The Legal Issues of Pharmaceuticals under Investment Treaty Arbitration: from R&D to Marketing Approval
Date Issued
2014
Date
2014
Author(s)
Hsu, Ching-Han
Abstract
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.
Subjects
藥品
專利
藥品試驗資料專屬權
上市許可
投資協定
公平公正待遇
徵收
Type
thesis
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