Saturday, January 12, 2008

Tyrosine Kinase Inhibitors: Patent Status in India?

Tyrosine kinase inhibitors are significantly important class of molecular target agents for the treatment of several cancers, and have considerably drawn attention in India mostly during pre/post grant oppositions. Over the last few months, three important tyrosine kinase inhibitors made news columns in India -- namely Imatinib (Gleevec), Gefitinib (Iressa), and Erlotinibe (Tarceva) -- all opposed by Indian generic companies during pre-grant opposition period. Out of these three, Gefitinib eventually lost the bid for Indian patent and is rejected by the Delhi Patent Office on the ground of prior knowledge, and Imatinib although rejected by the Chennai Patent Office but the final decision has to be come from the Intellectual Property Appellate Board. Only Erlotinib managed to escape through the pre-grant opposition and granted patent by the Delhi Patent Office, but after news spreading about the Cipla’s claim to launch generic version the game seems to be not over for Erlotinib. Apart from these already targeted tyrosine kinase inhibitors, there are some important ones pending with Indian Patent Offices including Nilotinib and Sunitinib. Not sure whether any of other below mentioned drugs are been opposed or not, but will be pleased anyone sharing information about any changes in below status.

Generic/Brand Name
Status
Imatinib Mesylate/Gleevec
Novartis
Application No. 1602/MAS/98 for beta crystalline form of Imatinib rejected by the Chennai Patent Office. Novartis appeal pending for hearing in the Intellectual Property Appellate Board.
Application(s) for pre-grant opposition made against Application No. 799/CHE/2004 for alpha crystalline form of Imatinib at the Chennai Patent Office.
Sunitinib Malate/Sutent
Pfizer
Application No. IN/PCT/2002/00785/DEL for Sunitinib molecule is pending with Delhi Patent Office. Till date not heard any opposition made against the application.
Gefitinib/Iressa
AstraZeneca
Application No. 841/DEL/1996 for Gefitinib molecule rejected by the Delhi Patent Office following pre-grant opposition by Natco Pharma and JM Pharmaceuticals on the ground of known prior use.
Nilotinib Monohydrate/Tasigna
Novartis
Application No. 3003/CHENP/2004 for Nilotinib molecule is pending with Chennai Patent Office. Till date not heard any opposition made against the application.
Lapatinib Ditosylate/Tykerb
GlaxoSmithKline
Application No. 1314/CAL/1997 for Lapatinib (genus) molecule is pending with Kolkata Patent Office. Till date not heard any opposition made against the application.
Application No. IN/PCT/00/130 for Lapatinib (species) molecule is pending with Indian Patent Office. Till date not heard any opposition made against the application.
Application No. IN/PCT/2002/1457 for Ditosylate salt of Lapatinib molecule is pending with Indian Patent Office. Till date not heard any opposition made against the application.
Sorafenib Tosylate/Nexavar
Bayer
Application No. 1633/MUMNP/2007 for Sorafenib is pending with Indian Patent Office.Till date not heard any opposition made against the application.
Dasatinib/Sprycel
Bristol-Myer Squibb
Application No. IN/PCT/2001/01138/MUM for Dasatinib molecule is pending with the Mumbai Patent Office. Till date not heard any opposition made against the application.

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