Court decision on SPC manufacturing waiver risks undermining its use

Generics and biosimilars trade group Medicines for Europe and its members are strongly concerned by the first judgement on the Supplementary Protection Certificate (SPC) manufacturing waiver issued by the Munich District Court, Germany, in October 2023.

The SPC manufacturing waiver is a legal tool enacted in 2019, aimed at enabling the manufacture of medicines, under certain conditions, during the up-to-five-year extension of the market protection of certain patented medicinal products in the European Union (EU), to preserve the competitiveness of the European generic and biosimilar medicines industry, stimulate investments in medicines manufacturing in Europe and avoid delocalization in the medicines industry.

In this judgement, the Munich District Court adopted an inordinately restrictive interpretation of the SPC manufacturing waiver, which cannot be derived from the letter of the law, and which contradicts the purpose and spirit behind the amendments that were introduced during its prosecution until its final approval. This utterly frustrates the aims of the legislation and disincentivizes investments in Europe.