Brief Facts of Case
Novartis, a Swiss pharmaceutical conglomerate, filed a patent application in
1997 for Glivec, an anticancer drug used to treat Chronic Myeloid Leukemia (CML)
and Gastrointestinal Stromal Tumors (GIST), claiming that it invented the beta
crystalline salt form (imatinib mesylate) of the free base, imatinib. It is a
life-saving medicine that is patented in more than 35 countries worldwide.
However, India did not give patents to pharmaceutical and agrochemical products
at the time. It was in the year 2005 in India when drug items were granted
patent protection under the TRIPS agreement. As a result, India amended its
patent law and began issuing patents on pharmaceutical products. In 2006, the
Madras Patent Office denied Novartis' patent application for Glivec, claiming
that the medicine did not show any significant differences in therapeutic
effectiveness over its pre-existing form, which was already patented outside
The judgement was made under Section 3(d) of the Indian Patents (Amendment) Act,
2005, which states that a known chemical can only be patented in novel forms
that have improved efficacy
. The Patent Office is a government agency
that issues patents. The Patent Office did not find any enhanced efficacy in the
drug Glivec and, therefore, considered it incapable of patentable under Section
3(d) of 2005 Act.
Novartis filed two writ petitions in the High Court of Madras in May 2006, one
appealing the order of the Madras Patent Office rejecting its patent request and
the other contesting that Section 3(d) of the Indian Patents Act is not in
compliance with TRIPS and is vague, arbitrary, and in violation of Article 14 of
the Indian Constitution.
The Madras High Court dismissed Novartis' Writ Petitions, ruling that it lacked
power to evaluate whether a domestic statute is in violation of an international
treaty, and hence could not judge if Section 3(d) complies with TRIPS. As far as
Section 3(d) is considered, the objective of the Amending Act was to prevent
evergreening and to make easy the access to life-saving drugs to the citizens.
Therefore, it cannot be considered to be vague and arbitrary.
The Intellectual Property Appellate Board, which is a patent controller's
appellate body, kicked up the new phase of litigation. The beta-crystalline form
of imatinib mesylate was deemed unique and creative by IPAB, but the drug of
Novartis was denied a patent due to Section 3(d) of the Act. Novartis filed a
Special Leave Petition with the Supreme Court in order to dispute the order.
NACTO pharma Ltd and M/S Cancer patients association
Two of the objectors, NATCO Pharma Ltd. and M/s Cancer Patients Aid
, have also filed a Special Leave Petition challenging the IPAB's
decision in Novartis AG's favour. All of these SLPs have been given leave to
appeal, which means that all questions are available to this Court, and this
Court can handle the case without regard to the Authority's or the Trial's
On 20/7/2002, NATCO Pharma applied for an Indian patent on what is known as the
A2 form of Imatinib Mesylate. Natco Pharma has again applied for a patent on
novel crystalline forms I and II of Imatinib Mesylate and has also accepted that
they exist in alpha and beta forms in NOVATIS Patent. Both parties challenging
the application of Novartis themselves applied for the patenting of the
crystalline forms of Imatinib Mesylate as novel inventions.
Arguments by petitioner
T.R Andhyarujina and Gopal Sbramanium, both senior attorneys for Novartis, led
the Novartis team. The main issue before the court was whether the beta
crystalline form of Imatinib Mesylate constitutes an innovation under section
2(j) and (j)(a), and if so, how does it affect section 3? (d). The appellant
claimed that imatinib Mesylate in beta crystalline form is a brand-new product.
Only Imatinib free base was previously recognized to exist as a prior art.
Novartis was the first to create the alpha and beta versions, which had
previously been unknown. The beta form offers additional benefits than the free
base, such as thermodynamic stability, which makes it a more effective medicine.
This would be an example of the drug's industrial use.
Imatinib as a compound, which was published in the Zimmerman patent, was the
prior art. As a result, there was a technological advancement over the prior
Patent. No crystalline form of Imatinib Mesylate was anticipated or disclosed in
the Zimmerman patent. In the Zimmermann patent, there was no method for
converting Imatinib to Imatinib Mesylate that worked. It is merely concealed and
not revealed. Furthermore, the parties opposing Novartis' application have filed
for and received patents for crystalline versions of Imatinib Mesylate as a
novel innovation. These data support the claim that the inventions are new.
