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    題名: 生物相似藥物藥廠專利行為及其對專利制度之啟示
    Patenting behavior of biosimilar manufacturers and its enlightenment for patent reform
    作者: 洪英愷
    Hung, Ying-Kai
    貢獻者: 鄭菀瓊
    Cheng, Wan-Chiung
    洪英愷
    Hung, Ying-Kai
    關鍵詞: 生物相似藥物專利
    生物製劑專利
    專利分析
    專利審查
    標準必要專利
    biosimilar patents
    biologic patents
    patent analysis
    patent examination
    standard-essential patent
    日期: 2021
    上傳時間: 2021-09-02 18:10:38 (UTC+8)
    摘要: 過去曾有研究揭示生物相似藥物藥廠可能會申請專利以保護其在商業上具有優勢的技術，然而，該專利行為似乎與專利制度的立法初衷背道而馳，現行的專利制度已確立了：先行者合法壟斷、後進者於專利到期後獲利之原則，因此，本研究全面性地探討生物相似藥物的專利行為，並證實其和原專利制度的理念相悖。
    透過與傳統化學學名藥相比較，本研究不僅證實生物相似藥的專利行為確實存在，亦發現其數量約佔其各自參照原廠藥物專利數量的 15%。本研究進一步分析了這群專利的類型、專利申請時間、專利申請順序等指標，發現生物相似藥的專利類型主要為製造方法和醫藥用途類型，另外，即使原廠藥物已被核發藥證，生物相似藥物藥廠的專利行為仍持續進行，有趣的是，在製造方法和醫療用途類型中所檢索到的專利，約有三分之一數量可在兩種以上的藥物被檢索到，這意味著該重複被檢索到的專利之技術可應用於多種藥物，最後，本研究嘗試以動態的視覺化圖形描繪本研究發現。
    本研究進一步依據專利申請人的申請動機、申請人對該專利技術的認知，和考量生物藥品的技術特性，將檢索到的專利初分成兩種類型：無意義的專利行為和目的性的專利行為。又根據目前的實證研究，雖然尚無法確定生物相似藥的專利行為是否不可避免，其原因可能和生物藥品難以界定的特性，與申請人豎立的專利叢林現象皆息息相關，經本研究討論，生物相似藥專利行為和生物原廠藥物的專利叢林互為複雜的因果關係，最終迫使所有相關利益者、整體社會、病患承擔更多成本。
    在不影響現行制度的前提下，應進行專利制度調整和其配套措施。本研究提出了兩種可能的改革方向，第一為提高生物藥品相關的專利審查標準、另一為將至少一種製造方法所涉及到的製造方法專利視為標準必要專利，讓生物相似藥物申請人，能以較為接近化學學名藥的情境進入生物藥品市場。
    Previous studies reveal that the bio-generic drug might apply for patents to protect their business-advantage techniques. However, the patenting behavior seems unexpected to the original purpose of the patent system. Patent system has long established the rule that: “pioneer monopolizes; followers gain after the patent expired.” Hence, this study explored the patenting behavior of biosimilars in the United states comprehensively and demonstrated that it is sometimes contrary to the traditional wisdom.
    Compared to the conventional chemical generics, the patenting behavior from biosimilars does exist and accounts for about 15% of their individual reference originators. The article further considers the indicators of patent types, filing time, filing order and finds that the favorite types of patent categories filed by biosimilar makers are manufacturing process and medical use. Furthermore, the patenting will not stop even if the originators got approvals. Interestingly, around one-third of the manufacturing methods and medical uses patent categories can be retrievable in more than two drugs, implying that the techniques involved may be applied for multiple drugs. Finally, the article proposes the visualization of the patenting behavior dynamically from biologics and biosimilars.
    The article further defines the patenting behavior based on the motivation and cognition of patent applicants into two categories: unintentional patenting behavior and purposeful patenting behavior with consideration of the natural properties of the biologic product. Although it is not clear that whether the patenting behavior from biosimilars is unavoidable, one of the motivations may be related to the patent thicket stacked by originators owing to the hard-to-define characteristic of the biologic product. The complicated reciprocal causation between biosimilar patenting behavior and patent thicket force all stakeholders and the society as a whole (including the patients) to bear more and more costs.
    Under the premise of not affecting the existing system, the standards and allocation measures of the patent framework should be adjusted. The investigation proposes two possible suggestions to unwind the problems. The first one is to enhance the criteria of patent examination. Another one is to put the manufacturing process patent as the standards-essential patent to those biosimilar applicants to mimic the scenario of the chemical generics.
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