Patents listed with the US Food and Drug Administration (FDA) related to drug delivery devices have more than tripled since 2000, researchers reported in February’s Nature Biotechnology
, noting that such patents can substantially delay competitors and drive up prices.
The researchers from the Program On Regulation, Therapeutics, And Law (PORTAL) at Brigham and Women’s Hospital and Harvard Medical School point to the example of Mylan’s EpiPen, which still does not have any equivalent competitors, except for Mylan’s own authorized generic
, which launched after an outcry over the 400% price increase.
“The current model, in which manufacturers can list whatever patents they want, rewards making any kind of change to regulated products that can earn a patent (a relatively low bar since therapeutic benefit is not one of the criteria of patentability),” author Reed Beall told Focus
. “In the case of device combinations, the FDA considers the device inseparable from the drug, which opens the door to listing tertiary patents. So one approach could be to not allow listing of device patents (tertiary patents, as we call them) at all.”
As such a move could exclude those device patents that are legitimate improvements providing real clinical advantages, Beall noted that perhaps manufacturers should be called on to submit additional data alongside a new patent listing that can support a legitimate improvement.
Over the four years covered in the study, the researchers found 1,784 distinct drug products associated with one or more patents, and 5,056 patents in total.
“About 7% (369) of these were tertiary patents and were associated with 144 drug-device combination products. The most common such products were inhalers (31%, 45/144), injector pens (24%, 34/144), and patches (18%, 26/144). These 144 products could be traced to 66 different manufacturers, with most coming from GlaxoSmithKline (9%, 13/144), AstraZeneca (6%, 9/144), Eli Lilly (6%, 9/144), Novo Nordisk (6%, 9/144), and Novartis (6%, 8/144),” the study said.
“If manufacturers could not list drug delivery device patents in the Orange Book, the median product in our sample would have had 13.9 years (IQR:3.2 to 17.1) of patent life remaining after FDA approval, as compared to the current situation in which the median is 17.3 years (IQR: 14.8 to 22.2),” the study notes.
The researchers also called for measures to discourage “excessive redevelopment and repatenting” of combo products so generic versions can come to market sooner.
“Other countries have established patent review bodies within their drug regulators to ensure that newly listed patents cover product changes that confer additional clinical benefit, which is not among the legal criteria for obtaining the patent in the first place,” the researchers noted.
Tertiary patenting on drug–device combination products in the United States