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EUROPEAN PHARMACEUTICAL PATENT CHALLENGES: A CASE-BASED PERSPECTIVE

DAMJAN BEKAROVSKI ^1,2, ANA POCEVA PANOVSKA ¹, ALEKSANDAR DIMKOVSKI ¹*, MARIJA MITKOVSKA ², KATERINA ANCEVSKA NETKOVSKA ¹

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Pharmaceutical patents play a central role in innovation-driven drug development by granting time-limited protection intended to reward research investment. However, although substantive patent law is formally harmonized under the European Patent Convention (EPC), enforcement remains nationally fragmented. Divergent judicial interpretations can influence legal certainty, pharmaceutical market dynamics, generic entry timing, and healthcare expenditure. This study examines how variation in national patent adjudication affects innovation incentives, competition, and public health outcomes in Europe. Using three case studies - rivaroxaban, apixaban, and tadalafil - the analysis integrates legal doctrine with pharmaceutical market data to assess how interpretations of inventive step, plausibility, and sufficiency of disclosure influence the timing of generic entry. The findings indicate that judicial fragmentation leads to asynchronous generic entry across member states, resulting in uneven price convergence and differences in healthcare expenditure. The establishment of the Unified Patent Court (UPC) may improve legal consistency, although its long-term impact on pharmaceutical market dynamics remains to be fully evaluated.