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Life sciences legal update: SPC refusal for drospirenone; FOI special category data ruling; MHRA-NICE aligned pathway; NHS England abolition plans; EMA PRIME tools; ASA action on supplement health claims

Published on: 26 March 2026

Published by a LexisNexis Life Sciences expert
Legal News
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In this issue:

  • Intellectual property
  • Data protection and life sciences
  • Commercialisation
  • Pharmaceuticals—regulatory framework
  • Research and development
  • Advertising of medicines
  • Daily and weekly news alerts
  • Trackers and horizon scanning
  • Useful information

Intellectual property

KEY CASE

Judgment Alert: Laboratorios Leon Farma SA v The Comptroller-General of Patents [2026] EWHC 663 (Ch)

The Chancery Division rejected Laboratorios Leon Farma SA’s (Leon) appeal against the UK Intellectual Property Office (UKIPO) decision refusing SPC application SPC/GB22/02 for the oral contraceptive ‘Slynd’, which has drospirenone as its sole active substance. The Recorder concluded the Hearing Officer was right to find Leon’s filing did not meet Article 3(d) of Regulation (EC) 469/2009 (the SPC Regulation), which requires the marketing authorisation (MA) relied on to be ‘the first authorisation to place the product on the market as a medicinal product’. The key question was whether existing MAs for Angeliq (combining drospirenone with estradiol) and Yasmin (drospirenone with ethinyl estradiol) amounted to earlier authorisations for placing drospirenone on the market. The court held that the Court of Justice of the European Union’s decision in Medeva (Case C-322/10) remains good law and sets a generally applicable principle that...

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