Why is HHS blocking FDA from regulating some diagnostics, and how will this affect COVID-19 testing?

By Lisa Larrimore Ouellette, Nicholson Price, Rachel Sachs, and Jacob S. Sherkow

This week’s FDA news has been dominated by the tumultuous emergency authorization of convalescent plasma on Sunday, but let’s not forget last week’s news: On August 16, the Department of Health and Human Services (HHS) surprised public health experts by publishing a one-paragraph notice on its website rescinding FDA guidance related to laboratory developed tests (LDTs). The notice states that the FDA will not require premarket review of LDTs absent notice-and-comment rulemaking, including for COVID-19 tests. LDTs are tests “designed, manufactured and used within a single laboratory,” such as tests run by large academic medical centers, hospitals like the Mayo Clinic, and testing giants LabCorp and Quest Diagnostics. Former HHS national coordinator for health information technology Farzad Mostashari described this change as “bizarre” and like “[c]losing the barn door 6 months after the horse left the barn, and 3 months after she moved to a different barn!” What’s going on, and how will this change affect COVID-19 testing?

Multi-Agency Funding for COVID-19 Vaccine Development

By Jacob S. Sherkow, Lisa Larrimore Ouellette, Nicholson Price, and Rachel Sachs

Moderna, Inc., a Cambridge, MA-based biotech company, is a leading contender in the race to develop a SARS-CoV-2 vaccine. Moderna’s vaccine, however, works using a completely novel mechanism, unlike any other vaccine currently approved anywhere in the world. Despite this, the U.S. government—and two agencies in particular, the NIH and Biomedical Advanced Research and Development Authority (BARDA)—has invested, heavily, in the vaccine’s development. This week, we explore how these investments interact through different forms of research partnerships, and what this says about IP, novel technologies, and innovation policy.

Race and Gender in the USPTO: Schuster’s Hard Data for Hard Issues

[I asked some of my RAs to write guest posts this summer, lightly edited by me.  This one is by Jennifer Black, a 3L at Villanova University Charles Widger School of Law]

Intellectual property rights are just that: rights.

Much like other rights, however, they have been unequally granted to people based on factors outside of their control throughout our country’s history. Intellectual property is a means for upward mobility of individuals who, through their own ingenuity, creativity, or otherwise, contribute something of value to our society. It is this exchange of benefits that the patent system is built upon. However, when certain individuals are less likely to reap the rewards of their inventions, they are both disincentivized from creating as well as from engaging with the patent system. Although the extent of these biases is yet unknown, research regarding the subject has been conducted with the intent of identifying and remedying inequity.

The scope of this inequity is difficult to comprehend except by collecting, analyzing, and comprehending the data. Mike Schuster and his coauthors did just that in his article, An Empirical Study of Patent Grant Rates as a Function of Race and Gender (published version in the American Business Law Journal), which examines the patent granting rates as a function of inventors’ races and genders. As scientists and engineers, patent practitioners and examiners will undoubtedly appreciate the amount and quality of his data.

How is the NIH seeking to encourage investment in diagnostic testing for COVID-19?

By Rachel Sachs, Jacob S. Sherkow, Lisa Larrimore Ouellette, and Nicholson Price

In this blog post series, we have written about the importance of ensuring an adequate supply of diagnostic testing for COVID-19, and about the challenges the United States has faced so far on this front. Many months after COVID-19 began spreading in the United States, there is still great concern that we lack sufficient testing to ensure that we can detect and respond to the virus quickly. In this post, we explain a new initiative from the National Institutes of Health (NIH)—the Rapid Acceleration of Diagnostics (RADx) Initiative—that aims to speed the development and marketing of new COVID-19 tests, how RADx is progressing so far, and what policymakers can learn from the initiative about the design of different types of innovation incentives. 

Are COVID-19 vaccine advance purchases a form of vaccine nationalism, an effective spur to innovation, or something in between?

By Nicholson Price, Rachel Sachs, Jacob S. Sherkow, and Lisa Larrimore Ouellette

No vaccine for the novel coronavirus has been approved anywhere. Nevertheless, governments and international organizations around the world are announcing deals for billions of dollars to procure tens of millions of doses of vaccines from companies that are still running clinical trials, including a $2.1 billion deal with Sanofi and GSK announced by the US on Friday. What’s going on? And what do these deals tell us about innovation policy for COVID-19 vaccines? In this post, we lay out the landscape of COVID-19 vaccine pre-purchases; we then turn to the innovation impact of these commitments, and finish by asking what role patents and compulsory licensing have to play.

