Wednesday, September 26, 2012

Novartis Supreme Court Update: Arguments on Imatinib Mesylate and Efficacy

In my last update on the Novartis case, I blogged on the submissions made on behalf of Novartis on September 13, 2012. The update of the submissions made on September 12, 2012 is available here by Lawyers’ Collective.

On the 12th, it appears that the submissions largely revolved around the contents of the patent application and the prior art cited against it. Mr.Gopal Subramanium, counsel for Novartis, seems to have submitted that the Zimmerman patent of 1993 disclosed only the imtainib freebase, whereas the subject-matter of Novartis’s application was beta crystalline form of imatinib mesylate.

Mr. Subramanium further submitted that the Zimmerman patent too was owned by Novartis and pointed out that although the Zimmer man patent disclosed methanesulphonic acid and the imatinib free base, there was no reference to methane sulphonate salt of imatinib.

Further, in light of the fact the Zimmerman patent disclosed a variety of compounds, their salts and acids, any number of combinations were possible, and that a person skilled in the art would not have arrived at the specific compound claimed in Novartis’s application. In short, the Zimmerman patent did not enable the working of beta crystalline form of imatinib mesylate.

It was also submitted that the free base of imatinib could not be administered to patients as it is and that the ingenuity of the invention lay in developing an administrable form, namely the beta crystalline form.

For the rest of the arguments relating to efficacy, I request the readers to read the update provided by Lawyers’ Collective. 

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