Nirma University Institute of Law VII Semester B.A.LL.B.(Hons.)Course
Submission of Synopsis o n t h e op op i ! o f
"#atent Laws in In$ia in !omp%ian!e with &I#s A'reement A'reement An overview
In the Course of Inte%%e!tua% #roperty &i'hts As a part of !ontinuous eva%uation s!heme.
Submitte$ to* +r. &ohit moon,a Submitte$ by* &upa%i -ani (/BAL01)
IN234 1
Sr. No.
1.
#arti!u%ars
Ch- I: Introduction •
#a'e No.
05 06-08
Synopsis
2.
Ch– II: Patent (Aendent! Act 2005
0"-10
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Ch – III: III: Ipa Ipact ct o$ %&IPs &IPs upon upon Indi ndian Pat Patent ent 'a
11-1#
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Ch – I*: Ip+ication o$ o$ ,o ,oartis Ca Case
1)-15
5.
Ch – *: Co Conc+usion
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i/+ioraphy
1
D E C LA R A T IO N
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Dat e:
Rupal iJani Rol lNo09BAL018 VI ISeme mest er ,( 201213) I ns t i t ut eofLaw Ni r maUni ver si t y
3
C E R TIFIC A TE
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Dat e:
Mr .Rohi tMoonka Ass t .Pr of essori nLaw, I ns t i t ut eofLaw, Ni r maUni ver si t y
Ahme me dabad
4
Chapter I Intro$u!tion
Patent is the ec+usie onopo+y riht ranted /y 3ot to Patentee. Patent is round in $aour o$ the inentor con$errin on hi the riht to use his inention to the ec+usie o$ a++ others. It is ranted $or a tie i.e 20years. I$ the inesto cannot use or or4 the inention /y hise+$ he can do son in association ith other or assin it to other or he can rant +icences to other to or4 the inention $or consideration or $or $ees hich is ca++ed &oya+ty.
%he patent syste is socia+ po+icy too+ that ais to stiu+ate innoation. Internationa++y patent protection is oerned /y the or+d %rade %rade 7raniation 7raniation (%7! %rade-&e+ated %rade-&e+ated Aspects o$ Inte++ectua+ Property &ihts (%&IPS! Areeent. %&IPS does not esta/+ish a uni$or internationa+ +a /ut sets out iniu standards o$ patent protection that ust /e et /y a++ %7 e/ers. 9ee+oped countries hae a+ready ip+eented the areeent and other countries such as India are ip+eented in 2005.1
%he Indian patent syste has su$$ered continuous odi$ications oer the past decade part+y as a re$+ection o$ the dierin standpoints and chanin priorities o$ oernent nationa+ industry pu/+ic hea+th ,37s and other sta4eho+ders. ore recent+y Indian
1 www.who.int.pdf 5
patent +as hae /een aended to cop+y ith the or+d %rade %rade 7ranisation 7ranisation (%7! Areeent on %rade-&e+ated Aspects Aspects o$ Inte++ectua+ Property &ihts (%&IPS!. 2
S5N6#SIS*
&;S;A&C< P&7'; Patent is an ec+usie onopo+y riht ranted /y the 3ot. $or the inention. An inention eans soethin ne or use$u+. %here$ore patent can /e ranted on+y to such inentions inentions hich are ne and use$u+. use$u+. 7n the other hand %&IPs %&IPs does not esta/+ish a uni$or internationa+ +a /ut sets out iniu standards o$ patent protection that ust ust /e et /y a++ %7 e/ers. e/ers. %here$ore it is essentia+ to so+e the pro/+es and intricacies reardin the Patent 'as ith cop+iance to %&IPs. •
AIS A,9 7=;C%I*; %he $undaenta+ o/>ectie o$ the present research is?
%o critica++y eaine the arious +as re+atin to Patent. %o critica++y o/sere and i++ hae a /road study upon %&IPs Areeent in re+ation to Patent.
<@P7%<;SIS
2 www.ipngos.org 6
In order to conduct a research or4 $oru+ation o$
•
&;S;A&C< ;%<797'73@
In order to accop+ish the present research or4 an attept has /een ade to study the ea+uation o$ ter Patent 'as in India.
%he ateria+ has /een co++ected $ro the secondary sources i.e. /oo4s arious e/sites artic+es.
SC7P; 7 %<; S%B9@
%he scope o$ the study is +iited to the Patent 'as etendin to India.
