THE INDIA CHALLENGE TO NOVARTIS GLIVEC1

Every story is set against a background and the fight for Novartis’ patent for Glivec is set
against the milieu of shifting patent laws in India.

In 2005, India transitioned from the process patent regime to the product patent regime [1]
.
While the process patent regime had aided in the development of a competitive domestic
industry, the product patent regime indicated integration of domestic enterprises with the
world markets [1]
. Its goal was to encourage innovations in the pharmaceutical industry [1]
.

Novartis filed a patent in India for a substance called Imatinib Mesylate in beta-crystalline
form on 17th July, 1998 at the Chennai Patent Office [2, Pg 7]
. This would allow it to patent a
newer version of Glivec [4]
. The priority date for the same was July 18, 1997 [2, Pg 7]
. The
patent application had been made in Switzerland on this date [2, Pg 8]
. They claimed that they
had invented processes to convert Imatinib in free base form to the salt Imatinib Mesylate
and then develop the beta-crystalline form of the same [2, Pg 3]
. As the patent law in India
was undergoing changes at that time, this application was put under a modus operandi
called the “mailbox procedure” [2, Pg8] [TN 1]
. Novartis also applied for Exclusive Marketing
Rights (EMR) for the product on 27 th
March, 2002 [2, Pg8] [TN 2]
. This request was granted by
the Patent Office on 10th November, 2003 [2, Pg 9]
.

In 2005, after changes were made in the patent laws of India, Novartis’ application was
taken out of the mailbox [2, Pg9]
. By this time the application had drawn pre-grant oppositions
from M/s. Cancer Patients Aid Association, NATCO Pharma Ltd., CIPLA Ltd., Ranbaxy
Laboratories Ltd, and Hetro Drugs Ltd [2, Pg 9]
. On the 25th of January in 2006, the Assistant
Controller of Patents and Designs rejected the patent application through five orders on the
five petitions [2, Pg 9]
. This was done on the grounds that the invention was anticipated in the
application made in Switzerland, it was obvious to a person skilled in the art, it could not be
allowed the test of patentability given under Section 3(d) of the Indian Patents Act, 1970,
and that the Swiss priority date was incorrectly claimed as that for India [2, Pg 9]
.

1
This case is prepared by Shaurya Saxena, Participant of Integrated Program in Management, Indian Institute of
Management Indore under the guidance of Prof. Siddhartha Kumar Rastogi, Indian Institute of Management
Indore. This case is meant to provide factual information and managerial insights through classroom discussion
rather than to illustrate effective or ineffective, right or wrong handling of a leadership, administrative, managerial
and policy situation.
In response to the orders of the Assistant Controller of Patents and Designs, Novartis filed
an appeal. The appropriate body for this appeal would have been the Intellectual Property
Appellate Board (IPAB) [2, Pg 9]
. However, at that time, this body was not functional [2, Pg 9]
. As
a result, Novartis filed its challenge to the orders of the Assistant Controller of Patents and
Designs at the Madras High Court [2, Pg 10]
. At the same time, it filed 2 writ petitions against
Section 3(d) of the Patents Act for violating Article 14 [TN] of the Indian Constitution and
breaching the TRIPS agreement [2, Pg 10]
. The challenge to the orders of the Assistant
Controller of Patents and Designs was transferred from the High Court to the IPAB on 4 th
April, 2007 [2, Pg 10]
. On 6th August of the same year, the Madras HC dismissed the writ
petitions challenging Section 3(d) of the Patents Act [2, Pg 10]
.

The IPAB passed its judgement regarding the matter on the 26 th of June, 2009 [2, Pg 10]
. It
held that the product was novel and nonobvious, and that there were no issues with the
priority date [2, Pg 10]
. However, it dismissed the appeals because the product failed to clear
the test of Section 3(d) of the Patents Act [2, Pg 10]
. The IPAB claimed that Indian law required
a higher standard of inventive step, especially in pharmaceutical products [2, Pg 11].
It also
noted that Novartis had been selling Glivec at a price of Rs.1, 20, 000 for a month’s supply
[2, Pg 11]
. This, in the opinion of the IPAB was unaffordable to poor patients [2, Pg 11]
. Thus, the
patent was also barred under Section 3(b) of the Patents Act, 1970, which held that patents
could not be given on inventions when the exploitation of these patents could create public
disorder [2, Pg 11]
. The IPAB ordered that Novartis could not be denied the patent for the
process of preparing Imatinib Mesylate in the beta-crystalline form [2, Pg 12]
.

