As has been reported in several papers now, Sun Pharma Global FZE has sued Novartis on June 7, 2013 before the Federal District Court in the American State of New Jersey, seeking a declaratory judgment that the patent covering Gleevec is invalid. According to media reports this action is a follow up to the ANDA filed by Sun Pharma back in 2007. Shamnad had written about that ANDA back in 2007, in a post which can be accessed over here. At the time, he had rightly speculated that Sun would have to sue for declaratory relief since Novartis had not sued Sun within 45 days of the filing of an ANDA to manufacture generic Gleevec.
As per the Orange Book listings, available over here, Gleevec is covered by more than one patent. The main patent covering the base compound, Imatinib is set to expire on January 4, 2015 but the patent covering the beta crystalline version of Imatinib Mesylate. The U.S. patent covering the beta crystalline version (‘051 patent) is set to expire only on May 23, 2019. The base compound was never patented in India because it was invented before 1995, the cut-off date for India to begin accepting mailbox applications pursuant to the signing of TRIPs. It is the Indian equivalent of this patent which was the subject of the much publicized Supreme Court judgment earlier this year on April 1, 2013. (It can be read over here)
According to the news reports, it is this ‘051 patent set to expire in 2019 that is the subject of Sun’s lawsuit in New Jersey. As noted by the Supreme Court in its judgment, the ‘051 patent did not have a smooth journey, with the examiner at the USPTO actually rejecting the application on the grounds of obviousness and inherent anticipation. The final decision of the USPTO rejecting the patent application in 2001 can be accessed over here. The decision of the USPTO was reversed by the Board of Patent Appeals and Interferences (BPAI) in a decision dated November, 2003. That order can be accessed over here.
If Sun Pharma manages to pull off a victory in this case and have the ‘051 patent invalidated, it would be more than a vindication for India’s decision to not grant Novartis a patent for Glivec in India. A victory for Sun would also send a strong signal to the rest of the developing world that India’s policy on Section 3(d) is a step in the right direction. Knowing the public health activists, they will make it a point to publicize any such victory to the rest of the world and use it as a tool in future propaganda battles. For Big Pharma, which has used the Novartis decision of the Supreme Court to flog India for being anti-pharmaceutical patent, any loss in New Jersey will result in a lot of egg on their face.
Hatip: Chris Ohly
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