New Commission Article 102 Guidelines – significance for IP rich companies

Article 102 of the Treaty on the Functioning of the EU can represent a source of risk for dominant companies. Holding IP rights may contribute to the existence of dominance, and with the use of IP in the spotlight in cases such as the Commission's Copaxone investigation, navigating the rules on abuse of dominance is of high importance to business.

That issue is particularly salient in the pharmaceutical sector, where a majority of competition law risk in the EU/EEA derives from Article 102. Case law developments in the analysis of relevant markets in dominance mean that many suppliers of branded pharmaceuticals will hold a dominant position, at least in the period leading up to and shortly following loss of exclusivity under a molecule/composition of matter patent.

Against that backdrop, the adoption by the European Commission in September 2026 of Guidelines on the application of Article 102 TFEU to abusive exclusionary conduct is significant. Unlike the earlier Guidance on enforcement priorities (which the new Guidelines replace), the Guidelines are binding on the Commission, but in a number of respects provide the Commission with greater flexibility to pursue abuse cases. The Commission also hopes that the Guidelines will improve consistency of enforcement by national competition authorities within the EU/EEA.

Overall takeaway

The Guidelines make a significant move away from the previous economic approach to abuse. Instead, they favour presumptions drawn from legal precedent, while retaining a role for economic analysis in more novel cases.

This move is partly motivated by the goal of ensuring better predictability for business – an important consideration, given the flexibility of Article 102. However, this approach is also likely to give the Commission more scope to resist being drawn into in-depth economic analysis, at least in cases relating to established forms of abuse. For example, the Guidelines make clear that economic concepts such as that of the ‘as-efficient competitor’ are not relevant in all cases, e.g. where exclusion occurs at an early stage of the potential competitor's attempt to enter the market (as would be the case for many cases concerning generic or biosimilar entry). Similarly, price-cost analysis is uninformative where non-pricing conduct is concerned.

Following Intel, the Commission will continue to need to engage with any justifications put forward by parties under investigation, but these will need to be tailored to the specific context. The Guidelines give some indications of what sorts of evidence will be relevant for different types of abuse.

Other points of note for potentially dominant companies in the pharma (or other IP rich) sectors:

• The Guidelines focus on exclusionary forms of abuse, but briefly consider dominance. They recognise that dominance is unlikely below a 40% market share, but in innovation-driven sectors such as pharmaceuticals, factors such as control of key IP rights, R&D expenditure and innovation capabilities are also relevant.
• The Guidelines also pay considerable attention to collective dominance, perhaps signalling a new appetite for cases based on conduct by undertakings linked through corporate or contractual connections (as has been deployed by the French Competition Authority in its investigation into Roche, Novartis and Genentech).
• The concept of exclusionary effects is very wide, encompassing anything making it more difficult for competitors to enter or remain on the market. Conduct need only be shown to be ‘capable’ of having such effects: this assessment requires a more than hypothetical effect to be produced, but falls short of requiring actual effects to be demonstrated.
• Exclusive dealing obligations imposed by a dominant undertaking are subject to a presumption that they distort effective competition. As noted above, evidence can be submitted to seek to rebut that presumption. Arrangements which de facto lead to exclusive dealing will only be treated as such where there is evidence that the dominant company intended to require or incentivise the customer to purchase all or most of their requirements from it.
• The Guidelines provide further details on a range of established types of foreclosure abuse. For example, the description of the legal principles for refusals to give access to IP rights closely tracks the case law. For example, the Guidelines emphasise that an undertaking seeking access will need to do more than essentially duplicate the goods or services already offered by the owner of the IP right. It therefore remains the case that it is only in exceptional circumstances that a refusal to give access to IP rights will give rise to a finding of abuse.
• For other ‘non-standard’ types of foreclosure, the role of “competition on the merits” (a central plank in cases such as Copaxone as well as the earlier AstraZeneca decision) remains key. Provision of misleading information to administrative authorities or misuse of regulatory or judicial procedures in a way that makes it more difficult for competitors to access the market are called out as “strong indicators” of that the party is not competing on the merits.
• The Guidelines include a significant section on objective justification. The burden of proving such justification (which operates akin to a defence to a finding of abuse) rests on the dominant undertaking. This may take the form of objective necessity or economic efficiency:
  • Objective necessity: In principle, this category can embrace public health objectives or product safety, but most such justifications have been rejected in the case law. Of note is a new category, “contribution to the resilience of the EU”, including mitigating shortages and disruptions in supply chains.
  • Economic efficiency: Encompasses static and dynamic considerations; the Commission recognises that some efficiencies may take some time to materialise, e.g. those related to innovation and R&D. Sustainability benefits (considered broadly, to include e.g. ensuring animal welfare) are included under this category.

Although objective justification is in principle possible, passing the burden of proof for any such justification will remain challenging. Among other things, the party is required to demonstrate that the measure is proportionate, directly related to a positive (non-marginal) impact on consumers, and could not be achieved by a less restrictive method. The case law relied upon by the Commission in the Guidelines mostly serves to establish the significant difficulty of proving objective justification (the 2016 UK judgment in Streetmap v Google being a rare example of such a defence being used successfully).

Final points to note

The Guidelines do not apply to exploitative abuses (e.g. excessive and unfair prices, which has been the subject of significant enforcement over recent years in the pharma sector, among others), nor do they apply in the UK - although they are likely to have considerable persuasive value in many cases.

The Guidelines do not represent a fundamental change to Article 102, but are an important roadmap through the case law on exclusionary abuses and a clear signal that the Commission remains committed to enforcement in this area. While its latest investigation (opened in October 2026 into supply of Calcium Carbonate for the paper industry by Omya) does not touch on IP, its focus on exclusive purchasing and exclusivity rebates will be a testing ground for the Commission's updated approach.