“Evergreening”, a process commonly practised by pharmaceutical companies

where patents are extended without any enhancement in the therapeutic efficiency
of the drug to give immortal value to their creation.

[Case Brief] NOVARTIS AG V/S UNION OF INDIA & Ors.

Case name: NOVARTIS AG V/S UNION OF INDIA & Ors..

Case number: CIVIL APPEAL Nos. 2706-2716 OF 2013

Court: THE SUPREME COURT OF INDIA

Bench: JUSTICE AFTAB ALAM

JUSTICE RANJANA PRAKASH DESAI

Decided on: April 01, 2013

Relevant Section 2(1)(j) , 2(1)(ja) , 3(b) , 3(d) Patent Act 1970

Act/Sections: Article 14 Constitution of India.
Article 27 , 64 TRIPS Agreement

 BRIEF FACTS AND PROCEDURAL HISTORY:

1. Jurg Zimmermann invented a number of derivatives of N-phenyl-2-pyrimidine-amine
one of which is Imatinib in free base form. These derivatives including Imatinib are
capable of inhibiting certain protein kinases and thus have valuable anti – tumour
properties and can be used in the preparation of pharmaceutical compositions for the
treatment of warm animals. These derivatives were granted a European patent.
2. The appellant claimed to have identified and invention to produce Imatinib Mesylate
from Imatinib an application was filed for the grant of the patent at the Chennai patent
office on July 17 1998 after the application was made and before it was taken up for
consideration and number of amendments introduced in the Indian Patent Act 1970
which brought about fundamental changes in the patent law of the country.
3. In 1998 Novartis International AG filed an application as per the TRIPS agreement
before the Chennai Indian patent office for the grant of a patent for an anticancer drug
'Glivec' which is used to treat Chronic Myeloid Leukemia (CML) and
Gastrointestinal Stromal Tumours (GIST) invented from Beta crystalline form of
"Imatinib Mesylate". This drug is famously used in the treatment of cancer and the same
is patented in more than 35 countries.
4. The appellant filed application for grant of patent for Imatinib Mesylate in beta
crystalline form at the Chennai patent office on July 17 1998 . In that application
Appellant claimed that the invented product beta crystal form of Imatinib has more
beneficial flow properties better thermodynamics stability and lower hygroscopicity then
the Alpha crystal form of Imatinib Mesylate. Further claimed that the aforesaid properties
makes the invented product “new”.
5. Novartis filed its patent application and stated that the grant used to be restricted to
methods or processes and not for products in India, as defined under section-5 of Patent
Act, 1970. After the Patent Act, 2005 Section 5 was repealed and patents came to be
granted for methods or processes but also for products.
6. In 2005 patent application of Novartis for the drug Glivec was taken into consideration
and the same was rejected by Madras Patent Office on the ground that the drug was
anticipated by prior publication and failed to satisfy the requirement of novelty and non-
obviousness.
7. It was further stated that the alleged invention was un-patentable under the provision of
section-3(d) of Patent Act, 1970 as the drug did not exhibit any major changes in
therapeutic efficacy over its pre-existing form i.e. Zimmermann patent.
8. The procedural history is :
a. Novartis filed two writ petitions in Madras High Court in the year 2006 under
Article 226 of Constitution of India and the appeals subsequently stated that the
section 3(d) of Patent Act 1970 is unconstitutional as it was not in compliance
with TRIPS agreement and also violates Article 14 of Constitution of India and
the other against the order passed by Madras Patent Office.
b. Madras High Court transferred the case to IPAB (Intellectual Property Appellant
Tribunal) in 2007.
 c. The appeal was finally heard and dismissed by IPAB stating that the invention
satisfied the tests of novelty and non-obviousness but the patentability of the
product was hit by Section 3(d) of the Patent Act, 1970.
d. The judgment given by IPAB is to prevent ever-greening of already patented
product by introducing minor changes and to provide easy access to the citizens
of India to life saving drugs.
e. Novartis filed SLP (Special Leave Petition) in 2009 before the Supreme Court
of India against the order passed by IPAB under Article 136 of Constitution of
India.

