStandardforPatentCases

TheSupremeCourtineBay,Inc.v.MercExchange,L.L.C.,determinedthatthatthetraditionalfour-factorinjunctiontestappliestopatentcases.86Thus,tobeentitledtoaninjunction,apatenteemustdemonstrate:(1)thatithassufferedirreparableinjury;(2)theinadequacyofmonetarydamages;(3)thatthebalanceofhardshipsweighsinfavorofaninjunction;and(4)thatthepublicinterestwouldnotbedisservedbyapermanentinjunction.87

Insettingforththisstandard,theCourtrejectedthenotionthatirreparableharmmaybepresumeduponafindingofpatentinfringementandvalidity.Inotherwords, patentees are no longer automatically, or almost automatically,entitled to an injunction. Instead, theCourt directed trial courts to apply thetraditional four-factor test in exercising their equitable discretion to grant ordeny a permanent injunction, andwarned against adopting categorical rulescompellingthegrantordenialofsuchrelief.Accordingly,themajorityopinionwrittenbyJusticeThomasemphasizedthatthedistrictcourtshave“considerablediscretion.”88Inaconcurringopinion,however,ChiefJusticeRobertsremindeddistrictcourtsthat“discretionisnotwhim”andthatthereisa“longtraditionofequitypractice”tofollow.89

Onremand,thedistrictcourtdeniedthemotionforpermanentinjunction,findingthat therewasnoirreparableharmandthat thereexistedanadequateremedyatlaw(i.e.,monetarydamages)whereMercExchangedidnotpractice

86eBay,Inc.v.MercExchange,L.L.C.,547U.S.388(2006).87Id.at 391.88Id. at 394.89Id.at395(Roberts,C.J.,concurring).

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theclaimedinventionanddidnothaveapresenceintheonlineauctionindus-try (i.e.,MercExchangewas not a direct competitor of eBay). Furthermore,MercExchange’s post-trial discussions regarding licensing suggested that itsrequestforaninjunctionwasa“litigationtactic”anddidnotarisefromalegiti-mateneedtoprotectitsbusiness.Thedistrictcourt’sdecisiononremandwasconsistentwithJusticeKennedy’sconcurringopinion,wherehehighlightedtherelativelynewphenomenonofpatenteesusingtheirpatentsnottomakeandsellproducts,butrather toextract licensingfees,andstated that in thesecircum-stancestheequitiesmaytipinfavoroftheinfringer.90Inthecontextofweighingtheinjunctionfactors,anon-practicingentityislesslikelytosufferirreparableharm,absentaninjunction,whereitisseekinglicensingfeesorsettlementsinanyevent.Inaddition,thebalanceofhardshipsmayfavoraninfringerwhohasaproductonthemarketandmaynotevenhavebeenawareofthepatentwhenitinvestedinthedevelopmentandmarketingofthatproduct.Ontheotherhand,thecourtshavebeenunsympathetictoinfringerswhoplantolaunchatriskandthencomplainoftheirhardshipifenjoined.91

B. IrreparableHarmpost-eBay

Post-eBaycaselawsuggeststhatthefactsmostdeterminativeinestablishingirreparableharmare(1)directcompetitionbetweenapatenteeandtheaccusedinfringerand(2)lossofsalesandmarketsharebythepatentee.92Anothercompel-lingfactthatcourtshavefoundtoweighinfavorofirreparableharmisthepatentee’sprotectionofitsrightofexclusivitybydecliningtolicenseitspatentrights.93

Apatenteewhoalleges these factsbut fails to substantiate itsclaimsofirreparableharmwillnotbeentitledtoaninjunction.Forexample,thedistrictcourt in Praxair,Inc.v.ATMI,Inc.,deniedaninjunctionwhere,eventhoughthepartiesweredirectcompetitors,thepatenteefailedtodemonstratethattheassertedpatentswerecriticaltotheoverallcorporatesuccessofthecompany.94 Inparticular,Praxairgenerallyarguedthatthepresenceoftheinfringingprod-uctwould cause Praxair to “likely lose additionalmarket share, profits, andgoodwill,”butdidn’tprovideanyevidenceordetailstosubstantiateitsclaims.

