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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