Law Commons^™

Cryptic Patent Reform Through The Inflation Reduction Act, Arti K. Rai, Rachel Sachs, Nicholson Price

Law & Economics Working Papers

If a statute substantially changes the way patents work in an industry where patents are central, but says almost nothing about patents, is it patent reform? We argue the answer is yes — and it’s not a hypothetical question. The Inflation Reduction Act (IRA) does not address patents, but its drug pricing provisions are likely to prompt major changes in how patents work in the pharmaceutical industry. For many years scholars have decried industry’s ever-evolving strategies that use combinations of patents to block competition for as long as possible, widely known as “evergreening,” but legislators have not been receptive to …

Pooling Patents For Pandemic Progress: Mrna Vaccines And The Broader Context Of Modernatx Inc V. Pfizer Inc., Francis Brefo

DePaul Journal of Art, Technology & Intellectual Property Law

No abstract provided.

Don't Tread On My Ip Rights: A Law And Economics Analysis Of "March-In Rights" Under The Bayh-Dole Act, Caitlin Grow

Cleveland State Law Review

The Bayh-Dole Act has been imperative to the development of the United States’ dynamic pharma-biotech sector. However, the use of march-in rights under the Bayh- Dole Act has remained controversial. On the one hand, there is the idea of market equilibrium with a need to secure health care for the public. Many believe march-in rights should be used to create this balance by regulating the pricing of drugs that were developed using federally funded research. On the other hand, some advocates recognize that the current relationship between public-sector institutions and business as the developers of basic research, and private-sector biotechnology …

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 …

Access To Medicines And Pharmaceutical Patents: Fulfilling The Promise Of Trips Article 31bis, Ezinne Miriam Igbokwe, Andrea Tosato

All Faculty Scholarship

The Agreement on Trade-Related Aspects of Intellectual Property (TRIPS) is one of the cornerstones of the World Trade Organization (WTO). TRIPS requires all WTO member countries (Members) to adopt minimum standards for the protection of intellectual property (IP). This international treaty is highly controversial. Its critics claim that TRIPS imposes a wealth transfer from poorer Members (net IP importers) to richer ones (net IP exporters). Its supporters maintain that trade between developing and developed economies cannot thrive without an internationally-harmonized IP framework. The most contentious issue has long been the impact of the TRIPS patents regime on access to medicines. …

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.

Covid-19 As An Example Of Why Genomic Sequence Data Should Remain Patent Ineligible, Jorge L. Contreras

Utah Law Faculty Scholarship

The researchers who determined the genomic sequence of the SARS-CoV-2 virus did not seek to patent it, but instead released it in the publicly-accessible GenBank data repository. Their release of this critical data enabled the scientific community to mobilize rapidly and conduct research on a range of diagnostic, vaccine, and therapeutic applications based on the viral RNA sequence. Had the researchers sought patent protection for their discovery, as earlier research teams had during the SARS, H1N1 and H5N1 outbreaks, global research relating to COVID-19 would have been less efficient and more costly. One of the reasons that patents are no …

The Intellectual Property Of Covid-19, Ana Santos Rutschman

All Faculty Scholarship

The response to COVID-19 is indissolubly tied to intellectual property. In an increasingly globalized world in which infectious disease pathogens travel faster and wider than before, the development of vaccines, treatments and other forms of medical technology has become an integral part of public health preparedness and response frameworks. The development of these technologies, and to a certain extent the allocation and distribution of resulting outputs, is informed by intellectual property regimes. These regimes influence the commitment of R&D resources, shape scientific collaborations and, in some cases, may condition the widespread availability of emerging technologies. As seen throughout this chapter, …

Should The U.S. Government Actively Assert Its Own Patents?, Christopher J. Morten, Barry Datlof, Amy Kapczynski, Donna Meuth, Zain Rizvi

Faculty Scholarship

On March 10, 2021, our journal partnered with the Engelberg Center on Innovation Law and Policy to host a symposium addressing the role and impact of U.S. innovation policy on access to medicine. Our 2021 Symposium Issue — Volume 11, Issue 1 — captures that event.

