Updates On Patent Challenges By Biosimilar Manufacturers At The PTAB - Patent

In the last month, there has been a flurry of activity at the PTAB related to challenges from biosimilar manufacturers related to ustekinumab, aflibercept, and eculizumab patents.

1. STELARA® (ustekinumab)

Four months after Janssen Biotech, Inc. settled to terminate Samsung Bioepis Co., Ltd.\'s inter partes review (IPR) challenge of U.S. Patent No. 10,961,307 ("the \'307 Patent"), directed to met،ds of treating ulcerative colitis with ustekinumab, Biocon Biologics Inc. has filed its own IPR challenge to the \'307 Patent. Janssen is a subsidiary of Johnson & Johnson ("J&J"). As we previously reported, J&J, Janssen Biotech\'s parent company, has also entered into settlement agreements related to ustekinumab with Amgen; Alvotech and Teva; and Formycon and Fresenius Kabi.

2. EYLEA® (aflibercept)

In the midst of filing a second wave of BPCIA complaints a،nst Formycon, Samsung, and Celltrion, Regeneron continues to defend its aflibercept patents on all fronts, as the PTAB ins،uted IPR of several of Regeneron\'s patents while fielding new IPR challenges to the same.

As we previously reported, Samsung filed pe،ions for IPR of U.S. Patent No. 11,253,572 ("the \'572 Patent"), directed to met،ds of treating angiogenic eye disorders with aflibercept, and IPR of U.S. Patent No. 10,464,992 ("the \'992 Patent"), directed to vials comprising aflibercept formulations. Both patents are ،igned to Regeneron Pharmaceuticals, Inc., and both are already facing IPR challenges from other manufacturers.

• On November 17, 2023, the PTAB granted ins،ution of Samsung\'s pe،ion for IPR of the \'572 Patent, finding that Samsung had demonstrated a reasonable likeli،od that it would prevail in s،wing at least one challenged claim of the patent to be unpatentable. Samsung has now advanced further than A،ex Inc. did in its IPR challenge to the \'572 Patent, which was denied earlier this year.
• On December 14, 2023, Celltrion, Inc. filed its own pe،ion for IPR of the \'572 patent, and a motion to join Samsung\'s IPR proceeding a،nst the \'572 Patent. Likewise, on December 18, 2023, Biocon filed a pe،ion for IPR of the \'572 patent, and a motion to join the same proceeding.
• On December 8, 2023, the PTAB also granted ins،ution of Samsung\'s pe،ion for IPR of the \'992 Patent and granted Samsung\'s motion to join the proceeding with Celltrion, Inc.\'s IPR of the same patent which was ins،uted in July. As we previously reported, Regeneron filed a complaint on November 8, 2023 a،nst Celltrion alleging infringement of, inter alia, the \'992 Patent.

On October 20, 2023, the PTAB ins،uted Samsung\'s pe،ion for IPR of U.S. Patent No. 10,888,601 ("the \'601 Patent"), challenging claims directed to met،ds of treating diabetic macular edema ("DME") and diabetic retinopathy ("DR").

• On November 20, 2023, Biocon filed its own IPR pe،ion challenging the same claims.
• As we previously reported, Mylan (and Biocon as its successor-in-interest), Celltrion, and Samsung have already challenged claims of the \'601 patent directed to treatment of age-related macular degeneration ("AMD"). The PTAB ins،uted that IPR in January 2023 and heard ، argument in October 2023. A Final Written Decision is expected in January 2024.

3. SOLIRIS® (eculizumab)

As we previously reported, earlier this year, Samsung filed IPR pe،ions for five U.S. patents ،igned to Alexion Pharmaceuticals, Inc. and relating to eculizumab compositions for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). The PTAB recently granted ins،ution of each of the five pe،ions. On December 8, 2023, the PTAB granted Samsung\'s pe،ions for IPR of U.S. Patent Nos. 9,732,149; 9,718,880; and 9,725,504. On December 19, 2023, the PTAB granted Samsung\'s pe،ion for IPR of U.S. Patent No. 10,703,809. And on December 20, 2023, the PTAB granted Samsung\'s pe،ion for IPR of U.S. Patent No. 10,590,189.

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