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 …

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.

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. …

Software Wars: The Patent Menace, Andrew Nieh

NYLS Law Review

No abstract provided.

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 …

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 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 …

Contrary To First Impression, Genes Are Patentable: Should There Be Limitations?, Amanda S. Pitcher

Journal of Health Care Law and Policy

No abstract provided.

Publish Or Perish, Gideon Parchomovsky

Michigan Law Review

The race model has been the darling of patent economists and game theorists. This model assumes that the winner, namely the first to invent, takes the patent grant with the market dominance that comes with it, whereas the second comer, in the best tradition of sports contests, obligingly accepts her loss and quietly vanishes from the scene. While the sports analogy has provided a useful framework for understanding the economics of invention, it has obfuscated an important aspect of the inventive process: the possibility of strategic publication of research findings in order to prevent the issuance of a patent to …

Public-Private Partnerships In Biomedical Research: Resolving Conflicts Of Interest Arising Under The Federal Technology Transfer Act Of 1986, Thomas N. Bulleit Jr.

Journal of Law and Health

The Federal Technology Transfer Act of 1986 offers private industry the opportunity to enter into cooperative research and development agreements with scientists in federal laboratories and to gain rights in intellectual property resulting from such collaborations. Increased collaborations with private industry, however, expands the potential for conflicts of interest. Resolution of the tensions between the Technology Transfer Act and federal conflict of interest rules is important because federal laboratories, such as the NIH, are experiencing a loss of senior scientists to universities and private industry due to inadequate compensation. These tensions may be resolved by some combination of policies, regulations, …

United States Policy Toward The Transfer Of Proprietary Technology: Licenses, Taxes, And Finance, Gary C. Hufbauer, George N. Carlson

Vanderbilt Journal of Transnational Law

Much of the nation's technology is developed in public institutions, especially universities and government research laboratories, and is freely available through libraries and classrooms. Roughly one-half of total United States research and development expenditures are funded by the United States Government, and the findings from this research are generally available to citizens and foreigners at little or no charge. In addition, a great deal of technology that was once guarded by patents or trade secrets has since passed into the public domain. This paper ignores these freely available segments of the national technology base and discusses proprietary technology.