The patent pillars that have supported Teva’s defenses of blockbuster Copaxone continue to collapse with Mylan winning yet another legal battle, this one in the U.K.
Mylan announced today that the United Kingdom's High Court of Justice stood with it and its European partner Synthon on a patent challenge for the long-acting Copaxone 40 mg, finding Teva’s claims invalid “on obviousness.”
Mylan, which just this month won approvals for its generic versions in the U.S. and Europe, seemed to relish the win. It pointed out in the release that in the last eight years it has “successfully overcome Teva's four waves of U.S. patent litigation, eight Citizen Petitions, injunction proceedings in India, more than 15 regulatory challenges, patent litigations or commercial actions across Europe, and now the litigation in the U.K., in addition to obtaining dismissal of Teva's suit against the FDA seeking to delay approval of the 20 mg/mL product.”
This victory comes on the heels of Mylan’s market surprise early this month with news that the FDA had given its approval to Mylan’s copies of both the long-acting, 40-mg version of blockbuster Copaxone—the market’s first—as well as the 20-mg original. The company may be in line for 180 days of exclusivity on the 40-mg product. It was a surprise because the generics maker had said in June that the FDA was asking for some more info about its long-acting version.
Two days later, it said that the EU had approved the long-acting version that it and Synthon share in that market.
Still, Teva battles on to try to hold on to some of the $1 billion in sales Copaxone generated for it last year, particularly in light of its other issues. Mylan said that Teva has now filed litigation against it with the High Court of Ireland alleging its long-acting generic has violated two patents for Copaxone.
For Teva, the U.K. ruling adds to a cascade of difficulties besetting the world’s largest copycat drugmaker. It was already suffering big-time from the pricing pressure that has sucked sales of generics industrywide, with its pain greater by virtue of its ill-fated $40.5 billion purchase of Allergan’s generics unit just as the markets got soft. And while the company recently heartened investors with the hiring of new chief exec Kåre Schultz, it’s still undergoing a major restructuring, shouldering a big debt burden, and expecting to fall far behind the financial expectations it laid out when 2017 began.