European Union: Commission Still at the Forefront, While Pay-for-Delay Cases Set New Precedents

The life sciences industry is one of the most heavily regulated industries in the European Union. In turn, competition authorities in Europe, and in particular the European Commission (the Commission), have historically been very active in terms of antitrust enforcement and merger control review in this industry. Consistent with its focus on innovation, the Commission has significantly increased its scrutiny in past years.

In the area of antitrust, pay-for-delay agreements have continued to be a hot topic for the Commission and the Court of Justice of the European Union (CJEU) in recent years. On the other hand, merger control has seen a significant development, with the Commission’s recent Guidance on Article 22 of the EC Merger Regulation (EUMR),^[2] which allows Member States to refer transactions that do not meet their national merger control thresholds to the Commission. This new referral policy represents a complete U-turn from previous merger control practice and is aimed at catching ‘killer acquisitions’. This will lead to a heightened scrutiny of life sciences transactions, as the ongoing Illumina/Grail review shows.

This chapter focuses on the enforcement of the EU competition rules in the life sciences industry. For a better understanding of the specificities and market dynamics of this industry, we include a brief overview of the EU regulatory framework.

EU regulatory framework

The EU very strictly regulates the placing on the market of medicinal products and medical devices.

Medicinal products

Legislative overview

The placing of medicinal products on the market has been harmonised through Directive 2001/83/EC^[3] and Regulation 726/2004,^[4] the cornerstones of EU pharmaceutical law.

Directive 2001/83/EC contains the basic principles and rules generally applicable to all medicinal products, from the key requirement to hold a prior marketing authorisation to manufacturing, safety and trade control, distribution, distant sales, labelling, pharmacovigilance and advertising.

Regulation 726/2004 sets up the centralised authorisation procedure and the European Medicines Agency (EMA). The centralised procedure involves a scientific assessment by the EMA and a decision by the Commission, which is applicable in all Member States.

Prior marketing authorisation as the foundation of the regulatory system

The foundation of EU pharmaceutical law is the requirement to hold a marketing authorisation before placing a medicinal product on the market.

The marketing authorisation is granted by the national competent authorities (decentralised procedure) or the Commission (centralised procedure) following a scientific assessment of the application. An authorised medicinal product may only be marketed in the Member State that granted the marketing authorisation, unless it has been centrally authorised.

Generics and biosimilars

A generic medicinal product has the same composition of active substances and the same pharmaceutical form as the reference medicinal product. Its bioequivalence with the reference medicinal product is demonstrated by appropriate studies.

A biosimilar is a ‘copy’ of a biological medicinal product, but contrary to generics, biosimilars are similar to, rather than the same as, their reference medicinal products due to the inherent variability of biological substances. As a result, biosimilars are subject to increased regulatory requirements, in particular the demonstration of their similarity with the reference product by means of non-clinical and clinical data.

Free movement of medicinal products

Given the differences in national prices, independent distributors may purchase a medicinal product in a Member State at a low price and resell it in another Member State at a higher price. Those distributors, which are called ‘parallel importers’, do not have to apply for their own marketing authorisation in the reselling country. Instead, they are granted an authorisation of parallel import, which is based on and linked to the initial marketing authorisation as the medicinal products they market are authorised and placed on the market under that initial marketing authorisation.

Medical devices and in vitro diagnostic medical devices

Legislative overview

Medical devices are regulated by the Medical Devices Regulation (MDR).^[5] In vitro diagnostic medical devices (IVDs) are regulated by the IVD Regulation (IVDR).^[6] The MDR and IVDR regulate many aspects such as placing on the market, clinical investigations, materiovigilance and market surveillance, but, remarkably, not advertising.

Certificate of conformity

In contrast to medicinal products, a prior authorisation granted by a public authority is not required for placing medical devices or IVDs on the EU market. Instead, manufacturers of medical devices and IVDs must hold a certificate of conformity issued by themselves or an independent notified body, depending on the class of the device concerned.

Impact of covid-19

On 23 March 2020, the European Competition Network issued a joint statement on the application of competition law during the covid-19 crisis,^[7] which stated that national competition authorities would ‘not actively intervene against necessary and temporary measures put in place to avoid a shortage of supply’ that may arise as a result of the covid-19 pandemic. The statement encouraged manufacturers to use maximum retail prices to combat price hikes and excessive pricing.

