India Intellectual Property Appeals Board (IPAB) upholds compulsory license on cancer drug in Bayer v Natco

As others have reported, the India Intellectual Property Appeals Board (IPAB) has upheld the compulsory license on the Bayer patents on the cancer drug sorafenib, sold under the trademark of Nexavar by Bayer.

Sorafenib is largely used for liver and kidney cancer. The Bayer price for Nexavar was Rs. 2.8 lakh for a pack of 120 tablets, or about $61,798 per year of treatment. The generic price is around 3 percent of the Bayer price and falling.

The decision in Bayer v Natco was read today by Justice Prabha Sridevan at the IPAB, but the printed version of the decision won’t be available until later this week. What we do know is that Bayer has lost on almost every issue, but the IPAB has increased the royalty rate from 6 to 7 percent. KEI was not in the courtroom when the decision was read, and it’s hard to know more until we read the decision itself.

On February 17, 2013, KEI had filed this statement in the appeal proceeding: /node/1657. The KEI statement focused on three main issues, the costs of R&D, the setting of a reasonable royalty, and relationship between the TRIPS and the India patent law.

It is likely that both Bayer and Natco will appeal the decision. Bayer has more to appeal, since they were on the losing side of so many issues. Natco will likely appeal the increase in the royalty rate.

The decision by the IPAB is an important reaffirmation of the pro-patient provisions in the India patent law, and creates more momentum to address the vast inequality of access to cancer drugs around the world. KEI calls upon other governments to make similar rulings when facing high prices for cancer drugs.

The Bayer logo for Nexavar: