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

Abstract

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.