In other words, the discretion to examine whether the CL application has any merit or not lies solely with the Controller. If he finds absolutely no merit in the application, he may reject it outright. Else, he has to publish it and afford the opportunity to the patentee and others to challenge the application, as he did in Natco’s case.
Bayer recently challenged this action of the Controller in the Mumbai high court, arguing that no “prima facie” case had been made out in Natco’s application and that it ought to have been “heard” before such a determination was made by the Controller.
I’m not sure I agree with this interpretation: a plain reading of the provision indicates that the Controller can make this determination after examining the application as filed. Insisting on a hearing at this stage does nothing more than the delay the proceedings. If compulsory licenses are unduly delayed through protracted proceedings, the very purpose of the regime is lost. I’m reminded of a CL case from India about three decades ago (Catalysts and Chemicals India v Imperial Chemical Industries Imperial case), where the proceedings were so protracted that the patent term expired by the time the compulsory licensing application was finally decided (after multiple court proceedings that finally culminated in the Supreme Court of India).
It’ll be interesting to see which way the Mumbai High Court goes. In the meantime, I’m given to believe that Bayer applied for a month’s extension to respond to Natco’s application and was granted this by the Controller (this extension appears to be in conformity with the law, given that the statute suggests that a patentee has to file its counter within two months of the application, extendible by a month at the discretion of the Controller).
One hopes that all such provisions that provide fodder for strategic delays be reviewed and amended, where necessary. Only then can our CL regime come alive, without remaining a mere letter of the law destined to die a slow unsung death.