Overview
On October 31, 2024, the European Commission (the Commission) delivered its long-awaited decision in the Teva Copaxone case (which was published on April 8, 2025). Teva, a global pharmaceutical company, was fined EUR 462.6 million for abusing its dominant position in the market for glatiramer acetate (GA), the active ingredient in its blockbuster multiple sclerosis (MS) drug, Copaxone.
It is the Commission’s first decision condemning the misuse of divisional patents and its second on disparaging therapeutically equivalent products (following the Vifor settlement decision). Both arms of the conduct form a comprehensive strategy which falls outside the boundaries of “competition on the merits”, referring back to the AstraZeneca case law (C-457/10 P), and constitute a single continuous infringement. The decision highlights the Commission’s commitment to closely scrutinize abuse of dominance in the pharmaceutical sector, especially where the market entry of generic companies is delayed and exclusivity is artificially extended.
In Depth
Background
The Commission opened proceedings against Teva Pharmaceutical Industries Limited and Teva Pharmaceuticals Europe B.V. in March 2021 under Article 102 TFEU, following dawn raids in October 2019; a Statement of Objections was issued in October 2022.
In its press release of October 31, 2024, the Commission mentions that it also relied on documents from Teva’s in-house lawyers who were involved in the design of its abusive strategy to protect Copaxone and emphasized that in-house lawyer communications are not privileged under EU law.
The Decision: Yet Another Confirmation of a Molecule Market at LoE
The Commission acknowledges that the definition of relevant product markets in the pharmaceutical sector; the decision recalls the judgments in Generics UK and Servier, where the European Court of Justice held that the lifecycle of a pharmaceutical product can be a key determinant when defining markets.
In fact, the Commission cites Generics UK when stating that the emergence of a competing generic molecule “could lead to a situation where the originator medicines is considered, in the professional circles concerned, to be interchangeable only with those generic medicines and, consequently, to belong to a specific market, limited exclusively to medicines which contain that active ingredient”.
To assess whether such a market definition applies to Copaxone, the Commission analyzed the relevant product market in a two step-assessment, in line with the approach in Generics (UK) and Servier: the Commission assessed (i) the therapeutic substitutability of other MS treatments with Copaxone; and (ii) which therapeutically substitutable products actually exert an effective competitive constraint on prices, volumes and profits of Copaxone.
In the first step of the analysis, the Commission assessed the therapeutic substitutability of Copaxone with other disease modifying therapies (DMTs) for the treatment of Relapsing-Remitting MS (RRMS), by far the most common form of MS. It concluded that non-GA first line DMTs (i.e. oral first line DMTs and interferon first-line DMTs) are at best imperfect substitutes based on their efficacy, safety and tolerability profiles. The different profiles cater to different patient needs, confirmed both by switching patterns, and Teva’s own acknowledgment of the significant therapeutic differences in submissions to national authorities. The Commission concluded that Synthon GA (Synthon’s generic version of Copaxone) is in fact therapeutically substitutable and even therapeutically equivalent to Copaxone.
For the second step of the analysis, the assessment of economic substitutability, the Commission looked at which first-line DMTs effectively constrained Copaxone during the period of the infringement and concluded that Synthon GA exerted an effective and immediate competitive constraint even before its launch as it significantly changed market dynamics. The Commission confirmed that while non-price competition (promotional efforts) drives the market before generic entry, when approaching and following the loss of exclusivity, competitive constraints and related market dynamics are typically transformed by the (prospective) entry of generics because of significant price competition. Thus, price competition replaces non-price competition as the main driver of demand.
Citing Generics UK, Synthon was “in a position to present itself within a short period on the market concerned with sufficient strength to constitute a serious counterbalance to the originator” because it had (i) a prior strategy for effective entry with its product; (ii) taken the steps necessary to achieve effective entry by applying for Marketing Authorizations (MAs); (iii) concluded license agreements with third parties; and (iv) there were no insurmountable entry barriers regarding IP rights or other barriers to the launch of Synthon GA.
The Commission thus concluded that only Synthon GA was apt to exert price pressure on Copaxone, contrary to non-GA first-line DMTs, and hence the relevant product market was that for glatiramer acetate, i.e. Copaxone and Synthon GA.
The Decision: Teva Misused the Patent System and Systematically Spread Misleading Information about a Competing Generic Product
Teva was found to have implemented a comprehensive and deliberately anticompetitive strategy, with the overall objective of delaying competition and artificially prolonging the exclusivity of Copaxone by hindering the market entry and uptake of competing, cheaper generic version of GA, over which Teva held a basic patent until 2015. The strategy involved gaming the patent system as well as systematic disparagement targeting Synthon GA. Teva named its strategy the “Copaxone Continuation Project” or “CCP”, which was set up to counter the “risk” of competing GA entering the market.
