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Prinášame rozhodnutie Súdneho dvora Európskej únie vo veci C‑195/09 k aktuálnej téme, ktorej bude venovaný tento mesiac- právo duševného vlastníctva v medicíne. Súd rozhodoval o štyroch prejudiciálnych otázkach týkajúcich sa výkladu článkov 2, 13 a 19 nariadenia Rady (EHS) č. 1768/92 z 18. júna 1992 o vytvorení dodatkového ochranného osvedčenia na liečivá (Ú. v. ES L 182, s. 1; Mim. vyd. 13/011, s. 200), zmeneného a doplneného Aktom o podmienkach pristúpenia Rakúskej republiky, Fínskej republiky a Švédskeho kráľovstva a o úpravách zmlúv, na ktorých je založená Európska únia (Ú. v. ES C 241, 1994, s. 21, a Ú. v. ES L 1, 1995, s. 1.

Vnútroštátny súd Court of Justice (England & Wales), Chancery Division (Patents Court), (Spojené kráľovstvo) mal pochybnosti tak o pôsobnosti nariadenia č. 1768/92, ako aj o definícii pojmu „prvé povolenie uvedenia na trh (PUT) v Spoločenstve“ v zmysle článkov 13 a 19 vyššie uvedeného tohto nariadenia. Preto  prerušil konanie vo veci  Synthon BV proti Merz Pharma GmbH & Co. KGaA.  a doručil  Súdnemu dvoru 29. mája 2009 návrh na začatie prejudiciálneho konania a
položil Súdnemu dvoru tieto prejudiciálne otázky:

1. Rozumie sa na účely článkov 13 a 19 nariadenia [č. 1768/92] povolením ‚prvé [PUT]… v Spoločenstve‘, ak je udelené podľa vnútroštátneho práva, ktoré je v súlade so smernicou [65/65], alebo je potrebné takisto preukázať, že pri vydaní daného povolenia vnútroštátny úrad vykonal posúdenie údajov, ako to vyžaduje správne konanie stanovené uvedenou smernicou?
2. Zahŕňa na účely článkov 13 a 19 nariadenia [č. 1768/92] výraz ‚prvé [PUT]… v Spoločenstve‘ povolenia, ktoré podľa vnútroštátneho práva môžu existovať spoločne so systémom povolení v súlade so smernicou [65/65]?
3. Spadá výrobok, pre ktorý bolo vydané prvé [PUT] v Európskom spoločenstve bez toho, aby bol predmetom správneho konania podľa smernice [65/65], do pôsobnosti nariadenia [č. 1768/92] definovanej v jeho článku 2?
4. V prípade zápornej odpovede na tretiu otázku je [DOO] vydané na tento výrobok neplatné?“

Súd  rozhodol
-    o tretej otázke, že  v prejednávanej veci je nesporné, že memantín bol uvedený na trh v Spoločenstve ako liek na základe nemeckého PUT a luxemburského PUT dotknutých vo veci samej, a to bez toho, aby bol predtým predmetom posúdenia bezpečnosti a účinnosti stanoveného smernicou 65/65. K takémuto posúdeniu prvý raz došlo pri udelení PUT z roku 2002. Z toho vyplýva, že takýto výrobok nespadá do pôsobnosti nariadenia č. 1768/92, tak ako je vymedzená v článku 2 tohto nariadenia, a teda nemôže byť predmetom DOO.
Vzhľadom na predchádzajúce je potrebné na tretiu otázku odpovedať tak, že článok 2 nariadenia č. 1768/92 sa má vykladať v tom zmysle, že výrobok, o aký ide vo veci samej, ktorý bol ako humánny liek uvedený na trh v Spoločenstve predtým, než bolo naň vydané PUT v súlade so smernicou 65/65, a najmä bez toho, aby bola posúdená jeho bezpečnosť a účinnosť, nepatrí do pôsobnosti tohto nariadenia, a preto nemôže byť predmetom DOO.

a

-    o štvrtej otázke, že pojem „výrobok“ uvedený v článku 3 nariadenia č. 1768/92 nevyhnutne odkazuje na výrobok patriaci do pôsobnosti tohto nariadenia vymedzenej v jeho článku 2. Vydanie DOO pre výrobok, ktorý nepatrí do pôsobnosti uvedeného nariadenia, tak porušuje rozsah uvedeného pojmu „výrobok“. DOO udelené za takýchto podmienok je preto neplatné na základe článku 15 nariadenia č. 1768/92.
V dôsledku toho je potrebné na štvrtú otázku odpovedať tak, že DOO vydané na výrobok, ktorý nespadá do pôsobnosti nariadenia č. 1768/92 vymedzenej v jeho v článku 2, je neplatné.

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