LexNOVARTIS AG versus UNION OF INDIA & OTHERS
Open in Lexace · Ask the AI about this caseJudgment (excerpt)
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[2013] 13 S.C.R. 148
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NOVARTIS AG
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v.
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UNION OF INDIA & OTHERS
(Civil Appeal Nos. 2706-2716 of 2013)
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APRIL 01, 2013
[AFTAB ALAM AND RANJANA PRAKASH DESAI, JJ.)
Patents Act, 1970:
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ss. 2(1}(j), 2(1)(ja) and 3(d) -
Grant of patent -
To
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limatinib Mesylate in Beta Crystalline form - Twin test of
"Invention" and "patentability" - Held: The patent product fails
in both the tests of 'invention' and 'patentability' - It is a known
substance of Zimmermann patent - It is not a new product -
D Not only is lmatinib Mesylate known as substance of
Zimmermann but its pharmacological properties are known
in the Zimmermann patent - It does not qualify the test of
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invention as laid down in s.2(1)(j) and 2(1}(ja) - lmatinib
Mesylate is known substance with known efficacy - Thus
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BETA Crystalline form of lmatinib Mesylate is a new form of
known substance - It fully attracts s.3(d} -
The higher
solubility that is attributed to the beta crystalline form of
lmatinib Mesylate would be limited to (i) More beneficial flow
properties, (ii) Better thermodynamic stability, and (iii) Lower
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hygroscopicity- These properties, "physical attributes" would
give the subject product improved processability and better
and longer storability but, on the basis of those properties
alone, the beta crystalline form of lmatinib Mesylate certainly
cannot be said to possess enhanced efficacy over lmatinib
Mesylate, the known substance immediately preceding it,
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within the meaning of s. 3(d) of the. Act.
s.2(1)lj), (ac), lja) - Invention - Held: In order to qualify
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as 'invention' a product must satisfy the test i.e. it must be
new, it must be capable of being made or used in the industry
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148
NOVARTIS AG v. UNION OF !NOIA
149
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and it must come into being as a result of an invention which
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has a feature that entails technical advance over existing
knowledge or has an economic significance and makes the
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invention not obvious to a person skilled in the art.
s.2(1)()) - Invention - Chemicals and pharmaceuticals
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Held: A new product in chemicals and especially B
pharmaceutical may. not necessarily mean something
altogether new or completely unfamiliar or notexisting before.
s.3(d) -
Test of Efficacy - Held: Depends upon the
fuhction, utility or the.purpose of product under consideration c
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- Test of enhanced efficacy in case of chemical substance,
especially medicine, should receive narrow and strict
interpretatio.n
s.3(d) - Mere change of form with properties inhereht to
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that form, would not qualify as "enhancement of efficacy" of a
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known substance.
Words and Phrases - 'Efficacy' - Meaning of, in the
context of Patents Act, 1970.
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The appellant in appeal Nos. 2706-2716 of 2013 filed
application before Patent Office for grant of patent for
lmatinib Mesylate in Beta Crystalline form. The application
was made on July 17, 1998 giving July 18, 1997, the date
on which the appellant had applied for grant of patent for
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the subject product in Switzerland as the 'priority date".
The application of the appellant lay dormant under an
arrangement called 'Mailbox Procedure'. In 2003, the
appellant was granted Exclusive Marketing Rights for the
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subject product. The application for patent was taken out
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of the 'Mailbox' after the amendments were made in the
P~tents Act, 1970, w.e.f. January 1,· 2005. Five pregrant
oppositions were filed against the patent application of
~the appellant.
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150
SUPREME COURT REPORTS
[2013] 13 S.C.R.
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The application of the appellant was rejected on the
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grounds viz. the invention claimed, was anticipated by
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prior publication i.e. Zimmerman patent; that the
invention claimed, was obvious to a person skUled in the
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art, in view of the disclosure provided in the Zimmerman
B patent specifications; that patentability of the claimed
invention was disallowed by s. 3(d); and that the Swiss
priority date i.e. July 17, 1997 was wrongly claimed as
priority date for the application in India and hence the
invention was also anticipated by the specification made
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c in the application submitted in Switzerland. The appellant
challenged the orders before High Court which was later
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transferred to Intellectual Property Appellate Board. The
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appeals were dismissed by the Board on the ground that
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patentability of the subject product was hit b~ s. 3(d) as
D well as 3(b).
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