Eighteen months after the European Commission put Teva’s Copaxone marketing practices under a microscope, the walls appear to be closing in on the aging multiple sclerosis blockbuster.
Monday, the Commission said it let Teva know of its preliminary view that the company breached European antitrust rules by angling to delay Copaxone competition. More specifically, the EC accused Teva of “artificially” prolonging patent protection on the drug, plus “systematically spreading misleading information about a competing product” in a bid to “hinder its market entry and uptake.”
Teva, for its part, said it will “defend itself vigorously” and continue to work with the EC to seek a resolution. A company spokesperson warned the process could “take several years.”
“While we will first seek to persuade the EC that their preliminary view is incorrect, we are also prepared if needed to contest any allegations resulting from the EC’s investigation using all the legal and other procedural rights at our disposal,” she added.
Diving into the Commission’s accusations, the EC said its early findings suggest Teva “abused its dominant position” in the glatiramer acetate markets in Belgium, Czech Republic, Germany, Italy, the Netherlands, Poland and Spain.
Since February 2015 “until today,” Teva has allegedly “misused patent procedures” and “implemented a systematic disparagement campaign” against a competitor, EC contends.
On the patent front specifically, Teva is accused of filing and withdrawing secondary patent applications after its original, basic patent expired. This in turn forced competitors to file “new lengthy legal challenges each time,” EC argued.
Copaxone, also known as glatiramer acetate, remains in wide use for MS in Europe and beyond, though it has fallen far from a 2014 high of around $4 billion per year to $1 billion these days. Teva’s last patent on the drug in Europe lapsed in 2015, the EC pointed out in its release.
Teva itself notes in its most recent annual report (PDF) that its attempts to prolong Copaxone’s European patent life fell short in 2020 and 2021. But the company is pressing its case over a 2030 patent in certain countries.
In the same report, Teva pointed out that competition to Copaxone is growing fierce, with generics and oral competitors like Tecfidera, Gilenya and Aubagio proving especially troublesome.
Teva’s total 2021 revenues landed at $15.9 billion, down about 6% versus the previous year, which it blamed in part on less-than-stellar Copaxone sales.
Looking ahead, Teva expects Copaxone to generate about $850 million this year, down from the roughly $1 billion it pulled down in 2021.