Private Patents and Public Health Changing intellectual property rules for access to medicines ·...

PrivatePatentsandPublicHealthChangingintellectualpropertyrules

foraccesstomedicinesAccesstoMedicinesintheBaltics,Riga,13October2017

Ellen‘tHoen,MedicinesLaw&Policy

www.medicineslawandpolicy.org@ellenthoen

HighMedicinesPricingaGlobalIssue

Essential Medicines for Universal Health Coverage

www.medicineslawandpolicy.org 2

Patent• Righttoexcludeothersfrommaking,using,offeringforsale,selling,andimportingthepatentedproduct(oraproductmadewithapatentedprocess)

• Rightgrantedbyanationalorregionalauthorityforacertainperiodoftime(minimum20years)whencertainconditionsaremet

• Patentsarenational– globalpatentapplicationproceduresexist(WIPOPCT)butaglobalpatentdoesnotexist.

3www.medicineslawandpolicy.org

Functionofpatents…toencourageinventorstomakeaninvestmentintimeandmoneyinresearchanddevelopmentbyprovidingexclusiverightsforalimitedtimeinexchangeforanearlypublicdisclosureoftheinvention.

Patentsystemisasocialpolicytoolmeanttocreatebenefitsforsociety.

But,itcomeswithaprice…


…anindustryviewofpatents

“…akeyelementofanylifecyclemanagementstrategyistoextendpatentprotectionbeyondthebasicpatenttermforaslongaspossible,byfilingsecondarypatentswhichareeffectivetokeepgenericsoffthemarket”

Burdon, Michael, and Kristie Sloper. "The art of using secondary patents to improve protection."

Journal of Medical Marketing: Device, Diagnostic and Pharmaceutical Marketing 3.3 (2003): 226-238.


IndustrialProfitMargins


21%averagepharmaprofitmargin53%GileadSciencesprofitmargin

WHYDOWEHAVEPATENTS?


1995WorldTradeOrganization(WTO)TradeRelatedAspectsofIntellectualPropertyRights(TRIPS)

� TRIPSsetsoutminimumrequirementsfortheprotectionofintellectualproperty(IP)obligatoryforallWTOmembers

� Mostrelevantforaccesstomedicines:◦ minimum20yearpatents◦ protectionofdata(article39.3)

� TRIPSFlexibilities

8

PatentsandMedicines• Patentsmaybeusedtodelaycompetitionofgeneric

medicinesandcreatemarketexclusivity/monopoly• Withoutgenericcompetitionmedicinespricesremainhigh

9

PatentsandMedicines:costofproductionandpriceofpatented

productsinUS$(TyrosineKinaseInhibitors)

* India is generic priceA.Hill, 18th ECCO - 40th ESMO European Cancer Congress, 27th September 2015, Vienna, Austria [abstract number: 1203]http://bmjopen.bmj.com/content/6/1/e009586.full.pdfSource UK Lapatinib: https://www.theguardian.com/business/2015/sep/23/uk-cancer-patients-being-denied-drugs-due-to-inflated-prices-say-experts

Medicine USA Latvia UK India* Targetimatinib(Gleevec-Novartis) 106.322 31.867 790 159erlotinib(Tarceva-Roche) 78.797 36.176 29.241 1.906 236sorafinib(Nexavar-Bayer) 137.232 66.953 57.232 1.313 1.387lapatinib(Tyverb-Novartis) 75.161 50.660 36.000 n/a 4.022dasatinib(Sprycel-BMS) 135.679 56.970 33.739 n/a 334


CostofproductionandpriceNewWHOEssentialMedicines

Medicine Originator priceintroUS Costofproduction1

bedaquiline $30,000 (6month) $48 -101

sofosbuvir(SOF) $84,000(12week) $68-136

SOF+ledipasvir $95,000(12weeks) $193

simeprevir $ 66,360(12weeks) $130- 270

daclatasvir $63,000 (12weeks) $10 - 30

imatinib $30.000- >$100,000(1y) $119-159

trastuzumab $54,000 (1y) $242

1. http://cid.oxfordjournals.org/content/early/2014/02/13/cid.ciu012.full (cost of production of HCV medicines) | Hill A. etal.,Target prices for mass production of Tyrosine Kinase Inhibitors (TKIs) for global cancer treatment access - Presented at 18th ECCO -