The following article represents the second of four panels. This panel asked, “Should the U.S. government actively assert its own patents?” The panel was moderated by Christopher Morten, Deputy Director of NYU Law’s Technology Law & Policy Clinic. The panelists included Barry Datlof, Chief of Business Development and Commercialization in the Office of Medical …

Evidence Supporting The Value Of Surgical Procedures: Can We Do Better?, Christopher Robertson, Jonathan Darrow, Willard S. Kasoff

Faculty Scholarship

There is an acknowledged need for higher-quality evidence to quantify the benefit of surgical procedures, yet not enough has been done to improve the evidence base. This lack of evidence can prevent fully informed decision-making, lead to unnecessary or even harmful treatment, and contribute to wasteful expenditures of scare health care resources. Barriers to evidence generation include not only the long-recognized technical difficulties and ethical challenges of conducting randomized surgical trials, but also legal challenges that limit incentives to conduct surgical research as well as market-based challenges that make it difficult for those funding surgical research to recoup investment costs. …

The Double-Edged Sword Of Medical Patents: How Monopolies On Healthcare Products Disparately Impact Certain American Populations, Sarah Mcgraw

The University of Cincinnati Intellectual Property and Computer Law Journal

No abstract provided.

Expanding Access To Patents For Covid-19, Jorge L. Contreras

Utah Law Faculty Scholarship

Two competing and linked sets of goals must be addressed when considering patent policy in response to a public health emergency. First is the allocation of existing resources among potential users (hospitals, patients, etc.); second is the creation of new technologies over time (innovation). Patents provide financial incentives to develop new technologies. Yet shortages of patented products often plague crisis response. In the case of COVID-19, allocative goals, particularly satisfying demand for patented medical products (e.g., vaccines, ventilators, PPE, and test kits), may be achieved through governmental interventions such as march-in and governmental use rights (compulsory licensing). But in cases …

Mapping Misinformation In The Coronavirus Outbreak, Ana Santos Rutschman

All Faculty Scholarship

The coronavirus outbreak has sent ripples of fear and confusion across the world. These sentiments—and our collective responses to the outbreak—are made worse by rampant misinformation surrounding the new strain of the virus, COVID-2019. In this post, I survey some of the most pervasive areas of tentacular coronavirus-related misinformation that has proliferated online -- as well as the responses of social media companies like YouTube, Facebook, Pinterest and TikTok that may ultimately prove inadequate given the magnitude of the problem.

From Discovery To Delivery: Public Sector Development Of The Rvsv-Zebov Ebola Vaccine, Matthew Herder, Janice Graham, Richard Gold

Articles, Book Chapters, & Popular Press

The discovery and development of the Ebola rVSV-ZEBOV vaccine challenge the common assumption that the research and development for innovative therapeutic products and vaccines is best carried out by the private sector. Using internal government documents obtained through an access to information request, we analyze the development of rVSV-ZEBOV by researchers at Canada’s National Microbiology Laboratory beyond its patenting and licensing to a biotech company in the United States in 2010. According to government documentation, the company failed to make any progress toward a phase 1 clinical trial until after the WHO Public Health Emergency of International Concern freed substantial …

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

All Faculty Scholarship

This Essay examines the ways in which intellectual property regimes influence incentives for the development of new vaccines for infectious diseases. Charting the tension between market forces and public health imperatives, the Essay considers an emerging solution to the long-standing problem of insufficient incentives for vaccine research and development: the rise of public-private partnerships in the health space. The Essay provides a short case study on CEPI, a large-scale public-private partnership dedicated exclusively to funding research on vaccines for infectious diseases. In exploring how the interaction between intellectual property rules and practices affect vaccine innovation, the Essay offers illustrations from …

That Is Northern Lights Cannabis Indica . . . No, It's Marijuana: Navigating Through The Haze Of Cannabis And Patents, Dawson Hahn

Concordia Law Review

By their very nature, patents are exclusionary. A patent grants the right to exclude others from making use of an invention or process. But patents are also tools to promote innovation. However, when an invalid patent is granted, the patent becomes an exclusionary tool that also chills innovation. Invalid cannabis patents may be chilling innovation in the cannabis market, but they may not be the only thing. While the Controlled Substances Act continues to prohibit cannabis at a federal level, researchers and medical professionals will be unsure of the legality of their actions. This naturally leads to another chilling effect …

The Cost Of Novelty, W. Nicholson Price Ii

Law & Economics Working Papers

Patent law tries to spur the development of new, better, innovative technology. But it focuses much more on “new” than “better” — and it turns out that “new” carries real social costs. I argue that patent law promotes innovation that diverges from existing technology, either a little (what I call “differentiating innovation”) or a lot (“exploring innovation”), at the expense of innovation that tells us more about existing technology (“deepening innovation”). Patent law’s focus on newness is unsurprising, and fits within a well-told narrative of innovative diversity accompanied by market selection of the best technologies. Unfortunately, innovative diversity brings not …

