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26
lageL Genomeby James N. Czaban, JDChair, FDA and Medical Products Regulatory
Group DLA Piper LLP (US)
Deal or No Deal? Legal and Regulatory
ConsiderationsIn the Business of
Precision Medicine
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recisionMedicineisrapidlytaking
alargerandlargershareofnew
therapeuticproductapprovalsas
industryandtheFDAaregaininga
moresolidgraspofwhatisrequiredto
developandapprovethesecutting-edge
products.Indeed,ofthe46NewMolecular
Entities(“NMEs”)approvedbyFDAin2017,
16(35%)werePrecisionMedicineproducts,
accordingtothePersonalizedMedicine
Coalition,whichalsocitesatleast14
supplementalapprovalsfornewPrecision
Medicine-relatedusesofpreviously-approved
products.Therearemultiplefactorsatplay
behindthesteadily-increasingfocuson,
andvolumeof,PrecisionMedicineproducts,
includingcontinuedscientificadvancement
andclarityonPrecisionMedicine,andgrowing
comfortwithinFDAregardingthescience
andreviewparametersforsuchproducts,
coupledwithinnovation-orientedregulatory
reformeffortsledbyFDACommissioner
ScottGottlieb.
Asthistrendcontinues,companiesand
investorswillbefocusingevenmoreclosely
onbusinessopportunitiesinthePrecision
Medicinespace.But,despitetheprogress
mentionedabove,headwindsremaininthe
forecastfortheforeseeablefuture,and
product-specificanddeal-specificpitfalls
awaitthosenotdeeplyimmersedinthelegal
andregulatorynuancesanduncertainties
underlyingasuccessfulPrecisionMedicine
businessstrategy.ThisissueofmyLegal
Genomecolumnaddressessomeofthekey
legalandregulatoryconsiderationsthatmust
beaddressedbycompaniesconsideringthe
developmentofnewPrecisionMedicine
therapiesandthosewhowouldacquireor
investinsuchcompanies.
The Continuing Evolution and Increasing
Complexity of FDA’s Precision Medicine
Regulatory Scheme
Asnoted,industryandFDAhavemade
encouragingprogressinbringingtomarket
anincreasingnumberandvarietyofPrecision
Medicineproductsoverjustthepastfew
years,andthereislittlereasontosuspecta
reversalormaterialplateauinthattrendany
timesoon.Thatsaid,FDA’sregulatoryapproval
criteria(whichinherentlyencompassesthe
agency’sclinicaldevelopmentpoliciesand
expectations)forPrecisionMedicineare
stillemerging,fluid,andinmanyrespects
uncertain,especiallyfornovelapproaches
forprecisiondiagnosisandtreatment.Touse
justtworecentexamples,inDecember2017,
FDAissuedtwodraftGuidancesrelatedto
differentaspectsofthedevelopmentand
approvalofPrecisionMedicinetechnologies,
buttheapproachesintheseGuidancesare
notablydifferentintoneandeffect,and
eachleavesmanyopenquestionsinthe
contextofanyparticularPrecisionMedicine
developmentprogram.
In the Draft Guidance,DevelopingTargeted
TherapiesinLow-FrequencyMolecularSubsets
ofaDisease(December2017)(the“Molecular
SubsetGuidance”),FDAexplainsthatbecause
“certaintargetedtherapiesmaybeeffective
inmultiplegroupsofpatientswhohave
differentunderlyingmolecularalterations…
FDAisprovidingguidanceonthetypeand
quantityofevidencethatcandemonstrate
efficacyacrossmolecularsubsetswithina
disease,particularlywhenoneormore
molecularsubsetsoccuratalowfrequency.”
Theactualguidanceprovidedacrossfour
subtopics–(1)IdentificationofPatients
forInclusioninClinicalTrials,(2)Generaliza-
bilityofFindings,(3)BenefitandRisk
DeterminationandLabeling,and(4)Refining
theTargetPopulation/IndicationAfterInitial
Approval–isframedasapositive,proactive
approachbytheagencytofacilitatecreative
andflexibleapproachestothedevelopmentof
coveredtargetedtherapies.
