patent law in india

7/21/2019 Patent Law in India

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PATENT LAW IN INDIA CRITICAL OVERVIEW

Perspectives on Law and

Business

Su !itted "Nis#ant B#as$aran


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PATENT LAW IN INDIA CRITICAL OVERVIEW

Introduction

T#e #istor" o% Patent &aw in India starts %ro! '('' w#en t#e Indian Patents andDesi)ns Act* '('' was enacted+ T#e present Patents Act* '(,- ca!e into %orce int#e "ear '(,.* a!endin) and conso&idatin) t#e e/istin) &aw re&atin) to Patents inIndia+ T#e Patents Act* '(,- was a)ain a!ended " t#e Patents 0A!end!ent1 Act*.--2* w#erein product patent was e/tended to a&& %ie&ds o% tec#no&o)" inc&udin) %ood*dru)s* c#e!ica&s and !icro or)anis!s+ T#e Patent 0A!end!ent1 Act .--20#ereina%ter re%erred to as t#e .--2 A!end!ent1 was passed " t#e Par&ia!ent in its

ud)et session o% .--2 to a!end T#e Patent Act* '(,- #ereina%ter re%erred to asT#e Act1 and !eet its o &i)ation under TRIPS A)ree!ent o% WTO+ T#e Act wase%%ective %ro! 'st 3anuar" .--2+ A%ter t#e a!end!ent* t#e provisions re&atin) toE/c&usive 4ar$etin) Ri)#ts 0E4Rs1 #ave een repea&ed* and a provision %or ena &in) )rant o% co!pu&sor" &icense #as een introduced+ T#e provisions re&atin) topre5)rant and post5)rant opposition #ave een a&so introduced+ A&t#ou)# t#e Act!a$es wide ran)in) c#an)es to India6s patent re)i!e* t#e !ost controversia&provision is t#e one introducin) product patents in t#e area o% p#ar!aceutica&s+

An invention re&atin) to a product or a process t#at is new* invo&vin) inventive stepand capa &e o% industria& app&ication can e patented in India+ 7owever* it !ust not%a&& into t#e cate)or" o% inventions t#at are non5patenta &e as provided under Section8 and 9 o% t#e 0Indian1 Patents Act* '(,-+ In India* a patent app&ication can e %i&ed*eit#er a&one or :oint&"* " true and %irst inventor or #is assi)nee+

Meaning of Patent

In si!p&e words* Patent is a docu!ent w#ic# is )enera&&" issued " )overn!entcon%errin) a !onopo&" ri)#t on an inventor to e/p&oit #is invention %or a &i!itedperiod+ T#e person to w#o! patent is )ranted in ca&&ed as Patentee+ It )ives t#epatentee an e/c&usive ri)#t to use* !anu%acture and se&& t#e invention %or a &i!itedperiod o% ti!e+ T#e )rant o% suc# a patent to t#e inventor o% an" invention is on&" %or a%i/ed or &i!ited period o% ti!e and t#us a%ter t#e e/pir" o% suc# period* t#e patentedinvention passes on to t#e pu &ic do!ain+


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Patents are one o% t#e o&dest %or!s o% inte&&ectua& propert" protection and* as wit# a&&%or!s o% protection %or inte&&ectua& propert"; t#e ai! o% a patent s"ste! is toencoura)e econo!ic and tec#no&o)ica& deve&op!ent " rewardin) inte&&ectua&creativit"+ T#e purpose o% a patent is to provide protection %or tec#no&o)ica& advancesi+e+ inventions+ It provides an award %or t#e disc&osure o% t#e creation o% so!et#in)new as we&& as %or t#e %urt#er deve&op!ent* or re%ine!ent* o% e/istin) tec#no&o)ies+ Ins#ort* t#rou)# patents* pro)ress in c#an)in) tec#no&o)ies %inds incentive to i!prove+

A ra#a! Linco&n descri es t#e i!portance o% Patent as nited States Constitution?* an" !an !i)#t instant&" use w#at anot#er #adinvented; so t#at t#e inventor #ad no specia& advanta)e %ro! #is own invention+ T#epatent s"ste! c#an)ed t#is; secured to t#e inventor* %or a &i!ited ti!e* t#e e/c&usiveuse o% #is invention; and t#ere " added t#e %ue& o% interest to t#e %ire o% )enius* in t#ediscover" and production o% new and use%u& t#in)s@+

Procedure for Grant of a Patent in India

A%ter %i&in) t#e app&ication %or t#e )rant o% patent* a re uest %or e/a!ination isre uired to e !ade %or e/a!ination o% t#e app&ication " t#e Indian Patent O%%ice+

