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Department of Legal Studies Synopsis-2013: B.A. LL.B. (Hons.), Sem-VII (Sec A)

The Supreme Court of India rejected Novartis AG's attempt to obtain patent protection for Gleevec, a major cancer drug. While criticized by pharmaceutical companies, public health activists praised the decision as it would allow India to produce inexpensive generics for the developing world. The legal battle highlighted tensions between public health and intellectual property rights. The Supreme Court found that Gleevec failed to meet the tests of invention and patentability under Indian law.

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Devika Agarwal
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73 views

Department of Legal Studies Synopsis-2013: B.A. LL.B. (Hons.), Sem-VII (Sec A)

The Supreme Court of India rejected Novartis AG's attempt to obtain patent protection for Gleevec, a major cancer drug. While criticized by pharmaceutical companies, public health activists praised the decision as it would allow India to produce inexpensive generics for the developing world. The legal battle highlighted tensions between public health and intellectual property rights. The Supreme Court found that Gleevec failed to meet the tests of invention and patentability under Indian law.

Uploaded by

Devika Agarwal
Copyright
© Attribution Non-Commercial (BY-NC)
We take content rights seriously. If you suspect this is your content, claim it here.
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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;:

,+ailable at F1ttp:GGwww3)stor3orgGdis*o+erG103230HG!02H43HHI uidJ3H3C274KuidJ213!KuidJ1741C214KuidJ17!47762KuidJ2KuidJH76HH4KuidJH0KuidJ3KuidJ1741C20 CKuidJH4KuidJ40KsidJ2110277CH061!HL Last a**essed on 10GCG2013


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,+ailable at F1ttp:GGwww3palgra+e-)ournals3*omGbioso*G)ournalG+3Gn2GabsGbioso*200C16a31tmlL Last a**essed on 11GCG2013


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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

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