by April Breyer Menon | Apr 15, 2024
On April 10, 2024, the Court granted Plaintiffs Genentech, Hoffmann-La Roche, and Biogen and Defendants Dr. Reddy’s and Fresenius Kabi’s joint stipulation of dismissal due to settlement in Case No. 1:23-cv-22485 (D.N.J.) related to Dr. Reddy’s and Fresenius...
by April Breyer Menon | Apr 10, 2024
In an interview with the Center for Biosimilars, Venable’s Ha Kung Wong discusses the advantages of the BPCIA patent dance in answering the question, “What are the key objectives of the patent dance, and how does it contribute to streamlining the exchange...
by April Breyer Menon | Apr 10, 2024
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by April Breyer Menon | Apr 2, 2024
On March 27, 2024, the PTAB summarily denied Seagen’s February 14, 2024 request for Director Review of the PTAB’s January 16, 2024 Final Written Decision (“FWD”) in PGR2021-00030 related to Adcetris® (brentuximab vedotin). In the FWD, the PTAB held that the...
by April Breyer Menon | Mar 31, 2024
On March 10, 2024, Celltrion announced in a press release that it submitted an abbreviated Biologics License Application (aBLA) for FDA approval of CT-P39 (omalizumab), a proposed interchangeable biosimilar of Genentech’s / Novartis’ Xolair® (omalizumab). This is the...