Document Type

Article

Publication Title

American University Law Review

Publication Date

4-2026

ISSN

0003-1453

Page Number

1047

Keywords

patent theory, invention, pharmaceuticals

Disciplines

Law | Medicinal and Pharmaceutical Chemistry | Pharmaceutics and Drug Design

Abstract

Unexpected discoveries have transformed human existence. They’ve revolutionized science and spawned entire new fields of research. While unexpected discoveries seem inventive and worthy of patent protection, they don’t formally align with traditional patent theory. The bedrock principle that an invention begins with the conception of an idea in the inventor’s mind and ends with implementation doesn’t apply to unexpected discoveries. This misalignment is most acute for pharmaceuticals, where the discovery of new uses for old drugs has tremendous social and economic importance. Since a drug can inherently treat multiple conditions in a patient—even those unknown to the patient, doctor, or manufacturer at the time of administration—it stands to reason that many purported new uses for old drugs aren’t new: the drug is actually doing what it’s always done. In other words, the serendipitous discovery of an inherent characteristic of a drug may not confer novelty. To address these problems, this Article offers an alternative theory of invention for unexpected discoveries that recognizes the practical realities of modern science. It allows those seeking to patent unexpected discoveries to obtain, maintain, or enforce patent rights that are often absent or jeopardized under the current regime.

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