UPC Sets Precedent in First Second Medical Use Patent Ruling: Sanofi and Regeneron Lose Against Amgen
• The Unified Patent Court (UPC) issued its first ruling on second medical use pharmaceutical patent claims, upholding Sanofi and Regeneron's patent as valid but finding no infringement by Amgen's cholesterol drug Repatha.
• The landmark decision establishes that proving infringement requires evidence of actual or likely off-label use of a drug for the patented indication, plus the alleged infringer's awareness of such use.
• The Düsseldorf Local Division adopted a "foreseeability" test for infringement, determining that rights holders must demonstrate the generic manufacturer "knows or reasonably should have known" about off-label prescriptions.
EMA Recommends Approval of Tepezza for Thyroid Eye Disease, First Targeted Treatment in EU
• The European Medicines Agency has recommended approval of Tepezza (teprotumumab) for adults with moderate to severe thyroid eye disease, marking the first targeted therapy for this condition in the EU.
• Clinical trials demonstrated significant reduction in eye protrusion (2-2.3mm) and inflammatory symptoms after 24 weeks of Tepezza treatment compared to placebo, providing a non-surgical alternative for patients.
• Despite promising efficacy, Tepezza carries risks including potential permanent hearing loss and fetal development concerns, prompting additional risk minimization measures to be implemented alongside approval.
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