Intellectual Property Law Commons^™

Enhancing Public Access To Agency Law, Bernard Bell, Cary Coglianese, Michael Herz, Margaret Kwoka, Orly Lobel

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A just, democratic society governed by the rule of law requires that the law be available, not hidden. This principle extends to legal materials produced by administrative agencies, all of which should be made widely accessible to the public. Federal agencies in the United States do disclose online many legal documents—sometimes voluntarily, sometimes in compliance with statutory requirements. But the scope and consistency of these disclosures leaves considerable room for improvement. After conducting a year-long study for the Administrative Conference of the United States, we identified seventeen possible statutory amendments that would improve proactive online disclosure of agency legal materials. …

The Coming Copyright Judge Crisis, Saurabh Vishnubhakat, Dave Fagundes

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Commentary about the Supreme Court's 2021 decision in United States v. Arthrex, Inc. has focused on the nexus between patent and administrative law. But this overlooks the decision's seismic and as-yet unappreciated implication for copyright law: Arthrex renders the Copyright Royalty Board ("CRB") unconstitutional. The CRB has suffered constitutional challenge since its 2004 inception, but these were seemingly resolved in 2011 when the D.C. Circuit held that the CRB's composition did not offend the Appointments Clause as long as Copyright Royalty Judges ("CRJs") were removable atwill. But when the Court invalidated the selection process for administrative patent judges on a …

Color Of Creatorship - Author's Response, Anjali Vats

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This essay is the author's response to three reviews of The Color of Creatorship written by notable intellectual property scholars and published in the IP Law Book Review.

Post-Grant Adjudication Of Drug Patents: Agency And/Or Court?, Arti K. Rai, Saurabh Vishnubhakat, Jorge Lemus, Erik Hovenkamp

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The America Invents Act of 2011 (AIA) created a robust administrative system-the Patent Trial and Appeal Board (PTAB)-that provides a route for challenging the validity of granted patents outside of district courts. Congress determined that administrative adjudication of the validity of initial patent grants could be cheaper and more scientifically accurate than district court adjudication of such validity.

For private economic value per patent, few areas of technology can match the biopharmaceutical industry. This is particularly true for small-molecule drugs. A billion-dollar drug monopoly may be protected from competition by a relatively small number of patents. Accordingly, the social cost …

A Functional Approach To Judicial Review Of Ptab Rulings On Mixed Questions Of Law And Fact, Rebecca S. Eisenberg

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The Court of Appeals for the Federal Circuit (“Federal Circuit”) has long relied on active appellate review to bring uniformity and clarity to patent law. It initially treated the PTO the same as the federal district courts, reviewing its factual findings for clear error and its legal conclusions de novo. Following reversal by the Supreme Court in Dickinson v. Zurko, the Federal Circuit began giving greater deference to PTO factual findings. But it continued to review the PTO’s legal conclusions de novo, while coding an expansive list of disputed issues in patent cases as legal conclusions, even when they …

Innovation Prizes In Practice And Theory, Michael J. Burstein, Fiona Murray

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Innovation prizes in reality are significantly different from innovation prizes in theory. The former are familiar from popular accounts of historical prizes like the Longitude Prize: the government offers a set amount for a solution to a known problem, like £20,000 for a method of calculating longitude at sea. The latter are modeled as compensation to inventors in return for donating their inventions to the public domain. Neither the economic literature nor the policy literature that led to the 2010 America COMPETES Reauthorization Act — which made prizes a prominent tool of government innovation policy — provides a satisfying justification …

Manufacturing Barriers To Biologics Competition And Innovation, W. Nicholson Price Ii., Arti K. Rai

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As finding breakthrough small-molecule drugs becomes more difficult, drug companies are increasingly turning to "large molecule" biologics. Although biologics represent many of the most promising new therapies for previously intractable diseases, they are extremely expensive. Moreover, the pathway for generic-type competition set up by Congress in 2010 is unlikely to yield significant cost savings. This Article provides a fresh diagnosis of and prescription for this major public policy problem. It argues that the key cause is pervasive trade secrecy in the complex area of biologics manufacturing. Under the current regime, this trade secrecy, combined with certain features of Food and …

