Report of the Technical Expert Group on

Patent Law Issues

( Revised, March 200 !
I"#E$
%ontents Pa&e
Executive Summary 2
'(0 Introduction )
2(0 *pproach +
,(0 Practices in -ther %ountries .
)(0 /u00ar1 of /u20issions and Presentations .
+(0 %onclusions and Reco00endations .3'+
*nnexures I to 4 '.3.'
*nnexure I %op1 of Govern0ent of India, Ministr1 of '.
%o00erce 5 Industr1, #epart0ent of Industrial
Polic1 5 Pro0otion vide -rder
"o( '26')6200+3IPR3III dated *pril +, 200+
*nnexure 7 II Patentin& Practices in -ther countries '8
*nnexure 7 III /u00ar1 of /u20issions and Presentations 2,
*nnexure 7 I4 P%T *pplications filed 21 Indians in the field ))
-f dru& and phar0aceuticals (0ostl1 pertainin&
To different for0s of sa0e su2stance!
*nnexure 7 4 Mo0sen Leonardos 5 %I* ++
EXECUTIVE SUMMARY
1.0 Background
The Patents (Amendment) Bill, 2005, introduced in the Parliament in March, 2005
with the objective of main! the Patents Act com"atible with #ndia$s international
obli!ations, "articularl% under the A!reement on Trade &elated As"ects of #ntellectual
Pro"ert% &i!hts (T&#P' A!reement) had the bene(t of detailed discussion in both the
)ouses* +urin! the debate, the issues re!ardin! "atentabilit% of micro,or!anisms
and the de(nition of -"harmaceutical substance- to mean .a new chemical entit%
(/01)2 or .new medical entit% (/M1)2 were raised* The 0ommerce and #ndustr%
Minister then assured the Parliament that he would refer these issues to an 13"ert
0ommittee for detailed e3amination and re"ort the matter to the Parliament*
Accordin!l%, a Technical 13"ert 4rou" (T14) on Patent 5aw #ssues was set u" b% the
4overnment of #ndia, Ministr% of 0ommerce 6 #ndustr%, +e"artment of #ndustrial
Polic% 6 Promotion vide 7* M* /o* 8298:92005,#P&,### dated A"ril 5, 2005*
2.0 Terms of Reference of !e "rou#$
2*8 whether it would be T&#P' com"atible to limit the !rant of "atent for
"harmaceutical substance to new chemical entit% or to new medical entit%
involvin! one or more inventive ste"s; and
2*2 whether it would be T&#P' com"atible to e3clude micro,or!anisms from
"atentin!*
%.0 A##roac!
<*8 The T14 ado"ted a consultative a""roach to see in"uts from di=erent
stae holders such as industr% associations, non,!overnmental or!ani>ations,
intellectual "ro"ert% attorne%s, etc* throu!h written submissions,
"resentations, etc* The T14 studied the in"uts received and also too into
account other relevant literature to arrive at their assessment* The T14 has
arrived at s"eci(c recommendations and conclusions as !iven below*
<*2 #n main! the recommendations, the T14 was !uided b% the need for access
of a=ordable medicines to #ndian "eo"le at lar!e, encoura!in! innovation b%
#ndian industr%, its current ca"abilities in &6+, and balancin! of #ndia$s
obli!ations under international a!reements with the wider "ublic interest and
also the ?e3ibilities allowed under the T&#P' A!reement to the Member states*
&.0 'e( C!em)ca* En))es
:*8 Article 2@ of T&#P', which deals e3"licitl% with the issue of "atentabilit%, inter
alia, states that AMember 'tates ma% not e3clude an% (eld of technolo!% from
"atentabilit% as a whole and the% ma% not discriminate as to the (elds of
technolo!%, the "lace of innovation$ etc* &eadin! this obli!ation in the li!ht of
the overall "ur"ose of the A!reement, it a""ears that linin! the !rant of
"atents for "harmaceutical substances onl% to a new chemical entit% or to a
new medical entit% ma% "rima facie amount to Ae3cludin! a (eld of
technolo!%$ even when the% satisf% the basic reBuirements of "atentabilit%$*
1
#n such a situation, T14 concludes that it is "ossible to hold the "rovision as
bein! not T&#P' 0om"atible*
:*2 The T14 carefull% e3amined the ?e3ibilities allowed under the T&#P'
A!reement to the member states (es"eciall% Articles @ 6 C) and also as a
conseBuence of the +oha +eclaration* The detailed anal%sis and reassessin!
"rovided in the &e"ort has led T14 to conclude that it is debatable as to
whether national interest or the ?e3ibilit% allowed under the A!reement to
Member 'tates would be accommodated b% such Astatutor% e3clusion$ of an
entire class of inventions*
:*< 1ver% e=ort must be made to "revent the "ractice of Aever !reenin!$ often
used b% some of the "harma com"anies to unreasonabl% e3tend the life of the
"atent b% main! claims based sometimes on Atrivial$ chan!es to the ori!inal
"atented "roduct* The #ndian "atent oDce has the full authorit% under law
and "ractice to determine what is "atentable and what would constitute onl%
a trivial chan!e with no si!ni(cant additional im"rovements or inventive ste"s
involvin! bene(ts* 'uch authorit% should be used to "revent Aever!reenin!$,
rather than to introduce an ar!uable conce"t in the li!ht of :*8 and :*2 above
of .statutor% e3clusion2 of incremental innovations from the sco"e of
"atentabilit%*
:*: The "rocess of innovation is continuous and "ro!ressive leadin! to an ever
e3tendin! chain of nowled!e* #nnovative incremental im"rovements based
on e3istin! nowled!e and e3istin! "roducts is a Anorm$ rather than an
Ae3ce"tion$ in the "rocess of innovation* 1ntirel% new chemical structures with
new mechanisms of action are a rarit% rather than a rule* Therefore,
.incremental innovations2 involvin! new forms, analo!s, etc* but which have
si!ni(cantl% better safet% and eDcac% standards, need to be encoura!ed*
Ehat is im"ortant, however, is for the "atent oDce to be vi!ilant about settin!
hi!h standards of jud!in! such innovations so that e=orts on .ever!reenin!2
are scru"ulousl% "revented*
:*5 The T14 was not mandated to e3amine the T&#P' com"atibilit% of 'ection <(d)
of the #ndian Patents Act or an% other e3istin! "rovision in the same Act*
Therefore, the committee has not en!a!ed itself with these issues*
+.0 M)cro,organ)sm
5*8 The T14$s conclusion is based on the reBuirements of Article 2@*< of the T&#P'
as articulated in 5*2< above and the "rovision of #ndian Patent Act ('ection < (j))*
)owever, strict !uidelines need to be formulated for e3amination of the
"atent a""lications involvin! micro,or!anisms from the "oint of view of
substantial human intervention and utilit%*
5*2 T14 has concluded that e3cludin! micro,or!anisms per se from "atent
"rotection would be violative of T&#P' A!reement*
2
1.0 Inroduc)on
8*8 The Patents (Amendment) Bill, 2005, introduced in the Parliament in March,
2005 with the objective of main! the Patents Act com"atible with #ndia$s
international obli!ations, "articularl% under the A!reement on Trade &elated
As"ects of #ntellectual Pro"ert% &i!hts (T&#P' A!reement) had the bene(t of
detailed discussion in both the )ouses* +urin! the debate, the issues
re!ardin! "atentabilit% of micro,or!anisms and the de(nition of
-"harmaceutical substance- to mean .a new chemical entit% (/01)2 or .new
medical entit% (/M1)2 were raised* The 0ommerce and #ndustr% Minister then
assured the Parliament that he would refer these issues to an 13"ert
0ommittee for detailed e3amination and re"ort the matter to the Parliament*
Accordin!l%, a Technical 13"ert 4rou" (T14) on Patent 5aw #ssues was set u"
b% the 4overnment of #ndia, Ministr% of 0ommerce 6 #ndustr%, +e"artment of
#ndustrial Polic% 6 Promotion vide 7* M* /o* 8298:92005,#P&,### dated A"ril 5,
2005 (Anne-,I)*
8*2 The Technical 13"ert 4rou" consisted of the followin!F
(Positions as on 5 A"ril 2005)G
+r* &*A* Mashelar 0hairman
+irector 4eneral
0ouncil of 'cienti(c and #ndustrial &esearch
/ew +elhi
Prof* 4overdhan Mehta Member
+irector
#ndian #nstitute of 'cience
Ban!alore
Prof* Asis +atta Member
+irector
/ational 0entre for Plant 4enome &esearch
/ew +elhi
Prof* /*&* Madhava Menon Member
+irector
/ational Hudicial Academ%
Bho"al
Prof* Moolchand 'harma Member
+irector
/ational 5aw #nstitute Iniversit%
Bho"al
8
1
G The current "ositions and addresses are !iven belowF
+r* &*A* Mashelar, Bhatna!ar Jellow, /ational 0hemical 5aborator%, Pune :88 00C, Prof* 4overdhan
Mehta, )onorar% Professor 6 0'#& Bhatna!ar Jellow, #ndian #nstitute of 'cience, Ban!alore 5K0 082,
Prof* Asis +attaL, Professor of 1minence, /ational #nstitute for Plant 4enome &esearch, /ew +elhi 880
0K@, Prof*(+r*) /*&* Madhava Menon, Member, 0ommission on 0entre,'tate &elations, Mi!%an Bhawan
Anne3e, Maulana A>ad &oad, /ew +elhi,880088, Prof* Moolchand 'harma, Mice 0hairman, Iniversit%
4rants 0ommission (I40), Bahadur 'hah Nafar Mar!, /ew +elhi 880 002
L &esi!ned from T14 in 200@
3
8*< Terms of &eference of the T14 wereF
1.%.1 whether it would be T&#P' com"atible to limit the !rant of
"atent for "harmaceutical substance to new chemical entit% or
to new medical entit% involvin! one or more inventive ste"s;
and
1.%.2 whether it would be T&#P' com"atible to e3clude micro,
or!anisms from "atentin!*
2 A##roac!
2*2 The T14 ado"ted a consultative a""roach to see in"uts from di=erent
stae holders such as industr% associations, non,!overnmental
or!ani>ations, intellectual "ro"ert% attorne%s, etc* throu!h written
submissions, "resentations, etc* The T14 studied the in"uts received and
also too into account other relevant literature to arrive at their
assessment* The T14 has arrived at s"eci(c recommendations and
conclusions as !iven below*
2*< #n main! the recommendations, the T14 was !uided b% the need for
access of a=ordable medicines to #ndian "eo"le at lar!e, encoura!in!
innovation b% #ndian industr%, its current ca"abilities in &6+, and
balancin! of #ndia$s obli!ations under international a!reements with the
wider "ublic interest and also the ?e3ibilities allowed under the T&#P'
A!reement to the member states*
2*: The &e"ort was submitted b% the T14 to the 4overnment on 2O +ecember
200K* #t was subseBuentl% noted that there were some Atechnical
inaccuracies$ in the &e"ort* The 0hairman wrote a letter dated 8O
th
Jebruar% 200@ to see 4overnment$s a""roval to A$withdraw the &e"ort, re,
e3amine it and resubmit a &e"ort, which meets with the reBuirements of
the hi!hest standards$$* The 4overnment, vide +*7* 5etter /o*8298:92005,
#P& ### on @
th
of March 200@ acce"ted this reBuest*
2*5 'ubseBuentl%, due to certain develo"ments, the 0hairman of the
0ommittee e3"ressed his desire to resi!n from the 0hairmanshi" of the
T14 vide letter dated 85
th
of March 200@* The 4overnment, however, did
not acce"t this reBuest of resi!nation vide +*7* letter /o*8298:92P5,#P& ##
dated 8
st
Ma% 200@ and reBuested the T14 to submit the &e"ort
incor"oratin! the chan!es* Jurther communications followed, and most
recentl%, the same decision was communicated b% the 4overnment vide
+*7* letter /o*8298:92005 Q #P& ### of 80
th
Jebruar% 200O, and the T14 was
reBuested to e3"edite and submit the &e"ort at the earliest* Mide letter
dated O
th
March 200O, the 0hairman, while res"ectin! the decision b% the
4overnment, a!reed to acce"t his res"onsibilit% as the 0hairman a!ain
and to submit the &e"ort* Accordin!l%, the &e"ort, incor"oratin! the
chan!es, has been resubmitted*
4
% .rac)ces )n /!er Counr)es
<*8 Patentin! "ractices relatin! to new chemical entities and micro,
or!anisms in some countries are summarised in Anne-,II*
& Summar0 of Su1m)ss)ons and .resena)ons
:*8 A summar% of the various submissions and "resentations made to T14
is "resented in Anne-,III*
+ Conc*us)ons and Recommenda)ons
5*8 Based on the interactions T14 had with various staeholders and a
detailed e3amination of the critical le!al and technical issues involved,
"erusal of related literature, the T14 has done a detailed anal%sis and
come to the conclusions and recommendations outlined below*
2a3 'e( C!em)ca* En)0
Terms of Reference$ Whether it would be TRIPS compatible to limit the grant
of patent for pharmaceutical substance to new chemical entity or to new medical
entity involving one or more inventive steps$
5*2 The term Rne( c!em)ca* en)0R a""ears for the (rst time in
#nternational #ntellectual Pro"ert% a!reements in the T&#P' A!reement
of 8OO:, under Article <O*<F
RMembers, when reBuirin!, as a condition of a""rovin! the
maretin! of "harmaceutical or of a!ricultural chemical
"roducts which utili>e ne( c!em)ca* en))es4 (em"hasis
added) the submission of undisclosed test or other data, the
ori!ination of which involves a considerable e=ort, shall "rotect
such data a!ainst unfair commercial use* #n addition, Members
shall "rotect such data a!ainst disclosure, e3ce"t where
necessar% to "rotect the "ublic or unless ste"s are taen to
ensure that the data are "rotected a!ainst unfair commercial
use*R
5*< Accordin! to the Inited 'tates (I') Jood and +ru! Administration
(J+A), a new molecular entit% (/M1) or new chemical entit% (/01)
means a dru! that contains no active moiet% that has been a""roved
b% J+A in an% other a""lication submitted under section 505(b) of the
Jederal Jood, +ru!, and 0osmetic Act*
5*: The term Rne( med)ca* en)0R has neither been used nor de(ned in
the T&#P' A!reement*
5*5 Article 2@ of the T&#P' A!reement elaborates the sco"e of "atentable
subject matter as followsF
5
.8* 'ubject to the "rovisions of "ara!ra"hs 2 and <, "atents
shall be available for an% inventions, whether "roducts or
"rocesses, in all (elds of technolo!%, "rovided that the% are
new, involve an inventive ste" and are ca"able of industrial
a""lication* 'ubject to "ara!ra"h : of Article K5, "ara!ra"h C of
Article @0 and "ara!ra"h < of this Article, "atents shall be
available and "atent ri!hts enjo%able without discrimination as
to the "lace of invention, the (eld of technolo!% and whether
"roducts are im"orted or locall% "roduced*
2* Members ma% e3clude from "atentabilit% inventions, the
"revention within their territor% of the commercial e3"loitation
of which is necessar% to "rotect ordre public or moralit%,
includin! to "rotect human, animal or "lant life or health or to
avoid serious "rejudice to the environment, "rovided that such
e3clusion is not made merel% because the e3"loitation is
"rohibited b% their law*
<* Members ma% also e3clude from "atentabilit%F
(a) dia!nostic, thera"eutic and sur!ical methods for the
treatment of humans or animals;
(b) "lants and animals other than micro,or!anisms, and
essentiall% biolo!ical "rocesses for the "roduction of
"lants or animals other than non,biolo!ical and
microbiolo!ical "rocesses* )owever, Members shall
"rovide for the "rotection of "lant varieties either b%
"atents or b% an e=ective sui generis s%stem or b% an%
combination thereof* The "rovisions of this sub"ara!ra"h
shall be reviewed four %ears after the date of entr% into
force of the ET7 A!reement*2
5*K Article 2@ of T&#P' deals e3"licitl% with the issue of A"atentabilit%$* #t, inter
alia, states that AMember 'tates ma% not e3clude an% (eld of
technolo!% from "atentabilit% as a whole and the% ma% not
discriminate as to the (elds of technolo!%, the "lace of innovation$ etc*
&eadin! this obli!ation in the li!ht of the overall "ur"ose of the
a!reement, it a""ears that linin! the !rant of "atents for
"harmaceutical substances onl% to a new chemical entit% or to a new
medical entit% ma% "rima facie amount to Ae3cludin! a (eld of
technolo!%$ even when the% satisf% the basic reBuirements of
"atentabilit%* #n such a situation it is "ossible to hold the "rovision as
not T&#P' 0om"atible* Jurthermore, as shown later (see the anal%sis
"rovided in "aras 5*82 Q 5*2C), it is debatable as to whether national
interest or the ?e3ibilit% allowed under the A!reement to Member
'tates would be accommodated b% such Astatutor% e3clusion$ of an
entire class of inventions*
5*@ Throu!h various submissions that T14 had received, as well as the stud%
of the "ublished literature, T14 found a number of anal%ses and views
on the T&#P' ?e3ibilities* )owever, from a develo"in! world
"ers"ective, it is im"ortant to note at this sta!e the conclusions in a
&e"ort b% 'outh 0entre, which is an A#nter!overnmental Polic% Thin
Tan of +evelo"in! 0ountries$* 'outh 0entre "rovides intellectual and
"olic% su""ort reBuired b% develo"in! countries for collective and
6
individual action, es"eciall% in international arena* The &e"ort is
authored b% a well nown international authorit% on #P& and its role in
develo"ment, Prof* 0arlos 0orrea* The &e"ort is entitled .#nte!ratin!