A%ter t#e irst E/a!ination Report is issued* t#e App&icant is )iven an opportunit" to!eet t#e o :ections raised in t#e report+ T#e App&icant #as to co!p&" wit# t#ere uire!ents wit#in '. !ont#s %ro! t#e issuance o% t#e irst E/a!ination Report+ I% t#e re uire!ents o% t#e %irst e/a!ination report are not co!p&ied wit# wit#in t#eprescri ed period o% '. !ont#s* t#en t#e app&ication is treated to #ave eena andoned " t#e app&icant+ A%ter t#e re!ova& o% o :ections and co!p&iance o% re uire!ents* t#e patent is )ranted and noti%ied in t#e Patent O%%ice 3ourna&+ T#e

process o% t#e )rant o% patent in India can a&so e understood %ro! t#e %o&&owin) %&owc#art


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Filing of A lication for Grant of Patent in India !" Foreigner#

India ein) a si)nator" to t#e Paris Convention %or t#e Protection o% Industria&Propert"* ' 8 and t#e Patent Cooperation Treat" 0PCT1* '(,-* a %orei)n entit" canadopt an" o% t#e a%oresaid routes %or %i&in) o% app&ication %or )rant o% patent in India+

W#ere an app&ication %or )rant o% patent in respect o% an invention in a ConventionCountr" #as een %i&ed* t#en si!i&ar app&ication can a&so e %i&ed in India %or )rant o%

patent " suc# app&icant or t#e &e)a& representative or assi)nee o% suc# personwit#in twe&ve !ont#s %ro! t#e date on w#ic# t#e asic app&ication was !ade in t#eConvention Countr" i+e+ t#e #o!e countr"+ T#e priorit" date in suc# a case isconsidered as t#e date o% !a$in) o% t#e asic app&ication+

Pre$Grant O o#ition

A representation %or pre5)rant opposition can e %i&ed " an" person under Section

''A o% t#e Patents Act* '(,- wit#in si/ !ont#s %ro! t#e date o% pu &ication o% t#eapp&ication* as a!ended 0t#e Patents Act 1 or e%ore t#e )rant o% patent+ T#e


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)rounds on w#ic# t#e representation can e %i&ed are provided under Section .20'1 o% t#e Patents Act+ T#ere is no %ee %or %i&in) representation %or pre5)rant opposition+Representation %or pre5)rant opposition can e %i&ed even t#ou)# no re uest %or e/a!ination #as een %i&ed+ 7owever* t#e representation wi&& e considered on&"w#en a re uest %or e/a!ination is received wit#in t#e prescri ed period+

Po#t$Grant O o#ition

An" interested person can %i&e post5)rant opposition wit#in twe&ve !ont#s %ro! t#edate o% pu &ication o% t#e )rant o% patent in t#e o%%icia& :ourna& o% t#e patent o%%ice+

Ground# for O o#ition

So!e o% t#e )rounds %or %i&in) pre5and post5)rant opposition are as undera+ Patent wron)%u&&" o tained;

+ Prior pu &ication;

c+ T#e invention was pu &ic&" $nown or pu &ic&" used in India e%ore t#e priorit"date o% t#at c&ai!;

d+ T#e invention is o vious and does not invo&ve an" inventive step;

e+ T#at t#e su :ect o% an" c&ai! is not an invention wit#in t#e !eanin) o% t#is Act*or is not patenta &e under t#is Act;

%+ Insu%%icient disc&osure o% t#e invention or t#e !et#od " w#ic# it is to eper%or!ed;

)+ T#at in t#e case o% a patent )ranted on convention app&ication* t#e app&ication%or patent was not !ade wit#in twe&ve !ont#s %ro! t#e date o% t#e %irstapp&ication %or protection %or t#e invention !ade in a convention countr" or inIndia;

#+ T#at t#e co!p&ete speci%ication does not disc&ose or wron)&" !entions t#esource and )eo)rap#ica& ori)in o% io&o)ica& !ateria& used %or t#e invention;and


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i+ T#at t#e invention was anticipated #avin) re)ard to t#e $now&ed)e* ora& orot#erwise* avai&a &e wit#in an" &oca& or indi)enous co!!unit" in India ore&sew#ere+

Ter% of Patent

T#e ter! o% ever" patent in India is twent" "ears %ro! t#e date o% %i&in) t#e patentapp&ication* irrespective o% w#et#er it is %i&ed wit# provisiona& or co!p&etespeci%ication+ 7owever* in case o% app&ications %i&ed under t#e Patent CooperativeTreat" 0PCT1* t#e ter! o% twent" "ears e)ins %ro! t#e internationa& %i&in) date+

Pa"%ent of Rene&al Fee

It is i!portant to note t#at a patentee #as to renew t#e patent ever" "ear " pa"in)t#e renewa& %ee* w#ic# can e paid ever" "ear or in &u!p su!+

