Intellectual Property Law Commons^™

Encouraging Public Access To Pharmaceuticals Through Modified Protection Of Clinical Trial Data, Scott M. Nolan Ii

IP Theory

Part I of this Article investigates the development of pharmaceuticals and clinical trial data with a focus on patent and data protection. Part II evaluates the effects of protection and the challenges it poses to widespread public pharmaceutical access. Part III discusses two scholarly approaches to the public access issue that focus on clinical data protection and their associated challenges. In light of these scholarly works, Part IV suggests a new approach to clinical trial data protection that aims to improve public pharmaceutical access while maintaining the incentives to invent for drug developers.

Jury-Related Errors In Copyright, Zahr K. Said

Indiana Law Journal

Copyright law is surprisingly hard. Copyright does not do what laypeople think it does, nor do its terms mean what laypeople expect. Copyright also possesses systemic indeterminacy about what it protects and the extent of that protection. For laypeople, copyright law is decidedly “user-unfriendly.” Nonetheless, copyright law reserves for lay jurors its most-litigated, most difficult, and most consequential question at trial: whether works are “substantially similar” and thus infringing. Many have criticized this allocation because in the context of copyright law, juries effectively have the power to expand or contract owners’ rights with little oversight or correction. But blaming the …

The Constitution Commandeth: Thou Shalt Not Protect The Same Subject Matter Under Design Patent And Trade Dress Laws, Kenneth B. Germain, Louis H. Sitler

IP Theory

For many years and still currently, it has been assumed—and even expressly asserted—that it is perfectly permissible to “stack” various legal theories (concurrently or consecutively) to protect nonfunctional “designs” for products. This is despite infrequent but cogent arguments that the available theories, notably design patents and product design trade dress—both of which are based upon federal statutes—are not Constitutionally compatible due to at least the concept of Superfluity. The authors of this article carefully examine the origin, nature, and meaning of these two types of IP protections in the context of their two Constitutional bases—the Patent/Copyright Clause and the Commerce …

A Hot Spit-Take: Why The Supreme Court Will Hold That There Is No Privacy Interest In Commercial Dna Data, Mounir Jamal

IP Theory

No abstract provided.

Indian Pharmaceutical Patenting Under Section 3(D): A Model For Developing Countries, Nicholas Eitsert

IP Theory

No abstract provided.

Managing Digital Resale In The Era Of International Exhaustion, Seth Niemi

Indiana Journal of Global Legal Studies

The Copyright Act of 1970 and Directive 2001/29/EC of the European Parliament both guarantee copyright holders’ exclusive rights of reproduction and distribution of their copyrighted material. Starting from a similar statutory basis, United States and European Union courts have diverged in their interpretation of these protections with respect to the first sale rule for digital goods. This paper analyzes the treatment of such “digital exhaustion” arguments under copyright law between the two legal systems from both the statutory interpretations employed and the policy rationales considered. The paper concludes by discussing the implications of adoption of digital exhaustion, within international law, …

How The Supreme Court Ghosted The Phosita: Amgen And Legal Constructs In Patent Law, Timothy R. Holbrook, Mark D. Janis

Articles by Maurer Faculty

This Essay is an invited response to The Ghost in the Patent System: An Empirical Study of Patent Law’s Elusive “Skilled Artisan,” by Professors Laura Pedraza-Fariña and Ryan Whalen. In their piece, Pedraza-Fariña and Ryan Whalen offer an empirical study and use it to argue for a new conception of the Person Having Ordinary Skill in the Art (“PHOSITA”), patent law’s nod to the “reasonable person” construct.