Public )ealth 0oncerns into Patent 5e!islation in +evelo"in! 0ountries
(htt"F99www*who*int9medicinedocs9fr9d9Hh2OK<e9K*html)* The anal%sis
and recommendations in this &e"ort are es"eciall% relevant to the T7&
of the T14*
5*C* Ehile e3aminin! Article 2@, the same 'outh 0entre &e"ort e3"licitl%
concludesF
Literally interpreted, rticle !"#$ does not permit the e%clusion from
patentability of medicines in general or, arguably, of speci&c groups thereof#
'nder this interpretation, WT( members could not e%clude from patentability
even the )essential medicines* listed by the World +ealth (rganisation ,W+(-#.
The statement that /rticle "#$ does not permit the e%clusion from
patentability of 00 speci&c groups thereof* is directly pertinent to the T(R of
T12#
5*O Article 8 of the T&#P' A!reement reBuires com"liance to the "rovisions of
the A!reement, while T&#P' "lus "rovisions are o"tional* This would
mean that limitin! !rant of "atents to "harmaceutical substances to
new chemical entities onl%, and e3cludin! new forms of cr%stals,
"ol%mor"hs, etc*, if the% satisf% the criteria of "atentabilit%, is not
consistent with T&#P' A!reement*
5*80 'ection 2 (8) (j) of the #ndian Patents Act de(nes .invention2 as a new
"roduct or "rocess involvin! an inventive ste" and ca"able of industrial
a""lication* The term ."harmaceutical substance2 has also been
de(ned in 'ection 2 (8) (ia) as an% new entit% involvin! one or more
inventive ste"s* The term .inventive ste"2 has been de(ned in 'ection
2 (8) (ja) as a feature of an invention that involves technical advance
as com"ared to the e3istin! nowled!e or havin! economic
si!ni(cance or both and that maes the invention not obvious to a
"erson silled in the art* Thus, a chemical to be "atentable must be
new, non,obvious and have utilit%* )owever, 'ection < e3cludes certain
inventions from bein! "atented* This, inter alia, includes the e3clusions
under 'ection < (d) as underF
The mere discovery of a new form of a 3nown substance which does
not result in the enhancement of the 3nown e4cacy of that substance
or the mere discovery of any new property or new use for a 3nown
substance or of the mere use of a 3nown process, machine or
apparatus unless such 3nown process results in a new product or
employs at least one new reactant#
1%planation5 6or the purposes of this clause, salts, esters, ethers,
polymorphs, metabolites, pure form, particle si7e, isomers, mi%tures of
isomers, comple%es, combinations and other derivatives of 3nown
substance shall be considered to be the same substance, unless they
di8er signi&cantly in properties with regard to e4cacy#.
Thus, the new form of a nown substance would not be "atentable
unless it di=ers si!ni(cantl% in "ro"erties with re!ard to eDcac%*
7
5*88 The committee was not mandated to e3amine the T&#P' com"atibilit%
of 'ection <(d) of the #ndian Patents Act or an% other e3istin! "rovision
in the same Act* Therefore, the committee has not en!a!ed itself into
these issues*
5*82 The committee too a careful loo at the "ossible ?e3ibilities "rovided
under Article @ (Sobjects$) and Article C (S"rinci"les$) of T&#P'* #t also
e3amined the "ossible ?e3ibilities im"licit in +oha +eclaration on T&#P'
and Public )ealth*
5*8< Article @ statesF
$$The protection and enforcement of intellectual property rights should
contribute to the promotion of technological innovation and to the
transfer and dissemination of technology, to the mutual advantage of
producers and users of technological 3nowledge and in a manner
conducive to social and economic welfare, and to a balance of rights of
obligations#.
5*8: Article C statesF
$$$# 9embers may, in formulating or amending their laws and
regulations, adopt measures, necessary to protect public health and
nutrition, and to promote the public interest in sectors of vital
importance to their socio economic and technological development,
provided that such measures are consistent with the provisions of this
greement#**
**!# ppropriate measures, provided that they are consistent with the
provisions of this greement, may be needed to prevent the abuse of
intellectual property rights by right holders or the resort to practices
which unreasonably restrain trade or adversely a8ect the international
transfer of technology#**
5*85 Article @ "rovides a descri"tion of the Sobjects$ in !eneral terms*
Article 2@, however, "rovides a Ss"eci(c mandate$*

5*8K Article C*8, which "rovides Sa "rinci"le$, is also worded in !eneral
terms but, it e3"licitl% states that the measures under this article have
to be Sconsistent with the "rovisions of this a!reement$*
5*8@ The 0ommittee concluded that however noble and welcome the
objects !iven in Article @, in its a""lication to s"eci(c obli!ations
mandated in the A!reement, one should be able to show As"ecial
overridin! situations$ critical to the objects sou!ht to be achieved*
7therwise, the s"eci(c mandate is to be res"ected*
5*8C There is a clear anal%sis about Ss"ecial overridin! situations$, which
mi!ht authorise e3clusion of "harmaceuticals from "atentabilit%, that
8
has been "rovided in the 'outh 0entre &e"ort, which is Buoted below
(htt"F99www*who*int9medicinedocs9fr9d9Hh2OK<e9K*htm )*
:#$; )* second e%ception which might authori7e e%clusion of pharmaceuticals from
patentability is rticle <#$ of the TRIPs greement, which e%plicitly recogni7es
the right of WT( 9embers to adopt policies in accordance with public health
concerns# +owever, the adopted policies are sub=ect to a test of necessity.
and of consistency with other obligations under the TRIPs greement# The
)*consistency. re>uirement may permit patentability e%clusions in cases of
distinct public health emergencies as de&ned by the national government, and
as distinct from ordinary or everyday health and nutrition measures#.
:#!? )*1mergency cases could trigger the application of a di8erent test of
inconsistency. ,as provided for under rticle <#$- or >ualify as a situation not
conducive to social and economic welfare. ,as provided for under rticle "-#
In such a case, a suspension or e%clusion from patentability might be lin3ed to
and =usti&ed by a speci&c emergency# (nce the emergency subsides, the TRIPs
re>uirement of patentability could be restored#.
:#!$ 3ey consideration is clearly the purpose for which any sub=ect matter
e%clusion were to be adopted# If, for e%ample, the same ob=ective could be
obtained by imposing permissible compulsory licenses under rticle @$, an
e%clusion of patentability could be seen as merely an attempt to circumvent
the preconditions of rticle @$# If, instead, local situations posed such unusual
problems as to merit a public interest e%ception, these problems might also
=ustify overriding or limiting other articles, such as rticle @$, in favour of some
nonApermanent e%clusion of sub=ect matter, if that e%clusion was necessary to
solving the problem#.
5*22 #n summar%, under Anormal circumstances$, in res"ect of a""lication of
Articles @ 6 C*8 to the T7&, the T14 could not (nd justi(able reasons to
override the mandate of Article 2@*
5*2< )avin! dealt with both Article @ 6 C*8, T14 (nds that Article C*2 in
s"eci(c terms deals with a situation, when a "atent has been actuall%
!ranted, and addresses the issue of Sabuse$ of #P&* 'o this article is
not "ertinent to determinin! the "ossible ?e3ibilit% before the !rant of
a "atent, an issue, which the committee is s"eci(call% e3aminin!*
5*2: The T14 also e3amined the "ossible ?e3ibilities that ma% be im"licit in
+oha +eclaration* The e% "ara!ra"h in +oha +eclaration is the
o"enin! "hrase of "ara!ra"h :, which states as followsF
We agree that the TRIPS greement does not and should not prevent 9embers
from ta3ing measures to protect public health# ccordingly, while
reiterating our commitment to the TRIPS Agreement, we a4rm that the
greement can and should be interpreted and implemented in a manner
supportive of WT( 9embers* right to protect public health and, in particular, to
promote access to medicines for all#
5*25 #t is em"hasi>ed here that Members )reiterate their commitment to the
TRIPS agreement** This su!!ests that an% ?e3ibilities to cater to "ublic
health concerns have to be e3ercised Awithin the overall con(nes$ of
the T&#P' a!reement*
5*2K T14 noted that this Scommitment to the T&#P' A!reement$ is a!ain
reinforced b% the o"enin! "hrase of "ara!ra"h 5, which states as
9
followsF
ccordingly and in the light of paragraph B above, while maintaining our
commitments in the TRIPS agreement, we recogni7e that these
Ce%ibilities include 00.
5*2@ &eferrin! bac to the "oint made in 5*8@ about e3ce"tions under
Ss"ecial overridin! situations$, it is worth re,e3aminin! and
reem"hasisin! the followin! from "ara : of +oha +eclaration*
$# In applying the customary rules of interpretation of public
international law, each provision of the TRIPS greement shall be read in
the light of the ob=ect and purpose of the greement as e%pressed, in
particular, in its ob=ectives and principles#.
!# 1ach member has the right to grant compulsory licences and the
freedom to determine the grounds upon which such licences are
granted#.
@# 1ach member has the right to determine what constitutes a national
emergency or other circumstances of e%treme urgency, it being
understood that public health crises, including those relating to
+IDEIFS, tuberculosis, malaria and other epidemics, can represent a
national emergency or other circumstances of e%treme urgency#.
B# The e8ect of the provisions in the TRIPS greement that are relevant
to the e%haustion of intellectual property rights is to leave each 9ember
free to establish its own regime for such e%haustion without challenge,
sub=ect to the 96G and national treatment provisions of rticles @ and
B#.
5*2C #n the above, clause 8 reem"hasises the im"ortance of Articles @ 6 C of
T&#P'* 0lauses 2,<,: "ertain to the "rotection of "ublic health in a
S"ost !rant$ situation, but these do not deal with a S"re,!rant$
situation, which the T7& of T14 are mandated to address*
5*2O T14 concluded that +oha +eclaration cannot override the e3"ress
"rovisions of the T&#P' "rovisions, and an% ?e3ibilities therein have to
be inter"reted within the overall con(nes of T&#P', which, as has been
e3"lained, rules out an% Sstatutor% e3clusion$ from "atentabilit% of
entire class of inventions*
'a)ona* Ineres #ers#ec)5e
5*<0 T14 recommends that ever% e=ort must be made to "revent the
"ractice of Aever !reenin!$ often used b% some of the "harma
com"anies to unreasonabl% e3tend the life of the "atent b% main!
claims based sometimes on Atrivial$ chan!es to the ori!inal "atented
"roduct* The #ndian "atent oDce has the full authorit% under law and
"ractice to determine what is "atentable and what would constitute
onl% a trivial chan!e with no si!ni(cant additional im"rovements or
inventive ste"s involvin! bene(ts* 'uch authorit% should be used to
"revent Aever!reenin!$, rather than to introduce an ar!uable conce"t in
the li!ht of the fore!oin! discussion ("aras 5*K Q 5*C and "aras 5*82 Q
5*2O) above of Astatutor% e3clusion$ of incremental innovations from
the sco"e of "atentabilit%*
10
5*<8 The anal%sis leadin! to conclusion 5*2O is endorsed a!ain b% the 'outh
0entre &e"ort entitled A#nte!ratin! Public )ealth 0oncerns into Patent
5e!islation in +evelo"in! 0ountries
(htt"F99www*who*int9medicinedocs9fr9d9Hh2OK<e9K*htm), which also
e3amines the "ossible e3ce"tions and concludes as followsF
In sum, under the current TRIPs greement, a straightforward e%clusion from
patentability of pharmaceuticals H even the category of essential medicines H
does not seem to be a viable option# The admissibility of e%ceptions based on
ordre public will depend on the interpretation of both rticle !"#! and rticles
" and <, but does not seem a promising basis for e%clusion from patentability#
1%clusions to meet speci&c public health emergencies, especially if limited in
time, might be =usti&able if they are a necessary part of an overall strategy for
addressing the emergency#.
Policy ma3ers should recogni7e that, while healthArelated inventions may
re>uire special attention, the rules adopted will apply to all felds of
technology, and that the personnel of the Patent Ofce should be well
trained in order to ade>uately apply the provisions on this matter#.
5*<2 The "rocess of innovation occurs continuousl% and contributes to the
ever e3tendin! chain of nowled!e* #nnovative incremental
im"rovements based on e3istin! nowled!e and e3istin! "roducts is a
Anorm$ rather than an Ae3ce"tion$ in the "rocess of innovation* 1ntirel%
new chemical structures with new mechanisms of action are a rarit%*
Therefore, .incremental innovations2 involvin! new forms, analo!s,
etc* but which have si!ni(cantl% better safet% and eDcac% standards,
need to be encoura!ed* Ehat is im"ortant, however, is for the "atent
oDce to be vi!ilant about settin! hi!h standards of jud!in! such
innovations so that e=orts on .ever!reenin!2 are scru"ulousl%
"revented*
5*<< &estrictin! "atentabilit% just to /01s or /M1s could have both le!al
and scienti(c rami(cations* +ru! discover% research is still (ndin! its
feet in #ndia* The T14 noted that a few #ndian com"anies, which had
invested in discover% research, were be!innin! to see some success in
buildin! a "i"eline of new molecules* )owever, these molecules are in
earl% sta!es of evaluation and entr% and success in the maret"lace is
still awaited* 7verall, it seems, that at least as of now, restrictin!
"atentabilit% to just /01s would mean that most of the "harmaceutical
"roduct "atents would be owned b% M/0s*
5*<: #n case of "atentin! of dru!s, the "rotection to various forms of same
substance (salts, esters, ethers, "ol%mor"hs, metabolites, "ure form,
"article si>e, isomers, mi3ture, etc*) is often seen as Aever,!reenin!$
(e3tendin! incremental "rotection to a subsistin! "atent) and hence
such "rotection is objected to*

5*<5 #n most countries, "atentin! of an invention for di=erent forms of the
same substance is subjected to the test of novelt%, non,obviousness
(une3"ected e=ect) and utilit% before it is !ranted "atent "rotection*
'uch a "rotection in the form of incremental inventions in res"ect of
nown and new molecules or a "rocess "otentiall% "rovides an added
advanta!e to an inventor or a (rm to retain its maret share or ca"ture
a s"ace in the established maret* )owever, "atentin! an invention
11
does not im"l% that a "erson can "ractice the invention; he would have
to e3ercise due dili!ence and ensure that the ri!hts of others are not
infrin!ed*
5*<K Man% dru! industr% staeholders feel that the use of the e3"ression
.new chemical entit%2 under the Patents Act would lead to man%
inter"retations* Ehile some #ndian dru! industr% re"resentatives
feel that limitin! !rant of "atents to new chemical entities will not be
conducive to com"etitive !rowth, some others feel that "atent
"rotection should onl% be !iven based on the strict com"liance of the
"atentabilit% criteria* Man% #ndian industr% re"resentatives are not in
favour of widenin! the sco"e of "atentabilit%*
5*<@ The T14 e3amined the level and t%"e of &6+ innovations that the
#ndian dru!s and Pharma industr% was undertain!* Anne3ure #M and M
"rovide some re"resentative sam"les of international "atents (led b%
the #ndian industr%, when the T14 &e"ort was (rst submitted in the
%ear 200K* #t is clearl% seen that most of them were based on
incremental inventions*
5*<C T!e TE" conc*udes !a ) (ou*d no 1e TRI.S com#*)an o
*)m) gran)ng of #aens for #!armaceu)ca* su1sance o 'e(
C!em)ca* En))es on*04 s)nce ) #r)ma fac)e amouns o a
6sauor0 e-c*us)on of a 7e*d of ec!no*og08. 9o(e5er4 e5er0
e:or mus 1e made o #ro5)de drugs a a:orda1*e #r)ces o
!e #eo#*e of Ind)a. ;ur!er4 e5er0 e:or s!ou*d 1e made o
#re5en !e gran of fr)5o*ous #aens and <e5er,green)ng=.