Re#toration of Patent

A re uest %or restoration o% patent can e %i&ed wit#in ei)#teen !ont#s %ro! t#e date

o% cessation o% patent a&on) wit# t#e prescri ed %ee+ A%ter t#e receipt o% t#e re uest*t#e !atter is noti%ied in t#e o%%icia& :ourna& %or %urt#er processin) o% t#e re uest+

Patent of 'iological Material

I% t#e invention uses a io&o)ica& !ateria& w#ic# is new* it is essentia& to deposit t#esa!e in t#e Internationa& Depositor" Aut#orit" 0 IDA 1 prior to t#e %i&in) o% t#eapp&ication in India in order to supp&e!ent t#e description+ I% suc# io&o)ica& !ateria&s

are a&read" $nown* in suc# a case it is not essentia& to deposit t#e sa!e+ T#e IDA inIndia &ocated at C#andi)ar# is $nown as Institute o% 4icro ia& Tec#no&o)" 0I4TEC71+

W(at are t(e Rig(t# granted !" Patent)

I% t#e )rant o% t#e patent is %or a product* t#en t#e patentee #as a ri)#t to preventot#ers %ro! !a$in)* usin)* o%%erin) %or sa&e* se&&in) or i!portin) t#e patented productin India+ I% t#e patent is %or a process* t#en t#e patentee #as t#e ri)#t to preventot#ers %ro! usin) t#e process* usin) t#e product direct&" o tained " t#e process*


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o%%erin) %or sa&e* se&&in) or i!portin) t#e product in India direct&" o tained " t#eprocess+

Be%ore %i&in) an app&ication %or )rant o% patent in India* it is i!portant to note*W(at i#not Patenta!le in India)*

o&&owin) i+e+ an invention w#ic# is 0a1 %rivo&ous* 0 1 o vious* 0c1 contrar" to we&&esta &is#ed natura& &aws* 0d1 contrar" to &aw* 0e1 !ora&it"* 0%1 in:urious to pu &ic #ea&t#*0)1 a !ere discover" o% a scienti%ic princip&e* 0#1 t#e %or!u&ation o% an a stract t#eor"*0i1 a !ere discover" o% an" new propert" or new use %or a $nown su stance or process* !ac#ine or apparatus* 0:1 a su stance o tained " a !ere ad!i/tureresu&tin) on&" in t#e a))re)ation o% t#e properties o% t#e co!ponents t#ereo% or aprocess %or producin) suc# su stance* 0$1 a !ere arran)e!ent or rearran)e!ent or dup&ication o% $nown devices* 0&1 a !et#od o% a)ricu&ture or #orticu&ture and 0!1inventions re&atin) to ato!ic ener)"* are not patenta &e in India+

Maintaina!ilit" of +ecrec" !" t(e Indian Patent Office ,IPO-

A&& patent app&ications are $ept secret up to ei)#teen !ont#s %ro! t#e date o% %i&in) or priorit" date* w#ic#ever is ear&ier* and t#erea%ter t#e" are pu &is#ed in t#e O%%icia&3ourna& o% t#e Patent O%%ice pu &is#ed ever" wee$+ A%ter suc# pu &ication o% t#e

patent app&ication* pu &ic can inspect t#e docu!ents and !a" ta$e t#e p#otocop"t#ereo% on t#e pa"!ent o% t#e prescri ed %ee+

Co% ul#or" Licen#ing

One o% t#e !ost i!portant aspects o% Indian Patents Act* '(,-* is co!pu&sor"&icensin) o% t#e patent su :ect to t#e %u&%i&&!ent o% certain conditions+ At an" ti!e a%ter t#e e/piration o% t#ree "ears %ro! t#e date o% t#e sea&in) o% a patent* an" person

interested !a" !a$e an app&ication to t#e Contro&&er o% Patents %or )rant o% co!pu&sor" &icense o% t#e patent* su :ect to t#e %u&%i&&!ent o% %o&&owin) conditions* i+e+

t#e reasona &e re uire!ents o% t#e pu &ic wit# respect to t#e patented

invention #ave not een satis%ied; or

t#at t#e patented invention is not avai&a &e to t#e pu &ic at a reasona &e price;

or


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t#at t#e patented invention is not wor$ed in t#e territor" o% India+

It is %urt#er i!portant to note t#at an app&ication %or co!pu&sor" &icensin) !a" e!ade " an" person notwit#standin) t#at #e is a&read" t#e #o&der o% a &icense under t#e patent+

or t#e purpose o% co!pu&sor" &icensin)* no person can e stopped %ro! a&&e)in)t#at t#e reasona &e re uire!ents o% t#e pu &ic wit# respect to t#e patented inventionare not satis%ied or t#at t#e patented invention is not avai&a &e to t#e pu &ic at areasona &e price " reason o% an" ad!ission !ade " #i!* w#et#er in suc# a&icence or " reason o% #is #avin) accepted suc# a &icence+

