By Cristina Roca and Pierre Bertrand
The European Union has informed Teva Pharmaceutical Industries Ltd. of its preliminary opinion that the company broke antitrust rules to protect its multiple sclerosis drug Copaxone from competition.
The bloc’s executive arm, the European Commission, said on Monday that the Israel-based drug company could have artificially extended its exclusivity on Copaxone by blocking glatiramer acetate competitors from entering the market.
Teva said it would vigorously defend itself against the allegations.
“While we seek first to persuade the EC that its preliminary view is incorrect, we are also prepared, if necessary, to challenge any claims arising from the EC’s investigation using all legal and procedural rights to our disposal,” he said. He warned that the issue could take years to resolve.
Teva had a basic patent on glatiramer acetate, the active ingredient in Copaxone, until 2015, the Commission said.
“Our concern is that Teva may have abused the patent system to protect itself from competition,” European Commission Executive Vice President Margrethe Vestager said in a statement. “He may have disseminated misleading information to discredit his nearest competitor, to the detriment of patients and EU public health systems,” she added.
If the alleged violations are confirmed, Teva could be fined, the Commission said.