Indian Patent Office has finally started proceedings over Natco’s applications for Compulsory License for anti-cancer drugs Tarceva and Sutent to be exported to
Reading section 92A, there is nothing explicitly mentioned about hearing will be allowed to patentee or not, but that even does not mean to exclude the possibility for hearing. This can further be supported by the rule 97(1) of the Patents Rules, 2003 which reads as –
If, upon consideration of the evidence, the Controller is satisfied that a prima facie case has not been made out for the making of an order under any of the sections referred to in rule 96, he shall notify the applicant accordingly, and unless the applicant requests to be heard in the matter, within one month from the date of such notification, the Controller shall refuse the application.
The rule clearly allows the Controller to consider evidence to judge a prima case for making an order under section 92A. Now the question is, how the Controller will decide is there a prima case for compulsory license or not? Only by hearing Natco (and may be doing some additional search over Google)? Obviously that will be unfair enough to do that, particularly when
It would be interesting to know, who approached whom? Whether Nepal Drug Authority approached Natco for supplying the generic Tarceva in