# NOVARTIS AG v. UNION OF !NOIA

- **Citation:** [2013] 13 S.C.R. 148
- **Court:** Supreme Court of India
- **Decided:** 2013-04-01
- **Case number:** Civil Appeal Nos. 2706-2716 of 2013
- **Bench:** Aftab Alam, Ranjana Prakash Desai
- **Source:** https://unisonlegal.in/judgment/supreme-court-of-india/novartis-ag-v-union-of-noia-28968
- **Pages:** 143

## Headnote

Patents Act, 1970:
c
ss. 2(1}(j), 2(1)(ja) and 3(d) -
Grant of patent -
To
'F
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
{
invention as laid down in s.2(1)(j) and 2(1}(ja) - lmatinib
Mesylate is known substance with known efficacy - Thus
E
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
F
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,
G
within the meaning of s. 3(d) of the. Act.
s.2(1)lj), (ac), lja) - Invention - Held: In order to qualify
-J
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
H
148
NOVARTIS AG v. UNION OF !NOIA
149
>-
and it must come into being as a result of an invention which
A
-1
has a feature that entails technical advance over existing
knowledge or has an economic significance and makes the
""""
invention not obvious to a person skilled in the art.
s.2(1)()) - Invention - Chemicals and pharmaceuticals
-
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
-
- 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
D
'*'
that form, would not qualify as "enhancement of efficacy" of a
I
known substance.
Words and Phrases - 'Efficacy' - Meaning of, in the
context of Patents Act, 1970.
E
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
F
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
m
subject product. The application for patent was taken out
G
~
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.
•
H
150
SUPREME COURT REPORTS
[2013] 13 S.C.R.
A
The application of the appellant was rejected on the
~
grounds viz. the invention claimed, was anticipated by
;
prior publication i.e. Zimmerman patent; that the
invention claimed, was obvious to a person skUled in the
F
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
yc in the application submitted in Switzerland. The appellant
challenged the orders before High Court which was later
.....

## Text

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'-
' ' ,_
[2013] 13 S.C.R. 148
A
NOVARTIS AG
--.(_
v.
...
UNION OF INDIA & OTHERS
(Civil Appeal Nos. 2706-2716 of 2013)
B
APRIL 01, 2013
[AFTAB ALAM AND RANJANA PRAKASH DESAI, JJ.)
Patents Act, 1970:
c
ss. 2(1}(j), 2(1)(ja) and 3(d) -
Grant of patent -
To
'F
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
{
invention as laid down in s.2(1)(j) and 2(1}(ja) - lmatinib
Mesylate is known substance with known efficacy - Thus
E
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
F
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,
G
within the meaning of s. 3(d) of the. Act.
s.2(1)lj), (ac), lja) - Invention - Held: In order to qualify
-J
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
H
148
NOVARTIS AG v. UNION OF !NOIA
149
>-
and it must come into being as a result of an invention which
A
-1
has a feature that entails technical advance over existing
knowledge or has an economic significance and makes the
""""
invention not obvious to a person skilled in the art.
s.2(1)()) - Invention - Chemicals and pharmaceuticals
-
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
-
- 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
D
'*'
that form, would not qualify as "enhancement of efficacy" of a
I
known substance.
Words and Phrases - 'Efficacy' - Meaning of, in the
context of Patents Act, 1970.
E
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
F
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
m
subject product. The application for patent was taken out
G
~
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.
•
H
150
SUPREME COURT REPORTS
[2013] 13 S.C.R.
A
The application of the appellant was rejected on the
~
grounds viz. the invention claimed, was anticipated by
;
prior publication i.e. Zimmerman patent; that the
invention claimed, was obvious to a person skUled in the
F
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
yc in the application submitted in Switzerland. The appellant
challenged the orders before High Court which was later
.........
transferred to Intellectual Property Appellate Board. The
\-
appeals were dismissed by the Board on the ground that
..-
patentability of the subject product was hit b~ s. 3(d) as
D well as 3(b).
One of the appellants had also filed writ petitions
~
seeking a declaration thats. 3(d) of the Patents Act was
unconstitutional being violative of Art. 14 and being not
in compliance with Trade Related Aspects of Intellectual
E Property Rights (TRIPS). The petitions were dismissed by
the High Court.
The appellant directly approached the Supreme
Court u/Art. 136 of the Constitution against the order of
F Appellate .Board.