Section 3(d) which was amended in 2005 is provision of what cannot be patented
but the product otherwise is seen as an invention according to section 2(j) and
(j)(a). the strategy of evergreening
was discus by the parliament as a
tactic to obtain a trifling measure in 2005.on the facts pleaded by Novartis,
section 3(d) was not applicable to the patent as reasons stated below:
- Section 3(d) applies only to a single step discovery of a new form of
substance. The claim made by Novartis was that the Imatinib free base which
was a known substance had to undergo various technical procedures and hence
it is not a single step form and has dual stages. Thus section 3(d) should
not be considered.
- The word which does not result in enhancement of the known substance
is made for the patentee for a mere trifling change to create a new form of
a known substance. If there is an enhancement of the known substance, then
it must be patentable.
The known substance, in Novartis invention was Imatinib free base. The
efficiency of the beta crystallin form is practical efficiency has anti-tumour
property and not just a theoretical possibility and it should be known to
public, which was not in case of Imatinib free base. It has an known
efficiency and hence section 3(d) should not be applicable.
The creation of the beta crystalline form of imatinib mesylate from the free
base of imatinib was thus the outcome of a technological breakthrough in
comparison to previous knowledge and the creation of a novel material. In order
to selectively prepare the beta crystalline form of imatinib mesylate,
researchers required to identify and optimize process parameters.
Arguments by respondents
There were seven named respondents who were represented before the court along
with two Intervenor/Amicus. Paras Kuhad, India's Additional Solicitor General,
was in charge of the respondents. The argument was that all salts have qualities
such as hygroscopicity, flow properties, and thermodynamic stability, and that
these properties should be clear to a professional.
The beta form of Imatinib Mesylate was the first oral medication form nation to
treat CML with Gleevec, and it was commercialised successfully. The respondent's
reasoning was founded on hindsight bias betrayal.
The world did not have to wait for CML to be cured if hindsight bias was right.
In light of prior art of knowledge, it was contended that the claimed invention
was not expected nor novel. The petitioner's application to the United States
Food and Drug Administration as an extension of the Zimmermann patent with
respect to Glivec.
Various claims were presented to the court, but the main focus was on
demonstrating that imatinib mesylate in beta crystalline form is neither new nor
ambiguous, citing Cancer Research and Nature publications on imatinib mesylate
in 1996, disclosures in Zimmerman patents, FDA disclosures, and finally, that
efficacy as defined in section 3(d) should be interpreted as therapeutic
efficacy. Bioavailabity is a property that gives an impact of efficiency of the
Efficiency must mean effectiveness as the only difference between a pure and
impure form. Thus, inclusion of these forms within explanation implies that
efficiency in strict sense would be therapeutic.
The issue of prior published article of Cancer Research article published on
1/1/1996 which was prior to the date of patent application which disclosed that
the product can be synthesized. Thus, Imatinib Mesylate along with efficiency
towards the treatment of tumours was already known before filing the patent. The
expression “economic significance” cannot just mean profit to the inventor it
also means the invention leads to significant reduction in costs or reduction of
consumption of imported components. This invention did not have economic
The respondents quoted extensively from the Doha Declaration, quotes from
parliamentary debates, petitions from NGOs, WHO, etc to illustrate arguments on
the public policy dimension in terms of simple affordability and life-saving
Summary of judgment
In April 2013, the two-judge bench of Supreme Court of India rejected the appeal
filed by Novartis and upheld that the beta crystalline form of Imatinib Mesylate
is a new form of the known substance i.e., Imatinib Mesylate, wherein the
efficacy was well known. Supreme Court made it crystal clear that in the case of
medicine "Efficacy" in section-3(d) only means "Therapeutic Efficacy" and states
that all properties of drug are not relevant, the properties which directly
relate to efficacy in case of medicine is its therapeutic efficacy.
The Supreme Court also ruled that patent applicants must demonstrate an increase
in therapeutic efficacy in animals based on in vivo research results. Under
section-3(d) of the Patent Act of 1970, a 30% increase in bioavailability
qualifies as an increase in therapeutic efficacy if evidence is supplied. The
Supreme Court found that the underlying intent of Section 3(d) was to preclude
the concept of evergreening, and that an invention that does not pass the
Section 3(d) test will not be given a patent. The court went on to say that this
decision should not be taken to suggest that all incremental inventions are
prohibited by Section 3(d).