How should policymakers use “pull” mechanisms to improve COVID-19 innovation incentives?

By Lisa Larrimore Ouellette, Nicholson Price, Rachel Sachs, and Jacob S. Sherkow

As we have emphasized throughout this COVID-19 blog post series, even though patent law historically has been the primary field in which legal scholars consider questions of innovation policy, governments use a wide variety of policies to incentivize and allocate access to new innovations. One of the key dimensions for comparing these different policies is when the incentive occurs. Under ex ante or “push” policies such as grants or R&D tax incentives, innovators receive funding early in the research process, before the results are known; for ex post or “pull” policies such as patents or prizes, only successful projects receive a reward. 

In a recent talk for the Iowa Innovation, Business & Law Center’s speaker series on COVID-19 innovation policy, one of us (RS) explained why pull mechanisms are very effective innovation policy levers to achieve the kind of clear technological goals presented by the pandemic. Here, we will unpack these ideas and explain how lawmakers should be adjusting these policies to bring this crisis to a more rapid close.

David Simon: Trademark Law and Consumer Safety

I was happy to read David Simon's new article, Trademark Law and Consumer Safety, forthcoming in the Florida Law Review. Simon argues trademark law should pay more attention to the physical harms that products pose for consumers, rather than just economic harms. The conventional view is that trademark law exists to prevent consumer confusion and lower consumers' search costs for finding the products they want. At the same time, trademark law protects sellers' investments in product quality and advertising.

Simon's article argues that trademark law does, or should do, a lot more than this: it should protect consumers from physical injury.

How should policymakers incentivize and regulate convalescent serum therapy for COVID-19?

By Jacob S. Sherkow, Lisa Larrimore Ouellette, Nicholson Price, and Rachel Sachs

Over 120 years ago, a milk wagon horse named Jim was the United States’ most potent weapon against a raging diphtheria epidemic. During his lifetime, Jim—inoculated against the bacterial toxin that causes the disease—produced gallons of anti-diphtheria serum that, once extracted, could then be administered directly to patients. But tragic difficulties in making a safe and standard therapy from a single horse led Congress to pass the 1902 Biologics Control Act—the predecessor to the FDA’s current oversight over biologic products.

While convalescent sera have largely fallen out of favor since the development of modern vaccines, there is renewed hope in the space: the development of therapeutic sera from recovered COVID-19 patients. Encouraging the development of safe, pure, and potent COVID-19 convalescent serum has recently tasked policymakers with numerous challenges—some old, and some new. In this post, we explain the “manufacture” of COVID-19 convalescent sera and explore the regulatory and innovation policy difficulties in maintaining it.

How will the FDA’s new COVID-19 vaccine guidance affect development efforts?

By Rachel Sachs, Jacob S. Sherkow, Lisa Larrimore Ouellette, and Nicholson Price

Policymakers are expectantly awaiting the development of a COVID-19 vaccine, which they view as critical to future management of the pandemic. A number of pharmaceutical companies have jumped into the vaccine race, moving at record speed, with several vaccines already about to enter Phase III trials. Last week, the Food and Drug Administration (FDA) released a guidance document on the development of new vaccines for COVID-19. In this post, we review the FDA’s new guidance, consider the ways in which the FDA must attempt to balance risk and access in this context, and address the critical question of patient access to future approved vaccines.

Racial disparities in healthcare innovation in the time of COVID-19

By Nicholson Price, Rachel Sachs, Jacob S. Sherkow, and Lisa Larrimore Ouellette

In previous posts, we have explored how structural racism contributes to disparities in COVID-19 cases and deaths and in access to COVID-19 treatments and preventatives. Legal institutions have also been complicit in creating a healthcare innovation system in which those receiving scientific and medical education are far from representative of the U.S. public. The resulting disparities by race, gender, and class raise substantial problems for both equity and economic growth—but these inequalities receive too little attention from most health and innovation scholars, ourselves included. This week, we examine how the COVID-19 pandemic has highlighted and exacerbated racial disparities in three slices of the healthcare innovation ecosystem: medical education, medical patenting, and clinical trials.

generic.com

Today, the Supreme Court ruled (8-1) that merely adding ".com" to a generic term may allow the combination to be protected as a non-generic trademark. In other words, adding ".com" can confer meaning to the consuming public, and thus is not the same as adding "company" or "inc," which does not confer meaning. That was really the linguistic question in the case. Case law has long held that "Booking, Inc." is really "Booking." So, is "Booking.com" also "Booking"? Or is it "Booking.com"?

