醫療單獨軟體之專利保護-以美國比較法對台灣之啟示為中心

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Title:	醫療單獨軟體之專利保護-以美國比較法對台灣之啟示為中心 Patent Protection of Medical Stand-alone Software: Focusing on the Enlightenment of Taiwan through Comparing with American Law
Authors:	郭庭妤 Kuo, Ting-Yu
Contributors:	李崇僖鄭菀瓊
Keywords:	醫療單獨軟體;上市監管;軟體專利;專利適格性 medical stand-alone software;regulate;software patent;patent-eligibility
Date:	2019-06-13
Issue Date:	2020-01-07 10:32:32 (UTC+8)
Abstract:	有鑑於Alice案對電腦軟體專利帶來的重大影響，醫療軟體作為電腦軟體之一環勢必受有影響。而美國聯邦最高法院於判決中強調在請求項中添加一般電腦元件並不足以將抽象概念轉換為具專利適格性的客體，有專家即指出此判準似乎意味著結合新的硬體元件的軟體方具有專利適格性，並建議在專利申請的撰寫上應該多描述硬體或電路元件之細節。然而，對許多軟體發明而言，新的硬體元件往往不是關鍵。隨著科技的發展，有別於過去醫療軟體通常內嵌於醫療器材中用於驅動或控制醫療器材，如今醫療軟體可配置在一般電腦或行動裝置上，並透過網際網路連結其他系統或資料庫，此類具有跨平台特性的「醫療單獨軟體」已成為近期蓬勃發展的產品。再加上醫療軟體受到主管機關上市監管之規範，其開發成本遠高於一般電腦軟體，一般顯認專利制度對於鼓勵創新具有重要性，因此最高法院於Alice案確立之二步分析法是否有礙於醫療單獨軟體取得專利保護，便相當值得探討。由於我國不論是醫療軟體上市監管架構或是專利制度均與美國近似，美國法之研究除能有助於業者了解醫療軟體發明在美國申請專利可能遇有之困難外，亦能作為我國實務詮釋相關法規之借鑒。本研究即利用判決分析的方式驗證二步分析法的操作結果是否特別不利於醫療單獨軟體，進而提出其對產業可能之影響與相關建議。 In view of the considerable impact of Alice on computer software patents, medical software as a part of computer software will be affected. In A lice, the U.S. Supreme Court emphasizes that adding generic computer components into the claim is not enough to transform an abstract idea into a patentable subject matter. Thus, some experts indicate that this criterion seems to mean only if the software combined with a new hardware components will be patent-eligible, and recommend that the details of the hardware or circuit components should be described in the patent application. However, for many software inventions, new hardware components are not critical. With the development of technology, unlike medical software used in the past, it was usually embedded in medical devices to drive or control medical device. Today, medical software can be deployed on generic computers or mobile devices, and connect other systems or database through the Internet.The medical stand-alone software with cross-platform features has become a booming product recently. In addition, medical software is regulated by authority, and its development cost is much higher than that of general computer software. The patent system is important for innovation. Therefore, whether the two-step analysis method established in Alice obstruct patent protection to medical stand-alone software is worth exploring. Since the regulatory structure for medical software and patent system in Taiwan are similar to that of the United States, the study of American law can help the industry understand the difficulties that medical software inventions may encounter in applying for patents in the United States, and it can also provide experience for the court in Taiwan. This study uses the method of judgment analysis to verify whether the operation of the two-step framework is particularly detrimental to the medical stand-alone software, and then propose its possible impact on the industry and related recommendations.
Description:	碩士指導教授：李崇僖共同指導教授：鄭菀瓊委員：莊弘鈺委員：何建志委員：梁志鳴
Data Type:	thesis
Appears in Collections:	[Graduate Institute of Health and Biotechnology Law] Dissertations/Theses

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