It is in the realm of medicine, particularly in the case of life-saving
pharmaceuticals, that a great deal of care and caution must be exercised in
order to defend the masses' right to life. The Supreme Court compared the
efficacy of "Beta Crystalline form of Imatinib Mesylate" to "Imatinib Mesylate"
based on its flow properties, better thermodynamic stability, and lower
hygroscopicity, and concluded that none of these properties contribute to an
increase in therapeutic efficacy under section-3(d) of the Patent Act, 1970, and
Novartis has not provided any document demonstrating that the efficacy of "Beta
Thus, Supreme Court rejected the appeal filed by Novartis and concluded that
since there was no substantive and conclusive material and evidence prove that
beta crystalline for Imatinib Mesylate will produce an enhanced or superior
therapeutic efficacy, therefore failed to meet the requirements under Sec 3(d).
It was being very rightly said that the ever greening of the patents is not
permitted. Furthermore, the court safeguards the rights of ordinary people and
prohibits pharmaceutical firms from selling drugs at exorbitant prices that are
out of reach for the average person. Companies cannot market identical
pharmaceuticals by simply modifying the molecular structure of the material,
according to Section 3(d) of the Patent Act. Imatinib Mesylate, on the other
hand, lacks an "innovative step." As a result, perpetual greening of patents is
The evergreening of patented drugs is restricted because once the drug gets
patent license, no one has a right to manufacture such drug again. Only the
patent owner owns the exclusive licence for such a medicine. This clause is in
place to protect patents' originality. The patent holder has a one-of-a-kind
licence to exploit his creation. No one else has the authority to utilize or
abuse this right. The compulsory licencing provision is written in such a way
that evergreening is prohibited.
The Novartis case, by bringing the pharmaceutical business into the purview of
patent law, may set a significant precedent for access to medications. The
Supreme Court of India's decision could serve as a precedent for how other
developing countries interpret and execute the TRIPS Agreement in the future.
This case demonstrates how India is upholding its global intellectual property
commitments while also ensuring that domestic demands are met by interpreting
its legal duties in a way that is consistent with home preferences and needs.
The decision prioritizes social justice over commercial interests while
simultaneously benefiting India's local industries. This is the first time that
an Indian law prohibiting drug patents has been enacted, with just minimal
This is the first time an Indian law has been implemented to ban drug patents
with only minimal modifications to an existing one. Patenting will henceforth be
used to protect only truly unique and inventive drugs that have a real
therapeutic impact. In the case of India, we are witnessing a sophisticated game
that has resulted in a conflict between global trade commitments and domestic
public health concerns. In this scenario, the latter has definitely taken
The Supreme Court's decision aims to prevent the ever-greening of patented items
and to provide relief to individuals who cannot afford life-saving treatments
since pharmaceutical corporations sell them at exorbitant prices, making them
expensive to the average person.
The Supreme Court stated in its decision that India is a developing country,
and that access to affordable medications is critical for the lives of 1 billion
people. If Section 3(d) fulfils its stated purpose of avoiding evergreening in
the sense of patenting ineffective, small medicinal alterations, then it makes
little or no impact in the availability of generic medications.
On the other hand, if Section 3(d) actually promotes earlier access to generic
medicines, then it must do so by precluding the patenting of genuine innovations
and free-riding on innovations incentivized by stronger patent regimes. Thus,
even if the results have been consistent with India's underlying social welfare
goals, the reasoning behind these decisions has been flawed.
Whether India wishes to interpret enhanced efficacy to require no more than
inventive step and industrial application, to mean improved efficacy in a broad
sense, or to mean therapeutic efficacy, depends on which legal and policy
rationales it finds most appealing and legally sustainable going forward. One
hopes that India succeeds in reconciling the Supreme Court's decision to choose
with both the theoretical underpinnings and practical realities of
pharmaceutical patenting and innovation in India.
This decision is widely praised since it prohibits the ever-greening of patented
products, and Section-3(d) of the Patent Act of 1970 bans major pharma
businesses, such as Novartis, from obtaining a second Patent simply by making
minor improvements to pre-existing knowledge or technology. Despite the fact
that section 3(d) is constitutional and has a noble goal of avoiding
, it is a poorly drafted clause.
The main section and the explanation are incompatible when it comes to the
patentability of a new form
with a new use
, for example. Section
3(d) has creases that need to be ironed out in order for it to work more
"efficaciously" and to provide the law more certainty. This becomes even more
pertinent, given that there are more cases at the patent office that hinge on
section 3(d) and several countries that are seeking to emulate this unique