Although ignored by most media outlets (but not IP Watch), the India Patent Controller is considering an application from Indian generic pharmaceutical company Natco to produce two drugs for export to Nepal under compulsory licence. If approved and implemented, this would be the second compulsory licence issued for export under the TRIPS ‘waiver’ granted in 2003 (Canada issued one last year for the export of an AIDS drug to Rwanda).
The important (and interesting) aspect of the application is not the use of TRIPS to issue a compulsory licence for export, but more so the ease (or difficulty) with which the Indian Patent Controller will issue compulsory licences to Indian manufacturers.
Section 84(1) of the Indian Patent Act prevents compulsory licences from being issued for the domestic market for the first three years of a patent. Given that three years has now passed since India has had to provide protection for pharmaceutical patents, the generic industry is keenly interested in exploiting the provision for the domestic market. Generally speaking, India’s patent act allows a wide range of avenues for compulsory license, including if a drug is not available in adequate quantities, not reasonably priced, or (in a possible violation of TRIPS) not manufactured in India.
If approved, the Patent Controller may have to deal with a lot more applications in the months and years to come. Watch this space!