>ea)*ed "u)de*)nes s!ou*d 1e formu*aed and r)gorous*0 used
10 !e Ind)an .aen /?ce for e-am)n)ng !e #aen
a##*)ca)ons )n !e #!armaceu)ca* secor so !a !e remoes
#oss)1)*)0 of gran)ng fr)5o*ous #aens )s e*)m)naed*
12
213 M)cro,organ)sms$
Terms of Reference$ Whether it would be TRIPS compatible to e%clude microA
organisms from patenting#
5*<O The 0oncise 73ford +ictionar%, de(nes the term micro,or!anism as
RAn% of various microsco"ic or!anisms, includin! al!ae, bacteria, fun!i,
"roto>oa and virusesR and the 0ollins 1n!lish +ictionar%, de(nes this
term as RAn% or!anism, such as a virus, of microsco"ic si>e*2
5*:0 The #nstitute of 'cience, IT (www*i,sis*or!*u) describes micro,
or!anism as an or!anism that can be seen onl% under a microsco"e,
usuall%, an ordinar% li!ht microsco"e* The% are usuall% of the order of
microns (millionths of a metre) or tens of microns in linear dimensions,
and include bacteria, m%co"lasma, %easts, sin!le celled al!ae and
"roto>oa* Multicellular or!anisms are normall% not included, nor fun!i,
a"art from %easts* Miruses are also not automaticall% included; man%
scientists do not classif% them as or!anisms, as the% de"end on cells to
multi"l%* )awer and 5inton, (1dward Arnold, 5ondon, 8O@O) in their
boo -Micro,or!anisms, Junction, Jorm and 1nvironment- state that the
term micro,or!anism is derived from the minute si>e of the various
or!anisms* Miruses are included, thou!h the% are non,cellular "articles,
which are not ca"able of inde"endent life and can "roliferate onl% in
livin! cells* The authoritative te3t (Pearson, 5ondon, 200C) for
introductor% biolo!%, namel% Broc Biolo!% of Microor!anisms (edited
b% Madi!an, Martino +unla" 0lar and Broc) describes micro,
or!anisms, as a microsco"ic or!anism consistin! of a sin!le cell or cell
cluster, includin! the viruses* )erita!e, 1vans and Tillin!ton in their
boo -#ntroductor% Biolo!% (0ambrid!e Iniversit% Press, 0ambrid!e,
8OOK) de(ne Micro,or!anisms as microsco"ic life forms includin!
microsco"ic fun!i, Protista, "roar%otes and viruses* )awer, 5inton,
Joles and 0arlile in their boo (1dward Arnold, 5ondon, 8OK0) titled as
-Biolo!% of Micro,or!anisms- describe micro,or!anisms as consistin! of
several distinct !rou"s of or!anism, most of whose members are of
microsco"ic dimensions*
5*:8 Microbiolo!ical inventions include new "roducts, "rocesses, uses and
com"ositions involvin! biolo!ical materials* These inventions cover
methods to isolate and obtain new or!anisms, im"rove their character,
modif% them and (nd their new and im"roved uses*
5*:2 Patentin! of new micro,or!anisms is based on their di=erences with
the characters and uses of micro,or!anisms as available in the "rior
art* Tnown micro,or!anisms are restricted to new uses, wherever
"atent law "ermits such a "rotection* The same is the case with
!eneticall% modi(ed micro,or!anisms* 4enes and !ene "roducts are
treated similar to chemical com"ositions* Patentin! of animal and
human !enes Buite often attracts issues re!ardin! "ublic order and
moralit%*
5*:< Position of micro,or!anisms in the #ndian Patents Act, 8O@0 as
amended u" to 2005 is as followsF
13
'ection < of the Patents Act s"eci(es inventions which are not
"atentable* The relevant "rovisions of that 'ection are as belowF
< ( c )F Rthe mere discover% of a scienti(c "rinci"le or the
formulation of an abstract theor% or discover% of an% livin!
thin! or non,livin! substances occurrin! in nature*R
<(j) F R"lants and animals in whole or an% "art thereof other
than micro,or!anisms but includin! seeds, varieties and s"ecies
and essentiall% biolo!ical "rocesses for "roduction or
"ro"a!ation of "lants and animals*R
The above "rovisions clearl% identif% micro,or!anisms as "atentable
subject matter, "rovided the% ful(l the "rescribed criteria*
#n the Fimminaco 2 vs# Iontroller of Patents, the 0alcutta )i!h 0ourt
held in 2002 that a "atent on a micro,or!anism is valid* The court ruled
that the Act did not "reclude a livin! end "roduct from bein! "atented*
5*:: Article 2@*< of the T&#P' A!reement states that Members ma% also
e3clude from "atentabilit%F
.(a) dia!nostic, thera"eutic and sur!ical method for the treatment
of humans or animals;
(b) "lants and animals other than micro,or!anisms, and essentiall%
biolo!ical "rocesses for the "roduction of "lants and animals other
than non,biolo!ical and microbiolo!ical "rocesses* .
5*:5 Thus, Article 2@*< of the T&#P' A!reement clearl% e3cludes "lants and
animals from bein! "atented, but re!ards micro,or!anisms as di=erent
from "lants and animals* Ehile naturall% occurrin! micro,or!anisms
should not Bualif% for "atentin!, micro,or!anisms involvin! human
intervention and utilit% are "atentable subject matter under the T&#P'
A!reement, "rovided the% meet the "rescribed "atentabilit% criteria*
5*:K Iniversall%, as "ractised b% most "atent oDces, new micro,or!anisms
isolated for the (rst time from the natural surroundin! can onl% be
"atented if the% di=er in character from the nown micro,or!anisms
and (nd a new or im"roved use or function* The issue has been
discussed and debated in 1uro"e for a number of %ears* #n man%
countries, includin! 1uro"ean countries, I'A, &e"ublic of Torea, Ha"an
and 0hina, "atentin! of micro,or!anisms is not an issue* 0laims to
micro,or!anisms have been allowed on the !rounds that the% are the
"roducts of micro,biolo!ical "rocesses*
'a)ona* Ineres #ers#ec)5e
5*:@ Biotech industr% is one of the fastest !rowin! industries in the world,
includin! in #ndia* #ndia bein! one of the bio,diversit% rich countries, it
would, thus, be "rudent for us to "rotect biotechnolo!ical inventions as
that would hel" #ndian biotechnolo!% research com"ete !loball%
attractin! collaborations, J+#, contract &6+, etc* to the best
advanta!e of the #ndian &6+ and biotech industr%* #ndia needs to
rea" the due bene(ts from its rich bio,resources with an enablin!
"rovision for "rotection of intellectual "ro"ert% in bio,technolo!ical
14
innovations and inventions*
15
5*:C There have been instances of "atentin! of #ndian biolo!ical materials
b% other countries* #t would, thus, be in our interest to document,
"rotect and modif% new micro,or!anisms isolated from various "arts of
our countr% and (nd their new and im"roved industrial uses* This ste"
would hel" #ndian biotech industr%*
5*:O The !rou"$s conclusion is based on the reBuirements of Article 2@*< of
the T&#P' as articulated in 5*2< above and the "rovision of #ndian
Patent Act ('ection < (j))* )owever, strict !uidelines need to be
formulated for e3amination of the "atent a""lications involvin! micro,
or!anisms from the "oint of view of substantial human intervention
and utilit%*
5*50 T!e TE" !as conc*uded !a e-c*ud)ng m)cro,organ)sms per se
from #aen #roec)on (ou*d 1e 5)o*a)5e of TRI.S Agreemen.
16
Anne-,I
0o"% of 4overnment of #ndia, Ministr% of 0ommerce 6
#ndustr%, +e"artment of #ndustrial Polic% 6 Promotion vide
7rder /o* 8298:92005,#P&,### dated A"ril 5, 2005
/R>ER
Su1@ec$, Tec!n)ca* E-#er "rou# on .aens *a( )ssues
A Technical 13"ert 4rou" com"risin! the followin! "ersons has been
constituted to stud% certain "atents law issuesF
8* +r* &*A* Mashelar , 0hairman
+irector 4eneral
0ouncil of 'cienti(c and
#ndustrial &esearch
2, &a( Mar!,
/ew +elhi Q 880 008
2* Prof* 4overdhan Mehta , Member
+irector
#ndian #nstitute of 'cience
Ban!alore Q 5K0 082
<* Prof* Asis +atta , Member
+irector
/ational 0entre for
Plant 4enome
&esearch
H/I 0am"us
/ew +elhi Q 880 0K@
:* Prof* Madhav Menon , Member
/ational Hudicial Academ%
Bho"al
5* Prof* Moolchand 'harma , Member
+irector
/ational 5aw #nstitute Iniversit%
Bho"al
0ontdU**
17
,2,
2* The 4rou" will have the followin! terms of referenceF
a) whether it would be T&#P' com"atible to limit the !rant of "atent for
"harmaceutical substance to new chemical entit% or to new medical entit%
involvin! one or more inventive ste"s; and
b) whether it would be T&#P' com"atible to e3clude micro,or!anisms from
"atentin!*
<* The !rou" will submit its re"ort to the +e"artment of #ndustrial Polic% and
Promotion*
:* The !rou" will be serviced b% the +e"artment of #ndustrial Polic% and
Promotion*
'd9,
2Ra@ee5 Ran@an 3
>)recor
Co#0 o$

All the members of the 4rou"*
Co#0 a*so o
8* Prime Minister$s 7Dce
2* 0abinet 'ecretariat*
<* 7Dce of 0#M
:* 7Dce of 'ecretar% (#PP)
5* Ministries9+e"artments of 0hemicals 6 Petro,chemicals, )ealth,
Biotechnolo!%, 'cience 6 Technolo!%, 0ommerce, 'cienti(c and #ndustrial
&esearch, A!ricultural &esearch 6 1ducation, 1nvironment 6 Jorests*
18
Anne- , II
.aen)ng .rac)ces )n /!er counr)es
!amination "uidelines for Patent Applications relating to
#iotechnological In$entions at the %& Patent Ofce
These 4uidelines set out the "ractice within the IT Patent 7Dce as it
relates to "atent a""lications for biotechnolo!ical inventions* The 2000
&e!ulations came into force on 2C Hul% 2000 and im"lemented the
"rovisions of Articles 8 to 88 of the 1uro"ean +irective OC9::910 on the
le!al "rotection of biotechnolo!ical inventions*
#n the IT, the Patents &e!ulations 2000 con(rmed and clari(ed that
inventions concernin! biolo!ical material, includin! !ene seBuences,
ma% be le!itimatel% the subject of "atent a""lications* #n other words,
these &e!ulations have established be%ond doubt the le!itimac% of
biotechnolo!% "atents in the IT*
n invention shall not be considered unpatentable solely on the
grounds that it concerns ,a- a product consisting of or containing
biological materialJ or ,b- a process by which biological material is
produced, processed or used.
KParagraph $, Schedule ! to the Patents ct $;""L
Iniversall%, it is an established "ractice that a natural substance which
has been isolated for the (rst time and which had no "reviousl%
reco!ni>ed e3istence, does not lac novelt% because it has alwa%s
been "resent in nature*
#t is !enerall% a!reed, and it is "articularl% relevant in the (eld of
biotechnolo!%, that a "atent should not be !ranted merel% because the
a""licant had been involved in laborious and costl% e=ort* #f the !oal is
nown and suDcient of the theor% and "ractice is nown for the
a""licant to "redict where he is !oin!, without there bein! an ori!inal
ste", then an obviousness objection would be well founded*
Jollowin! the seBuencin! of various !enomes, there is unliel% to be an
inventive ste" in identif%in! from within a seBuenced !enome an% new
!ene, even those without nown homolo!ues* #t is obvious to trawl the
!enome for "reviousl% unidenti(ed !enes, and an% silled worer
would have some e3"ectation of success* #n 2enentech, an idea was
considered obvious if .the materials in Buestion were l%in! in the road
and read% for a research worer to use2, even if the silled man faced
a number of obstacles in "roceedin! to his !oal* )owever, if
overcomin! these obstacles reBuired .a s"ar of ima!inationU*be%ond
the ima!ination "ro"erl% attributable to him as a man silled in the art2
then there ma% be some element of inventive ste"* The use of
bioinformatics tools would not seem to "ose obstacles reBuirin! a
s"ar of ima!ination to overcome*
Para!ra"h 2 of 'chedule A2 to the British Patents Act, 8O@@ "ermits
biolo!ical material which is isolated from its natural environment or
19
"roduced b% means of a technical "rocess to be the subject of an
invention even if it "reviousl% occurred in nature* 0laims to micro,
or!anisms per se have been allowed on the !rounds that the% are
"roducts of microbiolo!ical "rocesses* This a""lies even when the% are
merel% isolated from their natural surroundin!s, their isolation, culture,
characteri>ation and the (ndin! of a utilit% turnin! what would be a
discover% into an invention*
0laims for micro,or!anisms per se which have been isolated or
obtained b% arti(ciall% induced random mutation, are allowed but
!enerali>ations from such s"eci(c micro,or!anisms to novel s"ecies
would not normall% be "ermitted* 7n the other hand, claims to
!eneticall% modi(ed micro,or!anisms derived from readil% available
nown micro,or!anisms where the invention resides in the !ene
introduced, ma% be claimed more !enerall%* Also claims to mutants
and variants of a s"eci(ed de"osited micro,or!anism are allowed
"rovided the% "ossess the same inventive "ro"ert% as the de"osited
micro,or!anism*
Patenting of 'icro(organisms in )hina
0laims for micro,or!anisms per se are allowed in 0hina* +/A
seBuences are considered to be lar!e chemical com"ounds, and ma%
be "atented as com"ositions of matter* Althou!h "atent claims to
naturall% occurrin! +/A seBuences mi!ht be e3"ected to tri!!er the
A"roducts of nature$ rule, courts have u"held "atent claims coverin!
A"uri(ed and isolated$ +/A seBuences as new com"ositions of matter
resultin! from human intervention* An e3cised !ene is eli!ible for a
"atent as a com"osition of matter or as an article of manufacture
because that +/A molecule does not occur in that isolated form in
nature; or s%nthetic +/A "re"arations are eli!ible for "atents because
their "uri(ed state is di=erent from the naturall% occurrin! com"ound*
Article 25 of the 0hinese Patent 5aw states thatF
Jor an% of the followin!, no "atent ri!ht shall be !rantedF
(8) 'cienti(c discoveries;
(2) &ules and methods for mental activities;
(<) Methods for the dia!nosis or for the treatment of diseases
(:) Animal and "lant varieties;
(5) 'ubstances obtained b% means of nuclear transformations*
Jor "rocesses used in "roducin! "roducts referred to in items (:) of the
"roceedin! "ara!ra"h, "atent ri!ht ma% be !ranted in accordance with
the "rovisions of the 5aw*
Patenting of 'icro(organisms in urope
The 1uro"ean Inion has de(ned .-biolo!ical materialR instead of
Rmicro,or!anismR, as under VArticle 2*8 (a)W
.Biolo!ical material means an% material containin! !enetic information
and ca"able of re"roducin! itself or bein! re"roduced in a biolo!ical
s%stemR
20
#n Plant 4enetic '%stems a""lication (T<5K9O<) 1uro"ean Board of
A""eal was sei>ed with the Buestion as to what is meant b% the term
-micro,or!anism- The Board held that a micro,or!anism would include
bacteria, %east, fun!i, al!ae, "roto>oa, "lasmids and viruses, but also
animal or "lant cells and !enerall% all unicellular entities with
dimensions beneath the limits of human vision*
Article 5<(b) of the 1uro"ean Patent 0onvention (1P0) "rovides that
1uro"ean "atents shall not be !ranted in res"ect of A"lant or animal
varieties or essentiall% biolo!ical "rocesses for the "roduction of "lants
or animals; this "rovision does not a""l% to microbiolo!ical "rocesses
or the "roducts thereof$*
#n its decision of 8K Hune 8OOO the Administrative 0ouncil inserted a
new 0ha"ter M# entitled ABiotechnolo!ical inventions$ in Part ## of the
1P0 #m"lementin! &e!ulations* The new "rovisions entered into force
on 8 'e"tember 8OOO and im"lemented the reBuirements of the 1I
Biotechnolo!% +irective in 1uro"ean "atent law* The 1P7 has
introduced four new rules, &ules 2<b to 2<e* &ule 2<b sets out !eneral
matters and de(nes the meanin! of biotechnolo!ical inventions,
biolo!ical material, "lant variet%, and microbiolo!ical "rocess* &ule 2<c
states "atentable biotechnolo!ical inventions, includin!F
Biolo!ical material isolated from their environment, even if
nown in nature* This "articularl% a""lies to !enes that are
isolated from their natural environment b% means of technical
"rocesses and made available for industrial "roduction*
Plants or animals if the invention is not con(ned to a sin!le
variet%
The "rovision clari(es the sco"e of Article 5<(b) of 1P0* #t indicates that
a "lant !rou"in! characteri>ed onl% b% a "articular !ene, but not b% its
whole !enome, is not covered b% the "rotection of new varieties and
therefore is in "rinci"le "atentable* This also a""lies if such "lant
!rou"in! com"rises "lant varieties*
&ule 2<d sets out what is not "atentable* This includes "rocesses for
clonin! human bein!s, "rocesses for modif%in! the !enetic identit% of
human bein!s, usin! human embr%os for commercial "ur"oses and
modif%in! the !enetic identit% of animals such as ma% cause them
su=erin! without substantial medical bene(t* The list is to be seen as
!ivin! concrete form to the conce"ts of Aordre "ublic$ and Amoralit%$*
&ule 2<e indicates what is and is not "atentable with res"ect to the
human bod%* The human bod% and its elements cannot be "atented*
)owever, elements of the bod%, when isolated from the bod%, ma% be
"atented*
Patenting of 'icro(organisms in *apan
#n 8OO@, the Ha"anese Patent 7Dce (HP7) "ublished its A#m"lementin!
