Intellectual Property Law Commons^™

The Case Of The Missing Device Patents, Or: Why Device Patents Matter, Erika Lietzan, Kristina M. L. Acri, Evan Weidner

Faculty Publications

A company that earns premarket approval of its medical device is entitled to an extension of one patent claiming the device, to make up for some of the time it spent doing premarket research. Yet, surprisingly, a mere thirteen percent of those eligible for this extension (also known as patent term "restoration") ask for one. In contrast, most drug companies entitled to this same patent extension ask for one.

In this Article, we attribute the imbalance largely to differences between the two regulatory frameworks. In brief, because the FDA classifies and regulates devices based on what they do and how …

Rethinking Innovation At Fda, Rachel Sachs, W. Nicholson Price Ii, Patricia J. Zettler

Scholarship@WashULaw

In several controversial drug approval decisions in recent years, the Food & Drug Administration (FDA) has publicly justified its decision partly on the ground that approving the drugs in question would support innovation in those fields going forward. To some observers, these arguments were surprising, as the agency’s determination whether a drug is “safe” and “effective” does not seem to depend on whether its approval also supports innovation. But FDA’s use of these innovation arguments in drug approval decisions is just one example of the ways in which the agency has come to make many innovation-related judgments as part of …

Noticing Patents, John R. Thomas

Georgetown Law Faculty Publications and Other Works

Patents take the form of public letters that the U.S. Patent and Trademark Office (USPTO) actively disseminates. Whether these documents sufficiently provide the public with notice of the technologies they describe, as well as the proprietary rights that they assert, has been subject to long-standing debate. Many commentators conclude that patents are often filed too early in the research and development cycle, are deliberately drafted in a vague or obtuse manner, or are simply too numerous. As a result, identifying the relevant patent landscape is not just difficult for technology implementers, but possibly undesirable as a matter of innovation policy. …