Bayer Corporation v. Union of India, Controller of Patents and Natco Pharma Ltd.
Whether India's first compulsory licence, granted over a patented cancer medicine, was validly granted under section 84.
What the court held
The Court upheld the compulsory licence. It found all three grounds in section 84(1) made out. Supply had reached only a small fraction of the patients who needed the medicine, so the reasonable requirements of the public were not being met. A discretionary patient assistance scheme did not answer the separate question of a reasonably affordable price, which is judged largely from the public's side. On working in India, the Court accepted that importation can amount to working, but said the patentee must justify why local manufacture was not attempted.
Why it matters to a reader of this provision
This is the only Indian compulsory licence that has been through the full appellate process, and it remains the standard reference for how sections 83 and 84 are applied. It separates the three statutory grounds, shows the weight given to actual supply and to affordability, and marks the limits of arguing that importing alone satisfies the working requirement. Later discussion of section 84 keeps returning to it.
Provisions this judgment interprets
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Does this judgment affect your matter?
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