OPSearch: American Journal of Open Research

The Doctrine of Equivalents in Balancing Patent Exclusivity and Generic Competition: Insights from the Novartis v. Pharmathen Dutch Jurisprudence

Allif Juliansyah — 2026-08-08

The intersection of pharmaceutical patent protection and public health imperatives presents a persistent global challenge, particularly in reconciling innovation incentives with affordable access to medicines. This legal memorandum examines the application of the doctrine of equivalence in Novartis v. Pharmathen before the Dutch courts and analyzes its relevance for the development of Indonesian patent law under Law No. 13 of 2016 concerning Patents. The central issue is whether a pharmaceutical process that does not literally fall within a patent claim may nevertheless constitute infringement when it performs substantially the same function and achieves substantially the same technical result as the claimed invention. This research employed a normative juridical method, utilizing statutory, case, comparative, and conceptual approaches to examine relevant legislation, judicial decisions, and legal doctrine. The analysis focuses on the Dutch courts' decisions, which applied principles developed in Eli Lilly v. Actavis, concluding that Pharmathen's generic production process infringed Novartis' patent through equivalence, despite formal differences in manufacturing steps. The courts emphasized that patent protection must carefully balance fair protection for patent holders against legal certainty for third parties, including generic producers and the public. This memorandum concludes that while the doctrine of equivalence can prevent the avoidance of patent liability through minor modifications, its application requires robust safeguards against excessive patent expansion and evergreening practices. The case offers instructive lessons for Indonesia in developing a balanced patent framework that protects pharmaceutical innovation while maintaining fair competition and public access to medicines, an area where Indonesian jurisprudence remains comparatively underdeveloped.

Identifying Critical Delay Risks in Internal Corporate Procurement Through Business Process Mapping: A Case Study of Air Compressor System Projects

Cokro Yudha Nugroho — 2026-08-11

Internal corporate procurement plays an essential role in supporting project delivery performance, particularly in complex industrial systems involving multiple functional units, technical requirements, and global supply chain coordination. However, the procurement of air compressor systems remains vulnerable to delivery delays arising from uncertainties related to technical specifications, approval procedures, production capacity, component availability, and international logistics. This study aimed to analyze the existing business process structure for the internal procurement of air compressor systems at PT X and to identify potential risks at each stage of the procurement process that could contribute to delivery delays and contractual penalties. The study employed a qualitative case study design. Data were collected through document analysis, procurement project records from 2021–2024, direct observations, and in-depth interviews with personnel involved in project management, engineering, procurement, factory coordination, and logistics. The data were analyzed using business process mapping and qualitative risk identification based on the principles of ISO 31000 and the Project Management Body of Knowledge (PMBOK). The findings revealed that the procurement process comprised five major stages: technical planning and specification, internal approval, factory order placement, production and subvendor management, and logistics and delivery. Five major delay risks were identified: specification changes, approval delays, delayed factory order placement, subvendor component delays, and customs clearance and shipping disruptions. These risks increased procurement lead times and adversely affected project delivery performance. The study concluded that greater process standardization, stronger cross-functional coordination, and structured risk control mechanisms were necessary to minimize procurement delays and improve project delivery reliability.

The Effect of Financial Ratios on Stock Prices Through Financial Distress as a Mediating Variable

Rodiansyah Rodiansyah — 2026-08-01

The Indonesian textile and garment sector has experienced persistent declines in stock prices, reflecting weakened corporate fundamentals and increasing risks of financial distress. Although previous studies have examined the relationships among financial ratios, financial distress, and stock prices, limited evidence explains the mediating role of financial distress in linking corporate financial performance to market valuation. Grounded in signaling theory, this study investigates the effects of Net Profit Margin (NPM), Total Asset Turnover (TATO), and Current Ratio (CR) on stock prices through financial distress measured using the Altman Z-Score. A quantitative explanatory approach was employed using secondary data from 14 textile and garment companies listed on the Indonesia Stock Exchange during the 2021–2024 period, yielding 56 firm-year observations selected through purposive sampling. The data were analyzed using multiple linear regression, path analysis, and the Sobel test. The results indicate that NPM, TATO, and CR simultaneously affect financial distress, while only CR demonstrates a significant positive partial effect, indicating that stronger liquidity contributes to improved financial health. Furthermore, only financial distress significantly influences stock prices, whereas NPM, TATO, and CR do not have direct significant effects. The Sobel test result (Z = 2.624; p = 0.0087) confirms that financial distress fully mediates the relationship between CR and stock prices. These findings support signaling theory by demonstrating that investors respond more strongly to firms’ overall financial health than to individual liquidity ratios. The findings provide practical insights for managers seeking to strengthen financial stability and enhance investor confidence.

Legal Pluralism in The Practice of Underage Marriage: The Interaction of State Law, Islamic Law, and Bugis Customary Law in Mattiro Sompe

Subhan Subhan — 2026-08-15

Child marriage remains a persistent legal and social issue in Indonesia despite regulatory reforms establishing a minimum legal age of marriage of 19 years under Law Number 16 of 2019. The persistence of child marriage indicates that legal compliance is shaped not only by state law but also by religious interpretations and customary norms embedded within local communities. This study aimed to analyze the interaction among state law, Islamic law, and Bugis customary law in the practice of child marriage in Mattiro Sompe District, Pinrang Regency, and to identify forms of negotiation, adaptation, and integration among these legal systems. The study employed qualitative field research using socio-legal and normative juridical approaches. Data were collected through in-depth interviews, observations, and document analysis involving religious leaders, customary leaders, government officials, and community members and were analyzed using the interactive model of Miles, Huberman, and Saldaña. The findings revealed that child marriage practices reflected a condition of legal pluralism in which state law, Islamic law, and Bugis customary law simultaneously influenced community decision-making. The interaction among these legal systems did not always generate conflict but also involved processes of negotiation and adaptation. The Bugis cultural value of siri’ could be reconstructed as a principle of responsibility for safeguarding children’s dignity and future well-being, while Islamic legal considerations could be interpreted through the objectives of Islamic law (maq??id al-shar??ah). The study concluded that effective prevention of child marriage requires dialogical integration among formal legal frameworks, Islamic legal principles, and local customary norms to strengthen legal legitimacy and ensure sustainable child protection.