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62019CJ0151-67	67 As regards the first stage of that analysis, the Court has already held that, in the specific context of the opening of the market for a medicinal product to the manufacturers of generic medicines, it is necessary to determine, in order to assess whether one of those manufacturers, although absent from a market, is ...	67 As regards the first stage of that analysis, the Court has already held that, in the specific context of the opening of the market for a medicinal product to the manufacturers of generic medicines, it is necessary to determine, in order to assess whether one of those manufacturers, although absent from a market, is ...
62019CJ0151-68	68 Thus, it is necessary to assess, first, whether, at the time those agreements were concluded, the manufacturer of generic medicines had taken sufficient preparatory steps to enable it to enter the market concerned within such a period of time as would impose competitive pressure on the manufacturer of originator med...	68 Thus, it is necessary to assess, first, whether, at the time those agreements were concluded, the manufacturer of generic medicines had taken sufficient preparatory steps to enable it to enter the market concerned within such a period of time as would impose competitive pressure on the manufacturer of originator med...
62019CJ0151-69	69 The Court has already held that any patents protecting an originator medicine or one of its manufacturing processes are indisputably part of the economic and legal context characterising the relationships of competition between the holders of those patents and the manufacturers of generic medicines. However, the ass...	69 The Court has already held that any patents protecting an originator medicine or one of its manufacturing processes are indisputably part of the economic and legal context characterising the relationships of competition between the holders of those patents and the manufacturers of generic medicines. However, the ass...
62019CJ0151-70	70 Furthermore, a finding of potential competition between a manufacturer of generic medicines and a manufacturer of originator medicines can be confirmed by additional factors, such as the conclusion of an agreement between them when the manufacturer of generic medicines was not present on the market concerned, or the...	70 Furthermore, a finding of potential competition between a manufacturer of generic medicines and a manufacturer of originator medicines can be confirmed by additional factors, such as the conclusion of an agreement between them when the manufacturer of generic medicines was not present on the market concerned, or the...
62019CJ0151-71	71 At a second stage of that analysis, in order to determine whether a delay in the market entry of generic medicines, as the result of a patent dispute settlement agreement, in exchange for transfers of value by the manufacturer of originator medicines to the manufacturer of those generic medicines must be regarded as...	71 At a second stage of that analysis, in order to determine whether a delay in the market entry of generic medicines, as the result of a patent dispute settlement agreement, in exchange for transfers of value by the manufacturer of originator medicines to the manufacturer of those generic medicines must be regarded as...
62019CJ0151-72	72 In that regard, it must be borne in mind that challenges to the validity and scope of a patent are part of normal competition in the sectors where there exist exclusive rights in relation to technology, so that settlement agreements whereby a manufacturer of generic medicines that is seeking to enter a market recogn...	72 In that regard, it must be borne in mind that challenges to the validity and scope of a patent are part of normal competition in the sectors where there exist exclusive rights in relation to technology, so that settlement agreements whereby a manufacturer of generic medicines that is seeking to enter a market recogn...
62019CJ0151-82	82 In that regard, it should be recalled that it is apparent from Article 256(1) TFEU and the first paragraph of Article 58 of the Statute of the Court of Justice of the European Union that an appeal is to be limited to points of law and that the General Court therefore has sole jurisdiction to find and appraise the re...	82 In that regard, it should be recalled that it is apparent from and the first paragraph of of the Statute of the Court of Justice of the European Union that an appeal is to be limited to points of law and that the General Court therefore has sole jurisdiction to find and appraise the relevant facts and evidence. The ...
62019CJ0151-83	83 However, where the General Court has found or appraised the facts, the Court of Justice has jurisdiction to carry out a review, provided that the General Court has defined their legal nature and determined the legal consequences. The jurisdiction of the Court of Justice to review extends, inter alia, to the question...	83 However, where the General Court has found or appraised the facts, the Court of Justice has jurisdiction to carry out a review, provided that the General Court has defined their legal nature and determined the legal consequences. The jurisdiction of the Court of Justice to review extends, inter alia, to the question...
