Design Patents: A Potential Threat to Drug Competition
Document Type
Article
Publication Date
4-8-2025
ISSN
1175-5652
Publisher
Springer Nature
Language
en-US
Abstract
Brand-name drugs are protected by patents that provide an incentive for investment in innovation by blocking competition from entering the market and thereby allowing manufacturers to charge high prices. In recent years, there has been growing controversy over how brand-name manufacturers gather patents on minor changes to drug formulation and even on the devices that deliver the medicine to build large portfolios that delay competition [1 ]. New legislation or administrative changes to patent review and issuance practices have been proposed to reduce drug patent portfolios and facilitate timely competition in the US drug market [2 ].
One component of these portfolios has not been widely discussed: the fact that brand-name drug manufacturers can seek and receive “design patents” that protect the ornamental appearance of the drug, such as the shape and look of a pill, injector, or inhaler (see Fig. 1 for examples of designs patented by pharmaceutical companies). Design patents protect only the appearance of a product and cannot cover its useful or functional elements. As compared with other patents, design patents go through a less rigorous examination process before being granted and are quicker and cheaper to obtain [3 ]. However, like all patents, design patents on brand-name drugs can be used to block entry of generics or biosimilars. Design patents on drugs have largely been ignored but are increasing in popularity and can pose a threat both to drug competition and to patient safety.
Recommended Citation
Janet Freilich & Aaron S. Kesselheim,
Design Patents: A Potential Threat to Drug Competition
,
Applied Health Economics and Health Policy
(2025).
Available at:
https://scholarship.law.bu.edu/faculty_scholarship/4042
