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Gene Patents and Access to Genetic Diagnostic TestsKhanijoun, Harleen 20 November 2012 (has links)
The utilitarian theory contemplates rewarding the risks of inventors by providing them with
a defined period of exclusivity to recoup their investment. For inventions requiring further
investment, patents enable the creation of financial relationships between inventors and investors by
providing patent exclusivity during the commercialization process. Innovation, contrasted from
invention and conceptualized as commercialization, however, does not necessarily form the best
means for delivering to the public inventions intended to improve health. Although patent policy
conflates the economic growth and health improvement objectives of innovation, these goals do not
always align. While the exercise of BRCA patents instantiates exclusive practicing of patents that
failed to adequately deliver health technology, the patent system does not need significant change.
Rather, to maintain the expectations of patent holders while balancing the needs of the public,
current practices should continue with the encouragement of the creation of voluntary patent pools.
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Gene Patents and Access to Genetic Diagnostic TestsKhanijoun, Harleen 20 November 2012 (has links)
The utilitarian theory contemplates rewarding the risks of inventors by providing them with
a defined period of exclusivity to recoup their investment. For inventions requiring further
investment, patents enable the creation of financial relationships between inventors and investors by
providing patent exclusivity during the commercialization process. Innovation, contrasted from
invention and conceptualized as commercialization, however, does not necessarily form the best
means for delivering to the public inventions intended to improve health. Although patent policy
conflates the economic growth and health improvement objectives of innovation, these goals do not
always align. While the exercise of BRCA patents instantiates exclusive practicing of patents that
failed to adequately deliver health technology, the patent system does not need significant change.
Rather, to maintain the expectations of patent holders while balancing the needs of the public,
current practices should continue with the encouragement of the creation of voluntary patent pools.
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人體基因序列的專利適格性─從美國Myriad案再省思 / The Patent Eligibility of Human Genes in the Wake of AMP v. USPTO & Myriad Genetics Case吳振群 Unknown Date (has links)
美國最高法院於2013年6月13日,發佈自2010年起纏訟多年的 AMP v. USPTO & Myriad Genetics案判決,最高法院全體一致認為,與天然相同的DNA序列,即使經過單離(isolated)仍然不具有可專利性,但補償性的DNA(complementary DNA,簡稱cDNA),則為人為發明產物具有可專利性。
判決出來後,引發各界譁然,相關基因測試業者擔心,最高法院的見解,會使基因研發的投資意願大幅減少,反而會阻礙往後創新研發。但支持者認為基因本屬人類共有產物,且否准基因專利後,能夠讓其他更低價、更有效率的檢測方法進入市場,對社會有助益。在專利權人的私有利益與公共衛生利益激烈衝突下,各方都有鏗鏘有力的理由。
美國專利商標局(USPTO)從1980年代起,開始核發與基因有關之專利,並在2001年公布「實用性檢查指引」(Utility Examination Guidelines),認為單離的人類DNA或純化DNA分子,亦可賦予專利,透過賦予專利排他權,達鼓勵研發創新之目的。從過去三十年來,基因相關專利數量劇增,也因為專利排他的特性,對現有的科學研究產生阻礙,不僅如此,對於患者而言,因為專利權人積極行使權利,成為市場唯一壟斷者,使患者無法獲得其他醫療意見(second opinion)的權利,這也是Myriad案備受矚目的原因之一。
因此,本論文將藉由AMP v. USPTO & Myriad Genetics案,重新省思對於人體基因是否具有可專利性,並整理美國司法實務過往對於可專利標的、基因專利等重要判決進行分析,最後提出本文的見解,試圖提出一些可能的解決方案。
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