In reaction to this, Novartis filed a Special Leave Petition challenging the order of IPAB in
the Supreme Court on August 11, 2009 [2, Pg 12]
. While discussing the case, the Court
outlined the history of patent law in India, emphasised significant changes, and traced the
path that led to the changes in 2005.

The advocates for Novartis highlighted several remarkable aspects of the law while
presenting their defence. Novartis argued that Section 3(d) was ex majore cautela (for
greater caution) [2, Pg 55][3]
. Its main aim was to encourage incremental inventions but
prevent evergreening [2, Pg 55]
. Further, Novartis stated, as far as concerns of public health
existed, these concerns had been attended to in the Act, through the laws regarding
compulsory licensing, revocation of patents, and the multiple stages for opposition to the
grant of patent [2, Pg 56]
. Novartis felt that the invention of Imatinib Mesylate in beta-
crystalline form involved 2 inventions [2, Pg 57]
. The preparation of Imatinib Mesylate from
Imatinib in free base form was an invention, and so was the conversion of Imatinib Mesylate
into its beta-crystalline form [2, Pg 58]
.

The Court set out to verify this claim [2, Pg 59]

. The background of the patent for Imatinib
Mesylate in beta-crystalline form is covered in a previous patent called the Zimmermann
Patent [2, Pg 59]
. Jürg Zimmermann invented various derivatives of N-phenyl-2- pyrimidine-
amine [2, Pg 3]
.These derivatives have certain anti-tumour properties [2, Pg 3]
. One of these
derivatives is CGP 571481 in free base form [2, Pg 3]
. It was given the International Non-
proprietary name Imatinib by WHO [2, Pg 3]
. On April 2, 1993 Ciba Geigy filed for a patent on
these inventions in the United States of America [2, Pg 59]
. After the abandonment of this
application, another continuation-in-part application was filed on April 28, 1994 [2, Pg 59]
. In
1996, Novartis was formed from the merger of Ciba Geigy and Sandoz [2, Pg 59]
. The
Zimmermann patent was granted on May 28, 1996 in the US [2, Pg 63]
. On January 18, 2000,
Novartis filed an application for patent on the beta-crystalline form of Imatinib Mesylate in
the USA, which was granted on May 17, 2005 [2, Pg 63]
.

Having mentioned this, we must seek to understand the view of the Court. The Court noted
that Gleevec was launched on the basis of the Zimmermann patent [2, Pg 64]
. In drug
applications, it was declared that the Zimmermann patent covered the composition,
formulation, and/or method of use of Imatinib Mesylate [2, Pg 64]
. Citing the time taken in
reviewing Glivec, Novartis also asked for an extension of the term of the Zimmermann
patent in the US [2, Pg 65]
. Novartis also served a notice to NATCO Pharma for marketing a
drug called VEENAT 100 in the UK on the grounds that the active ingredient Imatinib
Mesylate was claimed under the Zimmermann patent [2, Pg 67]
. The Court concluded that
Glivec originated from the Zimmermann patent [2, Pg 68]
. The Court also referred to academic
publications to conclude that Imatinib Mesylate was known from the Zimmermann Patent [2,

Pg 71]
. The fact that Novartis never requested for a patent on Imatinib Mesylate in the US
was taken as an indication of its belief that Imatinib Mesylate was covered in the
Zimmermann patent [2, Pg 71]
. Thus, the Court concluded that the coming into being of
Imatinib Mesylate from Imatinib could be considered neither outside the Zimmermann
patent nor as an invention in India [2, Pg 71]
.

