Intellectual Property 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 …

Smart Patents, Stephanie Plamondon

Faculty Scholarship

Intellectual property (IP) rights differ from traditional property rights in a crucial respect: the ascertainability of their boundaries. While it is usually a simple task to figure out where a traditional property right (e.g., an ownership right in a piece of land) begins and ends, delineating the metes and bounds of an IP right (e.g., a right to exclude others from practicing an invention as described in a patent claim) can be much more difficult to do.

The indeterminate scope of patent rights in particular leads to many layers of inefficiency. Downstream inventors may find it necessary to engage in …

Manufacturing Innovation, Xuan-Thao Nguyen

Articles

Using intellectual property assets as the proxy for innovation measures, this paper provides a comprehensive analysis of the legal and policy strategies that form the foundation for China's new role as the global manufacturer of innovation. Manufacturing innovation is evident through China's multi-prong approach regarding intellectual property production and maximization. Significantly, among many other policies that target innovation, China encourages the production of innovation by accepting patents and trademarks as collateral assets for financing. Entrepreneurs can quickly obtain loans against their portfolios of patents and trademarks. China also requires enterprises seeking to undergo an initial public offering (IPO) on the …

Rethinking Innovation At Fda, Rachel Sachs, W. Nicholson Price Ii, Patricia J. Zettler

Scholarship@WashULaw

In several controversial drug approval decisions in recent years, the Food & Drug Administration (FDA) has publicly justified its decision partly on the ground that approving the drugs in question would support innovation in those fields going forward. To some observers, these arguments were surprising, as the agency’s determination whether a drug is “safe” and “effective” does not seem to depend on whether its approval also supports innovation. But FDA’s use of these innovation arguments in drug approval decisions is just one example of the ways in which the agency has come to make many innovation-related judgments as part of …

From Patients To Patents: The Disappearing I Of Innovation, Maggi Robert

St. Mary's Law Journal

The creation of the Mayo/Alice two-step test for patent eligible subject matter flipped the patent world upside down. Following its establishment, invalidation rates soared—particularly in the healthcare sector—impacting patients everywhere. The importance of patents in healthcare innovation and innovation generally has been emphasized as the consequences of this framework are realized.

The United States is no longer seen as a clear leader in innovation, and as a result, the economy is at risk. Start-ups and investors have turned to foreign nations where return on their investments in innovation are protected. This level of uncertainty regarding patents has never been seen …

Competition And Innovation: The Breakup Of Ig Farben, Felix Poege

Faculty Scholarship

The relationship between competition and innovation is difficult to disentangle, as exogenous variation in market structure is rare. The 1952 breakup of Germany’s leading chemical company, IG Farben, represents such a disruption. After the Second World War, the Allies occupying Germany imposed the breakup because of IG Farben’s importance for the German war economy instead of standard antitrust concerns. In technology areas where the breakup reduced concentration, patenting increased strongly, driven by domestic firms unrelated to IG Farben. An analysis of patent texts shows that an increased propensity to patent does not drive the effect. Descriptively, IG Farben’s successors increased …

Patent Performativity, Dan L. Burk

Georgia Journal of Law & Technology

Gender bias is rife in the patent system; a large and growing body of empirical literature demonstrates the exclusion of women from the patent system at every level. Such pervasive marginalization cannot be explained by the paucity of women in STEM fields. Rather, more fundamental discriminatory mechanisms must be at work. In this paper I examine one aspect of such biases, arguing that patents operate as performatives, that is, as social assemblages that enact what they disclose, and that create their own social facts. To demonstrate patent performativity, I briefly trace the development of performative concepts, from Austinian declarations, through …

Paths To Downstream Innovation, Janet Freilich

Faculty Scholarship

All innovation is "downstream innovation" - research that builds on prior discoveries. Patent law has an outsized influence on downstream innovation because such innovation often falls within the scope of an in-force upstream patent. In these cases, innovators cannot conduct even the most basic research towards downstream technologies without addressing the upstream patent. Because upstream patents block downstream research, and it is often impractical to license the upstream patent, downstream researchers frequently exploit a group of doctrines that permit research to proceed even in the presence of an otherwise blocking patent.

