免疫檢驗試劑專利分析

Abstract

生醫產業的特性為專利權取得的成本高，或是廠商間普遍存在共生結構，研究機構或生醫公司與藥廠之間的合作關係無可避免，故以企圖以營業秘密的方式來保護智財權相對困難，因此多以專利權保護之。免疫檢驗試劑屬於生醫產業的一部分，也具有此特性，是故台灣欲發展免疫檢驗試劑產業的第一步，必須先分析此領域的專利。 檢驗試劑（immuno-diagnostic reagents）是指利用抗體與抗原結合所產生的免疫專一性反應，定性或定量分析檢體中抗原或抗體的測試藥劑，為體外診斷醫療器材（In Vitro Diagnostics, IVD）的一部分。免疫檢驗試劑技術具有特異性高、敏感性強、使用方便、價格便宜及應用範圍廣泛等優點，其應用產品已成為體外診斷醫療器材的主流，其應用類別可分為傳染性疾病、內分泌、腫瘤、過敏免疫、藥物濫用、藥物殘留及血球檢驗等，其市場規模占了整體體外診斷醫療器材市場1/3以上，且有日趨成長的趨勢。 目前免疫檢驗試劑的領導廠商多為美國或德國醫療設備大廠，如：Abbott Laboratories、Bayer Diagnostic、Becton Dickinson等，台灣廠商在此領域的全球市場占有率非常小。故本研究試圖以專利搜尋軟體搜尋免疫檢驗試劑領域的專利，並進行專利分析以及各領導廠商的專利地圖及專利策略。藉由搜尋結果和專利分析後得知，免疫檢驗試劑領導大廠的專利大多集中在血液檢驗、免疫檢驗和檢驗試劑設計上。因此，台灣如欲發展此產業，必須先迴避這三方面的市場，發展專利較少的傳染病領域，以取得利基市場，增強本身的競爭優勢。

The characteristics of the industry of immuno-diagnostic reagents are high cost, collaboration and strategy alliance. The patents are necessary for immuno-diagnostic companies to protect their intellectual property. Therefore, it has to analyze patents in the fields of immuno-diagnostic reagents when Taiwan’s companies enter the industry. The immuno-diagnostic reagent is one kind of In Vitro Diagnostics. The theory of immuno-diagnostic reagents is that the antigen combines the antibody to make unique reaction and then the reagents can analyze the quality or capacity by the reactions. The advantages of immuno-diagnostic reagents are high sensitivity, easy using, cheap and widespread applications. The categories of immuno-diagnostic reagents are infectious disease, endocrine, tumor, allergic reactions, drug misapplied and blood test. The market of immuno-diagnostic reagents is occupied more than one-third market of In Vitro Diagnostics now and it will grow in the future. In the field of immuno-diagnostic reagents, Abbott Laboratories, Bayer Diagnostic and Becton Dickinson are the leader companies. Their patents focus on blood test, immune test and reagent design. If Taiwan’s companies want to enter the industry, they can’t focus on the three fields. They have to concentrate on different fields to get the niche market.