The US Court of Appeals for the Federal Circuit has again found that US Patent No 5,800,808, related to a method of manufacturing glatiramer acetate, the active ingredient of Israel-based Teva Pharmaceutical Industries (NYSE: TEVA) blockbuster multiple sclerosis drug Copaxone, is invalid as indefinite.
Announcing the news, US drugmaker Momenta Pharmaceuticals (Nasdaq: MNTA), whose share rose 7.7% to $24.65 in morning trading, said the decision clears the way for the launch of its Glatopa, the first generic version of Copaxone 20mg that has been approved by the Food and Drug Administration (The Pharma Letter April 17). Teva's US sales of Copaxone in 2014 totaled $3.1 billion,
"We are very pleased with the Federal Circuit's decision to declare Teva's manufacturing process patent invalid once again," said Craig Wheeler, president and chief executive of Momenta, adding: "We look forward to providing patients with a more affordable generic alternative for the treatment of multiple sclerosis."
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