Robert Schwartz

Dec 10, 2024 | mondaq.com | Robert Schwartz

On November 20, 2024, Samsung Bioepis filed IPR2025-00176 against Regeneron's U.S. Patent No. 11,084,865 ("the '865 patent"), challenging as obvious 48 claims (claims 1-12, 14-17, 19-20, 22-36, 39-42, 44-45, and 47-55) covering ophthalmic formulations of a vascular endothelial growth factor (VEGF) in vials and prefilled syringes. On December 2, 2024, Formycon filed IPR2025-00233 against the same patent, requesting joinder with Samsung Bioepis's petition if it is instituted.

Nov 18, 2024 | mondaq.com | Robert Schwartz

Amgen announced during its Q3 2024 Earnings Call that it had launched Pavblu" (aflibercept-ayyh) as the first biosimilar of Regeneron's EYLEA® (aflibercept) to be marketed in the U.S. The launch follows the Federal Circuit's decision on October 22, 2024 (CAFC Appeal No. 24-2351) to deny a temporary injunction that would prevent Pavblu" from launching at-risk while Regeneron appeals an earlier District Court (Case No. 1:24-cv-00039 (N.D.W. Va.) / MDL 1:24-md-03103 (N.D.W. Va.)) denial of a...

Nov 7, 2024 | mondaq.com | Robert Schwartz

On October 30, 2024, Organon announced the FDA acceptance of its aBLA for HLX14, a proposed biosimilar of Amgen's Prolia® / Xgeva® (denosumab). Organon licensed the commercialization rights for HLX14 in the U.S. from Shanghai Henlius Biotech. Earlier in October, Teva announced that the FDA and EMA accepted applications for its proposed Prolia® biosimilar TVB-009P.

Oct 28, 2024 | mondaq.com | Robert Schwartz

On October 22, 2024, the Federal Circuit (CAFC Case No. 24-2351) denied Regeneron's request for an injunction pending appeal for Amgen's EYLEA® (aflibercept) biosimilar Pavblu" (aflibercept-ayyh), concluding that "Regeneron has not established that an injunction pending appeal is warranted." The appeal concerns the District Court's (Case No. 1:24-cv-00039 (N.D.W. Va.) / 1-24-md-2103 (N.D.W. Va.)) September 2024 denial of a preliminary injunction against Pavblu".

Oct 26, 2024 | spectator.org | Robert Schwartz

After the death of Yahya Sinwar, the choir of blessed peacemakers resumed the refrain for an immediate ceasefire and a plan for “the day after.” Kamala Harris, the lead singer, glanced repeatedly at her politically crafted score that proclaimed, “it is time for the day after to begin without Hamas in power.”What criteria determine when the day after a war begins?