Patent Criteria Presentation Draft 1 March 23 2012

7/31/2019 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

Documents

Patent Criteria Presentation Draft 1 March 23 2012