Report of the Technical Expert Group on Patent Law Issues

December 2006

INDE
!ontents
Executive Summary

Pa"e
2

#$0 %ac&'rop 2$0 )pproach *$0 Practices in +ther !ountries ($0 ,ummar- of ,ubmissions an' Presentations .$0 !onclusions an' Recommen'ations

( 2 #0 #. 2

)nnexures I to /

01.*

EXECUTIVE SUMMARY 1.0 Backgr u!"

The Patents (Amendment) Bill, 2005, introduced in the Parliament in March, 2005 with the objective of ma in! 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 benefit of detailed discussion in both the (ouses) *urin! the debate, the issues re!ardin! "atentabilit% of micro+or!anisms and the definition of ,"harmaceutical substance, to mean -a new chemical entit% (./0)1 or -new medical entit% (.M0)1 were raised) The /ommerce and #ndustr% Minister then assured the Parliament that he would refer these issues to an 02"ert /ommittee for detailed e2amination and re"ort the matter to the Parliament) Accordin!l%, a Technical 02"ert 3rou" on Patent 4aw #ssues was set u" b% the 3overnment of #ndia, Ministr% of /ommerce 5 #ndustr%, *e"artment of #ndustrial Polic% 5 Promotion vide 6) M) .o) 7287982005+#P&+### dated A"ril 5, 2005) 2.0 2)7 Term# $ Re$ere!ce $ t%e &r u'( 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 whether it would be T&#P' com"atible to e2clude micro+or!anisms from "atentin!) A''r ac% The 02"ert 3rou" ado"ted a consultative a""roach to see in"uts from different sta e holders such as industr% associations, non+!overnmental or!ani<ations, intellectual "ro"ert% attorne%s, etc) throu!h written submissions, "resentations, etc) The 3rou" studied the in"uts received and also too into account other relevant literature to arrive at their assessment) The 02"ert 3rou" has arrived at s"ecific recommendations and conclusions as !iven below) #n ma in! the recommendations the 3rou" was !uided b% the need for access of affordable medicines to #ndian "eo"le at lar!e, encoura!in! innovation b% #ndian industr%, its current ca"abilities in &5*, and balancin! of #ndia$s obli!ations under international a!reements with the wider "ublic interest) +e, C%emica- E!titie#

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;)2

*.0 9)7

#n the li!ht of the above discussion, it would not be T&#P' com"liant to limit !rantin! of "atents for "harmaceutical substance to .ew /hemical 0ntities onl%) (owever, ever% effort must be made to "rovide dru!s at affordable "rices to the "eo"le of #ndia) =urther, ever% effort should be made to "revent the !rant of frivolous "atents and >ever+ !reenin!$) *etailed 3uidelines should be formulated and ri!orousl% used b% the #ndian Patent 6ffice for e2aminin! the "atent a""lications in the "harmaceutical sector so that the remotest "ossibilit% of !rantin! frivolous "atents is eliminated)

..0

Micr / rga!i#m

5)7

The !rou"$s conclusion is based on the re?uirements 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 e2amination of the "atent a""lications involvin! micro+or!anisms from the "oint of view of substantial human intervention and utilit%) 02cludin! micro+or!anisms per se from "atent "rotection would be violative of T&#P' A!reement)

5)2

1.0 Back"r ' 7)7 The Patents (Amendment) Bill, 2005, introduced in the Parliament in March, 2005 with the objective of ma in! 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 benefit of detailed discussion in both the (ouses) *urin! the debate, the issues re!ardin! "atentabilit% of micro+or!anisms and the definition of ,"harmaceutical substance, to mean -a new chemical entit% (./0)1 or -new medical entit% (.M0)1 were raised) The /ommerce and #ndustr% Minister then assured the Parliament that he would refer these issues to an 02"ert /ommittee for detailed e2amination and re"ort the matter to the Parliament) Accordin!l%, a Technical 02"ert 3rou" on Patent 4aw #ssues was set u" b% the 3overnment of #ndia, Ministr% of /ommerce 5 #ndustr%, *e"artment of #ndustrial Polic% 5 Promotion vide 6) M) .o) 7287982005+#P&+### dated A"ril 5, 2005 (A!!ex/I)) 7)2 The Technical 02"ert 3rou" consisted of the followin!A *r) &)A) Mashel ar *irector 3eneral /ouncil of 'cientific and #ndustrial &esearch .ew *elhi Prof) 3overdhan Mehta *irector #ndian #nstitute of 'cience Ban!alore Prof) Asis *atta *irector .ational /entre for Plant 3enome &esearch .ew *elhi Prof) .)&) Madhava Menon *irector .ational Budicial Academ% Bho"al Prof) Moolchand 'harma *irector .ational 4aw #nstitute Cniversit% Bho"al /hairman

Member

Member

Member

Member

7); Terms of &eference of the 3rou" wereA 7);)7 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 whether it would be T&#P' com"atible to e2clude micro+or!anisms from "atentin!)

7);)2 2 A''r ac%

2)2 The 02"ert 3rou" ado"ted a consultative a""roach to see in"uts from different sta e holders such as industr% associations, non+!overnmental or!ani<ations, intellectual "ro"ert% attorne%s, etc) throu!h written submissions, "resentations, etc) The 3rou" studied the in"uts received and also too into account other relevant literature to arrive at their assessment) The 02"ert 3rou" has arrived at s"ecific recommendations and conclusions as !iven below) 2); #n ma in! the recommendations, the 3rou" was !uided b% the need for access of affordable medicines to #ndian "eo"le at lar!e, encoura!in! innovation b% #ndian industr%, its current ca"abilities in &5*, and balancin! of #ndia$s obli!ations under international a!reements with the wider "ublic interest) ) 0ractice# i! 1t%er C u!trie# ;)7 * Patentin! "ractices relatin! to new chemical entities and micro+or!anisms in some countries are summarised in A!!ex/II)

Summary $ Su2mi##i !# a!" 0re#e!tati !# 9)7 A summar% of the various submissions and "resentations made to the 3rou" is "resented in A!!ex/III)

C !c-u#i !# a!" Rec mme!"ati !# 5)7 Based on the interactions the 3rou" had with various sta eholders and a detailed e2amination of the critical le!al and technical issues involved, "erusal of related literature, the 3rou" has come to the followin! conclusions and recommendationsA

3a4

+e, C%emica- E!tity

Term# $ Re$ere!ce( 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 D!e, c%emica- e!tityD a""ears for the first time in #nternational #ntellectual Pro"ert% a!reements in the T&#P' A!reement of 7EE9, under Article ;E);A DMembers, when re?uirin!, as a condition of a""rovin! the mar etin! of "harmaceutical or of a!ricultural chemical "roducts which utili<e !e, c%emica- e!titie#5 (em"hasis added) the submission of undisclosed test or other data, the ori!ination of which involves a considerable effort, shall "rotect such data a!ainst unfair commercial use) #n addition, Members shall "rotect such data a!ainst disclosure, e2ce"t where necessar% to

"rotect the "ublic or unless ste"s are ta en to ensure that the data are "rotected a!ainst unfair commercial use)D 5); Accordin! to the Cnited 'tates (C') =ood and *ru! Administration (=*A), a new molecular entit% (.M0) or new chemical entit% (./0) means a dru! that contains no active moiet% that has been a""roved b% =*A in an% other a""lication submitted under section 505(b) of the =ederal =ood, *ru!, and /osmetic Act) The term D!e, me"ica- e!tityD has neither been used nor defined in the T&#P' A!reement) Article 2@ of the T&#P' A!reement elaborates the sco"e of "atentable subject matter as followsA -7) 'ubject to the "rovisions of "ara!ra"hs 2 and ;, "atents shall be available for an% inventions, whether "roducts or "rocesses, in all fields of technolo!%, "rovided that the% are new, involve an inventive ste" and are ca"able of industrial a""lication) 'ubject to "ara!ra"h 9 of Article F5, "ara!ra"h G 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 field of technolo!% and whether "roducts are im"orted or locall% "roduced) 2) Members ma% e2clude from "atentabilit% inventions, the "revention within their territor% of the commercial e2"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 e2clusion is not made merel% because the e2"loitation is "rohibited b% their law) ;) Members ma% also e2clude from "atentabilit%A (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 effective 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 HT6 A!reement)1 5)F 3rantin! "atents onl% to ./0s or .M0s and thereb% e2cludin! other cate!ories of "harmaceutical inventions is li el% to contravene the mandate under Article 2@ to !rant "atents to all ,inventions,) .either Articles @ and G of the T&#P' A!reement nor the *oha *eclaration on T&#P' A!reement and Public (ealth can be used to dero!ate from this s"ecific mandate under Article 2@)

5)9 5)5

5)@ Article 7 of the T&#P' A!reement re?uires 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 e2cludin! 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)G

'ection 2 (7) (j) of the #ndian Patents Act defines -invention1 as a new "roduct or "rocess involvin! an inventive ste" and ca"able of industrial a""lication) The term -"harmaceutical substance1 has also been defined in 'ection 2 (7) (ia) as an% new entit% involvin! one or more inventive ste"s) The term -inventive ste"1 has been defined in 'ection 2 (7) (ja) as a feature of an invention that involves technical advance as com"ared to the e2istin! nowled!e or havin! economic si!nificance or both and that ma es the invention not obvious to a "erson s illed in the art) Thus, a chemical to be "atentable must be new, non+obvious and have utilit%) (owever, 'ection ; e2cludes certain inventions from bein! "atented) This, inter alia, includes the e2clusions under 'ection ; (d) as underA -The mere discover% of a new form of a nown substance which does not result in the enhancement of the nown efficac% 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) 02"lanationA =or the "ur"oses of this clause, salts, esters, ethers, "ol%mor"hs, metabolites, "ure form, "article si<e, isomers, mi2tures of isomers, com"le2es, combinations and other derivatives of nown substance shall be considered to be the same substance, unless the% differ si!nificantl% in "ro"erties with re!ard to efficac%)1 Thus, the new form of a nown substance would not be "atentable unless it differs si!nificantl% in "ro"erties with re!ard to efficac%)

+ati !a- I!tere#t 'er#'ective 5)E #f the aim of limitin! "atents to new chemical entities 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) #t is im"ortant to distin!uish ,ever+!reenin!, from what is commonl% referred to as ,incremental innovation,) Hhile ,ever+!reenin!, refers to an e2tension of a "atent mono"ol%, achieved b% e2ecutin! trivial and insi!nificant chan!es to an alread% e2istin! "atented "roduct, ,incremental innovations, are se?uential develo"ments that build on the ori!inal "atented "roduct and ma% be of tremendous value in a countr% li e #ndia) Therefore, such incremental develo"ments ou!ht to be encoura!ed b% the #ndian "atent re!ime) &estrictin! "atentabilit% just to ./0s or .M0s could have both le!al and scientific ramifications) There is a "erce"tion that even the current "rovisions in the Patents Act could be held to be T&#P' non+com"liant) *ru! discover% research is still findin! its feet in #ndia) Thou!h man% com"anies are investin!, it will at least be a decade before a critical mass is in "lace and results start accruin!) Thus, restrictin! "atentabilit% to just ./0s would mean that most of the "harmaceutical "roduct "atents would be owned b% M./s) #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, mi2ture, etc)) is often seen as >ever+!reenin!$ (e2tendin! incremental "rotection to a subsistin! "atent) and hence such "rotection is objected to) #n most countries, "atentin! of an invention for different forms of the same substance is subjected to the test of novelt%, non+obviousness (une2"ected effect) 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