40th ESMO European Cancer Congress, 27th September 2015, Vienna, Austria [abstract number: 1203] | Dzintars Gotham, Joseph Fortunak, Anton Pozniak, Saye Khoo, Graham Cooke, Frederick E. Nytko, III, Andrew Hill; Estimated generic prices for novel treatments for drug-resistant tuberculosis. J Antimicrob Chemother 2017 dkw522. doi: 10.1093/jac/dkw522

www.medicineslawandpolicy.org

2001WTODohaDeclarationonTRIPSandPublicHealth

"theTRIPSAgreementdoesnotandshouldnotpreventMembersfromtakingmeasurestoprotectpublichealth".…“weaffirmthattheAgreementcanandshouldbeinterpretedandimplementedinamannersupportiveofWTOmembers'righttoprotectpublichealthand,inparticular,topromoteaccesstomedicinesforall.”

TRIPSFlexibilities

• Compulsorylicensing/GovernmentUse

• ExtensionforLDCs(paragraph7)• Parallelimport• Patentexceptions• Dataprotection(NotDataexclusivity)• Patentabilitycriteria

– Section3(d)IndianPatentsAct

http://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_trips_e.htm

12

Lessonsfromthepast:AccesstopatentedmedicinesintheUKin

60/70ties• MedicinesfortheNHSboughtthroughinternationaltenders

• MoH requiredthesuppliertoofferatthelowestpriceregardlessofthepatentstatus

• à CrownUse(Publicnon-commercialuseofpatents)

• Patentholderhadarighttoremunerationbutcouldnotstopgenericsupply

• Pfizervs.MoH 1965

13

Lessonsfromthepast:AccesstopatentedmedicinesintheUKin

60/70ties• MedicinesfortheNHSboughtthroughinternationaltenders

• MoH requiredthesuppliertoofferatthelowestpriceregardlessofthepatentstatus

• à CrownUse(Publicnon-commercialuseofpatents)

• Patentholderhadarighttoremunerationbutcouldnotstopgenericsupply

• Pfizervs.MoH 1965

“AlthoughthispoweroftheMinistryofHealthtopurchasedrugsandmedicinesfromsourcesindependentofthepatenteehasbeenmuchcriticisedbythepharmaceuticalindustry,itisnotlikelytobeaffectedbysuchcriticism.Suchpowerwillbeexercisedifthepatenteeisallegedtomaintainundulyhighpricesfortheseproducts(StephenLadas,1975).”

14

TRIPSflexibilitiesandlicensing2001-2017

7/9NCD

15

0

10000

20000

30000

40000

50000

60000

70000

80000

USA EU Malaysia LATAM CountriesGileadLicence

Cambodia Egypt India

SOF+DCVpriceexpectedby2020incountrieswith

robustGxcompetition.

PriceavailabletodayinIndia.

US$7,800to71,000 US$900

U$108

US$47,500to56,000

US$180

US$40,000to52,000

US$370

US$74,000to147,000

PricevariationofHCVmedicines

Source:DNDi

2017Malaysiaissuesgovernmentuselicence forSOF


AREPATENTSTHELEASTOFOURWORRIES?

Non-PatentMarketExclusivity


Marketexclusivities

• Dataexclusivity• Marketexclusivity• Pediatricextension• Orphandrugexclusivity• PatentsandSupplementaryProtectionCertificate(patentextensionofmax.5yr)

->basedonthepremisethatgrantingexclusiverightsencouragesinnovation


7of10topsellingmedicineshadFDAorphanindicationordesignation

Drug Globalsales2015(US$Bn)

Company Therapyarea

Humira 14.1 Abbvie Anti-rheumatic

Rituxan 7.6 Roche Cancerantibody

Avastin 7.2 Roche Cancerantibody

Herceptin 6.6 Roche Cancerantibody

Remicade 6 Johnson&Johnson Anti-rheumatic

Revlimid 5.7 Celgene Bloodcancers

Crestor 5.2 AstraZeneca Statin

http://www.cnbc.com/2015/12/01/an-obscure-fda-rule-adding-to-drug-company-profits.html


TransparencyofR&Dcost

$231

$802

$1,500

$2,500

$-

$500

$1,000

$1,500

$2,000

$2,500

$3,000

1991 (DiMasi) 1993 (OTA) 2003 (DiMasi) 2012(OHE) 2014(DiMasi) 2013(DNDi)

R&DCo

stEstim

ate(in

millions)