90Id.at396(Kennedy,J.,concurring).91MercExchange,L.L.C.v.eBay,Inc.,500F.Supp.2d556,584(E.D.Va.2007).92See,e.g.,NovozymesA/Sv.GenencorInt’l,Inc.,474F.Supp.2d592,613(D.Del.2007)(grant-

ingpermanent injunctionbecause, interalia,“[t]hesearehead-to-headcompetitors,andNovozymeshasaright,grantedbyCongress,nottoassist itsrivalwiththeuseofproprietarytechnology”);FreseniusMed.CareHoldings, Inc.v.Baxter Int’l, Inc.,2008U.S.Dist.LEXIS79689,at*11(N.D.Cal.Mar.21,2008)(“ThelawfavorsBaxter’srighttothefullvalueofitsproperty,particularlytheabilitytokeepitoutofitsmaincompetitor’shands.”);Muniauction,Inc.v.ThomsonCorp.,502F.Supp.2d477,482(W.D.Pa.2007)(“Plaintiffanddefendantsaredirectcompetitorsinatwo-suppliermarket.Ifplaintiffcannotpreventitsonlycompetitor’scontinuedinfringementofitspatent, thepatentisoflittlevalue.”)(vacatedonothergrounds532F.3d1318);AmgenInc.v.Hoffmann-LaRocheLtd.,581F.Supp.2d160,212(D.Mass.2008)(grantingpermanentinjunctionwhere“[t]hevastmajorityofRochesaleswouldbetotheexclusionofAmgensales,resultinginlostprofits,marketshare,andgoodwill”).

93See,e.g.,3MInnovativePropertiesCo.v.AveryDennisonCorp.,2006U.S.Dist.LEXIS70263,at*4–5(D.Minn.Sept.25,2006)(Because3Mspentseveralyearsconsistentlyrefusingtolicenseitspat-entrights,“[t]heCourtwillnotdisturb3M’sdeterminationthatitsbusinessinterestswillnotbeservedbythelicensingofthisproduct.”);cf.IMX,Inc.v.Lendingtree,LLC,469F.Supp.2d203,225(D.Del.2007)(“Plaintiff’swillingnesstoforegoitspatentrightsforcompensation,thoughcertainlynotdispositive,isonefactortoconsiderwithrespecttowhetherplaintiffwillsufferirreparableharm.”).

94Praxairv.Adv.Tech.Materials,479F.Supp.2d440(D.Del.2007).

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Thedistrictcourtnotedthat,whileitwasunclearwhatquantumofevidenceisrequired,Praxairhadn’tmetitsburdeninanyevent.95

Conversely,theabsenceofdirectcompetitionorlossofsalesandmarketsharedoesnotprecludeapatenteefrombeingentitledtoaninjunctionwhereirreparableharmcannonethelessbeestablished.InCommonwealth Scientific & IndustrialResearchOrganisationv.BuffaloTechnologyInc.,forexample,thedistrict courtgrantedaninjunctionwherethepatentee,anon-practicingentity,spentlargesumsofmoneyintheresearchanddevelopmentofitspatentedtech-nologies.96ThecourtfounditparticularlycompellingthatCSIROisaresearchinstitute that reliesheavilyon itsability to license its intellectualproperty tofinance its research and development. If, at the end of the day, an infringermerelyhadtopayaroyalty insteadoffacingapotential injunction, itwouldhavenoincentivetoenterintoalicenseagreementinthefirstinstanceratherthanchallengethepatents.Furthermore,ifCSIROhadtopursueeachinfringertoenforceitspatentsanddivertmillionsofdollarsforeachlitigation,itsresearchanddevelopmentoperationswouldbesignificantlydelayedandhindered.Thus,sinceCSIRO’slicensingstrategywenttothecoreofitsbusinessmodel,itwouldbeirreparablyharmedabsentaninjunction.97

