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Thursday, August 22, 2013

The BDR compulsory licensing application and the BMS ‘Statements of Working’

Posted on 12:08 AM by Unknown
It has been almost 6 months since BDR Pharmaceuticals filed a compulsory licensing application for the Dastinib patent owned by BMS. We had written about it over here. There has been little news about this CL and so we did a bit of prodding around. And as always the online records of the patent office are incomplete – so we do the next best thing – speculate! 

As per the documents we found on the Patent Office’s website, it appears that BDR Pharmaceutical’s application for a CL was in serious jeopardy, a few months ago. As per this petition for condonation of delay filed by BDR, four months, after the initial application for the CL was filed in March. Apparently, in May, the CG had issued a notice to BDR informing it that it had not made out a prima facie case for grant of a CL – if a prima facie case is not made the CG can reject the CL application. I’m not quite clear on what happened next but BDR appears to have tried re-negotiating a voluntary licence with BMS, after which it submitted more information and a request for the Controller to find a prima facie case for grant of compulsory licence. This last request appears to have been made after some deadline because of which it was accompanied by an application for condonation of delay. We don’t know what happened after this petition. 

While we are on the topic of Dastinib, we might itself point out the manner in which BMS has been filing its Form 27 or statement of workings. Here’s an affidavit from BMS explaining the delay in filing a Form 27 for the year 2008, four years later in 2012. If that delay was not enough, BMS filed the Form 27 for 2012 on July 31, 2013 i.e. four months after the March 31, 2013 deadline. 

May I add that we had mailed the Patent Office on 30th July, 2013 asking for a copy of the Form 27 and voila – the very next day BMS files a Form 27 with a bland Rule 137 petition without any reasons for the delay in filing the same. Why is the Patent Office allowing these Rule 137 petitions without passing any reasoned orders?
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