Momenta Pharmaceuticals, Inc.
) recently announced a favorable ruling from the U.S. Court of
Appeals for the Federal Circuit which may allow the company to
launch its generic version of
Teva Pharmaceutical Industries Ltd.
U.S. Court of Appeals for the Federal Circuit dismissed many
Copaxone patents, including one set to expire in Sept 2015. The
favorable ruling reverses the 2012 district court decision and
would enable the launch of generic Copaxone in May 2014 subject
to the U.S. Food and Drug Administration (FDA) approval.
We note that in 2012, the U.S. District Court for the Southern
District of New York had ruled in favor of Teva in its patent
infringement lawsuit and held all nine patents valid. Teva had
filed a patent infringement lawsuit against Momenta /
) generic unit Sandoz Inc. and
) / Natco Pharmaceuticals.
These companies were looking to launch their generic versions
of Copaxone. The court had then ruled that the claims made by
Momenta/Sandoz and Mylan/Natco about the Copaxone patents being
invalid and unenforceable were unfounded.
Copaxone is approved for the reduction of the frequency of
relapses in relapsing-remitting multiple sclerosis, including
patients who have experienced a first clinical episode and have
MRI features consistent with multiple sclerosis.
The drug generated global sales of $1.1 billion in the first
quarter of 2013. However, Copaxone revenues are already under
pressure given that the multiple sclerosis market is heavily
crowded with drugs like Avonex, Tysabri, Rebif and Gilenya.
Additionally, new entrants in the form of Aubagio and Tecfidera
can further stiffen competition.
Momenta carries a Zacks Rank #2 (Buy). Momenta's share price
increased 11.7% on this news.
The news is disappointing for Teva, and the company intends to
appeal the court's decision regarding four of the 2014 patents
and the 2015 patent. The news had a negative impact on the Teva's
stock price. Teva carries a Zacks Rank #3 (Hold).
MOMENTA PHARMA (MNTA): Free Stock Analysis
MYLAN INC (MYL): Free Stock Analysis Report
NOVARTIS AG-ADR (NVS): Free Stock Analysis
TEVA PHARM ADR (TEVA): Free Stock Analysis
To read this article on Zacks.com click here.