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Life sciences law weekly: SPC strategy setback, EHDS data-sharing rules, clinical trial transparency duties, AIaMD sandbox expansion, device regime reforms, enforcement actions and manufacturing funding review

Published on: 16 April 2026

Published by a LexisNexis Life Sciences expert
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In this issue:

  • Intellectual property
  • Data protection and life sciences
  • Research and development
  • Disputes and regulatory enforcement
  • Medical devices
  • Commercialisation/Pricing, reimbursement and imports
  • Daily and weekly news alerts
  • New and updated content
  • Trackers and horizon scanning
  • Useful information

Intellectual property

Article 3(d) entitlement of an uncombined medicinal product (drospirenone) to an SPC (Laboratorios Leon Farma SA v Comptroller)

The court had to decide whether the Court of Justice’s ruling in Medeva (Case C-322/10) prevents a supplementary protection certificate where the product was previously authorised only within a combination. It held that it does. Endorsing the IPO’s stance, the court found that an SPC for drospirenone could not be granted: because an earlier marketing authorisation covered drospirenone with oestrogen, the subsequent authorisation for drospirenone alone was not the first MA for that active. This outcome is significant for SPC planning: any prior MA—whether for a monotherapy or a combination—can bar SPC protection for an active ingredient. Written by Dan Byrne, partner at Venner Shipley LLP...

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