NOVARTIS GLIVEC CASE STUDY

ASSIGNMENT ON NOVARTIS GLIVEC CASE STUDY

SUBMITTED BY:
ANU KHARE
BATCH:
WEEKEND

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NOVARTIS GLIVEC CASE STUDY

ACKNOWLEDGEMENT

It is an honor for me to express my deep gratitude for those people

involved in this endeavor.
I take this privilege to express my deep sense of gratitude and heartfelt
gratefulness to Miss. Richa Khullar. And Ms. Shruti for their support and
guidance.
I would also like to thank Bimla and Kuldeep, my batchmates for their
support.
At last I am also grateful to IIPTA for providing me knowledge, guidance
and study material.

Anu Khare

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ABSTRACT:
Novartis , a Swiss based pharmaceutical company has filed two cases both on Indian Patent
Office on rejection of patent application for the cancer drug Imatinib Mesylate ( Brand name
Glivec) and the sec 3 d of the new Indian Patent lawcthat form base of opposition.

INTRODUCTION:
Imatinib Mesylate is (Glievac) is a cancer drug used in the treatment of Myeloid Leukemia
(cancer of blood). It is produced and marketed internationally by swiss pharmaceutical Novartis
and various Indian Pharma companies such as Cipla,Hetero, Natco and Ranbaxy. Novartis sell
gleivac at rate of 1,20,000 per patient per month in India. However generic version of drugs
costs at about 8000 per patient per month in India. Novartis filed the application for patent in
Chennai High Court in 1998 ,at that time India did not grant patents on medicine ,so they are
given EMR (Exclusive Marketing rights) , which excludes others from production and sales of
generic version in the market . After 2005 as India starts reviewing product patent applications
application of Novartis has been rejected on basis of sec 3d and pre grant opposition. Novartis
has filed two cases against Indian patent offices rejection of patent application for the cancer
drug Imatinib Mesylate (Glivec) and the section of the new Indian patent law which formed the
basis of the patent office decision.

HISTORY OF CASE:
Filing of patent by Novartis:
Novartis filed an application at Chennai patent office in 1998 to grant a patent on Imatinib
mesylate (glivec). At that time India did not yet grant patents on medicines but in Nov., 2003
Novartis able to get EMR (Exclusive Marketing Rights) for a period of 5 years based on previous
provision of Indian patent act. Granting EMR was a TRIPS obligation for countries like India
which do not give patent on pharmaceutical products. After 2005 , Indian Patent Office began
to review pharma product patent applications EMR are either given patent or are rejected .If
rejected EMR rights also ends. EMR works like a patent monopoly which prevents other pharma
companies to manufacture of sell generic products of Imatinib Mesylate.

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PRE GRANT OPPOSITION OF PATENT:

Cancer patient aid association has filed an opposition on behalf of cancer patients in the
Chennai patent office, as it is allowed to oppose a patent before it is granted by a person or
group. Pre grant oppositionof Glivec is made on five points:
1) There is prior publication of the invention through patent applications filed in many
countries, including Canada and the US, in 1993, by taking priority from the Swiss
application filed in 1992. Claims show that patent is granted not on the compound in its
free form but also for the salt form of Imatinib Mesylate.
2) There is no inventive step , specifications do not show any inventive step in making salt
from the free base of Imatinib Mesylate.and the process described is too obvious for the
person skilled in art.
3) Crystal salt form does not allow to invention.
4) Patent application does not claim any therapeutic efficacy. Rejection ground of sec 3(d)
5) At the time of filing the patent application in 1998 Switzerland is not recognized as
convention country in India .Therefore the patent application from Switzerland is not
eligible for the one year priority available to applications from convention countries.
Moreover to these grounds Glivec costs Rs.1,20,000 per patient per month which is not
affordable in comparison to cost of generic medicines which is Rs. 8000 per month per
person. This is beneficial for public health in developing countries like India. Also India is
the main market of medicine for developing countries. So low cost medicines are needed .
Issuing of patent will effect such requirements.
REJECTION OF PATENT APPLICATION BY CHENNAI PATENT OFFICE:
Chennai Patent Office in January, 2006 rejected the patent application on the ground that the
application claimed only a new form of a known substance. This ground of rejection on the
basis of sec 3 d. As per chapter II of Indian Patent Act, 2002, some inventions are not
patentable, these are
Sec 3: What are not inventions
Sec 4: Inventions relating to atomic energy are not patentable
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Sec 5: Inventions where only methods or processes of manufacture are patentable.

As per Sec 3(d) of Indian Patents (amendment) act, 2005 the mere discovery of a new form of
a known substance which does not result in the enhancement of the known efficacy of that
substance or the mere discovery of any new property or use for a known substance or of the
mere use of a known process, machine or apparatus unless such known process results in a new
product or employs atleast one new reactant. Indian Patent Office rejected Novartis patent
application for Glivec on the basis of this sec3 (d), which states polymers, isomers metabolites
etc are considered to be same substance unless they show difference in properties in regard of
efficacy. This rejection of patent application also ends EMR on glivec upto 2018.
NOVARTIS CHALLENGES PATENT ORDER AND INDIAN PATENT LAW:
On 17, May 2006 Novartis filed two cases in Chennai Patent Office
1) First case challenges the order of the Chennai Patent office, which rejected patent
application of Novartis for Glivec on the ground of pre grant opposition by the Cancer
patient aid association.
2) The second case filed by Novartis challenges the constitutionality of Sec 3(d) of Indian
patent act, 2005. This sec was introduced to prevent the misuse of the product patent
regime. Novartis claims that sec is not in compliance with TRIPS. This sc prevents
pharma companies to obtain patent on trivial improvements or new medical uses of
known molecule. Indian patent law ,when become fully compliant with TRIPS
Agreement and introduced a product patent Regime in 2005, it safeguard the law using
condition that patent is not given on mere discoveries of new forms or new medical
uses of known substance until an enhancement in efficacy is proven. This is as per TRIPS
agreement. TRIPS do not define what invention is and what is the measure of efficacy,
which allows WTO countries to use the provision as per their understanding.
NOVARTIS PERSPECTIVE:
As per Novartis Our case in India is solely about safeguarding intellectual property, not about
patient access
As stated, Novartis is not trying to change any provision that support access, they are only
challenging parts of Indian law that rejects Glivec. They do not challenge provisions that provide
for access under International trade agreements, specifically the WTOs Agreement on TRIPS
and the Doha Declaration. They are only trying to protect the Intellectual Property rights on
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Glivec, by contesting the rejection of Glivec. Novartis supports TRIPS condition that promotes
access for developing countries. They are challenging to additional hurdles to patentability in
India that discourage both breakthrough and incremental innovation. If the patent law is
effective, with the help of this companies like Novartis can continue to bring improvements and
innovations to patients and societies. Moreover Glivec , a life saving drug of cancer is a true
innovation . Rejection of its patent application shows the deficiencies in Indian Patent system.

COURTS DECISION:
Court rejected patent application of Novartis on Glivec as it is not able to prove
therapeutic efficacy. Therefore the court held that sec 3(d) is not violative of article 14
of the Constitution of India.

Court also rejected the argument of petitioner that sec 3(d) is not compliant to TRIPS
agreement.

CONCLUSION:
The judgement is welcomed globally by treatment activists and public interest groups. Novartis
disagree with the judgement and warned that court ruling will discourage much required
investment in drug innovation.
As per judgement efficacy is judged on the basis of therapeutic efficacy of the drug.
Judgment is in favour of patients and developing countries.

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REFERENCES:

novartis glivc study/Ipr-Case-Study.htm

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