Patent Criteria Presentation Draft 1 March 23 2012
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Transcript of Patent Criteria Presentation Draft 1 March 23 2012
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Standardsofpatentability:
TheIndianandSouthAfrican
examples
MaraKardas-Nelson
MSF,AccessandInnovaonOfficerTAC&MSFMediaTraining,IntellectualProperty
andAccesstoMedicines
Johannesburg,March282012
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Weakversusstrong:Whatisbestfor
A2M?
Weakpatentlaw=easytoobtainpatents;nopreorpostgrantopposion
Strongpatentlaw=moredifficulttoobtainpatents;preandpostgrantopposion
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SouthAfrica
India
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Thebasics:Isthereapatentreview
system?SouthAfrica:
Nopatentreviewsystemyoufileforapatent,yougetapatent.Withoutanyreviewsystem,patentapplicaonsarenotevencomparedwith
countriesweakstandardsofpatentability
Leadstoexcessivepatenng:Inoneyear(2008),SouthAfricagranted2,442pharmaceucalpatents,whilebetween2003and2008Brazilonly
granted278pharmaceucalpatents.
Why?Brazilhasapatentreviewsystem,andincludesitsDepartmentofHealthinthisreviewtoensurethatpatentswouldntunderminehealth
Argumentthatitstooexpensivetoimplement(buttheIndianreviewsystem,forexample,paysforitselfbyrequiringfilingfees)
FilingapatentinSA20to30xcheaperthanotherpatentregimes,openingusuptofrivolousapplicaons(studyesmates80%ofpatents
wouldnothavebeengrantedifSAexamined).
Whatsourcall?Atleastreviewpharmaceucalpatents/thoseaffecngtheConstuonalobligaonforthestatetofulfiltherighttohealth
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Whatnecessitatesapatent?
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TRIPSArcle27.1
1.Subjecttotheprovisionsofparagraphs2and3,patentsshallbeavailableforanyinvenons,whetherproductsorprocesses,inallfieldsoftechnology,providedthattheyarenew,involveaninven1vestepandarecapableofindustrialapplica1on.5Subjecttoparagraph4ofArcle65,paragraph8ofArcle70andparagraph3ofthisArcle,patentsshallbeavailableandpatentrightsenjoyablewithoutdiscriminaonastotheplaceofinvenon,thefieldoftechnologyandwhetherproductsareimportedorlocallyproduced.
5.ForthepurposesofthisAr.cle,thetermsinven.vestepandcapableofindustrialapplica.onmaybedeemedbyaMembertobesynonymouswiththetermsnon-obviousandusefulrespec.vely
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TRIPSArcle1.1
Membersshallbefreetodeterminethe
appropriatemethodofimplemen.ngthe
provisionsofthisAgreementwithintheirown
legalsystems.
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Paragraph4,DohaDeclaraon
Accordingly,whilereiterangourcommitment
totheTRIPSAgreement,weaffirmthatthe
Agreementcanandshouldbeinterpreted
andimplementedinamannersuppor1veof
WTOMembers'righttoprotectpublichealth
and,inpar1cular,topromoteaccessto
medicinesforall.
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IndianPatentAct:Secon3d
ThefollowingarenotinvenonswithinthemeaningoftheActThemerediscoveryofanewformofaknownsubstancewhichdoesnotresultintheenhancementof
theknownefficacyofthatsubstanceorthemerediscoveryofanynewpropertyornewuseforaknowsubstance...Explanaon.Forthepurposesofthisclause,salts,esters,ethers,polymorphs,metabolites,pureform,parclesize,isomers,mixturesofisomers,complexes,combinaonsandotherderivavesof[a]knownsubstanceshallbeconsideredtobethesamesubstance,unlesstheydiffersignificantlyinproper.eswithregardtoefficacy;
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MYIDEAOFABETTERORDERED
WORLDISONEINWHICHMEDICAL
DISCOVERIESWOULDBEFREEOF
PATENTSANDTHEREWOULDBENO
PROFITEERINGFROMLIFEOR
DEATH.
