## Facts

- Novartis AG sought patent protection in India for the beta-crystalline form of imatinib mesylate (marketed as Glivec/Gleevec).
- The Chennai Patent Office rejected the application under § 3(d) of the Patents Act, 1970 (as amended in 2005), which limits patentability for new forms of known substances absent enhanced efficacy.
- Novartis AG and Novartis India Ltd. filed two writ petitions in the Madras High Court under Article 226 of the Constitution of India.
- The petitions initially sought (i) a declaration that § 3(d) was unconstitutional and (ii) an order directing grant of the patent; the request for a direction to grant the patent was later withdrawn.
- Generic manufacturers and patient/public-interest groups participated as opposing parties.
- A Division Bench heard the matter and issued judgment on August 6, 2007.

## Issues

1. Whether a High Court, in a writ proceeding, may invalidate § 3(d) on the ground that it conflicts with Article 27 of the TRIPS Agreement.
2. If such review were available, whether § 3(d)’s enhanced-efficacy requirement is inconsistent with TRIPS Article 27.
3. Whether § 3(d) violates Article 14 of the Constitution of India due to vagueness, arbitrariness, discriminatory effect, or unguided administrative discretion.

## Decision

- The court held it lacked jurisdiction in a writ petition to invalidate § 3(d) for alleged inconsistency with TRIPS; TRIPS disputes are to be pursued through WTO state-to-state mechanisms.
- The court upheld § 3(d) against the Article 14 challenge, finding it neither vague nor arbitrary and not a grant of unguided discretion.
- Both writ petitions were dismissed.

## Legal Principles

- International treaty obligations such as TRIPS generally do not create directly enforceable private rights in domestic constitutional litigation; alleged treaty noncompliance is not, by itself, a basis to strike down a statute.
- Where statutory text is clear, international agreements may serve as interpretive aids but cannot be used to invalidate domestic legislation.
- Under Article 14, a classification is valid if it rests on an intelligible differentia and bears a rational nexus to a legitimate legislative objective.
- A statutory term is not unconstitutional for vagueness merely because it is undefined; technical terms may be assessed in light of field-specific meaning and can be applied through administrative decision-making subject to appellate and judicial review.
- § 3(d) permissibly treats certain derivatives or new forms of known substances as the same substance unless the applicant shows a significant difference in properties related to efficacy, supporting the legislative aim of limiting patents for non-therapeutically beneficial modifications.

## Conclusion

The Madras High Court sustained § 3(d) as a constitutionally valid patentability filter for new forms of known substances and held that alleged TRIPS inconsistency could not be used by private parties in a writ petition to invalidate the statute.


Novartis AG v. Union of India, W.P. Nos. 24759 & 24760 of 2006 (Mad. H.C. 2007)