Law Commons^™

International Rights Affecting The Covid–19 Vaccine Race, Samantha Johnson

University of Miami Inter-American Law Review

The impact of the COVID–19 pandemic has been felt world-wide, and despite having several vaccines in the market at this point, there are still issues of accessibility for certain countries. International intellectual property law has been a breeding ground for the exploration of intellectual curiosity and creation as it provides strong protections to creators. These strong protections have allowed for the monopolization of certain goods, such as vaccines, under the concept of patents. While patents are important to incentivize pharmaceutical companies to create life–saving medicines, these protections have also become a barrier for access to medicines, especially in less–developed countries. …

Association For Molecular Pathology V. Myriad Genetics: A Critical Reassessment, Jorge L. Contreras

Michigan Technology Law Review

The Supreme Court’s 2013 decision in Association for Molecular Pathology v. Myriad Genetics is an essential piece of the Court’s recent quartet of patent eligibility decisions, which also includes Bilski v. Kappos, Mayo v. Prometheus, and Alice v. CLS Bank. Each of these decisions has significantly shaped the contours of patent eligibility under Section 101 of the Patent Act in ways that have been both applauded and criticized. The Myriad case, however, was significant beyond its impact on Section 101 jurisprudence. It was seen, and litigated, as a case impacting patient rights, access to healthcare, scientific freedom, …

The Intellectual Property Of Vaccines: Takeaways From Recent Infectious Disease Outbreaks, Ana Santos Rutschman

Michigan Law Review Online

In late 2019 and early 2020, a new strain of coronavirus, a family of pathogens causing serious respiratory illness, began infecting populations across the globe. A quick uptick in COVID-19, the disease caused by the novel pathogen, prompted the World Health Organization to declare the outbreak a Public Health Emergency of International Concern on January 30, 2020. By mid-February 2020, with 26 countries reporting cases of COVID-19 infection, the global case count had surpassed 50,000, and had resulted in over 1,500 deaths. The World Health Organization elevated the status of the outbreak to a pandemic in mid-March. As of early …

Opting Into Device Regulation In The Face Of Uncertain Patentability, Rebecca S. Eisenberg

Articles

This article examines the intersection of patent law, FDA regulation, and Medicare coverage in a particularly promising field of biomedical innovation: genetic diagnostic testing. First, I will discuss current clinical uses of genetic testing and directions for further research, with a focus on cancer, the field in which genetic testing has had the greatest impact to date. Second, I will turn to patent law and address two recent Supreme Court decisions that called into question the patentability of many of the most important advances in genetic testing. Third, I will step outside patent law to take a broader view of …

Universities: The Fallen Angels Of Bayh-Dole?, Rebecca S. Eisenberg, Robert Cook-Deegan

Articles

The Bayh-Dole Act of 1980 established a new default rule that allowed nonprofit organizations and small businesses to own, as a routine matter, patents on inventions resulting from research sponsored by the federal government. Although universities helped get the Bayh-Dole Act through Congress, the primary goal, as reflected in the recitals at the beginning of the new statute, was not to benefit universities but to promote the commercial development and utilization of federally funded inventions. In the years since the passage of the Bayh-Dole Act, universities seem to have lost sight of this distinction. Their behavior as patent seekers, patent …

Chinese Innovation And Global Integration- Theoretical Framework Of Perceived Insecurities In University Technology Transfer, Clovia Hamilton

Winthrop Faculty and Staff Publications

University technology transfer is growing in China and is vital to China’s innovation and intellectual property program. This paper provides a literature review used to create a theoretical framework for explaining conflicts between university technology transfer participants. Economic development and business competitiveness relies on innovation and intellectual property generation. Given increased investments in university research and Chinese universities, it is important to be aware of conflicts between university technology transfer office staff and faculty within academic exchanges. University technology transfer is growing in China and is vital to China’s innovation and intellectual property program. Conflicts between university technology transfer participants …

Black Americans Past And Present Created Frugal Innovations And Embraced Circular Economy Principles: The Marketing Dilemma, Clovia Hamilton

