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On December 17, 2024, after a seven-day jury trial in Case No. 1:22-cv-00035 (D. Del.), the jury returned its verdict, finding Lindis Biotech’s U.S. Patent Nos. 8,709,421 (claims 3, 8, and 15) and 10,071,158 (claims 1, 12, and 20) willfully infringed by Amgen’s Blincyto® (blinatumomab).  The jury found both direct and induced infringement.  The jury also found the patents had not been shown to be obvious, or invalid for lack of written description or enablement.  A reasonable royalty was awarded on over $2.2 billion in sales of Blincyto® in the U.S., amounting to approximately $50 million in damages to Lindis.  The jury did not award any damages for Blincyto® sales outside the U.S.

On December 13, 2024, Amgen filed a Motion for Judgment as a Matter of Law of no direct, induced, or willful infringement and no damages, after the close of Lindis’s case-in-chief.  In its request for JMOL of no damages, Amgen argued that Lindis’s damages calculations were impermissibly based on non-infringing off-label and pediatric uses.  This motion is pending.

In FY 2023, Amgen reported Blincyto® sales of $566 million in the U.S., a 48% increase over FY 2022.

For more information on this and other biologic patent disputes, please visit BiologicsHQ.

 

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The author would like to thank April Breyer Menon for her contributions to this article.


    Methodology

    Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable BiologicsHQ database.

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