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    Title: 探討基因治療相關發明專利暨其必要之因應措施
    Other Titles: A Study on Gene Therapy-Related Invention Patents and RequiredMeasures
    Authors: 陳文吟
    Chen, Wen-Yin
    Keywords: 基因治療;專利保護客體;專利要件;產業上可利用性;生物安全性;廣泛專利權;實驗研究;強制授權;告知同意
    Gene Therapy;Patentable Subject Matter;Patent Requirement;Utility;Bio-safety;Broad Patent
    Date: 2006-10
    Issue Date: 2016-05-16 16:49:52 (UTC+8)
    Abstract: 基因疾病者,因基因突變、缺失或表達異常等所致的疾病。基因治療,則係針對諸多目前仍難以治癒的基因疾病所進行的治療方式。它利用正常或具有治療效果的DNA或RNA片段,藉由載體轉移到人體的標的細胞,進行修正基因缺陷、抑制或關閉異常基因的表現,達到改善疾病的治療方法。美國NIH於西元一九九○年完成首件成功的病例,並以此向PTO申請取得體外基因治療專利。\r專利權的賦予,固然有著鼓勵研發的效果。惟,專利權顯現的經濟上的誘引,卻也使研究人員汲汲營營於研究的完成與試驗,而忽略其生物安全性;專利權的取得,亦誤導受試驗者或患者相信其療效暨安全性。研究人員亦常對受試驗者隱瞞其研究之潛在經濟利益,如專利之申請。再者,其亦使得申請人試圖擴張其專利權利範圍,甚至就尚未知悉功能的基因發現申請專利。凡此,無論就人類健康或產業科技的發展均呈負面的影響。不同於美國,我國專利法並不予治療、診斷方法專利,是以基因治療、診斷方法亦非專利保護客體。然而,無論基因治療本身、抑或其相關發明技術,均有著前揭患者權益堪虞及廣泛專利權之疑慮。\r下列措施當可確保患者權益:(一)專利法上之產業上可利用性(或實用性)之兼顧生物安全性,適度防止危險性過高的發明取得專利。專利審查人員於審查時應審慎審理其安全性,倘未知其安全性為何、或危險過高,則應以其不具產業上可利用性否准其專利。(二)告知同意——依現行告知同意之規範,研究人員對患者施行基因治療相關發明之試驗前,應告知與醫療、研究行為直接有關的事項。本文以為應於告知事項中,增列其潛在經濟利益(如專利之申請)。\r至於廣泛專利權的賦予,可採行現有的相關制度以為因應:(一)產業上可利用性的審查從嚴——專利專責機關於審查時,對申請專利範圍之界定應予從嚴,俾免予以廣泛專利權,箝制產業科技的發展。(二)研究、教學暨試驗目的——研究人員亦可基於研究、教學暨試驗目的免費使用專利技術,而毋需負專利侵權責任。(三)強制授權(特許實施)——除使其他業者,得以合理的權利金,使用專利權人之技術;亦可兼顧公共利益及避免專利權人的濫用。凡此,當可有助於解決基因治療相關發明專利所衍生之疑慮。
    Genetic diseases are genetic disorders caused by gene flaws, gene mutations etc.. Gene therapy is a technique for correcting defective genes responsible for disease development. In most gene therapy studies, a “normal” gene is inserted into the genome to replace an “abnormal,” disease-causing gene. A carrier molecule called a vector must be used to deliver the therapeutic gene to the patient's target cells. In 1990, the first gene therapy clinical trial was approved and was declared to be successful. However, no government anywhere in the world has approved any human gene therapy product for sale. Gene therapy may eliminate pain brought on by disease. The question whether it represents a real hope, an illusion or a tragedy is determined by how scientists approach it. Scientific techniques, such as gene therapy, that are still in the early stages of development, may cause more harm than good to human beings when made available to society without thorough study. The patent system, surely, provides economic incentive to study gene therapy. The death of Jesse Gelsinger taught us the importance of bio-safety and that no gene therapy should be conducted on human beings without thorough study and evaluation. The Moore case and the Greenberg case remind us of the patient’s right to be fully informed, including potential economic interests. In sum, the patient’s interest should not be ignored, and, broad patents that may deter innovation should be restricted. The above-mentioned issues may occur in the case of gene therapy and testing as well as gene therapy-related inventions, such as, genes, proteins, vectors etc. In order to protect the patient’s interest, the author suggests that the utility requirement under the patent system may ensure bio-safety, and the informed consent under health regulations should include the revelation of potential economic interests. To avoid the deterrence of innovation, the application of broad patents should be restricted. The following measures may be taken into consideration: 1. Application of a utility requirement to define claims narrowly. 2. Application of use in research/experiment to avoid patent infringement. 3. Compulsory licensing to prevent patentee from abusing his rights.
    Relation: 法學評論, 93, 269-329
    Data Type: article
    Appears in Collections:[法學評論 TSSCI] 期刊論文

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