T#e Contro&&er* i% satis%ied t#at t#e reasona &e re uire!ents o% t#e pu &ic wit# respectto t#e patented invention #ave not een satis%ied or t#at t#e patented invention is notavai&a &e to t#e pu &ic at a reasona &e price* !a" order t#e patentee to )rant a&icence upon suc# ter!s as #e !a" dee! %it+ 7owever* e%ore t#e )rant o% aco!pu&sor" &icense* t#e Contro&&er o% Patents s#a&& ta$e into account %o&&owin)%actors

T#e nature o% invention;

T#e ti!e e&apsed* since t#e sea&in) o% t#e patent;

T#e !easures a&read" ta$en " t#e patentee or t#e &icensee to !a$e %u&& use

o% t#e invention;

T#e a i&it" o% t#e app&icant to wor$ t#e invention to t#e pu &ic advanta)e;

T#e capacit" o% t#e app&icant to underta$e t#e ris$ in providin) capita& and

wor$in) t#e invention* i% t#e app&ication %or co!pu&sor" &icense is )ranted;

As to t#e %act w#et#er t#e app&icant #as !ade e%%orts to o tain a &icense %ro!

t#e patentee on reasona &e ter!s and conditions;

Nationa& e!er)enc" or ot#er circu!stances o% e/tre!e ur)enc";


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Pu &ic non co!!ercia& use;

Esta &is#!ent o% a )round o% anti co!petitive practices adopted " t#e

patentee+

T#e )rant o% co!pu&sor" &icense cannot e c&ai!ed as a !atter o% ri)#t* as t#e sa!eis su :ect to t#e %u&%i&!ent o% a ove conditions and discretion o% t#e Contro&&er o% Patents+ urt#er :udicia& recourse is avai&a &e a)ainst an" ar itrar" or i&&e)a& order o% t#e Contro&&er o% Patents %or )rant o% co!pu&sor" &icense+

Infringe%ent of Patent

Patent in%rin)e!ent proceedin)s can on&" e initiated a%ter )rant o% patent in Indiaut !a" inc&ude a c&ai! retrospective&" %ro! t#e date o% pu &ication o% t#e app&ication

%or )rant o% t#e patent+ In%rin)e!ent o% a patent consists o% t#e unaut#oriFed !a$in)*i!portin)* usin)* o%%erin) %or sa&e or se&&in) an" patented invention wit#in t#e India+>nder t#e 0Indian1 Patents Act* '(,- on&" a civi& action can e initiated in a Court o% Law+ urt#er* a suit %or in%rin)e!ent can e de%ended on various )rounds inc&udin)t#e )rounds on w#ic# a patent cannot e )ranted in India and ased on suc#de%ence* revocation o% Patent can a&so e c&ai!ed+

Co "rig(t

Indian cop"ri)#t &aw is at parit" wit# t#e internationa& standards as contained inTRIPS+ T#e 0Indian1 Cop"ri)#t Act* '(2,* pursuant to t#e a!end!ents in t#e "ear '(((* %u&&" re%&ects t#e Berne Convention %or Protection o% Literar" and Artistic Wor$s*' G and t#e >niversa& Cop"ri)#ts Convention* to w#ic# India is a part"+ India is a&soa part" to t#e Heneva Convention %or t#e Protection o% Ri)#ts o% Producers o% P#ono)ra!s and is an active !e! er o% t#e Wor&d Inte&&ectua& Propert" Or)aniFation0WIPO1 and >nited Nations Educationa&* Scienti%ic and Cu&tura& Or)aniFation0 >NESCO 1+

*Wor.* rotected in India

>nder t#e Cop"ri)#t Act* '(2, t#e ter! wor$ inc&udes an artistic wor$ co!prisin) o% a paintin)* a scu&pture* a drawin) 0inc&udin) a dia)ra!* a !ap* a c#art or p&an1* an

en)ravin)* a p#oto)rap#* a wor$ o% arc#itecture or artistic cra%ts!ans#ip* dra!atic


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wor$* &iterar" wor$ 0inc&udin) co!puter pro)ra!!es* ta &es* co!pi&ations andco!puter data ases1* !usica& wor$ 0inc&udin) !usic as we&& as )rap#ica& notations1*sound recordin) and cine!ato)rap#ic %i&!+In order to $eep pace wit# t#e )&o a& re uire!ent o% #ar!oniFation* t#e Cop"ri)#t

Act* '(2, #as rou)#t t#e cop"ri)#t &aw in India in &ine wit# t#e deve&op!ents in t#ein%or!ation tec#no&o)" industr"* w#et#er it is in t#e %ie&d o% sate&&ite roadcastin) or co!puter so%tware or di)ita& tec#no&o)"+ T#e a!ended &aw #as a&so !ade provisionsto protect per%or!er6s ri)#ts as envisa)ed in t#e Ro!e Convention+

