Critique on the Novartis Case Supreme Court Decision

Facts
Novartis applied for a patent in the Madras Patent Office in 1998 for Imanitib
Mesylate in Beta crystalline form. The Indian Patent regime was in a transitional
phase during 1995 to 2005, as per the TRIPS Agreement, therefore, the Patent
application filed by Novartis remained dormant in the "Mailbox Procedure". It was
taken up for consideration only after amendments in compliance with the TRIPS
Agreement were made in 2005.
It was contended that a product patent should be granted to Novartis on grounds of
enhanced efficacy. The enhanced efficacy was asserted by Novartis with respect to
the better flow properties and thermodynamic stability, but the most important
being bioavailability.
Bioavailability refers to the proportion of the pharmaceutical product which is
absorbed into the blood during circulation and thus is an indicator of its efficiency.
The Beta Crystalline form was contended to have 30% increased bioavailability,
which would enhance the effectiveness of Glivec . The Assistant Controller of
Patents and Design rejected the application on the grounds of:
a) Obviousness to a person skilled in the art under scrutiny
b) Novelty
Accordingly, patentability of the product was hit by Section 3 (d)8 of the Indian
Patent Act , 19709 . Novartis filed two writ petitions before the Madras High Court
seeking to declare Section 3(d) of the Act unconstitutional as it violates Article 14 of
the Indian Constitution and is not in compliance with the Agreement on TRIPS. The
High Court rejected these petitions and upheld the constitutionality of Section 3 (d)
of the act. The Madras High Court then transferred the petitions challenging the
orders of the Assistant Controller to the IPAB (Intellectual Property Appellate Board),
as it did not have the jurisdiction in the matter. The IPAB held that the patentability
of beta crystalline form of Imatinib Mesylate was affected by Section 3 (d) 1 of the
Act, although the requirements of novelty and non obviousness were being met. The
provisions of Section 3 (d) were interpreted strictly and it was observed that with
respect to India, the grant of patents requires a "higher standard of inventive step".
1 What are not inventions.The following are not inventions within the meaning of this Act,
(a) an invention which is frivolous or which claims anything obviously contrary to well
established natural laws;
(b) an invention the primary or intended use or commercial exploitation of which could be
contrary public order or morality or which causes serious prejudice to human, animal or
plant life or health or to the environment;
(c)the mere discovery of a scientific principle or the formulation of an abstract theory or
discovery of any living thing or non-living substance occurring in nature;

The Appellate Board relied on the decision of the Madras High court, which held that
enhanced efficacy means enhanced therapeutic effect and stated that the
compound in question lacked efficacy and therefore fell within the scope of Section
3 (d). The above observation was made keeping in mind the constitutional
obligations of the State to provide healthcare and easier access to life saving drugs
and to curb Evergreening . Novartis challenged the decision of the Appellate Board
in the Supreme Court.
Critique of the judgment
The judgment rendered by the Supreme Court has been applauded as a landmark one that will help
provide millions of people around the world access to cheaper medicines and prevent pharmaceutical
giants from evergreening their patents. While no doubt the effect of the judgment will be to ensure the
availability of affordable life saving drugs to people in India and elsewhere, the crux of the judgment lies in
the fact that Novartis AG was denied a patent not on account of the pricing of its drugs or its profit motive
but on the basis that the drug that it sought a patent for did not involve an invention that was patentable
under Indian law. The Supreme Court in delivering its judgment delved deep into various issues including
the history of patent law in India, legislative debates surrounding the now famed amendment to Section
3(d) of the Patents Act, 1970 (the Patents Act), development of the pharmaceutical market in India and
the chemical composition and properties of the beta crystalline form of Imatinib Mesylate (marketed as
Gleevec), the drug which was under consideration for the patent.

The Supreme Court considered the following questions:

(i)
Is Imatinib Mesylate, the salt version of the free base form of Imatinib, an invention that is
patentable under Indian law?
(ii)

Is the beta crystalline version of Imatinib Mesylate an invention patentable under Indian law?

In answering the first question, the Supreme Court made the following observations:
(a)
The application for grant of the Zimmermann patent in the US specified that the invention related
to Formula 1 (being derivatives of N-phenyl-2-pyrimidne-amine, one of which was Imatinib) and its
compounds. The application further stated that the compounds of Formula 1 included their respective
salts. The application also stated that the invention was in relation to the treatment of tumor in warmblooded animals by administering a Formula 1 compound or its pharmaceutically acceptable salt to such
animals.
(b)
The beta crystalline form of Imatinib Mesylate was later patented in the US in 2005. However, the
drug Gleevec was launched in the market on the basis of the Zimmermann patent itself much before
(d) 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 new 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 at least one
new reactant

