62019CJ0176_RES
Case C‑176/19 P
European Commission
v
Servier SAS and Others
Judgment of the Court (First Chamber) of 27 June 2024
(Appeal – Competition – Pharmaceutical products – Market for perindopril – Article 101 TFEU – Agreements, decisions and concerted practices – Market sharing – Potential competition – Restriction of competition by object – Strategy to delay the market entry of generic versions of perindopril – Patent dispute settlement agreement – Patent licence agreement – Technology assignment and licence agreement – Article 102 TFEU – Relevant market – Abuse of dominant position)
Appeal – Grounds – Incorrect assessment of the facts and evidence – Inadmissibility – Review by the Court of Justice of the assessment of the facts and evidence – Possible only where the clear sense of the evidence has been distorted – Review by the Court of the legal classification given to the facts of the dispute – Whether permissible
(Art. 256(1) TFEU; Statute of the Court of Justice, Art. 58, first para.)
(see paragraphs 69-75)
Appeal – Grounds – Mere repetition of the pleas and arguments put forward before the General Court – Inadmissibility – Challenge to the interpretation or application of EU law made by the General Court – Admissibility
(Art. 256 TFEU; Statute of the Court of Justice, Art. 58, first para.; Rules of Procedure of the Court of Justice, Arts 168(1)(d) and 169(2))
(see paragraphs 77-79)
Agreements, decisions and concerted practices – Adverse effect on competition – Criteria for assessment – Characterisation of an undertaking as a potential competitor – Real and concrete possibilities of entering the market – Criteria – Firm intention and inherent ability of the undertaking to enter the relevant market – No insurmountable barrier – Assessment – Existence of patents protecting an originator medicine or one of its manufacturing processes – Characterisation of a manufacturer of generic medicines as a potential competitor of the originator manufacturer holding the patents
(Art. 101 TFEU)
(see paragraphs 91, 92, 100-103, 130-135, 425, 427-440)
Agreements, decisions and concerted practices – Adverse effect on competition – Patent dispute settlement agreement and patent licence agreement – Agreements concluded between a manufacturer of originator medicines and a manufacturer of generic medicines – Agreements containing clauses under which the generic manufacturer undertakes not to challenge patents and not to market products in certain markets – Characterisation as a restriction by object – Criteria – Degree of harm of the agreements to competition in the market concerned – Assessment in the light of the content, origin and legal and economic context of the agreements concerned – Need to examine the effects of the anticompetitive conduct on competition – None – Undertakings involved which acted without having an intention to prevent, restrict or distort competition – Facts which are not decisive
(Art. 101(1) TFEU)
(see paragraphs 93-96, 104-108, 174-184, 196-200, 223-226, 236-244)
Agreements, decisions and concerted practices – Adverse effect on competition – Criteria for assessment – Anticompetitive object – Market-sharing agreements – Infringement by object – Absence of a hermetic division of the markets – Irrelevant
(Art. 101(1) TFEU)
(see paragraphs 97, 215-219)
Appeal – Grounds – Criticism of grounds which have an effect on the operative part of the judgment under appeal – Effective ground of appeal
(Art. 256(1) TFEU; Statute of the Court of Justice, Art. 58, first para.)
(see paragraphs 111-120)
Appeal – Grounds – Incorrect assessment of the facts and evidence – Inadmissibility – Review by the Court of Justice of the assessment of the facts and evidence – Possible only where the clear sense of the evidence has been distorted – Ground of appeal alleging distortion of the clear sense of the evidence – Evidence construed by the General Court in a manner manifestly at odds with its wording
(Art. 256(1) TFEU; Statute of the Court of Justice, Art. 58, first para.)
