Beginning in November 2024, Merck Sharp & Dohme, LLC (“Merck”) requested post-grant review (“PGR”) of 14 patents owned by Halozyme, Inc. (“Halozyme”), with claims directed to modified PH20 hyaluronidase polypeptides,...more
10/27/2025
/ Biologics ,
Enablement Inquiries ,
Intellectual Property Litigation ,
Merck ,
Obviousness ,
Patent Invalidity ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Post-Grant Review ,
Written Descriptions
On October 2, 2025, Celltrion launched Avtozma® (tocilizumab-anoh), in intravenous and subcutaneous formulations, as the third biosimilar of Genentech’s Actemra® (tocilizumab). ...more
On October 9, 2025, Celltrion announced the FDA approved Eydenzelt® (aflibercept-boav), a biosimilar of Regeneron’s EYLEA® (aflibercept). ...more
On September 26, 2025, Amneal / Kashiv announced the submission to the FDA of an aBLA for ADL-018, a proposed biosimilar of Genentech’s Xolair® (omalizumab)....more
10/8/2025
/ aBLA ,
Biologics ,
Biosimilars ,
BPCIA ,
Celltrion ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Genentech ,
Interchangeability ,
Pharmaceutical Industry ,
Pharmaceutical Patents
On September 5, 2025, Amgen and Samsung Bioepis reached a settlement in Case No. 1:24-cv-08417 (D.N.J.) / 1:25-md-3138 (D.N.J.), and the Court entered a consent judgment. The litigation related to Samsung Bioepis’s Prolia® /...more
9/30/2025
/ Amgen ,
Biologics ,
Biosimilars ,
BPCIA ,
Food and Drug Administration (FDA) ,
Intellectual Property Litigation ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Samsung ,
Settlement
On August 18, 2025, Accord and Dong-A ST announced the U.S. launch of Imuldosa® (ustekinumab-srlf), a biosimilar of Janssen / Johnson & Johnson’s Stelara® (ustekinumab). Imuldosa® is approved for all the reference product’s...more
On August 14, 2025, Genentech filed BPCIA litigation No. 2:25-cv-14648 (D.N.J.) against Shanghai Henlius Biotech (“Henlius”) and Organon alleging infringement of 24 patents by Henlius / Organon’s proposed Perjeta®...more
Denosumab Challenged Claim Types in Litigation: Claims are counted in each litigation, so claims from the same patent challenged in multiple litigations are counted more than once. Within each litigation a claim is counted...more
8/13/2025
/ Biocon ,
Biologics ,
Biosimilars ,
BPCIA ,
Inter Partes Review (IPR) Proceeding ,
Life Sciences ,
Patent Infringement ,
Patent Invalidity ,
Patent Litigation ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Teva Pharmaceuticals
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
8/13/2025
/ Biologics ,
Celltrion ,
Fresenius ,
Inter Partes Review (IPR) Proceeding ,
Life Sciences ,
Patent Invalidity ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Section 102 ,
Section 103
Etanercept Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more
8/13/2025
/ Amgen ,
Biologics ,
Biosimilars ,
Coherus ,
Hoffman LaRoche ,
Intellectual Property Litigation ,
Inter Partes Review (IPR) Proceeding ,
Life Sciences ,
Patent Infringement ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Sandoz
Rituximab Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more
8/12/2025
/ Biogen Idec ,
Biologics ,
Biosimilars ,
Boehringer ,
Celltrion ,
Genentech ,
Inter Partes Review (IPR) Proceeding ,
Patent Infringement ,
Patent Litigation ,
Pfizer ,
Pharmaceutical Industry ,
Pharmaceutical Patents
On July 14, 2025, Fresenius Kabi filed IPR2025-01268 against Regeneron’s U.S. Patent No. 11,084,865 (“the ’865 patent”) and IPR2025-01269 against U.S. Patent No. 10,828,345 (“the ’345 patent”), both relating to EYLEA®...more
8/4/2025
/ Biologics ,
Biosimilars ,
BPCIA ,
Fresenius ,
Inter Partes Review (IPR) Proceeding ,
Patent Invalidity ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Regeneron
Trastuzumab Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more
Adalimumab Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more
Denosumab Challenged Claim Types in Litigation: Claims are counted in each litigation, so claims from the same patent challenged in multiple litigations are counted more than once. Within each litigation a claim is counted...more
Rituximab Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more
Welcome to Venable’s BiologicsHQ Monthly Injection - December 2024....more
1/15/2025
/ Biologics ,
Biosimilars ,
Compliance ,
Data Privacy ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Healthcare ,
Life Sciences ,
Loper Bright Enterprises v Raimondo ,
Medical Devices ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Regulatory Requirements
Venable's Welcome to Venable’s BiologicsHQ Monthly Injection - November 2024....more
Welcome to Venable’s BiologicsHQ Monthly Injection – October 2024...more
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...more
Welcome to Venable’s BiologicsHQ Monthly Injection – July 2024...more
7/10/2024
/ Biologics ,
Biosimilars ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Inter Partes Review (IPR) Proceeding ,
Interchangeability ,
Life Sciences ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Post-Grant Review ,
Prescription Drugs ,
Purple Book
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
5/23/2024
/ AstraZeneca ,
Biologics ,
Biosimilars ,
Celltrion ,
EU ,
European Patent Office ,
Genentech ,
Inter Partes Review (IPR) Proceeding ,
Life Sciences ,
Novartis ,
Patent Applications ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Popular ,
Samsung Bioepis ,
Unified Patent Court
Welcome to Venable’s BiologicsHQ Monthly Injection – April 2024...more
5/1/2024
/ Biden Administration ,
Biologics ,
Biosimilars ,
Food and Drug Administration (FDA) ,
Interchangeability ,
Life Sciences ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
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. ...more
On January 28, 2024 Celltrion announced the submission to the FDA of an aBLA for CT-P47, a proposed biosimilar of Genentech’s Actemra® (tocilizumab). This is the third publicly announced aBLA filing for an...more