62019CJ0164-105	105 The Court of Justice has already held that challenges to the validity and scope of a patent are part of normal competition in the sectors where there exist exclusive rights in relation to technology, so that settlement agreements whereby a manufacturer of generic medicines that is seeking to enter a market recognis...	105 The Court of Justice has already held that challenges to the validity and scope of a patent are part of normal competition in the sectors where there exist exclusive rights in relation to technology, so that settlement agreements whereby a manufacturer of generic medicines that is seeking to enter a market recognis...
62019CJ0164-108	108 As regards the criticism levelled against the criteria that the General Court used to characterise an agreement between undertakings as a restriction of competition by object, it must be found that, as the General Court held, in essence, in paragraphs 263 and 264 of the judgment under appeal, the presence of non-ch...	108 As regards the criticism levelled against the criteria that the General Court used to characterise an agreement between undertakings as a restriction of competition by object, it must be found that, as the General Court held, in essence, in of the judgment under appeal, the presence of non-challenge and non-marketi...
62019CJ0164-109	109 It should be noted in that respect that, if it is to be subject to the prohibition in principle laid down in Article 101(1) TFEU, a collusive practice must have as its ‘object or effect’ the prevention, restriction or distortion to an appreciable extent of competition within the internal market. It follows that tha...	109 It should be noted in that respect that, if it is to be subject to the prohibition in principle laid down in a collusive practice must have as its ‘object or effect’ the prevention, restriction or distortion to an appreciable extent of competition within the internal market. It follows that that provision, as inter...
62019CJ0164-110	110 Accordingly, as regards practices characterised as restrictions of competition by object, there is no need to investigate nor, a fortiori, to demonstrate, their effects on competition, in so far as experience shows that such behaviour leads to falls in production and price increases, resulting in poor allocation of...	110 Accordingly, as regards practices characterised as restrictions of competition by object, there is no need to investigate nor, a fortiori, to demonstrate, their effects on competition, in so far as experience shows that such behaviour leads to falls in production and price increases, resulting in poor allocation of...
62019CJ0164-111	111 On the other hand, where the anticompetitive object of an agreement, a decision by an association of undertakings or a concerted practice is not established, it is necessary to examine its effects in order to prove that competition has in fact been prevented or restricted or distorted to an appreciable extent (see,...	111 On the other hand, where the anticompetitive object of an agreement, a decision by an association of undertakings or a concerted practice is not established, it is necessary to examine its effects in order to prove that competition has in fact been prevented or restricted or distorted to an appreciable extent (see,...
62019CJ0164-112	112 That distinction arises from the fact that certain forms of collusion between undertakings can be regarded, by their very nature, as being injurious to the proper functioning of normal competition (judgments of 20 November 2008, Beef Industry Development Society and Barry Brothers , C‑209/07, EU:C:2008:643, paragra...	112 That distinction arises from the fact that certain forms of collusion between undertakings can be regarded, by their very nature, as being injurious to the proper functioning of normal competition (judgments of and and of and Others ).
62019CJ0164-113	113 As Niche asserts, the concept of a restriction of competition by object must be interpreted strictly and can be applied only to certain agreements between undertakings which reveal, in themselves and having regard to the content of their provisions, their objectives, and the economic and legal context of which they...	113 As asserts, the concept of a restriction of competition by object must be interpreted strictly and can be applied only to certain agreements between undertakings which reveal, in themselves and having regard to the content of their provisions, their objectives, and the economic and legal context of which they form ...
62019CJ0164-116	116 Accordingly, the assessment of the degree of economic harm of an agreement to the proper functioning of competition in the market concerned must be based on objective considerations, where necessary as a result of a detailed analysis of the agreement at issue, its objectives and the economic and legal context of wh...	116 Accordingly, the assessment of the degree of economic harm of an agreement to the proper functioning of competition in the market concerned must be based on objective considerations, where necessary as a result of a detailed analysis of the agreement at issue, its objectives and the economic and legal context of wh...