+OME MA/OR C0ANGE+ INTROD1CED '2 T0E 3445 AMENDMENT

T#e .--2 A!end!ent a!ended !an" provisions o% t#e Act; t#ese a!end!ents

were a so&ute&" necessar" %or India to !eet its o &i)ation under TRIPS A)ree!ent+So!e o% i!portant a!end!ents are discussed e&ow 5

67 E8ten#ion of roduct atent rotection to all field# of tec(nolog"

T#e !ost pro!inent and controversia& c#an)e o% t#e .--2 A!end!ent #aseen t#e de&etion o% section 2 o% t#e Act* t#ere " pavin) t#e wa" %or product

patents in t#e area o% p#ar!aceutica& and ot#er c#e!ica& inventions+ Section

2 o% t#e Act 0as it stood a%ter t#e .--. a!end!ents1 #ad provided t#at* in t#ecase o% inventions ein) c&ai!ed re&atin) to %ood* !edicine* dru)s or c#e!ica&su stances* on&" patents re&atin) to t#e !et#ods or processes o% !anu%actureo% suc# su stances cou&d e o tained+ Be%ore t#is A!end!ent in t#e Act*Product Patent was not )ranted on t#e inventions re&ated to dru)s* %oods andc#e!ica&s and on&" process patents were )ranted on t#ese inventions+ It!eans i% a co!pan" invented a !edicine to cure a disease usin) a certain

process+ T#at co!pan" can t c&ai! a patent on t#at !edicine w#i&e t#eco!pan" can c&ai! a patent on t#e process w#ic# it #as used to !anu%acture


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t#at !edicine+ In t#e ot#er words t#at co!pan" can t stop ot#er co!petitors%ro! !anu%acturin) t#e end product ut can stop ot#ers %ro! producin) t#eend product usin) t#eir patented process or !et#od+ T#is resu&ted in asituation in w#ic# reverse en)ineerin) !ec#anis! was #i)#&" used to deve&opt#e sa!e !edicine and dru)s wit# s&i)#t&" or su stantia&&" di%%erent process+T#is cop"cat usiness #e&ped a %ew p#ar!ac" co!panies* to )row into )&o a&p&a"ers and !ade !edications c#eaper+ T#e p#ar!ac" 4NCs were %orced towatc# Indian co!panies eat into t#eir !ar$et s#are as Indian co!paniesdeve&oped sa!e !edicine at !uc# &ower cost ecause o% re&ative&" &ower invest!ent in RJD+ T#e Process Patent re)i!e &e%t no scope %or a so&ute!onopo&" in t#e !ar$et; t#is resu&ted in increased co!petition in !ar$et andconse uent&" &eads to %urt#er drop in !edicine prices+

T#is de&i erate strate)" o% den"in) product patent protection top#ar!aceutica& inventions is tracea &e to t#e A""an)ar Co!!ittee Report* areport t#at %or!ed t#e ver" asis o% t#e Patents Act* '(,-+ T#e Co!!ittee%ound t#at %orei)ners #e&d etween ei)#t" and ninet" percent o% Indian patentsand t#at !ore t#an ninet" percent o% t#ese patents were not even wor$ed in

India+ T#e Co!!ittee conc&uded t#at t#e s"ste! was ein) e/p&oited "!u&tinationa&s to ac#ieve !onopo&istic contro& over t#e !ar$et* especia&&" inre&ation to vita& industries suc# as %ood* c#e!ica&s and p#ar!aceutica&s+4edicines were ar)ua &" una%%orda &e to t#e )enera& pu &ic and t#e dru) priceinde/ was risin) rapid&"+ T#e Co!!ittee t#ere%ore reco!!ended t#at certaininventions suc# as p#ar!aceutica& inventions* %ood and ot#er c#e!ica&inventions e )ranted on&" process patent protection+ India s we&&5deve&oped

)eneric industr" toda" is testi!on" to t#e %arsi)#tedness o% t#is report+

Fe& ca#e# re orted !" %edia and ne a er#9 gi:en !elo&9 ro:ide

gli% #e# of (o& Indian co% anie# (a:e ta.en legal %ea#ure# to refute

clai%# of %ultinational drug %a;or# for e8ten#ion of t(eir atent#7

a+ A case t#at attracted a &ot o% attention in India is t#at o% t#e

Swiss dru) co!pan" Novartis+ Novartis #ad c#a&&en)ed Section 80d1 o% t#e Indian Patents Act c&ai!in) i!!unit" %or t#eir dru) H&eevic* a !a:or


