Copaxone’s patent remains in force at least until the Federal Circuit Appeals Court reconsiders the case.
The rivals of Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) who are developing a generic version of multiple sclerosis treatment Copaxone, have urged the US Supreme Court to expedite sending the case back to the appellate court. Last week the US Supreme Court rejected the Federal Circuit’s long-standing rule that district court claim construction rulings must be reviewed afresh on appeal.
The ruling was a victory for Teva and relates to its flagship branded drug Copaxone and whether its patent expires in September 2015, as upheld by the New York District Court, or May 2014 as ruled by the Federal Circuit Appeals Court. 15 months of exclusive branded sales is worth a great deal to Teva, with Copaxone recording annual sales of $4 billion.
Sandoz, Mylan, Momenta and Natco, all of whom are developing generic versions of Copaxone, urged the justices to quickly transmit to the Federal Circuit a certified copy of the Supreme Court’s January 20 opinion and judgment, to vacate a July 2013 decision that invalidated, and not to wait the customary 25 days. They wrote, “In the past decade, the price of Copaxone has risen almost fourfold to about $60, 000 per year, ” and thus any delay “would cause substantial harm to the public.”
The companies mentioned that the price has risen during the legal proceedings and there have been two price hikes in recent months, which Teva’s rivals describe as a “monopolistic injustice.”
Published by Globes [online], Israel business news – www.globes-online.com