62019CJ0164-117	117 In that context, it should also be noted that a manufacturer of generic medicines, after assessing its chances of success in the court proceedings between it and the manufacturer of the originator medicine concerned, may decide to abandon entry to the market concerned and to conclude with the latter an agreement in...	117 In that context, it should also be noted that a manufacturer of generic medicines, after assessing its chances of success in the court proceedings between it and the manufacturer of the originator medicine concerned, may decide to abandon entry to the market concerned and to conclude with the latter an agreement in...
62019CJ0164-118	118 Consequently, wherever an agreement to settle a dispute relating to the validity of a patent, between a manufacturer of generic medicines and a manufacturer of originator medicines that holds that patent, involves transfers of value from the manufacturer of originator medicines to the manufacturer of generic medici...	118 Consequently, wherever an agreement to settle a dispute relating to the validity of a patent, between a manufacturer of generic medicines and a manufacturer of originator medicines that holds that patent, involves transfers of value from the manufacturer of originator medicines to the manufacturer of generic medici...
62019CJ0164-120	120 At the second stage, if that net gain from the transfers is not fully justified by such a need, it must be ascertained whether, in the absence of such justification, those transfers can have no explanation other than the commercial interest of those manufacturers of medicines not to engage in competition on the mer...	120 At the second stage, if that net gain from the transfers is not fully justified by such a need, it must be ascertained whether, in the absence of such justification, those transfers can have no explanation other than the commercial interest of those manufacturers of medicines not to engage in competition on the mer...
62019CJ0164-134	134 Furthermore, it can be seen from that case-law that the General Court’s duty to state reasons does not require it to provide an account which follows exhaustively and one by one all the arguments put forward by the parties to the case, and that the General Court’s reasoning may therefore be implicit, on condition t...	134 Furthermore, it can be seen from that case-law that the General Court’s duty to state reasons does not require it to provide an account which follows exhaustively and one by one all the arguments put forward by the parties to the case, and that the General Court’s reasoning may therefore be implicit, on condition t...
62019CJ0164-151	151 It should be recalled that, if a given operation or activity is not covered by the prohibition rule laid down in Article 101(1) TFEU, owing to its neutrality, in the sense that it does not involve any restriction of competition, an ancillary restriction of the commercial autonomy of one or more of the participants ...	151 It should be recalled that, if a given operation or activity is not covered by the prohibition rule laid down in owing to its neutrality, in the sense that it does not involve any restriction of competition, an ancillary restriction of the commercial autonomy of one or more of the participants in that operation or ...
62019CJ0164-152	152 Where it is not possible to dissociate such an ancillary restriction from the main operation or activity without jeopardising its existence and aims, it is necessary to examine the compatibility of that restriction with Article 101 TFEU in conjunction with the compatibility of the main operation or activity to whic...	152 Where it is not possible to dissociate such an ancillary restriction from the main operation or activity without jeopardising its existence and aims, it is necessary to examine the compatibility of that restriction with in conjunction with the compatibility of the main operation or activity to which it is ancillary...
62019CJ0164-157	157 By a first argument, Niche submits that the General Court misinterpreted the provisions of the Niche agreement. However, the interpretation of a term of a contract by the General Court constitutes a question of fact which, unless there is distortion, cannot be subject, as such, to review by the Court of Justice in ...	157 By a first argument, Niche submits that the General Court misinterpreted the provisions of the Niche agreement. However, the interpretation of a term of a contract by the General Court constitutes a question of fact which, unless there is distortion, cannot be subject, as such, to review by the Court of Justice in ...
62019CJ0164-159	159 In that respect, as noted in paragraph 81 of the present judgment, complaints based on findings of fact and on the assessment of those facts in the contested decision are admissible on appeal where it is claimed that the General Court has made findings which the documents in the file show to be substantially incorr...	159 In that respect, as noted in of the present judgment, complaints based on findings of fact and on the assessment of those facts in the contested decision are admissible on appeal where it is claimed that the General Court has made findings which the documents in the file show to be substantially incorrect or that i...