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"rocess "otentiall% "rovides an added advanta!e to an inventor or a firm to retain its mar et share or ca"ture a s"ace in the established mar et) (owever, "atentin! an invention does not im"l% that a "erson can "ractice the invention: he would have to e2ercise due dili!ence and ensure that the ri!hts of others are not infrin!ed) 5)79 Man% dru! industr% sta eholders feel that the use of the e2"ression -new chemical entit%1 under the Patents Act would lead to man% inter"retations) Hhile 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%) The !rou" e2amined the current level and t%"e of &5* innovations that the #ndian dru!s and Pharma industr% was underta in!) Anne2ure #I and I "rovide some re"resentative sam"les of international "atents filed b% the #ndian industr%) #t is clearl% seen that most of them are based on incremental inventions) I! t%e -ig%t $ t%e a2 ve "i#cu##i !5 it , u-" ! t 2e TRI0S c m'-ia!t t -imit gra!ti!g $ 'ate!t# $ r '%armaceutica- #u2#ta!ce t +e, C%emicaE!titie# !-y. 6 ,ever5 every e$$ rt mu#t 2e ma"e t 'r vi"e "rug# at a$$ r"a2-e 'rice# t t%e 'e '-e $ I!"ia. 7urt%er5 every e$$ rt #% u-" 2e ma"e t 'reve!t t%e gra!t $ $riv - u# 'ate!t# a!" 8ever/gree!i!g9. :etai-e" &ui"e-i!e# #% u-" 2e $ rmu-ate" a!" rig r u#-y u#e" 2y t%e I!"ia! 0ate!t 1$$ice $ r exami!i!g t%e 'ate!t a''-icati !# i! t%e '%armaceutica- #ect r # t%at t%e rem te#t ' ##i2i-ity $ gra!ti!g $riv - u# 'ate!t# i# e-imi!ate" )

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Micr / rga!i#m#(

Term# $ Re$ere!ce( Whether it would be TRIPS compatible to exclude micro-organisms from patenting 5)7@ The /oncise 62ford *ictionar%, defines the term micro+or!anism as DAn% of various microsco"ic or!anisms, includin! al!ae, bacteria, fun!i, "roto<oa and virusesD and the /ollins 0n!lish *ictionar%, defines this term as DAn% or!anism, such as a virus, of microsco"ic si<e)1 5)7G The #nstitute of 'cience, CJ 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) Iiruses are also not automaticall% included: man% scientists do not classif% them as or!anisms, as the% de"end on cells to multi"l%) (aw er and 4inton in their boo ,Micro+or!anisms, =unction, =orm and 0nvironment, state that the term micro+or!anism is derived from the minute si<e of the various or!anisms) Iiruses 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) Broc in his boo ,Biolo!% of Micro+or!anisms, describes micro+or!anisms, as a microsco"ic or!anism consistin! of a sin!le cell or cell cluster, includin! the viruses) 0vans and Jillin!ton in their boo ,#ntroduction to Microbiolo!%, (erita!e, define Micro+or!anisms as microsco"ic life forms includin! microsco"ic fun!i, Protista, "ro ar%otes and viruses) (aw er, 4inton, =ol es and /arlile in their boo ,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)7E

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 find their new and im"roved uses) Patentin! of new micro+or!anisms is based on their differences with the characters and uses of micro+or!anisms as available in the "rior art) Jnown micro+or!anisms are restricted to new uses, wherever "atent law "ermits such a "rotection) The same is the case with !eneticall% modified micro+or!anisms) 3enes and !ene "roducts are treated similar to chemical com"ositions) Patentin! of animal and human !enes ?uite often attracts issues re!ardin! "ublic order and moralit%) Position of Micro+or!anisms in the #ndian Patents Act, 7E@0 as amended u" to 2005 is as followsA 'ection ; of the Patents Act s"ecifies inventions which are not "atentable) The relevant "rovisions of that 'ection are as belowA ; ( c )A Dthe mere discover% of a scientific "rinci"le or the formulation of an abstract theor% or discover% of an% livin! thin! or non+livin! substances occurrin! in nature)D ;(j) A D"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)D The above "rovisions clearl% identif% micro+or!anisms as "atentable subject matter, "rovided the% fulfil the "rescribed criteria) #n the !imminaco "# vs $ontroller of Patents, the /alcutta (i!h /ourt 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)

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Article 2@); of the T&#P' A!reement states that Members ma% also e2clude from "atentabilit%A -(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)2;

Thus, Article 2@); of the T&#P' A!reement clearl% e2cludes "lants and animals from bein! "atented, but re!ards micro+or!anisms as different from "lants and animals) Hhile naturall% occurrin! micro+or!anisms should not ?ualif% 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) Cniversall%, as "ractised b% most "atent offices, new micro+or!anisms isolated for the first time from the natural surroundin! can onl% be "atented if the% differ in

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character from the nown micro+or!anisms and find a new or im"roved use or function) The issue has been discussed and debated in 0uro"e for a number of %ears) #n man% countries, includin! 0uro"ean countries, C'A, &e"ublic of Jorea, Ba"an and /hina, "atentin! of micro+or!anisms is not an issue) /laims to micro+ or!anisms have been allowed on the !rounds that the% are the "roducts of micro+ biolo!ical "rocesses) +ati !a- I!tere#t 'er#'ective 5)25 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, =*#, contract &5*, etc) to the best advanta!e of the #ndian &5* and biotech industr%) #ndia needs to rea" the due benefits from its rich bio+resources with an enablin! "rovision for "rotection of intellectual "ro"ert% in bio+technolo!ical innovations and inventions) 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 find their new and im"roved industrial uses) This ste" would hel" #ndian biotech industr%) The !rou"$s conclusion is based on the re?uirements 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 e2amination of the "atent a""lications involvin! micro+or!anisms from the "oint of view of substantial human intervention and utilit%) Exc-u"i!g micr / rga!i#m# per se $r m 'ate!t 'r tecti ! , u-" 2e vi -ative $ TRI0S Agreeme!t.

5)2F

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5)2G

A!!ex/I /o"% of 3overnment of #ndia, Ministr% of /ommerce 5 #ndustr%, *e"artment of #ndustrial Polic% 5 Promotion vide 6rder .o) 7287982005+#P&+### dated A"ril 5, 2005
1R:ER
Su2;ect(/ Tec%!ica- Ex'ert &r u' ! 0ate!t# -a, i##ue#

A Technical 02"ert 3rou" com"risin! the followin! "ersons has been constituted to stud% certain "atents law issuesA 7) *r) &)A) Mashel ar + /hairman

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*irector 3eneral /ouncil of 'cientific and #ndustrial &esearch 2, &afi Mar!, .ew *elhi K 770 007 2) Prof) 3overdhan Mehta *irector #ndian #nstitute of 'cience Ban!alore K 5F0 072 Prof) Asis *atta *irector .ational /entre for Plant 3enome &esearch B.C /am"us .ew *elhi K 770 0F@ Prof) Madhav Menon .ational Budicial Academ% Bho"al Prof) Moolchand 'harma *irector .ational 4aw #nstitute Cniversit% Bho"al + Member

;)

Member

9)

Member

5)

Member

/ontdL))

11

+2+ 2) The 3rou" will have the followin! terms of referenceA 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 e2clude micro+or!anisms from "atentin!) ;) 9) 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) 'd8+ 3Ra;eev Ra!;a! 4 :irect r

C 'y t ( All the members of the 3rou") C 'y a-# t 7) 2) ;) 9) 5) Prime Minister$s 6ffice /abinet 'ecretariat) 6ffice of /#M 6ffice of 'ecretar% (#PP) Ministries8*e"artments of /hemicals 5 Petro+chemicals, (ealth, Biotechnolo!%, 'cience 5 Technolo!%, /ommerce, 'cientific and #ndustrial &esearch, A!ricultural &esearch 5 0ducation, 0nvironment 5 =orests)

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A!!ex / II 0ate!ti!g 0ractice# i! 1t%er c u!trie#

Examination Guidelines for Patent Applications Biotechnological Inventions at the UK Patent Office relating to

These 3uidelines set out the "ractice within the CJ Patent 6ffice as it relates to "atent a""lications for biotechnolo!ical inventions) The 2000 &e!ulations came into force on 2G Bul% 2000 and im"lemented the "rovisions of Articles 7 to 77 of the 0uro"ean *irective EG89980/ on the le!al "rotection of biotechnolo!ical inventions) #n the CJ, the Patents &e!ulations 2000 confirmed and clarified that inventions concernin! biolo!ical material, includin! !ene se?uences, 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 CJ) %"n invention shall not be considered unpatentable solely on the grounds that it concerns &a' a product consisting of or containing biological material( or &b' a process by which biological material is produced, processed or used) *Paragraph +, Schedule ", to the Patents "ct +-../ Cniversall%, it is an established "ractice that a natural substance which has been isolated for the first time and which had no "reviousl% reco!ni<ed e2istence, 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 field of biotechnolo!%, that a "atent should not be !ranted merel% because the a""licant had been involved in laborious and costl% effort) #f the !oal is nown and sufficient 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) =ollowin! the se?uencin! of various !enomes, there is unli el% to be an inventive ste" in identif%in! from within a se?uenced !enome an% new !ene, even those without nown homolo!ues) #t is obvious to trawl the !enome for "reviousl% unidentified !enes, and an% s illed wor er would have some e2"ectation of success) #n #enentech, an idea was considered obvious if -the materials in ?uestion were l%in! in the road and read% for a research wor er to use1, even if the s illed man faced a number of obstacles in "roceedin! to his !oal) (owever, if overcomin! these obstacles re?uired -a s"ar of ima!inationL)be%ond the ima!ination "ro"erl% attributable to him as a man s illed in the art1 then there ma% be some element of inventive ste") The use of bioinformatics tools would not seem to "ose obstacles re?uirin! a s"ar of ima!ination to overcome) Para!ra"h 2 of 'chedule A2 to the British Patents Act, 7E@@ "ermits biolo!ical material which is isolated from its natural environment or "roduced b% means of a technical "rocess to be the subject of an invention even if it "reviousl% occurred in nature) /laims 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 findin! of a utilit% turnin! what would be a discover% into an invention)