>-
Dismissing the appeal of the appellant-applicant and
allowing those filed by the objectors, the Court
HELD: 1. Any attempt to challenge the order passed
G by Intellectual Property Appellate Board directly before
""'
this Court, side-stepping the High Court, needs to be
j
strongly discouraged. But the present case, if directed to
High Court might ·render the matter infructuous inasmuch
as the period for the patent applied for would come to an '
H end in July 2018. Therefore, this court itself would decide
NOVARTIS AG v. UNION OF INDIA
151
the appeals instead of directing the appellant to move the
A
High Court. However, the present case cannot be treated
as a precedent in that regard. [Paras 21 and 22] [175-BC, F-G]
The WTO and India's Pharmaceuticals Industry (Patent
8
Protection, TRIPS, and Developing Countries) by Chaudhuri,
Sudip (Oxford University Press, 2005) - referred to.
2.1. The patent product, the beta crystalline form of
lmatinib Mesylate, fails in both the tests of invention and
patentability as provided under clauses (j), (ja) of section
C
2(1). and section 3(d) respectively. [Para 195) [276-C]
2.2. The Patents Act, 1970, dealt with "invention" and
"patentability" as two distinctly separate concepts. The
duality of the two concepts is best illustrated by section
D
4 of the Act, which prohibits the grant of patent (either
process or product) "in respect of inventions relating to
atomic energy falling within sub-section (1) of section 20
of the Atomic Energy Act, 1962", and which has not
undergone any change since inception. It is, therefore,
E
fundamental that for grant of patent, the subject must
satisfy the twin tests of "invention" and "patentability".
Something may be an "invention" as the term is generally
unde'rstood and yet it may not qualify as an "invention"
for the purposes of the Act. Further, something may even
qualify as an "invention" as defined under the Act and
yet may be denied patent for other larger considerations
as may be stipulated in the Act. [Para 91) [226-B-E]
F
2.3. Chapter II has the Heading "Inventions Not
Patentable" and section 3 has the marginal heading "What G
are not inventions." As suggested by the Chapter heading
and the marginal heading of section 3, and as may be seen
simply by going through section 3, it puts at one place
provisions of two different kinds: one that declares that
certain things shall not be deemed to be "inventions" [for
H
152
SUPREME COURT REPORTS
[2013] 13 S.C.R.
A instance clauses (d) & (e)); and the other that provides
that, though resulting from invention, something may yet
not be granted patent for other considerations [for instance
clause (b)). [Para 92] (226-F-H]
8
2.4. The amendment in section 3(d) is primarily in
respect of medicines and drugs and, to some extent,
agricultural chemical substances. In view of the larger
perspective of the development of the law of patent over
the past 100 years and especially keeping in mind the
debates in the Parliament preceding the 2005
r
C amendment, it cannot be said that section 3(d) is a
provision ex majore cautela. There is vital distinction
between the concepts of invention and patentabilifV -- a
distinction that was at the heart of the Patents Act as it
was framed in 1970, and which is reinforced by the 2005
D amendment in section 3(d). [Paras 98 and 102] (228-F;
230-8.D]
2.5. The importance of the amendment made in
section 3(d), that is, the addition of the opening words in
E the substantive provision and the insertion of explanation
to the substantive provision, cannot be under-estimated.
In the course of the Parliamentary debates, the
amendment in section 3(d) was the only provision cited
by the Government to allay the fears of the Opposition
F members concerning the abuses to which a product
patent in medicines may be vulnerable. Therefore, th·e
amendment/addition made in section 3(d) is meant
especially to deal with chemical substances, and more
particularly pharmaceutical products. The amended
G portion of section 3(d) clearly sets up a second tier of
qualifying standards for chemical substances/
.J
pharmaceutical products in order to leave the door open
for true and genuine inventions but, at the same time, to
check any attempt at repetitive patenting or extension c1f
the patent term on spurious grounds. [Para 103] (230-0H G; 231-A]
NOVARTIS AG v. UNION OF INDIA
153
...._
..., >-
2.6. If clause (d) is isolated from the rest of section 3,
A
and the legislative history behind the incorporation of
Chapter II in the Patents Act, 1970, is disregarded, then it
is possible to see section 3(d) as an extension of the
definition of "invention" and to link section 3(d) with
clauses (j) and Oa) of section 2(1 ). In that case, on reading
B
clauses (j) and (ja) of section 2(1) with section 3(d) it
would appear that the Act sets different standards for
qualifying as "inventions" things belonging to different
classes, and for medicines and drugs and other chemical
substances, the Act sets the invention threshold further c
higher, by virtue of the amendments made in section 3(d)
in the year 2005. [Para 104] (231-8-D]
2.7. On a combined reading of clauses (j), (ac) and
Oa) of section 2(1 ), in order to qualify as "invention", a
D
product must, therefore, satisfy the following test: (i) It
)I.
must be "new"; it must be "capable of being made or
used in an industry" and (iii) it must come into being as
a result of an invention which has a feature that entails
technical advance over existing knowledge; or has an
economic significance; and makes the invention not
E
obvious to a person skilled in the art. [Para 90] (225-E-G;
226-A]
-..\
2.8. Section 2(1)(j) defines "invention" to mean, "a new
product or ... ", but the new product in chemicals and
F
especially pharmaceuticals may not necessarily mean
r
something altogether new or completely unfamiliar or
strange or not existing before. It may mean something
"different from a recent previous" or "one regarded as
~•
better than what went before" or "in addition to another
lit--
or others of the same kind" However, in case of chemicals
G
and especially pharmaceuticals if the product for which
patent protection is claimed is a new form of a known
substance with known efficacy, then the subject product
must pass, in addition to clauses (j) and Oa) of section 2(1 ),
H
154
SUPREME COURT REPORTS
[2013] 13 S.C.R.