InessencetheGuidancesuggeststhatFDA
willconsideranyandalltypesofapproaches
proposedforthefourtypesofdevelopmental
activities,butalsooffersastratifiedlistingof
typesofevidencethatsponsorsmaysubmitto
supportthe“strengthofevidence”supporting
ofaproposedpatientgroupingstrategyfor
clinicaltrials.Thesecategoriesofsupport,in
decreasingorderofstrength,are:clinicalstudy
evidence;nonclinicalstudyevidence;insilico
ormechanism-basedevidence;evidencefrom
otherdrugsinthesamepharmacologicalclass;
andphenotypiccharacterizationofmolecular
alterations.Thus,althoughtheGuidanceleaves
muchtobedeterminedforanyparticular
developmentprogram,atleastsponsorshave
someclarityontherelativevalueofdifferent
typesofevidencethatmaybeusedinsupport
ofseekingapprovalofatherapyformultiple
molecularsubsetsofadisease.
Incontrasttothetoneandflexibilityreflected
intheMolecular Subset Guidance,theDraft Guidance,
InvestigationalIVDsUsedinClinicalInvestiga-
tionsofTherapeuticProducts(December
2017)(the“InvestigationalIVDGuidance”),
isessentiallyproscriptive,andreadsmore
likeawarningshotacrossthebowof
PrecisionMedicinesponsorswhoseekto
supportapprovaloftheirproductsthrough
useof“investigational”invitrodiagnostic
devices.ThisGuidancealsoexplicitlywarns
InstitutionalReviewBoardsoverseeingsuch
studiestoconsiderthesafetyandlegalityof
theIVDsusedinsuchresearch.TheGuidance
P
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canbeseenasacontinuationofFDA’scontro-
versialeffortstoassert(orre-assert)regulatory
controloverinvitrotestsusedinconnection
withPrecisionMedicine,aspreviouslypursued
intheagency’sDraftGuidances,Framework for
Regulatory Oversight of Laboratory Developed
Tests (LDTs) (Oct. 3, 2014), Use of Standards in FDA
Regulatory Oversight of Next Generation Sequencing
(NGS)-Based In Vitro Diagnostics (IVDs) Used for
Diagnosing Germline Diseases (July 8, 2016), and Use
of Public Human Genetic Variant Databases to Support
Clinical Validity for Next Generation Sequencing
(NGS)- Based In Vitro Diagnostics (July 8, 2016).
TheInvestigationalIVDGuidanceaggressively
discourages,andinsomecasespurportsto
prohibit,theuseofanyinvestigationalIVDs
outsidethescopeofanactiveinvestigational
deviceexemption(“IDE”),byofferingaparade
ofhorriblesinQ&Aformatcoveringtopics
suchas:“EvaluatingWhetheranInvestigational
IVDUsedinaClinicalInvestigationofa
TherapeuticProductisSignificantRisk;”
“InvestigationalIVDRiskandtheDesign
ofClinicalInvestigationsforTherapeutic
Products;”and“HowInvestigationalIVD
RiskMayChangeDuringtheCourseofa
ClinicalInvestigation.”Indeed,thestated
bottomlineconclusionofthisGuidanceis
that“[s]ponsorsshouldbeawarethatall
investigationalIVDsusedintherapeutic
producttrialsarealsosubjecttotheIDE
regulationandmayalsorequirethesubmission
ofaseparateIDEapplicationifdeterminedto
beSR[significantrisk].Atherapeuticproduct
trialthatalsoincorporatestheuseofanSR
investigationalIVDmaynotbeinitiated
withoutanapprovedIDEapplication.”
