Lieky, patenty a jedno ne-evergreenové rozhodnutie Indického najvyššieho súdu | Medicínske právo
              

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Lieky, patenty a jedno ne-evergreenové rozhodnutie Indického najvyššieho súdu


 | 24.7.2013 | komentárov: 382

Prinášame pohľad na aprílové rozhodnutie Najvyššieho súdu v Indii, ktoré zabezpečilo výrobu a prístup ku generickým verziám liekov pôsobiacim napr. proti vírusu H.I.V. či určitým druhom rakoviny pre najchudobnejších obyvateľov krajiny.

Obrazok Diskusie zaoberajúce sa prístupom krajín tretieho sveta k farmaceutickým výrobkom a ich trhovými cenami sú na dennom poriadku odborníkov pre oblasť práv duševného vlastníctva a medicínskeho práva. Na jednej strane globálnej barikády stoja rozvojové krajiny, ktoré sa snažia získať prístup k čo najširšiemu portfóliu liekov vo forme čo najlacnejších generík, ktoré by sprístupnili liečbu miliónom obyvateľov. Na druhej strane stoja farmaceutické spoločnosti snažiace sa zabezpečiť svoje investície do inovácii prostredníctvom patentového práva, a tým ochrániť a znásobiť svoj zisk z vývoja, výskumu a výroby liekov.

India, známa ako svetová továreň na lacné lieky, si analyzovaným rozsudkom NS zaistila možnosť legálnej produkcie generík existujúcich liekov. Rozsudok sa týka lieku Gleevec (v Európe známy ako Glivec), ktorý vyrába švajčiarska spoločnosť Novartis a používa sa na liečbu určitej formy leukémie. Noviny New York Times upozorňujú, že liek Gleevec patrí k najvýznamnejším objavom na poli farmaceutického priemyslu v uplynulých dekádach. Pre porovnanie, cena pôvodného Glivecu sa pohybuje na úrovni  1.700 libier mesačne, kým generická verzia lieku vyrábaná v Indii len okolo 115 libier.

Indické patentové právo až do roku 2005 neumožňovalo patentovanie farma výrobkov. Zmena nastala po pristúpení k Dohode o obchodných aspektoch práv duševného vlastníctva (TRIPS), priatej v rámci WTO. Hoci pristúpením k TRIPS sa India zaručila, že umožní patentovateľnosť liekov a medicínskych výrobkov, záruka sa týkala len liekov objavených a vyrábaných po roku 1995.

Liek Gleevec bol patentovaný a uvedený na trh už v roku 1993, preto sa naň nevzťahovala ochrana indického patentového práva. Aby si Novartis zabezpečil patentovú ochranu aj v Indii, pokúšal sa patentovať novú verziu lieku Gleevec, s rovnakými účinnými látkami, liečebným efektom avšak s drobnou zmenou v zložení.

Na tomto mieste sa dostávame k meritu aprílového rozhodnutia indického súdu, ktorý sa uzniesol na závere, že pôvodná a novšia verzia lieku Gleevec nie sú v podstatnej miere odlišné, a preto tu neexistuje dôvod na uznanie dvoch odlišných patentov na jeden takmer totožný liek.

Medzinárodná organizácia Doktori bez hraníc na jednej strane víta rozhodnutie ako formu garancie, v rámci ktorej sa obyvateľom Indie zabezpečí prístup ku lacnejším verziám už jestvujúcich liekov, avšak zároveň podotýka, že tu stále leží nezodpovedaná otázka, ako dosiahnuť prístup k najnovším objavom farmaceutického priemyslu najchudobnejším obyvateľom sveta.

Ranjit Shahani, vice - prezident  indickej pobočky spoločnosti Novartis, v komentári NYT konštatuje, že: „spoločnosti ako Novartis budú v dôsledku tohto rozhodnutia investovať do výskumu menšie finančné prostriedky, čo bude mať v konečnom dôsledku neblahý dopad práve na pacientov “. Dôvodom je samozrejme demotivácia farmaceutických spoločnosti, ktorá vyplýva z otvorenej hrozby straty zisku. Zároveň  pán Shahani vyjadruje želanie, aby sa klíma okolo práv duševného vlastníctva v Indii v budúcnosti zlepšila a aby súdy v Indii spravodlivo rozlišovali skutočné inovácie od tých domnelých.