A the test of enhanced efficacy as provided in section 3(d)
~
read with its explanation. [Para 192] [275-B-D]
'
2.9. The drug Gleevec directly emanates from the
Zimmermann patent and comes to the market for
8 commercial sale. Since the grant of the Zimmermann
patent, the appellant has maintained that Gleevec (that is,
lmatinib Mesylate) is part of the Zimmermann patent. It
obtained drug approval for Gleevec on that basis. It
claimed extension of the term of the Zimmermann patent
- for the period of regulatory review for Gleevec, and it
C successfully stopped NATCO Pharma Ltd. from marketing
its drug in the UK on the basis of the Zimmermann patent
Not only the appellant but the US Board of Patent
Appeals, in its judgment granting patent for beta
crystalline form of lmatinib Mesylate, proceeded on the
D basis that though the beta crystal form might not have
been covered by the Zimmermann patent, the
:'I'.
Zimmermann patent had the teaching for the making of
lmatinib Mesylate from lmatinib, and for its use in a
pharmacological compositions for treating tumours or in
E a method of treating warm-blooded animals suffering
from a tumoral disease. This finding was recorded by the
US Board of Patent Appeals, in the case of the appellant
itself, on the very same issue that is under consideration
in the present case. The appellant is, therefore, fully
~-
F bound by the finding and cannot be heard to take any
contrary plea. [Para 126] [244-F-G; 245-A-C]
2.10. lmatinib Mesylate cannot be said to be a new
product. lmatinib Mesylate is all there in the Zimmermann
patent. It is a known substance from the Zimmermann
G patent. lmatinib Mesylate is fully part of the Zimmermann
patent is also borne out from another circumstance. After·
the Zimmermann patent, the appellant applied for, and in
several cases obtained, patent in the US not only for the
beta and alpha crystalline forms of lmatinib Mesylate, but
H also for lmatinib in a number of different forms. The
NOVARTIS AG v. UNION OF INDIA
155
appellant, however, never asked for any patent for lmatinib
A
Mesylate in non-crystalline form, for the simple reason that
it had always maintained that lmatinib Mesylate is fully a
part of the Zimmermann patent and does not call for any
separate patent. Therefore, it cannot be said that the
development of lmatinib Mesylate from lmatinib is outsi.de
B
the Zimmermann patent and constitutes an invention as
understood in the law of patent in India. [Paras 131,. 132
and 133) [248-E-H; 249-A-B]
2.11. Under the scheme of patent, a monopoly is
granted to a private individual in exchange of the C
invention being made public so that, at the end of the
patent term, the invention may belong to the people at
large who may be benefited by it. To say that the coverage
in a patent might go much beyond the disclosure thus
seem to negate the fundamental rule underlying the grant D
of patents. [Para 139) [252-D-E]
2.12. lmatinib Mesylate is not a new product. lmatinib
Mesylate is a known substance from the Zimmermann
patent itself. Not only is lmatinib Mesylate known as a
substance in the Zimmermann patent, but its
pharmacological properties are also known in the
Zimmermann patent and in the article published in the
Cancer Research journal. The consequential finding,
therefore, is that lmatinib Mesylate does not qualify the
test of "invention" as laid down in section 2(1 )(j) and
section 2(1)(ja) of the Patents Act, 1970. [Para 157] [260E-G]
E
F
2.13. So far as the beta crystal form of lmatinib
Mesylate is concerned, even if accepted to be new, in the
G
sense that it is not known from the Zimmermann patent,
this being a pharmaceutical substance and moreover a
polymorph of lmatinib Mesylate, it directly runs into
section 3(d) of the Act with the explanation appended to
the provision. [Para 158) [261-A-B]
H
156
SUPREME COURT REPORTS
[2013] 13 S.C.R.
A
2.14. It is not correct to say that in order to attract
section 3(d), the subject product must be a new form of
a known substance having known efficacy, and that a
"conceivable" substance is not a "known substance"
within the meaning of the provision. There is no sanction
8 to construe the expression "known" in section 3(d).