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/laims for micro+or!anisms per se which have been isolated or obtained b% artificiall% induced random mutation, are allowed but !enerali<ations from such s"ecific micro+or!anisms to novel s"ecies would not normall% be "ermitted) 6n the other hand, claims to !eneticall% modified 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"ecified de"osited micro+or!anism are allowed "rovided the% "ossess the same inventive "ro"ert% as the de"osited micro+or!anism) Patenting of Micro-organisms in hina /laims for micro+or!anisms per se are allowed in /hina) *.A se?uences 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 se?uences mi!ht be e2"ected to tri!!er the >"roducts of nature$ rule, courts have u"held "atent claims coverin! >"urified and isolated$ *.A se?uences as new com"ositions of matter resultin! from human intervention) An e2cised !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 "urified state is different from the naturall% occurrin! com"ound) Article 25 of the /hinese Patent 4aw states thatA =or an% of the followin!, no "atent ri!ht shall be !rantedA (7) 'cientific discoveries: (2) &ules and methods for mental activities: (;) Methods for the dia!nosis or for the treatment of diseases (9) Animal and "lant varieties: (5) 'ubstances obtained b% means of nuclear transformations) =or "rocesses used in "roducin! "roducts referred to in items (9) of the "roceedin! "ara!ra"h, "atent ri!ht ma% be !ranted in accordance with the "rovisions of the 4aw) Patenting of Micro-organisms in Europe The 0uro"ean Cnion has defined -,biolo!ical materialD instead of Dmicro+ or!anismD, as under MArticle 2)7 (a)N -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%stemD #n Plant 3enetic '%stems a""lication (T;5F8E;) 0uro"ean Board of A""eal was sei<ed with the ?uestion 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 0uro"ean Patent /onvention (0P/) "rovides that 0uro"ean "atents shall not be !ranted in res"ect of >"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$)

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#n its decision of 7F Bune 7EEE the Administrative /ouncil inserted a new /ha"ter I# entitled >Biotechnolo!ical inventions$ in Part ## of the 0P/ #m"lementin! &e!ulations) The new "rovisions entered into force on 7 'e"tember 7EEE and im"lemented the re?uirements of the 0C Biotechnolo!% *irective in 0uro"ean "atent law) The 0P6 has introduced four new rules, &ules 2;b to 2;e) &ule 2;b sets out !eneral matters and defines the meanin! of biotechnolo!ical inventions, biolo!ical material, "lant variet%, and microbiolo!ical "rocess) &ule 2;c states "atentable biotechnolo!ical inventions, includin!A 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 confined to a sin!le variet%

The "rovision clarifies the sco"e of Article 5;(b) of 0P/) #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 sufferin! without substantial medical benefit) The list is to be seen as !ivin! concrete form to the conce"ts of >ordre "ublic$ and >moralit%$) &ule 2;e indicates what is and is not "atentable with res"ect to the human bod%) The human bod% and its elements cannot be "atented) (owever, elements of the bod%, when isolated from the bod%, ma% be "atented) Patenting of Micro-organisms in !apan #n 7EE@, the Ba"anese Patent 6ffice (BP6) "ublished its >#m"lementin! 3uidelines for #nventions in '"ecific =ields$) #nventions in the biotechnolo!% field in the 3uidelines are divided into four t%"esA !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 Ba"an, micro+or!anism means %east, molds, mushrooms, bacteria, actinom%cetes, unicellular al!ae, viruses, "roto<oa, etc) and further includes undifferentiated animal or "lant cells as well as animal or "lant tissue cultures) Patenting of "e# hemical Entit$ in U%&

Accordin! to the Cnited 'tates (C') =ood and *ru! Administration (=*A), a new molecular entit% (.M0) or new chemical entit% (./0) means a dru! that contains

15

no active moiet% that has been a""roved b% =*A in an% other a""lication submitted under section 505(b) of the =ederal =ood, *ru!, and /osmetic Act) Patenting of Micro-organisms in U%A Art) ;5 C'/ 'ec 707 of the C' "atent law statesA 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 thereofL1 #n C'A, utilit% re?uirement in res"ect of biotech inventions are ver% strict) A discover% that is not a creation does not meet the re?uirement of utilit%) A newl% discovered micro+or!anism e2istin! 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 re?uirement 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"ecification or cannot be inferred, do not meet the re?uirement 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 re?uirement of utilit%) Accordin! to the new >Ctilit% 02amination 3uidelines$ of the C'PT6, if an isolated *.A fra!ment has a s"ecific, substantial, and credible utilit%, the *.A fra!ment invention satisfies the re?uirement of utilit% and a "atent can be !ranted for the *.A fra!ment) Hhere a new use is discovered for the "atented *.A fra!ment, that new use ma% ?ualif% for its own "rocess "atent) 6f course, the later "atent is a de"endent "atent of the *.A fra!ment "atent) Patenting of Micro-organisms in Australia The Australian "atent law defines invention as Dan% new manner of manufacture)D The ?uestion of "atents for livin! or!anisms was considered at len!th in &an s (ovis Mc*ou!all 4td),s A""lication M7E@F A 6BP ;E75N and the /ourt held thatA a) .o objection can be ta en 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 effect on the wor in! 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"ecified in!redients would satisf% the re?uirement of a technical intervention) The !uidelines for a micro+or!anism in Australian Patent 4aw states, -what is discovered in nature without an% "ractical a""lication, is a mere chemical curiosit%1, and is not "atentable MPart G)2)5); Australian Manual of Patent PracticeN) (owever, isolated micro+or!anisms are considered "atentable)

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 hydro en or coordination #onds&, or other noncovalent derivative $such as a com!lex, chelate, or clathrate& o" the molecule, res!onsi#le "or the !hysiolo ical or !harmacolo ical action o" the dru su#stance' $(ource) htt!)**en'%i+i!edia'or &

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Patenting Practices of Micro-organism in Bra'il Article 70 states that the followin! shall not be considered inventions or utilit% modelsA Dall 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)D Article 7G states that the followin! should not be "atentableA Dlivin! bein!s, in whole or in "art, e2ce"t for trans!enic micro+or!anisms meetin! the three re?uirements of "atentabilit% + novelt%, inventive ste" and industrial a""lication + in accordance with Article G and which are not mere discoveries)D =or the "ur"oses of this law, trans!enic micro+or!anisms mean or!anisms, e2ce"t for "lants or animals in whole or in "art, that due to direct human intervention in their !enetic com"osition e2"ress a characteristic that cannot normall% be achieved b% the s"ecies under natural conditions)

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A!!exe / III

Summary $ Su2mi##i !# a!" 0re#e!tati !#

Ra!2axy
"e# hemical Entit$ (" E)&

As #ndia$s leadin! Pharmaceutical /om"an% committed to &5 * in the field of dru! develo"ment, we are of the o"inion that incremental innovations in terms of develo"in! new forms, new derivatives and new deliver% s%stems of e2istin! dru! should be !ranted "atent "rotection "rovided the% are new, involve an inventive ste" and have commercial utilit%) This will "rovide the necessar% filli" to develo"ment of .ovel *ru! *eliver% '%stem (.**') in our laboratories) &estrictin! "atentabilit% to ./0s ma% a""ear to be an attractive solution in the short Kterm to com"anies with a >&everse K0n!ineerin!$ mindKset, but will not benefit hundreds of scientists wor in! in our "ublic 5 "rivate & 5 * /enters, who are just startin! off on the difficult tas of new dru! discover% research) &estriction of "atentabilit% to ./0s alone is li el% to benefit onl% M./s which have the resources and the e2"erience to develo" ./0s) #ndian com"anies that have far less resources are better "laced to benefit from earl% commerciali<ation of incremental innovations) A "rere?uisite 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 ./0s is not com"liant with Article 2@)7 of T&#P') Patent A""lications filed b% &anba2%A 'e!ment 3enerics .**' .**& Strategic :irecti ! 2009 200@ OOO OOO O OO 2072 OOO OOO OOO

3lobal 'ales C' P 7 Bn C' P 2Bn C' P 5 Bn <'tars indicate im"ortance8direction in the se!ment A&0AH#'0 PAT0.T =#4#.3 83&A.T T6 &A.BAQR (Total number uni?ue "atent a""lications filedA @0E) I!"ia 7i-e" Process AP#s *osa!e .**' .**& ;GG 29F 792 @5 @5 &ra!te"< E5 5G ;@ 27 2; USA 7i-e" GG F9 29 7G 90 &ra!te" ;G ;0 0G 0G 7;

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(erbal Pac a!in! Total

0F 07 595

+ + 7;E

+ + 79F

+ + 5E

Oincludes acce"ted "atent The firm em"hasi<es that 0!!S products need patent protection since stren!th of #ndian scientists lie in innovations that im"rove e2istin! "roducts) =urther, .**' "ro!rams are less e2"ensive, have lower !estation "eriods and result in #P that can be licensed) 02am"le /i"ro 6* licensed b% &anba2% to Ba%er) &anba2% has further tried to define -efficac%1 as the ca"acit% of the dru! to "roduce a desired effect) #n medical terms, clinical efficac% is the ma2imal effect that can be "roduced b% a dru!) An% factor such as bioavailabilit% that substantiall% enhances a clinical outcome benefit would be deemed to be included in the definition of efficac%) An% invention on derivatives or "ro"erties that affect these factors should be deemed to be "atentable, if it demonstrabl% and si!nificantl% influences the efficac%) This would include inventions on chemical modifications 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) Micro-organisms& .o comments)

=ri#%!a > Saura#tri5 Tra"emark# > 0ate!t Att r!ey#

"e# a) hemical Entit$ (" E)&

#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: Both the above thin!s will be a!ainst s"ecific interests of #ndian inventors and a bonan<a for multinational com"anies: Time has come to re+e2amine entire #P& "olic% of #ndia) Best "olic% will be to ensure im"lementation of "rovisions of com"ulsor% licensin! "rovisions and 'ection FF in letter and s"irit) Hith fear of misuse or mischievous use !one, ma e sco"e of "atentabilit% as broad as "ossible b% deletin! A44 restrictive "rovisions on "atentabilit% e2ce"t 'ections ; (b), ; ("), 9, ;E) 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 benefits)

b) c)

d) Article 7 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 e2tensive "rotection than has been sti"ulated in the A!reement) This clearl% means that e2cludin! "harmaceutical substances other than new entities, which ma% include new forms of cr%stals, "ol%mor"hs etc, is not consistent with T&#P' re?uirements if the% satisf% the criteria of "atentabilit%)

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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) &5* in new chemical entities re?uires a hu!e financial commitment, sta%in! abilit% and &5* ca"abilit%, which ver% few #ndian Pharma com"anies have) 0ven at "resent, "atents "ortfolio of most #ndian "harma com"anies, e2ce"t one e2ce"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 wor in! around in "resentl% !eneric "roducts) f) This ma% include findin! out better forms which have some strate!ic economic advanta!e such as better handlin! "ro"erties, better stabilit%, etc

!) #t is also "ossible that a new efficient "rocess of an economicall% !eneric dru! ma% be "atented, but e2ce"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 e2traordinar% 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) Hhen a new "rocess is different and far more efficient, 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 effective wa% to detect infrin!ement will be !iven b% onl% a "roduct claim which claims "resence of this im"urit% in trace ?uantities) 4imitin! "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 find it circuitous and more e2"ensive to "rove that their "rocess is bein! infrin!ed in absence of an e2"ress "roduct claim bein! !ranted) i) Man% such e2am"les are "ossible, and man% unantici"ated and une2"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 Dnew chemical entitiesD) B% o"tin! to e2clude "harmaceutical substances other than new chemical entities from "atentin! in "harmaceutical area, we shall be offerin! bonan<a to multinational com"anies, because Dnew chemical entities1 is their e2clusive stren!th at "resent and e2cludin! all other "harmaceutical substances from "atentabilit% will ma e their com"etitive "osition further e2clusivel% "rotected) This a""roach will hit #ndian "harma com"anies) 4oss of the multinationals will be mar!inal) ) The entire reason for e2cludin! D.ew =ormsD from bein! held "atentable emer!es from the fear of D3reenin! of PatentsD) This is basicall% not a "ractical fear because even if a D.ew =ormD is "atented, this does not revive "atent "rotection to the off+"atent form nor to that chemical entit%) Hhat has e2"ired as "atent "rotection has e2"ired) Ma% be, the "atentee can e2ercise his e2clusivit% on the D.ew =ormD, which shall not include "rotection to the chemical entit%, but just the new form) But as lon! as the D6ld =ormD is useful for its "ur"ose, the "atent on D.ew =ormD can be i!nored and not used at all

j)

