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“Well, You have not made out prima facie case for Compulsory License”: Notifies Rajiv Agarwal, Controller General of Patents, Designs and Trademarks, to Lee Pharma!

In a major update for the patent circle (and of course Pharma industry), reportedly, Lee Pharma, a Hyderabad based Indian pharma company, which had filed a Compulsory Licensing (CL) Application on June 29, 2015, in India, against one of the patented drug Saxagliptin of AstraZeneca (used for treating Diabetes Mellitus), has failed to make out prima facie case for the same. Cognizance of the same has already been taken by Economic times and SpicyIP. This is the second blog written on the CL filed by Lee Pharma by IIPRD, an earlier blog which discusses patent details, grounds of application can be accessed directly by clicking here.

This development has to be recognized as a major one because application by Lee Pharma is the third instance of applying for Compulsory Licensing in India and of the earlier two, one was accepted and the other was rejected. Of course, this development is also important when Pharma and Patent world wants to see how India is responding to US pressure on amending the patent laws.

It is noteworthy that Controller has not refused CL application for Lee Pharma, rather he has only notified Lee Pharma that it has not made out the prima facie case for the order under section 84. The controller was required to do so by Rule 97 (1). Further according to rule 97 (1), Lee pharma has one month from the date of notification to request for the hearing, if it wants to proceed with the application and if the request for a hearing is not made, the controller shall refuse the application. According to Rule 97 (2), if a request for a hearing is made within 1 month from the relevant notification, the Controller shall, after giving the applicant an opportunity of being heard, determine whether the application may be proceeded with or whether it shall be refused.

Though, Economic times claims to have seen the copy of notification given to Lee Pharma by the controller, and also claims that the controller has found Lee Pharma’s proposed selling price several times the import cost and only marginally below that of AstraZeneca, and the controller has also stated that manufacture in India is not a necessary precondition to establish working in India according to the relevant section. It is expected that Lee Pharma will likely exercise the provision for hearing available to it.

So here we are, all eyes on you now, Lee Pharma, the clock is already ticking.

Once the final decision regarding the CL application is issued and made public, we will be back here for a detailed discussion on the same, as this is something we just can’t afford to miss, right?

About the Author: Swapnil Patil, Patent Associate at Khurana & Khurana, Advocates and IP Attorneys and can be reached at [email protected]

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