We previously reported on the litigation brought by ModernaTX, Inc. and Moderna US, Inc. (collectively, “Moderna”) against BioNTech SE, BioNTech Manufacturing GmbH, BioNTech US Inc. (collectively, “BioNTech”), and Pfizer Inc....more
As we settle into 2024, we reflect on the significant legal developments of 2023 that hold potential impact on the biologics and biosimilars market. The following is a recap of some of the top five legal decisions and...more
1/22/2024
/ Antitrust Litigation ,
Biologics ,
Biosimilars ,
BPCIA ,
Inflation Reduction Act (IRA) ,
Inter Partes Review (IPR) Proceeding ,
Life Sciences ,
Patent Infringement ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Popular ,
Prescription Drugs ,
Regeneron
As previously reported by Big Molecule Watch, trial in Regeneron’s BPCIA case against Biocon regarding Biocon’s proposed aflibercept biosimilar concluded on June 15, 2023 in the Northern District of West Virginia. The...more
As we previously reported, Biogen sued Sandoz and Polpharma (“Defendants”) in a BPCIA litigation related to Defendants’ natalizumab biosimilar. On October 19, 2022, Biogen filed a Motion for Preliminary Injunction and Motion...more
Last week REGENXBIO Inc. and the Trustees of the University of Pennsylvania filed suit in Delaware against Sarepta Therapeutics, Inc., Sarepta Therapeutics Three, LLC, and Catalent, Inc., alleging that the defendants’...more
Today Celltrion announced that the FDA approved its biosimilar product, YUFLYMA (adalimumab-aaty), a high-concentration (100mg/mL) and citrate-free formulation of HUMIRA. YUFLYMA is approved for the treatment of rheumatoid...more
Last week Alvotech announced that it has initiated a confirmatory study for its biosimilar candidate to EYLEA®, AVT06 (aflibercept). EYLEA® is indicated for treating a variety of eye disorders including wet AMD, macular...more
In a much anticipated opinion, the U.S. Court of Appeals for the Ninth Circuit reversed a California district court decision holding that Qualcomm violated U.S. antitrust laws in its licensing of standard-essential patents in...more
8/12/2020
/ 5G Network ,
Anti-Competitive ,
Antitrust Provisions ,
Antitrust Violations ,
Appeals ,
Breach of Contract ,
Contract Disputes ,
Corporate Counsel ,
Exclusive Dealing Agreements ,
Federal Trade Commission (FTC) ,
FRAND ,
Intellectual Property Protection ,
IP License ,
Patents ,
Popular ,
Qualcomm ,
Royalties ,
Standard Essential Patents
What a difference two years can make.
In 2012, the America Invents Act (“AIA”) created new proceedings to challenge the validity of claims in issued patents. These proceedings are administered by the United States...more
The U.S. Congress continues to focus on patent reform legislation with House passage of the Innovation Act, a bill primarily addressing the conduct of patent litigation. While much attention has been paid to litigation...more