(see paragraphs 145-154, 230-232)
Competition – Administrative procedure – Commission decision finding an infringement – Means of proof – Reliance on a body of evidence – Degree of evidential value necessary as regards items of evidence viewed in isolation – Permissibility of an overall assessment of a body of evidence – Content of anticompetitive agreements available to the Commission – Irrelevant
(Art. 101(1) TFEU)
(see paragraphs 271-276)
Agreements, decisions and concerted practices – Adverse effect on competition – Criteria for assessment – Distinction between restrictions by object and by effect – Restriction by object – Sufficient degree of harmfulness – Assessment – Pro-competitive effects on markets not falling within the geographical scope of the infringement irrelevant
(Art. 101(1) TFEU)
(see paragraphs 288-290, 452, 453, 489)
Agreements, decisions and concerted practices – Adverse effect on competition – Criteria for assessment – Distinction between restrictions by object and by effect – Restriction by effect – Examination of the operation of competition in the absence of the agreement at issue – Taking account of actual and potential competition – Patent dispute settlement agreement between an originator company and a generic undertaking – Requirement for the Commission to establish the possible competitive situation on the markets for the product concerned without the settlement agreement – Establishment of a counterfactual scenario which is realistic and credible – Need for a time reference point which is identical for the observed situation and the counterfactual scenario – Counterfactual scenario which cannot be based on events subsequent to the date of conclusion of the agreement – Counterfactual scenario which must establish the realistic possibilities with respect to the conduct of the generic undertaking
(Art. 101(1) TFEU)
(see paragraphs 338-356, 482-486)
Dominant position – Relevant market – Delimitation – Criteria – Medicinal products – Interchangeability – Criteria for assessment – Elasticity of demand for the pharmaceutical product in relation to changes in the prices of other products intended for the same therapeutic indication
(Art. 102 TFEU)
(see paragraphs 381-390)
Appeal – Appeal upheld – Judgment to be given on the substance by the appeal court – Condition – Whether the state of the proceedings permits final judgment to be given – State of the proceedings does not permit final judgment to be given – Referral of the case back to the General Court – Obligation to refer the case back to a Chamber with a different composition – None
(Art. 256(1) TFEU; Statute of the Court of Justice, Art. 58, first para.; Rules of Procedure of the General Court, Art. 216(1))
(see paragraph 417)
Agreements, decisions and concerted practices – Adverse effect on competition – Patent dispute settlement agreement and patent licence agreement – Agreements concluded between a manufacturer of originator medicines and a manufacturer of generic medicines – Agreements containing clauses under which the generic manufacturer undertakes not to challenge patents and not to market products in certain markets – Consideration consisting in the grant of a licence authorising the generic manufacturer to market the medicinal product in question on its core markets – Characterisation of market-sharing agreements restricting competition by object – Criteria – Inducive effect of the grant of the licence to the generic manufacturer on its decision not to market its product on the markets reserved for the originator manufacturer
(Art. 101(1) TFEU)
(see paragraphs 447-473)
Résumé
The Court of Justice upholds the appeals brought by the European Commission against two judgments of the General Court (
1
) which annulled in part the decision by which the Commission found the existence of agreements and an abuse of a dominant position on the market for the pharmaceutical product perindopril and imposed fines on the manufacturers of medicines involved. (
2
) In so doing, the Court of Justice clarifies the dividing line between legitimate action by manufacturers of medicines which consists in settling actual patent disputes in the pharmaceutical sector, on the one hand, and agreements which unlawfully share the market for a pharmaceutical product under the guise of a patent dispute settlement agreement, on the other.
The Servier pharmaceutical group, the parent company of which, Servier SAS, is established in France (individually or jointly, ‘Servier’), developed perindopril, a medicinal product in the class of angiotensin-converting enzyme inhibitors, used in cardiovascular medicine and primarily intended for the treatment of hypertension and heart failure. The perindopril compound patent, filed with the European Patent Office (EPO) in 1981, expired during the 2000s.
The active pharmaceutical ingredient of perindopril takes the form of a salt, which is erbumine. In 1988, Servier filed a number of patents with the EPO relating to processes for the manufacture of that active ingredient, with an expiry date of 16 September 2008.