4uidelines for #nventions in '"eci(c Jields$* #nventions in the
21
biotechnolo!% (eld in the 4uidelines are divided into four t%"esF
!enetic en!ineerin!, micro,or!anisms, "lants and animals* #nventions
relatin! to !enetic en!ineerin! include those of a !ene, a vector, a
recombinant vector, a transformant, a fused cell, a recombinant
"rotein, and a monoclonal antibod%* #nventions relatin! to micro,
or!anisms include micro,or!anisms per se as well as those relatin! to
the use of micro,or!anisms*
#n Ha"an, micro,or!anism means %east, molds, mushrooms, bacteria,
actinom%cetes, unicellular al!ae, viruses, "roto>oa, etc* and further
includes undi=erentiated animal or "lant cells as well as animal or
"lant tissue cultures*
Patenting of +ew )hemical ntity in %S,
Accordin! to the Inited 'tates (I') Jood and +ru! Administration
(J+A), a new molecular entit% (/M1) or new chemical entit% (/01)
means a dru! that contains no active moiet%

that has been a""roved

b% J+A in an% other a""lication submitted under section 505(b) of the
Jederal Jood, +ru!, and 0osmetic Act*
Patenting of 'icro(organisms in %SA
Art* <5 I'0 'ec 808 of the I' "atent law statesF whoever invents or
discovers an% new and useful "rocess, machine, manufactures, or
com"osition of matter, or an% new and useful im"rovement thereof,
ma% obtain a "atent thereofU2
#n I'A, utilit% reBuirement in res"ect of biotech inventions are ver%
strict* A discover% that is not a creation does not meet the reBuirement
of utilit%* A newl% discovered micro,or!anism e3istin! in nature, a
newl% discovered "lant per se are discoveries because the% do not
involve creativit%* #nventions that are inca"able of industrial a""lication
do not meet the reBuirement of utilit%* #nventions of a !ene, a vector, a
recombinant vector, a transformant, a fused cell, a recombinant
"rotein and a monoclonal antibod% whose utilit% is not described in a
s"eci(cation or cannot be inferred, do not meet the reBuirement of
utilit%* An invention of a micro,or!anism per se, a "lant per se or an
animal per se whose utilit% is not described or cannot be inferred does
not meet the reBuirement of utilit%*
Accordin! to the new AItilit% 13amination 4uidelines$ of the I'PT7, if
an isolated +/A fra!ment has a s"eci(c, substantial, and credible
utilit%, the +/A fra!ment invention satis(es the reBuirement of utilit%
and a "atent can be !ranted for the +/A fra!ment* Ehere a new use is
discovered for the "atented +/A fra!ment, that new use ma% Bualif%
for its own "rocess "atent* 7f course, the later "atent is a de"endent
"atent of the +/A fra!ment "atent*
Patenting of 'icro(organisms in Australia

An active moiety means the molecule or ion, excludin those a!!ended !ortions o" the molecule that cause
the dru to #e an ester, salt $includin a salt %ith hydroen or coordination #onds&, or other noncovalent
derivative $such as a com!lex, chelate, or clathrate& o" the molecule, res!onsi#le "or the !hysioloical or
!harmacoloical action o" the dru su#stance'
$(ource) htt!)**en'%i+i!edia'or&
22
The Australian "atent law de(nes invention as Ran% new manner of
manufacture*R
The Buestion of "atents for livin! or!anisms was considered at len!th
in &ans )ovis Mc+ou!all 5td*-s A""lication V8O@K A 7HP <O85W and the
0ourt held thatF
a) /o objection can be taen to a claim to a new or!anism on the !round
that it is somethin! livin!;
b) An% new variants claimed must have im"roved or altered useful
"ro"erties and not merel% have chan!ed mor"holo!ical characteristics
which have no e=ect on the worin! of the or!anism; and
c) /aturall% occurrin! micro,or!anisms per se are not "atentable as the%
re"resent a discover% and not an invention, but a claim to a "ure
culture in the "resence of some s"eci(ed in!redients would satisf% the
reBuirement of a technical intervention*
The !uidelines for a micro,or!anism in Australian Patent 5aw states,
.what is discovered in nature without an% "ractical a""lication, is a
mere chemical curiosit%2- and is not "atentable VPart C*2*5*< Australian
Manual of Patent PracticeW* )owever, isolated micro,or!anisms are
considered "atentable*
Patenting Practices of 'icro(organism in #ra-il
Article 80 states that the followin! shall not be considered inventions
or utilit% modelsF
Rall or "art of natural livin! bein!s and biolo!ical materials found in
nature or isolated there from, includin! the !enome or the !erm "lasm
of an% natural livin! bein! and an% natural biolo!ical "rocess*R
Article 8C states that the followin! should not be "atentableF
Rlivin! bein!s, in whole or in "art, e3ce"t for trans!enic micro,
or!anisms meetin! the three reBuirements of "atentabilit% , novelt%,
inventive ste" and industrial a""lication , in accordance with Article C
and which are not mere discoveries*R
Jor the "ur"oses of this law, trans!enic micro,or!anisms mean
or!anisms, e3ce"t for "lants or animals in whole or in "art, that due to
direct human intervention in their !enetic com"osition e3"ress a
characteristic that cannot normall% be achieved b% the s"ecies under
natural conditions*
23
Anne-e , III
Summar0 of Su1m)ss)ons and .resena)ons
Ran1a-0
+ew )hemical ntity .+)/,
As #ndia$s leadin! Pharmaceutical 0om"an% committed to &6 + in the
(eld of dru! develo"ment, we are of the o"inion that incremental
innovations in terms of develo"in! new forms, new derivatives and
new deliver% s%stems of e3istin! dru! should be !ranted "atent
"rotection "rovided the% are new, involve an inventive ste" and have
commercial utilit%* This will "rovide the necessar% (lli" to develo"ment
of /ovel +ru! +eliver% '%stem (/++') in our laboratories*
&estrictin! "atentabilit% to /01s ma% a""ear to be an attractive
solution in the short Qterm to com"anies with a A&everse Q1n!ineerin!$
mindQset, but will not bene(t hundreds of scientists worin! in our
"ublic 6 "rivate & 6 + 0enters, who are just startin! o= on the diDcult
tas of new dru! discover% research*
&estriction of "atentabilit% to /01s alone is liel% to bene(t onl% M/0s
which have the resources and the e3"erience to develo" /01s* #ndian
com"anies that have far less resources are better "laced to bene(t
from earl% commerciali>ation of incremental innovations* A "rereBuisite
to successful licensin! deal for such "roducts is the "rotection of the #P
in the form of a "atent, "referabl% in the countr% itself since "roducts
are bein! manufactured here*
&estrictin! "atentabilit% to /01s is not com"liant with Article 2@*8 of
T&#P'*

Patent A""lications (led b% &anba3%F
Sraeg)c >)rec)on
'e!ment 200: 200@ 2082
4enerics
/++'
/++&
G G G
G
G G G
G G
G G G
G G G
G G G
4lobal 'ales I' X 8 Bn I' X 2Bn I' X 5 Bn
A'tars indicate im"ortance9direction in the se!ment
A&1AE#'1 PAT1/T J#5#/4 94&A/T T7 &A/BAYZ
(Total number uniBue "atent a""lications (ledF @0O)
Ind)a USA
;)*ed "ranedA ;)*ed "raned
Process <CC O5 CC <C
24
AP#s 2:K 5C K: <0
+osa!e 8:2 <@ 2: 0C
/++' @5 28 8C 0C
/++& @5 2< :0 8<
)erbal 0K , , ,
Paca!in
!
08 , , ,
Total 5:5 8<O 8:K 5O
Gincludes acce"ted "atent
The (rm em"hasi>es that GFFS products need patent protection since
stren!th of #ndian scientists lie in innovations that im"rove e3istin!
"roducts* Jurther, /++' "ro!rams are less e3"ensive, have lower
!estation "eriods and result in #P that can be licensed* 13am"le 0i"ro
7+ licensed b% &anba3% to Ba%er*
&anba3% has further tried to de(ne .eDcac%2 as the ca"acit% of the
dru! to "roduce a desired e=ect* #n medical terms, clinical eDcac% is
the ma3imal e=ect that can be "roduced b% a dru!* An% factor such as
bioavailabilit% that substantiall% enhances a clinical outcome bene(t
would be deemed to be included in the de(nition of eDcac%* An%
invention on derivatives or "ro"erties that a=ect these factors should
be deemed to be "atentable, if it demonstrabl% and si!ni(cantl%
in?uences the eDcac%* This would include inventions on chemical
modi(cations such as "rodru!s, salts, "ol%mor"hs, etc* 'uch inventions
should be "atentable "rovided the% meet the strin!ent "atentabilit%
criteria under 'ection < (d) and < (e) and the invention is novel, non,
obvious and industriall% useful*
'icro(organisms,
/o comments*
Br)s!na C Saurasr)4 Trademarks C .aen Aorne0s
+ew )hemical ntity .+)/,
a# #t will not be T&#P' com"atible to limit the !rant of "atent to
"harmaceutical substances to new chemical entit% or to new
medical entit% involvin! one or more inventive ste"s;
b# Both the above thin!s will be a!ainst s"eci(c interests of #ndian
inventors and a bonan>a for multinational com"anies;
c# Time has come to re,e3amine entire #P& "olic% of #ndia* Best "olic%
will be to ensure im"lementation of "rovisions of com"ulsor%
licensin! "rovisions and 'ection KK in letter and s"irit* Eith fear of
misuse or mischievous use !one, mae sco"e of "atentabilit% as
broad as "ossible b% deletin! A55 restrictive "rovisions on
"atentabilit% e3ce"t 'ections < (b), < ("), :, <O* This will !ive a real
business im"etus in investin! in innovations, which will em"ower
individual #ndian inventors, which shall result in national as well as
"ersonal bene(ts*
25
d# Article 8 of the T&#P' A!reement clearl% indicates that what has
been included in the A!reement is the com"liance to minimum
commitment is mandator%* #f an%thin! is o"tional, it is !ivin! more
e3tensive "rotection than has been sti"ulated in the A!reement*
This clearl% means that e3cludin! "harmaceutical substances other
than new entities, which ma% include new forms of cr%stals,
"ol%mor"hs etc, is not consistent with T&#P' reBuirements if the%
satisf% the criteria of "atentabilit%*
e# #n "rocess "atents re!ime, stren!th of #ndian "harmaceutical
com"anies was in their ca"abilit% to invent new "rocesses* /ow in
"roduct "atent re!ime also, this abilit% shall hel" them to reassert
themselves* &6+ in new chemical entities reBuires a hu!e (nancial
commitment, sta%in! abilit% and &6+ ca"abilit%, which ver% few
#ndian Pharma com"anies have* 1ven at "resent, "atents "ortfolio
of most #ndian "harma com"anies, e3ce"t one e3ce"tion, is ver%
"oor as com"ared to the "atents culture in similar com"anies in
develo"ed countries* 'tren!th of our "harma com"anies lies at
"resent in worin! around in "resentl% !eneric "roducts*
f# This ma% include (ndin! out better forms which have some
strate!ic economic advanta!e such as better handlin! "ro"erties,
better stabilit%, etc#
g# #t is also "ossible that a new eDcient "rocess of an economicall%
!eneric dru! ma% be "atented, but e3ce"t for a new sha"e of
cr%stals of the "roduct "roduced b% that "rocess, there is nothin!
that can hel" in detectin! that the "atented "rocess has been used
b% the infrin!er, in which case, althou!h "harmaceutical substance
"roduced is not a new chemical entit%, the new cr%stal structure as
a "roduct claim shall have e3traordinar% strate!ic and economic
im"ortance* )owever, den%in! a "atent to this claim shall wor to
disadvanta!e of such inventions, which are distinctl% "ossible from
#ndian inventors in !enerics*
h# Ehen a new "rocess is di=erent and far more eDcient, uses some
reactants not used in earlier "rior,art "rocesses, and same
chemical entit% with same "h%sical "ro"erties of its "articles are
"roduced, in such cases, even when such a "rocess ma% be
"atented, the onl% "ractical and e=ective wa% to detect
infrin!ement will be !iven b% onl% a "roduct claim which claims
"resence of this im"urit% in trace Buantities* 5imitin! "atentabilit%
to new chemical entities onl% shall lead to denial of such a "roduct
claim from bein! !ranted, which shall wor a!ainst the interest
mainl% of #ndian inventors* The% will (nd it circuitous and more
e3"ensive to "rove that their "rocess is bein! infrin!ed in absence
of an e3"ress "roduct claim bein! !ranted*
i# Man% such e3am"les are "ossible, and man% unantici"ated and
une3"ected ma% arise in future, where the "ro"osed restrictions on
"atentabilit% ma% turn out to be counter"roductive*
=# This means that the% will be "roducin! inventions, which shall be in
the cate!or% other than Rnew chemical entitiesR* B% o"tin! to
26
e3clude "harmaceutical substances other than new chemical
entities from "atentin! in "harmaceutical area, we shall be o=erin!