Thebusinessandinvestmentconsiderations
stemmingfromtheseGuidances,andother
rapidly-emergingFDApoliciessurrounding
PrecisionMedicine,thusincludeatleasttwo
typesofuncertainties:theuncertaintyof
choosingbetweenmultiplepotentially
acceptabledevelopmentoptionsbutnot
knowinghowpersuasiveeachoptionmight
betoFDA(asintheMolecularSubset
Guidance);andtheuncertaintyofwhether
FDAmightoutrightreject,afterthefact,a
goodfaithuseofadevelopmentalapproach
(orworsetakeenforcementaction)basedon
anallegedregulatoryviolation(e.g.,underthe
InvestigationalIVDGuidance).
Asapracticalmatter,itisnotunreasonable
toassumethatsmaller,earlier-stagePrecision
Medicinedeveloperswillbelessablethan
largermore-establishedcompanies–financially
andasamatterofregulatoryexpertiseand
resources–tokeepupwith,muchlessadhere
to,theincreasinglycomplexpanoplyofFDA
regulatorydevelopmentsthatwillultimately
impactthesuccessorfailureoftheirproducts.
Entitiesconsideringbusinessarrangementsin
thePrecisionMedicinespaceneedtoconduct
sophisticatedandthoroughregulatorydiligence
beforeinvestinginaPrecisionMedicine
product,company,ortechnologyplatform,
andsuchdiligenceneedstocontinue
post-closingaspartoftheongoing
managementofcompanyoperations.
Pricing the Drug and Pricing the Investment
Asanyonewhoevenremotelyfollowscurrent
eventshasseen,theissueofdrugpricinghas
beenapoliticallightningrodformanyyears,
andwasespeciallysoduringthemostrecent
electioncycle.PresidentTrumpcontinuesto
fueltheissuewithcommentssuchasclaiming
thepharmaceuticalindustryis“getting
awaywithmurder”ondrugprices(inhisfirst
post-electionpressconference),toclaiming
thatfixingthe“injustice”ofhighdrugpricesis
oneofhisadministration’s“toppriorities”(in
his2018StateoftheUnionaddress).
SomeinCongresshaveputforthspecific
proposalstoattackdrugpricing,suchas
allowingunregulatedimportationof
prescriptiondrugsfromCanada,andvarious
statesareenactingorconsideringlegislation
thatwouldrequirepublicdisclosureofdrug
pricesbypharmaceuticalcompaniesand
possiblepricelimitsunderstate-controlled
reimbursementprograms(so-called
“name-and-shame”legislation).TheTrump
administration’smostconcreteprogrammatic
effortstodatetoaddressdrugpricinghave,on
theotherhand,focusedonstreamliningand
expeditingtheapprovalofcompetinggeneric
drugproducts.Thus,whilemuchofthepublic
andmediaattentiontendstofocusonthe
pricesofspecificinnovatordrugs,theadminis-
tration’seffortsare,todate,morefocusedon
solutionsthatwouldimpactdrugspendingon
anoverallmacro-level(e.g.,byincreasingthe
rateandextentofgenericcompetitionacross-
the-board).Whileamacroapproachtoreduc-
ingtheoverallcostsofdrugsmaybethemost
logicalapproach,itwouldhavelittleimpacton
mediaandpoliticalsnipingaboutthecosts
ofanyindividualdrug,sothatpressurepoint
islikelytoremainabusinessconcernindefinitely.
PricingofPrecisionMedicineproductsreflects
ananalogousmicro/macrodichotomyinthat
thesmallerandmore-focusedaPrecision
Medicine’sapprovedpatientpopulationis,
themorelikelythedrugistocommandan
eye-catchingly“high”pricecomparedtoa
non-precisiondrugapprovedforabroader
andlargerpatientpopulation.Thisreflects,
inpartthefactthattheoveralldevelopment
costsforaPrecisionMedicineremainhigh,
evenforasmallerpatientpopulation,sothe
economicsofrecoveringareasonablereturn
oninvestmentrequireshigherper-patient
pricingcomparedtoamorebroadly-indicated
drug..Butitalsoreflectstherealitythat
PrecisionMedicineproductshaveahigher
likelihoodoffillingatrulyunmetmedical
need,intermsofbeingthefirstevertreatment
foraparticulardiseaseorpatientsubset,or
insomecasesofferinganoutrightone-time
cureforaconditionthatpreviouslyrequired
prophylacticorsymptomatictreatmentover
thecourseofapatient’sremaininglifetime.
