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Supreme_Court_Patent_verdict

Supreme_Court_Patent_verdict

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Published by ndtvonline
The ruling is a serious blow to global pharmaceutical firms which are increasingly focusing on India to drive sales
The ruling is a serious blow to global pharmaceutical firms which are increasingly focusing on India to drive sales

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Published by: ndtvonline on Apr 01, 2013
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04/10/2013

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Page 1
 
REPORTABLE
IN THE SUPREME COURT OF INDIACIVIL APPELLATE JURISDICTION
CIVIL APPEAL Nos. 2706-2716 OF 2013
(ARISING OUT OF SLP(C) Nos. 20539-20549 OF 2009) NOVARTIS AG ….APPELLANTVERSUSUNION OF INDIA & OTHERS.RESPONDENTS
WITH
 
CIVIL APPEAL No. 2728 OF 2013
(ARISING OUT OF SLP(C) No. 32706 OF 2009) NATCO PHARMA LTD. ….APPELLANTVERSUSUNION OF INDIA & OTHERS ….RESPONDENTS
ANDCIVIL APPEAL Nos. 2717-2727 OF 2013
(ARISING OUT OF SLP(C) Nos. 12984-12994 OF 2013)SLP(C)………../2011 CC Nos.6667-6677M/S CANCER PATIENTSAID ASSOCIATION ….APPELLANTVersusUNION OF INDIA & OTHERS ….RESPONDENTS
 
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J U D G M E N TAftab Alam, J.
1.Delay condoned.2.Leave granted in all the special leave petitions.3.What is the true import of section 3(d) of the Patents Act, 1970? How does itinterplay with clauses (j) and (ja) of section 2(1)? Does the product for which the appellantclaims patent qualify as a “new product” which comes by through an invention that has a
 feature
that involves
technical advance over the existing knowledge and that makes theinvention “not obvious” to a person skilled in the art 
? In case the appellant’s productsatisfies the tests and thus qualifies as “invention” within the meaning of clauses (j) and(ja) of section 2(1), can its patentability still be questioned and denied on the ground thatsection 3(d) puts it out of the category of “invention”? On the answer to these questionsdepends whether the appellant is entitled to get the patent for the beta crystalline form of achemical compound called Imatinib Mesylate which is a therapeutic drug for chronicmyeloid leukemia and certain kinds of tumours and is marketed under the names “Glivec”or “Gleevec”.4.These questions were debated at the bar intensely and at great length. The debatetook place within a very broad framework. The Court was urged to strike a balance between the need to promote research and development in science and technology and tokeep private monopoly (called an ‘aberration’ under our Constitutional scheme) at theminimum. Arguments were made about India’s obligation to faithfully comply with itscommitments under international treaties and counter arguments were made to protectIndia’s status as “the pharmacy of the world”. The Court was reminded of its duty to
 
Page 3
 
uphold the rights granted by the statute, and the Court was also reminded that an error of  judgment by it will put life-saving drugs beyond the reach of the multitude of ailinghumanity not only in this country but in many developing and under-developed countries,dependent on generic drugs from India. We will advert to these and a number of other arguments at their proper place but we must first take note of the facts that give rise to theabove questions and provide the context for the debate.5.
 Jürg Zimmermann
invented a number of derivatives of N-phenyl-2- pyrimidine-amine, one of which is CGP 57148
1
in free base form (later given the International Nonproprietary Name ‘Imatinib’ by the World Health Organisation). These derivatives,including Imatinib
2
, are capable of inhibiting certain protein kinases, especially proteinkinase C and PDGF (platelet-derived growth factor)-receptor tyrosine kinase and thus havevaluable anti-tumour properties and can be used in the preparation of pharmaceuticalcompositions for the treatment of warm-blooded animals, for example, as anti-tumoraldrugs and as drugs against atherosclerosis. The N-phenyl-2-pyrimidine-amine derivatives,including Imatinib, were submitted for patent in the US. The application was made onApril 28, 1994 and patent was granted on May 28, 1996 under US Patent No. 5,521,184(hereinafter referred to as ‘the Zimmermann Patent’). The Zimmermann compounds (i.e.,derivatives of N-phenyl-2-pyrimidine-amine) were also granted a European patent under Patent No. EP-A-0 564 409.6.The appellant claims that beginning with Imatinib
3
in free base form (as the ‘e-duct’), in a two-stage invention they first produced its methanesulfonic acid addition salt,Imatinib Mesylate, and then proceeded to develop the beta crystalline form of the salt of 
1
4-(4-methylpiperazin-1–ylmethyl)-N-[4-methyl-3-(4-pyridin-3-yl)pyrimidin-2-ylamino)phenyl] benzamide.
2
Ibid
3
Ibid

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