RESTRICTED
WORLD TRADE IP/N/1/IND/1
8March 1995
ORGANIZATION(95-0515)
Original: English Council forTrade-Related Aspects
ofIntellectual Property Rights
NOTIFICATION OFLAWS AND REGULATIONS
UNDER ARTICLE 63.2OFTHE AGREEMENT
India
Thefollowing communication from thedelegation ofIndia, dated 6March 1995, hasbeen
received withtherequest thatitbecirculated totheMembers oftheCouncil forTRIPS.
_______________
1. Onbehalf oftheGovernment ofIndia, Ihavethehonour toforward thefollowing information
totheCouncil forTrade-Related Aspects ofIntellectual Property Rights.
2. Article 70,paras 8and9,oftheAgreement onTrade-Related Aspects ofIntellectual Property
Rights imposes certain obligations onMembers oftheWTO whodonotmake available, asofthedate
ofentryintoforceoftheWTOAgreement,patentprotectionforpharmaceuticalandagriculturalchemical
products commensurate withobligations under Article 27ofthesaidAgreement. These obligations
involve providing ameans bywhich applications forpatents forsuchinventions canbefiledandgranting
ofexclusivemarketingrightsundercertaincircumstanceswithintheoverallframeworkoftheAgreement
onTrade-Related Aspects ofIntellectual Property.
3. With aviewtomeetIndia'sobligations under paras 8and9ofArticle 70oftheAgreement
onTrade-RelatedAspectsofIntellectualPropertyRights,anOrdinancewaspromulgatedbythePresident
ofIndia on31December 1994, effective from 1January 1995, amending certain provisions ofthe
Patents Act,1970.
4. Ienclose acopy oftheOrdinance referred toabove. Thisisbywayofinformation tothe
Members oftheCouncil forTrade-Related Aspects ofIntellectual Property Rights.IP/N/1/IND/1
Page2
MINISTRY OFLAW, JUSTICE AND COMPANY AFFAIRS
(Legislative Department)
NewDelhi, the31stDecember, 1994/Pausa 10,1916 (Saka)
THE PATENTS (AMENDMENT) ORDINANCE, 1994
No.13OF1994
Promulgated bythePresident intheForty-fifth Year oftheRepublic ofIndia
AnOrdinance further toamend thePatent Act,1970.
WHEREAS India isasignatory totheagreement forthe
establishment oftheWorld Trade Organisation including the
Agreement onTrade-Related Aspects ofIntellectual Property
Rights forthepurpose ofreduction ofdistortions and
impediments tointernational trade andpromotion ofeffective and
adequate protection ofintellectual property rights.
AND WHEREAS with aview tomeeting India's
obligations under thesaidAgreement while safeguarding its
interests, ithasbecome necessary toamend thePatents Act,1970
inconformity with theobligations under theAgreement that
signatory countries, informulating oramending their laws and
regulations, may adopt measures consistent with thesaid
agreement, necessary toprotect public health andnutrition andto
promote public interest insectors ofvital importance totheir
socio-economic andtechnological development;
AND WHEREAS Parliament isnotinsession andthe
President issatisfied thatcircumstances exist which render it
necessary forhimtotakeimmediate action;
NOW, THEREFORE, inexercise ofthepowers conferred
byclause (1)ofarticle 123oftheConstitution, thePresident is
pleased topromulgate thefollowing Ordinance:-
Short titleand
commencement .1. (1) This Ordinance may becalled thePatents
(Amendment) Ordinance, 1994.
(2) Itshallcome intoforce onthe1stdayofJanuary,
1995.
Amendment of
section 5.2. Section 5ofthePatents Act,1970 (hereinafter referred to
asthePrincipal Act) shall bere-numbered assub-section (1)
thereof andaftersub-section (1)assore-numbered, thefollowing
sub-section shallbeinserted, namely:-39of1970.IP/N/1/IND/1
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"(2)Notwithstanding anything contained insub-
section (1),aclaim forpatent ofaninvention fora
substance itself intended foruse,orcapable ofbeing
used, asmedicine ordrug maybemade andshall be
dealt, without prejudice totheother provisions ofthis
Act,inthemanner provided inChapter IVA."
Insertion ofnew
Chapter IVA.3. After Chapter IVoftheprincipal Act, thefollowing
Chapter shallbeinserted, namely:-
"CHAPTER IVA
EXCLUSIVE MARKETING RIGHTS
Application for
grant ofexclusive
rights.24A. (1)Notwithstanding anything contained insub-
section (1)ofsection 12,theController shallnot,under thatsub-
section, refer anapplication inrespect ofaclaim forapatent
covered under sub-section (2)ofsection 5toanexaminer for
making areport tillthe31stdayofDecember, 2004 andshall,
where anapplication forgrant ofexclusive right tosellor
distribute thearticle orsubstance inIndia hasbeen made inthe
prescribed form andmanner andonpayment ofprescribed fee,
refer theapplication forpatent, toanexaminer formaking a
report tohimastowhether theinvention isnotaninvention
within themeaning ofthisActinterms ofsection 3orthe
invention isaninvention forwhich nopatent canbegranted in
terms ofsection 4.
(2)Where theController, onreceipt ofareport under
sub-section (1)andaftersuchother investigation ashemaydeem
necessary, issatisfied thattheinvention isnotaninvention within
themeaning ofthisActinterms ofsection 3ortheinvention is
aninvention forwhich nopatent canbegranted interms of
section 4,heshallreject theapplication forexclusive righttosell
ordistribute thearticle orsubstance.
(3)Inacasewhere anapplication forexclusive right to
sellordistribute anarticle orasubstance isnotrejected bythe
Controller onreceipt ofareport under sub-section (1)andafter
suchother investigation, ifany,made byhim,hemayproceed to
grant exclusive right tosellordistribute thearticle orsubstance
inthemanner provided insection 24B.
