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Mumbai:
Eli Lilly and Company, the US-based multinational pharmaceutical
major, has sued Indian company Sun Pharmaceuticals in
the US, alleging infringement on its patent on Gemzar,
a blockbuster cancer drug.
The
suit, filed with the Southern District of Indiana, is
in response to Sun''s abbreviated new drugs application
(ANDA) filed with the US FDA in October 2006 seeking approval
for a generic process to manufacture the drug Gemcitabine.
While
Eli Lilly''s basic patent on the active pharmaceutical
ingredient Gemcitabine hydrochloride will expire on November
15, 2010, another patent on the method to manufacture
the drug is valid until 2013. Sun Pharma claimed that
the 2013 patent is invalid.
Gemzar,
a commonly used cancer drug to treat non-small cell lung
cancer, pancreatic, bladder and breast cancer, is one
among the top selling drugs of Eli Lilly. The drug had
worldwide sales of US $ 1.408 billion in 2006, including
sales worth $609.8 million coming from the US market.
Sources
said Eli Lilly had earlier sued Sicor In February 2006,
Eli Lilly filed a lawsuit against Sicor in the U.S. District
Court for the Southern District of Indiana, and in response,
Sicor filed a declaratory judgment action in the US District
Court for the Central District of California demanding
to dismiss the suit, asserting the Indiana court lacks
jurisdiction. However, the California court dismissed
that case.
Patent
experts said the litigations initiated by Eli Lilly will
prevent launch of any generic versions of Gemzar by another
30 months, as per the US patent rules.
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