The much awaited Supreme
Court’s decision on patent rights of Novartis AG's cancer treatment
drug Glivec in India has been pronounced. As expected,
Novartis lost the patent battle in the Supreme Court of India. In
effect, the Supreme Court upheld the rejection of the patent
application (1602/MAS/1998) filed by Novartis for Glivec in 1998
before the Indian Patent Office.
We would cover the judgment in detail subsequently
but for the time being we are covering some of the crucial points
discussed by the Supreme Court of India. The Supreme Court of India
did not go into many complexities and decided the case on selective
criteria like invention and patentability.
Perry4Law
was expecting that the decision of Supreme Court would consider the
aspects of Doha Declaration, TRIPS Agreement, Public Health and
Public Interest, Compulsory License Requirements, etc. We are glad to
see that Supreme Court has properly covered these issues.
However, as the product of Novartis failed to clear
the patentability requirements of Indian Patent Act, there was no
need for the Supreme Court of India to go into many details. The
Supreme Court held that on the basis of the materials brought before
the Court, the subject product, that is, the beta crystalline form of
Imatinib Mesylate, fails the test of section 3(d) of the Indian
Patent Act.
However, the Supreme Court clarified that Section
3(d) does not bars patent protection for all incremental inventions
of chemical and pharmaceutical substances. The Court observed that it
will be a grave mistake to read this judgment to mean that section
3(d) was amended with the intent to undo the fundamental change
brought in the patent regime by deletion of section 5 from the Parent
Act. Thus, this judgement does not bar patent protection for all
incremental inventions of chemical and pharmaceutical substances.
The Court also observed that Section 2(1)(j) of the
Act defines “invention” to mean, “a new product or …”, but
the new product in chemicals and especially pharmaceuticals may not
necessarily mean something altogether new or completely unfamiliar or
strange or not existing before. It may mean something “different
from a recent previous” or “one regarded as better than what went
before” or “in addition to another or others of the same kind”.
However, in case of chemicals and especially
pharmaceuticals if the product for which patent protection is claimed
is a new form of a known substance with known efficacy, then the
subject product must pass, in addition to clauses (j) and (ja) of
section 2(1), the test of enhanced efficacy as provided in section
3(d) read with its explanation.
The court also observed that in the US the drug
Gleevec came to the market in 2001. Obviously this means that what
was marketed then was Imatinib Mesylate and not the subject product,
Imatinib Mesylate in beta crystal form. Even while the appellant’s
application for grant of patent lay in the “mailbox” awaiting
amendments in the law of patent in India, the appellant was granted
Exclusive Marketing Rights on November 10, 2003, following which
Gleevec was marketed in India as well.
On its package, the drug was described as “Imatinib
Mesylate Tablets 100 mg” and it was further stated that “each
film coated tablet contains: 100 mg Imatinib (as Mesylate)”. On the
package there is no reference at all to Imatinib Mesylate in beta
crystalline form. What appears, therefore, is that what was sold as
Gleevec was Imatinib Mesylate and not the subject product, the beta
crystalline form of Imatinib Mesylate.
In this background the claim for patent for beta
crystalline form of Imatinib Mesylate would only appear as an attempt
to obtain patent for Imatinib Mesylate, which would otherwise not be
permissible in India.
The Court, therefore, held that the patent product
in question i.e. the beta crystalline form of Imatinib Mesylate fails
in both the tests of invention and patentability as provided under
clauses (j), (ja) of section 2(1) and section 3(d) respectively.