A new patent relating to perindopril and the process for its manufacture was filed with the EPO by Servier in 2001 and was granted in 2004 (‘the 947 patent’). Servier also obtained national patents relating to the 947 patent in several Member States before they were parties to the Convention on the Grant of European Patents.
As from 2003, a number of disputes arose between Servier and manufacturers of generic medicines which were preparing to market a generic version of perindopril. In that context, 10 generic manufacturers filed opposition proceedings against the 947 patent before the EPO; the EPO Technical Board of Appeal revoked the contested patent in May 2009. Several manufacturers of generic medicines have also challenged the validity of the 947 patent before certain national courts. Servier, for its part, has brought infringement actions and applications for interim injunctions against the manufacturers of generic medicines in question, including the Slovenian company KRKA, tovarna zdravil, d.d. (‘Krka’).
In order to bring those disputes to an end, Servier concluded, between 2005 and 2007, settlement agreements with several generic manufacturers. With Krka, Servier thus concluded a settlement agreement covering the 947 patent and the equivalent national patents, a licence agreement and an assignment and licence agreement (‘the Krka agreements’). Those agreements covered all the States that were members of the European Union at the material time, as well as non-members of the European Union constituting Krka’s core markets.
According to the Commission, Servier and Krka concluded those agreements with the unlawful aim of dividing the territory of the countries covered into two spheres of influence, comprising, for each of them, their core markets, within which they could operate in the assurance, in the case of Servier, that it would not be subject to competitive pressure from Krka beyond the limits resulting from those agreements and, in the case of Krka, that it would not run the risk of being sued for infringement by Servier.
By decision of 9 July 2014, (
3
) the Commission found that the agreements concluded by Servier with Krka and the other generic manufacturers constituted restrictions of competition prohibited by Article 101 TFEU. It also considered that Servier had infringed Article 102 TFEU by drawing up and implementing an exclusionary strategy covering the market for perindopril and the technology market relating to the active ingredient of that medicinal product in France, the Netherlands, Poland and the United Kingdom.
Thus, the Commission imposed on Servier fines totalling EUR 289727200 for the infringements of Article 101 TFEU, including EUR 37661800 for its participation in the Krka agreements, and a fine of EUR 41270000 for the infringement of Article 102 TFEU. Krka, for its part, was fined EUR 10 million for having infringed Article 101 TFEU.
Hearing actions brought by Servier and Krka, the General Court found that the Commission had erred in law in characterising the Krka agreements as an infringement of Article 101(1) TFEU without having established the existence of a restriction of competition by object or by effect. As regards the infringement of Article 102 TFEU of which Servier was accused, the General Court considered that the Commission’s definition of the perindopril market was vitiated by errors of assessment such as to invalidate its findings relating to Servier’s dominant position on the relevant market.
Consequently, by two judgments delivered on 12 December 2018, (
4
) the General Court annulled the decision at issue in so far as it finds an infringement of Article 101 TFEU in relation to the Krka agreements and an infringement of Article 102 TFEU, and cancelled the fines imposed respectively on Servier and Krka in respect of those infringements.
The Commission brought two appeals before the Court of Justice against those judgments of the General Court.
Findings of the Court
The infringement of Article 101 TFEU
A. Existence of potential competition between Servier and Krka
The Court of Justice examines, in the first place, the Commission’s complaints alleging that the General Court erred in its interpretation and application of the concept of potential competition.
As a preliminary point, the Court notes that, for the purposes of the examination under Article 101(1) TFEU of collusive practices in the form of horizontal cooperation agreements between undertakings, such as the Krka agreements, it must be determined, at an initial stage, whether those practices may be classified as a restriction of competition by undertakings that are in competition with each other, even if only potentially. If that is the case, it is necessary to ascertain, at a second stage, whether, in the light of their economic characteristics, those practices fall within the characterisation of a restriction of competition by object. Where the anticompetitive object of those practices is not established, it is necessary to examine their effects.
