藥品研發到上市所涉投資保障之法律問題

Abstract

藥品從研發到獲得上市許可是一漫長的過程，其中不僅涉及許多金錢與資源的投入，亦與國家相關政策有關。從藥品研發開始之專利權登記、近期與藥品有關之藥品試驗資料專屬保護、最後是否得獲取上市許可，這三件事情對藥廠而言非常重要。尤其是地主國對於藥品專利之核准與是否授予上市許可，為藥廠評估是否進入地主國投資之主要因素。 另外對於藥品試驗資料專屬保護，是為避免藥品研發耗時，專利藥廠最終獲得上市許可時其專利權之保護已屆期或即將屆期，一旦專利藥廠之專利到期，學名藥廠即可使用該專利生產製造學名藥，並進入市場一同競爭。將導致專利藥廠無法回收其所投入之成本以及獲取利益，將可能使藥廠傾向生產學名藥，而不願意投入資源為新藥品之研發。因此，近幾年由歐美主導之FTA將試驗資料專屬權納入保護範圍，以期給予藥廠更多保護。故，如地主國明文將此專屬保護納入其所簽署之協定中，地主國即應該與藥廠該保護，否則將對藥廠造成侵害。 然而並非地主國所有之管制或政策變更皆得被評價為對投資之侵害，地主國基於其主權，有權採取各種措施與規範來保護其國內之公共利益，因此在判斷地主國是否該當賠償責任時，必須透過公平公正待遇及徵收之原理原則為判斷，非一概認為只要對投資造成侵害即需給予補償，如此動輒得咎，將使投資協定凌駕於國家主權。 本文將藉由投資協定（例如北美自由貿易協定、美韓自由貿易協定與美國Model BIT）下之投資定義、公平公正待遇以及徵收之原則與規範來討論藥廠於投資仲裁中較常主張之問題：專利、資料專屬權及上市許可，並納入相關之仲裁案件做分析。

From R&D to marketing approval of pharmaceuticals, the drug company invests a lot of money and resources, in this period, it’s also controlled by the national policies. The beginning of the drug development (patent registration), data exclusivity, which has been discussed in recent years, and obtaining the marketing approval, these are most important things to drug companies. The law that host country relies on granting the patent registration and marketing approval are the main factors to drug company to decides whether to access the host country or not. The purpose of data exclusivity is to give additional protection to original drug companies, preventing the patent protection had been expired or will be expired as the drug company obtain the marketing approval. Once the patent expired, the generic pharmaceutical companies can use the patent manufacturing generic drugs, which will result in the investment loss of original drug company, and then, there may no drug company wants to invest R&D for new drug. In recent years, some FTA start discussing the data exclusivity and adding it in the FTA, to give more protection to drug companies. When the host country changed the regulatory or policies, it may cause the loss of investment of drug company, but not all invasion can be evaluated as breach the investment treaty. Based on the sovereignty, the host country has the power to take various measures to protect public interest in its territory. Therefore, when determined whether the host country should assumed the responsibility to compensate the investor, must be considerate the principle of FET and expropriation. Only when the measure of host country can’t pass the inspection of these principles, the host country has to compensate the investor. This thesis will discuss the definition of investment, fair and equitable treatment and expropriation in investment treaties (such as NAFTA, KORUS and US Model BIT), then analyze the pharm claims against host country: patent, data exclusivity and marketing approval, with cases study under investment treaty arbitration.