A Patent Denied, a Principle Defined: How Novartis v. Union of India (2013) Redefined Patentability in India

The Novartis AG v. Union of India & Others case is one of the most significant decisions in the history of Indian patent jurisprudence. Delivered by the Supreme Court of India on 1 April 2013, this judgment reaffirmed India’s unique stance on patentability standards — especially in the pharmaceutical sector — and underscored the balance between innovation protection and public access to medicines.

A lawyer in formal attire reviews documents before a landmark case, showcasing the seriousness and gravity of the proceedings.

Background: What Was the Dispute About?

Novartis AG, a Swiss multinational pharmaceutical company, filed a patent application in India in 1998 for the beta crystalline form of imatinib mesylate, a compound marketed globally as Glivec (or Gleevec) — a breakthrough drug used to treat chronic myeloid leukemia (CML) and certain tumors.

When India amended its patent law in 2005 to allow product patents for pharmaceuticals (to comply with the TRIPS Agreement), Novartis sought patent protection under the revised regime. However, the Indian Patent Office rejected Novartis’s application on the grounds that the new form of the drug did not meet the statutory criteria under the law.

Key Legal Provision at the Heart of the Case — Section 3(d)

A central issue in the case was Section 3(d) of the Indian Patents Act, 1970 — a provision designed to prevent “evergreening” (i.e., obtaining multiple successive patents for minor modifications without significant therapeutic improvement).

Under this provision, a new form of a known substance is not patentable unless it results in a “significant enhancement of known efficacy”, especially in therapeutic effectiveness. Mere improvements in properties like stability, solubility, or bioavailability, without demonstrable clinical benefit, are insufficient.

Journey Through the Legal System

• After the Patent Office rejection in 2006, Novartis appealed to the Intellectual Property Appellate Board (IPAB). While the IPAB found the invention to be novel and non-obvious, it still refused the patent based on Section 3(d).

• Novartis also challenged the constitutionality of Section 3(d), but those petitions were dismissed.

• The matter ultimately reached the Supreme Court of India — culminating in the 2013 judgment.

Supreme Court’s Decision

The Supreme Court unanimously upheld the rejection of Novartis’s patent application. The bench — consisting of Justices Aftab Alam and Ranjana Prakash Desai — ruled that:

• The beta crystalline form of imatinib mesylate is a known substance or a variation of a known substance, and

• Novartis failed to demonstrate “enhanced therapeutic efficacy” over the known form of the drug, as required by Section 3(d).

The Court emphasized that therapeutic efficacy refers to actual improvement in treatment outcomes — and that increased bioavailability alone did not satisfy this standard without clinical evidence. This rejection essentially meant Novartis could not extend patent protection on Glivec in India, even though product patents are available elsewhere.

Why This Judgment Matters

The Novartis case is a landmark for patent law worldwide, with several important implications:

1. Clarifying Section 3(d) Standards

The judgment gave a strict and narrow interpretation to Section 3(d), reinforcing that minor modifications do not warrant patent protection unless tied to meaningful therapeutic advancement.

2. Preventing Evergreening

By rejecting the application, the Court sent a strong message about curbing evergreening practices that could prolong monopolies on essential medicines without real innovation.

3. Promoting Access to Affordable Medicines

The ruling ensured that generic manufacturers in India could continue producing affordable versions of Glivec — preserving access for millions of patients who depend on low-cost treatment.

4. Global Impact

The decision reverberated internationally, sparking debate between innovators and public health advocates about the optimal balance between IP protection and health equity.

Conclusion

Novartis AG v. Union of India (2013) remains a cornerstone in Indian IP law — not just for its legal reasoning, but for reflecting India’s broader approach to patentability in the pharmaceutical sector.

For patent professionals, public health advocates, and law students alike, this case exemplifies how legal frameworks can shape access to life-saving medicines, while also setting clear standards for what counts as meaningful innovation in patent law.