由AMP v. Myriad Genetics, Inc.案談基因專利之適格性

Abstract

本文以美國聯邦最高法院於Association for MolecularPathology 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。

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.