Novo Nordisk announced that Judge Avern Cohn of the US
District Court for the Eastern District of Michigan issued an adverse ruling in
a patent litigation case regarding Novo Nordisk's US Patent No. 6,677,358. The
district court ruled that the patent, which covers the combination use of
repaglinide and metformin for the treatment of type 2 diabetes, is invalid and
unenforceable. Novo Nordisk markets repaglinide under the trade name Prandin®
and a fixed dose repaglinide/metformin tablet under the trade name PrandiMet®.
The district court ruling has the potential to facilitate launch of a generic
repaglinide. At present, it is unclear whether or when a generic version of
Prandin® or PrandiMet® will be available in the U.S. market. Novo Nordisk intends
to appeal this ruling and is evaluating its best options for doing so.
"We are disappointed with today's ruling. We believe
that it is contrary to the evidence and we intend to appeal the ruling,"
says Jesper Brandgaard, executive vice president and chief financial officer of
Novo Nordisk.
For the first nine months of 2010, US sales of
Prandin® and PrandiMet® amounted to $134 million.