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.

The biopharma new year begins as the J.P. Morgan Healthcare Conference ends so here in no particular order, we take a look at five of the biggest stories of 2023, once again a year of highs and lows for the industry.