Some two years after the European Commission accused Teva of meddling with the competition for its former multiple sclerosis blockbuster Copaxone, the other shoe has finally dropped.
The European Commission (EC) has fined Teva 462.6 million euros ($503 million) over allegations that the Israeli-American pharmaceutical giant “[abused] its dominant market position to delay competition” to Copaxone.
The company is specifically accused of artificially inflating the MS drug’s patent protection and “systematically” spreading “misleading information” about a rival product, the EC said Wednesday. The EC contends that Teva used its position to strong-arm glatiramer acetate markets in Belgium, Czechia, Germany, Italy, the Netherlands, Poland and Spain.
“Teva's abusive conduct had the overall objective of delaying competition and artificially prolonging the exclusivity of Copaxone by hindering the market entry and uptake of competing, cheaper glatiramer acetate medicines,” the EC said in its release.
Teva disagreed with the EC’s position in a statement Thursday, arguing the commission reached its conclusions through “legal theories” that the company branded as “extreme, untested and factually unsupported.” Teva said it will appeal the judgment and fine, adding that it’s financially prepared to mount a defense if needed.
Taking a closer look at the accusations, the EC argued that Teva misused European Patent Office procedures on divisional patents to extend Copaxone’s exclusivity shortly before the protecting patent in question was due to expire. Teva allegedly filed multiple patent applications in a “staggered way,” which the EC claimed created a “web of secondary patents” on Copaxone focusing on manufacturing and dosing.
When rivals challenged those patents, Teva enforced its intellectual property by obtaining interim injunctions against competitors, and, when the patents seemed “likely to be revoked,” Teva strategically withdrew them to avoid a formal invalidity ruling, the EC claimed.
The EC also asserted that Teva initiated a “systematic disparagement campaign” against a particular glatiramer acetate medication for MS by spreading misleading information on the product’s safety, efficacy and therapeutic equivalence to Copaxone. Teva allegedly targeted doctors and decision-makers for pricing and drug reimbursement as part of its misinformation strategy, the EC added.
The EC’s probe into Teva’s purported misconduct kicked off in October 2019 with a series of unannounced inspections of several Teva subsidiaries. The commission opened formal legal proceedings in March 2021 and laid out preliminary objections in 2022.
Teva’s Copaxone marketing tactics have caused trouble for the drugmaker beyond Europe as well.
Earlier this month, Teva Pharmaceuticals USA and Teva Neuroscience agreed to pay a combined $450 million to resolve claims that the companies violated the U.S.’ Anti-Kickback Statute and the False Claims Act.
The first $425 million tranche of the settlement covers claims that Teva used two assistance foundations to fund patients’ Copaxone copays from 2006 through 2017. Over that same stretch, Teva “steadily” raised Copaxone’s price, the U.S. Department of Justice said at the time.