Teva is increasingly highlighting its innovative drug bona fides these days, seeking to style itself as both a novel drug-producing biopharma and a generics powerhouse.
Now, the company’s foot in both realms is being highlighted as Teva faces antitrust scrutiny over whether it stymied generics to its innovative drugs in Turkey.
Late last week, Turkey’s competition authority, Rekabet Kurumu, announced its investigation into the company, seeking to determine if Teva engaged in “conduct intended to restrict competition from generic medicines.”
The antitrust regulators are specifically looking at Teva’s potential use of “divisional patent procedures,” plus the “creation of a misleading impression before healthcare authorities regarding the efficacy and safety of competing products,” according to a release.
“The investigation will assess whether Teva’s divisional patent applications relating to the manufacturing process and dosage regimen following the expiry of the protection period of its basic molecule patent, together with withdrawal practices associated with these patents, are capable of restricting competition from generic medicines,” Rekabet Kurumu continued in its announcement of the Turkish probe.
"The Turkish Competition Authority's investigation relates to a legacy antitrust matter concerning Copaxone," a Teva spokesperson confirmed to Fierce, adding that the matter is similar to a Copaxone case from the European Commission. In that instance, Teva has denied any wrongdoing and is appealing a fine imposed by the Commission.
"This remains an investigation at this stage, and we will cooperate with the authorities throughout the process," the spokesperson said of the new investigation in Turkey.
The latest Copaxone strategy scrutiny comes two years after Teva was slapped with a 462.6 million euros ($503 million) fine by the European Commission.
After a multi-year probe, European regulators contended that Teva “[abused] its dominant market position" to ward off competition to Copaxone in markets including Belgium, Czechia, Germany, Italy, the Netherlands, Poland and Spain. Specifically, Teva was accused of misusing patent procedures to extend its drug exclusivity and spearheading a “systemic disparagement campaign” against rival products, allegedly spreading misleading information about competing products' safety, efficacy and therapeutic equivalence to Copaxone.
At the time, Teva made clear that it disagreed with the EC’s decision, calling the legal theories the ruling was based on “extreme, untested, and factually unsupported.”
Still, Teva has a long history of battling against Copaxone-related allegations. Over in the U.S., the Department of Justice filed a false claims complaint in 2020, accusing Teva of a layered kickback scheme concerning the drug. The company entered a deferred prosecution agreement on the matter, forking over a $225 million criminal penalty at the time and later paying up a separate $450 million agreement to formally put the claims to bed in 2024.