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Mai 29, 2012 (Newsletter Issue 9/12)
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First Compulsory License

In a much-awaited decision the Indian Patent Office issued its first compulsory licensing order relating to generic drugs.

On March 9, 2012, the Indian Patent Office allowed Natco Pharma Ltd, an Indian generic drug manufacturer to manufacture and sell generic version of a blockbuster cancer drug patented by the German Bayer Corp, thus invoking the compulsory license provisions of the Patents Act. The Patent Controller held that the the drug was exorbitantly priced, which conflicts with public requirements because the medicine was not affordable for many of them. While granting the compulsory license to Natco, the Patent Controller imposed certain conditions. This included that the price of the drug shall not exceed a certain amount for a month’s treatment, and that the licence is non-exclusive and non-assignable. In addition, Natco must pay royalty on net sales, manufacture on its own and sell only in India, and supply the drug free of cost to a certain amount of needy and deserving patients each year. Bayer has appealed against the order before Intellectual Property Appellate Board (IPAB).

Source: Lex Orbis IP Practice, India