bonan>a to multinational com"anies, because Rnew chemical
entities2 is their e3clusive stren!th at "resent and e3cludin! all
other "harmaceutical substances from "atentabilit% will mae their
com"etitive "osition further e3clusivel% "rotected* This a""roach
will hit #ndian "harma com"anies* 5oss of the multinationals will be
mar!inal*
3# The entire reason for e3cludin! R/ew JormsR from bein! held
"atentable emer!es from the fear of R4reenin! of PatentsR* This is
basicall% not a "ractical fear because even if a R/ew JormR is
"atented, this does not revive "atent "rotection to the o=,"atent
form nor to that chemical entit%* Ehat has e3"ired as "atent
"rotection has e3"ired* Ma% be, the "atentee can e3ercise his
e3clusivit% on the R/ew JormR, which shall not include "rotection to
the chemical entit%, but just the new form* But as lon! as the R7ld
JormR is useful for its "ur"ose, the "atent on R/ew JormR can be
i!nored and not used at all b% the world* 7n the contrar%, the-
R/ew JormR has such a si!ni(cant im"rovement that its use is
indis"ensable, in such a case wh% should an%one have a !rud!e
a!ainst its "atentabilit% and licensin! it lawfull%-[
l# &estrictive "rovisions on "atentabilit% are mainl% on account of fear
of misuse or mischievous use of e3clusivit%* This threat should not
e3ist for us due to ver% stron! com"ulsor% licensin! "rovisions and
defensive "rovision* #t shall be enou!h to !ive con(dence that
'ections C: and O8 shall be im"lemented in case of !enuine cases
without an% dela%* These "rovisions "rotect the e3istin! innovation
based com"anies from "ossible cri""lin! e=ects of mono"olies
from arrival of new critical "atents from "atentees of other
countries* #t is misconceived that the% are useful onl% in national
emer!encies or onl% #f "ublic demand is not satis(ed* #f read
"ro"erl%, these sections are available not onl% in case of national
emer!encies; but even when a "atentee is "roducin! the "roduct
to satisf% "ublic demand, if an alread% e3istin! enter"rise faces
closure due to the new "atent, com"ulsor% license is available to
avert the closure ('ee section C: (@) (a) (i))* The onl% objection and
that too valid one is that one has to wait for three %ears from the
date of sealin! of the "atent for a""lication of this "rovision* This
"roblem, however, is solved b% the ver% revolutionar% "rovision of
'ection O8, where, if an enter"rise has active &6+ in the same (eld
and the new "atent is related to their e3istin! on!oin! &6+, the%
!et the ri!ht from the date of sealin! the "atent* These two
"rovisions between them avert an% threat to #ndian business and
shall herald an era of coo"erative business rather than com"etitive
iller instinct based business*
m# To tae bene(t of the "otential "ro(ts from licensin! of new
molecules, #ndian com"anies will have to start !enuine wor on
several t%"es of molecules* 7nce &6+ culture settles in #ndian
Pharma com"anies, this avenue will also a""ear attractive and
"ractical to them* This will mean a !enuine and substantial chan!e
27
in #ndian "harma &6+, which shall brin! bene(ts to the #nventive
individuals and com"anies for themselves and for the countr%* #n
course of time, lead molecules ma% emer!e even from #ndia*
'icro(organism,
a* #t will not be T&#P' com"atible to e3clude micro,or!anisms from
"atentin!;
b* #t ma% be "ointed out here that we have full% e3"loited the
"ermitted e3clusions under 'ection < of the Article 2@* )owever,
same "rovision ver% s"eci(call% and e3"ressl% e3cludes "ermission
to e3clude micro,or!anisms from "atentabilit%* Eith so clear
e3"ress "rovisions, here is no wa% to inter"ret that micro,
or!anisms can be e3cluded from "atentabilit%*
S!r) V.R. Br)s!na I0er
+ew )hemical ntity,
#t is well within the T&#P' norms to limit "atentabilit% to new chemical
entitites in res"ect of "harmaceutical inventions
'icro(organism,
#t was observed that micro,or!anisms, which occur in nature and which
at best, could be re!arded, as discoveries cannot constitute "atentable
inventions* There should be no "atent "rotection in res"ect of such
cases*
#n clause <(j), the e3"ression Rother than micro,or!anisms, butR should
be deleted* Alternativel%, under "roviso to section 8(<) of the Act, the
commencement of the "rovision should be deferred till a review of the
Buestion of accordin! "atent "rotection to micro,or!anisms and non
biolo!ical and micro biolo!ical "rocesses, as initiated b% the ET7 in
8OOO, is com"leted, and the "osition is reviewed afresh b% #ndia* #t is
si!ni(cant !loball% there is o""osition to such "rotection*R
B)ocon
+ew chemical ntityF
/o 0omments
'icro(organismsF
The followin! should be considered un,"atentableF
a* Ehere the commercial e3"loitation would be contrar% to moralit% or
order "ublic;
b* Process for clonin! human bein!s;
c* Ise of human embr%os for industrial or commercial "ur"oses;
d* The human bod%, at the various sta!es of its formation and
develo"ment;
28
e* /aturall% occurrin! !ene and +/A seBuences and minor variations
thereof;
f* #nherent utilities such as !ene seBuences codin! for amino acids,
"e"tides, "roteins*
Er)c 9oe!ren1erg
+ew )hemical ntityF
Patent search carried out b% the leadin! Bra>ilian "atent law "ractice
concernin! "atents on salts, esters, "ol%mor"hs and similar
.incremental innovation2 b% #ndian com"anies in Bra>il* There are C:
such "atents from 0#P5A, +r* &edd%$s 5abs, and &anba3%* #t should be
noted that man% of these "atents are also "endin! at the 1uro"ean
Patent 7Dce* Thus, it seems that whatever rhetoric ma% be used
within #ndia re!ardin! such inventions, it is clear that leadin! #ndian
com"anies view such innovations as indeed im"ortant enou!h to
"atent in e% marets outside of #ndia* Ee would stron!l% su!!est that
"atents on salts, esters etc* should indeed be !ranted if such "roducts
meet the internationall%,acce"ted conditions of novelt%, involvin! an
inventive ste", and ca"able of industrial a""lication(T&#P'
Article2@(8))*
The 1I and I' have addressed the issue of "atents on .incremental2
or .ada"tive2 innovation as followsF
Article <5 under 'ection 808 of the I' "atent law statesF .whoever
invents or discovers an% new and useful "rocess, machine,
manufactures, or com"osition of matter, or an% new and useful
im"rovement thereof, ma% obtain a "atent thereofU2
A re"ort b% the 1I worin! 4rou" on Pharmaceuticals and "ublic
health noted in its 2C March 2000 re"ort to the )i!h,level 0ommittee
on health for "olicies and Actions in the framewor of the 1I treat% of
Amsterdam thatF .#nnovation in "harmaceuticals encom"asses man%
di=erent o"tions, !oin! from the develo"ment of a com"letel% new
medicine for the treatment of a disease otherwise incurable, to
modi(cations of nown formulations to im"rove bene(ts for the
"atients, such as a less invasive administration route or a sim"ler
administration schedule*2
'icro(organisms,
/o 0omments*
Ind)an >rug Manufacurers= Assoc)a)on
+ew )hemical ntityF
7ur submission is that the Parliament had onl% an /01 in mind when it
a""roved 'ection 2 and < "articularl% 'ection < clauses (d), (e) and (f);
The I' J+A uses onl% term /ew 0hemical 1ntit% althou!h their "atent
law is ver% broad and unsuitable for a develo"in! countr% lie #ndia*
29
+e(nition of /ew 0hemical 1ntit% in I'A , I' J+A &ule 'ec* 505 (b)
describes a -new chemical entit%- as .* * * a dru! that contains no active
moiet% that has been a""roved b% J+A in an% other a""lication
submitted under section 505 (b) of the Jood, +ru! and 0osmetic
Act* * **2 The "atentabilit% criteria should be such so as to
a* Avoid -Me,Too- "atents and ever,!reenin! of "atents*
Patentabilit% criteria should not be too broad so as to !ive rise
to ever,!reenin! of "atents* Ee do not want to follow the I'
e3am"le where for e3am"le , there are 2C new "atents issued
between 8OO5,2005 on the same one dru! Menin!itis Maccine,
mostl% for minor variations*
b* The de(nition of /01 should include -salts-, -esters-,
-metabolites-, -derivatives- etc* This will avoid multi"licit% of
"atent a""lications and !ross abuse of "atent mono"olies and
thus, would reduce liti!ation and "ublic e3"loitation*
c* #t should su""ort the "olic% of the 4overnment to brin! down
medicine "rices*
d* The new de(nition of "atentable -"harmaceutical substance-
should be su""orted b% other "rovisions of the Patents Act
"articularl% 'ections 2 and <*
'u!!estion 8F
'ection 2 (8) (ta)F
Present Te3tF R"harmaceutical substanceR means an% new entit%
involvin! one or more inventive ste"s;
Pro"osed te3tF 'ection 2 (8) (ta) , R"harmaceutical substanceR means
an% new chemical entit% with a si!ni(cant thera"eutic advancement
with one or more inventive ste"s*
13"lanation , Jor the "ur"oses of this clause, salts, esters, ethers,
"ol%mor"hs, metabolites, "ure form, "article si>e, isomers, mi3tures of
isomers, com"le3es, combinations and other derivatives of nown
substance shall be considered to be the same substance unless the%
di=er si!ni(cantl% in "ro"erties with re!ard to eDcac%, and therefore,
shall not be "atentable*
'u!!estion 2F
Present Te3t
'ection < (d)F -the mere discover% of a new form of a nown substance
which does not result in the enhancement of the nown eDcac% of that
substance or the mere discover% of an% new "ro"ert% or new use for a
nown substance or of the mere use of a nown "rocess, machine or
a""aratus unless such nown "rocess results in a new "roduct or
em"lo%s at least one new reactant-*
30
-13"lanationF Jor the "ur"oses of this clause, salts, esters, ethers,
"ol%mor"hs, metabolites, "ure form, "article si>e, isomers, mi3tures of
isomers, com"le3es, combinations and other derivatives of nown
substance shall be considered to be the same substance, unless the%
di=er si!ni(cantl% in "ro"erties with re!ard to eDcac%-
Pro"osed te3tF
'ection < (d)F Rthe mere discover% of a new form of a nown substance
which does not result in the enhancement of the nown eDcac% of that
substance or the mere discover% of an% new "ro"ert% or new use for a
nown substance or of the mere use of a nown "rocess, machine or
a""aratus unless such nown "rocess results in a new "roduct or
em"lo%s at least one new reactantR unless such nown "rocess results
in a new "roduct or em"lo%s at least one new reactantR and, therefore,
shall not be "atentable*
'u!!estion <
'ection 2 (8) (ja)
Present Te3tF Rinventive ste"R means a feature of an invention that
involves technical advance as com"ared to the e3istin! nowled!e or
havin! economic si!ni(cance or both and that maes the invention not
obvious to a "erson silled in the art*
Pro"osed te3tF
'ection 2 (8) (ja) , Rinventive ste"R means a feature of an invention
that involves technical advance as com"ared to the e3istin! nowled!e
or and havin! economic si!ni(cance or both and that maes the
invention not obvious to a "erson silled in the art*
'u!!estion :F
Present Te3tF
'ection 2 (8) (l)F Rnew inventionR means an% invention or technolo!%
which has not been antici"ated b% "ublication in an% document or used
in the countr% or elsewhere in the world before the date of (lin! of
"atent a""lication with com"lete s"eci(cation, i*e* the subject matter
has not fallen in "ublic domain or that it does not form "art of the state
of the art*
Pro"osed Te3tF
'ec* 2 (8) (l)F Rnew inventionR means an% invention or technolo!%
which has not been antici"ated b% "ublication in an% document or used
in the countr% or elsewhere in the world before the date of (lin! of
"atent a""lication with com"lete s"eci(cation, i*e* the subject matter
has not fallen in "ublic domain or that it does not form "art of state of
the art "rior art*
31
0han!es su!!estedF
(i) To use the term -/ew 0hemical 1ntit%- instead of the term -/ew
Medical entit%$ with a view to reduce liti!ation, "ublic e3"loitation and
ever,!reenin! b% M/0s;
(ii) To dro" words lie ReDcac%R, RmereR, Rsi!ni(cantR from the te3t of
'ection < of the Patents Act*
(iii) The term -Prior art- is "referred in 'ection 2(8)(l) instead of the
"hrase Astate of the art-;
(iv) #n the de(nition of inventive ste" the conjunction -or- between
****e3istin! Tnowled!e, havin! economic si!ni(cance ****should
be re"laced with Aand$*
'icro(organisms,
#t is our submission that naturall% occurrin! micro,or!anisms and other
naturall% occurrin! allied biolo!ical materials should be considered
non,"atentable*
'u!!ested te3t of 'ection < (j)
Plants and animals in whole or an% "art thereof other than micro
or!anisms other than man,made or biotechnolo!icall% altered micro,
or!anisms but includin! seeds, varieties and s"ecies and essentiall%
biolo!ical "rocesses for "roduction or "ro"a!ation of "lants and
animals*
0han!es su!!estedF
(i) Micro,or!anisms should be made "atentable as "er T&#P'* )owever,
in 'ection <(j) the relevant "hrase -micro,or!anisms- should be
re"laced with -Man,made or biotechnolo!icall% altered micro,
or!anisms-;
(ii) 7n the issue of "atentabilit% of micro,or!anisms, mandator% review
of T&#P'
"rovisions b% the T&#P' 0ouncil should be awaited;
"ene Cam#a)gn
+ew )hemical ntityF
/o 0omments*
'icro(organisms,
Patentabilit% of micro,or!anisms should be for those micro,or!anisms
which have been "roduced b% adeBuate human intervention and ful(l
32
the criterion of novelt%, non,obviousness and industrial utilit%* Mere
discover% and isolation will not be considered suDcient human
intervention*
Patents should not be !ranted on materials obtained from national and
international collections and de"ositories*
Ehen a material is taen from a countr%, Article 85 of the 0onvention
on Biolo!ical +iversit% should be res"ected* /o "atent should be
!ranted without "rior informed consent and material transfer
a!reements*
Ehen a "atent is !ranted, the "atent holder should be obli!ed to share
the economic bene(ts with the communities of the countr% from where
the material was obtained*
#n view of the critical nature of the subject matter, "atents involvin!
micro,or!anisms should not be !ranted on a broad basis (overarchin!
"atents with a ver% wide sco"e)*
Patents should be !ranted strictl% based on "atentabilit% criteria with
no !eneralisation, that is, for the or!anism onl% with res"ect to that
"articular function or "ro"ert% that constitutes the invention* The
or!anism should remain free for others to create inventions*
/-ford Ine**ecua* .ro#er0 Researc! Cenre4
Un)5ers)0 of /-ford4 U.B.

+ew )hemical ntity,
/o 0omments*
'icro(organismF
The issue re!ardin! "rotection to micro,or!anism is an inde"endent
one* The world has now moved far be%ond this debate and we ou!ht,
in view of the ra"id "ro!ress of our biotech industr%, to !rant
"rotection to those micro, or!anism that are new and non obvious*
The above su!!estions are con(ned to addressin! the T&#P' com"liant
le!al o"tions*
>rug Ac)on ;orum
+ew )hemical ntityF
Ee feel that there is an ur!ent need to restrict the de(nition of new
chemical entit%* The de(nition of "atentable A"harmaceutical
substance$ should be as follows Q .Pharmaceutical substance means
new dru! molecule involvin! one or more inventive ste"2* And the
de(nition of A"atentable invention$ should be as follows Q .#nvention
means a basic "roduct or "rocess involvin! an inventive ste" and
ca"able of industrial a""lication2*
'icro(organismsF
33
/o 0omments*
'a)ona* Dork)ng "rou# on .aen Ea(5
+ew )hemical ntity,
(i) The sco"e of -invention- should be limited to basic novel "roduct or
"rocess involvin! inventive ste" and ca"able of industrial
a""lication;
(ii) The sco"e of -"harmaceutical substance- should be limited to new
molecular entit% with si!ni(cant thera"eutic advancement
involvin! one or more inventive ste"s;
(iii) There is lacuna about the de(nition of -"harmaceutical substance-*
A"art from the de(nition there is no mention of this "atentable
subject matter an%where in the amended Patents Act 8O@0* 'ection
5 of the Act has been omitted throu!h the Patents (Amendment)
Act 2005* Ee would su!!est this 'ection which could incor"orate
s"eci(call% -"harmaceutical substance- should be re,introduced
with the followin! versionF
'ection 5
Patents shall be available for basic novel inventions includin!
