Rozhodnutie odvolacieho súdu vo veci genetického patentu v prospech spoločnosti Myriad | Medicínske právo
              

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Rozhodnutie odvolacieho súdu vo veci genetického patentu v prospech spoločnosti Myriad


 | 26.8.2012 | komentárov: 289

U.S. Federal Appeals Court opätovne potvrdil právo spoločnosti Myriad Genetics Inc. patentovať dva gény súvisiace s rakovinou prsníka a vaječníkov po tom, čo mu bol tento aktuálny prípad vrátený z U.S. Supreme Court na nové konanie.

Rozhodnutie washingtonského U.S. Federal Circuit Court of Appeals  v pomere 2 k 1 potvrdilo právo spoločnosti zaoberajúcej sa biotechnológiami patentovať „izolované gény“ známe ako BRCA1 a BRCA2, ktoré sú najčastejšou príčinou dedičných foriem rakoviny prsníka a vaječníkov. Súd však zamietol návrh spoločnosti na patentovanie metód „na porovnávanie“ alebo „analyzovania“ sekvencií DNA.
Ženy, ktoré boli pozitívne testované výrobkom spoločnosti Myriad nazvaným BRACAnalysis mali o 82 percent vyššie riziko rakoviny prsníka a o 44 percent vyššie percento rakoviny vaječníkov. Podľa žaloby proti spoločnosti Myriad a University of Utah Research Foundation, ktoré sú držiteľmi patentov,  sú patenty ilegálne, pričom súčasne obmedzujú vedecký výskum ako aj právo pacientov na zdravotnú starostlivosť.

Žalobca American Civil Liberties Union uviedol, že patentovanie ľudských génov je v rozpore s prvým dodatkom Ústavy USA a patentovými zákonmi, nakoľko gény sú „produktmi prírody.“ Avšak sudca Alan Lourie vo svojom odlišnom stanovisku uviedol: „Každý a všetko pochádza z prírody, je v súlade s jej zákonmi, avšak skúmané gény nie sú prírodným produktom. Ide o výtvor človeka, ktorý je však, ako všetky materiály, v súlade s prírodnými zákonmi.

Štvrtkové rozhodnutie v eticky kontroverznom spore prišlo päť mesiacov po tom, čo U.S. Supreme Court v prípade krvného testu spoločnosti Prometheus Laboratories Inc. jednohlasne rozhodol, že spoločnosti si nemôžu patentovať poznatky týkajúce sa prírodných javov. O týždeň neskôr Najvyšší súd zrušil rozhodnutie Federal Circuit Court z júla 2011 v prospech spoločnosti Myriad a nariadil súdu opätovne rozhodnúť zohľadňujúc prípad Prometheius.

Snaha spoločnosti Myriad narážala na odpor skupín ako napríklad American Medical Association, March of Dimes, American Society for Human Genetics či Association for Molecular Pathology.V krátkej debate zameranej proti patentovaniu génov Dr. James Watson, jeden z objaviteľov dvojšpirálovej štruktúry DNA uviedol, že sa obával pochybenia súdu, ak by nedokázal vziať na zreteľ jedinečnú povahu ľudských génov, ktoré ukladajú informácie potrebné na vznik a reprodukciu života. "Napriek tomu, že ide o chemickú látku, dôležitosť DNA vyplýva z jej schopnosti kódovať a odovzdávať informácie pre reprodukciu života. Podávanie týchto informácií by nemalo byť kontrolované právnymi monopolmi vytvorenými Kongresom či súdmi.“

Napriek uvedenému odvolací súd akceptoval tvrdenia zástancov spoločnosti Myriad, podľa ktorých neposkytnutie patentovej ochrany by mohlo utlmiť snahu o získavanie inovácií tejto spoločnosti zo Salt Lake City ako aj jej podobných.

„Patenty podporujú inovácie a dokonca povzbudzujú vynálezy, musíme však byť opatrní, aby nedošlo k zneužívanie patentových práv,“ uviedol Lourie.

Sklamanie kritikov

V súčasnom patentovom spore spoločnosti Myriad Federal Circuit Court opätovne zmenil prevažnú časť rozhodnutia Roberta Sweeta, sudcu z U.S. Disctrict Court v Manhattane. „Považovali sme to za najdôležitejšiu časť rozhodnutia v prípade Myriad a z toho dôvodu sme odvolaniu vyhoveli,“ uviedol Doug Schenkel, analytik zo spoločnosti Cowen and Co. Rozhodnutie vo veci Myriad považuje za spravodlivejšie.