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b% the world) 6n the contrar%, the, D.ew =ormD has such a si!nificant 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%,S l) &estrictive "rovisions on "atentabilit% are mainl% on account of fear of misuse or mischievous use of e2clusivit%) This threat should not e2ist for us due to ver% stron! com"ulsor% licensin! "rovisions and defensive "rovision) #t shall be enou!h to !ive confidence that 'ections G9 and E7 shall be im"lemented in case of !enuine cases without an% dela%) These "rovisions "rotect the e2istin! innovation based com"anies from "ossible cri""lin! effects 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 satisfied) #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% e2istin! enter"rise faces closure due to the new "atent, com"ulsor% license is available to avert the closure ('ee section G9 (@) (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 E7, where, if an enter"rise has active &5* in the same field and the new "atent is related to their e2istin! on!oin! &5*, 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 ta e benefit of the "otential "rofits from licensin! of new molecules, #ndian com"anies will have to start !enuine wor on several t%"es of molecules) 6nce &5* 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 in #ndian "harma &5*, which shall brin! benefits 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) Micro-organism& a) #t will not be T&#P' com"atible to e2clude micro+or!anisms from "atentin!: b) #t ma% be "ointed out here that we have full% e2"loited the "ermitted e2clusions under 'ection ; of the Article 2@) (owever, same "rovision ver% s"ecificall% and e2"ressl% e2cludes "ermission to e2clude micro+or!anisms from "atentabilit%) Hith so clear e2"ress "rovisions, here is no wa% to inter"ret that micro+or!anisms can be e2cluded from "atentabilit%)

S%ri V.R. =ri#%!a Iyer

"e# hemical Entit$&

#t is well within the T&#P' norms to limit "atentabilit% to new chemical entitites in res"ect of "harmaceutical inventions Micro-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

21

should be no "atent "rotection in res"ect of such cases) #n clause ;(j), the e2"ression Dother than micro+or!anisms, butD should be deleted) Alternativel%, under "roviso to section 7(;) of the Act, the commencement of the "rovision should be deferred till a review of the ?uestion of accordin! "atent "rotection to micro+or!anisms and non biolo!ical and micro biolo!ical "rocesses, as initiated b% the HT6 in 7EEE, is com"leted, and the "osition is reviewed afresh b% #ndia) #t is si!nificant !loball% there is o""osition to such "rotection)D

Bi c !
"e# chemical Entit$A .o /omments Micro-organismsA The followin! should be considered un+"atentableA a) Hhere the commercial e2"loitation would be contrar% to moralit% or order "ublic: b) Process for clonin! human bein!s: c) Cse 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: e) .aturall% occurrin! !ene and *.A se?uences and minor variations thereof: f) #nherent utilities such as !ene se?uences codin! for amino acids, "e"tides, "roteins)

Eric 6 e%re!2erg
"e# hemical Entit$A

Patent search carried out b% the leadin! Bra<ilian "atent law "ractice concernin! "atents on salts, esters, "ol%mor"hs and similar -incremental innovation1 b% #ndian com"anies in Bra<il) There are G9 such "atents from /#P4A, *r) &edd%$s 4abs, and &anba2%) #t should be noted that man% of these "atents are also "endin! at the 0uro"ean Patent 6ffice) 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% mar ets outside of #ndia) He 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@(7))) The 0C and C' have addressed the issue of "atents on -incremental1 or -ada"tive1 innovation as followsA Article ;5 under 'ection 707 of the C' "atent law statesA -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 thereofL1

22

A re"ort b% the 0C wor in! 3rou" on Pharmaceuticals and "ublic health noted in its 2G March 2000 re"ort to the (i!h+level /ommittee on health for "olicies and Actions in the framewor of the 0C treat% of Amsterdam thatA -#nnovation in "harmaceuticals encom"asses man% different o"tions, !oin! from the develo"ment of a com"letel% new medicine for the treatment of a disease otherwise incurable, to modifications of nown formulations to im"rove benefits for the "atients, such as a less invasive administration route or a sim"ler administration schedule)1 Micro-organisms& .o /omments)

I!"ia! :rug Ma!u$acturer#9 A## ciati !

"e# hemical Entit$A

6ur submission is that the Parliament had onl% an ./0 in mind when it a""roved 'ection 2 and ; "articularl% 'ection ; clauses (d), (e) and (f): The C' =*A uses onl% term .ew /hemical 0ntit% althou!h their "atent law is ver% broad and unsuitable for a develo"in! countr% li e #ndia) *efinition of .ew /hemical 0ntit% in C'A + C' =*A &ule 'ec) 505 (b) describes a ,new chemical entit%, as -) ) ) a dru! that contains no active moiet% that has been a""roved b% =*A in an% other a""lication submitted under section 505 (b) of the =ood, *ru! and /osmetic Act) ) ))1 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) He do not want to follow the C' e2am"le where for e2am"le + there are 2G new "atents issued between 7EE5+2005 on the same one dru! Menin!itis Iaccine, mostl% for minor variations) b) The definition of ./0 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 e2"loitation) c) #t should su""ort the "olic% of the 3overnment to brin! down medicine "rices)

d) The new definition of "atentable ,"harmaceutical substance, should be su""orted b% other "rovisions of the Patents Act "articularl% 'ections 2 and ;) 'u!!estion 7A 'ection 2 (7) (ta)A Present Te2tA D"harmaceutical substanceD means an% new entit% involvin! one or more inventive ste"s: Pro"osed te2tA 'ection 2 (7) (ta) + D"harmaceutical substanceD means an% new chemical entit% with a si!nificant thera"eutic advancement with one or more

23

inventive ste"s) 02"lanation + =or the "ur"oses of this clause, salts, esters, ethers, "ol%mor"hs, metabolites, "ure form, "article si<e, isomers, mi2tures of isomers, com"le2es, combinations and other derivatives of nown substance shall be considered to be the same substance unless the% differ si!nificantl% in "ro"erties with re!ard to efficac%, and therefore, shall not be "atentable) 'u!!estion 2A Present Te2t 'ection ; (d)A ,the mere discover% of a new form of a nown substance which does not result in the enhancement of the nown efficac% 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,) ,02"lanationA =or the "ur"oses of this clause, salts, esters, ethers, "ol%mor"hs, metabolites, "ure form, "article si<e, isomers, mi2tures of isomers, com"le2es, combinations and other derivatives of nown substance shall be considered to be the same substance, unless the% differ si!nificantl% in "ro"erties with re!ard to efficac%, Pro"osed te2tA 'ection ; (d)A Dthe mere discover% of a new form of a nown substance which does not result in the enhancement of the nown efficac% 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 reactantD and, therefore, shall not be "atentable)

'u!!estion ; 'ection 2 (7) (ja) Present Te2tA Dinventive ste"D means a feature of an invention that involves technical advance as com"ared to the e2istin! nowled!e or havin! economic si!nificance or both and that ma es the invention not obvious to a "erson s illed in the art) Pro"osed te2tA 'ection 2 (7) (ja) + Dinventive ste"D means a feature of an invention that involves technical advance as com"ared to the e2istin! nowled!e or and havin! economic si!nificance or both and that ma es the invention not obvious to a "erson s illed in the art) 'u!!estion 9A Present Te2tA

24

'ection 2 (7) (l)A Dnew inventionD 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 filin! of "atent a""lication with com"lete s"ecification, 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 Te2tA 'ec) 2 (7) (l)A Dnew inventionD 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 filin! of "atent a""lication with com"lete s"ecification, 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) /han!es su!!estedA (i) To use the term ,.ew /hemical 0ntit%, instead of the term ,.ew Medical entit%$ with a view to reduce liti!ation, "ublic e2"loitation and ever+!reenin! b% M./s: (ii) To dro" words li e Defficac%D, DmereD, Dsi!nificantD from the te2t of 'ection ; of the Patents Act) (iii) The term ,Prior art, is "referred in 'ection 2(7)(l) instead of the "hrase >state of the art,: (iv) #n the definition of inventive ste" the conjunction ,or, between ))))e2istin! Jnowled!e, havin! economic si!nificance ))))should be re"laced with >and$)

Micro-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 te2t 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) /han!es su!!estedA (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) 6n the issue of "atentabilit% of micro+or!anisms, mandator% review of T&#P' "rovisions b% the T&#P' /ouncil should be awaited:

&e!e Cam'aig! 25

"e#

hemical Entit$A

.o /omments) Micro-organisms& Patentabilit% of micro+or!anisms should be for those micro+or!anisms which have been "roduced b% ade?uate human intervention and fulfil the criterion of novelt%, non+obviousness and industrial utilit%) Mere discover% and isolation will not be considered sufficient human intervention) Patents should not be !ranted on materials obtained from national and international collections and de"ositories) Hhen a material is ta en from a countr%, Article 75 of the /onvention on Biolo!ical *iversit% should be res"ected) .o "atent should be !ranted without "rior informed consent and material transfer a!reements) Hhen a "atent is !ranted, the "atent holder should be obli!ed to share the economic benefits 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)

1x$ r" I!te--ectua- 0r 'erty Re#earc% Ce!tre5 U!iver#ity 1x$ r"5 U.=.
"e# hemical Entit$&

.o /omments) Micro-organismA 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 confined to addressin! the T&#P' com"liant le!al o"tions)

:rug Acti ! 7 rum

"e# hemical Entit$A

He feel that there is an ur!ent need to restrict the definition of new chemical entit%) The definition of "atentable >"harmaceutical substance$ should be as follows K -Pharmaceutical substance means new dru! molecule involvin! one or more inventive ste"1) And the definition of >"atentable invention$ should be as

26

follows K -#nvention means a basic "roduct or "rocess involvin! an inventive ste" and ca"able of industrial a""lication1) Micro-organismsA .o /omments)

+ati !a- ? rki!g &r u' ! 0ate!t @a,1

"e# hemical Entit$&

(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!nificant thera"eutic advancement involvin! one or more inventive ste"s: (iii) There is lacuna about the definition of ,"harmaceutical substance,) A"art from the definition there is no mention of this "atentable subject matter an%where in the amended Patents Act 7E@0) 'ection 5 of the Act has been omitted throu!h the Patents (Amendment) Act 2005) He would su!!est this 'ection which could incor"orate s"ecificall% ,"harmaceutical substance, should be re+ introduced with the followin! versionA 'ection 5 Patents shall be available for basic novel inventions includin! "harmaceutical substances as defined in 'ection 2 whether "roducts or "rocesses in all fields of technolo!ies e2cludin! 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 definitions of ,invention, and ,"harmaceutical substance, are in harmon% with each other and clause (d) includin! its e2"lanation under 'ection ; ?uoted above) He would em"hasi<e that basicall% the incrementall% chan!ed "resentation must not be allowed for "atentin!) Micro-organism& (i) Patentin! of life forms ma% have at least two dimensions) =irstl%, there is the ethical ?uestion of the e2tent of "rivate ownershi" that could be e2tended 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% modified falls in the cate!or% of invention because of human in"ut) 3eneticall% modified micro+or!anism ma% "erform an% number of activities) #f a researcher is able to research u"on a "articular

27

activit%, and he is allowed "atentin! of his !eneticall% modified micro+ or!anism this will result in bloc in! 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% modified micro+or!anism also as such)

A## ciati ! $ Bi tec%! - gy @e" E!ter'ri#e#

"e# hemical Entit$&

.o /omments) Micro-organismsA The inventions to be considered "atentable which have novelt%, inventive ste"s and commercial utilit%) The followin! to be considered non+"atentableA where the commercial e2"loitation would be contrar% to moralit% or ordre public Process for clonin! human bein!s Cse of human embr%os for industrial or commercial "ur"oses The human bod%, at the various sta!es and se?uence and minor variations thereof .aturall% occurrin! !ene and *.A se?uence and minor variations thereof) #nherent utilities such as !ene se?uences codin! for amino acids, "e"tide, "roteins)

I!"ia! 0%armaceutica- C !gre## A## ciati !

