20.500.12556/DKUM-62195 PATENTNE PORAVNAVE S POVRAČILI FARMACEVTSKIH PODJETIJ IN ČLEN 101 PDEU – KAKO RAZLIKOVATI MED ZAKONITIM IN NEZAKONITIM REŠEVANJEM SPOROV REVERSE PAYMENT PATENT SETTLEMENTS BETWEEN PHARMACEUTICAL COMPANIES AND ARTICLE 101 TFEU Diplomsko delo obravnava patentne poravnave s povračili in njihovo skladnost s členom 101 PDEU. Gre za sporazume, ki se sklepajo med originarnim in generičnim podjetjem, dvema različnima vrstama farmacevtskih podjetij, tako da generično sprejme omejitev trženja svojega zdravila, originarno pa nanj prenese določeno vrednost. Take poravnave ohranjajo visoko ceno zdravila in s tem negativno vplivajo na blaginjo potrošnikov. Po drugi strani pa lahko stranke postavljajo v boljši položaj zaradi delitve ohranjenega monopolnega dobička. Vendar obstoj obeh elementov v določeni patentni poravnavi ne pomeni avtomatične kršitve člena 101 PDEU. Ker imata oba lahko povsem zakonite pravne podlage, je potrebno analizirati vsako patentno poravnavo posebej. V diplomskem delu se osredotočamo na delo Komisije na tem področju, predvsem kar zadeva primernosti njenega pristopa in testa za presojo zakonitosti posameznih patentnih poravnav. Ugotavljamo, da je test Komisije, ki v glavnem temelji na presoji povratnega prenosa vrednosti, neprimeren za natančno razlikovanje med patentnimi poravnavami, ki omejujejo konkurenco in tistimi, ki je ne. Komisija se preveč osredotoča le na ekonomski model sklepanja patentnih poravnav s povračili in ne upošteva, da so prenosi vrednosti lahko posledica pomanjkljivosti pravnega okvirja v katerem deluje farmacevtski sektor. Poleg tega bi lahko v večji meri upoštevala, da se poravnava naša na patent, ki v kolikor je veljaven predstavlja povsem zakonito podlago za sprejeto omejitev generičnega podjetja, ob enem pa lahko izključuje obstoj potencialne konkurence med obema podjetjema. Komisija patentne poravnave sklenjene v zadevah Lundbeck in Perindopril opredeli kot sporazume, ki že po svoji naravi omejujejo konkurenco. Vendar splošen in ne popolni test ni primerna podlaga za tako strogo odločitev. To je še toliko bolj res od kar je Sodišče v zadevi Cartes Bancaires zavrnilo široko razlago kategorije omejitev po cilju, v katero se uvrščajo le najhujše in očitne kršitve prepovedi omejevanja konkurence. Patentne poravnave, tudi tiste s povračili, pa so po navadi vse prej kot to. Pojasnitev razlage s strani Sodišča bi lahko pomembno vplivala na postopanje Splošnega sodišča glede pritožb podjetij iz zadev Lundbeck in Perindopril, ki bi odločitvi Komisije glede omejevanja po cilju pri patentnih poravnavah s povračili lahko razveljavilo. Na isti rezultat pa lahko sklepamo tudi iz sodbe Vrhovnega sodišča ZDA v zadevi Actavis. This thesis deals with reverse payment patent settlements between pharmaceutical companies and their compliance with Article 101 TFEU. Reverse payment patent settlements are agreements concluded between originator and generic company, two different types of pharmarmaceutical companies, where generic agrees to limit the marketing of its medicine in exchange for originators transfer of certain value. Such settlements can keep the prices of medecines high and have a negative influence on consumer welfare. On the other side both companies can be better of by sharing monopoly profits. However, the existence ob both elements does not mean an automatic violation of Article 101 TFEU. Both can have completely legitimate legal basis, so it is necessary to analyze each patent settlement case by case. The thesis focuses on the Commission's work in this area, in particular as regards the appropriateness of presented approach and test for assessing the legality of individual patent settlements. We find the Commission's test, based primarily on the assessment of reverse transfer of value, inappropriate to accurately distinguish between patent settlements that restrict competition and those that do not. The Commission strictly focuses on the economic model of reverse payment patent settlements and consequently does not take into consideration that transfers of value can be a consequnce of shortcomings of the legal framework in which pharmaceutical sector operates. Moreover, the Commission could take better account of the fact that this are settlements of patent disputes, meaning, a valid patent represents completely legal basis for accepted restrictions and at the same time it can exclude the existence of potencial competition between the two companies. In its decision in Lundbeck and Perindopril cases, the Commission takes by object approach, definig reverse payment patent settlements as by their very nature injurious for competition. However, a simplistic and incomplete test is not an appropriate basis for such a strict decision. This is all more true since the judgement in Cartes Bancaires case where the Court rejected a broad interpretation of restrictions by object. Since then, only the most serious and obvious restrictions can be classified in that category and patent settlements, even those with reverse payments, are usualy anything but that. The need for restrictive interpretation could have an important impact on General Courts decisions regarding the appeals, which might be upheld regarding decisions of restrictions by object. Also, the same result can be expected from the US Supreme Courts judgment in the Actavis case. patent patentne poravnave s povračili sektorska preiskava omejitev vstopa generičnega podjetja povratni prenos vrednosti zadeva Lundbeck zadeva Perindopril člen 101(1) PDEU omejevanje konkurence po cilju patent reverse payment patent settlements sector inquiry limitation on generic entry transfer of value Lundbeck case Perindopril case article 101(1) TFEU restriction of competition by object true true false [J. Zadnik] Slovenski jezik Angleški jezik Diplomsko delo 2016-08-23 22:41:30 2016-09-19 09:08:47 2022-06-28 03:08:23 2019-07-11 12:47:05 2016 0 Maribor 0 0000-00-00 NiDoloceno NiDoloceno NiDoloceno 0000-00-00 0000-00-00 0000-00-00 346.545(043.2) 5312811 URN:SI:UM:DK:LQC6KGXO UN_Zadnik_Jure_2016.pdf UN_Zadnik_Jure_2016.pdf 1 2FB268A3766D17A599873BE87B3975B5 61c14c5e156e35e4aab58b4fe92d6db24d404246ad43e03a87e6989bada48f95 17f5a62b-7c0d-11eb-bb7a-00155d0001ca https://dk.um.si/Dokument.php?lang=slv&id=99719 Pravna fakulteta 0 0 0