-IndiraGandhi,PrimeMinisterofIndiaattheWorldHealthAssembly,Geneva,
1984
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3dcont
Nonewuse,newformulaonpatents Ifisanewversionofexisngmedicine,mustshowenhancedtherapeucefficacyinorder
toreceiveapatent(i.e.ifitsnotnew,isitat
leastbeer?)
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Indiasays:Noevergreening
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ThecaseofSouthAfrica
25.Patentableinven8ons.
(1)Apatentmay,subjecttotheprovisionsofthissecon,begrantedfor
anynewinven1onwhichinvolvesaninven1vestepandwhichis capableofbeingusedorappliedintradeorindustryoragriculture.25(5)
Aninvenonshallbedeemedtobenewifitdoesnotformpartofthestateoftheartimmediatelybeforetheprioritydateofthatinvenon.
[Sub-s.(5)substutedbys.31(a)ofActNo.38of1997.]
25(10)
Subjecttotheprovisionsofsecon39(6),aninvenonshallbedeemedtoinvolveaninven1vestepifitisnotobvioustoapersonskilledintheart,havingregardtoanymaerwhichforms,immediatelybeforetheprioritydateoftheinvenon,partofthestateoftheartbyvirtueonlyofsubsecon(6)(anddisregardingsubsecons(7)and(8)).
[Sub-s.(10)substutedbys.31(d)ofActNo.38of1997.]
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Ingeneral,theposi8onSouthAfricancourtshaveadoptedisthatonceasubstanceformspartofthestateoftheart,aneworsecondusethereofwillnotmakeiteligibleforanewpatent(Burrell,1999)
However,asSouthAfricadoesnothaveanexamina.onsystemforpatentapplica.ons,theappropriatestandardisnotlikelytobeobserved,unlesssubjectedtoalegalchallengethroughrevoca.onorinfringement
proceedings
FromVawday,Yousuf,DoctoralThesis,UKZN:AccesstoLife-SavingMedicaoninSouthAfrica:TheCaseforLegislaveReform.
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Becauseofnopatentreviewsystem,
SouthAfricasays:Evergreeningisfine
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Whydoesthismaer?
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FirstlineAIDSdrugs:Weretheytruly
new?ThestoryofAZT Ideainthemid20thcenturythatcancerscamefromenvironmental
retroviruses.Ifcantreataretrovirus,cancurecancer(nownewerevidenceshowsthatretrovirusesonlyresponsibleforasmallpercentageofcancers)
AZTfirstsynthesizedin1964withmoneyfromaNIHgrant;droppedbecausedidntshowsuccessinmicewithtumors
1967:Germaninstutefoundthatwasacveinaleukemiaretrovirusinmousecultures
1984:scienstsattheBurroughs-WellcomeCompany(nowGSK)beganlookingforatreatmentforAIDS.Foundtobeeffecvetreatment;filedforpatentin1985approvedbyFDAin1987fortreatmentofHIV(subsequentmanylegalbales,butpatentheldunl2005)
AZTformedbackbonefor1stlinetreatment/HAART(sllusedinmanycountries).AZTusedforPEPandforPMTCT.
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WouldAZThavebeengivenapatent
inIndia?
AndwhataboutSouthAfrica?
