Inimese pluripotentsete tüvirakkudega seotud leiutiste patentimise piirangud vastuolu tõttu avaliku korra ja moraaliga (Eesti patendiõiguse näitel)
Date
2018-03-13
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Abstract
Probleemi kirjeldus.
Inimese pluripotentsete (embrüonaalsete, indutseeritud pluripotentsete ja partenogeneetiliste) tüvirakkude abil loodetakse tulevikus asendada või parandada kahjustunud kudesid või organeid, ravida raskeid haigusi nagu diabeet, Alzheimeri või Parkinsoni tõbi. Nimetatud teadusuuringute tegemine nõuab suuri rahalisi investeeringuid. Selleks, et biotehnoloogia-ettevõtted sooviksid nimetatud valdkonda investeerida, on vajalik pakkuda neile midagi vastutasuks – patendikaitse saamise võimalus leiutistele on üheks võimaluseks, kuidas leiutustegevust hoogustada ja soodustada erasektori poolt investeeringute tegemist. Samas tuleb arvestada, et inimese pluripotentsete tüvirakkudega seotud leiutised põhinevad inimpäritolu materjalil. Inimembrüo enamasti hävib, kui sellest eraldatakse embrüonaalseid tüvirakke. Eelnev tekitab küsimuse, kas selliste leiutiste patentimine peaks olema lubatud või avaliku korra ja moraali argumentide alusel keelatud.
Tulemus ja kasutegur.
Doktoritöös uuriti, kas inimese pluripotentsete tüvirakkudega seotud leiutiste patendikaitse on seaduses sätestatud avalikust korrast ja moraalist tulenevate piirangute alusel välistatud, tehes seda Eesti patendiõiguse näitel. Seejuures analüüsiti, kuidas sisustada avalikust korrast ja moraalist tulenevaid piiranguid patendiõiguses ka Euroopa Liidu ja rahvusvaheliste õigusaktide ja praktika valguses. Analüüsiti ka seda, mis on Eesti regulatsiooni kitsaskohad. Doktoritöös on jõutud järeldusele, et inimese pluripotentsete tüvirakkudega seotud leiutiste patenditavust ei saa Eesti patendiseaduses sätestatud avalikust korrast ja moraalist tulenevate piirangute alusel välistada. Doktoritöö tulemusena leiti, et Eesti patendiseaduse regulatsioon vajab piirangute sõnastuse osas muutmist.
Description of the problem. With the help of human pluripotent (embryonic, induced pluripotent and parthenogenetic) stem cells researchers hope to find a way to replace or regenerate damaged tissue or organs, cure diseases such as diabetes, Alzheimer’s and Parkinson’s. Such research requires enormous financial investments. In order to motivate biotechnology enterprises to invest in the field, it is necessary to offer them something in return – the possibility to obtain patent protection for inventions is an option of encouraging invention and attracting investments to the field. However, one cannot overlook the fact that inventions related to human pluripotent stem cells concern material of human origin. The human embryo is usually destroyed upon isolating human embryonic stem cells from it. This raises the question of whether the patenting of such inventions should be permitted or there are public order arguments or moral arguments that would serve as the basis for prohibiting the patenting of such inventions. Result and benefit. In this dissertation, the author investigated whether the patenting of inventions related to human pluripotent stem cells is precluded on the basis of exceptions arising from the public order and morality and did so relying on the example of Estonian patent law. The author analysed how to substantiate these limitations in patent law on the basis of practice and legal acts of the European Union and international agreements. The author also investigated which are the bottlenecks of the Estonian legislation. The autor concluded that the patenting of inventions relating to human pluripotent stem cells cannot be precluded on the basis of exceptions arising from the public order and morality provided by the Estonian Patents Act. As the result of the dissertation it was found that the wording concerning the exceptions provided by the Estonian Patents Act needs to be modified.
Description of the problem. With the help of human pluripotent (embryonic, induced pluripotent and parthenogenetic) stem cells researchers hope to find a way to replace or regenerate damaged tissue or organs, cure diseases such as diabetes, Alzheimer’s and Parkinson’s. Such research requires enormous financial investments. In order to motivate biotechnology enterprises to invest in the field, it is necessary to offer them something in return – the possibility to obtain patent protection for inventions is an option of encouraging invention and attracting investments to the field. However, one cannot overlook the fact that inventions related to human pluripotent stem cells concern material of human origin. The human embryo is usually destroyed upon isolating human embryonic stem cells from it. This raises the question of whether the patenting of such inventions should be permitted or there are public order arguments or moral arguments that would serve as the basis for prohibiting the patenting of such inventions. Result and benefit. In this dissertation, the author investigated whether the patenting of inventions related to human pluripotent stem cells is precluded on the basis of exceptions arising from the public order and morality and did so relying on the example of Estonian patent law. The author analysed how to substantiate these limitations in patent law on the basis of practice and legal acts of the European Union and international agreements. The author also investigated which are the bottlenecks of the Estonian legislation. The autor concluded that the patenting of inventions relating to human pluripotent stem cells cannot be precluded on the basis of exceptions arising from the public order and morality provided by the Estonian Patents Act. As the result of the dissertation it was found that the wording concerning the exceptions provided by the Estonian Patents Act needs to be modified.
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Keywords
biomeditsiinitehnoloogia, raku- ja koeteraapia, tüvirakud, embrüonaalsed tüvirakud, patentimine, piirangud, bioeetika, patendiõigus, Eesti, biomedical technology, cell and tissue therapy, stem cells, embryonic stem cells, patenting, barriers, bioethics, patent law, Estonia