Article 101 TFEU. To assess whether a manufacturer of generic medicines that is not present in the market is a potential competitor of a manufacturer of originator medicines when the agreement at issue has the effect of temporarily keeping an undertaking outside a market first it must be determined whether 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 medicines, secondly it must be determined that the market entry of such a manufacturer of generic medicines does not meet barriers to entry that are insurmountable, existence of a patent as such cannot be regarded as an insurmountable barrier, because validity can be challenged. The finding that a manufacturer of generic medicines has a firm intention and an inherent ability to enter the market without there being insurmountable barriers can be confirmed by additional factors: an agreement between undertakings operating at same level in production chain, some of which had no presence in the market concerned, constitutes a strong indication that a competitive relationship existed between them, intention by manufacturer of originator medicines and acted upon to make transfers of value to manufacturer of generic medicines in exchange of postponement of latter’s market entry, even though the former claims the latter is infringing one or more of its process patents, the greater the transfer of value, the stronger the indication. A settlement agreement, with regard to pending court proceedings between a manufacturer of originator medicines and a manufacturer of generic medicines, who are potential competitors, concerning whether the process patent held by that manufacturer of originator medicines is valid and whether a generic version of that medicine infringes that patent has as its object the prevention, restriction or distortion of competition: when it is clear from the analysis of the settlement agreement concerned that the transfers of value provided for by it cannot have any explanation other than the commercial interest of both parties not to engage in competition on the merits, such transfers of value may involve indirect transfers resulting from profits to be obtained from a distribution contract concluded with the manufacturer of originator medicines enabling the generic manufacturer to sell a possibly defined quota of generic medicines manufactured by the manufacturer of originator medicines. A “restriction by object” cannot be rebutted by the fact that the agreement does not exceed the period of validity of the patent the fact that there is uncertainty about the validity of the patent. There is no “restriction by object” when the settlement agreement concerned is accompanied by proven pro‑competitive effects capable of giving rise to a reasonable doubt that it causes a sufficient degree of harm to competition. If a settlement agreement is to be demonstrated to have appreciable potential or real effects on competition and therefore has to be characterized as a “restriction by effect”, that does not presuppose a finding that, in the absence of that agreement, either the manufacturer of generic medicines who is a party to that agreement would probably have been successful in the proceedings relating to the process patent at issue, or the parties to that agreement would probably have concluded a less restrictive settlement agreement. Article 102 TFEU. To define the product market in a situation where a manufacturer of originator medicines covered by a process patent, the validity of which is disputed, impedes, on the basis of that process patent, the market entry of generic versions of that medicine not only the originator version of that medicine need to be taken into account, but also its generic versions, even if the latter would not be able to enter legally the market before the expiry of that process patent, if the manufacturers concerned of generic medicines are in a position to present themselves within a short period on the market concerned with sufficient strength to constitute a serious counterbalance to the manufacturer of originator medicines already on that market, which it is for the referring court to determine. Dominant undertaking that is the holder of a process patent for the production of an active ingredient that is in the public domain, which leads it to conclude, either as a precautionary measure, or following the bringing of court proceedings challenging the validity of that patent, a set of settlement agreements which have, at the least, the effect of keeping temporarily outside the market potential competitors who manufacture generic medicines using that active ingredient, constitutes an abuse of a dominant position within the meaning of Article 102 TFEU, provided that that strategy has the capacity to restrict competition and, in particular, to have exclusionary effects, going beyond the specific anticompetitive effects of each of the settlement agreements that are part of that strategy, which it is for the referring court to determine.
National competition authorities are allowed to consider medicinal products of which the MA lays outside the treatment of the diseases at issue, but can be used for this and therefore can be regarded as substitutable with other medicinal products as products in the same market. It is for national courts to decide whether such substitutability exists. An agreement restricting the conduct of third parties, which consists in encouraging the use of another medicinal product for the treatment of the same condition, does not escape the application of that provision on the ground the arrangement cannot be considered to be ancillary and objectively necessary for the implementation of the licensing agreement. An arrangement which consists in dissemination of misleading information relating to adverse reactions with a view to reducing the competitive pressure constitutes a restriction of competition ‘by object’ under Article 101(1) TFEU. An arrangement intended to disseminate such misleading information in respect of a medicinal product cannot be regarded as indispensable under Article 101(1) TFEU and therefore cannot be exempt.
IPPT20130411, CJEU, Novartis v Apozyt
No “new placement on the market” as a result of carrying out the preparation of ready-to-use syringes based on individual prescriptions
IPPT20120906, CJEU, Kreussler v Sunstar
Pharmacological action: interaction between substance and cellular constituent within user’s body is sufficient; interaction on molecular level not necessary. Interpretation of ‘pharmacological action’ in Pharma Directive on the basis of guidance document
A product which includes in its composition a substance which has a physiological effect when used in a particular dosage is not a medicinal product by function where it constitutes a risk to health without, however, being capable of restoring, correcting or modifying physiological functions in human beings.