On 30 March 2020, the Commission set up a website providing guidance to companies intending to engage in specific cooperation initiatives with an EU dimension, aimed at tackling the issues arising out of the covid-19 pandemic. The Commission also set up a dedicated mailbox for companies seeking informal guidance.

On 8 April 2020, the Commission released a temporary framework communication to provide guidance to companies cooperating in response to urgent situations resulting from the covid-19 pandemic with regards to ‘essential products and services’ (including medicines and medical equipment).^[8] The Commission also released guidelines to help optimise the supply and availability of medicines during the pandemic.^[9]

On 15 April 2020, in their ‘Joint European Roadmap towards lifting Covid-19 containment measures’,^[10] the Commission and the Council jointly stated that ‘a higher than normally allowed degree of cooperation between firms, including competitors’ may be necessary for ‘ensuring sufficient supplies of equipment and medicines for enabling the lifting of confinement measures’.

In this context, on 29 April 2020, the Commission published a comfort letter to Medicines for Europe, which had requested guidance concerning cooperation practices aimed at avoiding shortages of covid-19 medicines.^[11] Medicines for Europe proposed cooperation between pharmaceutical manufacturers producing relevant covid-19 medicines to: model the demand for medicines; identify production capacity and existing stocks; adapt and reallocate medicines based on actual or projected demand, production and stocks; and potentially address the distribution of covid-19 medicines. The Commission considered that the cooperation mechanism did not raise concerns under Article 101 of the Treaty on the Functioning of the European Union (TFEU), with the caveat that the comfort letter did not cover any discussion of price or coordination on issues that were not strictly necessary to address potential covid-19 medicine shortages.

Merger control

Merger control in the pharmaceutical sector has undergone significant developments at the EU level. Notably, when reviewing mergers the Commission has increased its scrutiny, assessing with particular interest and focus the impact of concentrations on innovation.

In horizontal mergers, the Commission is vigilant on mergers that would lead to situations where innovation by one of the merging firms would be lost or decreased (e.g., the discontinuation of research and development (R&D) programmes or abandonment of pipeline products). In vertical mergers, the Commission focuses on whether the combined entity would be able to harm innovation by, for example, restricting the access of downstream competitors to important input upstream.

Given the significant time required to bring pharmaceutical products to market (including R&D and market authorisation procedures), the Commission, in the pharmaceutical sector more than in other industries, seeks to predict future market outcomes by way of a dynamic competition analysis.

Together with the US Federal Trade Commission, Canada’s Competition Bureau and the UK Competition and Markets Authority, the Commission is also participating in the Multilateral Pharmaceutical Merger Task Force, which aims to identify concrete and actionable steps to review and update the analysis of pharmaceutical mergers.^[12]

Market definition

As is the case for other industries, in the life sciences industry the Commission applies the methodology outlined in its Market Definition Notice, irrespective of the fact that the sector is heavily regulated. Nonetheless, the following principles can be derived from past Commission practice.

As a starting point, the Commission generally uses the categorisation of medicines according to their intended use under the Anatomical Therapeutical Chemical (ATC) classification system, developed by the European Pharmaceutical Market Research Association. In the ATC classification system, the active substances are divided into different groups according to the organ or system on which they act and their therapeutic, pharmacological and chemical properties. Medicines are classified in groups at five different levels. The Commission’s market definition analysis generally starts at ATC3 level, which groups medicines in terms of therapeutic indications. When the ATC3 level is deemed insufficiently accurate, the analysis moves to the ATC4 level (chemical, pharmacological, therapeutic sub-groups) or to a mixture of ATC levels, or to the molecule.

The Commission has also considered single molecule markets for generic medicines, assessing any differences in the galenic formulation (i.e., dosage, non-active ingredients, pharmaceutical form, mode of delivery and route of administration) but found those to limit substitutability within or across molecules.

The Commission has also distinguished prescription medicines from over-the-counter or dual-status medicines, although there can also be overlap between these segments.

For future markets, the Commission considers competition from pipeline products, as well as potential competition from existing products, although it generally limits itself to advanced R&D pipeline products in Phase III clinical trials.