"e# hemical Entit$&

The recent Patent Act dis?ualifies !rant of "atents for salts, esters, ethers, "ol%mor"hs, metabolites, "ure forms, "article si<e, isomers, mi2ture of isomers, com"le2es, combinations and other derivatives of nown substance and shall be considered to be the same substance, unless the% differ si!nificantl% in "ro"erties with re!ard to efficac%) This ma% hel" to "revent ever !reenin! of "atents) This clause is a in to the *irective 200982@80/ of the 0uro"ean Parliament and /ouncil of ;7 March 2009, which "rovides !uidelines for D!eneric medicinal "roductD) The 6fficial Bournal of 0uro"ean Cnion 4 7;F8;E dated ;0)9)2009 under Article 70 'ee 2)(b) D!eneric medicinal "roductD shall mean a medicinal "roduct which has the same ?ualitative and ?uantitative com"osition in active substances and the same "harmaceutical form as the reference medicinal "roduct, and whose bioe?uivalence with the reference medicinal "roduct has been demonstrated b% a""ro"riate bioavailabilit% studies) The different salts, esters, ethers, isomers, mi2tures of isomers, com"le2es or derivatives of an active substance shall be considered to be the same active substance, unless the% differ si!nificantl% in "ro"erties with re!ard to safet% and8or efficac%) #n such cases, additional information "rovidin! "roof of the safet% and8or efficac% 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

28

forms shall be considered to be one and the same "harmaceutical form) Bioavailabilit% studies need not be re?uired of the a""licant if he can demonstrate that the !eneric medicinal "roduct meets the relevant criteria as defined in the a""ro"riate detailed !uidelines) This directive is aimed to avoid ever !reenin! of "atents) Micro-organisms& .o /omments)

I!"ia! 0%armaceutica- A--ia!ce

"e# hemical Entit$&

#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) Micro-organisms& .o /omments)

A$$ r"a2-e Me"ici!e# > Treatme!t Cam'aig!

"e# hemical Entit$A

The terms 8+e, c%emica- e!tity9 and 8!e, me"ica- e!tity9 are not inter chan!eable terms and each term has its own le!al meanin!) The s"ecific terminolo!% used in the "atent le!islation can ma e a si!nificant difference in e2"andin! or alternativel% restrictin! the sco"e of "atentabilit%, directl% affectin! access to affordable dru!s) 02"andin! the sco"e of "atentabilit% will lead to !reater number of dru!s bein! "atented adversel% affectin! access to affordable dru!s) 6n 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 -!e, c%emica- e!tity1 is normall% restricted onl% to mean a new chemical substance, which is not nown earlier) 6n the other hand the term -new medical entit%1 is an e2"ansive term which includes different 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 effectivel% limit the sco"e of "atentabilit% the criteria of novelt%, inventive ste" and industrial a""lication should be defined as "er national interests) This is to be done b% amendin! the definitions of "atentable criteria in the "resent Patents Act) =urther, the definition of "harmaceutical substance to be re"laced with a new definition and this definition should be then lin ed to the "rovisions and e2clusions mentioned in 'ection ; of the Act) #t would be T&#P' com"atible to limit the !rant of "atent to new chemical entities)

29

Micro-organisms& .o /omments)

T%e I!ter!ati !a- A## ciati ! $ r t%e 0r tecti ! 0r 'erty 3AI00I4 3I!"ia &r u'4
"e# hemical Entit$A

$ I!"u#tria-

The A#PP# (#ndian 3rou") felt that the current e2clusions should follow the T&#P' A!reement and the e2"lanation to 'ection ;(d) should be deleted) The 3rou" felt that ./0 is not a D"atentD term but a Dre!ulator%D term and it is not a""ro"riate to define the said term in the Act) The 3rou" felt that 'ection ;(d) which "revailed between the "eriod 7 st Banuar%, 2005 to Gth A"ril 2005 was the best and that the word ,mere, ou!ht to be restored in the 'ection) The 3rou" also felt that the 6rdinance 2009 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 6rdinance it would have been "atentable) The Patents Amendment Act, 2005 chan!ed this "osition) #nstead, it contains a rather too lon! e2"lanation on the e2em"tion to "atentabilit% under 'ection ;(d)) Accordin! to this 'ection what is not "atentable isA a) The mere discover% of a new form of a nown substance, which does not result in the enhancement of the nown efficac% 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) /onse?uentl%, if a discover% of a new form of a nown dru! molecule results in an enhancement of its nown efficac%, 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+"atentable) A joint readin! of the amended 'ection ;(d) and 'ection ;(i) is ca"able of ee"in! a major "ortion of "harmaceutical &5* outside the sco"e of "atents) #f this cannot be done then at least the e2"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 7st of Banuar%, 2005) The 3rou" also felt that substantial and une2"ected ?ualitative de"arture of "ro"erties of the claimed ./0 should ?ualif% for inventiveness) Hhen there is a si!nificant difference in effectiveness or utilit% com"ared to basic com"ounds, salts, esters, derivatives, isomers, "urified forms, com"le2es, h%drates, cr%stalline forms, etc), should be considered as havin! inventive merit) The 3rou" made the followin! su!!estionsA

30

(i) (ii)

The 02"lanation to 'ection ; (d) of Patents Act should be deleted) ,.ew /hemical 0ntit%, is not a "atent term but onl% a re!ulator% term and it is not a""ro"riate to define it in the Patents Act)

Micro-organisms& An inconsistenc% e2ists 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 ma es it "ossible to describe and re"eat "rocedures for the modification of a livin! or!anism) Patent "rotection for "articular biotechnolo!ical inventions e2ists 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+affirms 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 Baneiro, which laid down this "rinci"le has been well acce"ted and has had a "ositive influence on the on!oin! wor in H#P6) &esolution A A new '"ecial Arran!ement under Article 75 of the Paris /onvention should be made, "rovidin! forA de"osition in a culture collection of the micro+or!anism (s) described in a "atent s"ecification and not available to the "ublic as a re?uisite for !rant of a "atent: de"osition in one culture collection a""roved under this Arran!ement as bein! sufficient to meet the re?uirements of all 'tates "arties to this Arran!ement: de"osition on or before the filin! of the first "atent a""lication (with the "ossibilit% of formal details of de"osition bein! furnished, later within a "rescribed "eriod) The followin! su!!estions are madeA (i) 02clusion of "atentin! of micro+or!anisms mi!ht be violative of T&#P') 6nl% the sco"e of the term should be clarified) (ii) The broadest definition for micro+or!anisms should be used) The definition should be a !uideline or directive rather than a statutor% definition) (iii) /ell lines should not be e2cluded from "atentabilit%)

@ex 1r2i#
"e# hemical Entit$A

(i) #t would be T&#P' violative if #ndian Patent 4aw e2"ressl% e2cludes non+./0 Pharmaceutical "roduct inventions from "atentabilit%

31

(ii) The "ossibilit% of settin! a hi!h threshold with 'ection ; (d) to justif% the e2clusion of non+./0 "harmaceutical substances from "atentabilit% is to be e2"lored: Micro-organisms& (a) Article 2@(;)(b) of T&#P' mandates HT6 Members not to e2clude Dmicro+ or!anismsD, Dnon+biolo!icalD and Dmicrobiolo!ical "rocessesD 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 e2cluded 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 e2cluded from the sco"e of "atentabilit%) The a""roach, therefore, has to be more ,definitional, and ,inter"retative, than a blan et direct e2clusion that attracts %et another dis"ute at the HT6) The e% ?uestion that follows is + whether it is "ossible for #ndia to ado"t a ver% narrow and limited definition of ,micro+ or!anisms, to e2clude ever%thin! other than Dmicrosco"ic or!anisms includin! 6.4R al!ae, bacteria, fun!i, "roto<oa and viruses) #n the alternative, should there be an e2"ansive definition 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 0uro"e)) (d) #t could be in #ndia,s national interests to ma e ,micro+or!anisms, "atentable and also to "rovide an e2"anded definition of ,micro+or!anism, so as to include in its sco"e ,biolo!ical materials, includin! *.A fra!ments, !enes, and "roteins as /hina "rovides) (e) An alternative a""roach is to ado"t the 0uro"ean a""roach (0uro"ean *irective (EG89980/) and "rovide for a further broader definition of DBiolo!ical materialD to include Dan% material containin! !enetic information and ca"able of re"roducin! itself or bein! re"roduced in a biolo!ical s%stemD and brin! that under the sco"e of "atentable subject matter) (f) An e2"lanation to 'ection ;(j)+ could be added with a balanced definition on the followin! linesA 02"lanation + for "ur"oses of this clause, Dmicro+or!anismD means onl% microsco"ic or!anisms includin! al!ae, bacteria, fun!i, "roto<oa, viruses, *.A fra!ments, !enes, and "roteins)

Cr ' @i$e
"e# hemical Entit$A

The discover% and develo"ment of a new molecule is an e2"ensive "ro"osition in develo"ed countries, a new dru! cost about P7 billion for a new "esticide molecule, the cost is about P ;00 million) #n #ndia, all this could be done at a much lower cost) 'till, the cost would be hu!e, about P ;00 million (&s) 7,;50 /rore) for a new dru!: #ndian com"anies at their current level of & 5 * s"endin! (5+@ "ercent of their turnover) are not in a "osition to underta e such a hi!h level of investment

32

Besides, the ris is ver% hi!h) But incremental innovations are well within their reach) 6ur laws should "romote these) This will enable our 'cientists to "ut their creativit% to best use) Hhen #ndian com"anies can ta" these o""ortunities abroad (where these innovations are "atentable), wh% not our own turfS 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 e2tension) The Patent office will sim"l% not allow this) The "atentin! of a new dosa!e from, sa%, li?uid of an e2istin! medicine is a totall% im"endent ste") #t does nothin! to e2tend the "atent term of the medicine in its ori!inal form (solid) which on its e2"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 4aw should "rovide for "atentin! of new forms, new uses and new formulations as well as combinations of nown com"ounds so lon! as these fulfil three fold criteria of novelt%, inventive ste" and ca"able of industrial a""lication) Micro-organismsA .o /omments)