Anotherimportantconsiderationinassessingtheproprietyofaninjunctioniswhetherthepatentedinventionisonlyonepartofamulti-componentproductthat is accusedof infringement. In JusticeKennedy’sconcurringopinion,hespecificallypostulatesthataninjunctionmaynotservethepublicinterestwherethepatentedinventionisbutasmallcomponentoftheinfringingproductandthethreatofaninjunctionisusedtoobtainexorbitantfees.98 Courts also consider whethertherearenon-quantifiableintangiblelosses,suchasharmtoreputationandgoodwill,lossoftalent,priceerosion,lossofmarketposition,andlossofmarketopportunities.99

Thus,thecaselawsuggeststhatthereisacontinuumoffactualparadigmswiththepatenttroll(anon-practicingentityendeavoringtoextortlicensingfeesforprofitratherthanforfutureresearchanddevelopment)ononeendandthepath-breakingpioneer(aninnovatorthatpracticestheinventionandprotectsitsrightofexclusivitywhilemakingthebenefitsofitsinventionavailabletothepublic)ontheother.Themorecloselyapatentee’ssituationapproachesthatofapioneeringandpracticinginventor,themorelikelyitistosucceedinobtainingan injunction.

C. ImportanceofthePublicInterestFactor

Regarding thepublic interestprongof the injunction inquiry, courtsaredirectedtoconsiderwhetheraninjunctionwould“notdisservethepublicinter-

95Id.at 443–44.96CommonwealthScientificandIndustrialResearchOrganisationv.BuffaloTech.,492F.Supp.2d

600(E.D.Tex.2007).97Id.at 604–05.98eBay,Inc.v.MercExchange,L.L.C.,547U.S.388,396(2006)(Kennedy,J.,concurring).99See,e.g.,Sanofi-Synthelabov.Apotex,Inc.,470F.3d1368(Fed.Cir.2006)(lossofgoodwilland

potentiallay-offsevidencedirreparableharm);PurduePharmaL.P.v.BoehringerIngelheimGmbH,237F.3d1359,1368(Fed.Cir.2001)(priceerosionandlossofmarketpositionevidencedirreparableharm);PolymerTechnologies,Inc.v.Bridwell,103F.3d970,975-76(Fed.Cir.1996)(lossofmarketopportunitieswasevi-denceofirreparableharm).

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est”—notwhetheritwouldservethepublicinterest.Thisstandardisconsistentwiththelongtraditioninequitypracticeoffavoringthestatusquoversusamoreinterventionistapproach,whichseemsappropriatesincewhatwillorwillnotservethepublicinterestishighlyspeculative.Forexample,willanewproducthavebeneficialeffects?Willithaveapositiveimpactonthemarketand/orreducecosts?Inthepharmaceuticalindustry,theavailabilityofanewproductwillnotnecessarilydrivedowncosts.Giventhecomplexitiesofthepricingandpaymentforpharmaceuticals,companiesareoftenactuallyincentivizedtoenterthemar-ketatahigherpricethanacompeting,establishedproduct,ascustomersthenreceiveahighergovernmentreimbursementandthecompany’sprofitmarginisincreased.Accordingly,unlessaninfringingproductwouldfulfillanotherwiseunmetmedicalneed,thepublicinterestlikelyfavorspromotinginvestmentsininnovation.

On theotherhand,whatdoes itmean to “notdisserve thepublic inter-est”?Inthebiotechnologyfield,ifthereisapre-existingpublicrelianceonaninfringingproduct,oriftheinfringerprovidestheonlypublicsupplyorsatisfiesanotherwiseunmetmedicalneed,itmaydisservethepublictograntaninjunc-tion.Butevenwhereaninfringingmedicalproductisalreadyonthemarket,apermanentinjunctionmaystillbetheappropriateremedy.Forexample,thedistrict court in Smith&Nephew,Inc.v.Synthes(U.S.A.)grantedapermanentinjunctionenjoiningSynthesfromcontinuingtomarketandsellitsinfringingorthopedicproductwhereotherproductswereavailableandwheretherewasnotasignificantpublicrelianceontheinfringingproduct.100Thus,thecourtfoundthatdisruptingtheinfringingproduct’sdistributionwouldnotnegativelyimpactthepublicinterest.101