Article 22 Guidance

In March 2021, the Commission published its new Guidance on Article 22 of the EUMR (commonly referred to as the Article 22 Guidance).^[13] According to this Guidance, Member States are no longer discouraged from referring to the Commission transactions that do not meet their national merger control filing thresholds provided that the transaction: (1) affects trade between Member States; and (2) threatens to affect competition within the territory of the Member State or States making the request.^[14] This represents a U-turn from the Commission’s earlier referral policy, which discouraged Member States from referring transactions that did not meet the national thresholds to the Commission. The new referral policy is particularly aimed at catching ‘killer acquisitions’ (i.e., transactions removing firms that may develop into those playing a significant competitive role on the market despite generating little to no turnover at the time of the concentration).

Mergers in the life sciences sector, particularly the pharmaceutical industry, present an increased risk of referral, given the specificities of the industry and market dynamics. The Article 22 Guidance specifically mentions the pharmaceutical industry as one of the industries in which it is important to review potentially anticompetitive concentrations aimed at removing targets that have not yet commercialised the results of their innovation activities on the market.

Illumina/Grail

The Illumina/Grail merger is the first transaction in which the Commission applied its new referral policy.

In September 2020, DNA sequencing firm Illumina announced its intention to acquire oncology firm Grail. Grail develops cancer detection tests that rely on next-generation sequencing platforms, such as those developed by Illumina. Grail does not currently generate any turnover in the EU and only began commercialising its tests in the US in April 2021.

Soon after the announcement of the deal, but before the publication of the Article 22 Guidance, the Commission invited Member States’ competition authorities to make a referral under Article 22 of the EUMR. Subsequently, the French, Belgian, Greek, Dutch, Icelandic and Norwegian authorities made a referral, despite the transaction not meeting their respective national thresholds. The Commission formally accepted the referral in April 2021.

In April 2021, Illumina challenged: the national competition authorities’ decision to refer the transaction to the Commission; the Commission’s acceptance of the referral; and the Commission’s decision to impose a standstill obligation on Illumina. Illumina’s appeal to the General Court claimed, inter alia, that Article 22 of the EUMR was wrongfully interpreted by the Commission and the national competition authorities, and that the change of policy as regards referrals was contrary to Illumina’s legitimate expectations. The ruling from the General Court was announced on 13 July 2022, backing the Commission’s interpretation of Article 22 of the EUMR set out in the Commission’s Guidance.^[15] In particular, the General Court ruled that the referral request was made on time, even though more than 15 working days had passed between the transaction’s press release being published and the date the referral request was made. In that regard, the General Court ruled that the 15-working-day period only starts on the date of ‘active transmission of information’ to the Member State concerned, which is appropriate for it to be able to assess, on a preliminary basis, whether the necessary conditions for the purposes of a referral have been satisfied (i.e., the press release was irrelevant). The General Court also rejected Illumina’s claim that its legitimate expectations had been breached, noting that a company must have received ‘precise, unconditional and consistent assurances, originating from authorized, reliable sources’, which would lead it to entertain well-founded expectations. The General Court found that public statements made in a speech of 11 September 2020 by Margrethe Vestager (the vice president of the Commission), in which she stated that it was time to change the past referral policy, but that ‘this won’t happen overnight’, did not constitute precise, unconditional and consistent assurances.

In the meantime, on 16 June 2021, Illumina notified the transaction to the Commission.^[16] The Commission opened a Phase II investigation on 22 July 2021 over concerns that, post-transaction, Illumina could decide to restrict access to its next-generation sequencing platform for Grail’s competitors. Because Illumina has a particularly strong position on the market for next-generation sequencing, the Commission identified a risk of input foreclosure.

Despite the standstill obligation under EU law, on 18 August 2021 Illumina closed its acquisition of Grail claiming that the Commission’s acceptance of jurisdiction over the transaction was illegal. The Commission opened an investigation for breach of the standstill obligation and sent Illumina a statement of objections on 20 September 2021. On 29 October 2021, the Commission adopted a decision imposing interim measures on the combined entity, including a hold-separate obligation, an obligation to fund the operations and development of Grail and an obligation for Grail to look for alternative acquirers to Illumina. This was the first time the Commission adopted interim measures following the early completion of a merger.

