April Breyer Menon, Author at Venable's BiologicsHQ

Sarepta Files Two IPRs Against Genzyme’s Patents Gene Therapy Elevidys® Allegedly Infringes

by April Breyer Menon | Jun 27, 2025

On June 26, 2025, Sarepta Therapeutics filed IPR2025-01194, challenging as obvious claims 3-6 of Genzyme’s U.S. Patent No. 9,051,542 (“the ’542 patent), and IPR2025-01195 challenging claims 1-4, 6-7 and 11 of U.S. Patent No. 7,704,721 (“the ’721 patent”) as...

Samsung Bioepis and Formycon’s EYLEA® IPRs Discretionarily Denied Institution Among Wave of Fintiv Denials; Regeneron Files Second BPCIA Lawsuit Against Amgen’s Pavblu™

by April Breyer Menon | Jun 26, 2025

PTAB Denies Samsung Bioepis and Formycon’s IPR Petitions Under Fintiv On June 2, 2025, the Patent Trial and Appeal Board (“Board”) issued decisions denying institution of Samsung Bioepis’s IPR2025-00176 and Formycon’s IPR2025-00233 against claims...

Sandoz Launches Jubbonti® / Wyost® (denosumab-bbdz) as First Prolia® / Xgeva® Interchangeable Biosimilars

by April Breyer Menon | Jun 11, 2025

On June 2, 2025, Sandoz announced the launch of Jubbonti® / Wyost® (denosumab-bbdz), the first Prolia® / Xgeva® (denosumab) interchangeable biosimilars to launch in the U.S. Jubbonti® is indicated for increasing bone mass in patients with osteoporosis, prostate...

Federal Circuit Affirms PTAB’s Unpatentability Findings in Gene Therapy Hemgenix® IPRs

by April Breyer Menon | Jun 6, 2025

On May 22, 2025, the CAFC affirmed the PTAB’s (Board) Final Written Decisions in Pfizer’s IPR2021-00925 and IPR2021-00926 finding all challenged claims of uniQure’s U.S. Patent No. 9,982,248 (“the ’248 patent”) unpatentable (CAFC 23-1404 and 23-1405), and in...

Court Finds bluebird bio’s Gene Therapy Zynteglo® (betibeglogene autotemcel) Does Not Infringe San Rocco Therapeutics’ Patents

by April Breyer Menon | Jun 5, 2025

On May 16, 2025, the Court in Case No. 1:21-cv-01478 (D. Del.) granted bluebird bio’s motion for summary judgment, finding that its gene therapy Zynteglo® (betibeglogene autotemcel) does not infringe San Rocco Therapeutics’ exclusively licensed U.S. Patent...

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Methodology

Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable BiologicsHQ database.

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