Clauses (e) and (f) of section 64(1) of the Act, which
contain two of the grounds for revocation of patents, also
use the expression "publicly known". The expression
"publicly known" may normally be construed more
C widely than "known". But even the expression "publicly
known" received quite the opposite interpretation by this
Court in Monsanto Company case. [Para 158 & 159] [261A-D, F-H; 262-A]
2.15. On facts also it cannot be accepted that lmatinib
D Mesylate or even lmatinib was not a known substance
with known efficacy. lmatinib Mesylate was a known
substance from the Zimmermann patent. In the NOA
submitted by the appellant before the US FDA, it was
clearly stated that the drug had undergone extensive
E preclinical, technical and clinical research. The clinical
studies included one multiple dose tolerability/dosefinding study (Phase I) and three large open, uncontrolled
efficacy and safety studies (Phase II); and a total of 1,234
patients with CML and other Ph+ leukemias were enrolled
F in the studies. The efficacy of lmatinib was equally
known, as is evident from the Zimmermann patent itself.
[Para 160] [262-H; 263-A-C]
2.16. The subject product, that is, beta crystalline
form of lmatinib Mesylate, is thus clearly a new form of a
G known substance, i.e., lmatinib Mesylate, of which the
efficacy was well known. It, therefore, fully attracts
secti.on 3(d) and must be shown to satisfy the
substantiv~ provision and the explanation appended to
it. [Para 161] [263-C-D]
H
- >-
NOVARTIS AG v. UNION OF INDIA
157
2.17. On the issue of section 3(d), there appears to
A
be a major weakness in the case of the appellant. There
is no clarity at all as to what is the substance immediately
preceding the subject product, the beta crystalline form
of lmatinib Mesylate. In course of the hearing, the counsel
appearing for the appellant stressed that, in terms of 8
invention, the beta crystalline form of lmatinib Mesylate
is two stages removed from lmatinib in free base form.
But this position is not reflected in the subject
application, in which all the references are only to
lmatinib in free base form (or to the alpha crystalline form c
of lmatinib Mesylate in respect of flow properties,
thermodynamic stability and lower hygroscopicity). On
going through the subject application, the impression
one gets is that the beta crystalline form of lmatinib
Mesylate is derived directly from lmatinib free base. This
0
may, perhaps, be because once the beta crystalline form
of the methanesulfonic acid salt of lmatinib came into
being, the lmatinib free base got seeded with the nuclei
of lmatinib Mesylate beta crystalline form and, as a result,
starting from lmatinib one would inevitably arrive directly
E
at the beta crystalline form of lmatinib Mesylate. But all
this is nowhere said in the subject application. [Para 165]
[264-E-H; 265-A-B]
2.18. The whole case of the appellant, as made out
in the subject application and the affidavits filed the
appellant before the Controller, is that the subject
product, the beta crystalline form of lmatinib Mesylate, is
derived from lmatinib, and that the substance
immediately preceding the beta crystalline form is not
lmatinib Mesylate but lmatinib in free base form. This
G
position is sought to be canvassed in the subject
application and the affidavits on the premise that the
Zimmermann patent ended at lmatinib in free base and did
not go beyond to lmatinib Mesylate. Not only is this
premise unfounded, but the appellant itself appears to
F
H
158
SUPREME COURT REPORTS
[2013) 13 S.C.R.
A take a somewhat different stand, as before this Court-it
was contended that the subject product, in terms of
invention, is two stages removed from lmatinib in free
base, and the substance immediately preceding the
subject product is lmatinib Mesylate (non-crystalline).
s That being the position, the appellant was obliged to
show the enhanced efficacy of the beta crystalline form
of lmatinib Mesylate over lmatinib Mesylate (noncrystalline). There is, however, no material in the subject
application or in the supporting affidavits to make any
c comparison of efficacy, or even solubility, between the
beta crystalline form of lmatinib Mesylate and lmatinib
Mesylate (non-crystalline). [Paras 170 and 171] [267-B-F]
2.19. The higher solubility that is attributed to the beta
crystalline form of lmatinib Mesylate may actually be a
D property of lmatinib Mesylate itself. If that be so, the
additional properties that may be 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 hygroscopicify.
E These properties, ("physical attributes" according to
Manley), would give the subject product improved
processability and better and longer storability but, on the
basis of those properties alone, the beta crystalline forn'I
of lmatinib Mesylate certainly cannot be said to possess
F enhanced efficacy over lmatinib Mesylate, the known
substance immediately preceding it, within the meaning
of section 3(d) of the Act. [Paraq 172 and 173] [267-G-H;
268-A-C]
2.20. Efficacy means "the ability to produce a desired
G or intended result". Hence, the test of efficacy in the
context of section 3(d) would be different, depending
upon the result the product under consideration is
desired or intended to produce. In other words, the test
of efficacy would depend upon the function, utility or the
H purpose of the product under consideration. Therefore, .
t" ('
-:
>--
NOVARTIS AG v. UNION OF INDIA
159
.>-
in the case of a medicine that claims to cure a disease,
A
the test of efficacy can only be "therapeutic efficacy".