"harmaceutical substances as de(ned in 'ection 2 whether "roducts or
"rocesses in all (elds of technolo!ies e3cludin! inventions sti"ulated
under 'ection,< "rovided that the% are new, involve an inventive ste"
and are ca"able of industrial a""lication*
To sum u" our su!!estions in re!ard to de(nitions of -invention- and
-"harmaceutical substance- are in harmon% with each other and clause
(d) includin! its e3"lanation under 'ection < Buoted above* Ee would
em"hasi>e that basicall% the incrementall% chan!ed "resentation must
not be allowed for "atentin!*
'icro(organism,
(i) Patentin! of life forms ma% have at least two dimensions* Jirstl%,
there is the ethical Buestion of the e3tent of "rivate ownershi" that
could be e3tended to life forms* The second dimension relates to
the use of #P&s- conce"t as understood in the industriali>ed world
and its a""ro"riateness in the face of the lar!er dimension of ri!hts
on nowled!e, their ownershi", use, transfer and dissemination*
$ii& Micro,or!anisms as such occur in nature* #f an% micro,or!anism is
discovered it cannot be called invention, it falls in the cate!or% of
discover%* Micro,or!anism when !eneticall% modi(ed falls in the
cate!or% of invention because of human in"ut* 4eneticall% modi(ed
micro,or!anism ma% "erform an% number of activities* #f a
researcher is able to research u"on a "articular activit%, and he is
34
allowed "atentin! of his !eneticall% modi(ed micro,or!anism this
will result in blocin! of further research on that micro,or!anism*
This is a "eculiar situation arisin! out of "atentin! of micro,
or!anisms* #n view of these circumstances it would not be
a""ro"riate even to allow "atentin! of !eneticall% modi(ed micro,
or!anism also as such*
Assoc)a)on of B)oec!no*og0 Eed Ener#r)ses
+ew )hemical ntity,
/o 0omments*
'icro(organismsF
The inventions to be considered "atentable which have novelt%,
inventive ste"s and commercial utilit%*
The followin! to be considered non,"atentableF
where the commercial e3"loitation would be contrar% to
moralit% or ordre public
Process for clonin! human bein!s
Ise of human embr%os for industrial or commercial
"ur"oses
The human bod%, at the various sta!es and seBuence and
minor variations thereof
/aturall% occurrin! !ene and +/A seBuence and minor
variations thereof*
#nherent utilities such as !ene seBuences codin! for amino
acids, "e"tide, "roteins*
Ind)an .!armaceu)ca* Congress Assoc)a)on
+ew )hemical ntity,
The recent Patent Act disBuali(es !rant of "atents for salts, esters,
ethers, "ol%mor"hs, metabolites, "ure forms, "article si>e, isomers,
mi3ture of isomers, com"le3es, combinations and other derivatives of
nown substance and shall be considered to be the same substance,
unless the% di=er si!ni(cantl% in "ro"erties with re!ard to eDcac%* This
ma% hel" to "revent ever !reenin! of "atents*
This clause is ain to the +irective 200:92@910 of the 1uro"ean
Parliament and 0ouncil of <8 March 200:, which "rovides !uidelines
for R!eneric medicinal "roductR* The 7Dcial Hournal of 1uro"ean Inion
5 8<K9<O dated <0*:*200: under Article 80 'ee 2*(b) R!eneric
medicinal "roductR shall mean a medicinal "roduct which has the
same Bualitative and Buantitative com"osition in active substances
and the same "harmaceutical form as the reference medicinal "roduct,
and whose bioeBuivalence with the reference medicinal "roduct has
been demonstrated b% a""ro"riate bioavailabilit% studies* The
di=erent salts, esters, ethers, isomers, mi3tures of isomers, com"le3es
or derivatives of an active substance shall be considered to be the
35
same active substance, unless the% di=er si!ni(cantl% in "ro"erties
with re!ard to safet% and9or eDcac%* #n such cases, additional
information "rovidin! "roof of the safet% and9or eDcac% of the various
salts, esters or derivatives of an authori>ed active substance must be
su""lied b% the a""licant* The various immediate,release oral
"harmaceutical forms shall be considered to be one and the same
"harmaceutical form* Bioavailabilit% studies need not be reBuired of
the a""licant if he can demonstrate that the !eneric medicinal "roduct
meets the relevant criteria as de(ned in the a""ro"riate detailed
!uidelines* This directive is aimed to avoid ever !reenin! of "atents*
'icro(organisms,
/o 0omments*
Ind)an .!armaceu)ca* A**)ance
+ew )hemical ntity,
#t would be T&#P' com"atible to limit the !rant of "atent to new
chemical entities or new medical entit% involvin! one or more inventive
ste"s*
'icro(organisms,
/o 0omments*
A:orda1*e Med)c)nes C Treamen Cam#a)gn
+ew )hemical ntityF
The terms <'e( c!em)ca* en)0= and <ne( med)ca* en)0= are not
inter chan!eable terms and each term has its own le!al meanin!*
The s"eci(c terminolo!% used in the "atent le!islation can mae a
si!ni(cant di=erence in e3"andin! or alternativel% restrictin! the sco"e
of "atentabilit%, directl% a=ectin! access to a=ordable dru!s*
13"andin! the sco"e of "atentabilit% will lead to !reater number of
dru!s bein! "atented adversel% a=ectin! access to a=ordable dru!s*
7n the other hand restrictin! that sco"e of "atentabilit% will "revent
trivial "atentin! of dru!s leadin! to access to chea"er !eneric dru!s*
The term .ne( c!em)ca* en)02 is normall% restricted onl% to mean a
new chemical substance, which is not nown earlier* 7n the other
hand the term .new medical entit%2 is an e3"ansive term which
includes di=erent forms of the same chemical entit% i*e* usa!e form,
dosa!e form, salt form, etc* )ence all new chemical entities are new
medical entities but all new medical entities are not new chemical
entities*
The limitin! the sco"e of "atentabilit% is absolutel% necessar% for #ndia
not onl% to address the "ublic health concerns but also for the survival
of the domestic "harmaceutical industr%* To e=ectivel% limit the sco"e
36
of "atentabilit% the criteria of novelt%, inventive ste" and industrial
a""lication should be de(ned as "er national interests* This is to be
done b% amendin! the de(nitions of "atentable criteria in the "resent
Patents Act* Jurther, the de(nition of "harmaceutical substance to be
re"laced with a new de(nition and this de(nition should be then lined
to the "rovisions and e3clusions mentioned in 'ection < of the Act*
#t would be T&#P' com"atible to limit the !rant of "atent to new
chemical entities*
'icro(organisms,
/o 0omments*
T!e Inerna)ona* Assoc)a)on for !e .roec)on of
Indusr)a* .ro#er0 2AI..I3 2Ind)a "rou#3
+ew )hemical ntityF
The A#PP# (#ndian 4rou") felt that the current e3clusions should follow
the T&#P' A!reement and the e3"lanation to 'ection <(d) should be
deleted*
The 4rou" felt that /01 is not a R"atentR term but a Rre!ulator%R
term and it is not a""ro"riate to de(ne the said term in the Act*
The 4rou" felt that 'ection <(d) which "revailed between the "eriod 8
st
Hanuar%, 2005 to C
th
A"ril 2005 was the best and that the word -mere-
ou!ht to be restored in the 'ection* The 4rou" also felt that the
7rdinance 200: amended 'ection <(d) to ensure that what is not
"atentable is onl% mere new use* #f a second medical indication or
thera"eutic use of a nown dru! molecule "asses the test that it is not
a mere new use, as "er the 7rdinance it would have been "atentable*
The Patents Amendment Act, 2005 chan!ed this "osition* #nstead, it
contains a rather too lon! e3"lanation on the e3em"tion to
"atentabilit% under 'ection <(d)* Accordin! to this 'ection what is not
"atentable isF
a) The mere discover% of a new form of a nown substance,
which does not result in the enhancement of the nown
eDcac% of that substance;
b) The mere discover% of an% new "ro"ert% or new use for
a nown substance; and
c) The mere use of a nown "rocess, machine or a""aratus
unless such "rocess results in a new "roduct or em"lo%s
at least one new reactant*
0onseBuentl%, if a discover% of a new form of a nown dru! molecule
results in an enhancement of its nown eDcac%, it is "atentable*
)owever, the mere discover% of a new use of a nown substance is not
"atentable* The amended 'ection <(d) when read in conjunction with
'ection <(i) would ensure that all method of use inventions are non,
37
"atentable* A joint readin! of the amended 'ection <(d) and 'ection
<(i) is ca"able of ee"in! a major "ortion of "harmaceutical &6+
outside the sco"e of "atents*
#f this cannot be done then at least the e3"lanation to the said
'ection ou!ht to be deleted under the "resent Act so that the 'ection
should !o bac to its old form "rior to the 8
st
of Hanuar%, 2005*
The 4rou" also felt that substantial and une3"ected Bualitative
de"arture of "ro"erties of the claimed /01 should Bualif% for
inventiveness* Ehen there is a si!ni(cant di=erence in e=ectiveness or
utilit% com"ared to basic com"ounds, salts, esters, derivatives,
isomers, "uri(ed forms, com"le3es, h%drates, cr%stalline forms, etc*,
should be considered as havin! inventive merit* The 4rou" made the
followin! su!!estionsF
(i) The 13"lanation to 'ection < (d) of Patents Act should be
deleted*
(ii) -/ew 0hemical 1ntit%- is not a "atent term but onl% a
re!ulator% term and it is not a""ro"riate to de(ne it in
the Patents Act*
'icro(organisms,
An inconsistenc% e3ists between the actual laws which are based u"on
the !eneral "rinci"le that a livin! or!anism per se cannot be the
subject matter of a "atent, and the state of science which nowada%s
maes it "ossible to describe and re"eat "rocedures for the
modi(cation of a livin! or!anism*
Patent "rotection for "articular biotechnolo!ical inventions e3ists in
most countries*
Processes involvin! the industrial use of livin! or!anisms are
!enerall% "atentable*
Micro,or!anisms per se and other biolo!ical materials, includin! "lants,
per se, are "atentable in man% countries*
Plants and even animals are also "rotectable in some countries b%
s"ecial ri!hts*
A#PP# re,aDrms the "rinci"le that inventions relatin! to livin!
or!anisms, be the% micro,or!anisms, "lants, animals or "arts thereof,
or to other biolo!ical material or to "rocesses for obtainin! or usin!
them should be "atentable on the sole condition that the% com"l% with
the usual criteria of "atentabilit%* The &esolution of &io de Haneiro,
which laid down this "rinci"le has been well acce"ted and has had a
"ositive in?uence on the on!oin! wor in E#P7*
&esolution F A new '"ecial Arran!ement under Article 85 of the
Paris 0onvention should be made, "rovidin! forF
de"osition in a culture collection of the micro,or!anism
(s) described in a "atent s"eci(cation and not available
to the "ublic as a reBuisite for !rant of a "atent;
de"osition in one culture collection a""roved under this
Arran!ement as bein! suDcient to meet the
reBuirements of all 'tates "arties to this Arran!ement;
38
de"osition on or before the (lin! of the (rst "atent
a""lication (with the "ossibilit% of formal details of
de"osition bein! furnished, later within a "rescribed
"eriod*
The followin! su!!estions are madeF
(i) 13clusion of "atentin! of micro,or!anisms mi!ht be violative
of T&#P'* 7nl% the sco"e of the term should be clari(ed*
(ii) The broadest de(nition for micro,or!anisms should be used*
The de(nition should be a !uideline or directive rather than
a statutor% de(nition*
(iii) 0ell lines should not be e3cluded from "atentabilit%*
Ee- /r1)s
+ew )hemical ntityF
(i) #t would be T&#P' violative if #ndian Patent 5aw e3"ressl% e3cludes
non,/01
Pharmaceutical "roduct inventions from "atentabilit%
(ii) The "ossibilit% of settin! a hi!h threshold with 'ection < (d) to
justif% the e3clusion of non,/01 "harmaceutical substances from
"atentabilit% is to be e3"lored;
'icro(organisms,
(a) Article 2@(<)(b) of T&#P' mandates ET7 Members not to e3clude
Rmicro,or!anismsR, Rnon,biolo!icalR and Rmicrobiolo!ical "rocessesR
from the sco"e of "atentabilit%* Thus under Article 2@(<) (b) of T&#P',
the Members are under obli!ation to "rovide "atents for micro,
or!anisms*
(b) #n order to brin! the #ndian law in com"liance with the aforesaid T&#P'
"rovisions, a new clause to 'ection < was added in the #ndian Patents
Act (b% the Patents (Amendment) Act, 2002) which e3cluded from
"atentabilit%, "lants and animals in whole or an% "art thereof other
than micro,or!anisms but includin! seeds, varieties and s"ecies and
essentiall% biolo!ical "rocesses for "roduction or "ro"a!ation of "lants
and animals*
(c) Thus T&#P' and the #ndian law clearl% "rovide that -micro,or!anisms-
are "atentable* As such, it will violate T&#P' if -micro,or!anisms- per se
are e3cluded from the sco"e of "atentabilit%* The a""roach, therefore,
has to be more -de(nitional- and -inter"retative- than a blanet direct
e3clusion that attracts %et another dis"ute at the ET7* The e%
Buestion that follows is , whether it is "ossible for #ndia to ado"t a ver%
narrow and limited de(nition of -micro,or!anisms- to e3clude
ever%thin! other than Rmicrosco"ic or!anisms includin! 7/5Z al!ae,
bacteria, fun!i, "roto>oa and viruses* #n the alternative, should there
be an e3"ansive de(nition of -micro,or!anism- to include within its
sco"e all -biolo!ical materials- containin! !enetic information and
ca"able of re"roducin! itself or bein! re"roduced in a biolo!ical s%stem
(as in the 1uro"e)*
(d) #t could be in #ndia-s national interests to mae -micro,or!anisms-
"atentable and also to "rovide an e3"anded de(nition of -micro,
39
or!anism- so as to include in its sco"e -biolo!ical materials- includin!
+/A fra!ments, !enes, and "roteins as 0hina "rovides*
(e) An alternative a""roach is to ado"t the 1uro"ean a""roach (1uro"ean
+irective (OC9::910) and "rovide for a further broader de(nition of
RBiolo!ical materialR to include Ran% material containin! !enetic
information and ca"able of re"roducin! itself or bein! re"roduced in a
biolo!ical s%stemR and brin! that under the sco"e of "atentable
subject matter*
(f) An e3"lanation to 'ection <(j), could be added with a balanced
de(nition on the followin! linesF
13"lanation , for "ur"oses of this clause, Rmicro,or!anismR means onl%
microsco"ic or!anisms includin! al!ae, bacteria, fun!i, "roto>oa,
viruses, +/A fra!ments, !enes, and "roteins*
Cro# E)fe
+ew )hemical ntityF
The discover% and develo"ment of a new molecule is an e3"ensive
"ro"osition in develo"ed countries, a new dru! cost about X8 billion for
a new "esticide molecule, the cost is about X <00 million* #n #ndia, all
this could be done at a much lower cost*
'till, the cost would be hu!e, about X <00 million (&s* 8,<50 0rore) for
a new dru!; #ndian com"anies at their current level of & 6 + s"endin!
(5,@ "ercent of their turnover) are not in a "osition to undertae such a
hi!h level of investment
Besides, the ris is ver% hi!h* But incremental innovations are well
within their reach* 7ur laws should "romote these* This will enable our
'cientists to "ut their creativit% to best use* Ehen #ndian com"anies
can ta" these o""ortunities abroad (where these innovations are
"atentable), wh% not our own turf[
Patentin! of incremental innovations should not be confused with the
so called ever !reenin! of a "atent* 'uch a situation could arise onl%
when the "atentee havin! alread% enjo%ed the 20,%ear term of his
innovation, !ets a further e3tension* The Patent oDce will sim"l% not
allow this*
The "atentin! of a new dosa!e from, sa%, liBuid of an e3istin! medicine
is a totall% im"endent ste"* #t does nothin! to e3tend the "atent term
of the medicine in its ori!inal form (solid) which on its e3"ir% becomes
o"en to com"etitors to come u" with !eneric versions*
#n order to !ive desired incentive for innovations at all levels, the
Patent 5aw should "rovide for "atentin! of new forms, new uses and
new formulations as well as combinations of nown com"ounds so lon!
as these ful(l three fold criteria of novelt%, inventive ste" and ca"able
of industrial a""lication*
'icro(organismsF
/o 0omments*
40
Brad*0 Codon and Ta#en S)n!a
+ew )hemical ntity,
#n the conte3t of !lobal and ne!lected diseases, uniformit% of T&#P'
obli!ations relatin! to "atented medicine im"ose unnecessaril% hi!h
costs on users and "oor distribution of costs and bene(ts amon!
"roducers and users of intellectual "ro"ert%* Iniform rules can have
dis"arate e=ects that worsen ineBualities rather than correct them* To
achieve the correct balance between the ri!hts of "roducers and users
of "atented medicine, a broader ran!e of factors must be taen into
account than are currentl% used in the ET7 and I/ conte3ts*
'icro(organisms,
/o 0omments*
'edicine San 0rontiers 4 ;rance
+ew )hemical ntityF
This submission a""roaches this Buestion with an incremental
a""roach,dividin! "harmaceutical "roduct related inventions other
than /ew 0hemical 1ntities (/01s) into di=erent cate!ories, in
"articular new uses and new forms of nown com"ounds and
e3aminin! the "atentabilit% or otherwise of those cate!ories*
Based on the "rovisions of the T&#P' A!reement and tain! the
"resent #ndian le!islation as a !uide Ves"eciall% 'ection <(d)W, it is
ar!ued that it is T&#P' com"atible to e3clude, as the "resent #ndian
le!islation does, new uses of nown com"ounds as new forms of
nown substances that fail to meet the reBuisite threshold tests* The
determination of where the threshold tests (for e3am"le the meanin!
of -mere- discover%, and the reBuirements for eDcac% and inventive
ste") will be set is critical in determinin! which other inventions, other
than /01s will be "atentable*
The lo!ical end,"oint of a "rocess of raisin! the thresholds reBuired
would be a "osition where onl% /01s would be re!arded as "atentable*
'icro(organismsF
/o 0omments*
/rgan)sa)on of .!armaceu)ca* .roducers of Ind)a
2/..I3
+ew )hemical ntity,
&estrictin! Patentabilit% to /01s would have si!ni(cant ne!ative
conseBuences for the discover% and develo"ments of future
41
treatments for all disease areas and also will be an area of concern to
all investors, domestic and forei!n because of the "recedent it sets for
the treatment of #ntellectual Pro"ert% in #ndia*
'icro(organisms,
A clear de(nition of micro,or!anism needs to be "rovided*
I... Ins)ue4 Eondon5
+ew )hemical ntity,
1' 5imitin! the !rant of "atents to /01s9/M1s and thereb% e3cludin!
other cate!ories of "harmaceutical inventions the -"ro"osed
e3clusion$ is liel% to contravene the mandate under Article 2@ of
T&#P' to !rant of "atents to all -inventions-* /either Articles @ and C
nor the +oha +eclaration can be used to dero!ate from this s"eci(c
mandate under Article 2@*
2' The "ro"osed e3clusion amounts to an unjusti(ed di=erentiall%
disadvanta!eous treatment of "harmaceutical inventions and is
therefore liel% to violate the -non discrimination- mandate under
Article 2@*
3' #t the aim of the "ro"osed e3clusion is to "revent a "henomenon
loosel% referred to as -ever,!reenin!-, this can be done b% a "ro"er
a""lication of "atentabilit% criteria, as "resent in the current "atent
re!ime*
4' 5astl%, it is im"ortant to distin!uish the "henomenon of -ever,
!reenin!- from what is commonl% referred to as -incremental
innovation-* Ehile -ever,!reenin!- refers to an undue e3tension of a
"atent mono"ol%, achieved b% e3ecutin! trivial and insi!ni(cant
chan!es to an alread% e3istin! "atented "roduct, -incremental
innovations- are seBuential develo"ments that build on the ori!inal
"atented "roduct and ma% be of tremendous value in a countr% lie
#ndia* Therefore, such incremental develo"ment ou!ht to be
encoura!ed b% the #ndian "atent re!ime*
'icro(organisms,
#ndia ma% not "rovide for a per se e3clusion of Amicro,or!anisms$ from
"atentabilit%* )owever, should #ndian "olic% im"eratives reBuire some
limitation on the sco"e of "rotection "rovided for Amicro,or!anisms$, the
T&#P' a!reement does "rovide some latitude b% which this mi!ht be
achieved* #t is su!!ested that
8* The term Amicro,or!anism$ could be de(ned in "recise terms* )owever,
this route su=ers from certain drawbacs and the T&#P' im"lications of
such a solution are not entirel% clear*
2* The Adiscover%$ e3ce"tion could be stren!thened b% sti"ulatin! that
mere isolation or "uri(cation of a microor!anism b% nown "rocedures
will not render it "atentable* &ather, onl% trul% Ainvented$
42
microor!anisms such as !eneticall% en!ineered ones would be
!ranted "atent "rotection* )ere a!ain, in the absence of a ET7 "anel
rulin! on this or a related as"ect of "atent law, the e3tent to which
the Adiscover%$ e3ce"tion could be stretched without contravenin!