As Professors Pedraza-Fariña and Whalen suggest, the PHOSITA should be understood as a crucial concept in patent law, warranting more scholarly attention. Pedraza-Fariña and Whalen provide that attention. They assert, based on an …

Design Patent Nonobviousness: The Road Ahead?, Mark D. Janis

Articles by Maurer Faculty

In this Essay, I comment on Mark Bartholomew’s Article Nonobvious Design and link it to an important contemporary debate over the nonobviousness test for design patents in the en banc rehearing in LKQ. I begin by challenging the assertion that nonobviousness doctrine is the most compelling vehicle for design patent policy reform, suggesting that Nonobvious Design may be borrowing this thinking from utility patent law, where nonobviousness plays a different role. I then turn to Nonobvious Design’s elaboration of the concept of the “aesthetic middle,” which provides the chief impetus for the suggested nonobviousness reforms. I question the normative implications …

The Hidden Cost Of University Patents, Christopher J. Ryan Jr., W. Michael Schuster, Brian L. Frye

Articles by Maurer Faculty

Universities are encouraged to undertake research through grants from government agencies, foundations, and other organizations. The Bayh-Dole Act reinforces this incentive structure by allowing universities to take ownership of the resultant patents. The rights of ownership include the ability to generate income by licensing patents and bringing patent infringement lawsuits. Undoubtedly, exercising these rights to financially benefit the university is economically rational. But might such actions also impose a cost on the public despite the fact that these very patents arose from public research subsidies?

This study examines the relationship between a university’s research expenditures and its likelihood to litigate …

Psychedelic Drugs & The Prior Art Problem, Anneli E. Kawaoka

Indiana Law Journal

For the first time since the War on Drugs began in the 1970s, researchers have returned to the promise of psychedelic drugs for treating the growing mental health crisis in the United States. As research into psychedelic drugs as a conventional treatment method for mental health conditions grows, so does the number of filings at the U.S. Patent & Trademark Office for psychedelic-related patents. But the decades-long lapse in the development of psychedelic drugs creates the risk that low-quality psychedelic patents will issue, giving limited monopolies to companies that have not truly innovated in the psychedelic space. In this Note, …

Marshalling Copyright Knowledge To Understand Four Decades Of Berne, Peter K. Yu

IP Theory

In the year 1978, the 1976 Copyright Act had just entered into effect. Marshall Leaffer, whom this article will affectionately refer to by his first name, had just completed his duties as an attorney advisor at the U.S. Copyright Office. On his way to academia, he, like the fictional character Captain William “Buck” Rogers, was to experience cosmic forces beyond all comprehension. In a freak mishap, his car veered off a rarely used mountain road and was frozen by temperatures beyond imagination. He did not return to academia until more than forty years later. What will he discover upon his …

Life After Google V. Oracle: Three Reflections On A Theme, Daryl Lim

IP Theory

In 2004, Professor Leaffer published an article titled Life after Eldred: The Supreme Court and the Future of Copyright. He wrote about three cases decided in or after 2001 to provide a snapshot of the Supreme Court’s position on copyright issues. This Article discusses three reflections on this theme. The first reflection flows directly from Google. It discusses fair use in Andy Warhol Found. for Visual Arts, Inc. v. Goldsmith, as well as text and data mining for artificial intelligence uses. This Article then reflects on Arnstein v. Porter’s lessons for modern copyright infringement law. Finally, it reflects on the …

Reconciling Copyright "Restoration" For Pre-1972 Foreign Sound Recordings With The Classics Protection And Access Act, Tyler T. Ochoa

IP Theory

When Congress first added sound recordings to the Copyright Act, it acted prospectively only: sound recordings fixed on or after February 15, 1972, received federal statutory copyright protection, while sound recordings fixed before February 15, 1972, were left to the vagaries of state law. This historic inequity was corrected in 2018 with enactment of the Classics Protection and Access Act (CPA), which provides sui generis protection to pre-1972 sound recordings that is similar, but not identical, to federal copyright protection. But there is a subset of pre-1972 sound recordings that already had federal copyright protection before the CPA was enacted: …

Tokenized: The Law Of Non-Fungible Tokens And Unique Digital Property, Joshua A.T. Fairfield

Indiana Law Journal

Markets for unique digital property—digital equivalents of rare artworks, collectible trading cards, and other assets that gain value from scarcity—have exploded in the past few years. At root is the next iteration of blockchain technology, unique digital assets called non-fungible tokens. Unlike bitcoin, where one coin is the same as another, NFTs are unique, each with different attributes. An NFT that represented ownership of Boardwalk would be quite different from one that represented Baltic Avenue.

