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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

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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).

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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

james.czaban@dlapiper.com, or (202) 799-4045.