With regard to the genesis of section 3(d), and more
particularly the circumstances in which section 3(d) was
amended to make it even more constrictive than before
the "therapeutic efficacy" of a medicine must be judged
B
strictly and narrowly. The inference that the test of
enhanced efficacy in case of chemical substances,
especially medicine, should receive a narrow and strict
interpretation is based not only on external factors but
there are sufficient internal evidence that leads to the c
same view. The text added to section 3(d) by the 2005
amendment lays down the condition of "enhancement of
the known efficacy". Further, the explanation requires the
derivative to "differ significantly in properties with regard
to efficacy". What is evident, therefore, is that not all
D
~
advantageous or beneficial properties are relevant, but
only such properties that directly relate. to efficacy, which
in case of medicine, is its therapeutic efficacy. [Para 180]
[270-A-F]
2.21. Each of the different forms mentioned in the
E
explanation have some properties inherent to that form,
e. g., ·solubility to a salt and hygroscopicity to a
--{
polymorph. These forms, unless they differ significantly
in property with regard to efficacy, are expressly
excluded from the definition of "invention". Hence, the
F
mere change of form with properties inherent to that form
would not qualify as "enhancement of efficacy" of a
known substance. In other words, the explanation is
meant to indicate what is not to be considered as
,
;,...
therapeutic efficacy. [Para 181] [270-G-H; 271-A]
G
Goodman and Gilman in CPAA compilation, volume 9,
page 22; LHC [Dorland's Medical dictionary in Novartis']
volume P, page 19 - referred to.
2.22. Just increased bioavailability alone may not
H
160
SUPREME COURT REPORTS
[2013] 13 S.C.R.
A necessarily lead to an enhancement of therapeutic
·~ -
efficacy. Whether or not an increase in bioavailability
leads to an enhancement of therapeutic efficacy in any
given case must be specifically claimed and established
by research data. In the present case, no material ha·s
8 been offered to indicate that the beta crystalline form of
lmatinib Mesylate will produce an enhanced or superior
efficacy (therapeutic) on molecular basis than what could
be achieved with lmatinib free base in vivo animal modet
[Para 189] [27 4-C-E]
C
2.23. Thus, in whichever way section 3(d) may b•:t
viewed, whether as setting up the standards of
"patentability" or as an extension of the definition of
"invention", the subject product, that is, the beta
crystalline form of lmatinib Mesylate, fails the test of
o section 3(d), too, of the Act. [Para 190] [274-F]
2.24. In the US the drug Gleevec came to the market
in 2001. It is beyond doubt that what was marketed then
was lmatinib Mesylate and not the subject product,
lmatinib Mesylate in beta crystal form. Even while thE~
E appellant's application for grant of patent lay in thE~
"mailbox" awaiting amendments in the law of patent in
India, the appellant was granted Exclusive Marketin6J
Rights on November 10, 2003, following which Gleevec.
was marketed in India as well. On its package, the drug
F was described as "lmatinib Mesylate Tablets 100 mg" and
it was further stated that "each film coated tablet
contains: 100 mg lmatinib (as Mesylate)". On the package
there is no reference at all to lmatinib Mesylate in beta
crystalline form. What appears, therefore, is that what
G was sold as Gleevec was lmatinib Mesylate and not the
subject product, the beta crystalline form of lmatinib
Mesylate. If that be so, then the case of the appellan1t
appears in rather poor light and the claim for patent for
beta crystalline form of lmatinib Mesylate would only
.H appear as an attempt to obtain patent for lmatinib
NOVARTIS AG v. UNION OF INDIA
161
Mesylate, which would otherwise not be permissible in
A
this country. [Paras 193 and 194] [275-E-G; 276-A-B]
2.25. The finding of the court that the subject
product, the beta crystalline form of lmatinib Mesylate,
does not qualify the test of Section 3(d) of the Act, does
8
not mean that Section 3(d) bars patent protection_for all
incremental inventions of chemical and pharmaceutical
substances. It will be a grave mistake to read this
judgment to mean that section 3(d) was amended with the
intent to undo the fundamental change brought in the
patent regime by deletion of section 5 from the Parent Act.
C
That is not said in this judgment. [Para 191] [274-G~H;
275-A]
Monsanto Company v. Coramandal lndag Products (P)
Ltd. (1986) 1 SCC 642 - referred to.
D
Glaverbel vs. British (1993) RPC 80); In re Hogan 559
F.2d 595; A. C. Edwards Ltd. v. Acme Signs & Displays Ltd.
