Important Update on SPC Regulation Interpretation!


In a recent decision, the Swedish Patent and Market Court provided critical insights into the interpretation of Article 3(b) and 3(d) of the SPC Regulation.

The court opined that:

  • The Marketing Authorization (MA) for Trimbow cannot be considered the first MA for the combination of formoterol fumarate and glycopyrronium bromide (Bevespi Aeosphere) because Trimbow contains three active ingredients, while Bevespi Aeosphere contains only two.
  • Products with fewer active ingredients than previously approved products should generally be eligible for SPCs.
  • The court emphasized the importance of developing treatments with the necessary number of active ingredients to treat patients effectively, rather than more than necessary.

    As a result, AstraZeneca’s SPC application for Bevespi Aeosphere has been allowed and remanded for further processing by the patent office. The Swedish Patent Office may appeal the decision, with a potential decision in late 2025.

    This decision marks a significant step in understanding SPC eligibility and could influence similar cases across Europe.

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