Is Patent "Evergreening" Restricting Access to Medicine/Device Combination Products?

ABSTRACT:

Background

Not all new drug products are truly new. Some are the result of marginal innovation and incremental patenting of existing products, but in such a way that confers no major therapeutic improvement. This phenomenon, pejoratively known as "evergreening", can allow manufacturers to preserve market exclusivity, but without significantly bettering the standard of care. Other studies speculate that evergreening is especially problematic for medicine/device combination products, because patents on the device component may outlast expired patents on the medicine component, and thereby keep competing, possibly less-expensive generic products off the market.

Materials and methods

We focused on four common conditions that are often treated by medicine/device product combinati

SUBMITTER: Beall RF 

PROVIDER: S-EPMC4766186 | biostudies-literature | 2016

REPOSITORIES: biostudies-literature