All hope is not lost for Teva's ($TEVA) Copaxone protection. The Supreme Court has agreed to hear an appeal of a lower court's decision to invalidate a patent that, if restored, will shield the drug until September 2015. The decision may, in the least, leave competitors wary of proceeding with generics, giving Teva more time to convert patients to a new, long-acting version of the treatment.
It's a big boost for Teva, which said in a statement it was "pleased that the Court has agreed to hear its appeal" and it "remains committed to pursuing all options to protect its intellectual property for Copaxone." As it stands, the multiple sclerosis therapy, which generates $3.2 billion in U.S. sales yearly, is set to go off-patent in May.
But while that deadline is only just over a month away, the high court's review makes launching a generic risky territory for copycat drugmakers, who will have to compensate the Israeli company for lost sales if it prevails in court. "The generic filer will have to think if it wants to launch before the case is settled and run the risk of paying large fines," Ori Hershkovitz, a managing partner at Sphera Funds Management, told Bloomberg.
As of now, it's anyone's guess whether those drugmakers--including Momenta Pharmaceuticals ($MNTA), which developed its generic with Novartis ($NVS), and Mylan ($MYL)--will take that risk. Both Novartis and Mylan said in statements that they believed Teva's patent invalid, and a Novartis spokeswoman told Bloomberg that the Swiss company looks forward to "marketing an affordable, high-quality generic version of Copaxone at the earliest possible opportunity."
Bank of Jerusalem analyst Jonathan Kreizman, for one, doesn't see generics makers taking the plunge. "Teva has a good case with the particular patent," he told the news service.
Any extra competition-free time Teva can buy will help the struggling company, which Bloomberg says reaps $8.8 million a day from the blockbuster. Teva is also working feverishly to switch patients over to the new-and-improved version of the drug before generics hit, and early success has some analysts believing the company might just hit its conversion target of 30% to 50% of patients.
- read Teva's release
- see Mylan's statement
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Special Reports: Top 10 Drug Patent Losses of 2014 - Copaxone | Top 10 Generics Makers by 2012 Revenue - Teva - Mylan