生技產物或方法相關專利法制之研究

The Study of Patent Institutions in Relation to Biotechnological Products and Processes

近年來，各種生技產物或方法無論於技術研發或實際應用上均快速成長，因此關於何種生技產物或方法得授予專利，以及生技產物或方法之專利權人行使該等專利的權利範圍是否應加以限制與如何限制所衍生之爭議也愈來愈多，而專利法制先進之國家或地區無不企圖藉由司法裁判或增修法規以解決此等問題。美國法制上與專利之申請及應用有關之規範涵蓋範圍甚廣，包括35 U. S. C. §101、§102及§103所訂有關得成為申請專利之標的之條件及其他申請專利之要件、35 U. S. C.§112所訂有關專利說明書之記載方式與內容、35 U. S. C. §287（c）所訂醫療從業人員及健康照護相關機構利用有關醫療的生技產物或方法之專利從事醫療活動得適用責任限制之條件及其範圍；美國專利商標局公布的「實用性審查基準」中有關基因之成分可授予專利的條件；美國專利商標局在2018年修正公布的「專利審查程序手冊」有關如何判斷「專利標的之適格性」與如何適用「標的適格性之兩部標準」所進行的說明；以及由美國聯邦最高法院與美國聯邦巡迴上訴法院之判決所建立的關於生技產物或方法是否能取得專利之判斷標準，此部分之內容將於本文第二部份詳加分析說明。歐洲相關公約與法制中為有效解決生技產物或方法是否能取得專利之問題，主要由歐洲專利公約與歐洲專利公約執行規則的相關規定；歐洲議會與理事會公布的相關指令；以及歐洲專利局與歐洲法院的相關案例建立其判斷標準，此部分之內容將於本文第三部分詳細說明。在台灣，有關生技產物或方法是否能作為申請專利之標的，以及生技產物或方法是否符合發明專利審查之要件，其主要規範為專利法第24條第2款及第3款、第22條第1項及第2項、第26條第1項；專利審查基準第2篇第2章及第14章；以及智慧財產法院的相關案例對於生技產物或方法是否符合專利要件之見解，此部分之內容將於本文第四部份詳細分析說明。本文之內容係綜合研究生技產物或方法之專利對於生技產業之研發誘因、改良發明之技術障礙、醫療倫理與醫療資源之妥適性等層面之影響，並檢討有關醫療的生技產物或方法是否應授予專利及其專利權人行使該等專利之權限應如何限制較為合理。最後，對於與生技產物或方法之專利有關的重要議題進行比較分析與彙整討論，並提出相關建議，作為台灣的專利相關規範適用與修訂之參考，以促進台灣有關生技產物與生技方法之專利法制能夠健全發展，期能有助於台灣的生技產業之成長與人民福祉之提升。 In recent years, various biotechnological products and processes all rapidly grow regardless of the technology research and development or the practical application, so are the issues which biotechnological products and processes can be granted patents, whether the fields of the patents should be limited and how it will be done; therefore, a number of the advanced countries or regions of the various patent legal system all attempt to resolve the issues by the judicial judgments or upgrading regulations. The scope covered by the provisions related to the application and use of patents in the U.S. legal system is very wide, including the conditions for being a patentable subject set by the United States Patent Law Article 101, Article 102 and Article 103, the manner and content recorded in the patent specification set by the United States Patent Law Article 112, the conditions and its scope of the limitation of liability for the medical practitioners and the products and processes in relation to medical therapy to practice medical activities set by the United States Patent Law Article 287 (c); the conditions for being patentable genetic components set by the “Utility Examination Guidelines” published by the United States Patent and Trademark Office; the interpretations with regard to how to determine “Patent Subject Matter Eligibility” and how to apply “Two Criteria for Subject Matter Eligibility” set by the “Manual of Patent Examining Procedure” amended and published by the United States Patent and Trademark Office in 2018; the criteria for the patentable biotechnological products and processes established by the decision of the Supreme Court and the Court of Appeals for the Federal Circuit in U.S. The previous provisions will be particularly analyzed and explained in the Part 2 of this Article. On the relevant European conventions and the legal system to effectively solve the problem of the patentable biotechnological products and processes, respectively, it relies on the provisions of the directive published by European Parliament and the Council of the European Union, the European Patent Convention, and the Implementing Regulations to the Convention on the Grant of European Patents; the criteria established by the related case of the European Patent Office and the Eurpean Court. The previous provisions will be particularly explain in the Part 3 of this Article. In Taiwan, the provisions related to whether the biotechnological products and processes are patentable and match the requirement of the examination of the inventions are mainly regulated in Taiwan's Patent Law Article 24, Item 2 and Item 3, Article 22, Item 1 and Item 2, Article 26, Item 1; the Patent Examination Guidelines in Chapter 2 and Chapter 14; the criteria for the patentable biotechnological products and processes established by the decision of the Court of the Intellectual Property. The previous provisions will be particularly analyzed and explained in the Part 4 of this Article. biotechnological products and processes for the effects on the R & D incentives of biotechnology industry, the technical barriers to the improvement of the inventions, the appropriation of medical ethics and health care resources, the review on whether the biotechnological products and processes in relation to medical therapy are patentable and how it is more reasonable to limit the exercise of such patent of patent holders. Finally, by comparing, analyzing and collectively discuss the important issues regarding the patents of the biotechnological products and processes and providing suggestions as the references for the application and the modification of Taiwan's patent-related legal provisions, in order to promote the sound development and the patent-related legal systems of the biotechnological products and processes, so as to look forward to assisting the growth of the Taiwan's biotechnology industry and the promotion of the public welfare.