The advocates for Novartis submitted that the behaviour of the patentee was irrelevant in
the interpretation of the patent [2, Pg 72]
. The advocates argued that the Zimmermann patent
did not tell a person how to make Imatinib Mesylate [2, Pg 72]
. They argued that there was a
difference between what was disclosed and what was covered by a patent [2, Pg 72]
. According
to them, Imatinib Mesylate was covered but not disclosed in the Zimmermann patent [2, Pg

72]
. The argument went that in a patent, the scope of coverage and the scope of disclosure
were distinct [2, Pg 73]
. Imatinib Mesylate could be called known from the Zimmermann patent
only if the patent included the complete method of preparation [2, Pg 73]
. Disclosure was seen
as that which was taught in the patent while the claim was seen as embodying the various
possible uses of the product but not actualized products [2, Pg 74]
.

They argued that in reference to the academic articles mentioned, the first did not teach a
person how to make Imatinib Mesylate, and the other referred only to Imatinib [2, Pg 72]
.
Novartis also said that it had claimed in front of the US FDA that the Zimmermann patent
covered Gleevec, which was made out of the beta-crystalline form of Imatinib Mesylate [2, Pg

73]
. The advocates asserted that for the purpose of prior art, disclosure and not the
description of the claim should be considered [2, Pg 74]
. The other advocate said that anyone
could make Imatinib Mesylate from Imatinib and get a patent for the same but they would
require the permission of the holder of the Zimmermann patent for marketing it [2, Pg 74]
.

The Court disagreed with these views and ruled that coverage going beyond disclosure
would violate the fundamental rule governing the grant of patents [2, Pg 74]
. Thus, the Court
rejected the claim that Imatinib Mesylate was an invention outside the Zimmermann patent
[2, Pg 81]
. The advocates for Novartis also said that Imatinib Mesylate in beta-crystalline form
did not attract Section 3(d) of the Indian Patents Act as a known substance was not equal to
a conceivable substance [2, Pg 81] [2, Pg 82].
Further, neither Imatinib or Imatinib Mesylate were
claimed to have any known efficacy so the question of improvement over known efficacy for
Imatinib Mesylate in beta-crystalline form [2, Pg 81] [2, Pg 82]
. The Court disagreed with both
these submissions [2, Pg 84]
. Imatinib Mesylate was a known substance from the Zimmermann
patent [2, Pg 84]
. The efficacy of Imatinib was also well known [2, Pg 84]
. Thus, according to the
Court, Imatinib Mesylate in beta-crystalline form needed to be examined under Section 3(d)
[2, Pg 84]
.

With regard this, the patent application submitted by Novartis said that Imatinib in free
base form had all the therapeutic properties present in Imatinib Mesylate in beta-crystalline
form [2, Pg 84]
. There was no question of enhanced efficacy to be considered [2, Pg 85]
. There
were also substantial similarities between the patent under consideration and the
Zimmermann patent [2, Pg 85]
. In the Court’s opinion, the patent under consideration looked
like a cut and paste job [2, Pg 85]
. There was no clarity on what substance preceded Imatinib
Mesylate in beta-crystalline form [2, Pg 85]
. Novartis seemed to have taken 2 different stands
on what substance preceded Imatinib Mesylate in beta-crystalline form [2, Pg 88]
. In the
hearing, Novartis had claimed that Imatinib Mesylate in beta-crystalline form was preceded
by Imatinib Mesylate [2, Pg 88]
. It was obligated to show enhanced efficacy of Imatinib
Mesylate in beta-crystalline form over Imatinib Mesylate [2, Pg 88]
.

However, in the application for patent, Novartis had submitted material justifying the
enhanced efficacy of Imatinib Mesylate in beta-crystalline form over Imatinib [2, Pg 88]
. It had
made no comparisons between Imatinib Mesylate and its beta-crystalline form [2, Pg 88]
. The
Court held that Imatinib Mesylate preceded Imatinib Mesylate in beta-crystalline form [2, Pg

89]
. Novartis had claimed that Imatinib Mesylate in beta-crystalline form had better
solubility, more beneficial flow properties, higher thermodynamic stability, and lesser
hygroscopicity over Imatinib [2, Pg 87]
. Assuming that higher solubility would be a shared
attribute of Imatinib Mesylate and its beta-crystalline form, the Court accepted the other
three characteristics as being additions in the beta-crystalline form of Imatinib Mesylate
over Imatinib Mesylate [2, Pg 88]
. These would make the substance storable for longer periods
and render it higher processability [2, Pg 89]
.