2005. Novartis application before the Food and Drug Administration, USA stated that the active ingredient
in the drug for treatment of patients suffering from Chronic Myeloid Leukamia was Imatinib Mesylate and
that the Zimmermann patent covered this drug.
(c)
When Novartis applied for a patent for the beta crystalline form of Imatinib Mesylate in the US, the
Board of Patent Appeals held that there was a presumption that the Zimmermann patent teaches a
person skilled in the art, the manner of use of Imatinib or a pharmaceutically acceptable salt thereof in the
treatment of tumors in warm blooded animals.
(d)
When Natco Pharma Limited marketed a drug called Veenat 100 in the UK, Novartis issued a legal
notice against Natco pointing out that the active pharmaceutical ingredient of Veenat 100 was Imatinib
Mesylate, which was covered by the Zimmermann patent in Europe.
Based on these observations the Supreme Court came to the conclusion that Imatinib Mesylate, the salt
version of Imatinib in its free base form is covered under the Zimmermann patent and is a known
substance from the Zimmermann patent.
To rebut this finding of the court, Novartis argued that the scope of coverage under a claim in a patent is
different from and wider than what is disclosed under the patent in its specification. In other words
according to Novartis, Imatinib Mesylate was covered under the Zimmermann patent and therefore out of
bounds for production by any person other than Novartis, but since it was not disclosed under the
Zimmermann patent, there was scope for it to be invented and consequently for it to be patented by
Novartis in India. The Supreme Court held that such distinction if considered acceptable would invalidate
the rationale of patent law. Patent laws allow monopoly to be granted to certain persons in respect of
inventions for a specific period of time on the basis that the invention be disclosed and made available to
the public for their benefit. The court held that covering undisclosed inventions under a patent would
negate the fundamental rule underlying the grant of patent. The court also held that it does not wish
Indian law to develop in a manner where there is a vast gap between coverage and disclosure under a
patent.
On this basis the Supreme Court held that Imatinib Mesylate and its pharmacological properties are
known from the Zimmermann patent itself and therefore it is not an invention that can be patented under
Indian law.
The Supreme Court then went on to answer the second question and observed that the beta crystalline
form of Imatinib Mesylate being a polymorph of Imatinib Mesylate is directly covered under Section 3(d).
Novartis contended that Section 3(d) was inserted in the Patents Act in its present form out of abundant
caution and any invention that meets the threshold of novelty and inventive step under Section 2(1) of the
Patents Act cannot fall within the restrictions of Section 3(d). Here, the Supreme Court referred to the
parliamentary debates in 2005 when Section 3(d) was amended and observed that Section 3(d) was
amended to prevent abuse of product patents in medicines and agricultural products and to allay the fears
of the opposition that product patents, especially in the pharmaceutical sector were capable of being
abused by evergreening. The court observed that in its opinion, the amended Section 3(d) is meant to
especially cover pharmaceutical products and is meant to set up a second tier of qualifying standards for
patenting pharmaceutical products. This is a very strong observation by the Supreme Court and clearly all
pharmaceutical patents need to satisfy the Section 3(d) test.

Novartis also argued that a conceivable substance is not necessarily a known substance as required
under Section 3(d) and that known meant well established and proven beyond doubt. Novartis further
argued that neither Imatinib nor Imatinib Mesylate had any known efficacy in that sense and therefore
the question of enhanced efficacy of the beta crystalline form of Imatinib Mesylate did not arise. The
Supreme Court however rejected this submission and held that even the term publicly known although it
may warrant a wider interpretation than known was, in fact, interpreted more narrowly than the
construction submitted by Novartis. On this basis, the Supreme Court held that the beta crystalline form of
Imatinib Mesylate is a form of a known substance (i.e. Imatinib Mesylate) with known efficacy.
On the question of whether the beta crystalline version had enhanced efficacy as compared to that of the
salt version of Imatinib Mesylate, the Supreme Court observed that all the material on record compared
the beta crystalline version of Imatinib Mesylate to the free base form of Imatinib. There was nothing on
record to compare the beta crystalline version with the intermediate salt version. The Supreme Court also
held that enhanced efficacy of a medicine should be determined by taking into account its therapeutic
efficacy. The Supreme Court further held that better flow, thermodynamic stability and lower
hygroscopicity, while beneficial do not determine efficacy of a medicine. On the basis that there was no
evidence to prove that the beta crystalline form of Imatinib Mesylate provided enhanced therapeutic
efficacy over Imatinib in its free base form, the court held that the beta crystalline version failed the
Section 3(d) test.
The Supreme Court came to this conclusion after a detailed analysis of the facts and circumstances of
this case. The court went on to specify that this case should not be interpreted to mean that Section 3(d)
bars all incremental inventions. Keeping that in mind, it is unfair to criticize this decision as a loss for
innovation. If anything this decision is a sign of strength and indicates that our judiciary is empowered to
see through any attempt at evergreening existing patents and is capable of recognizing a genuine
invention from a masked one. The Court in fact went ahead to note that the marketed package of
Gleevec specified that the drug contained Imatinib Mesylate in its salt form and not in the beta
crystalline form. Therefore, it observed that the patent claim appeared to be a camouflaged attempt to
obtain a patent for Imatinib Mesylate, the salt form, which was not otherwise possible under Indian law.