Winthrop Faculty and Staff Publications

Frugal innovation is the practice whereby the rich learns from innovations developed in poor countries, and there is purportedly a current rivalry between India and China in the frugal innovation arena. This research advocates that the concept of frugal innovation did not originate in Asia or India. The practice of the rich taking the poor’s innovations is not new. In particular, Black American slaves and freed slaves developed a number of inventions in poverty conditions. It is imperative that frugal innovation research be more historically accurate so as to reduce the marginalization of contributions developed by poor innovators and to …

Trends In Private Patent Costs And Rents For Publicly-Traded United States Firms, James Bessen, Peter Neuhausler, John L. Turner, Jonathan Williams

Faculty Scholarship

We use detailed data to estimate the private costs and private rents of United States patents for publicly-traded firms. In analyzing costs, we first introduce a novel theoretical model to interpret our estimates. We then combine lawsuit data from Derwent Litalert with non-practicing entity (NPE) lawsuits collected by Patent Freedom, and use an event-study approach to estimate losses suffered by alleged infringers during 1984-2009. To estimate rents, we combine patent data from the USPTO and EPO with financial data from COMPUSTAT, and use market-value regressions to estimate the value of patent rents for publicly-traded US firms during 1979-2002. We find …

A Bridge Between Copyright And Patent Law: Towards A Modern-Day Reapplication Of The Semiconductor Chip Protection Act, Timothy T. Hsieh

Fordham Intellectual Property, Media and Entertainment Law Journal

This Paper analyzes the history of the Semiconductor Chip Protection Act (SCPA), 17 U.S.C. §§ 901–914, and asks why the statute is so seldom used in intellectual property litigation. Afterwards, this Paper makes the argument that the SCPA should be used more in intellectual property litigation, perhaps in tandem with patent litigation, and can be a viable form of protection for semiconductor micro-fabrication companies or integrated circuit design companies engaged in pioneering innovations within the cutting-edge field of semiconductor technology.

The Uneasy Case For Patent Law, Rachel E. Sachs

Michigan Law Review

A central tenet of patent law scholarship holds that if any scientific field truly needs patents to stimulate progress, it is pharmaceuticals. Patents are thought to be critical in encouraging pharmaceutical companies to develop and commercialize new therapies, due to the high costs of researching diseases, developing treatments, and bringing drugs through the complex, expensive approval process. Scholars and policymakers often point to patent law’s apparent success in the pharmaceutical industry to justify broader calls for more expansive patent rights.

This Article challenges this conventional wisdom about the centrality of patents to drug development by presenting a case study of …

Neglected Diseases: How Intellectual Property Can Incentivize New Treatment, Vinita Banthia

Chicago-Kent Journal of Intellectual Property

No abstract provided.

Curated Innovation, Lital Helman

Akron Law Review

The regulation of innovation-intensive industries is a critical issue for both innovation policy and regulation. In this Article, I propose a new framework to the way innovation-intensive industries are regulated.

My proposal is a four-pronged model, which I term “Curated Innovation.” In the first stage, policymakers would set a standard that would represent the outcome the regulation seeks to achieve. Second, policymakers would launch a competition, where innovative technologies or methods would race to meet the standard that was defined. Third, policymakers would select the methods or technologies that come closest to meeting the standard and create an incentive in …

An Administrative Meter Maid: Using Inter Partes Review And Post-Grant Review To Curb Exclusivity Parking Via The "Failure To Market" Provision Of The Hatch-Waxman Act, Brian T. Apel

Michigan Law Review

Congress created the unique Hatch-Waxman framework in 1984 to increase the availability of low-cost generic drugs while preserving patent incentives for new drug development. The Hatch-Waxman Act rewards generic drug companies that successfully challenge a pharmaceutical patent: 180 days of market exclusivity before any other generic firm can enter the market. When a generic firm obtains this reward, sometimes drug developers agree to pay generic firms to delay entering the market. These pay-for-delay agreements give rise to exclusivity parking and run counter to congressional intent by delaying full generic drug competition. The Medicare Prescription Drug, Improvement, and Modernization Act created …

More Than Bric-A-Brac: Testing Chinese Exceptionalism In Patenting Behavior Using Comparative Empirical Analysis, Jay P. Kesan, Alan Marco, Richard Miller

Michigan Telecommunications & Technology Law Review

Although many developing economies are increasingly influencing the global economy, China’s influence has been the greatest of these by far. Once hindered from competition by political and economic restrictions, China is now a major economic player. As China’s economic might has grown, so too has the demand for intellectual property protection for technologies originating from China. In this article, we present a detailed empirical study of Chinese patenting trends in the United States and the implications of these trends for the global economy. We compare these trends to patenting trends from earlier decades. Specifically, we compare Chinese patenting trends to …

The Need For Adequate And Effective Protection Of Intellectual Property: Perspective Of The Private Sector - Patents, Peter C. Richardson

Georgia Journal of International & Comparative Law

No abstract provided.

