## Facts

- Novartis developed imatinib (an anti-cancer agent) and later produced imatinib mesylate and a beta crystalline form of imatinib mesylate, marketed as Glivec/Gleevec for certain cancers.
- Novartis filed an Indian product-patent application in 1998 for the beta crystalline form, claiming priority from a 1997 foreign application; the application was held under India’s “mailbox” regime until pharmaceutical product patents became examinable in 2005.
- In 2006, the Patent Office rejected the application, citing (among other grounds) lack of novelty/inventive step in light of prior disclosures and failure to satisfy the Patents Act § 3(d) requirement for new forms of known substances.
- In 2009, the Intellectual Property Appellate Board rejected the application, concluding the claimed subject matter was barred by § 3(d) because Novartis had not shown enhanced efficacy.
- Novartis appealed to the Supreme Court of India; related appeals by generic manufacturers and patient groups were heard together.

## Issues

1. Whether the beta crystalline form of imatinib mesylate satisfied the Patents Act’s definition of “invention,” including novelty and inventive step under §§ 2(1)(j) and 2(1)(ja).
2. Whether, even if the claim otherwise met the definition of “invention,” § 3(d) excluded it as a new form of a known substance without demonstrated enhancement of known efficacy.
3. For pharmaceutical substances, what “efficacy” and “enhancement of known efficacy” mean under § 3(d), and what proof is required.

## Decision

- The Supreme Court dismissed Novartis’s appeals and affirmed rejection of the patent application.
- The Court held that the claimed subject matter did not satisfy the statutory requirements for “invention” and “inventive step” because imatinib mesylate was treated as already known from earlier disclosures.
- The Court further held that, in any event, the claim failed § 3(d) because the asserted improvements did not establish a significant enhancement in therapeutic efficacy over the known substance.
- Evidence of improved physical properties (such as stability, flow properties, and reduced hygroscopicity) and increased bioavailability did not, on this record, prove better therapeutic outcomes.

## Legal Principles

- Patentability requires satisfying both: (1) the definitional requirements for an “invention” (novelty, inventive step, and industrial applicability), and (2) the statutory exclusions, including § 3(d).
- Under § 3(d), a new form of a known substance (including salts and polymorphs) is not patentable unless it differs significantly in properties with regard to efficacy.
- For medicines, “efficacy” in § 3(d) means therapeutic efficacy; improved manufacturability, storage, stability, or other physical advantages are insufficient without proof of improved therapeutic effect.
- Increased bioavailability may be relevant but does not by itself establish enhanced therapeutic efficacy; the applicant must show a meaningful link to improved therapeutic results.

## Conclusion

The Supreme Court of India denied patent protection for the beta crystalline form of imatinib mesylate, interpreting § 3(d) to require proof of significantly enhanced therapeutic efficacy for new forms of known pharmaceutical substances, and holding that improved physical properties and bioavailability were not enough on the evidence presented.


Novartis AG v. Union of India, Civ. Appeal Nos. 2706–2716 (India 2013)