That clarification having been made, the Court of Justice finds the complaints alleging errors in the interpretation and application of the concept of potential competition to be effective, since the General Court had examined several recitals of the decision at issue relating to the issue of potential competition between Krka and Servier, as well as certain complaints put forward in that regard by Servier.
As regards the substance, the Court of Justice finds that, by holding that, at the time the Krka settlement and licence agreements were concluded, there were consistent indications capable of leading Servier and Krka to believe that the 947 patent was valid, the General Court inferred from those indications that competition between those undertakings on the national markets within the European Union was now precluded and that there was therefore no potential competition between them.
In order to reach such a conclusion as to the absence of potential competition, the General Court should have ascertained whether the Commission had failed to establish that, on the date on which the Krka agreements were concluded, there were real and concrete possibilities for Krka to enter the relevant market and compete with Servier, in view of sufficient preparatory steps and the absence of insurmountable barriers to that entry.
However, instead of carrying out the necessary verifications on that point, the General Court merely stated that Servier and Krka were convinced that the 947 patent was valid and that Krka’s conduct consisting in maintaining competitive pressure on Servier could be explained by Krka’s desire to strengthen its position in potential negotiations with a view to reaching a settlement agreement accompanied by a licence agreement. In so doing, the General Court was mistaken as to the legal relevance of the patent situation found to exist on the markets in question, as well as of the parties’ intentions. It also failed to state the reasons for its implicit finding that Servier and Krka were no longer potential competitors, despite the evidence in the decision at issue aimed at demonstrating the contrary.
Furthermore, the Court of Justice points out that, in its examination of the context in which the Krka settlement and licence agreements were concluded, the General Court not only distorted the clear and precise terms of a decision of a United Kingdom court concerning a counterclaim for annulment of the 947 patent brought by Krka, but also the meaning and scope of the decision at issue as regards the effects of a decision of the EPO Opposition Division, which had validated that patent.
Thus, the Court of Justice upholds the Commission’s complaints alleging that the General Court erred in its interpretation and application of the concept of potential competition.
B. Characterisation of the Krka agreements as restrictions of competition by object
In the second place, the Court of Justice finds that the General Court erred in law in concluding that there was no restriction of competition by object.
In the judgments under appeal, the General Court held that, where there is a genuine dispute relating to a patent, an agreement settling that dispute containing competition-restricting clauses and which is linked to a licence agreement concerning that patent can be characterised as a restriction of competition by object only if the Commission can demonstrate that that licence agreement does not constitute a transaction concluded at arm’s length and thus masks a reverse payment.
However, according to the Court, that reasoning disregards the very nature of the agreements at issue, which consist not in a simple patent dispute settlement agreement in return for a reverse payment, but in an agreement to divide markets into two areas, one of which does not, moreover, fall within the scope of the infringement of Article 101 TFEU.
That error of law led the General Court to verify the characterisation of the unlawful practice attributed to Servier and Krka as a restriction of competition by object by analysing the form and legal characteristics of the agreements intended to implement that practice, whereas it was incumbent on that court to assess the degree of economic harm of those agreements by carrying out a detailed analysis of their characteristics, their objectives and the economic and legal context of which they form part.
Furthermore, in holding that, since the Krka settlement and licence agreements had not reserved a part of the market for Krka, it could not be concluded that there was market-sharing, the General Court also erred in its interpretation of Article 101(1)(c) TFEU, since the prohibition of agreements which share markets, laid down in that provision, is not limited to agreements establishing a ‘hermetic’ division between the markets.
In addition, the General Court made another error of law by introducing, in its reasoning relating to the absence of a restriction of competition by object, considerations relating to the allegedly hypothetical nature of the potential effects of the agreements at issue, whereas there is no need to investigate or, a fortiori, to demonstrate the effects on competition of practices classified as restrictions of competition by object, including in the context of any examination of whether the relevant conduct reveals the degree of harm required in order to be characterised as such.