Patents And Regulatory Exclusivity, Rebecca S. Eisenberg

Book Chapters

This article reexamines the sources of exclusivity for drugs, considers their limitations, and evaluates exclusivity under the new biologics legislation in light of these limitations. The current overlapping legal protections for exclusivity in the pharmaceutical marketplace reflect a series of political compromises, repeatedly renegotiated to correct for unintended consequences in the previous version of the rules. Patents and patent challenges play a central role in this system of protection, and many of the patents at stake are ultimately held invalid in litigation. It is not easy to untangle a complex legal regime that allocates billions of dollars of profits. But …

The Myth Of The Sole Inventor, Mark A. Lemley

Michigan Law Review

The theory of patent law is based on the idea that a lone genius can solve problems that stump the experts, and that the lone genius will do so only if properly incented. But the canonical story of the lone genius inventor is largely a myth. Surveys of hundreds of significant new technologies show that almost all of them are invented simultaneously or nearly simultaneously by two or more teams working independently of each other. Invention appears in significant part to be a social, not an individual, phenomenon. The result is a real problem for classic theories of patent law. …

Patent Costs And Unlicensed Use Of Patented Inventions, Rebecca S. Eisenberg

Articles

Recent commentators have observed, and sometimes lamented, significant gaps between the formal reach of the patent system and the practical exclusionary effect of patent law. It is costly for technology developers to obtain and assert patents, for technology users to identify the patents they might be infringing and to clear rights, and for the Patent and Trademark Office (PTO) to find patent-defeating prior art. The costs of the patent system provide shelter for infringing behavior that might otherwise lead to either licensing or liability, perhaps mitigating excesses in the patent system while retaining strong rights that motivated owners may enforce. …

Software Wars: The Patent Menace, Andrew Nieh

NYLS Law Review

No abstract provided.

Trade Secret Law And Information Development Incentives, Michael Risch

Michael Risch

Trade secrets differ from other forms of intellectual property in many subtle ways that affect incentives to invest in information development. These differences relate not only to the types of information protected, but also to the requirements one must meet to protect that type of information. The various divergences and intersections of trade secret laws with other intellectual property laws lead to differences in the amount and types of investments companies make in developing information. This chapter explores five types of differential incentives associated with trade secret law: - Trade secret law v. no trade secret law - Trade secret …

Noncompliance, Nonenforcement, Nonproblem? Rethinking The Anticommons In Biomedical Research, Rebecca S. Eisenberg

Articles

A decade ago the biomedical research community was sounding alarm bells about the impact of intellectual property (IP) rights on the ability of scientists to do their work. Controversies and delays in negotiating terms of access to patented mice and genes, databases of scientific information, and tangible research materials all pointed toward the same conclusion: that IP claims were undermining traditional sharing norms to the detriment of science. Michael Heller and I highlighted one dimension of this concern: that too many IP rights in "upstream" research results could paradoxically restrict "downstream" research and product development by making it too costly …

Do Patents Perform Like Property?, Michael J. Meurer, James Bessen

Faculty Scholarship

Do patents provide critical incentives to encourage investment in innovation? Or, instead, do patents impose legal risks and burdens on innovators that discourage innovation, as some critics now claim? This paper reviews empirical economic evidence on how well patents perform as a property system.

