Patent Case Laws .ppt

The patent law of India

1. Patent Case laws

2. BASMATI
OriginallyfromIndiaandPakistan,Basmatibecamea
controversial‘issue’afterRiceTec,aTexas-basedcompany,in
1997,patentedsometypesofricetheydevelopedas“American
basmati”.üRiceTecInc,hadbeentryingtoentertheinternational
Basmatimarketwithbrandslike“Kasmati”and“Texmati”.
Ultimately,thecompanyclaimedtohavedevelopedanewstrain
ofaromaticricebyinterbreedingbasmatiwithanothervariety.
TheysoughttocalltheallegedlynewvarietyasTexmatior
AmericanBasmati.üRiceTecInc,wasissuedthePatentnumber
5663484onBasmatiricelinesandgrainsonSeptember2,1997.ü
ThiswasobjectedtobytwoIndiannongovernmental
organizations(NGOs)—CentreforFoodSafety,aninternational
NGOthatcampaignsagainstbiopiracy,andtheResearch
FoundationforScience,TechnologyandEcology,anIndian
environmentalNGOwhofiled

3. RiceTechasgotapatentforthreethings:
growingriceplantswithcertaincharacteristics
identicaltoBasmati,thegrainproducedbysuch
plants,andthemethodofselectingricebasedon
astarchindex(SI)testdevisedbyRiceTec,Inc.
Thepatentwaschallengedonthefactthatthe
plantvarietiesandgrainsalreadyexistasa
stapleinIndia.75percentofU.S.riceimports
arefromThailandandthattheremainderis
fromIndiaandPakistanandbothvarietiesare
ricethatcannotbegrownintheUnitedStates.

4. Thelegaltheoryisthatthepatentisnotnovel
andforaninventionthatisobvious,beingbased
onricethatisalreadybeingimportedinthe
UnitedStates,thereforeitshouldnothavebeen
grantedinthefirstplace.
India’sattorneysalsoseektochallengetheuseof
theterm‘basmati’inconjunctionwiththepatent
andinmarketingoftherice.
Suchuseofthetermcreatesconfusionasto
geographicoriginandusurpsthegoodwilland
recognitionestablishedwithbasmatiricegrown
andsoldfromIndia.

5. Asaresultofthere-examinationapplication
filedbytheIndiangovernment,RiceTec
agreedtowithdrawseveraloftheclaims.In
January29,2002,theUnitedStatesPatentand
TrademarkOfficeissuedaReexamination
Certificatecancelingclaims1-7,10,and14-20
(thebroadclaimscoveringthericeplant)out
of24claimsandenteredamendmentstoclaims
12-13onthedefinitionofchalkinessoftherice
grains7

6. TurmericisatropicalherbgrowninEastIndia,andthe
powderedproductmadefromtherhizomesofitsflowershas
severalpopularusesworldwide.Turmericpowder,which
hasadistinctivedeepyellowcolorandbittertaste,isusedas
adye,acookingingredient,andalitmusinachemicaltest,
andhasmedicinalusesaswell.AU.S.patentonturmeric
wasawardedtotheUniversityofMississippiMedical
Centerin1995,specificallyforthe"useofturmericin
woundhealing."Thispatentalsograntedthemthe
exclusiverighttosellanddistributeturmeric.
Twoyearslater,acomplaintwasfiledbyIndia'sCouncilof
ScientificandIndustrialResearch,whichchallengedthe
noveltyoftheUniversity's"discovery,"andtheU.S.patent
officeinvestigatedthevalidityofthispatent.

7. InIndia,whereturmerichasbeenusedmedicinally
forthousandsofyears,concernsgrewaboutthe
economicallyandsociallydamagingimpactofthis
legal"biopiracy."
In1997,thepatentwasrevoked.Butfortwoyears
thepatentonturmerichadstood,althoughthe
processwasnon-novelandhadinfactbeen
traditionallypracticedinIndiaforthousandsof
years,aswaseventuallyprovenbyancientSanskrit
writingsthatdocumentedturmeric'sextensiveand
variedusethroughoutIndia'shistory.

8. Roche Vs. Cipla
DelhiHighCourthasbeenthebattlegroundfora
pharmaceuticalwarbetweenRocheandCipla,over
Roche’spatentforanticancerdrug‘Erlotinib’,sold
byRocheasTARCEVA.
BothRocheandCipladrugsarebasedona
compoundthatgoesbythenameof‘Erlotinib
Hydrochloride.’
Thiscaseisregardedasaveryimportantcaseina
seriesofhighprofilepatentbattlesbetween
multinationalpharmaceuticalcompaniesand
Indiangenericdrugcompanies.

9. InFebruary2007,RochealongwithPfizer(asajoint
applicant),claimedthatithadbeengrantedapatent
for“erlotinib”Thepatentedproduct,whichRoche
introducedontotheIndianmarketwasmarketed
underthebrandnameTARCEVA.
InDecember2007andJanuary2008,Indian
newspapersreportedCipla’splantolaunchageneric
versionof‘erlotinib’
Soonafterthat,Rochecommencedpatent
infringementproceedings.

