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Last week, generics makers asked the Supreme Court to let them launch their copies of Teva's Copaxone while it hears the Israeli company's appeal over the drug's patents.
Now, they'll likely get that chance. Chief Justice John Roberts rejected Teva's ($TEVA) bid to block competition until the court clash wraps, meaning generics could hit as soon as next month.
Though two generics teams--Novartis' ($NVS) Sandoz unit and Momenta Pharmaceuticals ($MNTA), and Mylan ($MYL) and India's Natco Pharma--are now free to move forward, they'll have to fork over infringement damages if Teva ultimately prevails in court. And that was enough to convince Roberts a court-ordered stay was unnecessary, Bloomberg reports.
"Given the availability of that remedy, the extraordinary relief Teva seeks is unwarranted," he wrote in a one-paragraph opinion, as quoted by the news service.
It's not a risk Teva wanted to take. That's because the price concessions it will be forced to make to compete with generics will be "for all practical purposes irreversible." The multiple sclerosis med accounts for more than half the drugmaker's profit, and it's milking this pre-generics window to switch as many patients as possible over to a new, long-lasting formulation of the drug.
If Roberts had granted Teva's stay request, that would have held off competition until the court reaches its verdict on the patent appeal--as late as June 2015. That, in effective, would "decide this litigation for Teva," Mylan, Momenta and Sandoz said in a court filing seen by Bloomberg. After all, Copaxone's 2015 patents are up for the SCOTUS review.
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| Mylan CEO Heather Bresch |
Now, the Petah Tikvah-based company's only recourse is to ask another Supreme Court justice for a stay--a request that's rarely granted, Reuters notes.
Teva's challengers cheered Roberts' move, though they haven't explicitly said they'll launch their copies next month. While some analysts have predicted the strength of Teva's case will drive them away--Roberts himself has said Teva has shown a "fair prospect of success on the merits" of the case--Copaxone's $3.2 billion in annual U.S. sales could be enough to lure them in.
"We are pleased with the Chief Justice's decision, and we look forward to introducing the first generic Copaxone treatment for multiple sclerosis patients in the U.S. at market formation," Mylan CEO Heather Bresch said in a statement.
- read Mylan's release
- get more from Bloomberg
- see Reuters' take
Special Reports: Top 10 Drug Patent Losses of 2014 - Copaxone | Top 10 Generics Makers by 2012 Revenue - Teva - Novartis (Sandoz) - Mylan