Economics And The Design Of Patent Systems, Robert M. Hunt

Michigan Telecommunications & Technology Law Review

I use intuition derived from several of my research papers to make three points. First, in the absence of a common law balancing test, application of uniform patentability criteria favors some industries over others. Policymakers must decide the optimal tradeoff across industries. Second, if patent rights are not closely related to the underlying inventions, more patenting may reduce R&D in industries that are both R&D and patent intensive. Third, the U.S. private innovation system has become far more decentralized than it was a generation ago. It is reasonable to inquire whether a patent system that worked well in an era …

Knowledge, Competition And The Innovation: Is Stronger Ipr Protection Really Needed For More And Better Innovations, Giovanni Dosi, Luigi Marengo, Corrado Pasquali

Michigan Telecommunications & Technology Law Review

The main questions addressed in this Article are thus: given that growth is a highly desirable phenomenon and that it is primarily spurred by technological innovation, how should society solve the problem of favoring a sufficient level of investments in R&D? In particular, is it necessarily true and always desirable that, independent of any other consideration, society should protect innovators from competition and shelter them in a legally protected and enforced monopoly? Is it true that the real source of economic value of new recipes is only found in the blueprints of ideas that those recipes implement? Is it necessarily …

The Role Of The Fda In Innovation Policy, Rebecca S. Eisenberg

Michigan Telecommunications & Technology Law Review

This Article reexamines the role of FDA regulation in motivating investment in biopharmaceutical innovation. I begin by challenging the standard story that it is the patent system that makes drug development profitable, and drug regulation that makes it costly, by showing how patents add to costs and how drug regulation works in tandem with patents to protect profits. I then compare FDA-administered exclusive rights to patents as a means of fortifying drug development incentives, suggesting ways that FDA-administered rights might be preferable both from the perspective of policy makers and from the perspective of firms. In the remainder of the …

Harnessing And Sharing The Benefits Of State-Sponsored Research: Intellectual Property Rights And Data Sharing In California's Stem Cell Initiative, Rebecca S. Eisenberg, Arti K. Rai

Articles

This Article discusses data sharing in California's stem cell initiative against the background of other data sharing efforts and in light of the competing interests that CIRM is directed to balance. We begin by considering how IP law affects data sharing. We then assess the strategic considerations that guide the IP and data policies and strategies of federal, state, and private research sponsors. With this background, we discuss four specific sets of issues that public sponsors of data-rich research, including CIRM, are likely to confront: (1) how to motivate researchers to contribute data; (2) who should have access to the …

Supporting Innovation In Targeted Treatments: Licenses Of Right To Nih-Funded Research Tools, Tanuja V. Garde

Michigan Telecommunications & Technology Law Review

Support for new drug development has taken some interesting turns in current patent law jurisprudence. Beginning with the severe curtailment of scope of the common law experimental use doctrine in Madey v. Duke University, and culminating with the recent Supreme Court decision in Merck KGaA v. Integra Lifesciences I, Ltd., broadening the scope of the statutory research exemption, the freedom to conduct experimental research using another's patented inventions becomes dependent in part on the purpose of the research. That the patent at issue in Merck was characterized by the Federal Circuit as being directed to a research tool raised the …

The Problem Of New Uses, Rebecca S. Eisenberg

Articles

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 …

The Experimental Purpose Doctrine And Biomedical Research, Tao Huang

Michigan Telecommunications & Technology Law Review

The experimental use doctrine is a common law rule in patent law that until a few years ago excused accused infringers who made and used patented products or processes on the basis of an experimental, educational, or nonprofit purpose when there was de minimis economic injury to the patent owner and de minimis economic gain to the infringer. While the application of the experimental purpose doctrine was always narrow, two recent Federal Circuit decisions indicate that there is not much left under its aegis. In Madey v. Duke University, the Federal Circuit strictly limited the application of the experimental purpose …

An Examination Of Patents, Licensing, Research Tools, And The Tragedy Of The Anticommons In Biotechnology Innovation, Michael S. Mireles

University of Michigan Journal of Law Reform

The continued development of and affordable access to potentially life saving pharmaceuticals, gene therapies and diagnostics is unquestionably a socially important issue. However, crafting government policy to encourage the development of and allowing affordable access to those services and products is difficult. On one hand, the development of those services and products requires a large investment of funds because of the complexity, collaborative nature, and uncertainty of the development of those products and services. Accordingly, investors require the safety of strong and stable patent rights to ensure a return on their investment in the development of a commercial end-product or …