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Janssen loses appeal over Stelara patent, Dutch court backs Samsung Bioepis

By Inbar Preiss ( April 8, 2025, 12:18 GMT | Insight) -- Janssen Biotech has lost its appeal against Samsung Bioepis in a Dutch patent dispute over biosimilar production of an active ingredient in a drug used to treat Crohn’s disease and others. The Hague Court of Appeal upheld an earlier ruling that Samsung Bioepis did not infringe Janssen’s Supplementary Protection Certificates by manufacturing and stockpiling the drug for export outside the EU. Judges confirmed that the SPC Regulation's production-for-export exemption does not require trade licenses at the time of notification and permits stockpiling for post-expiry market entry.Janssen Biotech Inc. has lost another bid to prove that Samsung Bioepis — owned by Samsung Biologics, the biotech arm of Samsung Group — infringed its patent in a drug used to treat conditions such as psoriasis and Crohn’s disease....

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