USA: Najvyšší súd USA rozhodol v prípade Association for Molecular Pathology v. Myriad Genetics | Medicínske právo
              

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USA: Najvyšší súd USA rozhodol v prípade Association for Molecular Pathology v. Myriad Genetics


 | 17.6.2013 | komentárov: 292

Najvyšší súd Spojených štátov amerických vo štvrtok jednohlasne nepotvrdil patent spoločnosti Myriad Genetic na izolovanú časť DNA (gén BRCA 1 a BRCA2). Ako uvádza vo svojom komentári Adam Liptak pre New York Times nepriaznivým následkom rozhodnutia Najvyššieho súdu môže byť neochota firiem investovať do genetického výskumu. Naopak, pozitívom rozhodnutia je zlacnenie testovania niektorých zdravotných rizík.

Obrazok Myriad Genetics (Inc.), spoločnosť zo štátu Utah, objavila presné umiestnenie a sekvenciu 2 ľudských génov (BRCA 1 a BRCA2). Ich mutácie môžu výrazne zvýšiť riziko rakoviny prsníka a rakoviny vaječníkov. Spoločnosť získala v súvislosti s týmto objavom niekoľko patentov.
Predmetom rozhodnutia Najvyššieho súdu USA boli dve otázky:

a)    je možné patentovať si časť DNA, na základe toho, že bola spoločnosťou izolovaná od zvyšku genetického materiálu?
b)    je patentovateľná  umelo vytvorená DNA- cDNA, ktorá obsahuje rovnaké proteínové kódovanie ako prírodná DNA  s tým, že chýbajú časti, ktoré neviažu proteíny?

Najvyšší súd USA potvrdil rozhodnutie Federálneho odvolacieho súdu (United States Court of Appeals for Federal Circuit) v časti, podľa ktorej je umelovytvorená DNA patentovateľná. Na druhej strane, sa však jednohlasne priklonil k tvrdeniu, že Myriad oddelením prirodzenej DNA „nič nevytvoril“, že samotné oddelenie génu od zvyšného genetického materiálu nie je „objavom“ , a preto nie je možné patentovať oddelenú časť DNA. V rozhodnutí sa uvádza. „ohromujúci, inovatívny či výnimočný objav sám o sebe nespĺňa požiadavku paragrafu 101 Zákona o patentoch (35 U.S.C.)“  Súd sa priklonil k tvrdeniu, že oddelené DNA je produktom prírody, na ktorý sa podľa zákona o patentoch vzťahuje výnimka. Zároveň bolo účelom rozhodnutia zabrániť tomu, aby nadmerné udeľovanie patentov nebolo prekážkou ďalšieho pokroku. 
Od rozhodnutia sa očakáva priamy dopad na zdravie obyvateľstva, ktorému bude testovanie (dovtedy drahšie aj kvôli patentu Myriardu) cenovo prístupnejšie.


AUTOR: Mgr. Zuzana Zoláková
FOTO: blog.solidcounsel.com

POUŹITÉ ZDROJE:

- Rozhodnutie Supreme Court of United States [on-line]. June 13, 2013  [cit. 2013-06-17] http://www.supremecourt.gov/opinions/12pdf/12-398_1b7d.pdf
- LIPTAK. Adam Justices, 9-0, Bar Patenting Human Genes in New York Times [on-line]. June 13, 2013  [cit. 2013-06-17]. Dostupný z: http://www.nytimes.com/2013/06/14/us/supreme-court-rules-human-genes-may-not-be-patented.html?ref=myriadgeneticsinc




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