KEI files affidavit in India compulsory licensing case involving Bayer patents on cancer drug Sorafenib (Nexavar)
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 Bayer price for sorafenib/Nexavar in India is $47 per 200 milligram tablet. At a daily dose of 4 tablets, this comes to $5,637 per month, or more than $68 thousand per year. In 2010, per capita income in India was $1,330.
The Natco case will test the new Section 84 of the India patent act, and in particular, set a precedent for a reasonably affordable price. 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.
A pdf of the filing is attached below.