The“value-basedpricing”ofsuchadrug–
fromaglobalhealthcaresystemcostperspec-
tive–can,andarguablyshould,beordersof
magnitudehigherthanthepricingofadrug
forwhichthesamepatientwouldbealifetime
user,gettinginferiorresultsforwhichgovern-
mentandprivatepayors,and
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patientsthemselves,wouldalwaysbepaying.
Thisreality,unfortunately,isnotwhat
media,politicians,andmanyindividual
patientsfocuson,evenassumingtheyunder-
standatanymeaningfulleveltheeconomic
andpublichealthpolicyfactorsthatunderlie
suchpricingconsiderations.
Thus,thereal-worldbusinessimplication
ofthesedynamicsisthatpoliticalandlegal
pressureagainst“high”individualdrugpricing
is,andwillcontinuetobe,amaterialfactorin
theevaluationofanyinvestmentinPrecision
Medicine,whetherbyacompanyseekingto
pursueaclinicaldevelopmentprogram,bya
privateequityfirmconsideringanacquisition
oforastakeinaPrecisionMedicine-focused
company,orbyanestablishedpharmaceutical
companytargetinganothercompanyfora
mergeroracquisition.Theuncertaintyof
bothachievingmarketentryatatargeted
pricepoint,andsuccessfullymaintaining
thatpricingoverthetargetedtimeframe,
areexacerbatedbythepossibilitythatevolving
publicsentimentondrugpriceswillleadto
longtermunsustainability,orthatCongres-
sionaland/orpresidentialelectionresultswill
leadtomoreabruptadversechangestohow
drugs,includingPrecisionMedicineproducts,
arepricedorreimbursed.
Overhangingthoserisksistheuncertaintyof
howmuchandhowaggressively,thefederal
governmentwillseektoassertownership,and
controloverthepricing,ofPrecisionMedicine
therapiesdevelopedbyprivateentitiesusing
dataandknow-howderivedfromgovern-
ment-runorgovernment-fundedresearch
initiativessuchastheNIH’s“AllofUs
ResearchProgram.”AsIcautioned“the
inauguralissueof,thefederalgovernment,
throughthePrecisionMedicineInitiative,
“appearstobepositionedtomovetowarda
“publicutilitymodel”forPrecisionMedicine,
analogoustogovernmentcontrolover
electricity,waterandnaturalgasproviders,
telecommunicationsspectrums,railroadsand
municipaltransportationservices,”allofwhich
industriesfacedirectorindirect
governmentalpricecontrols.Tothesame
end,callsforgivinggovernmenthealthcare
programsdirectnegotiationpoweroverdrug
prices,aslongadvocatedbyleft-leaning
politiciansandevenfloatedbyPresident
Trumponafewoccasions,cannotbeignored
asimplausibleoverthenear-tomid-term
timehorizon.AndPrecisionMedicineisnot
immunefromthebroadlyimpactfulinfluence
ofprivatepayorreimbursementpoliciesthat
limitaccessandseektodepresspricing.
Asalways,inmedicalproducttransactions,
pricingtheinvestmentdependsheavilyonthe
pricingofthedrug,butthelatter,especiallyfor
thenewwaveofPrecisionMedicineproducts,
isunfortunatelymoreuncertainthanever.
The IP-Regulatory Exclusivity Axis as a
Deal Driver
Athirdcriticalareaofconcernforthebusiness
sideofPrecisionMedicineistheintersection
ofpatentlawandtheregulatoryschemesfor
thedevelopment,approvalandmarketingof
therapeuticproducts.Theseissuesarecomplex
foranydrugorbiologicproduct,buttheytake
onaddeddimensionsofstrategicimportance
whenitcomestoproductsofPrecisionMedicine.