On 14 January 2022, the Commission sent Illumina a letter of facts, following up on the statement of objections received in the framework of the Phase II review in November 2021. On 27 January 2022, Illumina proposed its first set of remedies, consisting of a 12-year agreement with Grail rivals to supply them with Illumina gene-sequencing instruments. Following the judgment of the General Court, Illumina proposed a revised set of remedies, which, at the time of writing, still need to be market tested.

At present, the Phase II investigation is still ongoing, with the Commission having suspended the clock on several occasions to gather more information from the parties.

Other merger decisions

Other noteworthy recent merger cases illustrate the Commission’s heightened attention on potential losses of innovation.

In AbbVie/Allergan,^[17] for instance, the Commission was concerned that the product under development by Allergan would be abandoned once the transaction completed, leading to a loss of innovation on the market for treatments for inflammable bowel disease where the activities of AbbVie and Allergan overlapped. The Commission approved the deal in Phase I on condition that the product under development by Allergan (in Phase II clinical trials) was divested to a third party.

In Johnson & Johnson/Tachosil,^[18] Johnson & Johnson withdrew its notification after the Commission opened a Phase II investigation upon concerns that the proposed acquisition may reduce potential competition and innovation in the supply of dual haemostatic patches. At the time of the review, Tachosil was the dominant dual haemostatic producer in the European Economic Area (EEA). Although Johnson & Johnson did not sell dual haemostatic patches in the EEA, it sold some patches outside the EEA. The Commission’s investigation showed that absent the transaction, Johnson & Johnson would have had strong incentives to enter the EEA market either with its existing dual haemostatic patches or with new patches that it might have developed if the transaction did not take place. The Commission considered that Johnson & Johnson was the best placed potential entrant in the already concentrated market for dual haemostatic patches.

Main infringement proceedings

Policy background

In 2008, the Commission launched a sector inquiry in the pharmaceutical industry under Article 17 of Regulation 1/2003.^[19] The final report of the sector inquiry, published in July 2009, found that timely market entry of generic drugs was delayed and that there was a decline in the number of novel medicines reaching the market. The Commission concluded that the market conduct of originators, together with shortcomings of the regulatory framework, contributed to this phenomenon.

Between 2009 and 2017, the Commission and the national competition authorities adopted 29 antitrust decisions against pharmaceutical companies and imposed fines over €1 billion.

Enforcement

Prior to the sector inquiry, the Commission’s antitrust enforcement in the pharmaceutical industry primarily targeted restrictions to parallel trade. In a few landmark judgments, the CJEU delineated the perimeters of the Commission’s enforcement powers as regards parallel trade, notably in terms of quota systems, the frontier between Articles 101 and 102 TFEU,^[20] dual pricing, the notion of restriction of competition by object^[21] and the ability of the creation of barriers to parallel trade to constitute an abuse under Article 102 TFEU.^[22]

In AstraZeneca,^[23] the Commission fined AstraZeneca €60 million for misleading regulators. It was argued that AstraZeneca had gained a longer patent protection for its drug omeprazole and therefore delayed generic entry and parallel imports. The Commission’s decision was largely upheld by the General Court and the CJEU.^[24]

Following the sector inquiry, the Commission has continued to target originators’ strategies to extend the commercial life of their products by restricting generic entry.

In Lundbeck,^[25] the Commission fined Lundbeck €93.8 million for having paid several generic drug producers not to launch their own versions of Lundbeck’s originator drug, despite the fact that the protection granted by the patents had expired. Pursuant to the settlement agreements between Lundbeck and the generics manufacturers, Lundbeck paid significant lump sums, purchased generics’ stock for the sole purpose of destroying it and offered guaranteed profits in a distribution agreement. The decision was based on Article 101(1) TFEU, and the Commission found that the restriction of competition was a restriction by object. The Commission’s decision was upheld by both the General Court and the CJEU.^[26]

In December 2013, in Fentanyl,^[27] the Commission fined Johnson & Johnson and Novartis a total of €16 million for having entered into an agreement to delay the market entry of the painkiller fentanyl in the Netherlands; both companies have appealed the decision. In 2005, Johnson & Johnson’s protection for fentanyl patches had expired in the Netherlands, and Novartis was about to launch its generic fentanyl depot patch. However, in July 2005, Novartis concluded a ‘co-promotion agreement’ with Johnson & Johnson, which provided strong incentives for Novartis not to enter the market, including monthly payments exceeding the profits that Novartis could have hoped to obtain from selling the generic product, for as long as there was no generic entry. The agreement was terminated in December 2006 when a third party entered the market.

