生技製藥廠商就其疫苗產品的專利保護及攻防策略之研究

Abstract

本論文的研究目的，是希望能提供國內藥廠或生技公司一套與專利權相關的全面保護及攻防策略，使得其疫苗相關研發成果，能獲得周全的保障。 本論文主要分為四個部分:疫苗的概念、疫苗市場及疫苗專利之發展近況、疫苗發明之專利法規範、疫苗專利權期前及期間之保護策略。 經由第一部分的內容，理解疫苗作用及製作的原理、技術的困境及研發的進展何在，以及疫苗的研發從實驗室階段到真正得以上市、施用於人體，所需耗費的時間經費，可知單一疫苗產品的研發上市相當不易，而有賴於商業策略方面及專利保護方面同步運行來支持這個過程。因正確的智財策略能提供研發的方向及研發成果的保護，導致成功的研發與成功的市場銷售，而成功研發帶來商機，成功的市場銷售提供研發的經費，而故這三者之間是相輔相成的關係。因此，第二部分便從產業現況的角度，了解目前疫苗技術發展的趨勢及疫苗產品市場分配狀況，以及與疫苗技術有關的專利申請情形；並在第三部分簡單介紹專利法規。 第四部分又略分為三個子部分:從研發到上市期間對技術的保護策略、專利權取得後的攻防策略、專利權取得後的合作策略。第一子部分包括專利申請前的技術評估管理及專利權之取得策略；第二子部分則分別由訴訟原告及被告角度提出訴訟策略；第三部分則分述授權、聯盟至併購等不同程度的合作方式。

The purpose of this thesis is to provide a set of patent and battle strategies for the domestic pharmaceutical industry and biotechnology companies. The aim is to obtain a comprehensive protection of vaccine-related technology. The thesis is divided into four parts: the concept of vaccine, the current development of the vaccine market and the vaccine patents, patent law and finally the vaccine protection strategies before and during the period of patent right. Part I talks about how a vaccine works and how to manufacture vaccines, as well as how much time and money would be consumed during the whole process from the laboratory stage to the point where it is possible to apply the vaccine to human beings and be released onto the market. According to this study, it is evident that it is a long and difficult way for a single vaccine to become a final product, and it needs the combination of both business and patent protection strategies to support this process. This is because a correct patent strategy gives correct direction for the development and protection of research results, which then leads to successful development and marketing. Successful marketing, on the other hand, provides funds for the development and successful development brings good business. Therefore, these three elements -- development, marketing and patent strategy -- work together in a complementary fashion. Accordingly, Part II takes the perspective of the current market, to understand the development trend of the vaccine technology and the market distribution of vaccine products, as well as the vaccine-related patent applications. Part III then discusses the patent law. Part IV is further divided into three parts: the technology protection strategies from the research stage to the market, battle strategies after obtaining patent rights, and collaborations after obtaining patents. Part (i) includes the assessment and management of a technology before filing a patent application and the strategy of obtaining a patent; Part (ii) provides respective strategies for the plaintiff and the defendant in a patent suit; Part (iii) describes different levels of cooperation, from licensing to alliances and M&As.