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dru) %or &eu$e!ia on t#e p&eas t#at t#e new H&eevic was a !a:or i!prove!ent over a o&der version w#ose patent was over+ T#is wasdisputed " Indian co!panies suc# as Natco P#ar!aceutica&s+ T#ep&ea o% Novartis was re:ected conse uent&" ena &in) !anu%acture "Indian )eneric co!panies+ Cost esti!ates o% t#e new )eneric dru)p&ace it at one tent# t#e price o% H&eevic+

+ In a si!i&ar case t#e Dei Court re:ected t#e petition o% Ba"er

7ea&t#care* a Her!an dru) !a:or %ro! preventin) t#e Dru) Contro&&er Henera& o% India )ivin) !ar$etin) approva& to Indian co!pan" Cip&a %or t#e )eneric version o% t#e cancer dru) Ne/avar+ T#e ru&in) #owever #ad a caveat na!e&"* t#at i% t#e Indian dru) co!pan" is %ound )ui&t" o% patent in%rin)e!ent da!a)es wi&& #ave to e co!pensated " pa"!entto Ba"ers+

c+ Cip&a in anot#er case won t#e ri)#t to !anu%acture and !ar$ett#e )eneric version o% t#e anti5cancer dru) Tarceva ori)ina&&" patented

" t#e Swiss p#ar!a co!pan" 7o%%!an La Roc#e ot# in Dei Court

and t#e Supre!e Court+

d+ Recent&"* Auro indo P#ar!a an Indian dru) p#ar!a received>S DA approva& %or Risperidone Ora& So&ution a dru) used in t#etreat!ent o% !enta& and e!otiona& pro &e!s+ Indian co!panies are

eco!in) increasin)&" active in t#e >S !ar$et+ In t#e %irst uarter o% .--( Indian co!panies #ad ac#ieved 2- ANDA approva&s+

37 No +&i## Clai%# and E8 an#ion of E8clu#ion under +ection


13/21

%or!* partic&e siFe* iso!ers* !i/tures o% iso!ers* co!p&e/es* co! inationsand ot#er derivatives o% $nown su stances are to e considered to e t#esa!e su stances* un&ess t#e" di%%er si)ni%icant&" in properties wit# re)ard toe%%icac"+

In order to %u&&" understand t#e a!ended Section 80d1* one need to %irstaddress t#e issue o% w#at e/act&" t#e ter!


14/21

T#e 7on6 &e 7i)# Court a&so noted t#at t#ou)# section 80d1 is not on&" &i!itedto dru)s and p#ar!aco&o)ica& su stances* it is c&ear t#at certain portions o% t#e section and t#e attac#ed e/p&anation is on&" re%era &e to p#ar!aco&o)ica&su stances+


15/21

a1 T#e product !ust e patenta &e* t#at is* it !ust e an inventionas per Section . o% t#e Patents Act '(,-* and !ust not %a&& under t#enon5patenta &e products &isted in Sections 8 and 9* suc# as productsderived %ro! traditiona& $now&ed)e or ato!ic ener)"5re&ated products+

1 T#e invention !ust #ave een !ade in India or in a WTO

Convention countr"+ I% !ade in a convention countr"* t#e invention !ust#ave een

0i1 i&ed on or a%ter 3anuar" '* '((2* and0ii1 Be%ore )ettin) a patent in India* t#e app&icant !ust #ave

o tained suc# a patent in t#e Convention countr"+

c1 I% t#e invention #as een !ade in India*0i1 T#e app&ication %or patent %or t#e !et#od or process o% production o% suc# a su stance s#ou&d #ave een %i&ed on or a%ter 3anuar" '* '((2* and0ii1 T#e patent !ust #ave een )ranted on or a%ter t#e dateo% %i&in) o% suc# E4R+

57 Co% ul#or" Licen#ing Regi%e

Section 9 o% T#e Act provides %or t#e )rounds on and procedures " w#ic#* aco!pu&sor" &icense wi&& e )ranted+ T#e '((( A!end!ent adds an entirec#apter to t#e Patents Act on t#e wor$in) o% patents* co!pu&sor" &icenses*and revocation o% &icenses+ A%ter t#is a!end!ent* t#e )rounds on w#ic# aco!pu&sor" &icense wi&& e )ranted are

a+ Reasona &e re uire!ents o% t#e pu &ic wit# respect to t#epatented invention #ave not een satis%ied; or*

+ T#e patented invention is not avai&a &e to t#e pu &ic at areasona &" a%%orda &e price; or*c+ T#e patented invention is not wor$ed 0i+e+ not used or per%or!ed1 in t#e territor" o% India+

In respect to t#e .--2 A!end!ent %o&&owin) a!end!ents #ave een !ade inrespect o% co!pu&sor" &icencenin) re)i!e 5