Before eBay,courtsroutinelyfoundthattherewasapublicinterestinpro-motingsignificantinvestmentsininnovation.102Thisprinciplewasreinforcedbyadistrictcourtpost-eBay,whichgrantedaninjunctiontopreventacompetingtherapeuticfromenteringthemarket,statingthat“[i]fAmericaistocontinuetobeanengineofmedicalinnovationitwillbebecauseweprotecttherightofinventorstoexploitthelimitedmonopolygrantedinthePatentClause.”103 This isparticularlyimportantinthebiotechnologyindustry,whereittakeshundredsofmillionsofdollarsandmorethandecadetoresearch,develop,obtainFDAapprovalandbringonesuccessfulproducttomarket,withinvestmentsinmanymorefailedendeavorsorproductsalongtheway.

D. InjunctionStrategies

Not surprisingly, the strategies that the patentee and patent challengermayemploy,whethertoobtainortoprecludetheawardofaninjunction,willvaryconsiderablydependingonwhetherthepatenteeisapracticingoranon-practicingpatentee.

100Smith&Nephew,Inc.v.Synthes(U.S.A.),466F.Supp.2d978,985(W.D.Tenn.2006).101Id.102See,e.g.,PatlexCorp.v.Mossinghoff,758F.2d594,599(Fed.Cir.1985) (“Theencouragement

ofinvestment-basedriskisthefundamentalpurposeofthepatentgrant,andisbaseddirectlyontherighttoexclude.”);Sanofi-Synthelabov.Apotex,Inc.,470F.3d1368,1383(Fed.Cir.2006).

103AmgenInc.v.Hoffmann-LaRocheLtd.,581F.Supp.2d160,227(D.Mass.2008).

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Anon-practicingpatenteeshouldbepreparedtodemonstrateitsinvestmentinresearchanddevelopment,andtoshowthatlackofaninjunctionwouldcauseirreparableharmtoitsbusinessmodelandcycleofinnovation.Wherethepatenteedoesnotitselfpracticetheinventionbutsuppliesthemarketwithotherproductsorservices,thebrightlinedistinctionsfadeandcourtsmustlookatthebusinessmodelasawholewhenassessingirreparableharmandpublicinterestfactors.

Foranallegedinfringerdefendingagainstanon-practicingpatentee,itisimportanttodevelopafactualrecordregardingpublicinterestandthebalanceofhardships.Inbiotechnologycases,establishingthattheaccusedproductfillsanunmetneed(amedicalneed,andnotmerelyacosmeticone)anddemonstratingasustained,significantinvestmentinresearchanddevelopmentbytheallegedinfringer(andthelackofsuchinvestmentbythepatentee)augursinfavorofdenyingapermanentinjunction.

Apracticingpatentee,ontheotherhand,shouldmarshalevidencetodem-onstrateitssubstantialinvestmentinresearchanddevelopment,itsinvestmentin thedevelopment or cultivationof the relevantmarket, and its relianceonexclusivityinordertodemonstratetheirreparableharmitwouldsufferifanewentrantwerepermittedinthemarket.Atthesametime,apracticingpatenteewillwanttodevelopargumentsbothtoshowthataninjunctionfavorsthepublicinterestandtodefendagainsttheinevitableargumentsbythepatentchallengerregardingthebenefittoconsumers,thegovernment,andpatientsofallowinganalternativeorcompetingproductormethodonthemarket.

