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Bayer Leverkusen v. Union of India (2013) Indlaw IP AB 20


  • Whether a compulsory license can be granted in favour of Natco for the production of the patented drug?


  • Section 84(1) of the Patents Act allows any interested person to make an application to the Controller for the grant of Compulsory License after the expiry of three years from the date of grant of patent on any of the following grounds:
  • a) That the reasonable requirements of the public with respect to the patented invention have not been satisfied
  • b) That the patented invention is not available to the public at a reasonably affordable price
  • c) That the patented invention does not work in India.


  • Bayer, the Petitioner, is a corporation incorporated under the laws of the United States of America.
  • It invented and developed its patented drug to enable its administration to human beings named Nexavar. The patented drug is used in the treatment of patients suffering from Kidney Cancer and Liver Cancer.
  • Natco, a drug manufacturer in India, approached the Petitioner for a grant of a voluntary license for manufacturing and selling the patented drug in India.
  • The purpose behind it was to make the patented drug accessible to the public at an affordable price.
  • When applying for the voluntary license, Natco also stated the fact that the Petitioner had neither met the reasonable requirement of the public nor was it reasonably priced nor had it worked in the territory of India. Eventually, the petitioner rejected Natco’s application for a grant of a voluntary license.
  • Thereafter, Natco applied to the Controller General of Patents, Designs, and Trademarks for the grant of compulsory license which was granted by the Controller in 2011.
  • Aggrieved by this, Bayer filed a petition at the Intellectual Property Appellate Board, which also upheld the decision of the Controller. Finally, Bayer appealed to the Bombay High Court.


  • The Court saw no reason to interfere with the Tribunal granting a compulsory license under Section 84 of the Patent Act to Natco. Accordingly, the petition was dismissed.
  • The Court balanced patent rights and public health by noting the aim of increasing the availability of patented articles at reasonable prices.
  • The decision also highlighted the need for a balanced approach to patent law that considers both the interests of patent holders and the public interest in promoting access to essential medicines.