A Mathematical Solution To The Sine Of Madness That Is Pharmaceutical Compulsory Licensing Under The Trips Agreement And The Doha Declaration, Ashley E. Sperbeck

Marquette Intellectual Property Law Review

A viable economic solution is necessary to address the shortcomings, textual ambiguities, and deficiencies engulfing international patent protection, leading to the inability of LDCs facing public health crises or national emergencies and lacking pharmaceutical manufacturing facilities to obtain generic pharmaceuticals. This Note poses a solution to this problem via another Amendment to the TRIPS Agreement and the Doha Declaration, which provides a mathematical framework to determine when and under what circumstances a compulsory license should be granted. Furthermore, this Note contemplates establishment of a WTO subcommittee to oversee this proposed solution and to ensure compliance with this Amendment. This concrete …

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

Marquette Intellectual Property Law Review

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 …

Tribal Sovereign Immunity As A Defense At The Patent Trial And Appeal Board? Or A Violation Of U.S. Antitrust Laws?, Samantha Roth

Marquette Intellectual Property Law Review

This Comment will address two primary issues. First, it will analyze the basis of sovereign immunity rights of tribes, with a focus on the relationship between intellectual property rights and sovereignty. Second, it will discuss whether this arrangement violates the antitrust laws of the United States. This Comment concludes that even if a claim of tribal sovereign immunity is legitimate, it is likely that such an arrangement still violates the relevant antitrust claims.

Finding A Forest Through The Trees: Georgia-Pacific As Guidance For Arbitration Of International Compulsory Licensing Disputes, Karen Mckenzie

Marquette Intellectual Property Law Review

This paper will examine the challenges of international compulsory licensing by examining the issue historically and legally as well as offer possible solutions. Thus, this paper will explore the challenge of balancing corporate interests against the affordability and availability of pharmaceuticals by focusing on discrete situations in developing countries, the history of compulsory licensing, and how the World Health Organization (the “WHO”) and the WTO have attempted to tackle these challenges through compulsory licensing, and it will suggest a possible framework for use in arbitration, which balances equities through a Georgia-Pacific analysis.

Health Care Costs And The Arc Of Innovation, Neel U. Sukhatme, Maxwell Gregg Bloche

Georgetown Law Faculty Publications and Other Works

Health care costs continue their inexorable rise, threatening America’s long-term fiscal stability, competitiveness, and standard of living. Over the past half-century, efforts to rein in spending have uniformly failed. In this Article, we explain why, breaking with standard accounts of regulatory and market dysfunction. We point instead to the nexus of economics, mutual empathy, and social expectations that drives medical innovation and locks in low-value technologies. We show how law reflects and reinforces this nexus and how and why health-policy-makers avert their gaze.

Next, we propose to circumvent these barriers instead of surmounting them. Rather than targeting today’s excessive spending, …

Noa V. Doa: Increasing Medical Diagnostic Patentability After Mayo, Karen Mckenzie

Marquette Intellectual Property Law Review

The medical diagnostics market is expected to reach 65 billion by 2018. In March 2012, in Mayo Collborative Services v. Prometheus Labs, Inc. , ("Mayo") the U.S. Supreme held that the Mayo Clinic (the "Clinic") had not infringed on Prometheus Labs’ (“Prometheus”) diagnostic patent because the Prometheus patent involved ineligible subject matter, and was therefore invalid. Section 101 of the Patent Act defines eligible subject matter an “any new and useful process, machine, manufacture, or composition of matter” as patentable subject matter. Courts have held that Section 101 contains an implicit exception, making laws of nature, natural phenomena, and abstract …

3d Printing And Healthcare: Will Laws, Lawyers, And Companies Stand In The Way Of Patient Care?, Evan R. Youngstrom

Pace Intellectual Property, Sports & Entertainment Law Forum

Today, our society is on a precipice of significant advancement in healthcare because 3D printing will usher in the next generation of medicine. The next generation will be driven by customization, which will allow doctors to replace limbs and individualize drugs. However, the next generation will be without large pharmaceutical companies and their justifications for strong intellectual property rights. However, the current patent system (which is underpinned by a social tradeoff made from property incentives) is not flexible enough to cope with 3D printing’s rapid development. Very soon, the social tradeoff will no longer benefit society, so it must be …

Funding Antibiotic Innovation With Vouchers: Recommendations On How To Strengthen A Flawed Incentive Policy, Kevin Outterson, Anthony Mcdonnell