The decision also refers to product hopping as part of Teva’s CCP: “Teva also pursued a large-scale pre-emptive conversion of its patients from the daily 20 mg dose to a three-times-a-week 40 mg dose of Copaxone […]” and “by the time Synthon GA’s 20 mg was ready to be launched [..] most patients had already been moved from Teva’s 20 mg Copaxone to 40 mg Copaxone“. The Commission noted that the conversion was not primarily driven by patient needs but served the purpose of extending the market exclusivity for Copaxone and formed part of its measures to defend Copaxone against generic competition.
In addition, the Commission also mentioned Teva’s interventions in the regulatory procedures for the granting of an MA to Synthon GA with a view to raising regulatory barriers and Teva’s engagement in a comprehensive EEA-wide regulatory litigation campaign aimed at getting Synthon GA’s MA annulled.
The Commission acknowledges that these activities within the framework of the CCP “significantly increased the difficulties” of generic GA entry, but took the decision to focus only on two major parts of Teva’s CCP: the misuse of the divisional patent system and the disparagement campaign, while not taking a position on the legality of these other activities.
The First Abuse: “The Divisionals Game”
Under the first abuse, Teva artificially extended Copaxone’s patent protection by misusing the available European Patent Office (the EPO) rules and procedures on divisional patents.
Divisional patents are based on parent patents in that they share the same invention but focus on different or more narrow aspects of that invention. Their validity is assessed independently from the parent patent, but their lifespan ends with the parent patent even if filed much later than the parent patent.
The main patent protecting the composition of Copaxone was filed in 1995, granted by the EPO in 2002 and expired in 2015. In 2005, Teva filed a patent protecting an improved manufacturing process, granted by the EPO in 2010; a day before the grant, Teva started to file divisional process patents. In 2010, Teva, filed a patent protecting a new dosing regimen (40mg instead of 20mg), granted by the EPO in 2013; again, a day before grant, Teva started to file divisional dosage patents.
The divisional process and dosage patents were filed over a period of 8 years, between 2010 and 2018. According to the Commission, Teva made use of the divisional patent instrument and multiplied these secondary patents to create two patent families, each consisting of various divisionals with significantly overlapping content i.e. the same inventive concepts and suffering from the same key weaknesses. According to the Commission, the intervals between the filings were not driven by research, as the science disclosed in them was already known from the parent patents and the differences from the parent patents were marginal. The Commission states that key Teva employees had doubts about the validity of the parent process and dosage patents and did not believe they would survive challenges before the EPO; equally, since the divisional patents shared essential features and the ingrained weaknesses of their parent patents, key Teva employees did not believe the divisional patents would survive challenges before the EPO either.
The Commission concludes that by staggering the filing of divisional patents, Teva obtained staggered grant dates which then meant that generic entrants who wanted to clear the path had to repeatedly challenge divisional patents belonging to the same patent family. Yet, this behavior alone did not amount to an infringement (while the Commission stated that Teva’s staggered patent filings may have been problematic, it left open the question of whether the filings themselves could amount to an infringement). According to the Commission, the infringement lies in the systematic withdrawal of the various divisional patents just before a revocation decision, thereby denying generic companies the possibility to clear the path to market entry and avoiding legal precedents that could have undermined other divisional patents in its portfolio with the same essential features and overlapping claims.
Logically, the Commission set the start date of the abuse at the time of the first withdrawal of one of Teva’s patents.
The Second Abuse: Systematically Denigrating Competing Products
The Commission also condemned Teva’s systematic disparagement campaign against Synthon GA, which started on April 12, 2016 across all relevant Member States. Despite regulatory approval by the appropriate health authorities confirming the safety, efficacy and therapeutic equivalence of these alternatives to Copaxone, Teva disseminated misleading information targeting key stakeholders, including doctors and national authorities responsible for pricing and reimbursement decisions, by emphasizing clinically irrelevant compositional differences between the two products and by making misleading inferences from experiences with other glatiramer-related substances unrelated to Synthon’s GA product. These claims had been rejected by the competent medicines’ authorities when granting a marketing authorisation for Sunthon’s GA product.
These efforts were aimed at undermining confidence in rival generic products (in contrast to the Vifor case, which concerned competition between two originators), thereby slowing their market entry and uptake in certain Member States.
The Commission concluded that Teva’s successful dissemination objectively misleading information on a large scale was in fact capable of discrediting Synthon GA to key stakeholders, influencing their decision-making and prescription behavior. This was found to depart from competition on the merits.
Conclusion
This decision marks the Commission’s first finding that the use of divisional patents can amount to an antitrust infringement under certain circumstances. What may be perfectly legal under patent law, the Commission found that such a conduct cannot be considered as “competition on the merits”, a test established by the Commission in AstraZeneca in 2005 and upheld on appeal by the European Court of Justice in 2012.
It was also the first time the Commission imposed a fine for disparagement practices, given that the Vifor case was settled. The decision also confirms the application the two-part test set in Generics (UK) and Servier used to define the market as that of the molecule.
According to former Executive Vice-President Margrethe Vestager, Teva’s conduct had significant consequences for public health budgets across Member States by delaying price reductions associated with generic competition. In some markets, list prices dropped by up to 80% after generic GA products entered.