SC<;; 7 %<; S%B9@ or the sa4e o$ conenience the present or4 is sip+i$ied /y chapterisation and hence it is diided in * chapters nae+y? o o o
Chapter I : Introduction Chapter II : Patent (Aendent! Act Act 2005 Chapter III : Ipact o$ %&IPs areeent upon Indian Patent 'a 7
o
Chapter I* : Conc+usion
&3VI37 68 LI3&AU&3
In order to accop+ish the research or4 the researcher has co++ected the ateria+ $ro secondary sources i.e. /oo4s e/sites. %he or4 has /een ain+y depended on the ana+ysis o$ Patent 'as in India. esides the researcher has isited e/site o$ anupatra ind+a heinon+ine in order to a4e an authentic study o$ the topic. oreoer the researcher researcher has read arious artic+es in order to understand the aspect o$ Patent 'as in India. oreoer the researcher has re$erred the $o++oin /oo4 nae+y? o Indian Patents 'a- 'ea+ and usiness Ip+ications A>it Paru+e4ar and o o
Sarita 9soua Pu/+ished /y aci++an India 'td. Patent 'a P. ,arayanan ourth edition ;astern 'a
8
Chapter II #atent (Amen$ment) A!t 9:
%he Indian patent syste datin as $ar /ac4 as 1856 has su$$ered seera+ odi$ications at di$$erent ties that hae strenthened or re+aed patent rihts. %he Patents Act 1"0 that cae into $orce in Apri+ 20 1"2 as a response to the roin nationa+ de/ate on ho to /est stri4e a /a+ance /eteen patent rihts as incenties to innoation and the need to protect the pu/+ic interest and to /oost industria+ dee+opent. Bp unti+ the 1"60s $orein u+tinationa+ pharaceutica+ copanies supp+ied a+ost 85 percent o$ edicines in India and prices ere aon the hihest in the or+d. #
%o redress this pro/+e and ith a ie to a4e the patent +a copati/+e ith Indian dee+openta+ o/>ecties in the post independence period $ro 1") to 1"0 the Indian Par+iaent eheent+y de/ated aendents to the Patents Act. 7ne o$ the ain chanes o$ the Patents Act 1"0 as that it a++oed process patents in pharaceutica+ and arocheica+ /ased products /ut not product patents. %his a++oed the nationa+ pharaceutica+ industry to dee+op technica+ epertise in reerse enineerin o$ eistin edicines – odi$yin the anu$acturin process – and thus to /ecoe an e$$icient producer o$ eneric edicines.) 3 www.ipngos.org 4 supra 9
7n arch 2# 2005 the Indian Par+iaent passed the Patent (Aendent! i++ 2005. It as the third aendent to the Indian Patent Act (1"0!. 5 %he aended Patent Act con$ors to reEuireents set $orth /y the or+d %rade 7raniations (%7! Areeent on %rade-&e+ated Aspects o$ Inte++ectua+ Property &ihts (%&IPS!. Since the ne +a cae into e$$ect on =anuary 1 2005 there hae /een serious concerns reardin the ro+e o$ the doestic Indian eneric industry in the ne product patents reie 6 and the continued aai+a/i+ity o$ essentia+ edicines at a$$orda/+e prices.
%he Patents (Aendent! Act o$ 2005 reoed the prohi/ition o$ product patents $or pharaceutica+ copounds a++oin any copany to see4 /oth product and process patents in India.
5 www.ipindia.nic.in 6 www.healthgap.org 7 supra 8 supra 10
Chapter III Impa!t of &I#s a'reement upon In$ian #atent Law
%&IPs hich stands $or %rade &e+ated Aspects o$ Inte++ectua+ Property &ihts inc+udin trade in counter$eit oods is an iportant areeent. %he %&IPs Areeent cae into e$$ect on 1 =anuary 1""5 is to date the ost coprehensie u+ti+atera+ areeent on inte++ectua+ property. property." %he areas o$ inte++ectua+ property that it coers are copyriht and re+ated rihts tradear4s eoraphica+ indications industria+ desins patents inc+udin the protection o$ ne arieties o$ p+ants and undisc+osed in$oration inc+udin trade secrets. It is andatory $or a++ e/ers to cop+y ith the %&IPS areeent.