Bra"-y C " ! a!" Ta'e! Si!%a

"e# hemical Entit$&

#n the conte2t 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 benefits amon! "roducers and users of intellectual "ro"ert%) Cniform rules can have dis"arate effects that worsen ine?ualities 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 ta en into account than are currentl% used in the HT6 and C. conte2ts) Micro-organisms& .o /omments)

Medicine %an *rontiers5 7ra!ce

"e# hemical Entit$A

This submission a""roaches this ?uestion with an incremental a""roach+dividin! "harmaceutical "roduct related inventions other than .ew /hemical 0ntities (./0s) into different cate!ories, in "articular new uses and new forms of nown com"ounds and e2aminin! the "atentabilit% or otherwise of those cate!ories) Based on the "rovisions of the T&#P' A!reement and ta in! the "resent #ndian le!islation as a !uide Mes"eciall% 'ection ;(d)N, it is ar!ued that it is T&#P' com"atible to e2clude, as the "resent #ndian le!islation does, new uses of nown com"ounds as new forms of nown substances that fail to meet the re?uisite threshold tests) The determination of where the threshold tests (for e2am"le the meanin! of ,mere, discover%, and the re?uirements for efficac% and inventive

33

ste") will be set is critical in determinin! which other inventions, other than ./0s will be "atentable) The lo!ical end+"oint of a "rocess of raisin! the thresholds re?uired would be a "osition where onl% ./0s would be re!arded as "atentable) Micro-organismsA .o /omments)

1rga!i#ati ! $ 0%armaceutica- 0r "ucer# $ I!"ia 3100I4

"e# hemical Entit$&

&estrictin! Patentabilit% to ./0s would have si!nificant ne!ative conse?uences for the discover% and develo"ments of future 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) Micro-organisms& A clear definition of micro+or!anism needs to be "rovided)

I.0. I!#titute5 @ !" !1

"e# 1' hemical Entit$&

4imitin! the !rant of "atents to ./0s8.M0s and thereb% e2cludin! other cate!ories of "harmaceutical inventions the ,"ro"osed e2clusion$ is li el% to contravene the mandate under Article 2@ of T&#P' to !rant of "atents to all ,inventions,) .either Articles @ and G nor the *oha *eclaration can be used to dero!ate from this s"ecific mandate under Article 2@) The "ro"osed e2clusion amounts to an unjustified differentiall% disadvanta!eous treatment of "harmaceutical inventions and is therefore li el% to violate the ,non discrimination, mandate under Article 2@) #t the aim of the "ro"osed e2clusion 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) 4astl%, it is im"ortant to distin!uish the "henomenon of ,ever+!reenin!, from what is commonl% referred to as ,incremental innovation,) Hhile ,ever+!reenin!, refers to an undue e2tension of a "atent mono"ol%, achieved b% e2ecutin! trivial and insi!nificant chan!es to an alread% e2istin! "atented "roduct, ,incremental innovations, are se?uential develo"ments that build on the ori!inal "atented "roduct and ma% be of tremendous value in a countr% li e #ndia) Therefore, such incremental develo"ment ou!ht to be encoura!ed b% the #ndian "atent re!ime)

2'

3'

4'

Micro-organisms& #ndia ma% not "rovide for a per se e2clusion of >micro+or!anisms$ from "atentabilit%) (owever, should #ndian "olic% im"eratives re?uire some limitation on the sco"e of

34

"rotection "rovided for >micro+or!anisms$, the T&#P' a!reement does "rovide some latitude b% which this mi!ht be achieved) #t is su!!ested that 7) The term >micro+or!anism$ could be defined in "recise terms) (owever, this route suffers from certain drawbac s and the T&#P' im"lications of such a solution are not entirel% clear) 2) The >discover%$ e2ce"tion could be stren!thened b% sti"ulatin! that mere isolation or "urification of a microor!anism b% nown "rocedures will not render it "atentable) &ather, onl% trul% >invented$ microor!anisms such as !eneticall% en!ineered ones would be !ranted "atent "rotection) (ere a!ain, in the absence of a HT6 "anel rulin! on this or a related as"ect of "atent law, the e2tent to which the >discover%$ e2ce"tion could be stretched without contravenin! T&#P' is not absolutel% certain) ;) #n "rinci"le, the >moralit%$ e2ce"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 fit well with the !overnment$s recent "olic% towards fuellin! the !rowth of the biotechnolo!% industr%) 9) The !eneral "atentabilit% criteria (novelt%, non obviousness, utilit% and written descri"tion) could be tailored to s"ecificall% a""l% to "atent a""lications claimin! micro+or!anisms) This could be in the form of e2amination !uidelines to be a""lied strictl% b% the "atent office to ensure that onl% trul% meritorious inventions are !ranted "atent "rotection) 6n the various o"tions, 2 and 9 ma% be best suited for #ndia +++ these o"tions cater a""ro"riatel% to #ndia$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')

=>S 0art!er#
"e# hemical Entit$&

#n !eneral, the sco"e of "rotection !ranted in res"ect of a dru!8chemical e2tends toA The chemical that has been disclosed The a""lication8use for which disclosed #t does not e2tend to Cndisclosed derivatives, salts, esters etc which have a si!nificant or une2"ected "ro"ert% or result Metabolites that ma% be formed u"on in!estion of dru! .ew use of the dru! 'u!!ested a""roachA #n view of the above discussion re!ardin! 'ection ;, it is su!!ested that the /ommittee ou!ht not to define the term Dnew chemical entit%D or Dnew medical entit%D) (owever, should the /ommittee "roceed to define this term, the followin! wor able definition is "ro"osedA

35

'u!!ested definitionA DA new chemical entit% is an entit% that is new, not obvious to a "erson s illed in the art in the form and for the a""lication claimedD) =inal commentsA *efinin! Dnew chemical8medical entit%D is unwarranted as far as "atent is concerned) .ew chemical entit% should never be the basis for "atentabilit%) #f the definition of Dnew chemical8medical entit%D limits or conflicts with T&#P' Art 2@ then it would violate T&#P') Patent Act is for inventors, &5* institutions)

Micro-organisms& Hith re!ard to hi!her life forms such as animals (e)!) (arvard mouse), HT6 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' ma es 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) Isolated2 3s 2#enetically modified micro-organisms1 T&#P' (Article 2@);) does not distin!uish between ,isolated, and ,!eneticall% modified 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% modified micro+or!anism would be violative of T&#P')

A-ter!ative @a, 7 rum

"e# hemical Entit$&

.o comments Micro-organism& #t is im"ortant to devise "ro"er novelt% and non+obvious tests for the "atentin! of micro+or!anisms, use the fle2ibilities 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 offer no or little inventiveness and ultimatel% would amount to discoveries) As T&#P' allows Member 'tates to define the sco"e of micro+or!anisms, "atents over micro+or!anisms should be strictl% limited to the scientific definition 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 e2clude the

36

"atentin! of materials found in nature, even if isolated or "urified from "lants and animals) B% "rovidin! a scientific definition of micro+or!anism, the Patents Act should e2clude "atents over !enes, "roteins, *.A se?uences, cells, seeds, etc) The "rior art and novelt% tests should be constructed in such a wa% that micro+ or!anisms nown to "erform a definite function or "rocess in an environment be reco!nised as alread% e2istin! or nown, in case the new claim is over the micro+ or!anism "erformin! similar functions or "rocesses in another environment or or!anism)

Ce!tre $ r Stu"y $ &- 2a- Tra"e Sy#tem a!" :eve- 'me!t

"e# hemical Entit$&

7) Pharmaceutical "roducts with annual sales totallin! nearl% P7 billion in /anada have had their mar et mono"olies e2tended b% ever !reenin! strate!ies under the "atented medicines (.otice of /om"liance) &e!ulations) 2) Brand+name dru! com"anies have em"lo%ed strate!ies under the &e!ulations to e2tend their e2clusive mar etin! ri!hts on bloc buster dru!s) ;) (ealth /anada a""roved onl% 7F new active substances in 200;, %et brand+ name dru! com"anies added 70; "atents to health /anada$s Patent &e!ister in that same %ear) 9) Cnder the &e!ulations, brand+name dru! com"anies are allowed to list "atents for uses of a dru!: even throu!h the dru! is not a""roved for that use b% (ealth /anada) Patents can be listed to restart the automatic sta% even %ears after the basic "atent on the dru! has e2"ired) 5) Polic%ma er$ concerns + Iarious "olic%ma ers have e2"ressed concerns about the &e!ulations) The &omanow &e"ort of .ovember 2G,2002 referred to ever !reenin! as a "articular concern affectin! the cost of dru!s) F) A "articular concern with current "harmaceutical industr% "ractice is the "rocess of -ever !reenin!,1 whereb% manufacturers of brand name dru!s ma e variations to e2istin! dru!s to e2tend their "atent covera!e) This dela%s the abilit% of !eneric manufacturers to develo" chea"er "roducts for the mar et"lace and is a ?uestionable outcome of /anada$s "atent law) @) A number of e2am"les illustrate the use of multi"le+"atent strate!ies to ee" !eneric "roducts off the mar et in /anada and the C)') has been em"lo%ed increasin!l% for bloc +buster dru!s whose basic "atents have e2"ired, to e2tend mar et e2clusivit% as lon! as "ossible) G) #t is im"ortant to ensure that such ever !reenin! as in /anada does not ha""en in #ndia)

37

A++EXURE IV

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38

Sr. + . 2F 2@ 2G ;0

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39

Sr. + . 'AM0 @5 @G

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43

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47

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0CT A''-icati ! A Tit-e (H6 200;802FF;@) *6'A30 =6&M =6& T&0ATM0.T 6= *#AB0T0' M044#TC' (H6 200;807725F) 6&A4 /6.T&6440* &040A'0 P(A&MA/0CT#/A4 /6MP6'#T#6. 6= A P&6J#.0T#/ A30.T (H6 200F80250@0) .0B#I6464 A.* #T' P(A&MA/0CT#/A44R A//0PTAB40 'A4T', P&6/0'' =6& P&0PA&AT#6. A.* P(A&MA/0CT#/A4 /6MP6'#T#6.' 6= .0B#I6464 (H6 20098072@00) *6'A30 =6&M /6MP&#'#.3 (#3( *6'0 (#3( '64CB40 A/T#I0 #.3&0*#0.T A' M6*#=#0* &040A'0 A.* 46H *6'0 A/T#I0 #.3&0*#0.T A' #MM0*#AT0 &040A'0 (H6 20098072FEE) M6*#=#0* &040A'0 /6MP6'#T#6. /6MP&#'#.3 /6AT0* M#/&6 MAT&#Q PA&T#/40' /6.TA#.#.3 T(0 (#3( '64CB40 A/T#I0 #.3&0*#0.T A.* A &040A'0 /6.T&644#.3 A30.T (H6 200;87097E2) /6.T&6440* &040A'0 =6&MC4AT#6. 6= 4AM6T&#3#.0 (H6 200F80E5;F;) #.B0/TAB40 P&0PA&AT#6.' 6= *#/46=0.#/ A.* #T' P(A&MA/0CT#/A44R A//0PTAB40 'A4T' (H6 200F800G@5;) /&R'TA44#.0 A.* AM6&P(6C' =6&M 6= &A.64AT#.0 A.* T(0 P&6/0'' =6& MA.C=A/TC&#.3 T(0M (H6 200F8700FGF) .6I04 P64RM6&P( =6&M 3 6= =4CIA'TAT#. '6*#CM A.* P&6/0'' =6& T(0 P&0PA&AT#6. T(0&06= (H6 200F8077759) A .6I04 P64RM6&P( 6= (7+B0.TR4+ 9+M(5,F+*#M0T(6QR+7+#.*A.6.0)+2+R4N M0T(R4 P#P0&#*#.0 (R*&6/(46&#*0 (*6.0P0T#4 (R*&6/(46&#*0) A.* A P&6/0'' =6& P&6*C/#.3 T(0&06= (H6 200F80070;7) 7+B0.TR4+9+ V (5,F+*#M0T(6QR+7+ #.*A.6.0)+2+R4W M0T(R4 P#P0&#*#.0 6QA4AT0 (*6.0P0T#4 6QA4AT0) A.* #T' P64RM6&P(' (H6 200780G@22G) 'C'TA#.0* &040A'0 P(A&MA/0CT#/A4 /6MP6'#T#6. /6.TA#.#.3 34#P#T#*0 A.* M0T(6* =6& P&6*C/#.3 'AM0 (H6 200F8059;75) .6.AUC06C' 4#UC#* PA&0.T0&A4 A/0/46=0.A/ =6&MC4AT#6. (H6 200F8077007) /6.T&6440* &040A'0 /6MP6'#T#6.' 6= *#IA4P&60Q '6*#CM (H6 200F8070EE5) /6.T&6440* &040A'0 /6MP6'#T#6.' 6= *#IA4P&60Q '6*#CM

