藥品因為事涉公眾健康以及人類生命之延續，因此世界各國衛生主管機關皆以上市審查制度加以嚴格管制。為了通過審查，得到衛生主管機關之上市許可，藥廠必須提供藥品相關之臨床前與臨床試驗等測試資料，讓主管機關相信該藥品確實具有其所宣稱之安全性及有效性。「與貿易有關之智慧財產權協定」第39.3條乃規定會員國政府應對藥品測試資料提供保護，防止其洩漏以及被不公平商業使用。惟各會員國政府依賴第一家專利藥廠所提供之測試資料，以作為核准後續學名藥上市許可之依據，是否構成該條所謂的「不公平商業使用」？本文以為從該條之沿革、立法目的觀之，應擴張解釋第39.3條之適用範圍，使上述情形包括在內。基於此，台灣衛生署在七七公告以及雙十二公告中僅要求後續學名藥廠繳交較小規模之「國內臨床試驗報告」以及「銜接性試驗報告」，而免除其須繳交與專利藥廠相同之大規模測試資料之行為乃構成不公平商業使用，違反第39.3條之規定。

Pharmaceutical drugs are often hailed as the poster child for the proposition that patents foster accelerated rates of innovation. This sentiment stems, in large part, from the significantly high research and development (R&D) costs endemic to the pharmaceutical sector. I argue that if the role of the patent regime is one of fostering higher amounts of investment in the R&D process, it is better served by a direct investment protection regime, where the protection does not depend upon whether or not the underlying idea behind the drug is 'new' and 'inventive', the two central tenets of patent law. Rather, any drug that successfully makes it past the regulatory filter ought to be entitled to protection, since its discovery and development entail significant investment and risk. Owing to the inadequacy of the current patent regime in appropriately protecting intensive pharmaceutical R&D investments from free-riders, I propose a comprehensive investment protection regime that protects all the investment costs incurred during the drug discovery and development process. Though similar to existing data protection regimes in some respects, it differs in others. Firstly, it enables a recovery of all R&D costs, and not only costs associated with clinical trials. Secondly, unlike patents and data exclusivity which offer uniform periods of protection, it rewards investments in a proportionate manner, wherein drug originators are entitled to protection against free-riders only until such time as they recoup their specific investments and earn a rate of return on investment that is dependent on the health value of the drug. Given that a pure market exclusivity based investment protection regime is likely to foster excessive pricing and subject the market to the dictates of a single firm, I advocate a compensatory liability model based on a novel cost sharing methodology, where follow-on entrants are free to manufacture the drug, but must pay a reasonable amount of compensation to the originator.