[1992] R.P.C. 131; Astellas Pharma Inc v. ComptrollerGeneral of Patents 2009 EWHC 1916 (Pat); Plant Genetics
System, N. V. v. DeKalb Genetics Corp, 315 F. 3d 1335, 1341
E
(Fed. Cir. 2003); Chiron Corp. v. Genentech, Inc 363 F. 3d
1247, 1257 (Fed. Cir. 2004) - referred to.
Article under the title "Inhibition of the Ab/ ProteinTyrosine Kinase in
Vitro and in
Vivo by a 2F
Phenylaminopyrimidine Derivative". A published in journal
called 'Cancer Research', in January 1996 issue; Nature
Medicine magazine of the year 1996 under the title "Effects of
a selective inhibitor of the Abl tyrosine kinase on the growth of
Bcr-Abl positive cells"; Terrell on Law of Patents 16th edition,
G
page no. 51, para 3.217; Terrell on Law of Patent 16th
edition, page no. 192; Terrell on the Law of Patents
(Seventeenth Edition, 2011) in Chapter 9; Chisum on
Patents: A Treatise on the Law of Patentability, Validity, and
H
162
SUPREME COURT REPORTS
[2013] 13 S.C.R.
A
Infringement (Vol. 3, June 2007) in Chapter: "Adequate
~ . .
Disclosure" - referred to.
3. The haste with which the Government was
constrained to rush the Bill for amendment of Patent's
B Act, 1970 through Parliament to make the law compatible
with the TRIPS Agreement perhaps explains the
somewhat unclear drafting of some very important
provisions, which called for much greater clarity; the
presence of some terms and expressions in the definition
c section that are nowhere used in the Act; and a few
loose ends that could have been properly tied up if more
time and attention was given to the drafting. [Para 86)
(223-G-H; 224~A]
4. The best way to understand a law, is to know the
D reason for it. In order to understand what the law really
is, it is essential to know the 'why' and 'how' of the law.
)(
Why the law is what it is and how it came to its ·present
form? [Paras 27 and 29) (177-F; 179-C]
E
Utkal Contractors and Joinery Pvt. Ltd. and others v. State
of Orissa and others (1987) 3 SCC 279; Reserve Bank of
India v. Peerless General Finance and Investment Co. Ltd.
and others (1987) 1 sec 424 - relied on.
Case Law Reference:
,._
F
(1987) 3 sec 219
relied on
Para 27
(1987) 1 sec 424
relied on
Para 28
(1992) R.P.C. 131
relied on
Para 145
2009 EWHC 1916 (Pat)
referred to
Para 145
G
-4. .
(1986) 1 sec 642
Para 159
(1993) RPC 80
referred to
Para 134
559 F.2d 595
referred to
Para 149
315 F. 3d 1335, 1341
referred to
Para 154
H
(Fed. Cir. 2003)
NOVARTIS AG v. UNION OF INDIA
163
363 F. 3d 1247, 1257
referred to
Para 154
A
(Fed. Cir. 2004)
CIVIL APPELLATE JURISDICTION : Civil Appeal Nos.
2706-2716 of 2013.
From the Judgment & Order dated 26.06.2009 in MP
B
No.1/2007, TA No.1/2007, MP. No. 2/2007, TA No. 2/2007, MP
No. 3/2007, TA No. 3/2007, MP No. 4/2007, TA No.4/2007, MP
No. 5/2007, MP No. 5/2007, TA No. 5/2007, MP No. 33/2008
of the Intellectual Property Appellate Board.
C.A. No. 2717-27 of 2013.
C.A. No. 2728 of 2013.
WITH
Paras Kuhad, ASG, Gopal Subramanium, Harish N. Salve,
T.R. Andhiyarujina, Anand Grover, L. Nageswara Rao, Dr.
Rajeev Dhawan, Pravin Anand, Archana Shankar, Binny Kalra,
Hari Shankar K., Tusha Malhotra, Aditya Gupta, Shyam
Nandan, Rahul Narayan, Soumik Ghosal, Vikas Singh Jangra,
Aditya Verma, Nishit Agrawal, Baldev Atreya, Shipra Ghose,
Jitin Chaturvedi, Tanushree Sinha, Vikrant Y.S. Narula (for B.K.
Prasad), Julie George, Prathiba Sivasubramanian, Chanchal
c
D
E
F
Kr. Ganguli, C. Mukund, Rajeshwari, S. Hariharan, Mayank
Pandey, Pratibha M. Singh, S. Majumdar, Saya Choudhary,
Ashutosh Kumar, Surbhi Mehta, Kripa Pandit, Chetna Rai,
Varun Tikmani, Ashwin Kumar, Abhinav Mukerji, Gaurav
Sharma, Ashutosh Kumar, Taruna Prasad, Mohit Garg, (for Fox
Mandal & Co.), Jayant K. Mehta, Sukant Vikram, Aditi Bhat,
Renuka Iyer, Malavika Kapila, for the appearing parties and
Shamnad Basheer (In-person) Gopal Shankarnarayanan.
