It's been a long legal road for Copaxone, and one that took yet another turn Thursday as the U.S. Court of Appeals struck down the drug's patent for the second time.
In January, the U.S. Supreme Court ruled in maker Teva's ($TEVA) favor, reversing an initial appeals-court ruling that had invalidated Copaxone's IP shield and sending the case back down for reconsideration. But now, after taking another look, the court has come back to the same conclusion it initially reached almost two years ago, The Wall Street Journal reports.
The result? Momenta ($MNTA) and Novartis ($NVS) Sandoz, no longer at risk of having to pay Teva damages down the line, have launched their generic--dubbed Glatopa--that won FDA approval in April.
And while it's bad news for Teva, it's not the end of the world, Bernstein analyst Ronny Gal wrote in a Thursday note to investors. "There is not much material difference between launch now vs. September"--when the drug's patent was set to expire anyway. And "the entry of [the] Momenta generic was expected," anyway.
In preparation, Teva's been doing what it can to lock up its blockbuster's market share by switching patients over to a new, long-acting version of the drug. As of April, it had already converted 67% of patients; the following month, company CFO Eyal Desheh said Copaxone's successor boasted more than 20% of total U.S. market share, noting that the Israeli pharma expected "very little switch back" from that treatment to a generic.
Still, though sales of Teva's top dog will erode once Glatopa rolls out--and even more so if a team comprising Mylan ($MYL) and India's Natco Pharma wins FDA approval and rolls out its own knockoff. In April, consensus estimates had Copaxone sales sinking 31% by 2016, and 50% by 2018, Evercore ISI analyst Umer Raffat wrote in a note at the time.
But Teva is doing what it can to pursue other avenues for growth--including M&A. It's currently locked in a takeover spat with Mylan, which itself is trying to hammer out a deal for Perrigo ($PRGO) that would thwart Teva's acquisition efforts.
- read the WSJ story (sub. req.)
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