 ISSUE BEFORE THE COURT:

1. What is the true import of Section 3(d) of the Patents Act, 1970 ?
2. What is the interplay between Section 3(d) and Section 2(1)(j) read with Section 2(1)
(ja) ?
3. Does the product on which the appellant claims patent qualify as a new product which
comes by through an invention ?
4. In case the appellants product satisfies the tests and thus qualifies as “invention” within
the meaning of Section 2(1)(j) and Section 2(1)(ja), can its patentability still be
questioned and denied on the ground that Section 3(d) puts it out of the category of
“invention”?
5. Whether the appellant is entitled to get the patent for the beta crystalline form of a
chemical compound called Imatinib Mesylate which is a therapeutic drug marketed under
the names Glivec or Gleevec ?

 RATIO OF THE COURT:

1. The Court observed that the Patent Act 1970 underwent wide-ranging changes from
January 1 1995 to January 1, 2005 but the noticeable most important change brought in
the patent law in India as a result of the country’s obligations under the international
agreement was the deletion of section 5 from the Act. The time-frame for this set of
amendments was most crucial as any slippage in meeting the January 01, 2005 deadline
had the potential of inviting retaliatory action under the WTO disputes mechanism.
2. The court holds that section 5 of the Act expressly excluded product patents for
substances intended for use and capable of being used as food or as medicine or drug, and
substances prepared or produced by a chemical process, and made these substances non-
patentable. through the Patents Ordinance, 2004 .
3. Court holds that the present application for patent leaves no room for doubt that Imatinib
Mesylate, marketed under the name Gleevec, was submitted for drug approval as covered
by the Zimmermann patent. Since the grant of the Zimmermann patent, the appellant has
maintained that Gleevec i.e. Imatinib Mesylate is part of the Zimmermann patent.
4. The Court is of the opinion that the inventor of Imatinib Mesylate, be it Zimmermann or
anyone else, would also be entitled to get patent for Imatinib Mesylate, but in case the
inventor was anyone other than Zimmermann, he would require Zimmermann’s
permission for marketing Imatinib Mesylate since Imatinib had the protection of the
Zimmermann patent.
5. It was observed that Imatinib Mesylate is a known substance from the Zimmermann
patent was not based on the conduct of the appellant alone but the finding has been
arrived at on an objective consideration of all the material facts and circumstances.
6. On the basis of observation, the Court rejected the appellant’s case that Imatinib
Mesylate is a new product and the outcome of an invention beyond the Zimmermann
patent. It was found that Imatinib Mesylate is a known substance from the Zimmermann
patent itself.
7. Observed by the court that the solvent and the emulsifier were not secrets and they were
ordinary market products. On facts the court was unable to accept that Imatinib Mesylate
or even Imatinib was not a known substance with known efficacy.
8. It was noted that pharmacological properties of a beta crystalline form of Imatinib
Mesylate are equally possessed by Imatinib in free base form or its salt and thus there
 was no question of the subject product having any enhanced efficacy over the known
substance of which it is a new form.
9. It was also held that there is no clarity at all as to what is the substance immediately
preceding the subject product, the beta crystalline form of Imatinib Mesylate.
10. Observed that the beta crystalline form of Imatinib Mesylate is derived directly from
Imatinib free base. The Court thus held that the beta crystalline form of Imatinib
Mesylate certainly cannot be said to possess enhanced efficacy over Imatinib Mesylate
within the meaning of section 3(d) of the Act.
11. It was observed by the court that all the pharmacological effects of Imatinib Mesylate in
beta crystalline form are equally possessed by Imatinib in free base form. Further, no
material has been offered to indicate that the beta crystalline form of Imatinib Mesylate
will produce an enhanced or superior efficacy (therapeutic) on molecular basis than what
could be achieved with Imatinib free base in vivo animal model.

 DECISION HELD BY COURT:

1. The Court held that the patent product fails in both the tests of invention and patentability
as provided under clauses (j), (ja) of section 2(1)and section 3(d) respectively.
2. The appeals filed by Novartis AG failed and were dismissed with cost.

- Author : Aditya das