T&#P' is not absolutel% certain*
<* #n "rinci"le, the Amoralit%$ e3ce"tion could be used to den% "atents to
micro,or!anisms* )owever, this could not be done without, at the same
time, "rohibitin! an% form of commercialisation of a micro,or!anism, a
result that ma% not (t well with the !overnment$s recent "olic% towards
fuellin! the !rowth of the biotechnolo!% industr%*
:* The !eneral "atentabilit% criteria (novelt%, non obviousness, utilit% and
written descri"tion) could be tailored to s"eci(call% a""l% to "atent
a""lications claimin! micro,or!anisms* This could be in the form of
e3amination !uidelines to be a""lied strictl% b% the "atent oDce to
ensure that onl% trul% meritorious inventions are !ranted "atent
"rotection*
7n the various o"tions, 2 and : ma% be best suited for #ndia ,,, these
o"tions cater a""ro"riatel% to #ndia$s current "olic% im"eratives (!iven its
current socio,economic realities), whilst at the same time remainin!
com"liant with #ndia$s international obli!ations under T&#P'*
BCS .arners
+ew )hemical ntity,
#n !eneral, the sco"e of "rotection !ranted in res"ect of a
dru!9chemical e3tends toF
The chemical that has been disclosed
The a""lication9use for which disclosed
#t does not e3tend to
Indisclosed derivatives, salts, esters etc which have a
si!ni(cant or une3"ected "ro"ert% or result
Metabolites that ma% be formed u"on in!estion of dru!
/ew use of the dru!
'u!!ested a""roachF
#n view of the above discussion re!ardin! 'ection <, it is su!!ested
that the 0ommittee ou!ht not to de(ne the term Rnew chemical entit%R
or Rnew medical entit%R*
)owever, should the 0ommittee "roceed to de(ne this term, the
followin! worable de(nition is "ro"osedF
'u!!ested de(nitionF
RA new chemical entit% is an entit% that is new, not obvious to a "erson
silled in the art in the form and for the a""lication claimedR*
Jinal commentsF
43
+e(nin! Rnew chemical9medical entit%R is unwarranted as far as
"atent is concerned*
/ew chemical entit% should never be the basis for "atentabilit%*
#f the de(nition of Rnew chemical9medical entit%R limits or con?icts
with T&#P' Art 2@ then it would violate T&#P'*
Patent Act is for inventors, &6+ institutions*
'icro(organisms,
Eith re!ard to hi!her life forms such as animals (e*!* )arvard mouse),
ET7 Members retain the discretion to !rant or not to !rant "atent
"rotection* )owever, as "er T&#P' there is no discretion with re!ard to
micro,or!anism since micro,or!anism should be "atentable in all
countries*
T&#P' maes it mandator% for the Members to !rant "atent "rotection
for micro,or!anism* )ence, a law that does not "rovide "atent
"rotection for micro,or!anisms is T&#P,violative*
IsolatedM Ds# M2enetically modi&ed microAorganisms5
T&#P' (Article 2@*<) does not distin!uish between -isolated- and
-!eneticall% modi(ed micro,or!anisms-* The onl% criteria for
"atentabilit% of micro,or!anisms is novelt%, non,obviousness and
industrial a""licabilit%, im"l%in! thereb% that an% substance (includin!
microbes) that is new, non,obvious with utilit% ou!ht to be !ranted
"atent "rotection*
An% Member countr% im"lementin! laws drawin! distinctions between
isolated and !eneticall% modi(ed micro,or!anism would be violative of
T&#P'*
A*erna)5e Ea( ;orum
+ew )hemical ntity,
/o comments
'icro(organism,
#t is im"ortant to devise "ro"er novelt% and non,obvious tests for the
"atentin! of micro,or!anisms, use the ?e3ibilities available within
T&#P' to set u" a""ro"riate tests of novelt% and non,obviousness for
determinin! the "atentabilit% of micro,or!anisms so as to avoid the
!rantin! of "atents which o=er no or little inventiveness and ultimatel%
would amount to discoveries*
As T&#P' allows Member 'tates to de(ne the sco"e of micro,or!anisms,
"atents over micro,or!anisms should be strictl% limited to the scienti(c
de(nition of the term, i*e* virus, bacteria, fun!i, "roto>oa and al!ae*
Member 'tates are free to determine the sco"e of invention*
Therefore, the Patents Act should e3clude the "atentin! of materials
found in nature, even if isolated or "uri(ed from "lants and animals*
44
B% "rovidin! a scienti(c de(nition of micro,or!anism, the Patents Act
should e3clude "atents over !enes, "roteins, +/A seBuences, cells,
seeds, etc*
The "rior art and novelt% tests should be constructed in such a wa%
that micro,or!anisms nown to "erform a de(nite function or "rocess
in an environment be reco!nised as alread% e3istin! or nown, in case
the new claim is over the micro,or!anism "erformin! similar functions
or "rocesses in another environment or or!anism*
Cenre for Sud0 of "*o1a* Trade S0sem and
>e5e*o#men
+ew )hemical ntity,
8* Pharmaceutical "roducts with annual sales totallin! nearl% X8
billion in 0anada have had their maret mono"olies e3tended b%
ever !reenin! strate!ies under the "atented medicines (/otice of
0om"liance) &e!ulations*
2* Brand,name dru! com"anies have em"lo%ed strate!ies under the
&e!ulations to e3tend their e3clusive maretin! ri!hts on
blocbuster dru!s*
<* )ealth 0anada a""roved onl% 8K new active substances in 200<,
%et brand,name dru! com"anies added 80< "atents to health
0anada$s Patent &e!ister in that same %ear*
:* Inder the &e!ulations, brand,name dru! com"anies are allowed to
list "atents for uses of a dru!; even throu!h the dru! is not
a""roved for that use b% )ealth 0anada* Patents can be listed to
restart the automatic sta% even %ears after the basic "atent on the
dru! has e3"ired*
5* Polic%maer$ concerns , Marious "olic%maers have e3"ressed
concerns about the &e!ulations* The &omanow &e"ort of
/ovember 2C,2002 referred to ever !reenin! as a "articular
concern a=ectin! the cost of dru!s*
K* A "articular concern with current "harmaceutical industr% "ractice
is the "rocess of .ever !reenin!,2 whereb% manufacturers of brand
name dru!s mae variations to e3istin! dru!s to e3tend their
"atent covera!e* This dela%s the abilit% of !eneric manufacturers
to develo" chea"er "roducts for the maret"lace and is a
Buestionable outcome of 0anada$s "atent law*
@* A number of e3am"les illustrate the use of multi"le,"atent
strate!ies to ee" !eneric "roducts o= the maret in 0anada and
the I*'* has been em"lo%ed increasin!l% for bloc,buster dru!s
whose basic "atents have e3"ired, to e3tend maret e3clusivit% as
lon! as "ossible*
C* #t is im"ortant to ensure that such ever !reenin! as in 0anada does
not ha""en in #ndia*
45
A''EXURE IV
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P)A&MA01IT#0A5'
5#M#T1+
56
Sr.
'o
.
.CT A##*)ca)on F T)*e Ass)gnee
<<
8
(E7 200K90O5<K<) #/H10TAB51 P&1PA&AT#7/' 7J
+#057J1/#0 A/+ #T' P)A&MA01IT#0A55Z
A001PTAB51 'A5T'
T&7#TAA
P)A&MA01IT#0A5' 5T+
<<
2
(E7 200K900C@5<) 0&Z'TA55#/1 A/+ AM7&P)7I'
J7&M 7J &A/75AN#/1 A/+ T)1 P&701'' J7&
MA/IJA0TI&#/4 T)1M
I/#0)1M
5AB7&AT7&#1' 5#M#T1+
<<
<
(E7 200K9800KCK) /7M15 P75ZM7&P) J7&M 4 7J
J5IMA'TAT#/ '7+#IM A/+ P&701'' J7& T)1
P&1PA&AT#7/ T)1&17J
I'M 5#M#T1+
<<
:
(E7 200K908885:) A /7M15 P75ZM7&P) 7J (8,
B1/NZ5,:,V(5,K,+#M1T)7YZ,8,#/+A/7/1),2,Z5W
M1T)Z5 P#P1&#+#/1 )Z+&70)57&#+1 (+7/1P1N#5
)Z+&70)57&#+1) A/+ A P&701'' J7& P&7+I0#/4
T)1&17J
I'M 5#M#T1+
<<
5
(E7 200K90080<8) 8,B1/NZ5,:, S (5,K,+#M1T)7YZ,8,
#/+A/7/1),2,Z5] M1T)Z5 P#P1&#+#/1 7YA5AT1
(+7/1P1N#5 7YA5AT1) A/+ #T' P75ZM7&P)'
I'M 5#M#T1+
<<
K
(E7 200890C@22C) 'I'TA#/1+ &151A'1
P)A&MA01IT#0A5 07MP7'#T#7/ 07/TA#/#/4
45#P#N#+1 A/+ M1T)7+ J7& P&7+I0#/4 'AM1
I'M 5T+*
<<
@
(E7 200K905:<85) /7/A\I17I' 5#\I#+
PA&1/T1&A5 A01057J1/A0 J7&MI5AT#7/
M1/I' &1M1+#1'
5#M#T1+
<<
C
(E7 200K9088008) 07/T&7551+ &151A'1
07MP7'#T#7/' 7J +#MA5P&71Y '7+#IM
E70T)A&+T 5#M#T1+
<<
O
(E7 200K9080OO5) 07/T&7551+ &151A'1
07MP7'#T#7/' 7J +#MA5P&71Y '7+#IM
E70T)A&+T 5#M#T1+
A''EXURE V
M/MSE' EE/'AR>/S C CIA
S.'/.
BraG)*)an A##*)ca)on H 2.CT )nerna)ona*
a##*)ca)on and F or Euro#ean .aen
graned3 su1@ec maer of !e )n5en)on
c*a)med4
Curren
saus /(ner
1
P80<0C0K2 (E70<0@25K:) P 0italo"ram, "uri(ed
base
Pendin!
a""lication 0i"la 5T+
2
P8028<<OC (E70<0<<50C) P Alendronate,
amor"hous form
Pendin!
a""lication 0i"la 5T+
%
P80<0C0K< (E70<0@25K<) , Amor"hous
"harmaceuticall% acce"table salt6of*citalo"ram
Pendin!
a""lication 0i"la 5T+
&
P80<0CK0< (E70<0C05CO) , Puri(ed citalo"ram
h%drochloride or h%drobromide
Pendin!
a""lication 0i"la 5T+
+
P80<0C0K0 (E70<0@25K2) , Amor"hous
citalo"ram base
Pendin!
a""lication 0i"la 5T+
I
P80288:CC (E70<088C2K) , 0r%stalline forms of
atorvastatin calcium
Pendin!
a""lication +r* &edd%$s 5ab* 5td
J
P8088<@<2 (E7022055<) , /ovel "ol%mor"hic
form of 8@, beta ,(/,ter*but%l carbamo%l),:,a>a,5,
al"ha ,androst,8,en,<,one
Pendin!
a""lication +r* &edd%$s 5ab* 5td
K
P8008 0KC< (E700K<8O2) , /ovel Pol%mor"hic an
Jorms of Antidiabetic A!ent
Pendin!
a""lication
+r* &edd%$s &esearch
Joundation
57
S.'/.
BraG)*)an A##*)ca)on H 2.CT )nerna)ona*
a##*)ca)on and F or Euro#ean .aen
graned3 su1@ec maer of !e )n5en)on
c*a)med4
Curren
saus /(ner
L
P#088K5@8 (E7002058C8O) , /ovel o3a>olidinone
0om"und
Pendin!
a""lication
+r* &edd%$s &esearch
Joundation
10
P8OC82@@0 , /ovel antiobesit% and
h%"ocholesterolemic com"ounds
Pendin!
a""lication
+r* &edd%$s &esearch
Joundation #/0* , &edd%,
0heminor
11
P8O@880OC (0A225CO:O) , /ovel antidiabetic
comPounds
Pendin!
a""lication
+r* &edd%$s &esearch
Joundation #/0* , &edd%,
0heminor
12
P8088:8OK (E7022K@<@) , /ovel
"ol%mor"hic9"seudo"ol%mor"hic forms of 5,V:,
V2V/,meth%l,/,(2,"%rid%l)aminoWetho3%Wben>%lW
thia>olidine,2,:,dione maleate
Pendin!
a""lication
+r* &edd%$s &esearch
Joundation
1%
P8088@05: (E7028 02@@@) , /ovel "ol%mor"h of
Je3ofenadine and Je3ofenadine h%drochloride
Pendin!
a""lication +r* &edd%$s 5ab* 5td
1&
P#028:K@5 , /ovel antidiabetic, h%"oli"idemic,
antiobesit% and h%"ocholesterolemic com"ounds
Pendin!
a""lication +r* &edd%$s 5ab* 5td
1+
P8OC82@@2 (E7OO8O<8<), Beta ,ar%l, al"ha ,
o3%substituted al%lcarbo3%lic acids
Pendin!
a""lication
+r* &edd%$s &esearch
Joundation #/0* , &edd%,
0heminor
1I
P80282OO0 (E70<02@88C)P Pharmaceuticall%
acce"table salts of 20('),cam"othecins
Pendin!
a""lication +r* &edd%$s 5ab* 5td
1J
P (1P0C:@<O@B8) , Eater,soluble 0,rin! analo!ues
of 20('),cam"tothecin
Pendin!
a""lication
+r* &edd%$s &esearch
Joundation #/0* , &edd%,
0heminor
&e!ularl% (led "endin! "harmaceutical "atent a""lications (led b% #ndian cor"oration in Bra>il and its
corres"ondin! 1uro"ean Patents (!ranted b% the 1P7) or international a""lications (led via the Patent
0oo"eration Treat% (E#P7,P0T) for salts, esters, "ol%mor"hs, h%drates, isomers and metabolites of nown
substances* Accordin! to the "atent owners, these "endin! a""lications and issued "atents do not claim
mere discoveries; frivolous "atents2; Aever!reenin!2 or ihe same nown substance*2
0 Momsen, 5eonardos 6 0ia, 2005*
1K
P8OO8 5C<5 (E700<28 O8) , 'table
"harmaceutical com"osition containin! 5,VV:,V<,
Meth%l,:, o3o,<,:, dih%dro,2,
Buina>olin%lWmetho3%j"hen%l ,meth%lW
thiadia>olidine ,2,:,dione
Pendin!
a""lication
/7M7 /7&+#'T A9' and
&edd%-s &esearch
Joundation
1L
P8028<<C0 (E70<0<<:C8, E70<0<<:5K) ,
Pro"ionic acid derivatives
Pendin!
a""lication +r* &edd%$s 5ab* 5td
20
P800808<O (E700KK5@2) , Antiobesit% and
h%"ocholesterolemic com"ounds, their derivatives,
their analo!s, their tautomeric forms, their
stereoisomers, their "ol%mor"hs, their
"harmaceuticall% acce"table salts, their
"harmaceuticall% acce"table solvates and
"harmaceuticall% acce"table com"ositions
containin! them
Pendin!
a""lication
+r* &edd%$s &esearch
Joundation
21
P8OO8::<C (E7002K200) , #m"roved "rocess for
the "re"aration of antidiabetic com"ounds
Pendin!
a""lication
+r* &edd%$s &esearch
Joundation
22
P8028<<50 (E70<0<<:C8, E70<0<<:5K) ,
Pro"ionic acid derivatives
Pendin!
a""lication +r* &edd%$s 5ab* 5td
58
S.'/.
