Access to Medicines: India Offers First Compulsory License

Groundbreaking Move Sets Precedent for Overcoming Drug Price Barriers

In a landmark case, the Indian Patent Office has issued the first-ever compulsory license in India to a generic drug manufacturer. This effectively ends German pharmaceutical company Bayer’s monopoly in India on the drug sorafenib tosylate, used to treat kidney and liver cancer.

The Patent Office acted on the basis that Bayer had not only failed to price the drug at an accessible and affordable level, but that it had also failed to ensure that the medicine was available in sufficient and sustainable quantities within India.

“We have been following this case closely because newer drugs to treat HIV are patented in India, and as a result are priced out of reach,” said Dr. Tido von Schoen-Angerer, director of the Doctors Without Borders Access Campaign. “But this decision marks a precedent that offers hope: it shows that new drugs under patent can also be produced by generic makers at a fraction of the price, while royalties are paid to the patent holder. This compensates patent holders while at the same time ensuring that competition can bring down prices.”

Competition from the generic version will bring the price of the drug in India down dramatically, from over US$5,500 per month to close to US$175 per month – a price reduction of nearly 97 per cent.