62019CJ0164-161	161 On the substance, as noted in paragraph 82 of the present judgment, a distortion must be obvious from the documents in the Court’s file, without there being any need to carry out a new appraisal of the facts and the evidence (judgment of 28 January 2021, Qualcomm and Qualcomm Europe v Commission , C‑466/19 P, EU:C:...	161 On the substance, as noted in of the present judgment, a distortion must be obvious from the documents in the Court’s file, without there being any need to carry out a new appraisal of the facts and the evidence (judgment of . Although such a distortion may consist in an interpretation of a document that is at odds...
62019CJ0164-184	184 The applicability of the exemption provided for in Article 101(3) TFEU is subject to the satisfaction of four cumulative requirements laid down in that provision. Those requirements are, first, that the arrangement concerned must contribute to improving the production or distribution of the goods or services in que...	184 The applicability of the exemption provided for in is subject to the satisfaction of four cumulative requirements laid down in that provision. Those requirements are, first, that the arrangement concerned must contribute to improving the production or distribution of the goods or services in question, or to promoti...
62019CJ0164-198	198 In relation to proceedings concerning the application of Article 101 TFEU, the Court has already held that the privileged nature of correspondence between lawyers and their clients is among the rights of the defence that must be respected at the preliminary inquiry stage (see, to that effect, judgments of 18 May 19...	198 In relation to proceedings concerning the application of the Court has already held that the privileged nature of correspondence between lawyers and their clients is among the rights of the defence that must be respected at the preliminary inquiry stage (see, to that effect, judgments of and of and the case-law cit...
62019CJ0164-199	199 Furthermore, as the General Court pointed out in paragraph 61 of the judgment under appeal, it is apparent from the case-law of the Court of Justice that, if the holder of evidence obtained by the Commission decides, in full knowledge of his or her rights, not to object to its use by the Commission despite being ab...	199 Furthermore, as the General Court pointed out in of the judgment under appeal, it is apparent from the case-law of the Court of Justice that, if the holder of evidence obtained by the Commission decides, in full knowledge of his or her rights, not to object to its use by the Commission despite being able to do so, ...
62019CJ0164-200	200 It should also be recalled that Article 48(2) of the Charter of Fundamental Rights of the European Union (‘the Charter’), according to which respect for the rights of the defence of anyone who has been charged is guaranteed, corresponds to Article 6(3) of the Convention for the Protection of Human Rights and Fundam...	200 It should also be recalled that of the (‘the Charter’), according to which respect for the rights of the defence of anyone who has been charged is guaranteed, corresponds to of the signed at on (‘the ’). According to of the Charter, which is intended to ensure the necessary consistency between the rights contained ...
62019CJ0164-41	41 Since the application of Article 101(1) TFEU presupposes, inter alia, coordination between undertakings that are in competition with each other, if not in reality, then at least potentially (see, to that effect, judgment of 30 January 2020, Generics (UK) and Others , C‑307/18, EU:C:2020:52, paragraph 32), it is appr...	41 Since the application of presupposes, inter alia, coordination between undertakings that are in competition with each other, if not in reality, then at least potentially (see, to that effect, judgment of Generics (UK) and Others ), it is appropriate to examine in the first place the fourth ground, relating to the Ge...
62019CJ0164-51	51 In order to respond to Niche’s line of argument to the effect that the General Court erred in law by finding that the Commission had been able to establish that Niche was a potential competitor of Servier, it should be recalled that, in the specific context of the opening of the market for a medicinal product to the...	51 In order to respond to ’s line of argument to the effect that the General Court erred in law by finding that the Commission had been able to establish that was a potential competitor of it should be recalled that, in the specific context of the opening of the market for a medicinal product to the manufacturers of ge...
62019CJ0164-52	52 Thus, it is necessary to assess, first, whether, at the time those agreements were concluded, the manufacturer of generic medicines had taken sufficient preparatory steps to enable it to enter the market concerned within such a period of time as would impose competitive pressure on the manufacturer of originator med...	52 Thus, it is necessary to assess, first, whether, at the time those agreements were concluded, the manufacturer of generic medicines had taken sufficient preparatory steps to enable it to enter the market concerned within such a period of time as would impose competitive pressure on the manufacturer of originator med...
