Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
Podcast: Non-binding Guidance: FDA Regulatory and Patent Implications of the Transition Provision of the Biologics Price Competition and Innovation Act
Drug Pricing Initiatives During the Trump Presidency
Biosimilars 2018 - A Year in Review
A changing competitive landscape: the role of the ITC in the biosimilars space
Polsinelli Podcasts - FDA Denies Amgen Citizen Petition in Biosimilar Dispute
On January 15, 2025, Celltrion filed IPR2025-00456 against Regeneron’s U.S. Patent No. 11,084,865 (“the ’865 patent”), challenging claims 1-17, 19-42, 44-50 as anticipated and claims 1-50 as obvious....more
As the era of biologics and biosimilar litigations heats up in the United States, Europe’s Unified Patent Court (UPC) is also taking center stage with the first two biosimilar disputes filed in March and April....more
On August 29, 2023, the PTAB issued final written decisions in IPR2022-00578 and IPR2022-00579, filed by Celltrion on two patents related to tocilizumab — U.S. Patent Nos. 8,580,264 and 10,874,677, owned by Chugai Seiyaku...more
Following the Celltrion and Pfizer settlements of the trastuzumab litigation, the Federal Circuit granted the request of the Director of the PTO to intervene under 35 U.S.C. § 143 (i.e., defend a PTAB decision when a...more
Earlier this week, Celltrion filed two petitions for inter partes review of Genentech’s U.S. Patent No. 6,407,213. According to Celltrion’s petitions, the patent is directed to humanized antibodies. ...more
Celltrion has filed two additional petitions for inter partes review of Genentech patents related to trastuzumab: IPR2017-01139, challenging U.S. Patent 6,627,196, and IPR2017-01140, challenging U.S. Patent 7,371,379....more
Celltrion has filed petitions for inter partes review of two patents related to Genentech’s trastuzumab: IPR2017-01121, challenging U.S. Patent 7,846,441, and IPR2017-01122, challenging U.S. Patent 7,892,549. According to...more