Apatentchallengerdefendingagainstapracticingpatenteewillneed todevelopevidencetochallengeboththeirreparableharmandthepublicinterestfactors.The complexity of that challengewill differmarkedlydependingonwhetherornottheaccusedproductormethodisalreadyonthemarketatthetimeofadjudication.Eitherway,patentchallengersinbiotechnologycasesareuniquelypositioned to implicate thechoice,cost,anddeliveryofhealthcarewhendevelopingarecordonhowinjunctivereliefwillaffectthepublicinterest.Inparticular,apatentchallengerwillseektodevelopevidenceofunmetmedicalneed,consumerchoice,andaffordabilitythateitherareorwouldbeaddressedbypermittingtheaccusedproductormethodonthemarket.Notably,apatentchallengermay be better positioned to develop its public-interest argumentswhereithasalreadyenteredthemarket;thechallengermaythenbaseargumentsregardingconsumerrelianceorchoicewheresomesegmentofthemarkethasalreadyadoptedtheaccusedproductormethod.Ofcourse,obviousdownsidestoalaunch-at-riskstrategyarewillfulinfringementdamagesandthesunkcostofmarketlaunch.

vi. evidentiary ConSiderationS: experiMentaL evidenCe

Onesignificantevidentiaryconsiderationinbiotechnologycasesiswhetherascientificexperimentcanbeusedtoproveordisproveadisputedissue.Forexample,apatenteemayconductscientificexperimentstoprovewhethertheaccusedproduct,process,ormethodmeetsthelimitationsoftheassertedclaims.Atthesametime,apatentchallengermayconductexperimentstoprovethatthepriorartmeetsallofthelimitationsoftheassertedclaims,orthatthepatentee’s

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preferredembodimentdoesnotfallwithinthescopeoftheclaims,thusbluntingthepatentee’sargument that theproduct’scommercialsuccess isevidenceofnonobviousness.Assumingsuchanexperimentispossible,determiningwhethertoconductthescientificworkisadifficultstrategicandtacticaldecisiongiventhelevelofvariabilityandunpredictabilityinthelifesciences.Thereisnoguaranteethatexperimentswillyield the supportingevidence thecommissioningpartyseeks.Ontheotherhand,afactfindercoulddrawanegativeinferencewhereapartyhadtheopportunitytoconductexperimentswiththerelevantproductbutfailed to do so.104

The strategypoints set forth beloware recommendedbest practices fordevelopingthemostreliableexperimentaldatawiththebestlikelihoodofgettingtheresultsofsuchexperimentsadmittedintoevidence.

A. TheExpert’sCredibilityandExpertise

Beforedesigningorexecutingscientificexperiments,apartymustdecidewhichexpert(orindependentlaboratory)isgoingtoperformtheexperimentsandwhetheroneormoreotherexpertswillrelyonthoseexperimentsinformingtheirownopinions.Insomecases,itmakessenseforthesameexpertbothtoperformtheexperimentsandtoprovideanopinionbasedontheresults,suchaswheretheexpert’squalificationsandexperiencemakehimorheruniquelyqualifiedtodoso.However,thereisnorequirementthattheexpertofferingopinionsbasedontheexperimentalevidencehaveahands-onroleinconductingtheexperiments,andtheremaybeimportantreasonstoshieldatestifyingexpertfromtheexperi-mentsuntiltheyarecompleted.105Inanycase,itisimperativethattheexpertperformingorrelyingontheexperimentshavetheappropriate—andhopefullyimpressive—credentialstodoso.106Investingthetimeandresourcesrequiredtoconductexperimentaltestingisnosmallfeat,anditisnotworththeriskofhavingtheresultingevidenceexcludedbyrelyingonanexpertwhoseexpertiseisonlymarginallyrelevant.

Therearebenefitsinretainingtwoormoreexpertsandkeepingtherolesdistinct.First, different expertsmaybebest qualified fordifferent roles.Forexample,theprincipalexpert(i.e.,theoneofferingultimateopinionsinthecase)mayneedabroadbackgroundandabroadarrayofexperiencesinordertobequalifiedtoaddressalltheissuesrelevanttoanultimatelegalissueinthecase,suchasinfringementorvalidity.Ontheotherhand,theexpert(orindependentlaboratory)bestqualifiedtoconducttheexperimentsmayneedspecificexper-tiseandlaboratoryexperience.Earlyattentiontoeachexpert’scredentialsandexperienceonlyservestoenhancethereliabilityandcredibilityofthetestimonyandopinionsoffered.