Podobne sa vyjadrujú ďalší reprezentanti farmapriemyslu, podľa ktorých je rozhodnutie dôkazom, že India odmieta rešpektovať svetovú úroveň ochrany práv duševného vlastníctva, čo per se systematicky ničí vhodné prostredie pre rozvoj vedy a inovácii.

Zo štatistického hľadiska India ročne vyprodukuje generické lieky určené na export v hodnote 10 miliónov dolárov. Zaujímavým faktom však je, že až 80 percent vyrobených účinných látok v Indii a Číne sa vyváža a spracúva v USA. Práve americké spoločnosti sú najhlasnejšími kritikmi tohto rozhodnutia, pretože rozhodnutie jasne zakazuje prax využívanú bežne v obchodnom prostredí USA, známu ako „Evergreening“.

Pod termínom Evergreening sa v súčasnosti rozumie obchodná taktika, ktorej cieľom je získanie nového patentu na už existujúci a patentom chránený liek. Farmaceutická spoločnosť, pod rúškom inovácie, vykoná určitú nepatrnú zmenu v pôvodnom zložení lieku, následne novému lieku pridelí odlišné obchodné meno a snaží sa udržať si patentový monopol získaním patentu na tento inovovaný a premenovaný liek, čím de facto dochádza k predĺženiu pôvodnej patentovej ochrany lieku s takmer totožným zložením ako už patentovaný pôvodný liek. Bezprostredný vplyv Evergreeningu sa potom prejavuje na umelom udržovaní vysokých cien týchto liekov, kvôli nemožnosti výroby generických náhrad. Preto kritici tejto obchodnej praktiky argumentujú prílišnou benevolentnosťou v udeľovaní patentov na lieky v USA, či v zbytočných investíciách, ktoré pacientom neprinášajú žiadny alebo len minimálny benefit a v zásade ani inak neprispievajú k verejnému záujmu. Výsledok tohto patentového boja medzi jednotlivými výrobcami liekov je nasledovný. Na jednej strane sa štáty ako India či Argentína bránia voči týmto liberálnym patentovým praktikám rôznymi spôsobmi (napr. aj analyzovaným rozhodnutím), na druhej strane v USA je zaznamenaná najvyššia cena liekov na svete a reálne zahatanie prístupu Američanov k lacnejším generikám.

Práve predmetné rozhodnutie Indického súdu odmieta takúto formu súťaženia a udeľovania patentov na pôvodné verzie liekov, keď súd v rozhodnutí formuloval požiadavku - podstatnú odlišnosť nového a pôvodne patentovaného lieku.

Rozhodnutie, ktoré odmieta udelenie patentu pre akúkoľvek inováciu jestvujúceho lieku nielenže otvára priestor pre výrobcov lacnejších generík liečiacich najzávažnejšie choroby, ale zároveň odmieta tzv. „evergreenové“ udeľovanie patentov a zavádza princíp posúdenia dôležitosti inovácie, resp. striktného porovnávania odlišnosti pôvodného a inovovaného lieku.
Zahraniční komentátori predpovedajú stav, ktorý by v Indii nastal, ak by k uvedenému rozhodnutiu nebolo došlo, a okrem spoločnosti Novartis, by metódu evergeeningu využili aj ďalšie farma firmy – štandardná termínovaná dvadsaťročná ochrana patentov by sa v reáli znásobila, čím by sa vysoké ceny liekov chránených patentovým právom držali dlhodobo v astronomických výškach, čo by bez debaty predznamenalo katastrofu nevyčísliteľných rozmerov pre obyvateľov krajín tretieho sveta, ktorým sú generiká prioritne určené.

Spracoval: Zoltán Nagy

Zdroje:
http://www.guardian.co.uk/world/2013/apr/01/novartis-patent-ruling-affordable-medicines
http://www.nytimes.com/2013/04/02/business/global/top-court-in-india-rejects-novartis-drug-patent.html?pagewanted=all&_r=1&
http://www.techdirt.com/articles/20130401/09233022536/indian-supreme-court-rejects-evergreening-pharma-patents.shtml
http://www.ip-watch.org/2013/06/12/geneva-study-finds-evergreening-increases-healthcare-costs/

Foto: freedigitalphotos.net



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