Compulsory Licensing of Proprietary Drugs

Compulsory licensing is the process by which a country such as India grants a license to produce a patented proprietary drug without the consent of the patent holder. A provision of Indian patent law is that a compulsory license may be granted three years after a patent has been granted. The first case involves Natco Pharma, an Indian generic drug manufacturer, and Pfizer, the patent holder for maraviroc. As far as I can tell from searching the Internet, this case is still at the stage in which Natco requests a voluntary license from Pfizer. There was supposed to be a response from Pfizer by May 2011, and a negative response is expected. If someone has factual information on the status of this case, please share it.

Since this first case, it is now a matter of public record that Natco has applied for a compulsory license for Bayer's sorafenib. If you like you can skip to PDF p. 16, item 7 of the application.

Today's post is a continuation of my post Proprietary Drug Patents.