SEM: VI (BT)
L: 03
SUBJECT: IPR BIOETHICS & BIOSAFETY
P: 00
T: 0
COURSE OBJECTIVES: To have a view at the laws governing biotechnolog an! I"#$ relate! at national an! international • level To gain %nowle!ge abo&t sa'et reca&tions necessar !&ring biotechnological wor% • To eval&ate the ethical ersective o' han!ling bioaterials • COURSE OUTCOMES: To be aware o' r&les an! reg&lations set& at international level 'or vario&s b iotechnolog relate! • wor% so that an '&rther research can be 'or&late! accor!ingl To %now the social an! legal state o' the societ with resect to geneticall engineere! ro!&cts • or other o&tcoes o' biotechnolog *or% *or% accor!ing to the sa'et reca&tions set & b international bo!ies while han!ling bio ha+ar!o&s aterial • REFERENCES: Reference Books – 1, I"#$ Biosa'et an! Bioethics b -eea .oel an! Shoini "arasha /, Intellect&al roert rights b -r, #e!!
SESSION PLAN Un!
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-e'ine I"# an! the !i''erent araeters that that coe &n!er I"#
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-escribe !i''erent tes o' Intellect&al Intellect&al "roert rights an! there s&btes which hel in categori+ing the tes,
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-escribe the !i' !i''erent tes es o' atents,
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E6l 6lain ain the !i' !i''ere erent co origh rightt law laws an! governing bo! arovals 'or vario&s corights,
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E6lain abo&t the !i''erent tra!ear%s &se! b coanies an! how geograhical in!ication allows the &sage o' these tra!ear%s,
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-esc -escri ribe be !i' !i''erent rent I"# in' in'ring ringeeent ent or breach an! the e''ect o' those with a sile case st&!,
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State vario&s laws &s &se! to gove overn the iss&ing o' the arovals o' coright atent an! tra!ear%s,
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E6lain how the registration o' !esigns an! lant acts are ileente! ileente! an! the geograhical variations,
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Enlist va vario&s In International conventions &se! in I"# an! Bioethics,
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-esc -escri ribe be the the !i !i''erent rent conv onvent entions ons &n!er the Berne conventions rotecting the rights rights o' artist an! the .;TT agreeent which covers the International tra!e an! the olicies covere! covere! &n!er it,
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Intellect&al In!r In!ro, o,#c #c! !on on !o In!e In!e++ ++ec ec!# !#%+ %+ Pro* Pro*er er!/ !/ Concet o' Intellect&al "roert Tra!ear%s$ .eograhical In!ication, In'ringeent o' I"#, Its rotection an! #ee!ies icensing an! its Tes in!s o' Intellect&al "roert 2 1, atents /, in!&strial !esigns 3, tra!e secrets in!s o' Intellect&al "roert "atents 2 , con'i!ential in'oration 4, lao&t5!esigns o' integrate! circ&its circ&its Corights 2 e6ression o' i!eas /, coright law 3, Coright rotection , coright non rotection -esigns 2 #egistere! -esign /, Unregistere! !esigns Tra!ear%s Tra!ear%s 7 .eograhical In!ication 2 i, Tra!ear% Classi'ication ii, Tra!ear% Sbols iii, 8ther ar%s B, .eograhical In!ication 2 "rotection o' .eograhical In!ication ii, #ights an! #ee!ies In'ringeent o' I"# 2 i, irac ii, Tra!ear% In'ringeent iii, #egistere! -esign In'ringeent Its rotection an! #ee!ies icensing an! its Tes 2 i, I"8S ;ct ii, Coright ;ct iii, "atent ;ct iv, Tra!ear% acts v, #egistere! -esigns vi, "lant varieties act vii, .eograhical -esigns ;ct
International Scenario 2 Intro!&ction to the lea!ing international instr&ents concerning intellect&al roert rights,
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The Berne Convention 2 i, ;rtistic an! literal aterial ii, ><ilateral convention iii, ter o' rotection iv, iitations 7 reg&lation .;TT 2 general agreeent o' tari'' an! tra!e
i, International tra!e goo!s ;ssociation o' .;TT 7 *T8 'or the categori+ation o' goo!s 11
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Enlist I?-I;? "atent act an! what were the changes an! other acts that were intro!&ce! in the In!ian In!&str
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;nal+e the Universal co right rotection act an! the "aris convention in rotecting rights 'or in!&strial ro ert,
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Enlist Tra!e relate! seci'icities on a global lat'or an! the treaties relate! to it,
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E6lain the role o' *I"8 'or the grants o' atents an! how it onitors local bo!ies on the sae,
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Enlist the B&!aest treat an! !isclos&re !isc&sse! 'or a &ni'or international !eosit sste,
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-escribe the sa'eg&ar! !eosit olicies an! the act&al eaning o' the ter icroorganiss in regar!s to the treat,
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Enlist the stes in atents wo&l! be iss&e! seeing the vario&s arts o' the new innovation,
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-isc&ss abo&t the rior en!ing atent alications when a new atent is alie! 'ro a coon so&rce,
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ist the artic&lar areas coing &n!er atentable an! non atentable categor an! how it varies 'ro co&ntr to co&ntr,
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E6lain how a researcher can al 'or a atent an! the legal asects heshe nee!s to loo% 'or while aling,
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-escribe the vario&s atent in'ringeent cases with an case st&!,