As a reminder, a mark is generic when it describes what the product is, and not who makes the product. So, Booking.com would refer to a single company (who) that makes bookings, and not to just any booking company (what). A generic term might be lawyer - it refers to what (legal services) and not to who (there are many lawyers). As the Court puts it, Travelocity is a booking company, but is it a booking.com company?

I signed on to an amicus brief supporting Booking.com, and I'll tell a story why (and why I so keenly followed this case). Way back in the beginning of the commercial internet, my firm registered the domain computerlaw.com. This was a big deal - making it work for email required complicated email gateways, etc. I hadn't even gone to law school yet, and I was in charge of setting it up. Connectivity looked a lot different for a small firm in 1994 than it does now.

How can health regulators maintain public trust when facing scientific uncertainty?

By Lisa Larrimore Ouellette, Nicholson Price, Rachel Sachs, and Jacob S. Sherkow

Health regulators such as the FDA and CDC always operate under uncertainty—evidence about health interventions inevitably comes with error bars. Under normal circumstances, regulators demand evidence that meets certain thresholds of validity and reliability before taking action, such as making a public health recommendation or approving a new drug. During a public health emergency like the COVID-19 pandemic, regulators are forced to act under higher-than-usual uncertainty: the social costs of waiting for better evidence often outweigh the costs of taking action before all the evidence is in. Regulators will thus make more mistakes than usual. And in addition to the direct costs of these mistakes, apparent flip-flopping on regulatory decisions risks undermining public trust in health agencies. In this post, we provide some examples of regulators reversing COVID-19-related decisions, describe the considerations these agencies are attempting to balance, and suggest ways for health regulators to maintain public trust while acting under high scientific uncertainty.

How can the government improve access to COVID-19 preventatives and treatments for low-income Americans?

By Jacob S. Sherkow, Lisa Larrimore Ouellette, Nicholson Price, and Rachel Sachs

In the United States, one of the most important factors in receiving COVID-19 testing or treatment is access to insurance. But insurance—like other health innovations—is grossly and unevenly distributed. In particular, because of the way income and employment are distributed in the U.S.—and the country’s long-standing connection between income, employment, and insurance—Black Americans and other people of color remain vastly uninsured or underinsured, problems likely to be exacerbated by the COVID-19 pandemic. In this post, we look at how insurance policy—itself, a form of health innovation policy—has a racially disparate effect in the pandemic, with a particular focus on Medicaid.

USPTO v. Booking.com – A Linguistic Justification for ‘Generic Trademarks’

Guest post by Jake Linford, Loula Fuller and Dan Myers Professor, Florida State University College of Law, whose trademark law scholarship I have highlighted on Jotwell

I want to thank Lisa Ouellette for inviting me to blog about United States Patent & Trademark Office v. Booking.com, a trademark case argued before the Supreme Court in May, with a decision expected soon. The Court selected that case for its first live telephonic oral argument. The night of the historic oral argument, Christine Farley of American University Washington College of Law hosted a discussion where I joined Rebecca Tushnet, Marty Schwimmer, and Cara Gagliano to recap the argument and discuss the case. Below, I summarize the oral argument in some detail (with page and line references to the transcript) and offer my prediction of what the forthcoming opinion might hold.

Structural Racism and COVID-19

By Rachel Sachs, Jacob S. Sherkow, Lisa Larrimore Ouellette, and Nicholson Price

Over the past two weeks, the United States—already hit hard by the COVID-19 pandemic—has reckoned with another public health crisis: police violence against Black Americans. The protests and outrage galvanized by the killing of George Floyd by a Minneapolis police officer have renewed public attention to the pervasiveness of racial inequality throughout the United States. With this backdrop, it is hard to ignore the disproportionate impact COVID-19 has had on Black Americans, who are dying at a rate twice as high as their share of the population.

In this blog post series, we have focused on how innovation and health laws have exacerbated the COVID-19 pandemic thus far, and how they can help spur development of affordable preventatives, diagnostics, and treatments. But we also think it is important to recognize how these laws and other legal institutions have often been complicit in creating the structural framework within which these racial disparities have persisted. In this post, we highlight the work of scholars who have focused on this issue and explain how structural racism contributes to disparities in COVID-19 cases and deaths, access to treatments among those who have been afflicted, and access to the most effective preventative interventions.