9 www.planningcommission.in 10 www.ponline.com 11
%he ain issues under %&IPS that had to /e addressed to a4e the Indian Patent Act cop+y ith c+auses o$ %&IPS areeent ere: a. %he riht o$ iportation and the prohi/ition o$ discriination /eteen +oca+ production and iportation11 /. roadenin patenta/+e patenta/+e su/>ect-atter su/>ect-atter to inc+ude icro-oraniss icro-oraniss c. 'iitin copu+sory +icensin to cop+y ith the conditions set $orth in Artic+e #1 d. Increasin the ter o$ protection to tenty years uni$or+y $or a++ su/>ect atters e. A++oin product patents $. Shi$tin the F/urden o$ proo$F in atters o$ process-patent process-patent in$rineent proceedins. proceedins. %he 4ey $eature o$ this areeent is that it ta4es a a>or step $or haroniation o$ the nors and standards o$ Inte++ectua+ Property Protection. It reEuires e/ers to cop+y ith a de$ined set o$ iniu standards $or the protection o$ IP&s coered coered in it. he hree main features of the A'reement are*
; Stan$ar$s Stan$ar$s09* In respect o$ each o$ the ain areas o$ inte++ectua+ property coered /y
the %&IPS Areeent sets out the iniu standards o$ protection to /e proided /y each e/er. ;ach o$ the ain e+eents o$ protection is de$ined nae+y the su/>ectatter to /e protected the rihts to /e con$erred and perissi/+e eceptions to those rihts and the iniu duration o$ protection.
; 3nfor!ement * %he second ain set o$ proisions dea+s ith doestic procedures and
reedies $or the en$orceent o$ inte++ectua+ property rihts. %he Areeent +ays don 11 supra 12 www.planningcommission.in 12
certain enera+ princip+es app+ica/+e to a++ IP& en$orceent procedures. In addition it contains contains proisions proisions on cii+ cii+ an adinistr adinistratie atie procedures procedures and reedies reedies proisiona proisiona++ easures easures specia+ specia+ reEuireen reEuireents ts re+ated re+ated to /order /order easures easures and criina+ criina+ procedure procedures s hich speci$y in a certain aount o$ detai+ the procedures and reedies that ust /e aai+a/+e so that riht ho+ders can e$$ectie+y e$$ectie+y en$orce their rihts.
; 2ispute sett%ement : %he Areeent a4es sett+eent procedures o$ disputes /eteen
%7 e/ers a/out the respect o$ the %&IPS o/+iation su/>ect to the %7s dispute. In addition the Areeent proides $or certain /asic princip+es such as nationa+ and ostost- $aour $aoureded-nat nation ion treat treatent ent and soe soe enera enera++ ru+es ru+es to ensure ensure that that proced procedura ura++ di$$icu+ties in acEuirin or aintainin IP& do not nu++i$y the su/stantie /ene$its that shou+d $+o $ro the Areeent. Areeent. %he o/+iations under the Areeent Areeent i++ app+y eEua++y to a++ e/er countries /ut dee+opin countries i++ hae a +oner period to phase the in. %he %&IPS Areeent is a iniu standards areeent hich a++os e/ers to proide ore etensie protection o$ inte++ectua+ property i$ they so ish. e/ers are +e$t $ree to deterine the appropriate ethod o$ ip+eentin the proisions o$ the Areeent ithin their on +ea+ syste and practice.1#
13 supra 13
Chapter IV Imp%i!ation of Novartis !ase upon In$ian #atent Law
In 1""# ,oartis $i+ed patents or+dide $or the actie o+ecu+e iatini/. ,oartis did not not pate patent nt iat iatin ini/ i/ in Indi Indiaa /eca /ecaus usee the the 1"0 1"0 Act did did not not a++o a++o pate patent ntin in o$ pharaceutica+ products at that tie. A$ter IndiaGs entry into the %7 in 1""5 ,oartis $i+ed a Hai+/oH patent app+ication in the adras Patent 7$$ice $or iatini/ esy+ate a /eta crysta++ine crysta++ine $or o$ the $ree /ase /ase iatini/. In 2002 ,oartis started its 3+eeec donation prora in India to proide 3+eeec to patients ho ere una/+e to a$$ord the edicine /ut ha+ted that prora a$ter Indian dru anu$acturers /ean to produce a eneric ersion o$ 3+eeec. In =anuary 2006 the adras Patent 7$$ice re$used to rant ,oartis a patent $or iatini/ esy+ate.
