專利新「纖」事——新興減重藥之專利有效性挑戰【本期企劃】 試閱
A Look at PTAB Validity Challenges Against GLP-1 Drug Patents
隨著統稱「瘦瘦筆」或「瘦瘦針」的一類減重藥物效果受到矚目，各大藥廠開始研發學名藥加入競爭，因而在專利連結制度下引發侵權訟爭。本文分析訴訟過程當中的有效性挑戰環節，介紹美國專利商標局審理暨訴願委員會就「瘦瘦筆」大廠諾和諾德專利所做成之三件多方複審成案裁決。由裁決中可以得知「瘦瘦筆」專利之技術保護重心，並擷取出可能適用於醫藥領域其他多方複審案件的通則，更可進一步反思美國生醫產業專利布局及訴訟之現況。
As a class of weight-loss medication known as GLP-1 drugs have skyrocketed in popularity, pharmaceutical companies are rushing to develop generic versions, triggering patent litigation with original brand-name manufacturers under the patent linkage system. This article explores the patent validity challenge aspect of this array of litigation, parsing three PTAB IPR institution decisions in challenges against leading manufacturer Novo Nordisk’s GLP-1 drug patents. These decisions reveal the technological focus of the company’s GLP-1 drug patent protection, allow for extracting general rules potentially applicable in future bio/pharma IPR cases, and further invite reflection on the patenting and litigation landscape in the pharmaceutical industry.
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