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

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.

[Editor’s note: There is an update to this available in a new post here]

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