G
The Judgment of the Court was delivered by
AFTAB ALAM, J. 1. Delay condoned.
H
A
164
SUPREME COURT REPORTS
[2013] 13 S.C.R.
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 it interplay with clauses (j) and (ja) of
section 2(1)? Does the product for which the appellant claims
8
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 the invention "not
obvious" to a person skilled in the art? In case the appellant's
product satisfies the tests and thus qualifies as "invention"
within the meaning of clauses (j) and (ja) of section 2(1), can
C its patentability still be questioned and denied on the ground
that section 3(d) puts it out of the category of "invention"? On
the answer to these questions depends whether the appellant
is entitled to get the patent for the beta crystalline form of a
chemical compound called lmatinib Mesylate which is a
D therapeutic drug for chronic myeloid 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
E at great length. The debate took 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 to keep private monopoly (called an
'aberration' under our Constitutional scheme) at the minimum.
Arguments were made about India's obligation to faithfully
F
comply with its commitments under international treaties and
counter arguments were made to protect India's status as "the
pharmacy of the world". The Court was reminded of its duty to
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
G beyond the reach of the multitude of ailing humanity 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
H the above questions and provide the context for the debate.
NOVARTIS AG v. UNION OF INDIA
165
[AFTAB ALAM, J.]
5. JOrg Zimmermann invented a number of derivatives of
A
N-phenyl-2- pyrimidine-amine, one of which is CGP 571481 in
free base form (later· given the International Nonproprietary
Name 'lmatinib' by the World Health Organisation). These
derivatives, including lmatinib,2 are capable of inhibiting certain
protein kinases, especially protein kinase C and PDGF
B
(platelet-derived growth factor)-receptor tyrosine kinase and
thus have valuable anti-tumour properties and can be used in
the preparation of pharmaceutical compositions for the
treatment of warm-blooded animals, for example, as antitumoral drugs and as drugs against atherosclerosis. The N- c
phenyl-2-pyrimidine-amine derivatives, including lmatinib, were
submitted for patent in the US. The application was made on
April 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.,
0
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 lmatinib3 in free
base form (as the 'e-duct'), in a two-stage invention they first
produced its methanesulfonic acid addition salt, lmatinib
E
Mesylate, and then proceeded to develop the beta crystalline
form of the salt of lmatinib. According to the appellant, starting
from lmatinib free base they could reach to the beta crystal form
of lmatinib ·Mesylate in two ways: one "by digesting another
crystal form, especially the alpha crystal form, or an amorphous
F
starting material of the methanesulfonic acid addition salt of
compound of formula I ... "; and second "by dissolving another
crystal form, especially the alpha crystal form, or an amorphous
starting material of the methanesulfonic acid addition salt of
compound of formula I. .. ". Describing the different processes,
G
step by step, for producing lmatinib Mesylate starting from
1.
4-(4-methylpiperazin-1-ylmethyl)-N-[4-methyl-3-( 4-pyridin-3- yl)pyrimidin-2ylamino)phenyl] benzamide.
2.
Ibid.
3.
Ibid.
H
166
SUPREME COURT REPORTS
[2013] 13 S.C.R.
A lmatinib, it is stated that in the first process they would first
arrive at lmatinib Mesylate in amorphous form, as the
intermediate stage, and thereafter, following further processes,
reach the beta crystal form of lmatinib Mesylate. Following the
second process, they would reach the beta crystal form of
B lmatinib Mesylate direc;tly, skipping the intermediate stage in
which lmatinib Mesylate first appears in amorphous form. In the
third process, they would start with the alpha crystal form of
lmatinib Mesylate and arrive at its beta crystal form.
7. It was stated in course of submissions, however, that
C for practical purposes, the best way to produce the beta form
is by proceeding directly from the free base form to the beta
form, as in examples 2 and 3 given below, by introducing a
specified amount of the beta crystals at the step specified. The
three processes are described by the appellant under the
D following three examples:
E
F
G
H
EXAMPLE -
1~
Step 1
-98.6 gms of lmatinib free base is added to
1.4 liters of ethanol.
Step 2 -
To the above, 19.2 gms of methanesulfonic
acid is added drop wise for over 20 minutes.
Step 3 -
Solution obtained in Step 2 is heated under
reflux (i.e. boiling). It is heated in a manner to
preserve the solution from escaping as a gas, so
the gas is captured, condensed and obtained as a
liquid. This solution is heated for 20 minutes.
Step 4 -
Filtering the solution - the filtrate (which is
obtained after filtering the resulting liquid) is
4.
