USA - Kmeňové bunky a rozhodnutie Patentového úradu | Medicínske právo
              

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USA - Kmeňové bunky a rozhodnutie Patentového úradu


 | 3.6.2010 | komentárov: 288

Dňa 20. mája oslavovali v dvoch spoločnostiach víťazstvo v prospech otvoreného vedeckého bádania, Americký patentový úrad (the U.S. Patent and Trademark Office - USPTO) odmietol kontroverzný patent na ľudské embryonálne kmeňové bunky, ktorý patril spoločnosti Wisconsin Alumni Research Foundation (WARF).

Obrazok

„Toto je veľké víťazstvo pre nespútaný vedecký výskum, ktorý by mohol viesť ku objaveniu liekov na niektoré z najviac vysiľujúcich chorôb.“ povedal John M. Simpson, riaditeľ spoločnosti Consumer Watchdog Stem Cell Project. Nezisková, apolitická spoločnosť Consumer Watchdog sa spojila so spoločnosťou Public Patent Foundation (PUBPAT) v snahe spochybniť platnosť patentových nárokov spoločnosti WARF v oblasti kmeňových buniek. Odvolací senát patentového úradu súhlasil so spoločnosťami, že vytvorenie línií ľudských embryonálnych kmeňových buniek bolo vykonané  na základe výsledkov výskumu, ktorý mu predchádzal v iných oblastiach. Pre získanie patentu musí práca spĺňať obe podmienky – novosť a nezvyčajnosť. Správa senátu patentového úradu o rozhodnutí z 28-ho apríla bola doručená v priebehu víkendu.

„Od začiatku sme tvrdili, že patenty spoločnosti WARF o kmeňových bunkách sú nezaslúžené.“ povedal Dan Ravicher, výkonný riaditeľ spoločnosti PUBPAT. „Ak by sa WARF naďalej snažila obhajovať svoje neodôvodnené patenty, my budeme aj naďalej pokračovať v dokazovaní ich neplatnosti."  K výzve týchto dvoch spoločností sa od počiatku pripojil aj Dr. Jeanne Loring, v súčasnosti riaditeľ Centra pre regeneratívnu medicínu v Scrippsovom Inštitúte. Neskôr Dr. Alan Trouson, vtedy z Austrálskej Monasch University a v súčasnosti prezident Kalifornského Inštitútu pre regeneratívnu medicínu, Dr. Douglas Melton z Harvardu a Dr. Chad Cowan taktiež z Harvardu vydali písomné vyhlásenie na podporu výzvy pre slobodné bádanie v oblasti kmeňových buniek.  „Toto sú skvelé správy pre medicínsky výskum. Ľudské embryonálne kmeňové bunky majú veľký prísľub pre zdokonalenie ľudského zdravia a nikto nemé etické právo ich vlastniť.“ povedal Dr. Loring.

Spoločnosti Watchdog (pôvodne Nadácia pre daňovníkov a práva spotrebiteľov) a PUBTA podali odvolanie na odvolací komisiu Amerického patentového úradu po tom ako skúšobný komisár patentového úradu schválil patent po zúžení ich nárokov. Obe spoločnosti pôvodne žiadali preskúmanie patentu v júli 2006 spolu s ďalšími dvoma vplyvnými patentmi z oblasti kmeňových buniek vo vlastníctve spoločnosti WARF. Spočiatku boli všetky tri patenty zamietnuté, avšak v roku 2008 ich po znížení nárokov skúšobný komisár patentového úradu schválil.

Podľa súčasne platného patentového práva, len jedno z troch patentových rozhodnutí mohlo byť oboma spoločnosťami napadnuté na odvolacom senáte. To bol práve spomínaný zamietnutý patent. Avšak, ako tvrdia spoločnosti, toto ostatné rozhodnutie odvolacie senátu je veľmi závažné a mohlo by založiť precedens smerujúci rovnako k zrušeniu ďalších dvoch patentov. Spoločnosti pripomenuli, že pôvodná výzva proti trom patentom, už stihla výrazne vylepšiť situáciu výskumníkov kmeňových buniek. V roku 2006, krátko po začatí preskúmavania patentov úradom na základe žiadosti spoločností, spoločnosť WARF ohlásila podstatné zmiernenie svojich licenčných požiadaviek. „Vedenie spoločnosti WARF sa správalo ako arogantní tyrani zaslepení znakom dolára,“ povedal Simpson. „Naše výzvy prispeli k viac kooperatívnemu postoju z ich strany voči komunite skúmajúcej kmeňové bunky.“ Obe spoločnosti však zdôraznili, že kým James Tmonpson, výskumník z University of Wisconsin, si zaslúži veľké uznanie za svoj výskum, ktorým sa podarilo izolovať ľudské kmeňové bunky, tak významné vedecké úspechy nie sú nevyhnutne patentovateľné. Tvrdia, že jedným z hlavných dôvodov pre ktorý bol schopný odvodiť líniu ľudských kmeňových buniek bolo to, že mal prístup k ľudským embryám a finančnej podpore, ktorú ostaní výskumníci nemali.

Spoločnosť WARF sa môže odvolať voči ostatnému rozhodnutiu patentového úradu a žiadať nové prejednanie veci pred komisiou (board). Môžu si taktiež zvoliť, či budú prezentovať nové dôkazy pôvodnému skúšobnému komisárovi (examiner), alebo zmenia patentové nároky. „Samozrejme najlepšie by bolo, ak WARF-u skutočne záleží na vedeckom pokroku,“ povedal Simpson, „aby jednoducho upustili od týchto prehnaných patentových nárokov.“

Rozhodnutie patentového úradu si môžete prečítať tu: http://www.consumerwatchdog.org/resources/WARFDecision042910.pdf

 Consumer Watchdog, predtým Foundation for Taxpayer and Consumer Rights je nezisková, nepolitická spotrebiteľská advokátska organizácia so sídlom vo Washingtone, DC, a Santa Monica, Ca. Ich webová stránka je www.consumerwatchdog.org.

The Public Patent Foundation na Benjamin N. Cardozo School of Law je organizácia neziskovo poskytujúca právne služby ktorá reprezentuje verejné záujmy voči škodám/zásahom spôsobeným patentovým systémom, najmä škody spôsobené nezaslúženými patentmi a nesprávnou patentovou politikou/postupom. Pre viac informácií navštívte: www.pubpat.org



Originál článku bol pripravený editormi Medical Verdicts & Law Weekly. <http://www.newsrx.com>

Preklad: Ján Richnavský

Foto: zdroj internet

 

 




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