A New Deal For End Users? Lessons From A French Innovation In The Regulation Of Interoperability, Jane K. Winn, Nicolas Jondet

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In 2007, France created the Regulatory Authority for Technical Measures (lAutoritj de Rdgulation des Mesures Techniques or ARMT), an independent regulatory agency charged with promoting the interoperability of digital media distributed with embedded "technical protection measures" (TPM), also known as "digital rights management" technologies (DRM). ARMT was established in part to rectify what French lawmakers perceived as an imbalance in the rights of copyright owners and end users created when the European Copyright Directive (EUCD) was transposed into French law as the "Loi sur le Droit d'Auteur et les Droits Voisins dans la Société de l'Information" (DADVSI).

ARMT is both …

The Problem Of New Uses, Rebecca S. Eisenberg

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Discovering new uses for drugs that are already on the market seems like it ought to be the low-lying fruit of biopharmaceutical research and development (R&D). Firms have already made significant investments in developing these drugs and bringing them to market, including testing them in clinical trials, shepherding them through the FDA regulatory approval process, building production facilities, and training sales staff to market them to physicians. By this point, the drugs have begun to enjoy goodwill among patients and physicians and casual observations in the course of clinical experience may point to potential new uses. One might expect that …

Re-Examining The Role Of Patents In Appropriating The Value Of Dna Sequences, Rebecca S. Eisenberg

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As public and private sector initiatives race to complete the sequence of the human genome, patent issues have played a prominent role in speculations about the significance of this achievement. How much of the genome will be subject to the control of patent holders, and what will this mean for future research and the development of products for the improvement of human health? Is a patent system developed to establish rights in mechanical inventions of an earlier era up to the task of resolving competing claims to the genome on behalf of the many sequential innovators who elucidate its sequence …

Intellectual Property Issues In Genomics, Rebecca S. Eisenberg

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Controversy over intellectual property rights in the results of large-scale cDNA sequencing raises intriguing questions about the roles of the public and private sectors in genomics research, and about who stands to benefit (and who stands to lose) from the private appropriation of genomic information. While the US Patent and Trademark Office has rejected patent applications on cDNA fragments of unknown function from the National Institutes of Health, private firms have pursued three distinct strategies for exploiting unpatented cDNA sequence information: exclusive licensing, non-exclusive licensing and dedication to the public domain.

Opinion Letter As To The Patentability Of Certain Inventions Associated With The Identification Of Partial Cdna Sequences, Rebecca S. Eisenberg, Robert P. Merges

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You have asked for our legal opinion on the patentability of inventions claimed in U.S. patent applications 07/716,831, filed June 21, 1991 (the '831 application, or .'831"), 07/837,195, filed September 25, 1992 ("'195"), and 07/952,911, filed February 12, 1993 (."911"), all filed in the name of Craig Venter and others and assigned to the National Institutes of Health "(NIH)." We understand that NIH has abandoned these patent applications and has no present intention of filing similar applications in the future, but that NIH remains interested in the patenting of human DNA sequences from a broader public policy perspective. We have …

Reply To Comments On The Patentability Of Certain Inventions Associated With The Identification Of Partial Cdna Sequences, Rebecca S. Eisenberg, Robert P. Merges

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A brief reply is in order to clarify our position on the patenting of research tools. We stand by the statement that "there are reasons to be wary of patents on research tools," but that statement should not be understood as a broad condemnation of patents on research tools in all contexts. Indeed, immediately after the cited language our opinion letter acknowledges that withholding patent protection from research tools could undermine private incentives to develop research tools and to make them available to investigators or lead to greater reliance on trade secrecy. Unlike the government, which purports to pursue patent …