Examples 1 to 3 stated below are reproduced from the written notes titled
"Novartis Document - XIV: Examples in 1602/MAS/1998 (Subject Patent
Specification), submitted by Mr. Subramanium, Senior Advocate appearing
for the appellant in course of hearing on September 20, 2012.
NOVARTIS AG v. UNION OF INDIA
167
[AFTAB ALAM, J.]
,>-
evaporated down to 50%. In other words, half of the
A
t.
filtrate is allowed to vaporize.
Step 5 -
Residue is again filtered at 25 degrees
Celsius.
Step 6 -
Mother liquor (the liquid filtrate of step 5) is
B
evaporated to dryness.
Step 7 -
Residue obtained after Step 6, and residue
obtained after Step 5 are suspended in 2.2 I
ethanol.
c
Step 8 -
The suspension obtained after Step 7 is
dissolved under reflux and it becomes clear upon
heating. Thereafter, 30 ml water is added to it.
Step 9 -
Substance is cooled overnight to 25 degrees
D
Celsius, filtered and dried at 65 degrees Celsius,
until weight is constant. This results in alpha
crystalline form.
Step 10 - Alpha form is stirred in methanol for two days
E
at about 25 degrees Celsius. Then the crystals are
isolated by filtration and dried overnight at room
temperature. This results in beta crystalline form.
EXAMPLE - 2
F
Step 1 -
50 gms of lmatinib free base is added to 480
liters (sic
milliliters!) of methanol.
Step 2 -
To the above, 9.71 gms of methanesulfonic
G
acid and 20 ml methanol is added. This mixture (sic
is heated) at 50 degrees Celsius.
Step 3 -
To the solution obtained from Step 2, 5 gms
of activated carbon is added and the mixture is
H
,..
168
SUPREME COURT REPORTS
(2013] 13 S.C.R.
)'-
A
boiled for 30 minutes under reflux, filtered and
~
evaporated.
~
Step 4 -
The residue obtained from Step 2 (sic 3) is
dissolved in 150 ml methanol and inoculated
B
(introduced) with a few mgms (sic mg) of beta form
of imatinib mesylate leading to crystallization of the
product.
Step 5 -
The product is dried at 50 megabars (unit to
measure pressure) and at 60 degrees Celsius.
c
This leads to crystallization of beta form of imatinib
mesylate.
Step 6 -
The retention values (distance traveled by
each chemical component in relation to the distance
D
the solution front moves) obtained are as follows;
Methylene chloride: ethyl acetate: Methanol: concentrated
aqueous ammonium hydroxide solution= 6:10:30:2
(sic 60: 10:30:2)
E
Step 7 -
To the above, High Pressure Chromatography
(technique for separation of mixtures) is applied for
10.2 minutes
EXAMPLE - 3
~
F
Step 1 -
670 gms of alpha form of imatinib mesylate is
heated in 1680 ml of methanol.
Step 2 -
The solution obtained from Step 1 is then
inoculated at 60 degrees Celsius with 55 (sic mg
G
of) beta form of imatinib mesylate. Upon this, the
product starts to crystallize.
Step 3 -
Thereafter, the crystals are dried at 50
megabars and at 100 degrees Celsius. This leads
H
to crystallization of beta form of imatinib mesylate.
NOVARTIS AG v. UNION OF INDIA
169
[AFTAB ALAM, J.]
)-
Step 4 • The retention values (distance traveled by
A
each chemical component in relation to the distance
the solution front moves) obtain~d are as follows;
Methylene chloride: ethyl acetate: Methanol:
concentrated aqueous ammonium hydroxide
B
solution = 6:10:30:2 (sic 60:10:30:2)
Step 5 -
To the above, High Pressure Chromatography
is applied for 10.2 minutes.
[Examples are also given for preparation of 100 mg tablets and c
100 mg capsules of lmatinib Mesylate but there is no need to
go into that at this stage.]
8. The appellant filed the application (Application No.1602/
MAS/1998)5 for grant of patent for lmatinib Mesylate in beta
D
~
crystalline form at the Chennai Patent Office on July 17 .. 1998.
In the application it claimed that the invented product, the beta
crystal form of lmatinib Mesylate, has (i) more beneficial flow
properties: (ii) better thermodynamic stability; and (iii) lower
- hygroscopicity than the alpha crystal form of lmatinib Mesylate.
E
It further claimed that the aforesaid properties makes the
invented product "new" (and superior!) as it "stores better and
is easier to process"; has "better processability of the
' methanesulfonic acid addition salt of a compound of formula
~
I", and has a "further advantage for prqgessing and storing".
F
9. It is significant to note that the comparison of the
afbresaid properties of the beta crystal form of lmatinib
Mesylate was made with its alpha crystal form.