This Article presents the first systematic review of the …

Beyond Compulsory Licensing: Pfizer Shares Its Covid-19 Medicines With The Patent Pool, Chenglin Liu

Faculty Articles

On March 15, 2022, the United States, European Union, India, and South Africa reached an agreement on the waiver of intellectual property rights (IP rights) for COVID-19 vaccines. The waiver agreement has rekindled the debate on the balance between IP rights protection and equitable access to medicines during a public health crisis. India, South Africa, and other developing countries maintain that a waiver was the only way to make vaccines affordable and accessible. Leading pharmaceutical companies argue that the waiver will stifle innovation and make lifesaving medicines less accessible. Both sides have seemingly overlooked Pfizer's voluntary agreement with the Medicines …

The Impact Of Uncertainty Regarding Patent Eligible Subject Matter For Investment In U.S. Medical Diagnostic Technologies, A. Sasha Hoyt

Washington and Lee Law Review

Historically, 35 U.S.C. § 101, the statute governing patent eligible subject matter, has been construed broadly—with its legislative history indicating that it should cover “anything under the sun that is made by man.” The Supreme Court crafted three exceptions to § 101: (1) abstract ideas, (2) laws of nature, and (3) natural phenomena. In recent years, the Supreme Court’s eligibility jurisprudence has further narrowed § 101 to effectively exclude meritorious medical diagnostic methods. Indeed, since the Court’s decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc., the Federal Circuit has held every single diagnostic method claim brought before it …

Confronting Intellectual Property Nationalism, Cynthia M. Ho

Faculty Publications & Other Works

Stories about nations engaging in vaccine (and medical) nationalism by hoarding limited COVID-19 vaccines and treatments are widespread, but there is a hidden phenomenon that has exacerbated vaccine nationalism and prolonged the pandemic: intellectual property nationalism or “IP nationalism.” This Article coins and explains this term and highlights its negative impacts. Essentially, some nations, primarily of the Global North, are hoarding essential knowledge protected by intellectual property (IP). This Article argues that IP nationalism has contributed to millions of unnecessary deaths and limited the growth of the global economy. Meanwhile, countries and pharmaceutical companies obscure the role of IP nationalism …

An Intellectual Property Fix For Platform Salesjacking, Eric E. Johnson

Faculty Articles

The aim of this Essay is to introduce an intellectual property angle to a current controversy that has been understood to be a matter for antitrust law. The controversy arises when a platform company--most famously Amazon--uses its platform to host a marketplace for independent retailers while simultaneously hosting itself as a retailer on the platform, thus competing as a retailer with an inside advantage. Critics say this setup allows platform firms to cherry-pick the best product ideas from small, independent retailers and then hijack their sales. This Essay seeks to advance the conversation about this controversy, making at least four …

Innovation's Hidden Externalities, Stephanie Plamondon Bair

Faculty Scholarship

When commentators discuss innovation’s externalities, they often classify them into one of two categories. On the positive externalities, or “spillovers” side, legal and economics scholars often speak of the benefits innovation confers on other innovators. Future innovators profit from past innovation as they “stand on the shoulders of giants” to develop progressively new and better innovation. Discussion of innovation’s negative externalities, on the other hand, has mainly focused on social harms not directly related to future innovation that particular advances impose on third parties—the classic example being pollution. Thus, the common understanding is that innovation’s spillovers positively impact innovation (among …

The Sociology And Psychology Of Innovation: A Synthesis And Research Agenda For Intellectual Property Scholars, Stephanie Plamondon Bair, Laura Pedraza-Fariña

Faculty Scholarship

Intellectual Property (IP) and innovation law scholarship is generally concerned with the question of how to promote socially beneficial innovation. Until recently, the analysis brought to bear on that question in the literature has been dominated by an individual, rational-actor-centered model grounded in the neoclassical economics tradition. Under this model, individual innovators are assumed to respond to innovation incentives in rational ways, unswayed by their social environments or their own psychology.

Of course, as innovation scholars are beginning to recognize, the road to innovation is much more winding and complex than the straight path from incentive to innovation that the …

Covid-19 And Its Impact(S) On Innovation, Clark Asay, Stephanie Plamondon Bair

Utah Law Review

In previous work, we explored how certain characteristics of adversity are often more conducive to innovation than others. In this Article, prepared as part of the Lee E. Teitelbaum Utah Law Review Symposium—The Law & Ethics of Medical Research, we review some of that work and apply it specifically to the COVID-19 context. We conclude by assessing certain policy implications in light of how the COVID-19 pandemic has both spurred and hindered innovation.

