by April Breyer Menon | Mar 6, 2024
On March 4, 2024, the PTAB granted Biocon and Janssen’s joint motion to terminate IPR2023-01444 due to a settlement reached prior to an institution decision. The parties announced in a press release that their settlement and license agreement allows Biocon to...
by April Breyer Menon | Feb 29, 2024
On February 23, 2024, the FDA approved Alvotech and Teva’s Simlandi® (adalimumab-ryvk) as biosimilar to and interchangeable with AbbVie’s Humira® (adalimumab). Simlandi® is the tenth Humira® biosimilar to be approved, and the third interchangeable, following...
by April Breyer Menon | Feb 26, 2024
In an interview with the Center for Biosimilars, Venable’s Ha Kung Wong examines proposed patent law changes that could significantly impact the biosimilars sector, including limitations on asserted patents, elimination of interchangeability requirements, and...
by April Breyer Menon | Feb 21, 2024
On February 14, 2024, Seagen requested director review of the PTAB’s January 16th Final Written Decision (“FWD”) in PGR2021-00030 finding antibody-drug conjugate claims in U.S. Patent No. 10,808,039 (the “’039 patent”) unpatentable. See PTAB Issues Final Written...
by April Breyer Menon | Feb 20, 2024
On February 12, 2024, Chugai, Genentech, and Hoffmann-La Roche (Roche) filed a motion to voluntarily dismiss CAFC Appeals 24-1111 and 24-1115, appealing the Final Written Decisions (FWDs) in IPR2022-00578 and IPR2022-00579, brought by Celltrion. In those FWDs, the...