複合式藥物商業模式之研究－以醫材公司為角度

Abstract

現行的藥物開發流程，不管是全新藥開發或者高階學名藥，多是曠日廢時；早早從實驗室延伸出來所申請到手的專利，往往經過化學結構的確認、劑量的調配、賦形劑的搭配、適用疾病的選定以及臨床試驗及法規認證多道關卡後，最後才會走到上市許可，此時原先藥物專利保護的年限可能所剩無幾，藥物上市沒多久馬上就會面臨到巨獸學名藥公司對產品及市場的虎視眈眈。 複合式藥物(藥械合一/Combination Products)是美國FDA針對藥物、器械或者生物製劑組合而成的產品所給的名稱。此種產品除了藥物本身的療效外，亦直接搭配了與該藥物最適的遞送裝置(方式)，可以提供患者最適的治療，亦可增加病患藥物依從性(Drug Compliance)、降低不良反應風險；此外，藥物與器械的專利屬兩種不同專業領域的範疇，在全球專業分工的企業經營模式下，鮮少有企業會同時具備藥物與器械豐富的專利及知識。 此篇除了介紹複合式藥物法規，亦透過案例分析複合式藥物的商業模式中，醫療器材公司如何在其產品及專利設計上適當的增加複合式藥物組合產品的在市場上的獨家銷售權，讓藥物開發公司原先認定所剩無幾的銷售年度可以延長，進而增加了醫療器材公司在藥物市場的不可取代性；又或者藥物開發公司透過老藥新用的模式配合複合式藥物法規，可以再次地以新藥的角色在市場上繼續銷售藥品，維持領先地位。

In the current day, drug company spends a lot of time developing new drugs and specific generic drugs in different chemical structures, dose, and formulation by laboratory in the early stage. After collocation, selection of applicable diseases, clinical tr, trials and regulatory certification, it will finally reach marketing authorization. At this time, the original patent protection period of the drug may be running out, and the drug will soon face competition from generic companies. Combination Products is the name given by the US FDA for products that combine drugs, devices, or biological agents. In addition to the curative effect of the drug itself, this product is also directly matched with the most suitable delivery device (method) for the drug, which can provide the most suitable treatment for the patient, increase the patient's drug compliance, and reduce the risk of adverse reactions; In addition, the patents of drugs and devices belong to two different professional fields. Under the business model of the global professional division of labor, few companies have rich patents and knowledge of drugs and devices at the same time. In addition to introducing the regulations on the combination of drugs and devices, this article also uses case studies to analyze how medical device companies can appropriately increase the exclusive sales rights of the combined products of durgs and devices in the market in terms of their products and patent designs in the business model of drug-device combination, so that the drug development company originally determined that the few remaining sales years can be extended, thereby increasing the irreplaceability of the medical device company in the drug market, and the company can continue to sell drugs in the market and maintain a leading position.