) recently announced that the US Court of Appeals for the Federal
Circuit has found the patent on its diabetes drug, Prandin
(repaglinide), to be invalid.
Novo Nordisk holds a patent for the combination of Prandin and
metformin for the treatment of type II diabetes. In the US, the
patent for Prandin has expired while the patent for PrandiMet
will expire in 2018.
The US Court of Appeals for the Federal Circuit partially
affirmed the district court's decision, with a two-to-one ruling,
finding the patent to be invalid. This will pave the way for the
introduction of generic versions of Prandin. The Court of
Appeals, however, unanimously reversed the ruling regarding Novo
Nordisk committing inequitable conduct at the time of acquiring
Novo Nordisk had filed a patent infringement lawsuit against
Caraco Pharmaceutical Laboratories, Ltd. in the US District Court
for the Eastern District of Michigan, in Jun 2005. The lawsuit
was regarding Caraco's abbreviated new drug application (ANDA)
for the generic version of Prandin. In Jan 2011, the district
court held this patent invalid and unenforceable. Instantly, Novo
Nordisk appealed this decision to the US Court of Appeals for the
Apart from Caraco Pharma, Novo Nordisk has filed patent
infringement lawsuits against three other companies, namely,
Paddock Laboratories, Aurobindo Pharma Ltd. and
) generic division, Sandoz.
Novo Nordisk still believes in the validity of its patent and
will provide an update on it at the time of announcing financial
results for the first six months of 2013, on Aug 8.
Combined US sales of the two drugs - Prandin and PrandiMet -
were 1.2 billion Danish kroner in 2012.
Novo Nordisk currently carries a Zacks Rank #2 (Buy).
Currently, companies like
Jazz Pharmaceuticals plc
) look more attractive with a Zacks Rank #1 (Strong Buy).
JAZZ PHARMACEUT (JAZZ): Free Stock Analysis
NOVO-NORDISK AS (NVO): Free Stock Analysis
NOVARTIS AG-ADR (NVS): Free Stock Analysis
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