US court denies Teva’s final shot at blocking Copaxone copies
A US district court has dismissed Teva’s case against the US Food and Drug Administration (FDA) aimed at stopping the administration from approving generic versions of its blockbuster multiple sclerosis drug Copaxone (glatiramer acetate).
The decision came days before eight patents covering the drug are due to expire, on May 24.
Copaxone is Teva’s most lucrative drug and generated sales of more than $1 billion in the three months ending March 31 this year.
On May 8, Teva sued the FDA for denying, without comment, its request to impose clinical trial requirements as a condition of approving generic versions of Copaxone.
The FDA filed a motion to dismiss the case on May 12, arguing that the motion was premature, as it had not approved any generic products, and “Teva does not know if or when, or on what basis, such an approval will occur”.
It added: “In pre-emptively seeking to eliminate competition by enjoining the [FDA] from approving a generic drug, Teva asks this court to review decisions that have not yet been made and to find injury where none exists.”
US District Court for the District of Columbia judge Ellen Segal Huvelle dismissed the case on May 14 as not ripe, therefore finding the court lacks jurisdiction.
Teva’s rival Mylan, which has said it will market its own version of Copaxone after the patents expire, said it had intervened in the case in the FDA’s favour.
Mylan’s chief executive, Heather Bresch, said in a statement on May 15: “Teva’s suit against FDA was simply a desperate, last minute tactic, among others, to delay access to more affordable generic versions of Copaxone for patients in the US.”
She 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.”
Teva did not immediately respond to a request for comment.
