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篇名 由AMP v. Myriad Genetics, Inc.案談 基因專利之適格性
卷期 12:2
並列篇名 GENE PATENTS IN THE AFTERMATH OF AMP V. MYRIAD GENETICS, INC.
作者 李治安
頁次 001-046
關鍵字 基因檢測基因專利DNA序列cDNA序列第二意見genetic testgene patentDNA sequencecDNA sequencesecond opinion
出刊日期 201412

中文摘要

本文以美國聯邦最高法院於Association for Molecular Pathology v. Myriad Genetics, Inc.案判決為中心,探討基因 技術之專利適格問題,本文首先概述美國聯邦最高法院歷 年就專利適格所作之重要判決,接著於介紹Myriad案歷審 判決,該案歷審法院之法律見解各有所重,判決結果亦有 相當差異,某種程度呈現了基因專利問題之複雜性與爭議 性。由於專利制度係採屬地主義,因此國際企業就重要技 術均會於不同法域申請專利,而不同法域之司法及審查機 關對相同專利技術有時會採取不同見解,本案Myriad公司 關於基因技術之系爭專利亦曾於歐洲及澳洲引發爭議,該 等法域之司法判決於本案討論亦有相當參考價值,因此本 文亦將析述之。最後,本文由自然產物之可專利性、專利 法促進創新之制度目的、病患權益維護、專利法與科學之 關連及專利與營業秘密之策略選擇等角度,分析本案所涉 及的專利政策及策略意涵。

英文摘要

The U.S. Supreme Court’s decision on Association for Molecular Pathology v. Myriad Genetics, Inc. has drawn wide attention from the academia and the biomedical industries. The most controversial issue underlying the decision is the patentability of isolated DNA and cDNA. This study first introduces a series of U.S. Supreme Court decisions on patentability and the subject matter issues. By providing an overview of the Myriad case decisions, from the district court to the Supreme Court, this Article illustrates the complicated legal issues associated with gene patenting. Interestingly, the European and Australia authorities have had different perspectives on the patentability of Myriad’s technologies, which are analyzed in the Article from a comparative perspective. Furthermore, this paper explores a number of policy implications from the Myriad case, including the patentability of product of nature, patent and innovation, and the protection of patients. This Article uses the Myriad case to illustrate the complicated interaction between science and the patent system. Finally, Myriad’s IP strategy after the Supreme Court decision also presents the tricky interface between patent protection and trade secret protection.

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