Facts:

• Bayer Corporation (Petitioner), a corporation incorporated under the laws of the United States of America (USA), was engaged in research and development (R&D) activities. They invented and developed a patented drug used in the treatment of Kidney cancer (Renal Cell Carcinoma - RCC) and liver cancer (Hepatocellular Carcinoma - HCC).
• Bayer Corporation applied for and was granted patents for this drug in the USA, India, and over 45 other countries, giving them exclusive rights to make, use, and sell the drug for 20 years.
• The Union of India and Natco Pharmaceuticals Limited (Natco) were the Defendants in this case.
• Natco, a drug manufacturer in India, approached Bayer Corporation for a voluntary license to manufacture and sell the patented drug in India at an affordable price. Bayer Corporation rejected Natco's application, after which Natco applied for a Compulsory License, which was granted by the Controller.
• Natco Pharmaceuticals Limited (Natco) initially sought a voluntary license from Bayer Corporation to manufacture and sell the patented drug in India at an affordable price, but their request was rejected.
• Subsequently, Natco applied for a Compulsory License under Section 84(1) of the Patents Act, arguing that Bayer Corporation's drug failed to meet the reasonable requirements of the public, was not reasonably priced, and not manufactured in India. The compulsory license was granted by the Controller.
• Bayer Corporation opposed this decision of the controller. Hence, the suit was filed. The Union of India was involved as a party due to its role in implementing and overseeing the patent laws and regulations in India.

Background/ Procedural Posture:

This petition under Article 226 challenged the order dated March 4, 2013, passed by the Intellectual Property Appellate Board (Tribunal), which upheld the order dated March 9, 2012, by the Controller of Patents granting a Compulsory License to M/s. Natco Pharmaceuticals Limited (Natco) under Section 84 of the Patents Act, 1970.

Main Issues:

1. Did the applicant (Natco) make efforts to obtainvoluntary licence from the Patent holder (Bayer)?
2. Has the reasonable requirements of the public been satisfied?
3. Was the patented drug available to the general; public at reasonably affordable price
4. Has the Patented Drug been worked in the territory of India?