Pharma Firms Can Sue Competitors For Violating Orphan Exclusivity, German Court Rules

A German civil court has ruled that pharma firms can enforce market exclusivity rights for orphan drugs by taking legal action against competitors. Lawyers say this decision, which relates to Alexion’s Soliris, is the first of its kind and will likely have a wider impact across the EU.

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Orphan drugmakers can sue competitors for breaching market exclusivity rules, a court said

Under EU orphan drug legislation, newly authorized medicines for rare diseases are eligible for a decade of protection from market competitors – a rule that offers an important financial incentive for pharmaceutical companies to develop therapies for niche indications.

The enforcement of this incentive, as set out under Article 8(1) of the EU Regulation on Orphan Medicinal Products, has traditionally fallen on the regulator, under public law

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