UndertheDrugPriceCompetitionandPatent
TermRestorationActof1984(the“Hatch-
WaxmanAmendments”totheFederalFood,
DrugandCosmeticAct(“FDCA”)),andthe
BiologicsPriceCompetitionandInnovationAct
of2009(“BPCIA”),newdrugproductsmaybe
eligibleforbothanextensionofanapplicable
patent,aswellasvariousregulatoryexclusivity
periodswhichdelaytheapprovalandmarketing
ofcompetinggenericorbiosimilarversionsof
thedrug.Eligibilityfortheseincentivesfor
drugdevelopmentcanbemorecomplicated
forPrecisionMedicineproductsforseveral
reasons.
Thepatenttermrestorationprovisionsunder
Hatch-Waxmanallowthetermofapatent
coveringanewly-approveddrugorbiologic
tobeextendedforuptofiveyears,based
ontheamountoftimetakenforclinical
developmentandFDA’sregulatoryreview,but
thesepatenttermextensions(“PTEs”)areonly
availableforthefirstapprovalofaparticular
activeingredient.Thus,thedevelopmentand
approvalofanewPrecisionMedicine-based
indicationforapreviously-approveddrug
wouldnotbeeligibleforanextension.
Moreover,whileaPTEmaybeappliedto
eitheracompound(activeingredient)patent,
aformulationpatent,oramethodofuse
patent,onlyonepatentperdrugmaybe
extendedundertheseprovisions.Asarule
ofthumb,itispreferabletoseekanextension
ofacompoundpatentbecausesuchpatents
aregenerallystrongerandmoreenforceable
thanmethodofusepatents.
Thishaspotentialrelevancetoafertileareaof
interestinPrecisionMedicine–“repurposing”
olderdrugswhichfailedtogainapprovalunder
previousdevelopmentprogramsforsafety
orefficacyreasons,butwhichnowmay
beapprovablebasedonamorelimited,
genetically-defined,patientpopulationusing
thenewtoolsofPrecisionMedicine.For
sucholderdrugs,however,theoriginal
compoundpatentmayhavelong-agoexpired,
leavingonlynarrowerformulationormethod
ofusepatentsaspotentialcandidatesforaPTE,
butsuchpatentsmaybeeasierforagenericor
biosimilarcompetitortodesignaround,orto
seekapprovalofaproductforunpatenteduses.
Inanycorporatedealinvolvingthetransferor
licensingofadrugproduct,thepatentestateis
acrucialsubjectforlegalduediligence,buta
criticalrelatedareaforcarefuldiligenceisthe
scopeofpotentialregulatoryexclusivitiesfor
whichtheproductmaybeeligible.Underthe
FDCA,anew(smallmolecule)drugproductis
potentiallyeligibleforoneormoreregulatory
exclusivities,including:OrphanDrugExclu-
sivity(7yearsduringwhichtimeFDAmaynot
approveanotherapplicationforthesamedrug
forthesame“orphan”disease);NCEExclusiv-
ity(delayingforfiveyearsthefilingdatefor
applicationsforacompetinggenericversion,
orasimilarproductthatreliesonthe505(b)
(2)NDAapprovalpathway);andnewclinical
30
studyexclusivity(delayingforthreeyearsFDA
approvalofacompetingproductforthesame
exclusivity-protectedconditionsofusefor
thedrug).Relatedprovisionsoflawallowfor
certainextensionsofregulatoryexclusivities,
suchasthe6monthpediatricexclusivity
extension,andthe5yearextensionfor
qualifiedinfectiousdiseaseproducts(“QIDPs”)
undertheGeneratingAntibioticIncentives
NowAct(the“GAINAct”).Separately,
biological(largemolecule)therapeutic
productsarepotentiallyeligiblefor12years
ofregulatoryexclusivityundertheBPCIA
beforeFDAmayapproveacompeting
“biosimilar”versionoftheproduct.Biologics
mayalsoqualifyforOrphanDrugExclusivity,
butareineligiblefortheNCEExclusivityor
newclinicalstudyexclusivitiesdescribed
above.