$140- $194 $100- $150


DutchMinisterofHealthandMinisterofForeignTradeonA2M

“Wecannotachieveanyrealprogresswithoutacknowledgingthatthecurrentpatent-basedbusinessmodelandthewayweapplyinternationalpatentrulesneedtochange.Thesystemisbroken.…Patentandintellectualpropertyexclusivitiesaretheonlycornerstoneofthecurrentmodel.Companiescanaskthepricetheylike.Thiswillnolongerdo.Weneedtodevelopalternativebusinessmodels.Andifpublicmoneyisusedforthedevelopmentofnewmedicines,agreementupfrontisneededaboutwhatthispublicinvestmentwillmeanforthefinalprice.Webelievethatcompaniesmustprovidefulltransparencyregardingthecostsofresearchanddevelopment(R&D). “

NLMinistersE.Schippers (Health)andL.Ploumen(ForeignTradeandDevelopmentCooperation)http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(16)31905-5/fulltext


DutchMinisterofHealthandMinisterofForeignTradeonA2M

“Wecannotachieveanyrealprogresswithoutacknowledgingthatthecurrentpatent-basedbusinessmodelandthewayweapplyinternationalpatentrulesneedtochange.Thesystemisbroken.…Patentandintellectualpropertyexclusivitiesaretheonlycornerstoneofthecurrentmodel.Companiescanaskthepricetheylike.Thiswillnolongerdo.Weneedtodevelopalternativebusinessmodels.Andifpublicmoneyisusedforthedevelopmentofnewmedicines,agreementupfrontisneededaboutwhatthispublicinvestmentwillmeanforthefinalprice.Webelievethatcompaniesmustprovidefulltransparencyregardingthecostsofresearchanddevelopment(R&D). “

NLMinistersE.Schippers (Health)andL.Ploumen(ForeignTradeandDevelopmentCooperation)http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(16)31905-5/fulltext


CouncilconclusionsonstrengtheningthebalanceinthepharmaceuticalsystemsintheEUanditsMemberStates(17/06/2016)

LancetCommissiononEssentialMedicinesPoliciesonDelinkage

TheconceptofdelinkingcostsfrompricesisbasedonthepremisethatcostsandrisksassociatedwithR&Dshouldberewarded,andincentivesforR&Dprovidedbymeansotherthanthroughthepriceoftheproduct.IftheR&Dcostofnewmedicinesdidnothavetoberecoupedthroughhighprices,thosemedicineswouldbefreeofmarketexclusivityandcouldbemademorewidelyavailableandmoreaffordablypricedthroughbettercompetition.


SomeRecommendations

• Immediateaction:– BundlebuyingpowerwithotherEuropeancountries– Takeactionwhenpatentshamperaccesstoproveneffective

medicines.• ActionatEUlevel:

– IncreasetransparencyinpricingandR&Dcost.– ReviewofEUincentivesshouldleadtoproposalsforpolicy

change.– DGcompetitiontoinvestigatehighmedicinesprices.

• International:– EnsureefficientfinancingforR&D=>Newglobalagreementson

sharingcostofR&Dbasedondelinkage principles.


Thankyou!

@ellenthoen

Pleasevisit:www.medicineslawandpolicy.orgwww.accesstomedicines.org


“Delinkage”Proposals-www.delinkage.org

Payingforthecostofresearchanddevelopmentofnewessentialmedicinesthroughothermeansthanhighprices.

Thismeans:- Nomorearationingofproven

effectivemedicines- SettingRF&Dprioritiesbasedon

need(notonprofitprospects)

27

Councilconclusionsonstrengtheningthebalanceinthepharmaceuticalsystemsinthe

EUanditsMemberStates(17/06/2016)

• AnevidencebasedanalysisoftheimpactoftheincentivesintheseEUlegislativeinstruments,….Amongthoseincentives,particularattentionshouldbegiventothepurposeof:

– supplementaryprotectioncertificatesasdefinedintherelevantEUlegislativeinstrument

– theuseofthe“Bolar”patentexemption[7],– thedataexclusivityformedicinalproductsandthemarketexclusivityfororphan

medicinalproducts.

• Whererelevant,theanalysisofimpactsshouldalsoaddress- interalia -thedevelopmentofmedicinalproductsandtheeffectsofthepricingstrategiesofindustryinrelationtotheseincentives


Private Patents and Public Health Changing intellectual property rules for access to medicines ·...

Documents

Transcript of Private Patents and Public Health Changing intellectual property rules for access to medicines ·...