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Bayer Corporation v. Union of India

Citation: W.P. No. 1323/2013

Court: Bombay High Court

Bench: M.S. Shah, C.J. and M.S. Sanklecha, J


Facts:

Bayer Corporation (“Bayer”), the petitioner in this case, a US-based company, developed a drug to treat patients suffering from kidney and liver cancer. After the drug was invented in 1999, Bayer applied for a patent in the U.S. and in India in the year 2001. Consequently, Bayer obtained an exclusive right to manufacture, use, license, and sell the drug. Natco Pharma Ltd. (“Natco”) approached Bayer to obtain a voluntary license, which Bayer declined. Thereafter, Natco applied to the Controller General of Patents, Designs and Trademarks (“Controller”) 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.


Issues:

  • Did Natco make efforts to obtain a voluntary license from Bayer?

  • Have the reasonable requirements of the public been satisfied?

  • Whether the application for compulsory license ought to have been adjourned by the Controller?

  • Was the patented drug available to the general public at a reasonably affordable price?


Relevant Legal Provisions:

Sections 82, 83, 84, 84(1)(3), 84, and 92A of the Indian Patents Act, 1970


Analysis:

Bayer contended that Natco did not make reasonable efforts to obtain a voluntary license. However, the Court did not agree to this contention. The Court considered the evidence presented by the parties(Globocan 2008 figures of cancer patients) and proceeded to note that even after the supply of the drug by Natco, the reasonable requirement of the public was not satisfied. The reasonable requirement of the public had to be considered by the authorities in the context of number of patients requiring the patented drug. While considering the reasonable requirement of the public, Bayer contended that the authorities had erred while arriving at the actual number of beneficiaries of this drug. The Court did not agree to this and found that the reasonable requirement had not been satisfied.


Furthermore, while considering the third issue, Bayer contended that the Controller did not adjourn the consideration of the application for compulsory license by Natco. However, this was subject to Bayer working the patent (commercially) in India and the Court found that Bayer had not worked the patent in India and hence found no fault in Controller’s order. Finally, the Court found that Bayer had recovered its research and development expenses in one year by which the Court concluded that the cost of the drug was not reasonably priced.


Conclusion:

Consequently, the Writ Petition was dismissed. The Petitioner filed a Special Leave Petition before the Hon’ble Supreme Court of India, challenging this decision. However, the Hon’ble Supreme Court did not interfere with the decision of the Bombay High Court and dismissed the Special Leave Petition. 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.




 




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