Similarly, by criticising the Commission for failing to demonstrate, in essence, that either Servier or Krka intended to restrict competition between them, although no such demonstration was required in order to establish the existence of a restriction of competition by object, the General Court also erred in law.
Moreover, the General Court infringed the principle that evidence may be freely adduced by holding that there is a distinction in law, as regards the taking into account of fragmentary and sparse evidence in order to establish the existence of an infringement, between situations in which the content of anticompetitive agreements, as in the present case, is available to the Commission and those in which that content is not available to it. Next, the General Court made a further error of law by holding that inferences drawn from partial extracts of emails or other documents purporting to establish the intentions of the parties cannot easily call into question a finding based on the actual content of the agreements at issue.
Lastly, the Court of Justice recalls that the possibility that a patent licence may have pro-competitive effects in certain geographical markets is entirely irrelevant for the purpose of assessing whether it should be characterised as a restriction of competition by object under Article 101(1) TFEU. By taking into account the positive effects of the Krka licence agreement in Krka’s core markets, the General Court therefore erred in its interpretation and application of Article 101(1) TFEU, especially since Krka’s core markets do not fall within the geographical scope of the infringement of Article 101 TFEU.
In the light of the errors referred to above, the Court of Justice concludes that the General Court’s reasoning relating to the absence of a restriction of competition by object brought about by the Krka agreements is, in its entirety, vitiated by illegality.
C. Characterisation of the Krka agreements as a restriction of competition by effect
In the third place, the Court of Justice criticises the General Court’s conclusion that the Commission had not established that the Krka agreements had had the effect of restricting competition, since the Commission had failed to prove that, in the absence of the agreements at issue, Krka would probably have entered Servier’s core markets.
In that regard, the Court recalls that, in order to assess the existence of anticompetitive effects caused by an agreement between undertakings, it is necessary to compare the competitive situation resulting from that agreement and the situation that would exist in its absence. That ‘counterfactual’ method requires taking into consideration the actual context in which that agreement is situated. Thus, the counterfactual scenario, envisaged on the basis of the absence of that agreement, must be realistic and credible.
In the light of that clarification, the Court of Justice holds that the General Court misconstrued, in three main respects, the characteristics of the counterfactual method for the purpose of applying Article 101 TFEU.
First, the General Court held that the assessment of the anticompetitive effects of the Krka settlement agreement was based on a hypothetical approach and an incomplete examination of those effects, since the Commission had not included in the counterfactual scenario the actual course of events subsequent to that agreement. However, that reasoning of the General Court disregards the fact that the counterfactual scenario which, by definition, is hypothetical, in the sense that it has not materialised, cannot be based on matters subsequent to the conclusion of that agreement.
Second, the General Court erred in holding that the case-law according to which an agreement between undertakings may be characterised as a restriction of competition by effect by reason of its potential effects ceases to be applicable once that agreement has been implemented, on the ground that the actual effects of that agreement on competition can be observed. Where, as in the present case, an agreement leads not to a change but, on the contrary, to keeping unchanged the number or the conduct of competing undertakings already present within a market, a mere comparison between the situations found to exist on that market before and after the implementation of that agreement would be insufficient to support the conclusion that there has been no anticompetitive effect, since the anticompetitive effect arises from the certain disappearance, as a result of that agreement, of a source of competition which, at the time that agreement is concluded, remains potential.
Third, it follows from the case-law that, when it establishes the counterfactual scenario for the purpose of examining a patent dispute settlement agreement between a manufacturer of originator medicines and a manufacturer of generic medicines, the Commission is not required to make a definitive finding in relation to the chances of success of the manufacturer of generic medicines in the patent dispute or to the probability of the conclusion of a less restrictive agreement. It follows that the General Court erred in its interpretation and application of Article 101(1) TFEU by holding that the Commission had failed to prove that, in the absence of the settlement agreement, Krka would probably have entered the relevant markets and that the continuation of the litigation challenging the validity of the 947 patent would probably, or even plausibly, have allowed a faster or more complete invalidation of that patent.
