Compulsory license for dasatinib rejected:emerging new trend

Controller of Patents (India) on 29th October 2013 rejected the Compulsory license (CL) application of BDR pharma against BMS's Dasatinib patent. The case is very interesting as it revolves around answering patentees questions relating to GMP, Quality systems, Plant's continuous manufacturing capacity, Litigation history of company, Environmental and safety policy etc. Questions related to these matters were asked by BMS to BDR when BDR entered in to dialogue with BMS for want of license against Dasatinib patent. BDR didn't answered these questions till 1 year when it filed application to "Controller of Patents" for want of compulsory license against Dasatinib patent. BDR argued that the timeframe for reaching to mutually agreed terms and condition for voluntary license is 6 months which is lapsed now and thus, BDR is entitled to apply for CL. The Controller rejected the CL application stating that BDR did not complied with procedure stated in Patent Act 1970 and applicable rules. He mentioned that first of all BDR needed to answer BMS's questions within 6 months to seek voluntary license, in which BDR completely failed. Thus, there is no prima facia case is made for grant of CL. Thus, even though the pre requisites for CL i.e. statistics and other supportive data was in hand to support the CL applications, BDR failed only because they didn't followed the procedure laid down in act. Of course, BDR made full efforts to explain its inability for answering BMS questions within given time. It strongly stated that, answering such questions may give an opportunity to BMS for collecting negative evidence against BDR and using them in later proceedings related to CL application and infringement suit filed by BMS against BDR which is pending at Delhi High court. It alleged that it's a delay tactic followed by BMS without expressing its willingness to give or reject voluntary license to BDR. It also alleged that such tactics and filing infringement suits by BMS against BDR completely fall within purview of "anti-competitive practices". But Hon'ble Controller in his decision made clear that he is not entitled to decide on such issue. The concluding note: Not only patent law, but lot of other factors play role in compulsory license. One of the scenario can be: Patentee will promptly reply to the voluntary license request and may ask for information pertaining to GMP, Quality System, Safety, Environment policy etc. to generic manufacturer. However, in my personal opinion, these are the common factors which any prudent business unit will investigate before entering in to any commercial relationship with other party. But, if the patentee has already decided not to issue license then he may ask for factory audit, documents and systems inspections (like any Quality audit in pharma) etc. and deliberately collect the negative information against the license seeker. This negative information can be used against the license seeker in all later date possible proceedings and litigations including CL proceedings, infringement suits etc. Thus, obviously generic player might refrain from providing such information. "This is true only when Patentee do not wish to grant license and in such situation he may follow this path. Then how can the compulsory license provision will be effectively utilized to keep medicines at affordable prices, available at adequate quantity and made in India (supporting and growing Industrial activities in India)? Let's see if BDR moves to IPAB or to Judiciary of Court to challenge Controller's decision and if it does so then these consequences might be discussed in those proceedings." Author: Parag M. More, M.Sc., LLB, Indian Patent Agent Statutory Notice: No part of this write up may be communicated to others, reproduced, published, distributed, displayed, performed, copied or stored for public or private use in any information retrieval system, or transmitted in any form by without written permission of the author.