First compulsory licence: Natco v. Bayer (Nexavar)

Background

Bayer's kidney and liver cancer drug sorafenib tosylate (Nexavar) cost about Rs 2.8 lakh for a month's treatment in India. In 2012 the Controller of Patents granted Natco Pharma a compulsory licence under Section 84 of the Patents Act, on the grounds that the drug was not reasonably affordable or available. Natco could sell it at about Rs 8,800 a month, paying Bayer a royalty.

Significance

India's first compulsory licence. It was upheld by the Intellectual Property Appellate Board in 2013, which raised the royalty from 6% to 7%, and by the Bombay High Court in 2014.

Fair to say

India has rarely used compulsory licensing since.

Path to modern innovation

A landmark for access to medicines.

Builds on

• 1970India's generic-medicine industry

Global impact

• Set a working precedent for using the public-health flexibilities of the WTO's TRIPS Agreement.

Transmission

Upheld on appeal (2013).

References

• 1BMJ blog
• 2Miller Canfield

Further reading

• 3Wikipedia: Natco Pharma
• 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