The Court of Justice concludes that the errors of law thus identified vitiate with illegality the entirety of the General Court’s reasoning rejecting the characterisation of the Krka agreements as a restriction of competition by effect.
The infringement of Article 102 TFEU
In the fourth place, the Court of Justice rejects the General Court’s conclusion that the definition of the relevant product market adopted by the Commission for the purposes of its examination of the existence of an abuse of a dominant position by Servier was vitiated by errors such as to invalidate that examination. In that regard, the General Court had found, inter alia, that the Commission wrongly limited the relevant market to perindopril alone, to the exclusion of other medicinal products in the class of angiotensin-converting enzyme inhibitors (‘the ACE medicinal products’).
On that point, the Court recalls that the definition of the relevant market, which is a prerequisite for the assessment of a possible dominant position within the meaning of Article 102 TFEU, involves defining, first, the product market and then, second, the geographical market for the product.
It is also apparent from the case-law that the concept of the relevant market presupposes that there is a sufficient degree of interchangeability between the products or services which form part of it. As regards, more specifically, the examination of the economic substitutability between medicinal products, it must be assessed in the light of the shifts in sales between medicinal products intended for the same therapeutic indication, brought about by the changes in the relative prices of those medicinal products. A finding that there is no such substitutability reveals the existence of a distinct market, whatever the reasons for that finding.
Since the Commission concluded that there was no interchangeability between perindopril and the other ACE medicinal products in the light of the finding, not disputed by Servier, of the relative inelasticity of demand for perindopril as compared with the sharp fall in the prices of other ACE medicinal products on the markets concerned, the General Court erred in law by criticising the Commission for having limited the relevant market to perindopril alone.
Since the General Court then held that the Commission’s conclusion as to Servier’s dominant position on the technology market relating to the active ingredient of perindopril was based on an incorrect definition of the relevant market, the Court of Justice holds that those findings of the General Court are based on an incorrect premiss and, therefore, are also vitiated by illegality.
Since the Commission’s grounds of appeal relating to the abovementioned errors have been upheld, the Court sets aside the judgments under appeal in part.
The actions for annulment brought by Servier and Krka
The Court of Justice considers, in the fifth place, that the state of the proceedings permits final judgment to be given concerning the pleas in law put forward by Servier and Krka before the General Court in order to challenge the characterisation, in the decision at issue, of the Krka settlement and licence agreements as a restriction of competition by object and the characterisation of the Krka settlement agreement and the Krka assignment and licence agreement as a restriction of competition by effect.
As regards, first, the characterisation of the Krka settlement and licence agreements as a restriction of competition by object, the Court ascertains, at an initial stage, whether the Commission was entitled to characterise those agreements as a restriction of potential competition exerted by Krka on Servier. To that end, it examines whether, on the date on which those agreements were concluded, there were real and concrete possibilities for Krka to enter the perindopril market and compete with Servier.
In that respect, the Court emphasises that the existence of a patent which protects the manufacturing process of an active ingredient that is in the public domain cannot, as such, be regarded as an insurmountable barrier to the market entry of generic medicines based on that active ingredient. It follows that the existence of such a patent does not mean that a manufacturer of generic medicines which has in fact a firm intention and an inherent ability to enter the market, and which, by the steps taken, shows a readiness to challenge the validity of that patent and to take the risk, upon entering the market, of being subject to infringement proceedings brought by the patent holder, cannot be characterised as a potential competitor of the manufacturer of the originator medicine concerned.
As regards Krka’s firm intention to continue its efforts to market its perindopril despite the legal defeats it had suffered in 2006 in patent disputes between it and Servier, the Court observes that it is apparent from the evidence cited by the Commission in the decision at issue that Krka had not ceased its efforts to enter Servier’s core markets.