104Medtronic,Inc.v.BostonScientificCorp.,2002U.S.Dist.LEXIS28355,at*55(D.Minn.Aug.8,2002)(findingexperimentsperformedbyaccusedinfringer’sexpertnotadequatesubstitutesfortestingtheaccusedproductitselfandnotingthattheaccusedproducts“wereavailabletohimfromhisownclientand/orontheopenmarket”).

105Daubertv.MerrellDowPharm.,Inc.,509U.S.579,592(1993)(“[A]nexpertispermittedwidelatitudetoofferopinions,includingthosethatarenotbasedonfirsthandknowledgeorobservation.”).

106FederalRuleofEvidence702requiresawitnesstobe“qualifiedasanexpertbyknowledge,skill,experience,training,oreducation.”

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Second,keepinginmindthepotentiallyvariableandunpredictablenatureoflifescienceswork,itmaybeadvisabletokeeptheprincipalortestifyingexpertshieldedfrompreliminaryexperimentalworkuntiltheresultsofsuchtestsareknownandaredeterminedtobereliableandrelevanttotheissuesinthecase.Ifthisavenueistaken,however,itiscriticaltogettheprincipalexpert’sinput—by,forexample,helpingtodesign,evenintheabstract,awell-controlledandreli-ableexperimentthatintheexpert’sviewprovestherelevantpoint, includingappropriate tests to perform and protocols to follow.This early consultationavoidstheriskofperforminganexperimentonlytofindthattheprincipalexpertis unwilling to rely on the results.

Third,separatingtheroleoftestifyingexpertfromthatofexperiment-con-ductoraddsanotherlayerofqualitycontrolandobjectivitytothescientificwork.Thismaybeespeciallytruewherethescientificworkisdonebyacommerciallaboratory that is in the business of performing such tests. Even though theindependentlaboratoryiscommissionedby,andprofitsfrom,thepartyseekingtorelyontheexperimentalresults,thescientistsundertakingtheworkwillbeonestepremovedfromtheissuesanddisputesinthecase,andwillbefollowingestablishedprotocolsandqualitycontrolprocedures.

B. DesignandExecutionofExperiments

Tobeadmittedintoevidence,anexpert’stestimonymustbe“relevanttothetaskathand”andrest“onareliablefoundation.”107TheSupremeCourtinDaubertv.MerrellDowPharmaceuticals,Inc.heldthatwhenexpertscientifictestimonyisproffered,“apreliminaryassessment[mustbemade]ofwhetherthereasoningormethodologyunderlyingthetestimonyisscientificallyvalid,andwhetherthatreasoningormethodologyproperlycanbeappliedtothefactsinissue.”108Thus,whenexperimentalevidenceisproffered,itmustbebasedonscientificallysoundmethodologiesanddesignedto testfor thespecificclaimlimitationindispute(forexample,whetheranaccusedproducthasaspecificrecitedbiologicalactivity,orwhetheranaccusedmethodoftreatmentresultsintherecitedbiologicaleffect).

Ascientific techniqueormethod thathasbeensubjected topeer reviewandpublicationandgenerallyacceptedbytherelevantscientificcommunityisindicative,thoughnotdispositive,ofscientificvalidity.109Conversely,itisdif-ficulttoprovethatascientifictechniqueormethodologythathasbeenwidelycriticizedor abandonedby the relevant scientific community is scientificallysoundandvalid.

Astorelevancy,oneshouldconsiderconductingthetestorexperimentsetforthinthepatentclaim,ifoneisrecited,ordisclosedinthepatentspecification.Itwouldbedifficultfortheopposingpartytoexcluderesultsprovingordisprovingtheexistenceofacharacteristicwherethesametestswereusedanddescribedbythepatenteetocharacterizehisorherinvention.Whilethisistherecommendedapproach,usingadifferentbutcomparabletestmaybesufficient—ifthetests

107Daubert,509U.S.at584–87.108Id. at 592–93.109Id. at 594.