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ist how the Biological atentabilit wor%s an! to which olec&les coe &n!er this categor,
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E6lain correlation o' I"# an! biotechnolog with the International bo!iesD scenario,
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-escribe the 'arer an! lant bree!er rights 'or conservation o' &re lant varieties,
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In!ian "atent ;ct Establishent o' ;ct 2 1=0 an! aen!ents, #&les an! reg&lations 2 i, @or Coright ii, 'or "atents Universal Coright Convention 2 i, Contracting state ii, ;rticles I 5 AVII The "aris Convention 2 "rotection 'or In!&strial roert T#I"S 2 Tra!e5#elate! ;sects o' Intellect&al "roert #ights i, S"ECI@IC ISSUES ii, geograhical in!ication 7 health iii, ;nel -ra't The *orl! Intellect&al "roert #ights 8rgani+ation (*I"8) 2 .overning bo! it Ilications an! r&les an! reg&lations,
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B&!aest treat 2 -eosit o' >icroorganiss 'or the "&roses o' "atent "roce!&re i, -isclos&re an! the #e&ireent 'or -eosit ii, ?ee! 'or a Uni'or International -eosit Sste b, International -eositar ;&thorities an! #ecognition o' Single -eosit ii, -eosit an! @&rnishing o' Sales iii, Sa'eg&ar! o' -eosits iv, >eaning o' the Ter >icroorganis "atents 5 #e&ireent o' atentable novelt i, I!eas ii, #esearch iii, Technological ;!vanceent with soe Inventive Ste, "rior art 2 "en!ing "atent ;lications i, ?ovelt ii, Vali!it iii, Clearance Classi'ing ro!&cts as atentable an! non5atentable i, B&siness etho! atents ii, So'tware atents
"roce!&re 'or aling 'or atent 2 i, Tr&e an! 'irst inventor ii, Tr&e an! 'irst inventorDs assignee iii, egal reresentative o' !ecease! tr&e an! 'irst inventor or hisher assignee "atent In'ringeent an! relate! case st&!ies 2 i, ;le vs, Sas&ng ii, ?ovartis hara vs, Union o' In!ia Biological "atentabilit 2 i, lant ro!&cts ii, olec&les iii, -r&g "atents I"# an! Biotechnolog 5 Congress o' the Unite! States$ 8''ice o' Technolog ;ssessent$ 1==0,
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@arers #ights an! "lant bree!ers rights 2 new varieties o' lants ii, Conserving iroving an! rovi!ing new lant varieties
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;nal+e the Bio!iversit act an! which all areas it covers,
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-escribe Bioirac an! how Bioirac has le! to lot o' in'ringeent,
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Bio!iversit 5 Bio!iversit ;ct "olicies ileente! b the ;ct
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Bioirac 2 #ero!&ce witho&t erission 'or own bene'it ca&sing Coright in'ringeent, ii, &n'air 'ree5ri!ing on genetic reso&rces iii, Una&thori+e! an! &n coensate! collection 'or coercial en!s o' genetic reso&rces an!or tra!itional %nowle!ge,
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Enlist rosects o' new ro!&cts an! the %nowle!ge o' bioactive coo&n!s with the 'ao&s ICB. controvers,
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E6lain the vario&s Biosa'et eas&re ta%en to revent the containants an! the 'ao&s Cartagena rotocol on Biosa'et,
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ist the !i''erent biological sa'et cabinets an! the ris% assessent etho!s an! IC.EB convention,
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ist the sa'et iss&es concerne! with the &se o' .>8 an! >8 an! the ris%s associate! with the &se o' these ro!&cts,
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Enlist the vario&s olicies o' #C.> an! .E;C 'or the aroval o' .>8,
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Enlist the ris% associate! with the &se o' .>8 in the 'oo! an! agric<&re in!&str,
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-escribe Bioethical iss&es relate! to the healthcare 'oo! an! e!icine In!&str,
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E6lain concerns on the &se o' .>8 an! the coerciall arove! .>8 cros in the ar%et,
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-escribe Bioethical iss&es relate! to U>;? .enoe "roFect,
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E6lain the e''ects o' .eneticall o!i'ie! cros on environent an! &an ealth
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Biorosecting 2 -iscover an! coerciali+ation o' new ro!&cts ii, In!igeno&s %nowle!ge o' Bioactive coo&n!s iii, >aa ICB. controvers Biosa'et 5 .oo! ab "ractices i, IC g&i!elines 'or lab ractices ii, .>" iii, ." iv, Cartagena "rotocol on Biosa'et Intro!&ction to Biological Sa'et Cabinets 5 "riar Containent 'or Bioha+ar!s i, Class III Biosa'et cabinet ii, Class I$ II$ III$ IV Biosa'et evel, iii, #is% ;ssessent an! .ro& s iv, IC.EB Convention an! acts Biosa'et evels .>8s 2 .ene atenting ii,, Bioethical ractices relate! to .>8 iii, Biosa'et in >icrobiolog an! Bioe!ical aborator >8s 2 iving >o!i'ie! 8rganiss i, Convention on Biological -iversit ii, #is% assessent o' >8 B, Their environental iact 2 ;I; ;greeent ii, >8s 2 @@" #oles o' Instit&tional Biosa'et Coittee 2 i, #C.> #&les ii, .E;C #&les @or .>8 alications in 'oo! an! agric<&re 2 i, #is% analsis assessent an! anageent
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Bioethics 5 Bioethical iss&es relate! to ealthcare ii, Bioethical iss&es in e!icine$ @oo! 7 agric<&re
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.enetic engineering 2 .>8 i, Concerns relate! to .E 'oo!s ii, "ro!&cts arove! coerciall in the ar%et The &an .enoe "roFect 2
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.enetic Testing Environental robles 2 a+ar!s ca&se! b the Intro!&ction o' .eneticall Engineere! cros ro!&cing e''ects on Soil an! &an ealth