Source: www.keionline.org
KEI has provided an affidavit in an India compulsory licensing dispute involving Natco and Bayer, for patents on the cancer drug sorafenib (sold by Bayer under the brand name Nexavar). The case will test the new Section 84 of the India patent act, and in particular, set a precedent for a reasonably affordable price. Bayer is currently charging 280430 Indian rupees for a 30 day supply of Nexavar, which is used to treat kidney and liver cancer. KEI has some background information on soafenib on the web at http://keionline.org/drugs, including data on research and development, orphan drug designations and global pricing.
The KEI affidavit covers three topics: the standards for determining if a price is reasonably affordable, the research and development that contributed to the development of sorafenib, and the calculations of a reasonable royalty for sorafenib.
Click here to see the affidavit