24B. (1)Where aclaim forpatent covered under sub-
section (2)ofsection 5hasbeenmade andtheapplicant has,-Grant of
exclusive
rights .
(a)where aninvention hasbeenmade inacountry other
thanIndia andbefore filing suchaclaim, filedanapplication for
thesame invention claiming identical article orsubstance ina
convention country onorafterthe1stdayofJanuary, 1995 and
thepatent onthebasis ofappropriate tests conducted inthat
country hasbeengranted onorafterthedateofmaking aclaim
forpatent covered under sub-section (2)ofsection 5;orIP/N/1/IND/1
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(b) where aninvention hasbeen made inIndia and
before filing suchaclaim, made aclaim forpatent onorafterthe
1stdayofJanuary, 1995 formethod orprocess ofmanufacture
forthatinvention relating toidentical article orsubstance andhas
beengranted thepatent therefore onorafterthedateofmaking a
claim forpatent covered under sub-section (2)ofsection 5,
andhasreceived theapproval tosellordistribute thearticle or
substance from theauthority specified inthisbehalf bythe
Central Government, then, heshall have theexclusive right by
himself, hisagents orlicensees tosellordistribute inIndia the
article orthesubstance onandfrom thedateofapproval granted
bytheController inthisbehalf tillaperiod offiveyears ortill
thedateofgrant ofpatent orthedateofrejection ofapplication
forthegrant ofpatent, whichever isearlier.
(2)Where, thespecifications ofaninvention relatable to
anarticle orasubstance covered under sub-section (2)ofsection
5have been recorded inadocument ortheinvention hasbeen
triedorused, or,thearticle orthesubstance hasbeensold, bya
person, before aclaim forapatent ofthatinvention ismade in
India orinaconvention country, then, thesaleordistribution of
thearticle orsubstance bysuchperson, aftertheclaim referred to
above ismade, shall notbedeemed tobeaninfringement of
exclusive righttosellordistribute under sub-section (1):
Provided thatnothing inthissub-section shallapply ina
casewhere aperson makes orusesanarticle orasubstance with
aviewtoselling ordistributing thesame, thedetails ofinvention
relatable thereto were given byaperson whowasholding an
exclusive righttosellordistribute thearticle orsubstance.
24C. Theprovisions inrelation tocompulsory licences in
Chapter XVIshall, subject tothenecessary modifications, apply
inrelation toanexclusive righttosellordistribute under section
24Bastheyapply to,andinrelation to,arightunder apatent to
sellordistribute andforthatpurpose thefollowing modifications
shall bedeemed tohave been made totheprovisions ofthat
Chapter andalltheir grammatical variations andcognate
expressions shallbeconstrued accordingly, namely:-Compulsory
licences .
(a)throughout Chapter XVI, working ofthe
invention shallbedeemed tobeselling ordistributing thearticle
orsubstance;
(b)three years from thedateofsealing ofa
patent insection 84shall bedeemed tobetwoyears from the
dateofapproval bytheController forexclusive right tosellor
distribute under section 24B;
(c)thetimewhich haselapsed since thesealing
ofthepatent under section 85shall bedeemed tobethetime
which haselapsed since theapproval bytheController for
exclusive righttosellordistribute under section 24B;IP/N/1/IND/1
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(d)clause (d)andclause (e)ofsection 90shall
beomitted;
Special provision
forselling or
distribution.24D. (1)Without prejudice totheprovisions ofany
other lawforthetimebeing inforce, where, atanytimeafteran
exclusive right tosellordistribute anyarticle orsubstance has
been granted under sub-section (1)ofsection 24B, theCentral
Government issatisfied thatitisnecessary orexpedient inthe
public interest tosellordistribute thearticle orsubstance bya
person other thanaperson towhom exclusive right hasbeen
granted under sub-section (1)ofsection 24B, itmay, byitself or
through anyperson authorised inwriting byitinthisbehalf, sell
ordistribute thearticle orsubstance.
(2)TheCentral Government may, bynotification inthe
Official Gazette andatanytimeafteranexclusive righttosellor
distribute anarticle orasubstance hasbeengranted, direct, inthe
public interest andforreasons tobestated, thatthesaidarticle or
substance shall besoldataprice determined byanauthority
specified byitinthisbehalf.
Suits relating to
infringements.24E. Allsuitsrelating toinfringement ofaright under
section 24Bshallbedealtwithinthesame manner asiftheyare
suitsconcerning infringement ofpatents under Chapter XVIII.
Central
Government and
itsofficers notto
beliable.24F. Theexamination andinvestigations required under
thisChapter shall notbedeemed inanywaytowarrant the
validity ofanygrant ofexclusive right tosellordistribute, and
noliability shall beincurred bytheCentral Government orany
officer thereof byreason of,orinconnection with, anysuch
examination orinvestigation oranyreport orother proceedings
consequent thereon.".
Omission of
section 39.4. Section 39oftheprincipal Actshallbeomitted.
Amendment of
section 40.5. Insection 40oftheprincipal Act,thewords andfigures
"ormakes orcauses tobemade anapplication forthegrant ofa
patent outside India incontravention ofsection 39"shall be
omitted.
Amendment of
section 64.6. Insection 64oftheprincipal Act,insub-section (1),in
clause (n),thewords andfigures "ormade orcaused tobemade
anapplication forthegrant ofapatent outside India in
contravention ofsection 39"shallbeomitted.
7. Insection 118oftheprincipal Act,thewords andfigures
"ormakes orcauses tobemade anapplication forthegrant ofa
patent incontravention ofsection 39"shallbeomitted.Amendment
ofsection
118.