Abstract: The practice of patenting genetic material is currently under sharp attack. Recent litigation has forced the courts to grapple with the doctrinal basis for patenting DNA sequences identical to those found in nature. Faced with conflicting authorities and difficult policy questions, courts have leaned heavily on history to guide—or at least to justify—their decisions. This article explores the history in question. It traces the patent law’s changing treatment of “products of nature” in an attempt to untangle the origins of present-day patentability arguments. The evidence suggests that the historical foundations of the bar on patenting products of nature are surprisingly shaky. The article also reveals how isolated biological materials first came to be patented. This task, I argue, requires looking not only to court decisions, but also to the history of patent practice. My principal vehicle for doing so is the case of Parke-Davis & Co. v. H. K. Mulford Co., a century-old decision by Judge Learned Hand, which now stands as a central (and much disputed) precedent for the patenting of DNA sequences. Parke-Davis arose at a key moment in the sociology of intellectual property, when the American pharmaceutical industry first learned to embrace the power of patents. The article shows how Parke-Davis came to prominence in half-understood form during the biotechnology era, and how the decision’s original rationale suddenly seems poised to play a major role in resolving the gene patent question. * Assistant Professor of Law, Brooklyn Law School. The author is grateful for the thoughts of Derek Bambauer, Frederic Bloom, Anisha Dasgupta, Rochelle Dreyfuss, Robin Effron, Daniel Hulsebosch, Osagie Imasogie, Daniel Kevles, Brian Lee, Irina Manta, Michael Risch, Joshua Sarnoff, Katherine Strandburg, Kara Swanson, Jane Yakowitz Bambauer, and participants in the NYU Law School Innovation Policy Colloquium and in junior-faculty workshops at Fordham and Brooklyn Law Schools. A Brooklyn Law School Dean’s Summer Research Stipend supported research for the project. 258 STANFORD TECHNOLOGY LAW REVIEW [Vol. 16:229 INTRODUCTION 258 I. PATENTABLE SUBJECT MATTER AND THE PROBLEM OF HISTORY 264 A. Patent Law 101 264 B. Problems of Nature 266 II. SEARCHING FOR THE ORIGINS OF THE PRODUCT-OF-NATURE DOCTRINE ......... 268 A. The Unpatentability of Natural Laws and Principles 268 B. The Murky Origins of the Product-of-Nature Doctrine 271 C. The Advent of “Useful Difference” 276 III. SCIENTIFIC INDUSTRY, PATENT CULTURES, AND PATENT LAW IN THE EARLY TWENTIETH CENTURY 280 A. American Pharmaceuticals and Patent Skepticism 280 B. Synthetic Drugs and the German Invasion 282 IV. THE ADRENALIN PATENT 284 A. Patenting Adrenalin 285 B. Adrenalin on Trial 289 C. Was Parke-Davis Rightly Decided? 293 V. THE PRACTICE AND LAW OF PATENTING NATURE AFTER PARKE-DAVIS 296 A. Practice 296 B. Law 299 C. A New View of Parke-Davis at the Federal Circuit? 306 CONCLUSION 310
Publication Year: 2013
Publication Date: 2013-01-01
Language: en
Type: article
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Cited By Count: 8
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