Swedish Court of Appeal success leads to new guidance on SPCs

21 March 2025

Zacco has successfully represented their client at the Patent and Market Court of Appeal, case PMÄ 10459-22, requiring a reinterpretation of Article 3(d) of the SPC regulation in Sweden.

In the case, our client claimed the marketing authorisation provided in late 2018 for Bevespi Aerosphere® (a drug comprising two active ingredients that is used to treat the symptoms of chronic obstructive pulmonary disease (COPD)) was the first valid authorisation to market their combination product as indicated. Their SPC application was rejected by the Swedish Patent Office, the PRV, who claimed it contravened Article 3(d) of the SPC Regulation, which requires SPCs must be based on the first marketing authorisation to place a drug on the market.

The rejection was underpinned by reference to another known drug, Trimbow®, with a marketing authorisation dated 2017 comprising three active ingredients. PRV had interpreted Article 3(d) to mean that the first marketing authorisation is the first to include the product among its active ingredients, even though these were for a different therapeutic use than what this drug was approved for comprising two active ingredients. The Court concluded, one approval to market the active ingredients A + B + C is not considered to constitute a valid approval for the marketing of A + B considering all facts in the case.

Michael Bystrom successfully argued on appeal, first at the Patent and Market Court which PRV appealed and thereafter at the Patent and Market Court of Appeal that the marketing authorisation for the drug dated 2017 was not valid for the new drug and thus cannot constitute the first marketing approval according to Article 3(d).

The successful result has a direct impact on the interpretation of Article 3(d) moving forward in Sweden.

Zacco’s client commented that “It was a pleasure to work with Michael Byström on this case. His expertise and collaborative approach were key factors in achieving this significant result.”

The final result was a team effort and follows on from another SPC success that also led to new guidance in Sweden. If you’re looking for expertise and advice regarding SPC filings or litigation, then reach out to Michael directly.