IPPT20090402, ECJ, Damgaard
Dissemination by a third party of information about a medicinal product, including its therapeutic or prophylactic properties, may be regarded as ad-vertising, even though the third party in question is acting on his own initiative and completely independently, of the manufacturer and the seller of such a medicinal product.
A product cannot be regarded as a medicinal product where it is incapable of appreciably restoring, correcting or modifying physiological functions. No medicinal product in case of doubt: The directive does not apply to a product in respect of which it has not been scientifically established that it is a medicinal product by function, without its being possible to exclude that possibility.
Where repackaging is necessary the packaging should be assessed only against the condition that it should not be liable to damage the reputation. It is for the parallel importer to furnish the proprietor of the trade mark with information to enable the latter to determine whether the repackaging is necessary. This information may not be used to enable the trade mark proprietor to detect weaknesses in his sales organisation.
Failure of a Member State to fulfil its obligations – Article 28 EC and Article 30 EC – Directive 2001/83/EC – Garlic preparation in capsule form – Preparation legally marketed as a food supplement in a number of Member States – Preparation classified as a medicinal product in the Member State of importation – Definition of ‘medicinal product’ – Obstacle – Justification – Public health – Proportionality.
Free movement of goods – Articles 28 EC and 30 EC – Articles 11 and 13 of the EEA Agreement – Imported medicinal products not authorised in the importing State – Prohibition of advertising – Directive 2001/83/EC.
The classification of a product as a medicinal product or as a foodstuff must take account of all the characteristics of the product, established both in the initial stage of the product and where it is mixed, in accordance with the method by which it is used, with water or with yoghurt.
Medicinal products – Marketing authorisation – Procedure relating to essentially similar products
By automatically classifying as medicinal products vitamin preparations lawfully manufactured or marketed as food supplements in the other Member States where they contain three times more vitamins, other than vitamins A and D, than the daily amount recommended by the Deutsche Gesellschaft für Ernährung (German Food Association), the Federal Republic of Germany has failed to fulfil its obligations under Article 28 EC.
Food preparations containing vitamins A, D or K or minerals in the chromate group or containing more than once the daily amount of other vitamins or minerals – Preparations lawfully marketed as food supplements in the Member State of exportation – Preparations classified as medicinal products in the Member State of importation
Free movement of goods – Medicinal products – Im-portation – Application for marketing authorisation under a simplified procedure – Common origin
The mere fact that a marketing authorisation of reference was withdrawn at the request of its holder should not entail the automatic withdrawal of the parallel import licence issued for the medicinal product in question, unless there is in fact a risk to the health of humans.
Parallel imports: If medicinal product X has the same active ingredients and therapeutic effect as medicinal product Y, but does not use the same excipients and is manufactured by a different manufacturing process, where the competent authority in Member State B is in a position to verify that medicinal product X complies with the requirements relating to quality, efficacy and safety in normal conditions of use and is in a position to ensure normal pharmacovigilance, a parallel import licence can be seeked and obtained without complying with all the requirements of the Directive.
Replacement of a trade mark: objectively necessary to replace the original trade mark by that of the importing Member State.
A medicinal product is essentially similar to an original medicinal product where it satisfies the cri-teria of having the same qualitative and quantitative composition in terms of active principles, of having the same pharmaceutical form and of being bio-equivalent, unless it is apparent in the light of scientific knowledge that it differs significantly from the original product as regards safety or efficacy.
IPPT19910416, ECJ, Upjohn v Farzoo
Definition medicinal product: a product which is not "for treating or prevent-ing disease in human beings or animals" is a medicinal product if it may be administered "with a view to [...] restoring, correcting or modifying physiological functions", and it is for the national courts to determine on a case-by-case basis the classification of each product having regard to its pharmacological properties as they may be ascer-tained in the current state of scientific knowledge, to the way in which it is used, to the extent to which it is sold and to consumers' familiarity with it. Medicinal product cannot also be a cosmetic product. Rules for medicinal products prevail
Definition medicinal product not exclusive: the fact that a product is classified as a foodstuff in another Member State cannot prevent its being classified as a medicinal product in the Member State concerned when it displays the characteristics of such a product. Hunger, heaviness in the legs, tiredness or itch-ing is are ambiguous symptoms and a reference to such states or sensations in the presentation of a product is therefore not decisive.
Definition of medicial product: product presented as having or being endowed with with properties 'for treating or preventing disease in human beings or animals. Classification of vitamins as medicinal product must be carried out case by case
Trade mark lawfully affixed to a product in a member state - repackaging by a third party and importation into another member state.
The proprietor of a trade-mark is justified in preventing a product from being marketed by a third party even if previously that product has been lawfully marketed in another member state under another mark held in the latter state by the same proprietor.
Trade-mark proprietor can prevent repackaging, unless (i) that contributes to the artificial partitioning of the markets between member states, (ii) the repackaging cannot adversely affect the original condition of the product, (iii) the proprietor receives prior notice, and (iv) it is stated on the new packaging by whom the product has been repackaged.
IPPT19765020, ECJ, De Peijper
Free movement of medicinal products: rules of practices which result in imports being channelled in such a way that only certain traders can effect these imports constitute a maesure having equivalent effect to a quantative restriction