The European Commission (EC) has fined pharmaceutical company Teva €462.6 million for “systematically spread[ing] misleading information” and abusing its dominant position to delay competition to its proprietary multiple sclerosis drug Copaxone (glatiramer acetate). The delay may have prevented “significant savings” for public health budgets, according to a statement by EC executive vice president Margrethe Vestager.
Vestager said that Teva had “artificially extend[ed]” Copaxone’s patent protection and implemented “a systematic disparagement campaign” against a rival glatiramer acetate product manufactured by Synthon, contrary to Article 102 of the Treaty on the Functioning of the European Union, which prohibits the abuse of a dominant position. Teva had spread “misleading information” about the safety, efficacy, and therapeutic equivalence of the Synthon product to hinder its market entry and uptake.
The campaign targeted key stakeholders, such as doctors and organizations involved in drug pricing and reimbursement, with the objective of slowing down or blocking the competitor’s entry in several member states. Teva was thus able to maintain a “quasi-monopoly” in some states for years after the basic patent for Copaxone had expired.
Gaming the SystemThe EC also found that Teva had misused the patent system, artificially extending patent protection for Copaxone’s active ingredient by engaging in a tactic known as a “divisionals game.”
Divisional patents derive from an earlier “parent” patent application and share similar content but focus on different aspects of the invention, and they are treated independently when it comes to assessing their validity.
Teva “gamed this system” by filing multiple divisional patents with the European Patent Office, protecting dosage and manufacturing process in a staggered way, and then strategically withdrew them when they seemed likely to be revoked. This avoided the European Patent Office ruling that one of the patents was invalid, which would have set a precedent causing other divisional patents to “fall like dominos,” Vestager’s statement said.
This meant that generic companies were forced repeatedly to start fresh challenges, such that eventually it took more than 9 years for all the divisional patents in question to be annulled.
Synthon, an international pharmaceutical company headquartered in Nijmegen, the Netherlands, describes itself as “a leader in the field of generic medicines.” It had won regulatory approval in Europe for its rival product in 2017, describing it as “therapeutically equivalent” to Copaxone. In 2020 it won a ruling that Teva’s product patent was invalid, and it was thus revoked across Europe. At the time, Synthon said its development partner Mylan had “once again overcome Teva’s attempts to restrict MS [multiple sclerosis] patients’ access to safe and affordable alternatives.”
The rival manufacturer said that over the course of the previous 11 years, Mylan had successfully defeated Teva’s four waves of US patent litigation, eight citizen petitions, injunction proceedings in India, and more than 15 regulatory challenges, patent litigations, or commercial actions across Europe. The patent office decision would allow Mylan immediately to return to the market across Europe.
The generic product is now marketed in all EU member countries under a number of brand names, including Brabio, Clift, Copemyl, Copemyltri, and Glatiramyl.
Rival Products Reduced List PricesIt had been estimated that when the Copaxone patent expired in 2015, introduction of rival generic products would have resulted in price decreases of around 40% or more in most countries. Maintaining the higher price for Copaxone therefore had “a negative impact on public health budgets.” That potential price reduction was not only confirmed but shown to have been an underestimate, because once the rival product entered the market, list prices for glatiramer acetate decreased by up to 80%, “leading to significant savings for health systems,” the Commission said.
In setting the level of the fine, which it described as “proportionate” and “necessary to achieve deterrence,” the Commission took into account the gravity and duration of the infringements — up to 9 years — as well as the value of Teva’s sales.
Vestager said the decision reaffirmed the Commission’s “commitment to competition enforcement in the pharmaceutical sector” and its contribution to keeping drugs affordable, preserving choice of treatment, and fostering innovation to the benefit of EU patients and national healthcare systems.
Teva to Appeal the RulingIn a statement, Teva said it planned to appeal the decision, which it believed was based on legal theories that are “extreme, untested, and factually unsupported.” It said the company was “deeply disappointed” by the EC’s decision, which it described as “misguided,” because it had been “cooperating extensively” with the EC since 2019.
“The company will vigorously defend its position on appeal and is well prepared financially to mount a defense,” the statement said.
Asked to comment by Medscape Medical News, Teva said that the company “upholds the highest standards of scientific integrity and transparency, and we ensure that all research is conducted following strict ethical guidelines and rigorous procedures.”
It said that Teva is dedicated to “fostering collaborative partnership with external experts while maintaining the highest standards of transparency and compliance.” All partnerships “are built on a foundation of mutual respect and clear communication” and are regularly audited to ensure compliance and maintain transparency. “Our compliance standards are stringent and follow European standards.”
This is the second EC decision about disparagement campaigns. In July 2024, the EC accepted commitments by Vifor addressing the Commission’s preliminary concerns that the pharmaceutical company could have engaged in a potentially anticompetitive disparagement campaign.
Synthon and Mylan have been approached for comment.
Dr Sheena Meredith is an established medical writer, editor, and consultant in healthcare communications, with extensive experience writing for medical professionals and the general public. She is qualified in medicine and in law and medical ethics.
Source : Medscape