Faculty Scholarship

A serious need to spur antibiotic innovation has arisen because of the lack of antibiotics to combat certain conditions and the overuse of other antibiotics leading to greater antibiotic resistance. In response to this need, proposals have been made to Congress to fund antibiotic research through a voucher program for new antibiotics, which would delay generic entry for any drug, even potential blockbuster lifesaving generics. We find this proposal to be inefficient, in part because of the mismatch between the private value of the voucher and the public value of the antibiotic innovation. However, vouchers have the political advantage in …

Antibiotic Reimbursement In A Model Delinked From Sales: A Benchmark-Based Worldwide Approach, Kevin Outterson, John Rex

Faculty Scholarship

Despite the life-saving ability of antibiotics and their importance as a key enabler of all of modern health care, their effectiveness is now threatened by a rising tide of resistance. Unfortunately, the antibiotic pipeline does not match health needs because of challenges in discovery and development, as well as the poor economics of antibiotics. Discovery and development are being addressed by a range of public-private partnerships; however, correcting the poor economics of antibiotics will need an overhaul of the present business model on a worldwide scale. Discussions are now converging on delinking reward from antibiotic sales through prizes, milestone payments, …

Big Data, Patents, And The Future Of Medicine, W. Nicholson Price Ii

Articles

Big data has tremendous potential to improve health care. Unfortunately, intellectual property law isn’t ready to support that leap. In the next wave of data- driven medicine, black-box medicine, researchers use sophisticated algorithms to examine huge troves of health data, finding complex, implicit relationships and making individualized assessments for patients. Black-box medicine offers potentially immense benefits, but also requires substantial high investment. Firms must develop new datasets, models, and validations, which are all nonrivalrous information goods with significant spillovers, requiring incentives for welfare-optimizing investment. Current intellectual property law fails to provide adequate incentives for black- box medicine. The Supreme Court …

International Cooperation To Improve Access To And Sustain Effectiveness Of Antimicrobials, Kevin Outterson, Christine Årdal, Steven Hoffman, Abdul Ghafur, Mike Sharland, Nisha Ranganathan, Richard Smith, Anna Zorzet, Jennifer Cohn, Didier Pittet, Nils Daulaire, Chantal Morel, Zain Rizvi, Manica Balasegaram, Osman Dar, David Heymann, Alison Holmes, Luke Moore, Ramanan Laxminarayan, Marc Mendelson, John-Arne Røttingen

Faculty Scholarship

Securing access to effective antimicrobials is one of the greatest challenges today. Until now, efforts to address this issue have been isolated and uncoordinated, with little focus on sustainable and international solutions. Global collective action is necessary to improve access to life-saving antimicrobials, conserving them, and ensuring continued innovation. Access, conservation, and innovation are beneficial when achieved independently, but much more effective and sustainable if implemented in concert within and across countries. WHO alone will not be able to drive these actions. It will require a multisector response (including the health, agriculture, and veterinary sectors), global coordination, and financing mechanisms …

Rebuttable Presumption Of Public Interest In Protecting The Public Health—The Necessity For Denying Injunctive Relief In Medically Related Patent Infringement Cases After Ebay V. Mercexchange, Lance E. Wyatt Jr.

Lance E Wyatt Jr.

The public’s interest in medicine and good health is substantial. However, this interest is harmed when important medical devices or pharmaceuticals, although infringing on valid patents, are suddenly taken off the market after a court grants a permanent injunction. While permanent injunctions were automatically granted by the Federal Circuit before the Supreme Court’s holding in eBay v. MercExchange, courts now have more discretion to deny injunctive relief. Now that courts have this newfound discretion after eBay, the public should no longer expect to be harmed by the sudden removal of medical supplies. Unfortunately, this has not been the course that …

Making Do In Making Drugs: Innovation Policy And Pharmaceutical Manufacturing, W. Nicholson Price Ii

Law Faculty Scholarship

Despite increasing recalls, contamination events, and shortages, drug companies continue to rely on outdated manufacturing plants and processes. Drug manufacturing’s inefficiency and lack of innovation stand in stark contrast to drug discovery, which is the focus of a calibrated innovation policy that combines patents and FDA regulation. Pharmaceutical manufacturing lags far behind the innovative techniques found in other industries due to high regulatory barriers and ineffective intellectual property incentives. Among other challenges, although manufacturers tend to rely on trade secrecy because of the difficulty in enforcing patents on manufacturing processes, trade secrecy provides limited incentives for innovation. To increase those …