Približne 20 neziskových skupín, lekárskych organizácií, lekárov a jednotlivcov spochybňuje patentové nároky spoločnosti Myriad, pričom nie je jasné, či proti rozhodnutiu plánujú podať odvolanie. „Štvrtkové rozhodnutie je veľkým sklamaním a bráni lekárom a vedcom slobodne zdieľať myšlienky a výsledky výskumov“, uviedol vo svojom stanovisku právnik ACLU Chris Hansen. „Ľudská DNA je prírodným produktom ako napríklad vzduch alebo voda. Nepatrí nikomu.“

Myriad však uvádza, že izoluje gény tak, že ich odstráni z ľudského tela, pričom týmto procesom dochádza k zmene ich chemickej štruktúry a právne tým sa vyhľadávajú odlišné chemické formy.

Gregory Castanias, partner v spoločnosti Jones Day zastupujúcej Myriad uviedol v telefonickom rozhovore: „Sme veľmi radi, že porota uznala, že izolované molekuly DNA sú produktom človeka a sú teda spôsobilé patentovej ochrany.“

Rovnako aj zástancovia názorov spoločnosti Myriad uviedli, že zamietnutie patentovej ochrany by mohlo spomaliť pokrok v personalizovanej medicíne, ktorá využíva genetické testy na zisťovanie potrebnej liečby pre pacientov.

Patentový zástupca pre oblasť biotechnológií Tim Worral z Dorsey and Whitney vo svojom vyjadrení uviedol, že dôsledky rozhodnutia súdu budú významné pre prevažnú časť biotechnologického priemyslu.

Aj keď bude voči rozhodnutiu pravdepodobne podané odvolania na U.S. Supreme Court, biotechnologický priemysel si aspoň dočasne vydýchol,“ dodal Worral. Momentálne je toto rozhodnutie výhrou, keďže prevažná časť hodnoty spojenej s vynálezmi týkajúcimi sa DNA je postavená na názore, že práva súvisiace s DNA sú patentovateľné, dodal.

Sudca Circuit Court William Bryson zaujal v štvrtkovom rozhodnutí odlišný názor, pričom uviedol, že rozhodnutie „bude mať pravdepodobne väčšie dôsledky“ a možno zabráni sekvencovaniu genómov.

Sandra Park, advokátka ACLU uviedla, že patenty spoločnosti Myriad umožnia spoločnosti „udržiavať monopol na BRCA testovanie v USA,“ a teda ženy majú iba jedinú možnosť ako zistiť ich predispozície na rakovinu prsníka a vaječníkov. Test však nevyhľadáva všetky príčiny zdedenej rakoviny prsníka, uviedla.

Park v posledných mesiacoch uviedla, že National Comprehensive Cancer Network vydala nový pokyn týkajúci sa BRCA genetických testov, podľa ktorého by mali  byť všetky ženy geneticky testované. Avšak test spoločnosti Myriad, ktorý stojí 3000 dolárov nevyhľadáva všetky genetické zmeny, v dôsledku čoho musia lekári vykonať ďalší 700 dolárový test, ktorý poisťovne môžu, ale nemusia preplatiť.

Park ďalej uvádza, že prípadné podanie odvolania, ktoré je potrebné podať v lehote 90 dní, bude ACLU konzultovať so svojimi klientmi.

V popoludňajšom obchodovaní na burze Nasdaq akcie spoločnosti Myriad klesli na 24,86 dolára za kus. Obchodovali sa v rozmedzí od 23,07 až po 25,24 dolára v čase pol hodinu po rozhodnutí súdu.


Prípad: Association for Molecular Pathology a spol. proti U.S. Patent and Trademark Office a spol. vedený U.S. Federal Circuit Court of Appeals číslo 2010-1046

 


Pôvodný text: Myriad wins gene patent ruling from US appeals court
Autor: Jonathan Stempel
Dostupné na: http://www.reuters.com/article/2012/08/16/us-myriad-patent-idUSBRE87F12K20120816
Preklad: Tomáš Szalontay
Editovala: Zuzana Zoláková




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