Let us refer to some arguments stated by the advocates for Novartis here. Imatinib (free
base) was the active therapeutic ingredient in this case [2, Pg 89]
. However, it was not soluble
[2, Pg 89]
. Imatinib Mesylate was soluble and thus could be administered to humans as a drug
[2, Pg 89]
. The beta-crystalline form had additional properties and was better than Imatinib [2,

Pg 89]
. Thus, Imatinib Mesylate in beta-crystalline form showed enhanced efficacy over
Imatinib in free base form [2, Pg 90]
.

To test this claim under Section 3(d), one would need to define the term efficacy [2, Pg 90]
.
The Court referred to The New Oxford Dictionary of English, Edition 1998 which defined
efficacy as “the ability to produce a desired or intended result” [2, Pg 90]
. Thus, the efficacy
was seen as depending upon the aim of a product [2, Pg 90]
. For the product under
consideration, this was taken to mean therapeutic efficacy which was to be judged strictly [2,

Pg 90] [2, Pg 91]

. The Court decided those beneficial flow properties, higher thermodynamic
stability, and lower hygroscopicity could not be considered for the purpose of Section 3(d)
as they were not important for therapeutic efficacy [2, Pg 94]
.
The Court next considered that Imatinib Mesylate in its beta-crystalline form had 30%
higher bio-availability than Imatinib [2, Pg 94]
. In this regard, the Court took the opinion of
Professor Basheer, an inventor-cum-amicus, who quoted that bio-availability, was not in
itself a determination of efficacy [2, Pg 94]
. Novartis had not submitted any research to show
that higher bio-availability led to increase in therapeutic efficacy [2, Pg 95]
. The Court thus
ruled that Imatinib Mesylate in beta-crystalline form failed Section 3(d) of the Indian
Patents Act, 1970 [2, Pg 95]
. The Court also noted that in 2001, when Glivec came to US, it
was Imatinib Mesylate that was being marketed [2, Pg 96]
. It was also described as Imatinib
Mesylate when it was being sold in India [2, Pg 96]
. Thus, to the Court, the patent application
for Imatinib Mesylate in beta-crystalline form looked like an effort to patent Imatinib
Mesylate [2, Pg 96]
.

Thus, the Court ruled that Imatinib Mesylate in beta-crystalline form fell short of the
standards of the tests of invention and patentability as given in clauses (j) and (ja) of
Section 2(1) and Section 3(d) of the Indian Patents Act [2, Pg 96]
. The Court dismissed
Novartis’ appeal with costs [2, Pg 96]
. It allowed the other 2 appeals by Natco Pharma Ltd. and
M/s Cancer Patients Association [2, Pg 96]
.

REFERENCES
[1] Indian Pharmaceutical Industry- Challenges and prospects – Occasional paper no.176-
EXIM bank

[2] IN THE SUPREME COURT OF INDIA, CIVIL APPELLATE JURISDICTION, CIVIL APPEAL
Nos. 2706-2716 OF 2013, (ARISING OUT OF SLP(C) Nos. 20539-20549 OF 2009)
NOVARTIS AG ….APPELLANT VERSUS UNION OF INDIA & OTHERS ….RESPONDENTS, WITH
CIVIL APPEAL No. 2728 OF 2013 (ARISING OUT OF SLP(C) No. 32706 OF 2009) NATCO
PHARMA LTD. ….APPELLANT VERSUS UNION OF INDIA & OTHERS ….RESPONDENTS AND
CIVIL APPEAL Nos. 2717-2727 OF 2013 (ARISING OUT OF SLP(C) Nos. 12984-12994
OF 2013) SLP(C)………../2011 CC Nos.6667-6677 M/S CANCER PATIENTS AID ASSOCIATION
….APPELLANT Versus UNION OF INDIA & OTHERS ….RESPONDENTS

[3] https://mylawdictionary.org/ex-majore-cautela/

[4] http://www.caravanmagazine.in/reportage/adverse-reaction (as on Oct 4, 2015)-

Adverse Reaction - India’s radical challenge to the global patent regime - By SUHRITH
PARTHASARATHY | 1 June 2013