Teva Faces New Antitrust Scrutiny in Turkey Over Copaxone Patents

Teva Pharmaceutical Industries Ltd. is facing a new antitrust investigation in Turkey over practices tied to its multiple-sclerosis drug Copaxone, adding to regulatory scrutiny of the medicine that has already resulted in a major European Union fine.

Turkey’s competition authority, Rekabet Kurumu, opened an investigation into whether Teva engaged in conduct that could have restricted competition from generic medicines, according to an Aug. 26 report by Fierce Pharma. The regulator is examining patent-related strategies as well as Teva’s communications to health authorities about competing products.

According to Fierce Pharma, the investigation includes Teva’s use of divisional patent applications covering Copaxone’s manufacturing process and dosing regimen after protection for the drug’s underlying molecule had expired. Turkish authorities are also reviewing practices involving the withdrawal of patents and whether those actions may have impeded generic competition.

Regulators are separately looking at whether Teva created a potentially misleading picture for health authorities regarding the safety and effectiveness of rival medicines, Fierce Pharma reported, citing the Turkish authority’s announcement.

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Teva told Fierce Pharma that the Turkish inquiry concerns a longstanding antitrust issue involving Copaxone and resembles a case pursued by the European Commission. The company emphasized that the Turkish proceeding remains at the investigative stage and said it intends to cooperate with authorities. Teva has denied wrongdoing in the European matter and is appealing the EU penalty, according to the publication.

The Turkish investigation puts renewed attention on the commercial and patent strategies surrounding Copaxone, a treatment that has previously drawn scrutiny from regulators in Europe and the US.

In 2024, the European Commission fined Teva €462.6 million, equivalent at the time to about $503 million, after concluding that the company abused a dominant market position to delay competition to Copaxone in several European countries, according to Fierce Pharma. The EU case covered markets including Belgium, Czechia, Germany, Italy, the Netherlands, Poland and Spain.

European regulators alleged that Teva used patent procedures in an effort to prolong Copaxone’s market protection and conducted a campaign that questioned competing medicines. The commission said information disseminated about rivals addressed issues including their safety, efficacy and therapeutic equivalence, Fierce Pharma reported.

Teva rejected the European Commission’s conclusions. According to Fierce Pharma, the company said at the time that the legal theories underpinning the EU decision were “extreme, untested, and factually unsupported.”

Copaxone has also been at the center of legal disputes in the US. The Justice Department filed a False Claims Act complaint against Teva in 2020 alleging a kickback arrangement connected with the medicine, Fierce Pharma reported. The company subsequently entered into a deferred prosecution agreement that included a $225 million criminal penalty and later reached a separate $450 million agreement in 2024 resolving related claims, according to the publication.

Source: Fierce Pharma