Momenta Pharmaceuticals, Inc. (MNTA - Analyst Report) 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.’s (TEVA - Analyst Report) Copaxone.
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 / Novartis AG’s (NVS - Analyst Report) generic unit Sandoz Inc. and Mylan Inc. (MYL - Analyst Report) / 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).