以美國Amgen公司為例探討生技醫藥公司發展之專利策略

Abstract

生技產業是一知識密集產業，研發期相當長，法規的障礙高，需投入龐大的研發資金，所以生物科技公司在發展的初期常與大藥廠結盟，將其擁有的專利授權或技術移轉給大藥廠，收取報酬與權利金，以支持後續的發展。所以專利權的取得是各生技公司回收巨額研發經費、與獲得利潤的關鍵。目前有關生物科技的專利權爭議並無太多判例，許多侵權糾紛甚至連智慧財產局的審查專家、法官、律師都無準則可依循，因此存在許多不確定因素。本研究藉由美國生技大藥廠Amgen公司發展過程所採行的策略行動、專利佈局，以及與Johnson & Johnson公司對於EPO專利授權糾紛的仲裁、與Genetics Institute 、Transkaryotic Therapies、Biogen公司等的專利侵權糾紛案例的分析，提供國內引進與移轉國外生物科技專利技術的參考。並歸納出Amgen公司產品技術發展的各個階段的專利策略，在產品導入期時的專利申請策略是重質不重量；在臨床、法規認證期則重在專利的部署與授權；而在專利權期間的專利侵權訴訟策略為將對手逐出市場，保障市場獨占的地位；最後在專利即將屆滿時的專利策略則著重在相關週邊技術的部署上，提供台灣發展生技醫藥的參考。

Biotechnology industry is highly knowledge and capital intensive. Not only the technology development takes very long time, the legal disputes display a tough entry barrier for new players. In order to collect enough capital, most new biotechnology companies have to be in alliance with and to license critical technology to major biomedicine companies. Patent plays a very critical role for a biotechnology company in making profit and collect its R&D funds. Legal and strategic analyses of patent litigation provide a useful reference for professional development and industrial analysis. This article presents Amgen’s business strategy, patent portfolio and strategy, as well as legal strategy as a case analysis. Especially, the arbitration of EPO patent licensing to Johnson & Johnson, and the patent infringement suits against Genetics Institute, Biogen, Tanskaryotic Therapies are analyzed. This study employs Amgen’s product development strategy and technology licensing as a guide to establish patent strategy for biomedicine product or biotechnology development. Amgen's patent strategy is evaluated in each stage of product life cycle. The patent quality is considered most important in the embryo stage of biotech product. To license patents and to design the patent portfolio in the patent certification stage determine the monopolistic position of a biotech product in the future markets. Legal strategy in managing patent infringement during patent granted period is critical to enhance competitive advantages. Finally, technology portfolio development while patents are expiring has significant influence in profit accumulation in the late stage. Amgen's strategy in each stage makes it a successful market leader, and it pays to learn this lesson with a case study presented herein.