In Servier,^[28] the Commission fined Servier and five generic companies a total of €427.7 million for entering into agreements aimed at protecting Servier’s blood pressure medicine perindopril from price competition by generics in the EU. Although Servier’s patent for the perindopril molecule expired, for the most part, in 2003, generic competitors continued to face secondary patents relating to processes and form. In 2004, Servier acquired one of the only sources of non-protected technologies that could help generic manufacturers to enter the market. Servier recognised that this acquisition merely sought to curb competition from generic companies. Generic manufacturers challenged Servier’s patents before courts, but on at least five occasions when a generic manufacturer came close to entering the market, Servier settled the challenge in agreements whereby the generic manufacturers agreed to delay entry on the market in exchange for a share of Servier’s revenues. In one case, Servier offered a generic company a licence for seven Member States, and in return the generic manufacturer agreed to ‘sacrifice’ all other EU markets and stop efforts to launch its perindopril there.

In December 2018, the General Court delivered a judgment in which it partly upheld and partly quashed the Commission’s findings in Servier.^[29] The CJEU’s judgment is expected later in 2022.

In Cephalon,^[30] the Commission fined Teva and Cephalon a total of €60.5 million; both companies have appealed the decision. The Commission’s investigation, which spanned over almost 10 years, showed that Teva and Cephalon settled patent disputes in the UK and US regarding modafinil, a drug treating sleeping disorders, which entailed Teva not selling generic modafinil in the EEA before October 2012 in exchange for a substantial transfer of value from Cephalon. The Commission found that the transfer of value was embedded in a number of commercial side deals that Teva would not have achieved without committing to staying out of the market. The infringement ended in October 2011 when Teva acquired Cephalon and the two entities became part of the same group.

In Aspen,^[31] the Commission investigated concerns that Aspen was engaged in excessive pricing concerning six oncology medicines for human use. Aspen started to increase its prices in all European countries in 2012, sometimes by several hundred per cent. The Commission’s analysis of Aspen’s accounting data showed that, after the price increases, Aspen consistently earned very high profits from its sales of these medicines in Europe, both in absolute terms and compared to profit levels of similar companies. Aspen’s prices exceeded its relevant costs by almost 300 per cent on average. The Commission noted that there were no legitimate reasons for such high profit levels, with Aspen’s medicines having been off-patent for 50 years, which means that any R&D investment on the medicines had long been recouped. In February 2021, the Commission accepted Aspen’s commitment to: reduce its prices in Europe for the medicines by 73 per cent on average; continue the supply of these off-patents for the next five years; and, for the following five years, either continue the supply or make its marketing authorisation available to other suppliers.

On 4 March 2021, the Commission announced that it was investigating whether Teva illegally delayed the market entry and uptake of medicines competing with its multiple sclerosis drug Copaxone by strategically filing and withdrawing divisional patents, which repeatedly delayed the entry of a generic competitor that was obliged to file a new legal challenge each time.^[32] The Commission is also investigating whether Teva pursued a communication campaign unduly denigrating competing glatiramer acetate products.

On 25 October 2021, the Commission announced that it had conducted unannounced inspections at the premises of a company active in the animal health sector in Belgium. The Commission suspects a potential infringement of Article 102 TFEU.^[33] This marks the return of dawn raids by the Commission after they had been put on hold because of the covid-19 pandemic.

Case law

Recent judgments from the CJEU in Paroxetine and Lundbeck have clarified the notions of potential competition and restriction by object in the context of pay-for-delay cases. The upcoming judgment in Servier, which is due later in 2022, promises to elaborate on these two judgments, in addition to providing guidance on market definition in pharmaceutical cases.

On 30 January 2020, the CJEU delivered a preliminary ruling in Paroxetine. In this case, the Competition Appeal Tribunal of the United Kingdom asked the CJEU whether a generic manufacturer could still be considered a potential competitor of an originator when their ability to enter the market depends on the outcome of court proceedings relating to the validity of a patent. The CJEU recalled that the test for potential competition is whether there are ‘real and concrete’ possibilities for the generic manufacturer to enter the market and compete with the originator, independently of the hypothetical possibility of their entry or the mere desire of the generic manufacturer to enter the market. However, the Court clarified that there was no need to demonstrate that the generic manufacturer would actually enter the market.^[34] In fact, the Court ruled that potential competition must be assessed depending on the circumstances of each case, taking into account the structure of the market and whether the generic manufacturer had taken sufficient preparatory steps to enable its entry on the market (e.g., steps towards obtaining marketing authorisation).^[35]

On 25 March 2021, the CJEU gave its judgment in Lundbeck,^[36] which builds upon Paroxetine and clarifies the concepts of potential competition and restriction by object in pay-for-delay cases.

