Novartis v. Union of India (Glivec, 2013)

Background

Novartis sought an Indian patent on the beta-crystalline form of imatinib mesylate, sold as Glivec for chronic myeloid leukaemia. The patent office rejected it in 2006 under Section 3(d) of the Patents Act, added in 2005, which bars patents on new forms of known substances unless they show significantly enhanced efficacy. Novartis challenged both the rejection and the section itself.

Significance

The first Supreme Court test of Section 3(d). The court held that the new form did not show enhanced therapeutic efficacy, confirming India's standard against 'evergreening', the practice of extending patent life through minor changes.

Meanwhile in the West

No other country had such a provision when it was enacted in 2005.

Fair to say

The court said the ruling does not bar all incremental pharmaceutical inventions.

Path to modern innovation

Keeps cheap generic cancer drugs available.

Builds on

• 1970India's generic-medicine industry

Global impact

• Generic imatinib remained available in India at a small fraction of the patented price.
• Section 3(d) is widely studied as a model anti-evergreening rule by other countries and public-health organisations.

Transmission

Later copied in spirit by countries such as Argentina and the Philippines.

References

• 1Petrie-Flom Center (Harvard)
• 2Miller Canfield

Further reading

• 3Wikipedia: Novartis v. Union of India and Others
• 4Of Evergreening and Efficacy, Part III - Petrie-Flom Center
• 5Supreme Court of India Denies Novartis Patent Application: Miller Canfield
• 6Leena Menghaney: India’s patent law on trial - The BMJ