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.
Perry4Lawwas 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.