• As regards potential competition, the Court reiterated its Paroxetine case law and stated that ‘in order to assess whether an undertaking that is not present in a market is a potential competitor . . . , it must be determined whether there are real and concrete possibilities of the former joining that market and competing with one or more of the latter’.^[37] To do so, the Commission must assess whether the generic company has already taken ‘sufficient preparatory steps’ to its entry on the market.^[38] The presence of a patent on the manufacturing process of an active ingredient does not, in the Court’s eye, represent an ‘insurmountable obstacle’ to entry on the market, regardless of the presumption of validity attached to the patent.
• As regards the notion of restriction by object, the Court reiterated its case law that an infringement by object can only be found when the transfer of value cannot have any other explanation other than the parties’ interest not to engage in competition on the merits.^[39] Because it is principally the size of the reverse payments that induced the generic manufacturer to accept delaying market entry, the Court confirmed that the agreement in Lundbeck was a restriction by object.^[40]

Later in 2022, the Court is set to deliver its judgment in Servier. In 2018, the General Court delivered a very lengthy judgment in which it partly confirmed the Commission’s 2014 decision, and partly annulled it (see above). Notably, the General Court’s judgment clarified a few points of importance in pay-for-delay cases.

• First, as regards market definition, the General Court insisted on the need of a concrete economic analysis beyond the anatomical therapeutic chemical classification, which can only serve as a starting point in the relevant market analysis.^[41]
• Second, the General Court determined that a settlement constitutes a restriction by object under Article 101 TFEU if: (1) the originator and generic manufacturers are at least potential competitors; (2) the settlement contained non-challenge and non-commercialisation clauses; and (3) the originator obtained these clauses in return for a value transfer and not due to the generic manufacturer’s assessment of the validity of the underlying patent right.^[42]
• Third, as regards potential competition, the General Court reiterated its finding that potential competition exists on a market before the expiry of a patent, and that the presumption of patent validity does not impede competitors from launching their generic drug product at risk. As long as generic manufacturers have the possibility to contest patent validity and the infringement of the relevant patents by their generic versions, the patents do not constitute an insurmountable barrier to generic entry.^[43]
• Fourth, as regards licensing agreements, the General Court annulled the Commission decision because the Commission did not prove that the licence agreement with Krka was not granted under normal market conditions. In reviewing the licensing agreement with Krka, the General Court concluded that, from the parties’ perspective, there were indications that the patent was valid before the negotiation of the licence and that the licensing agreement was concluded at arm’s length. The General Court also found that, although side deals^[44] were a serious indication of the existence of a reverse payment, this was not the case for licence agreements.^[45]

On 14 July 2022, Advocate General Juliane Kokott proposed that the CJEU set aside the General Court’s judgment insofar as the licence agreement with Krka is concerned. Advocate General Kokott took the view that the agreement between Servier and Krka was a restriction by object because the licence constituted a transfer of significant value by Servier in favour of Krka, which had no consideration from Krka other than the commitment not to compete with Servier on EU markets not covered by the licensing agreement. Advocate General Kokott also considered that the Commission had established to the requisite legal standard that the agreement had the effect of eliminating Krka as a potential competitor of Servier.

Advocate General Kokott also proposed that the CJEU annul the General Court’s judgment for failing to state its reasons for quashing the Commission’s findings relating to market definition.

Outlook

As evidenced by the number of enforcement actions, the life sciences industry remains a priority for the Commission. The Commission’s merger reviews are increasingly focusing on innovation concerns, pipeline products and dynamic competition, with it further tightening its grip on life sciences companies as shown by the recent Illumina/Grail Article 22 referral. With respect to antitrust, pay-for-delay cases have been in the limelight, with further developments expected, as several cases (notably Cephalon and Servier) are currently being appealed.

Notes