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areinfactcomparable.110Whenexecutingexperimentsusedatthetimeoftheinventionand/ordescribedinthepatentspecification,itisimportanttofollowthesameprotocolandusethesameconditions,asfaraspossible,thatwereusedatthetimeoftheinvention.Furthermore,failingtofollowscientificproceduresandprotocolsordinarilyexercisedbyscientistsinthefieldcouldbedetrimentaltotheadmissibilityofanexpert’stestimony.111

C. AdmittingExperimentalDataIntoEvidence

Iftheexperimentalresultsarehighlycompelling,theopposingpartywilluse any admissibility challenge available to keep them out of evidence andpreventthemfrombeingreliedupon.Forthisreason,inadditiontousingquali-fiedexpertsandfollowingstandardandwell-acceptedscientificmethodologies,asdiscussedabove,itiscriticaltomakecompleteandtimelydisclosureoftheexperimentsandresults.

FederalRuleofCivilProcedure26requiresapartyseekingtoofferexperttestimonytodisclose“(i)acompletestatementofallopinionsthewitnesswillexpressandthebasisandreasonsforthem;[and](ii)thefactsordataconsideredbythewitnessinformingthem.”112Toprepareforcompletedisclosure,everyaspectofthescientificwork—thechainofcustodyforallofthetestingmaterials,thereceiptandstorageofmaterials,preparatorysteps,performanceoftheexperi-ments,theinterpretationoftestresults,andqualitycontrolmeasures—shouldbedocumentedcontemporaneouslywiththeworktoensureanaccurateandcom-pleterecord.Comprehensivedocumentationanddisclosureaddstothecredibilityoftheresultsbecauseitallowstheopposingparty(andthecourt)toevaluate,scrutinize,andtestthedatasoughttobereliedupon.Furthermore,amissteporincompletedisclosureinvolvinganyphaseofthescientificworkcanrendertheexperimentalevidenceinadmissibleinitsentirety.

Lastly, to safeguard against an inadmissibility rulingbasedonuntimelyproduction,apartyshouldordinarilyerronthesideofover-inclusivenessindis-closingthedocumentationrelatedtotheexperiments,underlyingdata,andresultsbeforethedeadlineforexpertdiscoveryexpires.However,ifthereisastipulationinplaceprotectingfromdisclosuredraftdocumentsorcommunicationsbetweencounselandtheexpert(s),thencareshouldbetakennottoproducethesemateri-als,soasnottowaivethestipulatedprotection.Otherwise,fulldisclosureisthesafestwaytogettheexperimentaldataadmittedintoevidenceand,atthesametime,protectyourcredibilityandthatofyourexpert.

110CompareUnionCarbideChems.&PlasticsTech.Corp.v.ShellOilCo.,425F.3d1366,1374–75(Fed.Cir.2005)(affirminginfringementwherepatenteeestablishedthatalimitationwasmetbyaformulaallegedlydifferentfrom,butfoundtobecomparableto,thetestrequiredbytheclaims),withGenentech,Inc.v.WellcomeFound.Ltd.,29F.3d1555,1566(Fed.Cir.1994)(affirmingnoninfringementwherepatentee’sexpertofferedevidenceofatestdifferentfromandnotcomparabletothetestrequiredbytheclaimsinordertoestablishthatthespecificactivitylimitationwasmet).

111Medtronic,Inc.v.BostonScientificCorp.,2002U.S.Dist.LEXIS28355,at*55–56(D.Minn.Aug.8,2002)(concludingthattheexpert’s“failuretotestorvalidatehishypothesis,andhisapparentdeparturefromthelevelofintellectualrigorthatcharacterizeshisworkinhisusualprofessionalpractice,renderhisproposedopiniontestimony...inadmissibleunderRule702”(emphasisadded)).Scientificproceduresandprotocolsfollowedbyascientificcommunitycouldincludespecificqualitycontrolmeasuressuchasusingnegativeandpositivecontrolsorconductingablindstudy.

112fed. r. Civ. p.26(a)(2)(B)(2010).

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BIOTECHNOLOGY PATENT LITIGATION - Semantic Scholar · 2016-01-29 · In a nutshell, biotechnology...

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