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Lindis Biotech’s Patents Found Unenforceable Due to Inequitable Conduct

by Leah Watson; Robert S. Schwartz, Ph.D.
August 25, 2025

On August 20, 2025, after a bench trial in Case No. 1:22-cv-00035 (D. Del.), Lindis Biotech’s U.S. Patent Nos. 8,709,421 and 10,071,158 (“the Lindis patents”) were found unenforceable due to inequitable conduct for withholding known material references during prosecution of the Lindis patents with the intent to deceive.

Previously, on December 17, 2024, after a seven-day jury trial, the Lindis patents were found valid and infringed, and a reasonable royalty of approximately $50M was awarded for Amgen’s U.S. sales of Blincyto® (blinatumomab) (previously reported Blincyto® Found to Infringe Lindis Biotech’s Patents).

In 2024, Amgen reported U.S. sales for Blincyto® were $800 million, a 41% increase from the $566 million reported in 2023.

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

 

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The authors 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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