A##ig!ee 'C. P(A&MA/0CT#/A4 #.*C'T&#0' 4#M#T0* 'C. P(A&MA/0CT#/A4 #.*C'T&#0' 4#M#T0* T6&&0.T P(A&MA/0CT#/A4' 4#M#T0* T6&&0.T P(A&MA/0CT#/A4' 4#M#T0* T6&&0.T P(A&MA/0CT#/A4' 4#M#T0* T6&&0.T P(A&MA/0CT#/A4' 4#M#T0* T&6#JAA P(A&MA/0CT#/A4' 4T* C.#/(0M 4AB6&AT6&#0' 4#M#T0* C'I 4#M#T0*

;7E

;25

;2E

;;0 ;;7 ;;2 ;;;

;;9

C'I 4#M#T0*

;;5 ;;F ;;@ ;;G ;;E

C'I 4#M#T0* C'I 4T*) I0.C' &0M0*#0' 4#M#T0* H6/J(A&*T 4#M#T0* H6/J(A&*T 4#M#T0* A++EXURE V

M1MSE+ @E1+AR:1S > CIA BraBi-ia! A''-icati ! C 30CT i!ter!ati !a- a''-icati ! a!" A r Eur 'ea! 0ate!t gra!te"4 #u2;ect matter $ t%e i!ve!ti ! c-aime"5 P70;0G0F2 (H60;0@25F9) X /italo"ram, "urified base

S.+1. 1

Curre!t #tatu# Pendin! a""lication

1,!er /i"la 4T*

48

S.+1. 2 ) * . D

BraBi-ia! A''-icati ! C 30CT i!ter!ati !a- a''-icati ! a!" A r Eur 'ea! 0ate!t gra!te"4 #u2;ect matter $ t%e i!ve!ti ! c-aime"5 P7027;;EG (H60;0;;50G) X Alendronate, amor"hous form P70;0G0F; (H60;0@25F;) + Amor"hous "harmaceuticall% acce"table salt5of)citalo"ram P70;0GF0; (H60;0G05GE) + Purified citalo"ram h%drochloride or h%drobromide P70;0G0F0 (H60;0@25F2) + Amor"hous citalo"ram base P702779GG (H60;077G2F) + /r%stalline forms of atorvastatin calcium P7077;@;2 (H6022055;) + .ovel "ol%mor"hic form of 7@+ beta +(.+ter)but%l carbamo%l)+9+a<a+5+ al"ha +androst+ 7+en+;+one P7007 0FG; (H600F;7E2) + .ovel Pol%mor"hic an =orms of Antidiabetic A!ent P#077F5@7 (H6002057G7E) + .ovel o2a<olidinone /om"und P7EG72@@0 + .ovel antiobesit% and h%"ocholesterolemic com"ounds P7E@770EG (/A225GE9E) + .ovel antidiabetic comPounds P707797EF (H6022F@;@) + .ovel "ol%mor"hic8"seudo"ol%mor"hic forms of 5+M9+M2M.+ meth%l+.+(2+"%rid%l)aminoNetho2%Nben<%lN thia<olidine+2,9+ dione maleate P7077@059 (H6027 02@@@) + .ovel "ol%mor"h of =e2ofenadine and =e2ofenadine h%drochloride P#0279F@5 + .ovel antidiabetic, h%"oli"idemic, antiobesit% and h%"ocholesterolemic com"ounds P7EG72@@2 (H6EE7E;7;)+ Beta +ar%l+ al"ha + o2%substituted al %lcarbo2%lic acids P70272EE0 (H60;02@77G)X Pharmaceuticall% acce"table salts of 20(')+cam"othecins P (0P0G9@;E@B7) + Hater+soluble /+rin! analo!ues of 20(')+cam"tothecin

Curre!t #tatu# Pendin! a""lication Pendin! a""lication Pendin! a""lication Pendin! a""lication Pendin! a""lication

1,!er /i"la 4T* /i"la 4T* /i"la 4T* /i"la 4T* *r) &edd%$s 4ab) 4td

E F G

Pendin! a""lication Pendin! a""lication Pendin! a""lication Pendin! a""lication Pendin! a""lication

*r) &edd%$s 4ab) 4td *r) &edd%$s &esearch =oundation *r) &edd%$s &esearch =oundation *r) &edd%$s &esearch =oundation #./) + &edd%+ /heminor *r) &edd%$s &esearch =oundation #./) + &edd%+ /heminor

10 11

12 1) 1*

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*r) &edd%$s &esearch =oundation *r) &edd%$s 4ab) 4td *r) &edd%$s 4ab) 4td *r) &edd%$s &esearch =oundation #./) + &edd%+ /heminor *r) &edd%$s 4ab) 4td *r) &edd%$s &esearch =oundation #./) + &edd%+ /heminor

1. 1D

1E

&e!ularl% filed "endin! "harmaceutical "atent a""lications filed b% #ndian cor"oration in Bra<il and its corres"ondin! 0uro"ean Patents (!ranted b% the 0P6) or international a""lications filed via the Patent /oo"eration Treat% (H#P6+ P/T) 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 "atents1: >ever!reenin!1 or ihe same nown substance)1 / Momsen, 4eonardos 5 /ia, 2005)

1F

P7EE7 5G;5 (H600;27 E7) + 'table "harmaceutical com"osition containin! 5+MM9+M;+Meth%l+9+ o2o+;,9+ dih%dro+2+ ?uina<olin%lNmetho2%j"hen%l +meth%lN thiadia<olidine +2,9+dione

Pendin! a""lication

.6I6 .6&*#'J A8' and &edd%,s &esearch =oundation

49

S.+1. 1G

BraBi-ia! A''-icati ! C 30CT i!ter!ati !a- a''-icati ! a!" A r Eur 'ea! 0ate!t gra!te"4 #u2;ect matter $ t%e i!ve!ti ! c-aime"5 P7027;;G0 (H60;0;;9G7, H60;0;;95F) + Pro"ionic acid derivatives

Curre!t #tatu# Pendin! a""lication

1,!er *r) &edd%$s 4ab) 4td

20 21 22

P700707;E (H600FF5@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 P7EE799;G (H6002F200) + #m"roved "rocess for the "re"aration of antidiabetic com"ounds P7027;;50 (H60;0;;9G7, H60;0;;95F) + Pro"ionic acid derivatives

Pendin! a""lication Pendin! a""lication Pendin! a""lication

*r) &edd%$s &esearch =oundation *r) &edd%$s &esearch =oundation *r) &edd%$s 4ab) 4td

2)

P @755 (H60050979) + (%"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) P7EE799E; (H600i 5F;G) + #m"roved "rocess for the "re"aration of 5+M9+MM;+Meth%l+9+o2o+;,9+ dih%dro?uina<olin+2+%lNmetho2%N ben<%lN thia<olidine+2, 9+ dione

Pendin! a""lication

*r) &edd%$s &esearch =oundation

2*

Pendin! a""lication

*r) &edd%$s &esearch =oundation

2.

P#7070G0F9 (H6075@02F)+ *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 4ab) 4td

2D

P#07790;7 (H6027G;E0) + Method for the "re"aration of h%drates of 6lan<a"ine, "rocess for conversion of olan<a"ine reffered to as form+#

Pendin! a""lication

*r) &edd%,s 4ab) 4td

&e!ularl% filed "endin! "harmaceutical "atent a""lications filed b% #ndian cor"oration in Bra<il and its corres"ondin! 0uro"ean Patents (!ranted b% the 0P6) or international a""lications filed via the Patent /oo"eration Treat% (H#P6+ P/T) 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 "atents1: >ever!reenin!1 or ihe same nown substance)1 / Momsen, 4eonardos 5 /ia, 2005)

2E 2F

P#0272@@2 (H60;02@0@2) + cost effective and industriall% advanta!eous "rocess for the "re"aration of re"a!linide P#0;72@2G (H62009079;;@) + *is"ersible tablets of ce"hale2in

Pendin! a""lication Pendin! a""lication

&anba2% 4ab) 4td) &anba2% 4ab) 4td)

50

S.+1. 2G

BraBi-ia! A''-icati ! C 30CT i!ter!ati !a- a''-icati ! a!" A r Eur 'ea! 0ate!t gra!te"4 #u2;ect matter $ t%e i!ve!ti ! c-aime"5 P#0275FGF (H60;0G9597) + /arbo2imide derivatives

Curre!t #tatu# Pendin! a""lication

1,!er &anba2% 4ab) 4td)

)0

P#070F@52 (H607E5GGF) + Bioavilable "harmaceutical com"osition of 7;+cis vitamin A acid (also nown as 7;+ cis retinoic acid and isotretinoin)

Pendin! a""lication

&anba2% 4ab) 4td)

)1

"i07777E; (H607E009E) + .ovel amor"hous form of sertraline h%drochloride P#0;0FE2G (H60;05E;;0) + 'table "harmaceutical com"ositions com"risin! A/0 inhibitor(s) P#0770E2F (H607G@G;7) + .ovel amor"hous form of ome"ra<ole salts P#070GE5G (H607F97G;) + 6nce dail% tablet formulation for oral administration in humans for the controlled release of ci"roflo2acin P#0;0GEGE (H60;0G2297) + Pharmaceutical com"osition which includes microni<ed clarithrom%cin and e2hibits im"roved dissolution characteristics relative to a "harmaceutical com"osition that includes Aunmicrofli<ed clarithrom%cin P70272E;7 (H60;02G@09) + 02tended release"harmaceutical com"osition containin! metforrnin P70;0GEE0 (H60;0G229G) + Pharmaceutical com"osition which includes er%throm%cin A or a derivative thereof and al!inic add P70072GFF (0P7 209F;@B7) + Process for the "re"aration of isotretinoin, in a sin!le ste") P702 (0P792;0E@) + /ontrolled release formulation of clarithrorn%cin or tinida<ol P7020EG92 (H6020E9G2G) + Process for the "re"aration of imi"enem

Pendin! a""lication Pendin! a""lication Pendin! a""lication Pendin! a""lication

&anba2% 4ab) 4td)

)2

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))

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).

