Natco Pharma Ltd. v. Bayer Corporation
Rule established
India's first compulsory licence was granted under Section 84 where the patented drug was not available at a reasonably affordable price and the patent was not worked in India
Facts
- Bayer Corporation held Indian Patent No. 215758 for sorafenib tosylate, a drug for renal cell carcinoma and hepatocellular carcinoma
- Bayer sold the drug at approximately Rs. 2,80,000 per month per patient
- Only 2% of eligible Indian patients could access the drug at this price
- Bayer imported the drug rather than manufacturing it in India
- Natco Pharma applied for a compulsory licence under Section 84, offering to sell the drug at Rs. 8,800 per month
- Three years had elapsed since the grant of the patent (statutory waiting period satisfied)
Issue
- Whether a compulsory licence should be granted under Section 84 of the Patents Act, 1970 on the grounds that (a) the reasonable requirements of the public have not been satisfied, (b) the patented invention is not available at a reasonably affordable price, and (c) the patented invention is not worked in the territory of India.
Held
- S.84(1)(a): Only 2% of eligible patients had access to the drug; the public need was demonstrably unmet
- S.84(1)(b): Rs. 2,80,000 per month was beyond the reach of the overwhelming majority of Indian patients
- S.84(1)(c): Bayer imported the drug rather than manufacturing it in India, which did not constitute "working" of the patent
Ratio Decidendi
Under Section 84 of the Patents Act, 1970, a compulsory licence may be granted after three years from the date of patent grant if the reasonable requirements of the public are not satisfied, the invention is not available at a reasonably affordable price, or the invention is not worked in India. Importation alone does not constitute working of the patent in the territory of India. When a life-saving drug is priced beyond the reach of the vast majority of patients who need it, the requirement of reasonable affordability is not met, justifying compulsory licensing in the public interest.
How to use it in an exam
- Deploy when discussing compulsory licensing under Indian patent law and TRIPS flexibilities
- Use as the leading example of Section 84 in practice (India's first and most cited compulsory licence)
- Relevant for questions on access to medicines vs. patent rights
- Key line: "Mere importation of a patented product into India does not amount to working the patent in the territory of India within the meaning of S.84(1)(c)."
Source
Source: CLA No. 1/2011, Controller of Patents, Mumbai (2012); verified via IPO records
This is an educational summary, not the judgment itself. Cite the reported version in professional or academic work.