Months after an antitrust lawsuit challenged its deal with Sanofi and raised uncertainty about the future of MZE001, Maze secured a new partner for potentially the first oral Pompe disease drug.

The Federal Trade Commission broke new ground last year in its opposition to M&A transactions and challenge of Orange Book patent listings. The biopharma community is waiting to see if deals will face similar hurdles in 2024 and whether there will be legal battles if manufacturers of drug-device combination products decline to delist their patents. Researchers advocate that the FTC extend its inquiry to device patents on GLP-1 receptor agonists, including Wegovy and Ozempic.

BIO and PhRMA describe the complexity of pricing biopharmaceuticals in arguing price should not be a factor in deciding whether to exercise march-in rights. The FTC suggests agencies consider a patent holder’s private investment and breadth of patent coverage, while KEI, AUTM, the American Bar Association, and former USPTO directors also weigh in on NIST's proposed framework.

BIO and PhRMA describe the complexity of pricing biopharmaceuticals in arguing price should not be a factor in deciding whether to exercise march-in rights. The FTC suggests agencies consider a patent holder’s private investment and breadth of patent coverage, while KEI, AUTM, the American Bar Association, and former USPTO directors also weigh in on NIST's proposed framework.