NFTs have grown from a few early breakout successes to a rapidly developing market for unique digital treasures. The attraction to buyers is that, unlike …

Data Types, Data Doubts & Data Trusts, João Marinotti

Articles by Maurer Faculty

Data is not monolithic. Nonetheless, the word is frequently used indiscriminately—in reference to a number of distinct concepts. It may refer to information writ large, or specifically to personally identifiable information, discrete digital files, trade secrets, and even to sets of AI-generated content. Yet each of these types of “data” requires different governance regimes in commerce, in life, and in law. Despite this diversity, the singular concept of data trusts is promulgated as a solution to our collective data governance problems. Data trusts—meant to cover all of these types of data—are said to promote personal privacy, increase corporate transparency, facilitate …

An Introduction To "Marshall Law", Ip Theory Volume 12 Editorial Board

IP Theory

No abstract provided.

Hoosier Athletes Get An Assist From Law Students Through Name, Image And Likeness Initiative, James Owsley Boyd

Keep Up With the Latest News from the Law School (blog)

Student-athletes at Indiana University Bloomington will get an assist from their peers at the IU Maurer School of Law under a new Name, Image and Likeness Initiative through the school’s Center for Intellectual Property Research.

As student-athletes navigate the still-emerging complexities of the NCAA’s new policy surrounding name, image and likeness — also referred to as NIL — they’ll now have a homefield advantage: one of the country’s top intellectual property clinics.

Where Is The Author: The Copyright Protection For Ai-Generated Works, Chieh Huang

Maurer Theses and Dissertations

The two groups of the human-or-machine questions, whether AI-generated works are copyrightable and whether AI-generated works have human authors, are revisiting the current copyright law with the emergence of AI-generated works. These revisiting questions reveal that the current authorship requirement fails to provide a clear and operable standard on evaluating a human contributor’s intellectual labor for creative output. Such a defect of the current authorship requirement has to be fixed to respond to the technological change of artificial intelligence and the burgeoning prevalence of AI- or advanced computer program-generated works.

This dissertation’s main goal is to fix the flaw …

The Law Of Employee Data: Privacy, Property, Governance, Matthew T. Bodie

Indiana Law Journal

The availability of data related to the employment relationship has ballooned into an unruly mass of performance metrics, personal characteristics, biometric recordings, and creative output. The law governing this collection of information has been awkwardly split between privacy regulations and intellectual property rights, with employees generally losing on both ends. This Article rejects a binary approach that either carves out private spaces ineffectually or renders data into isolated pieces of ownership. Instead, the law should implement a hybrid system that provides workers with continuing input and control without blocking efforts at joint production. In addition, employers should have fiduciary responsibilities …

Interview By Zach Shepard And Chris Mcmillan With David Gindler, Partner, Milbank Llp, And Jasper Tran, Associate, Milbank Llp

IP Theory

No abstract provided.

Cannabis Derivatives And Trademark Registration: The Case Of Delta-8-Thc, W. Michael Schuster

Indiana Law Journal

The legal environment surrounding the cannabis industry is ambiguous and constantly changing. While cannabis is prohibited under federal law, a 2018 statute legalized a variant of the cannabis plant (“hemp”) that is low in its most common intoxicating agents. Recognizing this, entrepreneurs began to process hemp to extract and sell chemicals contained therein. Included in this trend is the extraction of Delta-8 Tetrahydrocannabinol (Δ8-THC)—a psychoactive drug with an increasing market presence in states where most cannabis (e.g., “marijuana”) is illegal.