Nor, moreover, is the fact that Krka negotiated with Servier with the aim of concluding the Krka settlement and licence agreements sufficient to demonstrate that Krka no longer had the firm intention to compete with Servier.
In view of the foregoing, the Court concludes that Krka was a potential competitor of Servier at the time of the conclusion of the Krka settlement and licence agreements.
At a second stage, the Court determines whether the Commission was wrong to consider that the object of the Krka settlement and licence agreements was to share the perindopril markets.
In that regard, it states that the fact that patent dispute settlement agreements, like licence agreements associated with such agreements, may be concluded in pursuit of an objective which may be legitimate cannot exclude them from the application of Article 101 TFEU if it is established that those agreements have the aim of restricting competition. In the present case, it is also clear from the wording of the Krka settlement and licence agreements and the circumstances surrounding their conclusion that they are economically connected and cannot be examined separately.
The combined effect of the Krka licence agreement, by which Servier decided not to oppose the marketing by Krka of a generic version of perindopril on Krka’s core markets, and of the settlement agreement, which provides for a non-infringement obligation on the part of Krka with respect to Servier’s core markets, amounts, from an economic point of view, to a quid pro quo, enabling Servier and Krka to maintain a more favourable position on their respective core markets. A set of agreements of that sort entails, in principle, a sharing of those markets and, therefore, a restriction of competition by object, which cannot be put in context or offset by any positive or pro-competitive effects on any market whatsoever.
In the light of those factors, the Court holds that the evidence put forward in the decision at issue demonstrates the existence of a practice aimed, for Servier and Krka, at sharing the perindopril market by means of the Krka settlement and licence agreements, and is sufficient to justify the characterisation of that practice as a restriction of competition by object.
As regards, second, the characterisation of the Krka settlement agreement and the Krka assignment and licence agreement as a restriction of competition by effect, the Court recalls that it was for the Commission to compare the competitive situation resulting from those agreements with the competitive situation resulting from a realistic and credible counterfactual scenario. In so far as, in the present case, the restriction of competition at issue related to the elimination of the source of potential competition exerted by Krka on Servier, the analysis of the counterfactual scenario corresponded, in essence, to the analysis of the existence of that potential competition.
In the light of those clarifications, the Court finds that the Commission was entitled to consider that Krka represented one of the most immediate threats for Servier, on account of the fact that it had real and concrete possibilities of entering the markets in France, the Netherlands and the United Kingdom. In the absence of the Krka agreements, that possibility of entry by Krka, by means of its perindopril, would not have been eliminated. Consequently, the Commission established that the elimination, through the implementation of those agreements, of that source of potential competition had the effect of appreciably restricting competition. That effect, which is neither hypothetical nor potential, but real, is such as to justify the characterisation as a restriction of competition by effect adopted in the decision at issue.
After thus ruling on certain pleas in law put forward by Servier and Krka before the General Court, the Court of Justice finds that the state of the proceedings does not, however, permit final judgment to be given in its entirety. Therefore, it refers the case back to the General Court for it to rule on the characterisation of the Krka assignment and licence agreement as a restriction of competition by object, and, in Commission v Servier and Others (C‑176/19 P), on the remaining pleas relating to the infringement of Article 102 TFEU and on the pleas put forward in the alternative seeking to challenge the amount of the fine.
(
1
)	Judgments of 12 December 2018, Servier and Others v Commission (T‑691/14, EU:T:2018:922), and Krka v Commission (T‑684/14, EU:T:2018:918) (together, ‘the judgments under appeal’).
(
2
)	Commission Decision C(2014) 4955 final of 9 July 2014 relating to a proceeding under Article 101 and Article 102 [TFEU] (Case AT.39612 – Perindopril (Servier)) (‘the decision at issue’).
(
3
)	See footnote 2.
(
4
)	See footnote 1.