by April Breyer Menon | Mar 29, 2024
In an interview with the Center for Biosimilars, Venable’s Ha Kung Wong discusses concerns about “bad patents” hindering biosimilar access, but assures that the FDA and United States Patent and Trademark Office are working to improve the system. He...
by April Breyer Menon | Mar 21, 2024
On March 13, 2024, Regeneron appealed the PTAB Board’s (“the Board”) recent Final Written Decisions (“FWDs”) that found claims of two Regeneron patents related to EYLEA® (aflibercept) unpatentable. In CAFC 24-1564 Regeneron appeals the Board’s FWD in IPRs brought by...
by April Breyer Menon | Mar 15, 2024
On March 13, 2024, Merck Sharp & Dohme, LLC (“Merck”) filed four additional IPRs challenging The Johns Hopkins University (“JHU”) patents covering methods of treatment using pembrolizumab, which Merck sells under the trade name Keytruda®. These follow four IPRs...
by April Breyer Menon | Mar 15, 2024
On March 11, 2024, the White House released President Biden’s FY 2025 Department of Health and Human Services (HHS) Budget in Brief, which outlines $130.7 billion in discretionary funding for HHS. Included in the budget proposal is a provision that would eliminate...
by April Breyer Menon | Mar 15, 2024
On March 5, 2024, the FDA approved Sandoz’s Jubbonti® and Wyost® (denosumab-bddz) as the first biosimilars of Amgen’s Prolia® and Xgeva® (denosumab). The launch date for these biosimilars has not been announced as Amgen and Sandoz continue their BPCIA litigation in...