Any comments on the bolded statement below (emphasis added)
District Court Rejects Teva Lawsuit Seeking to Block Generics of Copaxone
2014-05-15 16:03:37.899 GMT
District Court Rejects Teva Lawsuit Seeking to Block Generics of
Copaxone
By Dana Elfin
Litigation Over Copaxone Dismissed
Development: Court dismisses Teva suit against the FDA over
potential Copaxone generics, finding the suit isn't ripe.
Impending Generics? The patent protection for Copaxone is
scheduled to expire May 24.
May 15 (BNA) -- In a loss for Teva Pharmaceutical Industries
Ltd., a federal district court May 14 dismissed the company's
suit seeking to preliminarily enjoin the Food and Drug
Administration from approving generic versions of its multiple
sclerosis drug Copaxone (glatiramer acetate injection), finding
the suit wasn't ripe (Teva Pharm. Industries, Ltd. v. Sebelius,
D.D.C., No. 1:14-cv-00786-ESH, order 5/14/14).
Judge Ellen S. Huvelle of the U.S. District Court for the
District of Columbia said the court had no jurisdiction to hear
the suit, which she dismissed without prejudice.
In a brief order, Huvelle said, “the Court concludes that
the case is not ripe and therefore the Court lacks jurisdiction.”
Accordingly, the court granted the government's motion to
dismiss for lack of ripeness and denied as moot Israel-based
Teva's motion for a preliminary injunction.
Teva Reacts
Denise Bradley, Teva's vice president of global corporate
reputation, told Bloomberg BNA May 15 that the company is
“pleased that the judge has requested 24-hour notification of
final action from FDA” as to approval of abbreviated new drug
applications (generics) and the company continues “to evaluate
our options.”
“Teva remains committed to advocating for the development of
safe and efficacious products for the public—both generic and
branded,” she added.
Meanwhile, Pittsburgh-based Mylan Inc., one of Teva's
potential competitors in the generic Copaxone market, praised the
court's decision to dismiss.
In a May 15 statement, Mylan's chief executive officer
Heather Bresch called Teva's suit “a desperate, last minute
tactic, among others, to delay access to more affordable generic
versions of Copaxone for patients in the U.S.”
Bresch added, “Following the Court's decision against Teva,
we continue to see no barrier to FDA approval of Mylan's generic
Copaxone following patent expiry, and we look forward to being
able to launch this very important first generic product for
multiple sclerosis at market formation.” Mylan intervened in the
suit on the side of the FDA.
