Dr.

Ram Manohar Lohiya National Law University

B.A. LL.B. (Hons.), Sem-VII (Sec A)

Department of Legal Studies Synopsis-2013

Topic- Case Comment on Novartis A.G. v. UOI
Subject: Intellectual Property Ri !ts-II Submitted to:
Mr. Vikas Bhati

Submitted by:
Devika Agarwal
Enrollment o:

Asstt. Pro". (Law)

1001010!!

" #$%D&'#"% : "ndia(s Supreme 'ourt re)e*ted o+artis ,-(s attempt to win patent prote*tion for a ma)or *an*er drug. a landmar/ )udgment roundly *riti*i0ed by p1arma*euti*al *ompanies but praised by publi*-1ealt1 a*ti+ists. w1o said it would prote*t "ndia(s ability to ma/e ine2pensi+e generi*s for t1e de+eloping world3 #1e *ase began w1en "ndia first re)e*ted o+artis( patent appli*ation in 2004 for -li+e*.

/nown in t1e &3S3 as -lee+e*3 #1e legal fig1t 1as been a *losely wat*1ed struggle 1ig1lig1ting t1e tensions between publi*-1ealt1 interests and intelle*tual-property rig1ts3 "ndia for years didn(t offer patent prote*tion for *1emi*al *ompounds. but was obliged to do so after )oining t1e 5orld #rade %rgani0ation in 16673 "n 2007. it amended its patent prote*tion a*t to in*lude su*1 *ompounds. but said p1arma*euti*al *ompanies 1ad to pro+e signifi*ant *lini*al effi*a*y en1an*ements of t1eir drugs o+er already-patented *ompounds3 "n 2004. "ndia(s patent offi*e ruled against 1anding a patent to -li+e*. arguing t1at t1e drug(s a*ti+e ingredient. imatinib mesylate. was already /nown before -li+e*(s de+elopment3 o+artis foug1t ba*/ t1roug1 +arious *ourt *ases and appeals. saying t1at -li+e*(s no+elty was t1at it transformed t1e *1emi*al *ompound to a 8beta *rystal8 form. ma/ing it a +iable treatment for *an*er3 "n 2006 it filed a *ase wit1 t1e Supreme 'ourt *1allenging t1e patent denial and aspe*ts of "ndian patent law t1at it said defined inno+ation too narrowly3 #1e Supreme 'ourt re)e*ted t1e *ompany(s arguments3 , two-)udge ben*1 found -li+e* 1ad failed 8in bot1 t1e tests of in+ention and patentability38 , pertinent issue in t1is *ase was t1at of patentable sub)e*t-matter and w1et1er -li+e* fulfilled t1e re9uirement of patentable sub)e*t-matter or not3

$ESE,$': ;E#:%D%L%-<: #1e resear*1er 1as employed t1e Doctrinal Method of Research.

L"#E$,#&$E S&$=E<: S3 Srini+asan in >?attling @atent Laws: #1e -li+e* 'aseA 1 1as emp1asi0ed t1at t1is is a strong *ase for *ertain t1erapeuti* *lass of drugs important for publi* 1ealt1 being ta/en outside t1e pur+iew of legal disputation3 Stefan E*/s in >-lobal @1arma*euti*al ;ar/ets and 'orporate 'iti0ens1ip: #1e 'ase of o+artisA ,nti-*an*er Drug -li+e*A2 states t1at w1ile 1ealt1 a*ti+ists *elebrated t1e *ourt(s de*ision as a +i*tory for anti-*orporate *iti0ens. elsew1ere: to prote*t its profits in European and o+artis groups. and 1ow w1en it seemed to fail3 Linda L3 Lee in >#rials and #$"@S-ulations: "ndian @atent Law and Novartis AG v. Union of IndiaA (23 ?er/eley #e*13 L3B3 2C1 (200C))3 e2plores t1e possibility of grant of patent on -li+e* /eeping in mind "ndiaAs obligations under #$"@s3 o+artis won a more important battle ort1 ,meri*an mar/ets3 #1e arti*le t1en

goes on to e2plain 1ow *laims to >*iti0ens1ipA were mobili0ed by bot1 anti- o+artis and proo+artisA global *orporate *iti0ens1ip programme su**eeded e+en

#E #,#"=E ':,@#E$"D,#"% : '1apter 1: "ntrodu*tion '1apter 2: Ea*ts and 1istory of t1e *ase '1apter 3: "ssue(s) in+ol+ed '1apter !: Budgment deli+ered '1apter 7: 'on*lusion S#,#E;E # %E @$%?LE;:

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#1e )udgment deli+ered by t1e :onAble Supreme 'ourt in Novartis AG v. Union of India 1as not *on*lusi+ely resol+ed t1e issue of w1et1er s33(d) of #1e @atent ,*t 16H0 is in *omplian*e wit1 #$"@S or not3

S'%@E %E #:E $ESE,$':: #1e s*ope of t1e pro)e*t is to e2plore t1e issue w1i*1 was left unresol+ed by t1e Supreme 'ourt in t1is *ase. i3e3. 51et1er s33(d) of #1e @atent ,*t 16H0 is in *omplian*e wit1 #$"@s or notI

$ESE,$': M&ES#"% (S): "s se*tion 3(d) of #1e @atent ,*t 16H0 in *omplian*e wit1 #$"@sI