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ThebasicpatentsonNevirapine(NVP)wereappliedforbyBoehringerIngelheiminNovember1990,andare
duetoexpireinNovember2010(notpatentedinIndiabecausethecountrydidntrecognizepharmaceu.calpatentsatthe.me)
BIalsoappliedforapatentonthehemihydrateformofNVP,usedinthesuspensionin1998,whichisduetoexpire2018(rejectedbypatentofficebecausenewformula.onpatent)
Addionally,BIappliedforapatentontheextendedreleaseformulaon
ofnevirapinein2008,whichisduetoexpirein2028(patentopposi.oncurrentlyfiled)
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NevirapineinSA
PaediatricHIVandPMTCTEXTENDEDRELEASEFORMULATIONOFNEVIRAPINE(applicaondate2009,BoehringerInglehim)
PHARMACEUTICALCOMBINATIONSCONTAININGLAMIVUDINE,STAVUDINEANDNEVIRAPINE(applicaondate2008,Cipla)
IMPROVEDMETHODOFMAKINGNEVIRAPINE
(applicaondate2004,alsobyBI)PHARMACEUTICALSUSPENSIONCOMPRISINGNEVIRAPINEHEMIHYDRATE(applicaondate1998,alsobyBI)
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Some examples
Efavirenz 600 mg
Used in the treatment
of HIV/AIDS, first line
& second line therapy,prescribed by WHO
Merck lowest quoted
price is $237/ per patientper year
Not patented in India (under opposition on
grounds of new form of old
drug)
More than four producers.Lowest price $ 165/ppyPatented -
Thailand $420/ppy(Merck)(After CL - 216/ppy)
China - $ 900/ppy (Merck)
S th Af i I di
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SouthAfricavs.India:Abbo:Lopinavir/Ritonavir(Alluvia)
Consideredessen.almedicinebyWHO
RSA:Patent?Yes
Price?
Alluvia200mg/50mgtablet:R2.57
Alluvia100mg/25mgtablet:R1.28
India:
Patent?NocompoundpatentOn30December2010,
theIndianPatentOfficerejectedpatentforLopinavir/ritonavirasit
didnotinvolvean'inven.vestep'
Price?
Matrix200mg/50mgtablet:R2.18
Matrix100mg/25mgtablet:R1.19
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LPV/rcont
ThailandandEcuadorhaveissuedCLs(notpossibleinSA) Pre-grantopposionfiledbyI-MAK(notpossibleinSA) PriceofGenericLopinavir/Ritonavir200mg/50mghas
decreasedby61%since2007
SAbenefitsfromrelavelylowAbbopricesduetoAbbosHIVaccessprogramme(MICsincreasinglygengcutoutofsuchAccessprogrammes;fornow,SAstaysbecauseofhighburdenofdisease)
Since1992,whenAbbowasawardeditsfirstpatentrelatedtoRitonavirintheU.S.,thecompanyhassoughtatleast75newpatentsonessenallythesamesetofdrugs(I-MAK)
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Pushingbackagainst3d:Thecaseof
Novars
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2006:Indianpatentofficerejectedapatentforleukemiadrugimanibmesylate(Gleevec)
becausebasedonexisngcompound(i.e.not
trulyinvenve,noenhancedtherapeucbenefit)
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Whattheheck
ismesylate?
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GleevecinSouthAfrica?
IsthereapatentinSouthAfrica?
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YES
Forbothcancerandarthri.s
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Andtheprice?
SouthAfrica
R862.5per400mgtab(private
sector;notincludedin
publicsectortender)
India
R86per400mgtab(Cipla)
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NovarstooktheIndiangovernmenttocourtoverthedecisionandindoingsotook3dwith
it.ItsnotjusttheGleevecpatentthatsontheline,but3dasawhole
Novarshasbeenatthissixyears!!!FinaljudgmentfromIndianSupremeCourt(read:final
decision)tobeheardthisyear(wenttotheMadrasHighCourtrejected;wenttotheIntellectualPropertyAppellateBoardrejected)
TheIndianHighCourtbeginshearingthecaseonJuly0(wasmeanttobeMarch28,butitsbeendelayedagain)
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Challengingoneofthestrongesttools
wehave Specificallytakeson3dandthenoonoftherapeuc
efficiencywhich,accordingtoMadrasHighCourt,meanstherapeuceffectinhealingadisease.
3dasawholehasbeenessenalinblockingtheextensionofseveralimportantmedicines
AackscountriesrightstointerpretTRIPSlanguageintheirowncountrycontext(especiallythenoonofinvenveness)
NotonlycouldchallengeIndiasabilitytorejectnewuse/newformulaonpatents;butsetsnegaveprecedentforotherdevelopingcountriesinterpretaonofTRIPS/useofTRIPSflexibilies