16/21

a- Auto%atic Co% ul#or" Licence# for Mail!o8 A lication#

T#e .--2 A!ende!t provides t#at in t#e case o% t#ose !ai& o/app&ications t#at resu&t in t#e )rant o% a patent* an auto!aticco!pu&sor" &icence wou&d issue to t#ose )eneric co!panies t#at !adea Ksi)ni%icant invest!ent and were Kproducin) and !ar$etin) a dru)covered " t#e !ai& o/ app&ication prior to .--2+ Suc# &icence issu :ect to a pa"!ent o% a Kreasona &e ro"a&t" + 7owever* no speci%ic"ardstic$ is provided to deter!ine Kreasona &eness and t#is ter! is&i$e&" to &ead to disputes in co!in) "ears+

!- Co% ul#or" Licence# for E8 ort#

In order to incorporate w#at is co!!on&" re%erred to as t#e Para)rap#G Decision* t#e Ordinance introduced section (.A* w#ic# provides %or co!pu&sor" &icences to ena &e e/ports o% p#ar!aceutica& products tot#ose countries wit# no !anu%acturin) capacit" o% t#eir own+>n%ortunate&"* t#is su%%ered %ro! a #andicap 5 t#e provision re uiredt#at t#e e/porter o tain a co!pu&sor" &icence %ro! t#e i!portin)

countr" as we&&+ In t#e process* t#e provision %ai&ed to cater to t#osesituations w#ere t#ere was no patent in suc# i!portin) countr" and nore uire!ent %or o tainin) a co!pu&sor" &icence t#ere+ T#e .--2

A!en!ent t#ere%ore see$s to recti%" t#is " addin) t#at an e/porter can resort to section (.A w#ere t#e i!portin) countr"


17/21

?7 Ot(er A%end%ent#

T(ere are %an" c(ange# !roug(t !" t(e 3445 A%end%ent in t(e

ro:i#ion# of t(e Act9 t(at can !e #u%%ari@ed a# follo $

a1 T#e .--2 A!end!ent a!end t#e de%inition o%


18/21

patenta &e* t#e patent #o&der wi&& e )ranted a .-5"ear !onopo&" %ro! t#edate o% %i&in) as a resu&t o% t#e new ru&es+ Wit#out a co!pu&sor" &icense*)eneric versions wi&& not e per!itted on t#e !ar$et %or t#e &i%e o% t#e patent+In ot#er deve&opin) countries t#at #ave e)un protectin) patents on!edicines in accordance wit# WTO ru&es* t#e vast !a:orit" o% !edicinespatent %i&ers in deve&opin) countries are !u&tinationa& dru) co!panies asedin industria&iFed countries+

T#e second cate)or" o% !edicines t#at wi&& e a%%ected " t#e .--2

A!end!ent are t#ose t#at #ave een patent protected outside o% India since3anuar" '* '((2+ Accordin) to WTO ru&es 0TRIPS Art+ ,-+ 1* India wasre uired to esta &is# a

etween '((2 and .--2+ A%ter 3anuar" '* .--2* t#e !ai& o/ wi&& e opened*and re uests %or patents considered " t#e Indian Patent O%%ice+

In a nuts#e&&* t#ere is no dou t t#at* a%ter .--2 A!end!ent* t#e prices o% a ove !entioned dru) wi&& rise ut t#e uestion w#ic# rea&&" needs to eanswered is to w#at e/tent t#is price rise wi&& eventua&&" a%%ect t#e access and

a%%orda i&it" o% &i%e savin) or ver" essentia& dru)s to !ost o% t#e Indianpopu&ation+ In state!ent issued " S#ri a!a& Nat#* >nion 4inister o% Co!!erce J Industr"* on -9 Apr .--2 said t#at (, dru)s in t#e !ar$et* and'-- o% a&& essentia& dru)s are not covered " patents@+ On t#e ot#er #and%ear o% su stantia& price rise* in &i%e savin) dru)s patented a%ter .--2 can eaddressed to a certain e/tent " sa%e)uards ui&t in t#e .--2 A!end!ent andot#er re&ated &aws %or t#e ti!e ein) in %orce* suc# as

a+ Co!pu&sor" &icensin)*

+ Para&&e& i!port o% products*c+ Ac uisition o% patent ri)#ts " t#e )overn!ent*d+ Revocation o% patents in t#e pu &ic intereste+ Provisions to dea& wit# e!er)enc" situations%+ Patenta i&it" t#res#o&d*

)+ Opposition !ec#anis!* and#+ Price contro& re)i!e &i$e Essentia& Co!!odities Act* '(22* etc


19/21

Now t#e rea& issue is w#et#er t#ese provisions wou&d in %act e interpretedand i!p&e!ented in a !anner conducive to pu &ic #ea&t# needs o% Indiansociet" at &ar)e and wou&d &ar)e&" depends upon t#e e%%orts o% t#e )overn!enttowards t#e sa!e+ T#e Indian Po&ic" !a$ers #ave to $eep in !ind* t#e )roundrea&ities o% India w#i&e i!p&e!entin) t#ese provisions+ Hround rea&ities o% Indiais su stantia&&" di%%erent %ro! deve&oped nations* under pressure o% w#o! we#ave adopted product patent re)i!e in p#ar!aceutica&s+ In India t#ere is nosound #ea&t#care insurance s"ste! and per capita inco!e is a&so re&ative&"ver" &ow+