Gimme A Break: The Patent Term Restoration Act Should Give Environmental Innovators A Chance To Catch A (Cleaner) Breath, Gabrielle Gravel

Georgia Journal of Law & Technology

There is an abundance of frightening data painting a grim picture of Earth’s future. Humans have undoubtedly left a carbon footprint so deep, it will take drastic measures to undo our damage. To continue enjoying life as we know it, we humans must shift our focus to the powerful minds of creators and engineers to find ways to untangle our manmade webs. To generate interest and attract the best and brightest to do the challenging and time-consuming work of environmental inventions, the first step is to provide a greater incentive. This note calls upon the U.S. Patent and Trademark Office …

Stalking The Wild X Patent, Barbara J. Hampton

Journal of the Patent and Trademark Resource Center Association

For most of the history of the patent office, recorded patents were used primarily to enforce the patent holder’s rights during the life of the patent and to evaluate prior art, in determining patentability. The limits of manual indexes and hand counts of entries made more sophisticated analyses impractical. Recently, a number of researchers have begun to apply scientometric methods to assess trends and causation in patterns of innovation in the United States by organizing data elements from patent documents. Although most patents are now searchable, fully digital records, the records of the earliest patents (1790–1836) were incinerated in a …

Increasing Investment In Stem Education For Females: Policy Considerations, Becky Harris, Andrea Dassopoulos, Daniel Sahl, Anna Starostina

UNLV Gaming Research & Review Journal

During this difficult economic time, as policy makers decide how to use their limited resources to help prepare the rising generation for the demands of an ever-changing workforce, aligning K-12 educational priorities with higher education and economic development can help maximize public dollar investments in STEM education, particularly when females are given access to STEM and STEM-related education and programs. Smart public policy initiatives can help increase the representation of women in the technology, research and development, and innovation departments.

The purpose of this article is to provide policy recommendations that could help increase gender diversity and participation in STEM …

Enabling Science Fiction, Camilla A. Hrdy, Daniel H. Brean

Michigan Technology Law Review

Patent law promotes innovation by giving inventors 20-year-long exclusive rights to their inventions. To be patented, however, an invention must be “enabled,” meaning the inventor must describe it in enough detail to teach others how to make and use the invention at the time the patent is filed. When inventions are not enabled, like a perpetual motion machine or a time travel device, they are derided as “mere science fiction”—products of the human mind, or the daydreams of armchair scientists, that are not suitable for the patent system.

This Article argues that, in fact, the literary genre of science fiction …

What Is Cultural Misappropriation And Why Does It Matter? 03-31-2021, Roger Williams University School Of Law

School of Law Conferences, Lectures & Events

No abstract provided.

Patents As Signals Of Quality In Crowdfunding, Christopher A. Cotropia

Law Faculty Publications

Patents and crowdfunding both attempt to foster early stage innova-tions. In theory, patents signal quality and value to attract investment and buyers and ultimately facilitate commercialization. Crowdfunding allows multiple individuals to make small contributions to finance start-up ven-tures. This Article reports on two related studies investigating the interac-tion between these two innovation tools by determining the impact of a crowdfunding campaign’s patent status on the campaign’s success and de-livery. The first study examines 9,184 Kickstarter campaigns in patent-eli-gible categories to determine whether patented or patent-pending labeled projects are more likely to reach their funding goal and in turn achieve actual, …

Legal Opacity: Artificial Intelligence’S Sticky Wicket, Charlotte A. Tschider

Faculty Publications & Other Works

Proponents of artificial intelligence (“AI”) transparency have carefully illustrated the many ways in which transparency may be beneficial to prevent safety and unfairness issues, to promote innovation, and to effectively provide recovery or support due process in lawsuits. However, impediments to transparency goals, described as opacity, or the “black-box” nature of AI, present significant issues for promoting these goals.