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&anba2% 4ab) 4td)

)D

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)G

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&e!ularl% filed "endin! "harmaceutical "atent a""lications filed b% #ndian cor"oration in Bra<il and its corres"ondin! 0uro"ean Patents (!ranted b% the 0P6) or international a""lications filed via the Patent /oo"eration Treat% (H#P6+ P/T) 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 "atents1: >ever!reenin!1 or ihe same nown substance)1 / Momsen, 4eonardos 5 /ia, 2005)

*1

P70072GF9 (H6070GF;;)+ Process for the "roduction of an im"roved torn, of =orm # celi"rolol h%drochloride P7020EG9; (H6020E9@92) + /ost effective and industriall% advanta!eous "rocess for the "re"aration of amor"hous cilastatin sodium)

Pendin! a""lication

&anba2% 4ab) 4td)

*2

Pendin! a""lication

&anba2% 4ab) 4td)

51

S.+1. *)

BraBi-ia! A''-icati ! C 30CT i!ter!ati !a- a''-icati ! a!" A r Eur 'ea! 0ate!t gra!te"4 #u2;ect matter $ t%e i!ve!ti ! c-aime"5 P7027 092F (H602700;2;) + Meth%l analo! of simvastatin P707725E@ (H60205G7F) + Bioavailable oral dosa!e form of loratadine of s"ecific "article si<e and surface area) P7007F900 (H60799799 ) + Process for the "re"eraCon of sodium salts of statins, namel% /om"actin, 4ovastatin and Pravastatin P70;77F92 (H60;70;F;5)) 02tended release "harmaceutical com"osition com"risin! divai"roe2 P70275FG5 (H60;6G9E2G) Al"ha,orne!a+ dicarbo2imide derivatives P#077;702 (H60277@7F) + 4i?uid formulation of metformin P#07725EG (H6020F2GE) + Process for the "re"aration of hi!hl% "ure cr%stalline form of cefuro2ime a2etil

Curre!t #tatu# Pendin! a""lication

1,!er &anba2% 4ab) 4td)

**

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&anba2% 4ab) 4td)

*. *D *E *F

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&anba2% 4ab) 4td) &anba2% 4ab) 4td) &anba2% 4ab) 4td) &anba2% 4ab) 4td) &anba2% 4ab) 4td)

*G .0 .1 P#0;777E5 (H60;0E@F79) + Process for the "re"aration of &osuvastatin P#0;0EG5; (H60;0E2FF0) + Monocom"artment osmotic controlled dru! deliver% s%stem P#0779700 (H6022920;) + Pharmaceutical com"osition in the form of an oral controlled release solid dosa!e form .2 P#0772029 (H60200F75) + Process for the "re"aration and isolation of the h%"oli"aemic active substance lovastatin in substantiall% "ure form .) P#027920E (H60;092275) + /ost effective and industriall% advanta!eous "rocess for the "re"aration of imi"enem of hi!h "urit% .* P#0272G0@ (H60;02FF70) + Process for the "re"aration of fast dissolvin! dosa!e form, such as tablet, which disinte!rates ?uic l% in the mouth .. .D P#020@F90 (H6020F@E9;) + 'table "harmaceutical com"osition of cef"odo2ime "ro2etil

Pendin! a""lication Pendin! a""lication Pendin! a""lication &anba2% 4ab) 4td) &anba2% 4ab) 4td) &anba2% 4ab) 4td) Pendin! a""lication Pendin! a""lication

&anba2% 4ab) 4td)

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&anba2% 4ab) 4td)

Pendin! a""lication

&anba2% 4ab) 4td)

Pendin! a""lication

&anba2% 4ab) 4td)

&e!ularl% filed "endin! "harmaceutical "atent a""lications filed b% #ndian cor"oration in Bra<il and its corres"ondin! 0uro"ean Patents (!ranted b% the 0P6) or international a""lications filed via the Patent /oo"eration Treat% (H#P6+ P/T) 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 "atents1: >ever!reenin!1 or ihe same nown substance)1 / Momsen, 4eonardos 5 /ia, 2005) P#020EG99 (H6020E9@@;) + /ost effective and industriall% advanta!eous "rocess for the "re"aration of imi"enem of hi!h "urit% .E .F P#0;700@9 (H60;0E@05E) + Pol%mor"hic forms of "hen%l o2a<olidinone derivatives Pendin! a""lication &anba2% 4ab) 4td) Pendin! a""lication &anba2% 4ab) 4td)

52

S.+1. .G

BraBi-ia! A''-icati ! C 30CT i!ter!ati !a- a''-icati ! a!" A r Eur 'ea! 0ate!t gra!te"4 #u2;ect matter $ t%e i!ve!ti ! c-aime"5 P#0772G2F (H6020F2@G) + 'ubstituted "hen%l o2a<olidinones P#0070E2; (H600@777F) + Process for the "re"aration of amor"hous atorvastatin calcium and h%drates

Curre!t #tatu# Pendin! a""lication Pendin! a""lication

1,!er &anba2% 4ab) 4td) &anba2% 4ab) 4td)

D0 P#0272;E0 (H60;07G599) + 0fficient and industriall% advanta!eous "rocess for the "re"aratiobn of "ure cilastatin) D1 P#00779E0 (H600@@00F) + Process for the "re"aration of the esters of 7,G+disubstituted+7,;,9,E+tetrah%dro"%rano (;,9+b)+indole+7+acetic acid D2 P#EE72;7G (H60005205) + .ovel "i"era<ine derivatives substituted on one nitro!en b% an aromatic s%stem and on the other nitro!en b% (2,5+dio2o"%rrolidin)+7+%l) al anes or (2,F+dio2o"i"eridin+7+%l) al anes D) D* P#020EG95 (H6020E9@@9) + *osa!e forms of o2carba<e"ine for "ral administration P#020@GE5 (H6020@25F5) + #m"roved and industriall% advanta!eous "rocess for the "re"aration of citalo"ram D. P#000@9GE (0P7799925B7) + 'ubstituted "entose and he2ose monosaccharide derivative DD P#000@55; (0P779@77EB7) + 2,;+6+iso"ro"%lidene derivatives of monosaccharides as cell adhesion inhibitors DE DF P#0775GF5 (H60299757) + 7,9+disubstituted "i"era<ine derivatives P#0072EG7 (H6077097E) + 3astro+retentive oral dru! deliver% s%stem structurall% com"rised of a hi!hl% "orous matri2 com"risin! a dru! DG E0 E1 P#0;0E2EG (H60;0GF;F2) + 'table bu"ro"ion h%drochloride tablet P#020G509 (H6020@F;@F) + 'table "harmaceutical com"osition of "ravastatin Pendin! a""lication Pendin! a""lication &anba2% 4ab) 4td) &anba2% 4ab) 4td) Pendin! a""lication Pendin! a""lication &anba2% 4ab) 4td) &anba2% 4ab) 4td) Pendin! a""lication &anba2% 4ab) 4td) Pendin! a""lication &anba2% 4ab) 4td) Pendin! a""lication Pendin! a""lication &anba2% 4ab) 4td) &anba2% 4ab) 4td) Pendin! a""lication &anba2% 4ab) 4td) Pendin! a""lication &anba2% 4ab) 4td) Pendin! a""lication &anba2% 4ab) 4td)

&e!ularl% filed "endin! "harmaceutical "atent a""lications filed b% #ndian cor"oration in Bra<il and its corres"ondin! 0uro"ean Patents (!ranted b% the 0P6) or international a""lications filed via the Patent /oo"eration Treat% (H#P6+ P/T) 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 "atents1: >ever!reenin!1 or ihe same nown substance)1 / Momsen, 4eonardos 5 /ia, 2005) P#0;0E77; (H60;0G9579) + /ontrolled released "harmaceutical com"osition of carbido"a and levodo"a E2 P#0272;GG(H60;07G522)+ #ndustriall% advanta!eous "rocess for the "re"aration of beta+ ion%lidencacetaldeh%de Pendin! a""lication &anba2% 4ab) 4td Pendin! a""lication &anba2% 4ab) 4td)

E)

53

S.+1.

BraBi-ia! A''-icati ! C 30CT i!ter!ati !a- a''-icati ! a!" A r Eur 'ea! 0ate!t gra!te"4 #u2;ect matter $ t%e i!ve!ti ! c-aime"5 P#EE70@2; (H6EEF7022)+A stable oral "harmaceutical com"osition containin! a substituted "%rid%lsulfin%l ben<imida<ole P#077;FF7 (H6027@E2;)+ Pharmaceutical com"osition for tro"ical deliver% com"risin! a c%cloo2%!enase+2 en<%me inhibitor) P#EE7@27E (H6005F2FF)+/oatin! com"osition for the film coatin! of "harmaceutical cores P#020G57; (H6020@F;@5) Proceass for the "re"aration of bena<e"ril P#0770E@0(0P72G@00;B7)+ Process for the "re"aration of a "ure and "harmaco"oeial amor"hous form of cefuro2ime a2etil

Curre!t #tatu# Pendin! a""lication

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P#EE7;FEF (H600757EG)+ Pharmaceutical com"osition in the form of tablets or ca"sules "rovides a combination of tem"oral and s"atial control of dru! deliver% P#077F5@0 (H60205790G)+ *erivatives of s"eciall% substituted a<ole com"ounds Pendin! a""lication

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P#000E7@@(0P77F5057B7)+Process of mi2in! of cr%satlline cefuro2ime a2etil with amor"hous cefuro2ime a2etil for the "re"aration of a bioavailable oral dosa!e form com"risin! amor"hous cefuro2ime a2etil Pendin! a""lication P#0770E25(0P72G;G27B7)+ /ost effective and industriall% advanta!eous "rocess for the selective meth%lation of a h%dro2% !rou" at the F "osition of er%throm%cin A Pendin! a""lication

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P#020GEEE(H6020G;F;9)+#m"roved and cost effective "rocess for the industrial "re"aration of cef"odo2ime acid

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&e!ularl% filed "endin! "harmaceutical "atent a""lications filed b% #ndian cor"oration in Bra<il and its corres"ondin! 0uro"ean Patents (!ranted b% the 0P6) or international a""lications filed via the Patent /oo"eration Treat% (H#P6+ P/T) 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 "atents1: >ever!reenin!1 or ihe same nown substance)1 / Momsen, 4eonardos 5 /ia, 2005)

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54

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BraBi-ia! A''-icati ! C 30CT i!ter!ati !a- a''-icati ! a!" A r Eur 'ea! 0ate!t gra!te"4 #u2;ect matter $ t%e i!ve!ti ! c-aime"5

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&e!ularl% filed "endin! "harmaceutical "atent a""lications filed b% #ndian cor"oration in Bra<il and its corres"ondin! 0uro"ean Patents (!ranted b% the 0P6) or international a""lications filed via the Patent /oo"eration Treat% (H#P6+ P/T) 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 "atents1: >ever!reenin!1 or ihe same nown substance)1 / Momsen, 4eonardos 5 /ia, 2005)

55