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 …

The "Evergreening" Metaphor In Intellectual Property Scholarship, Erika Lietzan

Faculty Publications

This article is a plea for changes in the scholarly dialogue about "evergreening" by drug companies. Allegations that drug companies engage in "evergreening" are pervasive in legal scholarship, economic scholarship, medical and health policy scholarship, and policy writing, and they have prompted significant policymaking proposals. This Article was motivated by concern that the metaphor has not been fully explained and that policymaking in response might therefore be premature. It canvasses and assesses the scholarly literature-more than 300 articles discussing or mentioning "evergreening." It catalogues the definitions, the examples, and the empirical studies. Scholars use the term when describing certain actions …

The Myths Of Data Exclusivity, Erika Lietzan

Faculty Publications

This article contributes to an ongoing academic and public policy dialogue over whether and on what terms U.S. law should provide “data exclusivity” for new medicines. Five years after a new drug has been approved on the basis of an extensive application that may have cost more than one billion dollars to generate, federal law permits submission of a much smaller application to market a duplicate version of the drug. This second application is a different type of application, and it may cost no more than a few million dollars to prepare. A similar sequence is true for biological medicines: …

The History And Future Of E-Commerce Patents, Dennis D. Crouch, Mitchell L. Terry

Faculty Publications

The past two decades have seen a great rise in the patenting of e-commerce inventions. Now, those same patents are taking an equally great fall. In a series of four recent cases, the U.S. Supreme Court has shifted the doctrine of patent eligibility and, in the process, raised the bar for e-commerce and software patents - making it more difficult to obtain and enforce those types of patents.

The Standard For Awarding Attorney Fees Under 35 U.S.C. Section 285 To Prevailing Parties In Patent Litigation - Octane Fitness, Llc V. Icon Health & Fitness, Inc. And Highmark, Inc. V. Allcare Health Management Systems, Dennis D. Crouch, Jafon Fearson

Faculty Publications

The Supreme Court granted certiorari in two patent infringement cases that both concern shifting of attorney fees under the “exceptional case” standard of 35 U.S.C. § 285. The Federal Circuit has traditionally been resistant to fee shifting awards—especially in cases where an accused infringer is the prevailing party. In Octane Fitness, petitioner asks the Court to lower the standard for proving an exceptional case. In Highmark, petitioner asks for deference to lower court exceptional case findings.

A Trademark Justification For Design Patent Rights, Dennis D. Crouch

Faculty Publications

This article presents a new set of empirical results to support the theoretical construct that design patents fill a gap in trade dress law protection. Based on the data, I tentatively reject the oft-stated conventional wisdom that design patents are worthless for many because procurement is too slow, expensive, and difficult. Rather, based on a first-of-its-kind analysis of the prosecution history files of a large sample of recently issued design patents, I conclude that the current design patent examination system operates as a de facto registration system. Notably, more than ninety-eight percent (98%) of the patents in my study were …

An Empirical Study Of The Role Of The Written Description Requirement In Patent Prosecution, Dennis D. Crouch

Faculty Publications

An en banc Federal Circuit is now considering whether Section 112 of the Patent Act as properly interpreted includes a written description requirement that is separate and distinct from the enablement requirement. Although the USPTO has no direct role in the infringement dispute, the government submitted an amicus curie brief arguing that a separate written description requirement is “necessary to permit the USPTO to perform its basic examination function.” However, when pressed during oral arguments the government could not point to any direct evidence supporting its contention.

This essay presents the results of a retrospective empirical study of the role …

2004 Update - 180-Day Exclusivity Under The Hatch-Waxman Amendments To The Federal Food, Drug, And Cosmetic Act, Erika Lietzan

Faculty Publications

This article updates the author's previously published article on the topic, provides some insight into recent events in this area of the law, and specifies a few minor items that were noted incorrectly in the earlier work.

What's New In Intellectual Property - Business Is Booming In Copyright, Trademark And Patent Law, Richard C. Reuben

Faculty Publications

Forget the trendy law practice areas of the 1980s, such as mergers and acquisitions, real estate and antitrust. Intellectual property is where the action will be in the 1990s.