The first judgement on the Supplementary Protection Certificate (SPC) manufacturing waiver issued by the Munich District Court, Germany in October 2023 caused a deep concern among the generic and biosimilar industry, as highlighted in a note from Medicines for Europe. According to the industrial representative, the Munich District Court would have adopted an inordinately restrictive interpretation of the SPC manufacturing waiver, which contradicts the purpose and spirit behind the amendments introduced until its final approval. “This utterly frustrates the aims of the legislation and disincentivises investments in Europe”, writes Medicines for Europe.

More in particular, the industrial association disagrees with the judgment that SPC manufacturing waiver for export would require notification of a marketing authorisation (MA) number – even if no MA number is publicly available – or the disclosure of confidential information about future country of submission. According to the Court, these requirements would derive from an alleged need to ensure that there are no intellectual property rights in the foreign country of export. The German first-instance judgment further suggests that for manufacturing in the EU and export to a third country to be permissible, a granted MA in such third country would be required. 

Medicines for Europe concerns extend to the possibility the outcomes of the judgment could be used by SPC holders to threatener sue existing and future users of the SPC manufacturing waiver. The ongoing reform of the SPC regulation may also add some other confusion, according to the note. Medicines for Europe thus asks for a urgent clarification and simplification of the SPC manufacturing waiver legislation, to make the EU an attractive place for developers and manufacturers of pharmaceutical products, and to strengthen the security of supply.