Theseexclusivityopportunitiesarecomplex
tobeginwith,butobtainingtheirbenefitsfor
PrecisionMedicineproductsispotentiallyeven
morecomplicated.Forexample,NCEExclusivity,
likeaPTE,islimitedtothefirstapproved
productcontainingthedrug’sspecificactive
ingredient(althoughcertaincombination
drugproductsmayreceiveNCEExclusivity
ifatleastone,butnotall,ofitsactive
ingredientshasneverpreviouslybeenapproved
byFDA).Thus,aPrecisionMedicineproduct
thatprovidesforanewgenetically-defined
indicationorpatientpopulationforapreviously-
approveddrugoractiveingredientwouldnot
receiveNCEExclusivity.
Suchadrugwould,however,likelyreceivea
3-yearexclusivity,butthatexclusivitywould
belimitedtothenewly-approvedprecision
indication.Asaresult,agenericcompetitor
couldreachthemarketfortheprecisionuse
inaslittleasthreeyears,andifthedrughas
bothprecisionandnon-precisionindications,
agenericcouldbeapprovedatanytimewith
labelingthatonlyincludesthenon-exclusive
indication.Ifsuchagenericdrugispharmaceu-
ticallyequivalentandbioequivalenttothe
PrecisionMedicineproduct,thegeneric
productcouldbeautomaticallysubstitutedby
pharmacistsforpatientswhowereinfact
prescribedthedrugforthe“exclusive”
precisionindication,thuslargelyeviscerating
thevalueoftheexclusivity.
TheseIPandregulatoryexclusivityconsidera-
tionshaveoutsizedimplicationsforPrecision
Medicinebusinessdecisions–e.g.,whether,
andhow,todevelopanewPrecisionMedicine
product,andwhether,andhowmuchtopay,
toacquireorin-licenseaPrecisionMedicine
productcandidate.
Take,forexample,ahypotheticalsmall
moleculedrugthatshowspromisingefficacy
inallpatientswithacertaindiseaseforwhich
currentapprovedtreatmentoptionsare
limited,butwhichalsoshowsfargreater
efficacypotentialatanalternativedoseina
specificgeneticsubsetofpatientswiththe
disease.Therightbusinessdecisionregarding
developmentof,orinvestmentin,sucha
productcouldbeverydifferentdepending
onthepatentandregulatoryconsiderations
outlinedabove.
Toillustrate,iftheactiveingredienthas
recentlybeendiscoveredandiscovered
byarecentorpendingcompoundpatentand
variousmethodofusepatents,thelogical
businessdecisioncouldlikelybetodevelop
thedrugforthebroadpatientpopulation
use,andsimultaneouslyorshortlythereafter
seekapprovalofthealternativedoseversion
withlabelingspecifictothetargetedgenetic
subset.Afterall,thestrongestpatentwillbe
inforceandpotentiallyeligibleforaPTE,soto
reachthemarketforanyuseagenericsponsor
wouldhavetoinvalidatethecompoundpatent
andanyusepatentcoveringthegeneric’s
proposedindicationandthedrugwould
receivetheNCEExclusivitynogenericcould
evenbeginthepatentchallengeprocessuntil
atleastfouryearsafterthenewdrug’sinitial
approval.If,however,thedrug’sactive
ingredientwaspreviouslyapprovedin
anotherdrugforadifferentindication,
thekeycompoundpatentmaybeexpired
orhavelittleremaininglifeandwouldnot
beeligibleforaPTE.Moreover,thedrug
wouldnotbeeligibleforNCEExclusivity.
