With inter partes reviews (IPR) once feared as patent killers, the mere fact that an IPR petition challenging a drug or device patent had been filed with the U.S. Patent and Trademark Office was enough to send a company’s stock tumbling. That initial fear has “kind of ebbed and flowed” over the past 12 years as the patent reviews established by the America Invents Act have come of age, Aziz Burgy, a partner and patent litigator at Axinn, Veltrop & Harkrider LLP, told BioWorld.
In July, med-tech deal values surged to $200.88 million, up 116% from June's $93.07 million and ranking as the second-highest monthly total for 2024, behind only February’s $255.61 million.
The med-tech industry has seen a significant boost in fundraising, amassing $16.13 billion in the first seven months of this year, a nearly 38% increase from the $11.73 billion raised during the same period last year.
Inflation continues to take a toll on U.S. FDA drug and device user fees with some of the fees increasing as much as 44% for fiscal 2025. While most fee increases for generics and innovative drugs and biologics are below 10%, the ANDA fee is jumping 28% to $321,920.