An undertheorized perspective on opacity is legal opacity, where competitive, and often discretionary legal choices, coupled with regulatory barriers create opacity. Although legal opacity does not specifically affect AI only, the combination of technical opacity in AI systems with legal opacity …

Patents As Signal Of Quality In Crowdfunding, Christopher A. Cotropia

Law Faculty Publications

Patents and crowdfunding both attempt to foster early stage innovations. In theory, patents signal quality and value to attract investment and buyers and ultimately facilitate commercialization. Crowdfunding allows multiple individuals to make small contributions to finance start-up ventures. This Article reports on two related studies investigating the interaction between these two innovation tools by determining the impact of a crowdfunding campaign’s patent status on the campaign’s success and delivery. The first study examines 9,184 Kickstarter campaigns in patent-eligible categories to determine whether patented or patent-pending labeled projects are more likely to reach their funding goal and in turn achieve actual, …

Intellectual Property Through A Non-Western Lens: Patents In Islamic Law, Tabrez Y. Ebrahim

Faculty Scholarship

The intersection of secular, Western intellectual property law and Islamic law is undertheorized in legal scholarship. Yet the nascent and developing non-Western law of one form of intellectual property—patents—in Islamic legal systems is profoundly important for transformational innovation and economic development initiatives of Muslim-majority countries that comprise nearly one-fifth of the world’s population.

Recent scholarship highlights the tensions of intellectual property in Islamic law because religious considerations in an Islamic society do not fully align with Western notions of patents. As Islamic legal systems have begun to embrace patents in recent decades, theories of patents have presented conceptual and theological …

Innovoting: How Democracy Is Being Reshaped By Women's Innovative Voting Activism & Candidacy, Andrea Schneider, Kali Murray, Amber Wichowsky, Christina Wolbrecht, Mary Kelley, Kara Swanson

Marquette Intellectual Property & Innovation Law Review

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Clearing Opacity Through Machine Learning, W. Nicholson Price Ii, Arti K. Rai

Articles

Artificial intelligence and machine learning represent powerful tools in many fields, ranging from criminal justice to human biology to climate change. Part of the power of these tools arises from their ability to make predictions and glean useful information about complex real-world systems without the need to understand the workings of those systems.

Race Cartels: How Constructor Collaboration Is Curbing Innovation In Formula 1, Chandler C. Gerard-Reimer

Vanderbilt Journal of Entertainment & Technology Law

Formula 1 is in the midst of a copycat scandal: technology has made it possible for teams to reverse engineer clones of competitors’ race cars. This is a less than ideal state of affairs for the championship series, which prides itself on being the pinnacle of motorsport and automotive innovation, thanks in large part to the cars’ rapid rate of technological advancement. In order to address this problem, the Fédération Internationale de l’Automobile (FIA), Formula 1’s governing body, must increase independent innovation efforts by amending the technical regulations to restrict the extent of presently allowed inter-team collaboration. Worried that the …

Risk Taking And Rights Balancing In Intellectual Property Law, Clark D. Asay

Akron Law Review

Scholars have long worried that risk aversion can have significant negative effects in the marketplace. In the intellectual property law domain, some have worried that risk-averse actors can negatively influence the development of important intellectual property law doctrines, which can ultimately hamper innovation. For instance, risk-averse actors may frequently choose to obtain licenses for rights that the relevant laws do not actually require of them. When they do so, they inadvertently increase the scope of intellectual property rights because their risk-averse activities inform courts’ development of key intellectual property law doctrines.

In this Article, prepared as part of the IP …

Gene Patents, Drug Prices, And Scientific Research: Unexpected Effects Of Recently Proposed Patent Eligibility Legislation, Charles Duan

Scholarly Articles in Law Reviews & Journals

Recently, Congress has considered legislation to amend§ 101, a section of the Patent Act that the Supreme Court has held to prohibit patenting of laws of nature, natural phenomena, and abstract ideas. This draft legislation would expand the realm of patent-eligible subject matter, overturning the Court's precedents along the way. The draft legislation, and movement to change this doctrine of patent law, made substantial headway with a subcommittee of the Senate holding numerous roundtables and hearings on the subject.

This article considers some less-discussed consequences of that draft legislative proposal. The legislation likely opens the door to patenting of subject …

The Normative Molecule: Patent Rights And Dna, Saurabh Vishnubhakat

Faculty Scholarship

Throughout the biotechnology age, fears about the distortionary effects of property and other legal institutions upon the health and self-determination of individuals and societies have accompanied more popularly sensational fears about unscrupulous choices within the scientific community itself. Still, for most of that time the prevailing legal regime both in the United States and in Europe remained generally permissive of ownership of, and exclusionary power over, the fruits of much biomedical research, though this leniency took different forms and came about in different ways. In particular, the policy of the United States Patent and Trademark Office to grant patents on …