BraG)*)an A##*)ca)on H 2.CT )nerna)ona*
a##*)ca)on and F or Euro#ean .aen
graned3 su1@ec maer of !e )n5en)on
c*a)med4
Curren
saus /(ner
2%
P @855 (E70050:8:) , )%"oli"idemic,
antih%"er!l%cemic, antiobesit% and
h%"ocholesterolemic com"ounds, their derivatives,
their analo!s, theft tautomeric forms, their
stereoisomers, their "ol%mor"hs, their
"harmaceuticall% acce"table salts, their
"harmaceuticall% acce"table solvates and
"harmaceuticall% acce"table com"ositions
containin! Them*
Pendin!
a""lication
+r* &edd%$s &esearch
Joundation
2&
P8OO8::O< (E700i 5K<C) , #m"roved "rocess for
the "re"aration of 5,V:,VV<,Meth%l,:,o3o,<,:,
dih%droBuina>olin,2,%lWmetho3%W ben>%lW
thia>olidine,2, :,dione
Pendin!
a""lication
+r* &edd%$s &esearch
Joundation
2+
P#8080C0K: (E7085@02K), +erivatives of
Andro!ra"holide, their stereoisomers, their
"ol%mor"hs, their "harmaceuticall% acce"table
salts, and their "harmaceuticall% acce"table
solvates
Pendin!
a""lication +r* &edd%-s 5ab* 5td
2I
P#088:0<8 (E7028C<O0) , Method for the
"re"aration of h%drates of 7lan>a"ine, "rocess for
conversion of olan>a"ine re=ered to as form,#
Pendin!
a""lication +r* &edd%-s 5ab* 5td
&e!ularl% (led "endin! "harmaceutical "atent a""lications (led b% #ndian cor"oration in Bra>il and its
corres"ondin! 1uro"ean Patents (!ranted b% the 1P7) or international a""lications (led via the Patent
0oo"eration Treat% (E#P7,P0T) for salts, esters, "ol%mor"hs, h%drates, isomers and metabolites of nown
substances* Accordin! to the "atent owners, these "endin! a""lications and issued "atents do not claim
mere discoveries; frivolous "atents2; Aever!reenin!2 or ihe same nown substance*2
0 Momsen, 5eonardos 6 0ia, 2005*
2J
P#0282@@2 (E70<02@0@2) , cost e=ective and
industriall% advanta!eous "rocess for the
"re"aration of re"a!linide
Pendin!
a""lication &anba3% 5ab* 5td*
2K
P#0<82@2C (E7200:08:<<@) , +is"ersible tablets
of ce"hale3in
Pendin!
a""lication &anba3% 5ab* 5td*
2L
P#0285KCK (E70<0C:5:8) , 0arbo3imide
derivatives
Pendin!
a""lication &anba3% 5ab* 5td*
%0
P#080K@52 (E708O5CCK) , Bioavilable
"harmaceutical com"osition of 8<,cis vitamin A
acid (also nown as 8<,cis retinoic acid and
isotretinoin)
Pendin!
a""lication &anba3% 5ab* 5td*
%1
"i08888O< (E708O00:O) , /ovel amor"hous form
of sertraline h%drochloride
Pendin!
a""lication &anba3% 5ab* 5td*
%2
P#0<0KO2C (E70<05O<<0) , 'table "harmaceutical
com"ositions com"risin! A01 inhibitor(s)
Pendin!
a""lication &anba3% 5ab* 5td*
59
S.'/.
BraG)*)an A##*)ca)on H 2.CT )nerna)ona*
a##*)ca)on and F or Euro#ean .aen
graned3 su1@ec maer of !e )n5en)on
c*a)med4
Curren
saus /(ner
%%
P#0880O2K (E708C@C<8) , /ovel amor"hous form
of ome"ra>ole salts
Pendin!
a""lication &anba3% 5ab* 5td*
%&
P#080CO5C (E708K:8C<) , 7nce dail% tablet
formulation for oral administration in humans for
the controlled release of ci"ro?o3acin
Pendin!
a""lication &anba3% 5ab* 5td*
%+
P#0<0COCO (E70<0C22:8) , Pharmaceutical
com"osition which includes microni>ed
clarithrom%cin and e3hibits im"roved dissolution
characteristics relative to a "harmaceutical
com"osition that includes Funmicro?i>ed
clarithrom%cin
Pendin!
a""lication &anba3% 5ab* 5td*
%I
P80282O<8 (E70<02C@0:) , 13tended
release"harmaceutical com"osition containin!
metforrnin
Pendin!
a""lication &anba3% 5ab* 5td*
%J
P80<0COO0 (E70<0C22:C) , Pharmaceutical
com"osition which includes er%throm%cin A or a
derivative thereof and al!inic add
Pendin!
a""lication &anba3% 5ab* 5td*
%K
P80082CKK (1P8 20:K<@B8) , Process for the
"re"aration of isotretinoin, in a sin!le ste"*
Pendin!
a""lication &anba3% 5ab* 5td*
%L
P802 (1P8:2<0O@) , 0ontrolled release formulation
of clarithrorn%cin or tinida>ol
Pendin!
a""lication &anba3% 5ab* 5td*
&0
P8020OC:2 (E7020O:C2C) , Process for the
"re"aration of imi"enem
Pendin!
a""lication &anba3% 5ab* 5td*
&e!ularl% (led "endin! "harmaceutical "atent a""lications (led b% #ndian cor"oration in Bra>il and its
corres"ondin! 1uro"ean Patents (!ranted b% the 1P7) or international a""lications (led via the Patent
0oo"eration Treat% (E#P7,P0T) for salts, esters, "ol%mor"hs, h%drates, isomers and metabolites of nown
substances* Accordin! to the "atent owners, these "endin! a""lications and issued "atents do not claim
mere discoveries; frivolous "atents2; Aever!reenin!2 or ihe same nown substance*2
0 Momsen, 5eonardos 6 0ia, 2005*
&1
P80082CK: (E7080CK<<), Process for the
"roduction of an im"roved torn, of Jorm # celi"rolol
h%drochloride
Pendin!
a""lication &anba3% 5ab* 5td*
&2
P8020OC:< (E7020O:@:2) , 0ost e=ective and
industriall% advanta!eous "rocess for the
"re"aration of amor"hous cilastatin sodium*
Pendin!
a""lication &anba3% 5ab* 5td*
&%
P8028 0:2K (E702800<2<) , Meth%l analo! of
simvastatin
Pendin!
a""lication &anba3% 5ab* 5td*
&&
P808825O@ (E70205C8K) , Bioavailable oral
dosa!e form of loratadine of s"eci(c "article si>e
and surface area*
Pendin!
a""lication &anba3% 5ab* 5td*
&+
P8008K:00 (E708::8:: ) , Process for the
"re"eraIon of sodium salts of statins, namel%
0om"actin, 5ovastatin and Pravastatin
Pendin!
a""lication &anba3% 5ab* 5td*
&I
P80<88K:2 (E70<80<K<5)* 13tended release
"harmaceutical com"osition com"risin! divai"roe3
Pendin!
a""lication &anba3% 5ab* 5td*
60
S.'/.
BraG)*)an A##*)ca)on H 2.CT )nerna)ona*
a##*)ca)on and F or Euro#ean .aen
graned3 su1@ec maer of !e )n5en)on
c*a)med4
Curren
saus /(ner
&J
P80285KC5 (E70<7C:O2C) Al"ha,orne!a,
dicarbo3imide derivatives
Pendin!
a""lication &anba3% 5ab* 5td*
&K
P#088<802 (E70288@8K) , 5iBuid formulation of
metformin
Pendin!
a""lication
&anba3% 5ab* 5td*
&L
P#08825OC (E7020K2CO) , Process for the
"re"aration of hi!hl% "ure cr%stalline form of
cefuro3ime a3etil Pendin!
a""lication
&anba3% 5ab* 5td*
+0
P#0<888O5 (E70<0O@K8:) , Process for the
"re"aration of &osuvastatin
Pendin!
a""lication
&anba3% 5ab* 5td*
+1
P#0<0OC5< (E70<0O2KK0) , Monocom"artment
osmotic controlled dru! deliver% s%stem
Pendin!
a""lication
&anba3% 5ab* 5td*
+2
P#088:800 (E7022:20<) , Pharmaceutical
com"osition in the form of an oral controlled
release solid dosa!e form Pendin!
a""lication
&anba3% 5ab* 5td*
+%
P#088202: (E70200K85) , Process for the
"re"aration and isolation of the h%"oli"aemic
active substance lovastatin in substantiall% "ure
form
Pendin!
a""lication
&anba3% 5ab* 5td*
+&
P#028:20O (E70<0:2285) , 0ost e=ective and
industriall% advanta!eous "rocess for the
"re"aration of imi"enem of hi!h "urit%
Pendin!
a""lication
&anba3% 5ab* 5td*
++
P#0282C0@ (E70<02KK80) , Process for the
"re"aration of fast dissolvin! dosa!e form, such as
tablet, which disinte!rates Buicl% in the mouth
Pendin!
a""lication
&anba3% 5ab* 5td*
+I
P#020@K:0 (E7020K@O:<) , 'table "harmaceutical
com"osition of cef"odo3ime "ro3etil
Pendin!
a""lication
&anba3% 5ab* 5td*
&e!ularl% (led "endin! "harmaceutical "atent a""lications (led b% #ndian cor"oration in Bra>il and its
corres"ondin! 1uro"ean Patents (!ranted b% the 1P7) or international a""lications (led via the Patent
0oo"eration Treat% (E#P7,P0T) for salts, esters, "ol%mor"hs, h%drates, isomers and metabolites of nown
substances* Accordin! to the "atent owners, these "endin! a""lications and issued "atents do not claim
mere discoveries; frivolous "atents2; Aever!reenin!2 or ihe same nown substance*2
0 Momsen, 5eonardos 6 0ia, 2005*
+J
P#020OC:: (E7020O:@@<) , 0ost e=ective and
industriall% advanta!eous "rocess for the
"re"aration of imi"enem of hi!h "urit%
Pendin!
a""lication
&anba3% 5ab* 5td*
+K
P#0<800@: (E70<0O@05O) , Pol%mor"hic forms of
"hen%l o3a>olidinone derivatives
Pendin!
a""lication
&anba3% 5ab* 5td*
+L
P#0882C2K (E7020K2@C) , 'ubstituted "hen%l
o3a>olidinones
Pendin!
a""lication
&anba3% 5ab* 5td*
I0
P#0080O2< (E700@888K) , Process for the
"re"aration of amor"hous atorvastatin calcium
and h%drates
Pendin!
a""lication
&anba3% 5ab* 5td*
I1
P#0282<O0 (E70<08C5::) , 1Dcient and
industriall% advanta!eous "rocess for the
"re"aratiobn of "ure cilastatin*
Pendin!
a""lication
&anba3% 5ab* 5td*
61
S.'/.
BraG)*)an A##*)ca)on H 2.CT )nerna)ona*
a##*)ca)on and F or Euro#ean .aen
graned3 su1@ec maer of !e )n5en)on
c*a)med4
Curren
saus /(ner
I2
P#0088:O0 (E700@@00K) , Process for the
"re"aration of the esters of 8,C,disubstituted,
8,<,:,O,tetrah%dro"%rano (<,:,b),indole,8,acetic
acid
Pendin!
a""lication
&anba3% 5ab* 5td*
I%
P#OO82<8C (E70005205) , /ovel "i"era>ine
derivatives substituted on one nitro!en b% an
aromatic s%stem and on the other nitro!en b%
(2,5,dio3o"%rrolidin),8,%l) alanes or (2,K,
dio3o"i"eridin,8,%l) alanes
Pendin!
a""lication
&anba3% 5ab* 5td*
I&
P#020OC:5 (E7020O:@@:) , +osa!e forms of
o3carba>e"ine for "ral administration
Pendin!
a""lication
&anba3% 5ab* 5td*
I+
P#020@CO5 (E7020@25K5) , #m"roved and
industriall% advanta!eous "rocess for the
"re"aration of citalo"ram
Pendin!
a""lication
&anba3% 5ab* 5td*
II
P#000@:CO (1P88:::25B8) , 'ubstituted "entose
and he3ose monosaccharide derivative
Pendin!
a""lication
&anba3% 5ab* 5td*
IJ
P#000@55< (1P88:@88OB8) , 2,<,7,iso"ro"%lidene
derivatives of monosaccharides as cell adhesion
inhibitors
Pendin!
a""lication
&anba3% 5ab* 5td*
IK
P#0885CK5 (E702::858) , 8,:,disubstituted
"i"era>ine derivatives
Pendin!
a""lication
&anba3% 5ab* 5td*
IL
P#0082OC8 (E70880:8O) , 4astro,retentive oral
dru! deliver% s%stem structurall% com"rised of a
hi!hl% "orous matri3 com"risin! a dru!
Pendin!
a""lication
&anba3% 5ab* 5td*
J0
P#0<0O2OC (E70<0CK<K2) , 'table bu"ro"ion
h%drochloride tablet
Pendin!
a""lication
&anba3% 5ab* 5td*
J1
P#020C50: (E7020@K<@K) , 'table "harmaceutical
com"osition of "ravastatin
Pendin!
a""lication
&anba3% 5ab* 5td*
&e!ularl% (led "endin! "harmaceutical "atent a""lications (led b% #ndian cor"oration in Bra>il and its
corres"ondin! 1uro"ean Patents (!ranted b% the 1P7) or international a""lications (led via the Patent
0oo"eration Treat% (E#P7,P0T) for salts, esters, "ol%mor"hs, h%drates, isomers and metabolites of nown
substances* Accordin! to the "atent owners, these "endin! a""lications and issued "atents do not claim
mere discoveries; frivolous "atents2; Aever!reenin!2 or ihe same nown substance*2
0 Momsen, 5eonardos 6 0ia, 2005*
J2
P#0<0O88< (E70<0C:58:) , 0ontrolled released
"harmaceutical com"osition of carbido"a and
levodo"a
Pendin!
a""lication
&anba3% 5ab* 5td*
J%
P#0282<CC(E70<08C522), #ndustriall%
advanta!eous "rocess for the "re"aration of beta,
ion%lidencacetaldeh%de
Pendin!
a""lication
&anba3% 5ab* 5td
J&
P#OO80@2< (E7OOK8022),A stable oral
"harmaceutical com"osition containin! a
substituted "%rid%lsul(n%l ben>imida>ole
Pendin!
a""lication
&anba3% 5ab* 5td
J+
P#088<KK8 (E7028@O2<), Pharmaceutical
com"osition for tro"ical deliver% com"risin! a
c%cloo3%!enase,2 en>%me inhibitor*
Pendin!
a""lication
&anba3% 5ab* 5td
JI
P#OO8@28O (E7005K2KK),0oatin! com"osition for
the (lm coatin! of "harmaceutical cores
Pendin!
a""lication
&anba3% 5ab* 5td
62
S.'/.
BraG)*)an A##*)ca)on H 2.CT )nerna)ona*
a##*)ca)on and F or Euro#ean .aen
graned3 su1@ec maer of !e )n5en)on
c*a)med4
Curren
saus /(ner
JJ
P#020C58< (E7020@K<@5) Proceass for the
"re"aration of bena>e"ril
Pendin!
a""lication
&anba3% 5ab* 5td
JK
P#0880O@0(1P82C@00<B8), Process for the
"re"aration of a "ure and "harmaco"oeial
amor"hous form of cefuro3ime a3etil
Pendin!
a""lication
&anba3% 5ab* 5td
JL
P#OO8<KOK (E700858OC), Pharmaceutical
com"osition in the form of tablets or ca"sules
"rovides a combination of tem"oral and s"atial
control of dru! deliver%
Pendin!
a""lication
&anba3% 5ab* 5td
K0
P#088K5@0 (E702058:0C), +erivatives of s"eciall%
substituted a>ole com"ounds
Pendin!
a""lication
&anba3% 5ab* 5td
K1
P#000O8@@(1P88K5058B8),Process of mi3in! of
cr%satlline cefuro3ime a3etil with amor"hous
cefuro3ime a3etil for the "re"aration of a
bioavailable oral dosa!e form com"risin!
amor"hous cefuro3ime a3etil
Pendin!
a""lication
&anba3% 5ab* 5td
K2
P#0880O25(1P82C<C28B8), 0ost e=ective and
industriall% advanta!eous "rocess for the selective
meth%lation of a h%dro3% !rou" at the K "osition of
er%throm%cin A
Pendin!
a""lication
&anba3% 5ab* 5td
K%
P#020COOO(E7020C<K<:),#m"roved and cost
e=ective "rocess for the industrial "re"aration of
cef"odo3ime acid
Pendin!
a""lication
&anba3% 5ab* 5td
&e!ularl% (led "endin! "harmaceutical "atent a""lications (led b% #ndian cor"oration in Bra>il and its
corres"ondin! 1uro"ean Patents (!ranted b% the 1P7) or international a""lications (led via the Patent
0oo"eration Treat% (E#P7,P0T) for salts, esters, "ol%mor"hs, h%drates, isomers and metabolites of nown
substances* Accordin! to the "atent owners, these "endin! a""lications and issued "atents do not claim
mere discoveries; frivolous "atents2; Aever!reenin!2 or ihe same nown substance*2
0 Momsen, 5eonardos 6 0ia, 2005*
K&
P#0288KO8 (E70<08:0K0), 0ost e=ective and
industriall% advanta!eous "rocess for the
"re"aration of tolterodine
Pendin!
a""lication &anba3% 5ab* 5td*
K+
P#0285@0O (E70<0O82K8), Process for the
"re"aration of cefdinir or an industrial scale
Pendin!
a""lication &anba3% 5ab* 5td*
&e!ularl% (led "endin! "harmaceutical "atent a""lications (led b% #ndian cor"oration in Bra>il and its
corres"ondin! 1uro"ean Patents (!ranted b% the 1P7) or international a""lications (led via the Patent
0oo"eration Treat% (E#P7,P0T) for salts, esters, "ol%mor"hs, h%drates, isomers and metabolites of nown
substances* Accordin! to the "atent owners, these "endin! a""lications and issued "atents do not claim
mere discoveries; frivolous "atents2; Aever!reenin!2 or ihe same nown substance*2
0 Momsen, 5eonardos 6 0ia, 2005*
63