Well, that's not going to work. Teva's ($TEVA) latest move to try to fend off Copaxone copies, a lawsuit against the FDA, got tossed Wednesday by a federal judge in Washington just 10 days before the med's patent expiration date.
Earlier this week, Teva hit the agency with the suit, claiming its officials improperly dismissed the company's calls to subject generics of the multiple sclerosis drug to extensive testing before they reach the U.S. market. To that, the government said Teva does not have the right to impose conditions on the FDA's approval process, Reuters reports.
Now that its latest attempt to block generics has fallen flat, the company will continue to evaluate its options, spokeswoman Denise Bradley told the news service in a statement. Simultaneously, it will continue to pour resources into switching patients to a new, long-acting formula of the drug, before the two teams of copycats--Novartis' ($NVS) Sandoz and Momenta Pharmaceuticals ($MNTA), and Mylan ($MYL) and India's Natco Pharma--get a shot at the market.
|Mylan CEO Heather Bresch|
There's no guarantee those pairs will move in with their copies come May 2; if they do, they risk paying hefty damages, should the Supreme Court side with Teva after hearing its upcoming patent appeal. But Mylan CEO Heather Bresch said in a Thursday statement that her company continues "to see no barrier to FDA approval of Mylan's generic Copaxone following patent expiry."
"Teva's suit against FDA was simply a desperate, last-minute tactic," she said.
Teva has good reason to pull out all the stops. Copaxone, its leading seller, churns out more than half the company's profits; even if SCOTUS eventually sees things Teva's way, generic launches could cause it "irreparable harm," it said recently.
- get more from Reuters
- see Mylan's release
Special Reports: Top 10 Drug Patent Losses of 2014 - Copaxone | Top 10 Generics Makers by 2012 Revenue - Teva - Novartis (Sandoz) - Mylan