10. Cipla’s Defence and Counterclaim
IthadbeensellingitsdrugunderthebrandnameERLOCIPsince
December2007.
Roche’spatentwasinvalidbecause‘erlotinib’wasaderivativeof
Quinazolin.
Roche’sinvention,asdisclosedinthecompletespecificationand
claimswasobviousordidnotinvolveanyinventivestep.
Thecompletespecificationdidnotsufficientlyandfairlydescribe
theinventionorthemethodbywhichitwastobeperformed.
ThehugedifferenceinpricebetweenRoche’sdrug(Rs.4,800tablet
(approx.US$100)andCipla’sdrug(Rs.1,600(approx.US$33)
shouldbetakenintoaccountwhendecidingwhetherornottogrant
aninteriminjunction.
Ciplastronglyarguedthatbecausethedruginquestionwasalife
savingdrug,thepublicinterestissuewasanimportantfactorto
betakenintoaccount.

11. Roche’s Submission
Section3(d)ofthePatentsActisnotapplicableas
itprohibitsonlyderivativesof‘aknownsubstance’.
‘Erlotinib’isnot‘salts,esters,polymorphs,particle
size,mixtureofisomers,etc.’ofa‘known
substance’.Itisanovelcompound
Inanycase,‘erlotinib’isadifferentcompound;its
propertiesdifferfromthoseofAstraZeneca’s
Gefatinib,whichwascitedaspriorart.
Whendeterminingwherethebalanceof
conveniencelies,itisappropriatetoconsiderthe
issueof‘accessibility’to,anduseof,theinvention
intheterritory.Itisnot,however,necessarythatthe
drugshouldbemanufacturedinIndia.

12. SingleJudgeRulingWhilehearingthecase,the
judgenotedthefollowingpoints:
Publicinterest:Thegenericdrugversionof
‘erlotinib’manufacturedandmarketedbyCiplais
availableatone-thirdthepriceofRoche’sdrug,
Tarceva.Further,theCourtnotedthatTarcevaisnot
manufacturedinIndia,itisimported.TheCourt
notedthattherighttoaccesstolife-savingdrugs,
andtheneedforsecurelongtermsupplies,isa
seriousissueinIndia.Insuchcase,theinjurythat
wouldbecausedtothegeneralpublicifthegeneric
versionofthedrugwerenotavailableisastrong
pointinfavourofarefusaltograntaninjunction.
ThispointcompletelyfavouredCipla'sDefence.

13. DivisionBenchRulingRochefiledanappealagainstthe
Orderofthesinglejudge,arguingthatafailuretoprotectthe
rightsofthepatentee,iscontrarytothepublicinterestof
encouragingfurtherresearchinthepharmaceuticalfield.The
divisionbenchinitsrulingobserved:Noninfringement:The
benchwasoftheviewthatthepatentinquestionrelatedtoa
mixtureofPolymorphsAandB,whereasRoche’sTarceva
drugconsistedofonlyPolymorphB,forwhichapatenthad
notyetbeengranted.Thedivisionbenchconsideredthatthis
factoughttohavebeendisclosedbyRochebothatthetimeof
examination,andduringtheproceedingsbeforethesingle
judge.ThebenchgaveweighttothefactthatPolymorphBof
‘erlotinibhydrochloride’wasthesubjectofalaterpatent
application,andthatthishadnotbeenconsideredbythe
singlejudge.

14. ThebenchcriticisedRochefor:Itsfailuretoprovide
asufficientandfairdescriptionoftheinvention;and
FornothavingfiledX-raydiffractiondatafor
TarcevaandErlocipthatwouldhaveshownwhether
ornotthecrystallinestructureofCipla’sErlocip
tabletscorrespondedtoRoche’spatentedinvention.
TheCourtdismissedRoche’sappeal,andupheldthe
orderofthesinglejudge.
Insept2012CiplaLtdwonalandmarkpatentcase
againstRocheLtd.Ithadbeenscientificallyproven
thatCipla’sgenericversionwasapolymorphb
variantofRoche’spatenteddruganditdidn’t
infringeanypatentinIndia.

15. Novartis v. Union of India
Novartisfiledanapplicationforgrantofpatentfor
chemicalcompoundcalledImatinibMesylate
whichisatherapeuticdrugforchronicmyeloid
leukemiaandcertainkindsoftumoursandis
marketedunderthenames"Glivec"or"Gleevec"at
theChennaiPatentOffice.Intheapplicationit
claimedthattheinventedproduct,thebetacrystal
formofImatinibMesylate,hasmorebeneficial
flowpropertiesbetterthermodynamicstabilityand
lowerhygroscopicitythanthealphacrystalformof
ImatinibMesylateandfurtherclaimedthatthe
aforesaidpropertiesmakestheinventedproduct
novel.

16. Thepatentapplicationhadattractedfive(5)pre-grant
oppositions.TheAssistantControllerheardallthe
parties,andrejectedtheappellant's(Novartis)
applicationforgrantofpatenttothesubjectby5
(five)separate,thoughsimilar,orderspassedthe
oppositionpetitions.TheAssistantControllerheld
thattheinventionclaimedbytheappellantwas
anticipatedbypriorpublication,i.e.,the
Zimmermannpatent;thattheinventionclaimedby
theappellantwasobvioustoapersonskilledinthe
artinviewofthedisclosureprovidedinthe
Zimmermannpatentspecifications.TheSupreme
CourtofIndiarejectedNovartispatentpleaonApril
1,2013