Accordin) to 7ea&t# HAP 0H&o a& Access Pro:ect1* a >S5 ased NHO t#atadvocates t#e cause o% AIDS patients* #u!an ri)#ts and %air trade* t#e .--2

Act %ai&s nder t#is order* prices o% u&$dru)s and t#eir %or!u&ations were %i/ed " t#e )overn!ent as per a speci%ied%or!u&a t#at a&&owed a '-- !ar)in on e/ %actor" cost+ Price c#an)es o% t#ere!ainin) dru)s were a&so to e !onitored+ 7owever* over a period o% ti!e*as a resu&t o% sustained &o "in) " t#e Indian p#ar!aceutica& industr"* t#enu! er o% dru)s &isted in t#e DPCO %e&& %ro! 89, in '(,( to ,G in '((2+ A new

p#ar!aceutica& po&ic" in .--. t#at sou)#t to re&a/ contro&s even %urt#er wasc#a&&en)ed on t#e )round t#at* under t#e po&ic"* certain &i%e savin) dru)s #adt#e potentia& o% ein) e/c&uded %ro! t#e DPCO+ T#e c#a&&en)e !ade its wa"to t#e Supre!e Court and is "et to e reso&ved+

In Au)ust .--2 t#ere were indications t#at* t#e )overn!ent is considerin)stren)t#enin) t#e price contro& re)i!e to increase co!petition and ensure

a%%orda &e !edicines to t#e )enera& pu &ic+ To t#is end* a new Dru) Pricin)


20/21

0Re)u&ation J 4ana)e!ent1 Act was ein) considered* ut sti&& a%ter a&!ostsi/ "ears it is "et to e i!p&e!ented+

37 Culti:ating Inno:ation Culture in India

In t#e %ear su stantia& price rise pepo&e are i)norin) one o% t#e i))estadvanta)es o% t#e .--2 A!end!ent+ T#e Indian P#ar!aceutica& Industr"toda" consist o% a out ',9 u&$ dru) !anu%acturin) units and .8 (%or!u&ations units spread across t#e countr"+ P#ar!aceutica& Co!paniesOperatin) in India is a poo& representin) a out .2- &ar)e P#ar!aceutica&s!anu%acturers and supp&iers and a out --- S!a&& Sca&e P#ar!aceutica& JDru) >nits inc&udin) 2 Centra& Pu &ic Sector >nits+ T#e .--2 A!end!ent ")ivin) an e/tra incentive to new and innovative dru)s wi&& a&so cu&tiva&te aninnovation cu&ture in Indian p#ar!a industries+ It needs to e noted #owever t#at asic reverse en)ineerin) s$i&&s 0or)anic c#e!istr" s$i&&s1 are di%%erent%ro! t#e s$i&&s re uired to arrive at new dru)s 0!edicina& c#e!istr"s$i&&s1+ Besides* t#e costs o% researc#in) upon and introducin) a new dru) intot#e !ar$et are co&ossa&+ It t#ere%ore re!ains to e seen w#et#er incentivest#rou)# a patent re)i!e wi&& ac#ieve t#e desired resu&ts and w#et#er Indian

co!panies wi&& e a &e to co!pete wit# )&o a& !u&tinationa& co!panies on t#istur%+ A co!!entator ri)#t&" notes t#at ti&& recent&"* t#e e!p#asis #as een

%or o &i)ator" &icensin) invo&vin) t#e do!estic enterprises in t#e production o% patented dru)s+ 3udicious and care%u& i!p&e!entation o% TRIPS is needed %or itss!oot# app&ication and a&ancin) o% ri)#ts and o &i)ations o% t#e patent #o&der in a!anner conducive to socia& and econo!ic we&%are as stipu&ated in Artic&e , o% TRIPS

A)ree!ent+ India can p&a" an e%%ective ro&e in t#e re)ion a out t#e avai&a i&it" o% )eneric dru)s " t#e p#ar!aceutica& industr" on&" a%ter t#e i)nored issues areprovided t#rou)# %urt#er a!end!ents to t#e Patents Act '(,-+


21/21

In a&& possi i&it"* it can e said t#at Indian P#ar!a Industr" wi&& not end up w#ere itstarted in pre '(,- era ut it is sa%e to assu!e t#at Indian dru) co!panies !i)#t

eco!e dependent on 4NCs %or tec#no&o)" to produce new dru)s+ Accordin) toreputed !a)aFine

patent law in india

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