IP Law Daily, PATENT NEWS—European Commission fines drug maker Teva $500 million for abusing patent system, (Oct 31, 2024)

By Brian Craig, J.D.

The Israeli drug manufacturer improperly sought to protect the patent for its multiple sclerosis drug and for disparaging a rival company.

Finding that the Israeli drug manufacturer Teva abused the patent system involving its blockbuster multiple sclerosis drug Copaxone and implemented a systematic disparagement campaign against a competitor, the European Commission has fined the drug company 460 million euros ($500 million). The Commission found that Teva artificially extended the patent protection of the blockbuster drug in Belgium, Czechia, Germany, Italy, the Netherlands, Poland, and Spain while also engaging in a system disparagement against a competing glatiramer acetate medicine for the treatment of multiple sclerosis.

Misuse of patent procedures. Following unannounced inspections at the premises of several Teva subsidiaries in October 2019, the Commission opened proceedings in March 2021 against Teva Pharmaceutical Industries Limited and Teva Pharmaceuticals Europe BV. The Commission concluded that Teva misused the patent system to artificially extend patent protection for Copaxone, whose active ingredient is glatiramer acetate. When its patent protecting glatiramer acetate was about to expire, Teva artificially extended Copaxone’s patent protection by misusing the European Patent Office.

Teva filed multiple divisional patent applications in a staggered way, creating a web of secondary patents around Copaxone focusing on the manufacturing process and the dosing regimen of glatiramer acetate. Teva engaged in a tactic known as “divisionals game.” Divisional patents derive from an earlier “parent” patent application and share similar content. When the patents seemed likely to be revoked, Teva strategically withdrew them, to avoid a formal invalidity ruling, which would have set a precedent threating other divisional patents to fall like dominos. By doing so, Teva forced competitors to repeatedly start new lengthy legal challenges. This tactic allowed Teva to artificially prolong legal uncertainty over its patents and, potentially, hinder the entry of competing glatiramer acetate medicines. As a result of Teva’s withdrawal of contested patents, generic companies had to repeatedly start fresh challenges, prolonging the process. It took more than nine years for all the divisional patents in question to be eventually annulled. All Teva’s divisional patents have now been annulled.

Disparagement campaign. As part of a strategy to delay competition, the Commission found Teva launched a disparagement campaign against Synthon, the only other drug company authorized to produce glatiramer acetate. Teva sought to create doubts about its rival product. Teva spread information contradicted by health authorities’ findings, seeking to sow doubt on the safety, efficacy, and therapeutic equivalence of the rival product. Teva’s campaign targeted key stakeholders, such as doctors and organizations involved in drug pricing and reimbursement with the objective of slowing down or blocking entry into other markets.

This is the second Commission decision about disparagement campaigns. In July 2024, the Commission investigated a similar tactic and accepted commitments by Vifor to undo the effects of its potentially misleading communications on the safety of the closest competing medicine for intravenous iron treatment, marketed by Pharmacosmos. In the Vifor investigation, the Commission accepted commitments by Vifor addressing the Commission’s preliminary concerns that the pharmaceutical company could have engaged in a potentially anticompetitive disparagement campaign.

Commissioner’s statement. “Today’s decision to impose an antitrust fine on Teva for disparagement and misuse of the patent system reaffirms the Commission’s commitment to competition enforcement in the pharmaceutical sector,” said Margrethe Vestager, Executive Vice-President in charge of competition policy. “With today’s decision, the Commission contributes to keeping drugs affordable, preserving choice of treatment and fostering innovation, to the benefit of EU patients and national healthcare systems.” Vestegar added that the fine will “send a clear message to dominant pharmaceutical companies that we will not tolerate the use of disparagement campaigns to foreclose competing medicines.” Vestegar affirmed that Teva “undermined the objectives of the patent system, which is to provide legal certainty and to protect genuine innovation.”

Companies: Teva Pharmaceutical Industries Limited; Teva Pharmaceuticals Europe BV; Synthon

News: Patent GCNNews