Novartis AG v. Union of India (2013, Supreme Court of India – Section 3(d))

A milestone ruling restricting evergreening and strengthening India’s public-interest patent standards.

Summary :

This case is one of the most influential patent decisions in India, dealing with the leukemia drug Glivec. Novartis sought a patent for an updated form of the active ingredient imatinib mesylate. The Patent Office rejected the application under Section 3(d), which bars patents for minor modifications unless they significantly enhance efficacy. The Supreme Court upheld this rejection, emphasizing India’s unique balance between innovation and public health.

Facts of the Case :

Novartis developed a beta-crystalline form of imatinib mesylate and claimed it had better stability, flow properties, and bioavailability. However, the Indian Patent Office determined that these improvements did not constitute a significant enhancement in therapeutic efficacy. Several health organizations argued that granting the patent would block access to affordable generic medicines vital for cancer treatment in India.

Court Findings / Reasoning :

The Supreme Court clarified the correct interpretation of Section 3(d): only modifications that lead to real, meaningful improvement in therapeutic efficacy can qualify for patents. Novartis’s data did not sufficiently prove such an improvement. The Court stressed that India’s patent law aims to prevent evergreening, ensuring that corporations cannot extend patent monopolies through slight chemical tweaks.

Suggestions / Practical Lessons :

Pharmaceutical companies must present clear clinical evidence of improved therapeutic performance if they seek patents for modified forms. This case stands as a precedent protecting the Indian generics industry and promoting access to essential medicines.

Judgment :

Novartis’s patent application was rejected. The Court held that the modified form lacked significant therapeutic efficacy under Section 3(d).