[Ip-health] SPICY IP: SpicyIP Tidbit: Latest developments in Lee Pharma’s Saxagliptin CL application

Thiru Balasubramaniam thiru at keionline.org
Tue Aug 18 05:31:59 PDT 2015


SpicyIP Tidbit: Latest developments in Lee Pharma’s Saxagliptin CL

by Balaji Subramanian

August 18, 2015

The Economic Times reports that the Controller of Patents has rejected Lee
Pharma’s application for a Compulsory License to manufacture AstraZeneca’s
patented anti-diabetic drug saxagliptin. We covered the application
extensively on the blog, and this represents a substantial development in
the case. However, the ET article appears to be slightly misleading when it
implies that this decision is final and resolves the matter. That’s not the
case – we’ve learned that this is merely a notification under Rule 97(1) of
the Patent Rules, 2003, and not an “order”.

Rule 97 does not provide for any sort of decision on merits, but merely
states that the Controller must issue a notification to the CL applicant if
he is of the opinion that the application does not make out a prima facie
case for grant of a compulsory license. This now means that Lee has one
month to request a hearing to present their submissions in the case, based
on which the Controller will decide whether or not the application can
proceed. In case Lee does not request a hearing within a month, the
application stands rejected by default.

Thus, while ET reports that the Controller “found Lee Pharma’s proposed
selling price several times the import cost and only marginally below that
of AstraZeneca” and also found that manufacture in India is not a necessary
precondition to establish working in India, it’s important to note that
these findings are strictly prima facie and cannot be taken as conclusive.

We spoke to Lee Pharma’s lawyers, and they have confirmed that they intend
to seek a hearing at the earliest possible date to press their case. The
situation as it stands today is that Elvis has not left the building, but
he might well be on his way out.

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