Product life cycle was coined for the first time as a concept by Dr Raymond Verono at his published paper-"International Investment and International Trade in the Product Cycle". In this paper, Dr Verono specified that each product has its inherent periodicity or product life cycle pattern, the performance of each product cycle were varied based on different technical expertise which result in different global market sharing. And for those technical expertise differences can be calculated based on their product life cycle pattern. Based on this theory, data were extracted and collected from IMS database, resulted in 277 new FDA market approval new drug from 2005-2015 including drug sales, markets share and other parameters. Meanwhile, in total of 81l corresponding drug patents data were collects from FDA orange book edition 2018. The typical product life cycle pattern was set as standard to measure the drug sale pattern. After then, selected drug parameters such as net sale, agent nationality, ATC category were used to describe new drug market tendency by using statistical method. With that, the advice can be concluded for Chinese pharmaceutical company which want to set out on its march to the US market. The result illustrated that the total new drug market tendency is on the steady increase with most of drug sale pattern match typical product life cycle performance. To be specific, total new drug market sharing is well performed and so does authorized patent numbers. Net sale for 133 new marked drugs from 2005-2015 is 20.49 billion dollars, 19 of all are above 5 billion sales. Therefore, total drug sale has an ongoing tendency toward those high value drugs. In terms of patent, the high quality patent include drug product patent and active ingredient patent gain a large proportion of total patent. However, those patent were not evenly spread though out countries and pharmaceutical company. Counties like US, UK, JP has patents in various therapeutically field, and other countries were focus on one or two field. Based on the search result, two advises were given to Chinese pharmaceutical company which want to set out on its march to the US market. Firstly, focusing research and study on Japanese pharmaceutical company, to find out their strategical step in how to set on its march to the US market in advance. Secondly, the research has shown that even the big pharm has huge advantages in developing new high value drug however there is no significant difference between big pharm and small pharm in terms of high quality patent proposition. In other words, small company are still having opportunity to develop high value patent and make profit from it. Therefore, focusing on developing high value patent and cooperating with foreign pharm is an alternative stratagem for Chinese Pharmaceutical Company to make international market share. Keywords: US new market approval drug, drug sale analysis , drug market analysis, drug patent analysis, product life cycle

簡介：專利許可被廣泛作為大學商業化其研究成果和發明的重要途徑。許多大學會主動參與到專利許可的活動中。同時，專利許可在大學間的醫藥領域是非常常見的行為，值得深入研究。現今很少研究會注影響大學專利許可概率的因素。為了填補這個研究空白，我藥專利嘗們基於新試探索大學專利許可的影響因素和提出中肯的在研究上和實踐中的啟示。 方法：我們運用 IMS Lifecycle 資料收集了 369 個新藥專利資訊，實證性地探索專利許可概率的影響因素。這些資料包括來自 1980-2015 年間不同大學的 142 例許可專利和 227 例未被許可的專利。基於我們收集到新藥專利資訊，我們再通過美國專利局、歐洲專利局和 IMS Lifecycle 資料庫，構建出八個變量。這些變量由大學層面、專利層面、藥品層面的潛在影響因素共同組成。隨後，我們採用二元回歸模型分析這些變量。 結果：多次的回歸結果顯示我們的資料較好的吻合我們所用的模型。研究發現：(1)大學研發能力和研究的範圍與大學新藥專利的許可概率成正相關關係。(2)研究年限對專利許可的結果有負向的影響。(3)專利的認可度，專利的原始影響力和專利的複雜程度均能影響大學藥品專利的許可概率。(4)新藥的適應症的數量也能幫助提高大學新藥專利被成功許可的概率，而是否治療慢性病專利許可的結果沒有顯著影響。 結論：我們的研究驗證了專利品質仍然是影響大學新藥專利許可的核心影響因素。同時，大學層面和新藥層面的變量也能影響大學新藥專利的許可結果。大學在加強研發能力和研究的範圍的同時，科學性地構建更多的潛在的適應症將有助於提高大學藥品專利的許可概率。 關鍵詞：專利許可；大學專利；新藥；實證研究