藥品長青樹專利探討-以2015年全球前十大藥廠為研究對象

Abstract

「藥品的價值來自於專利權之排他性，其權益影響專利權人、學名藥廠與消費者等關係至深。專利權人憑藉此得以獨占技術與市場，以可觀的獲利填補龐大的研發成本」 。對製藥產業而言，藥品專利保護期間越長越能獲得高度優勢，為能繼續延長藥品生命週期、阻擋學名藥廠分食市場商機，則不斷用以長青樹專利作延伸擴張。綜觀製藥公司產業發展及營運皆需要莫大的資金潛力，此高度且具體關係到專利策略。然而，藥廠面臨「專利懸崖」（Patent cliff）的困境下，其關鍵策略之接續佈局、產生之商業效益與臨床實質發展將是利益與道德價值的雙面觀。

多年來，許多研究藥品專利的觀察家與學術論作的學者對於藥廠的專利策略存在許多質疑，認為藥品知識產權保護的概念精神與實際做法大相徑庭。《May your drug price be evergreen》 作者Robin Feldman及團隊依據美國食品和藥品管理局（U.S. Food and Drug Administration, FDA）自2005年至2015年專利「橘皮書」（Orange Book）公佈的資料做綜合性研究，統整出《Evergreen Drug Patent Search》資料庫 ，並於2018年12月在期刊發表研究結論表示「製藥公司不是全然創造新藥，而超過半數主要是回收和重新利用現有藥品再申請專利」 。研究團隊依據資料庫資訊及統計結果提出評論，揭露藥廠試圖運用長青樹專利的手段維持市場競爭地位，意指藥廠不斷藉由延長專利保護以維持高藥價，目的實則為壟斷市場而非具有創新研發專業。此評論除了令製藥界產生衝擊之外，更點出專利制度的瑕疵需要莫大程度的改革。

本文依據資料庫，統計蒐集並以2015年當年度全球前十大具研發能力之藥廠擁有長青樹專利添加數量（Evergreen Patent），相較在產品研發的支出占比（R&D spending rate）、與淨利率（Margin）探討其三者的相關聯性，以驗證作者Robin Feldman團隊資料庫研究分析評論的客觀性，以及對藥廠發展長青樹專利的看法與建議並依本文研究結果，此一資料庫對於藥廠的競爭分析研究與藥品專利佈局上是否具有更佳的資料參考價值總結。

"The value of pharmaceuticals comes from the exclusivity of patent rights, and their benefits deeply affect the interests of patent holders, generic drug manufacturers, and consumers. Patent holders are able to monopolize technology and the market, filling the vast R&D costs with considerable profits. For the pharmaceutical industry, longer patent protection periods provide greater advantages, allowing them to extend the life cycle of drugs and block generic drug manufacturers from sharing market opportunities by continuously using evergreening patents for expansion. The development and operation of pharmaceutical companies require significant financial potential, which is highly related to patent strategies. However, pharmaceutical companies face the dilemma of the "patent cliff," and the continuity of their key strategies will result in both commercial benefits and clinical development that reflect both profit and ethical values.

Over the years, many observers and academic scholars who have studied drug patents have questioned the patent strategies of pharmaceutical companies, believing that the concept and practice of protecting drug intellectual property rights are vastly different. This article's research subject, "May your drug price be evergreen," by author Robin Feldman's team, conducted comprehensive research based on the data from the Orange Book patents published by the U.S. Food and Drug Administration (FDA) from 2005 to 2015, and integrated the "Evergreen Drug Patent Search" database. The team published their research conclusion in a journal in December 2018, stating that "pharmaceutical companies do not entirely create new drugs, with over half primarily recycling and reusing existing drugs to reapply for patents." Based on the information and statistical results of the database, the research team made comments, revealing that pharmaceutical companies attempt to maintain their market competitiveness by using evergreening patents to keep drug prices high, indicating that their purpose is to monopolize the market rather than having innovative research and development expertise. This comment not only shocked the pharmaceutical industry but also pointed out that the patent system needs significant reform.

Based on the data from the database, this article collects and statistically analyzes the number of evergreen patents owned by the top ten R&D-capable pharmaceutical companies worldwide in 2015, and explores their correlation with R&D spending rate and net profit margin to verify the objectivity of the database analysis and provide views and recommendations for the development of evergreening patents by pharmaceutical companies. Based on the research results, this database may have better data reference value for pharmaceutical companies' competitive analysis research and drug patent layout."