專利延長期間權利與實施範圍的探討

Abstract

醫藥品專利權期間延長制度係為補償專利權人因申請上市許可而無法實施發明之期間所設。然而，關於延長期間之權利範圍解讀與實施態樣的限制，在學理與實務上常有爭議。本文從專利權之本質探討出發，來論述其權利邊界相較傳統物權更具高度之政策導向，應隨產業需求與公共利益動態調整。 本文進一步以比較法研究方法，分析美國、歐盟、日本與我國之專利延長制度，聚焦於「第一次許可之認定」、「得申請專利延長之適格專利」與「延長期間之權利範圍」之爭議。相較於其他各國已有相對完整與穩定之實務見解，我國現行實務在上述認定上仍有諸多爭議，以致對原開發廠或學名藥廠的發展與競爭皆造成影響。 基於上述分析，本文主張我國現行專利延長制度應進行雙軌調整：一方面在權利認定上回歸技術本質，將現行專利延長審查基準當中「第一次許可證」與「延長保護範圍」之審查標準，由現行以不同鹽類或水合物等形式有別之判斷，調整為以實際具有藥理作用的「活性部分（active moiety）」與其核准之適應症為核心進行保護，以給予原創藥廠實質保護；另一方面，鑑於維持國內學名藥產業競爭力與公共衛生之供應鏈韌性，本文建議參酌歐盟補充保護證書（SPC）製造免責（SPC Manufacturing Waiver）之立法趨勢，引入「專利延長期間之製造免責」，允許學名藥廠在專利延長期間內為出口進行製造。期能透過「實質保護核心發明」與「排他權效力出口例外」之調整，在獎勵創新與促進產業發展間取得最佳平衡。

The patent term extension (PTE) system is designed to compensate patentees for the inability to exploit their inventions during the regulatory review process for marketing authorization. However, the interpretation of claims and the limitations on types of exploitation during the extension period remain controversial. Starting from exploring the nature of patent rights, this thesis argues that, compared to traditional property rights, the boundaries of patent rights are highly policy-driven and should be dynamically adjusted in response to industrial needs and the public interest. Adopting a comparative legal research method, this study analyzes the PTE systems in the United States, the European Union, Japan, and Taiwan, focusing on controversies regarding the determination of the “first market authorization,” “patents eligible for extension,” and the “scope of claims during PTE.” In contrast to other jurisdictions where case laws are relatively established and stable, Taiwan's current practice involves significant ambiguity regarding these determinations, adversely affecting the development and competition of both brand and generic pharmaceutical companies. Based on the analysis, this thesis proposes a two-track structural adjustment for Taiwan's PTE system. First, regarding the determination of rights, the criteria for “first market authorization” and “scope of claims during PTE” within the current examination guidelines should return to the technical essence. The practice of differentiating based on forms such as salts or hydrates should be adjusted to focus on the “active moiety” that actually provides pharmacological effects and its approved indications, thereby providing substantive protection to innovators. Second, to maintain the competitiveness of the domestic generic drug industry and ensure supply chain resilience for public health, this thesis suggests introducing “Manufacturing Waiver” during PTE, modeled after the EU’s Supplementary Protection Certificate (SPC) regulations. This would allow generic manufacturers to manufacture for export purposes during PTE. Through this adjustment of “substantive protection for core inventions” combined with “exceptions to exclusive rights for export,” this study aims to achieve an optimal balance between incentivizing innovation and promoting industrial development.