On August 14, 2025, Genentech filed BPCIA litigation No. 2:25-cv-14648 (D.N.J.) against Shanghai Henlius Biotech (“Henlius”) and Organon alleging infringement of 24 patents by Henlius / Organon’s proposed Perjeta^® (pertuzumab) biosimilar HLX11.  Henlius and Organon’s aBLA for HLX11 was accepted by the FDA in January 2025 (previously reported Shanghai Henlius Biotech’s aBLA for Perjeta^® Biosimilar HLX11 Accepted by FDA).  The asserted patents include 10 with method of treatment claims, 10 with manufacturing claims, three with composition/formulation claims, two with composition of matter claims, and two with article of manufacture claims.  Nineteen of the 24 patents have not previously been asserted in a BPCIA litigation.  The parties completed the BPCIA patent dance prior to filing the case, and Genentech asserted 24 of the 47 patents it had listed during the information exchange.

Henlius and Organon’s aBLA is the only publicly announced aBLA for a pertuzumab biosimilar currently pending with the FDA, and this is the first BPCIA litigation to be filed.

For more information about this and other biosimilar patent disputes, please visit BiologicsHQ.

 

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