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Tocilizumab Challenged Claim Types in IPRs: Claims are counted in each IPR, so claims from the same patent challenged in multiple IPRs are counted more than once. Within each IPR, claims are counted only once, whether they...more
On February 28, 2025, Amgen filed three IPRs against Bristol-Myers Squibb’s patents covering methods of treatment using a combination of Opdivo® (nivolumab), an anti-PD-1 antibody, and Yervoy® (ipilimumab), an anti-CTLA-4...more
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
Welcome to Venable’s BiologicsHQ Monthly Injection - December 2024....more
Welcome to Venable’s BiologicsHQ Monthly Injection – October 2024...more
Welcome to Venable’s BiologicsHQ Monthly Injection – July 2024...more
On June 14, 2024, the PTAB issued a Final Written Decision (FWD) in Samsung Bioepis’s IPR2023-00442 (“the -00442 IPR) determining that the challenged claims of Regeneron’s U.S. Patent No. 10,130,681 (the ’681 patent) that...more
Last November, the U.S. Patent and Trademark Office issued Guidance to the Examiner Corps that was disclosed to the public at the March 19, 2024 Biotechnology, Chemical, and Pharmaceutical Partnership Meeting, on resources to...more
In a recent Federal Register notice, the PTO announced a proposed rule requiring that any settlement agreement resolving a PTAB proceeding, even if such agreement occurs prior to a decision to institute an inter partes review...more
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....more
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...more
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,...more
The new year has brought a wave of activity for EYLEA® (aflibercept) biosimilars. Following up on our previous report (EYLEA® (aflibercept) and Soliris® (eculizumab) IPR and BPCIA Litigation Updates, December 31, 2023), in...more
The U.S. Supreme Court’s May 2023 decision in Amgen, Inc. v. Sanofi (Amgen) sent shock waves through the patent world, particularly in the chemical and biotech segments, due to its invalidation of Amgen patents based on a...more
In the last month, there has been a flurry of activity at the PTAB related to challenges from biosimilar manufacturers related to ustekinumab, aflibercept, and eculizumab patents....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
Biologics have become the fastest-growing class of therapeutic compounds. They have provided innovative treatment alternatives for people who suffer from some of the most serious medical conditions known to man. The...more
2022 heralded the next chapter for biosimilars in the United States, including U.S. Food and Drug Administration approval of biosimilars in new therapeutic areas, additional interchangeable designations, and litigation...more
As we ring in the new year, we look back at the top legal developments of 2022 that could influence the market for biologics and biosimilars. There were many interesting decisions and other developments in district court, at...more
Welcome to our quarterly update relating to biologics and biosimilars, including post-grant and patent litigation challenges to blockbuster biologics. Since the enactment of the Biologics Price Competition and Innovation...more
President Biden’s Executive Order on Promoting Competition in the American Economy, 86 FR 36987 (2021), expressed concerns about the patent system being misused to unnecessarily inhibit or delay entry of generic drugs or...more
This June, join the “who’s who” of the biosimilars and innovator biologics industries as they gather in Boston for ACI’s 13th Annual Summit on Biosimilars & Innovator Biologics....more
On April 14, 2022, the U.S. Court of Appeals for the Federal Circuit reversed the PTAB’s determination in IPR2016-01542 that claims of Amgen’s U.S. Patent No. 8,952,138 are obvious. The ’138 patent claims are directed to...more
Premier forum which shapes the law, policy, and proceedings of Paragraph IV Litigation is back to New York City on April 26-27! Pharmaceutical patent practitioners from across the globe attend this flagship conference to...more