Overlapping Intellectual Property Regimes in the Pharmaceutical and Medical Device Sector: Regulatory Gaps, Tension Analysis, and a Harmonized Legal Protection Framework for Indonesia
Keywords
access to medicines compulsory licensing health law intellectual property overlap patent–trade secret tension pharmaceutical industry TRIPS flexibilitiesAbstract
Background: Pharmaceutical and medical device innovations in Indonesia often generate intellectual outputs eligible for overlapping protection under copyright, patent, and trade secret regimes. These inter-regime overlaps create regulatory gaps, enable cumulative exclusivity, and raise concerns regarding equitable access to health technologies. Objective: This study analyzes Indonesia’s intellectual property (IP) regulatory framework, identifies structural patterns of overlap across IP regimes, examines key legal tensions affecting public health access, and proposes a harmonized regulatory approach. Methods: A normative juridical method was employed, combining statutory analysis, conceptual legal interpretation, and comparative law. Primary materials include Indonesian IP laws and international instruments such as the TRIPS Agreement and the Doha Declaration. Case-based insights were drawn from selected examples in India, Brazil, and the European Union to contextualize regulatory approaches. Results: Four typologies of inter-regime overlap were identified, each associated with distinct public health implications. Two critical tensions emerged: (1) trade secret protection limiting the practical effectiveness of compulsory licensing mechanisms, and (2) copyright claims restricting access to safety-related regulatory data. Comparative analysis indicates that while existing regulatory models address specific dimensions of overlap, none provides a fully integrated coordination mechanism. In response, this study proposes a five-principle harmonized framework supported by an operational decision pathway. Conclusion: IP overlap represents a structural regulatory challenge in Indonesia’s health sector. Addressing this requires coordinated legal reform, strengthened institutional alignment, and clearer implementation mechanisms to balance innovation incentives with public health access
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