German Federal Patent Court’s landmark Safinamide ruling

The German Federal Patent Court’s landmark Safinamide ruling (14 W (pat) 23/24) provides a strategic blueprint for pharma industry, confirming that single-agent SPCs (Supplementary protection certificate) can be successfully secured via combination “use” claims. By applying the “Teva/Gilead” test to distinguish innovative “add-on” therapies from restrictive “composition” interpretations, this decision enables companies to maximize market exclusivity with 5-year extensions for complex treatment regimens.

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