Novartis AG v. Union of India & Ors.

Relevant Acts and provisions

Patents Act, 1970

Section 2(1)(j)Section 2(1)(ja)Section 3(d)Section 83

Provisions considered: Sections 2(1)(j), 2(1)(ja), 3(d) and 83 of the Patents Act, 1970 (as amended in 2005).

Brief facts

Novartis sought a patent for the beta crystalline form of Imatinib Mesylate, marketed as Glivec, a drug used to treat chronic myeloid leukaemia. The Assistant Controller of Patents rejected the application on several grounds including Section 3(d), and the Intellectual Property Appellate Board upheld the rejection of the product patent, holding that the beta crystalline form lacked enhanced efficacy over the known substance disclosed in an earlier patent. Novartis appealed to the Supreme Court against the Appellate Board's order.

Issues before the Court

1. What is the true meaning and scope of Section 3(d) of the Patents Act, 1970, and how does it interact with Sections 2(1)(j) and 2(1)(ja)?
2. Does the beta crystalline form of Imatinib Mesylate qualify as an invention involving novelty and an inventive step?
3. Is the product barred from patentability under Section 3(d) for want of enhanced efficacy over the known substance?

Court's findings

The Court held that Section 3(d) was introduced by the 2005 amendment specifically to prevent the patenting of trivial variants of already known pharmaceutical substances, commonly described as evergreening, and that it operates as an additional threshold of patentability distinct from the tests of novelty and inventive step under Section 2(1)(j). The Court held that, for a new form of a known substance, efficacy in Section 3(d) means therapeutic efficacy, and that improvements in physical properties such as flow characteristics, thermodynamic stability or hygroscopicity do not by themselves amount to enhanced efficacy.

The Court observed that Novartis's own data showed only about a thirty per cent increase in bioavailability of the beta crystalline form over Imatinib in free base form, and that Novartis had not established that this increased bioavailability produced any additional therapeutic benefit. The Court noted that the beta crystalline form was a polymorph of a substance already known from the earlier Zimmermann patent, so its patentability had to be tested against that known substance.

The Court further held that even if the product were assumed to satisfy the ordinary tests of novelty and inventive step, it would still fail the higher bar erected by Section 3(d) for known substances, in the absence of proof of enhanced therapeutic efficacy.

Decision

Appeals dismissed; a product patent for the beta crystalline form of Imatinib Mesylate was refused for failure to satisfy the enhanced efficacy test under Section 3(d).

Keywords

Efficacy Evergreening Inventive Step Known Substance Pharmaceutical Patent Section 3(d)