Janssen Seeks a Preliminary Injunction in BPCIA Ustekinumab Case Against Amgen

On March 1, 2023, Janssen filed a motion for preliminary injunction in Janssen Biotech, Inc. v. Amgen Inc., C.A. No. 22-1549-MN, seeking to enjoin Amgen from the commercial manufacturing, sale, and offer for sale of ABP 654, Amgen’s ustekinumab biosimilar.  On the same day, just prior to filing the motion, Janssen also filed a stipulation and proposed order to extend the page limits on the preliminary injunction briefing.  In the stipulation, Janssen stated that “it requires an extension of the default page limitation for opening briefs in order to thoroughly brief the issues in the PI Motion.”  The next day, Judge Maryellen Noreika entered an oral order denying the stipulation because “[t]he request to extend page limits was filed seven minutes before the over-the-page limit brief was filed” and  “[t]he effect of this was that Plaintiff granted itself an extension without leave of Court and without respect for the Court and its rule.”  The Court also denied Janssen’s preliminary injunction motion, but allowed Janssen to refile a brief that would comply with the Court’s rules.

On March 6, 2023, Janssen heeded the Court’s guidance and filed its preliminary injunction motion.  Redacted versions of Janssen’s papers are due to be filed on March 15, 2023.

As we previously reported, Janssen filed its BPCIA complaint against Amgen on November 29, 2022.  Janssen’s original complaint alleged that Amgen infringes two patents: U.S. Patent No. 6,902,734 (“the ’734 patent”), directed to “an isolated anti-IL-12 antibody with a certain amino acid sequence,” and U.S. Patent No. 10,961,307 (“the ’307 patent”), directed to methods of “treating moderately to severely active ulcerative colitis (UC)” with a “clinically proven effective amount of anti-IL-12/IL-23p40 antibody” having a certain amino acid sequence.  On February 21, 2023, Janssen filed an amended complaint, adding allegations of infringement of four additional patents—U.S. Patent Nos. 9,475,848; 9,217,168; 9,663,810; and 8,852,889.  According to Janssen, the four new patents are directed to “methods of using cell culturing processes to target and control features of biosimilar antibodies to assure equivalence to a reference product.”

Stay tuned to Big Molecule Watch for further updates about this litigation.