As competition in the Δ8-THC field emerged, firms sought to distinguish their wares through brand recognition and federal trademark registration. …

Patent Inconsistency, Saurabh Vishnubhakat

Indiana Law Journal

Despite the promise of efficiency through the use of expert agency adjudication in U.S. patent law, administrative substitution continues to fall short. In a variety of ways, the decade-old system of Patent Office adjudication is simply an additional place to litigate rather than the robust technocratic alternative it was meant to be. These problems have arisen from important defects in the statutory design, but also from the enormous expansion and ascendancy of the Patent Office itself. Moreover, while duplicative litigation over patent validity is recognized and criticized, its scale and scope has eluded detailed empirical analysis until now. This Article …

Arbitrating Copyright Disputes In Egypt, Islam Mohamed

Maurer Theses and Dissertations

Egypt is witnessing increasing difficulty in implementing and practicing protectionist policies for intellectual property rights, which includes copyright as a fundamental element. Since the Egyptian judicial system is exclusively concerned with adjudicating all disputes, it has become increasingly burdened in recent decades due to this monopoly. As a result, the Egyptian judiciary is witnessing a significant slowdown in resolving conflicts and procedural obstacles which delay the restitution of Intellectual property rights to its owners. Thus, we believe that applying arbitration will contribute to resolving copyright disputes in advance on one hand and will encourage an attractive climate in such matters …

Mitigating The Effects Of Intellectual Property Colonialism On Budding Cannabis Markets, Hughie Kellner

Indiana Journal of Global Legal Studies

Globalization has reduced barriers to trade, communication, and understanding, opening opportunities that extend far beyond national borders. However, in this bounty of opportunity lie obligations, and often those obligations tie a nation's hands when trying to deal with a problem that arises. One obligation nations face is upholding the United Nations' (UN) decision to prevent the illicit use of cannabis. Another is supporting and following the World Trade Organization's (WTO) near elimination of barriers for companies to bring patent and trademark protection with them into any country they do business with. In a modern globalized economy, if a nation fails …

Privacy Vs. Transparency: Handling Protected Materials In Agency Rulemaking, Christopher S. Yoo, Kellen Mccoy

Indiana Law Journal

Agencies conducting informal rulemaking proceedings increasingly confront conflicting duties with respect to protected materials included in information submitted in public rulemaking dockets. They must reconcile the broad commitment to openness and transparency reflected in federal law with the duty to protect confidential business information (CBI) and personally identifiable information (PII) against improper disclosure.

This Article presents an analysis of how agencies can best balance these often countervailing considerations. Part I explores the statutory duties to disclose and withhold information submitted in public rulemaking dockets placed on agencies. It also examines judicial decisions and other legal interpretations regarding the proper way …

Rethinking Copyright Harmonization, Clark Asay

Indiana Law Journal

For nearly half a century, the United States has been one of the main proponents of harmonizing the world’s copyright laws. To that end, the U.S. government has worked diligently to persuade (and, in some cases, bully) most of the world’s countries to adopt copyright standards that resemble those found in the United States. The primary reason for this push to harmonize the world’s copyright laws is simple: the United States has long been a net exporter of copyrighted works, and so the U.S. government has sought to ensure that other countries provide U.S. authors with the same economic rights …

Cyber Trespass And Property Concepts, Adam Macleod

IP Theory

No abstract provided.

The Future Of Female Inventors In The United States: A Comparative Analysis To The Republic Of Korea, Payton Hoff

IP Theory

No abstract provided.

Saving Face; The Unconstitutional Use Of Facial Recognition On Undocumented Immigrants And Solutions In Ip, Audrey Knutson

IP Theory

No abstract provided.

Copyright's Fixation Requirement: Is It Still Needed?, Attamongkol Tantratian

Maurer Theses and Dissertations

While the United States requires fixation for an original work to be entitled to federal copyright protection, many other countries ignore such requirement. The difference could lead to partial copyright protection standards across jurisdictions over certain works that are not fixed. Examples of such works include extemporaneous speeches, lectures, improvisational performances, and contemporary arts that are transitory. Moreover, with today’s rapid development of arts and technologies, creative works can be presented via new media without being fixed in a traditional way. The examples include live streams of lectures and music performances, which have become part of the “new normal.” In …