Andbecause,especiallyifthenewandold
drugshadthesamedose,thepreviously-
approveddrug(andgenericversionsofit)
couldendupbeingusedbydoctorsor
dispensedbypharmaciststotreatthe
diseaseforwhichthenewproduct
wasapproved,notwithstandingany3-year
exclusivityforthenewdrug.Thus,an
investmentinseekingapprovalforthebroad
populationmaynotmakeeconomicsense,
butadevelopmentplanlimitedtothenew
alternativedoseversionlabeledsolelyforthe
targetedgeneticsubsetmightmakesensefor
severalreasons.
First,amethodofusepatentfortheprecision
genetically-targetedusemaybestrongerthan
ausepatentonthelargerpatientpopulation,
andevenifnoteligibleforaPTEcouldstill
beenforcedagainstaproposedcompeting
product.Second,athree-yearexclusivity
onthealternativedoseprecisionusemay
havemoreteethtotheextentthatthe
previously-approveddrugwouldnotbe
equivalentto,orautomaticallysubstitutable
for,thenewdrug.Third,evenifthenew
drugisapprovedandlabeledsolelyforthe
precisionuse,totheextentthemedical
literatureteachesthepotentialefficacyof
thedruginabroaderpopulation,physicians
mayprescribethedrugforpatientsoutside
ofthegenetically-labeledsubsetofpatients,
allowingthecompanytocapturepartof
thebroadermarketindirectly(but,asponsor
wouldneedtotreadcautiouslyinthecontext
ofsuchoff-labeluses,aspromotionofa
drugforanunapproveduseorunapproved
patientpopulationcantriggerciviland
criminalliabilityundertheFDCA,theFalse
ClaimsAct(“FCA”),andotherlaws).
29
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JUNE 26-28 , 2018 Hyatt Regency
Jersey City on the Hudson
3 r d A N N U A L
P R E C I S I O N M E D I C I N E
L E A D E R S S U M M I T
F o r m o r e i n f o r m at i o n please visit pmls2018 .com
31
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Conclusion
Thereisavastrangeofpotentialfactualand
legalpermutationsthatcanariseinthecontext
regulatoryapprovalrequirements,pricing
considerations,andofpatentandexclusivity
rightsforinvestigationalPrecisionMedicine
products,andtheexamplesdescribedhere
comefromjustonesegmentoftheoverall
PrecisionMedicineuniverse.Otherchallenging
legalandregulatoryconsiderationsmustbe
accountedforinbusinesstransactions
involvingotherPrecisionMedicinetechnologies,
suchastheregulationofcompaniondiagnostics
usedwiththerapeuticproducts,thedevelop-
mentandsaleof”before“IVDs”IVDsand
LDTsusedinthetherapeuticproductresearch
anddevelopmentphase,andbiological
PrecisionMedicineproductssubjecttotheir
ownuniquepatentlitigationprocedures
whenfacedwithpotentialcompetitionfrom
biosimilarproducts.Spaceconsiderationsdo
notpermitmorethanthisbriefmentionof
theseotherscenariosinthiscolumn,but
readersmaycontactmedirectlytodiscuss
specificscenariosandstrategiestheymay
befacing,andtosuggestrelatedtopicsfor
coverageinfutureissuesoftheJournal.
James N. Czaban, is a Partner and the Chairman of
the FDA and Medical Products Regulatory Practice
Group at the international law firm DLA Piper LLP, in
Washington, D.C. In more than 25 years of private
practice, Jim has focused on counseling pharmaceutical,
medical device and diagnostic, and other life sciences
clients on a broad range of complex regulatory strategies
and compliance matters, and regularly represents such
clients in legal, public policy, and enforcement matters
before the FDA, other administrative agencies, and in the
federal courts. Jim has been deeply involved in the
law and regulation of Precision Medicine since mapping
of the human genome was completed more than
15 years ago.
Mr. Czaban can be reached at
[email protected], or (202) 799-4045.