62019CJ0164-53	53 In that regard, 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, and does not mean that a manufacturer of generic medicines which has in fact a firm intention and an inherent ability to e...	53 In that regard, 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, and does not mean that a manufacturer of generic medicines which has in fact a firm intention and an inherent ability to e...
62019CJ0164-55	55 The Court of Justice has already held that any patents protecting an originator medicine or one of its manufacturing processes are indisputably part of the economic and legal context characterising the relationships of competition between the holders of those patents and the manufacturers of generic medicines. Howev...	55 The Court of Justice has already held that any patents protecting an originator medicine or one of its manufacturing processes are indisputably part of the economic and legal context characterising the relationships of competition between the holders of those patents and the manufacturers of generic medicines. Howev...
62019CJ0164-56	56 Furthermore, a finding of potential competition between a manufacturer of generic medicines and a manufacturer of originator medicines can be confirmed by additional factors, such as the conclusion of an agreement between them when the manufacturer of generic medicines was not present on the market concerned, or the...	56 Furthermore, a finding of potential competition between a manufacturer of generic medicines and a manufacturer of originator medicines can be confirmed by additional factors, such as the conclusion of an agreement between them when the manufacturer of generic medicines was not present on the market concerned, or the...
62019CJ0164-65	65 In relation to the plea of inadmissibility raised by the Commission, to the effect that the line of argument developed by Niche under the second part of the fourth ground of appeal is inadmissible because it was not raised at first instance, it should be recalled that, according to Article 170 of the Rules of Proced...	65 In relation to the plea of inadmissibility raised by the Commission, to the effect that the line of argument developed by under the second part of the fourth ground of appeal is inadmissible because it was not raised at first instance, it should be recalled that, according to of the Rules of Procedure of the Court o...
62019CJ0164-69	69 On the substance, it must be borne in mind that, in EU law, the prevailing principle is that evidence may be freely adduced and that the only criterion for the purpose of assessing the evidence adduced is its credibility (judgments of 25 January 2007, Dalmine v Commission , C‑407/04 P, EU:C:2007:53, paragraphs 49 an...	69 On the substance, it must be borne in mind that, in EU law, the prevailing principle is that evidence may be freely adduced and that the only criterion for the purpose of assessing the evidence adduced is its credibility (judgments of and of .
62019CJ0164-70	70 In order to satisfy the burden of proof incumbent on it, the Commission must gather sufficiently serious, precise and consistent evidence to support the firm conviction that the alleged infringement took place (see, to that effect, judgments of 28 March 1984, Compagnie royale asturienne des mines and Rheinzink v Com...	70 In order to satisfy the burden of proof incumbent on it, the Commission must gather sufficiently serious, precise and consistent evidence to support the firm conviction that the alleged infringement took place (see, to that effect, judgments of and of ).
62019CJ0164-71	71 However, it is not necessary for every item of evidence produced by the Commission to satisfy those criteria in relation to every aspect of the infringement. It is sufficient if the body of evidence relied on by the institution, viewed as a whole, meets that requirement (see, to that effect, judgments of 15 October ...	71 However, it is not necessary for every item of evidence produced by the Commission to satisfy those criteria in relation to every aspect of the infringement. It is sufficient if the body of evidence relied on by the institution, viewed as a whole, meets that requirement (see, to that effect, judgments of P, P, P, P,...
62019CJ0164-72	72 Furthermore, according to the Court’s case-law, in matters of liability for an infringement of the competition rules, the factual evidence on which a party relies may be of such a kind as to require the other party to provide an explanation or justification, failing which it is permissible to conclude that the burde...	72 Furthermore, according to the Court’s case-law, in matters of liability for an infringement of the competition rules, the factual evidence on which a party relies may be of such a kind as to require the other party to provide an explanation or justification, failing which it is permissible to conclude that the burde...