WORLD TRADE WT/DS36/4
IP/D/2/Add.1
7March 1997
ORGANIZATION(97-0936)
Original: English
PAKISTAN -PATENT PROTECTION FOR PHARMACEUTICAL
AND AGRICULTURAL CHEMICAL PRODUCTS
Notification ofaMutually-Agreed Solution
Thefollowing communication, dated 28February 1997, from thePermanent Mission ofthe
United States andthePermanent Mission ofPakistan totheDispute Settlement Body, iscirculated
attherequest ofthose delegations.
_______________
TheGovernments oftheUnited States ofAmerica andPakistan wishtonotify theDispute
Settlement Body thattheyhavereached amutually satisfactory solution tothematter raised bythe
Government oftheUnited States inWT/DS36/1, dated 6May1996, concerning Pakistan ’sobligation
under theAgreement ofTrade Related Aspects ofIntellectual Property Rights (TRIPS Agreement)
toeither grant patent protection forpharmaceutical andagricultural chemical products asofthedate
ofentry intoforce ofWTO Agreement, ortoestablish systems forfiling applications forpatents on
suchinventions andforgranting exclusive marketing rights under certain circumstances.
Noting thatPakistan doesnotyetprovide patent protection forpharmaceutical andagricultural
chemical products, theGovernments oftheUnited States andPakistan agree thatPakistan wasobligated
under Article 70.8oftheTRIPS Agreement toestablish asystem forthefiling ofpatent applications
onsuchinventions by1January 1995. ThetwoGovernments alsoagree thatPakistan isalsoobligated
under Article 70.9oftheTRIPS Agreement toestablish asystem togrant exclusive marketing rights
tosuchpatent applicants iftheymeetcertain criteria. Tofulfil these obligations, Pakistan President
Farooq Ahmad Khan Leghari issued on4February 1997 Ordinance No.XXVI of1997.
Withrespect totheobligations inArticle 70.8oftheTRIPS Agreement, theOrdinance provides
thatallapplications filedafter1January 1995 shallbeconsidered validly filed. TheGovernment of
Pakistan willissue regulations implementing theOrdinance providing thatanyperson whofirstfiles
anapplication forpatent protection forpharmaceutical oragricultural chemical product inanother WTO
member afterthedatetheOrdinance wasissued willbeabletofileanapplication withPakistan ’spatent
authorities and(1)until1January 2000haveastheirfiling datethedatetheapplication wasreceived
bysuchauthorities, or(2)after1January 2000, havetherighttoclaim priority under therules laid
down inArticle 4oftheParis Convention fortheProtection ofIndustrial Property.
Furthermore, toensure thatpersons whowould havefiledapplications from 1January 1995
untilthedatetheOrdinance wasissued areabletodosoandreceive thefiling datetheywould have
received, theregulations implementing theOrdinance willprovide that:
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IP/D/2/Add.1
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- anyperson whofirstfiledanapplication forpatent protection forapharmaceutical
oragricultural chemical product inanother WTO Member after1January 1995 and
before thedateoftheOrdinance wasissued willbeabletofileanapplication under
thesystem established bytheordinance;
- suchapplications willbeaccepted byPakistan ’spatent authorities beginning onthe
datetheordinance wasissued andforoneyearthereafter; and
- theeffective filing dateofeachsuchapplication shallbethefiling dateoftheoriginal
application filedinanother WTO Member.
Withrespect totheobligations inArticle 70.9oftheTRIPS Agreement, theordinance provides
thatexclusive marketing rights willbegranted where (1)theapplicant isgranted apatent andmarketing
approval ontheproduct thatisthesubject oftheapplication inanother WTO Member and(2)the
applicant isgranted marketing approval inPakistan. Theperiod ofexclusive marketing rights shall
beforaperiod offiveyears aftertheseconditions aremetoruntilaproduct patent isgranted orrejected
inPakistan, whichever termisshorter. Inaccordance withtherequirement under Article 70.9ofthe
TRIPS Agreement thatmarketing rights beexclusive, theGovernment ofPakistan willimplement the
Ordinance sothatunder nocircumstances willexclusive marketing rights besubject toanylimitation
orexception, including theimposition ofacompulsory license. Accordingly, noparty willbegranted
marketing approval foraproduct thatisthesubject ofexclusive marketing rights without theexpress
consent oftheholder ofsuchexclusive marketing rights.
Assoonaspossible following thedateofthisjointnotification, theGovernment ofPakistan
willissue regulations implementing theOrdinance inaccordance withtheabove-stated description.
Based onthese developments, Pakistan andtheUnited States have agreed toterminate
consultations onthismatter andtheUnited States wished formally towithdraw thismatter fromfurther
attention under theprovisions oftheDispute Settlement Understanding. Thisagreement iswithout
prejudice totherights andobligations ofeither Member under theAgreement Establishing theWorld
Trade Organization.