14
%he $irst a>or round $or re>ection as that /ecause iatini/ esy+ate as a sa+t $or o$ the $ree /ase iatini/ and ,oartis c+aied a++ pharaceutica+ sa+t $ors o$ iatini/ in its 1""# patents the Indian app+ication there$ore +ac4ed noe+ty and inentieness. %he %he seco second nd a>o a>orr rou round nd $or $or re>e re>ect ctio ion n as as /ase /ased d on Sect Sectio ion n #(d! #(d! o$ the the 2005 2005 Aendent hich reEuired that ne $ors o$ a 4non su/stance cou+d on+y /e patented as a product product i$ they deonstra deonstrated ted Henhanced Henhanced e$$icacy. e$$icacy.HH A+thou A+thouh h ,oartis ,oartis disc+ose disc+osed d in$oration that iatini/ esy+ate had a #0 increase in /ioaai+a/i+ity (the percentae o$ the dru a/sor/ed into the /+oodstrea! as copared ith iatini/ the Patent 7$$ice $ound this insu$$icient to eet the Henhanced e$$icacyH reEuireent o$ Section #(d!. 1) In ay ay 2006 2006 ,oa ,oart rtis is peti petiti tion oned ed the the adr adras as ectin the 3+eeec patent app+ication that Section #(d! as not cop+iant ith %&IPS and that Section #(d! as aue a/iuous and in io+ation o$ Artic+e 1) o$ the Constitution o$ India /ecause it as discriinatory aainst ,oartis. %he adras urisdiction to decide a case concernin the cop+iance o$ a doestic Indian +a ith an internationa+ treaty. the court he+d that Section #(d! did not con$er un+iited discretionary poer to the Patent Contro++er and as as not not disc discri rii ina nato tory ry.. %he %he cour courtt eph ephas asi ied ed that that disc discre reti tion onar ary y poe poerr did did not not necessari+y ean that it ou+d /e discriinatory. %he Patent Contro++erGs discretionary poer under Section #(d! in decidin hether a 4non su/stance has enhanced e$$icacy e$$icacy did did not not auto autoa ati tica ca++ ++y y +ead +ead to an ar/i ar/itr trar ary y eer eerci cise se o$ disc discre reti tion onar ary y po poer or discriination aainst ,oartis. urtherore the court opined that the >udiciary shou+d /e ore de$erentia+ de$erentia+ to the +eis+ature +eis+ature in the $ie+d o$ econoic econoic reu+ation.
14 www.ponline.com
15
hen pharaceutica+ copany ,oartis cha++ened the re>ection o$ its patent app+ication $or the +eu4eia dru 3+eeec in ,oartis A3 A3 . Bnion o$ India it /ecae the $irst a>or +ea+ cha++ene to Indias ne+y aended patent +a. In 2005 India purported+y ade the $ina+ chanes reEuired to /rin its inte++ectua+ property +as in cop+iance ith the %rade %rade-&e -&e+at +ated ed Aspects spects o$ Inte++ Inte++ect ectua+ ua+ Proper Property ty &ihts &ihts (%&IP (%&IPS! S! the or+d %rade %rade 7raniations (%7! iniu standards $or inte++ectua+ property protection /ut its patent +a is sti++ $rauht ith a nu/er o$ controersia+ proisions. %he a/i+ity o$ pharaceutica+ copanies such as ,oartis to secure patent protection in India not on+y is iportant in creatin incenties $or pharaceutica+ research /ut a+so reat+y a$$ects the Indian eneric dru industry and there$ore the price o$ edicine aai+a/+e to patients.15
Chapter V Con!%usion
Patent Patent is an ec+u ec+usi siee onopo onopo+y +y riht riht rante ranted d /y the 3ot. $or the inent inention ion.. An inention eans soethin ne or use$u+. %here$ore patent can /e ranted on+y to such inent inention ionss hich hich are ne and and use$u+ use$u+.. 7n the other hand %&IPs %&IPs does does not esta/+i esta/+ish sh a uni$or internationa+ +a /ut sets out iniu standards o$ patent protection that ust /e et /y a++ %7 %7 e/ers. e/ers.
%he %&IPS Areeent reEuires e/ers countries to a4e patents aai+a/+e $or any ine inent ntio ions ns het hethe herr prod produc ucts ts or proc proces esse ses s in a++ a++ $ie+ $ie+ds ds o$ tech techno no+o +oy y ith ithou outt discri discriin inati ation on su/>ec su/>ectt to the nora+ nora+ tests tests o$ noe+t noe+ty y inent inentie ienes nesss and indust industria ria++ 15 upra 16
app+ica/i+ity. It is a+so reEuired that patents /e aai+a/+e and patent rihts en>oya/+e ithout discriination as to the p+ace o$ inention and hether products are iported or +oca++y produced.
Bib%io'raphy
Boo,s *< •
Indian Patents 'a- 'ea+ and usiness Ip+ications A>it Paru+e4ar and Sarita
•
9soua Pu/+ished /y aci++an India 'td. Patent 'a P. ,arayanan ourth edition ;astern 'a
•
7eb &eferen!es *< •
.ho.int.pd$
•
.ipnos.or 17
•
.ipindia.nic.in
•
.p+annincoission.in
•
.p$ion+ine.co
•
.hea+th.or.in
18
