How can policymakers encourage COVID-19 vaccine trials for children?

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

The past two weeks have been full of exciting COVID-19 vaccine news, including the FDA’s emergency use authorizations (EUAs) for the Pfizer–BioNTech and Moderna vaccines and the nationwide rollout of Pfizer’s vaccine. Choosing how to allocate access to vaccine doses has been left to individual states, leaving policymakers with difficult decisions about how to prioritize their populations, complicated in part by the federal government’s reduction in some vaccine shipments. 

With a limited supply of doses, who should get the first shots? Some commentators have suggested prioritizing children early for a host of reasons, including hope about children returning to school. Last month a New York Times column asserted that “saving the most lives could mean prioritizing the vaccination of children and young adults.” But there is an important reason that kids can’t be part of the vaccine line yet: we don’t know whether these vaccines work for them. In this post, we explain why COVID-19 vaccines are only just starting to be tested in children and what policymakers can do to spur pediatric vaccine trials.

Patents and Science Fiction: Does Science Fiction Promote Innovation?

Dan Brean and I have just posted a new essay called Enabling Science Fiction. We wrote the essay for the upcoming Association of American Law Schools panel: Science Fiction and the Law, co-sponsored by Biolaw and Intellectual Property. The panel, put together by Nicholson Price, will take place at AALS on January 8th at 11AM EST, and will feature myself (Camilla Hrdy), Dan Brean, Marc Blitz, Deven Desai, and Victoria Sutton.  

The full version of Enabling Science Fiction can be downloaded on SSRN. The essay itself, which will be published in a symposium issue in Michigan Technology Law Review, is under 8000 words. This is like 20% of an average law review article, but below is an even shorter excerpt. We welcome your comments! (chrdy@uakron.edu).

In recent years, patent scholars [such as Janet Freilich and Lisa Ouellette] have [observed that, thanks to lax disclosure and enablement rules] patent examiners are allowing inventors to achieve patents on what seems, quite literally, like "science fiction."

But of course, this is an exaggeration: what’s acceptable in patent law pales in comparison to what is acceptable in literary science fiction. In science fiction, undue experimentation isn’t just permitted, it’s encouraged. Reduction to practice can be, literally, light years away.  ...

However, we argue that, counterintuitively, the genre of science fiction has its own unique enablement requirement: works of science fiction must sufficiently explain—enable—the technologies and inventions that they posit.  ...  

What administrative actions might we expect on COVID-19 in President-elect Biden’s administration?

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

When President-elect Joe Biden is inaugurated in January, his administration will face the ongoing public health and economic challenges created by COVID-19. Even if Biden takes office without control of Congress, we can expect his administration to take important actions regarding COVID-19 innovation in response to the pandemic. In this post, we consider three main pillars of his administration’s likely response (as articulated by the Biden-Harris transition website) and explain the legal foundations behind them.

What role is AI playing in the COVID-19 pandemic?

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

Promising results for the Pfizer/BioNTech and Moderna vaccines have been the most exciting COVID-19 innovation news in the past few weeks. But while vaccines are a crucial step toward controlling this virus, it is important not to overlook the many other technological developments spurred by the pandemic. In this week’s post, we explore how the COVID-19 pandemic is proving a fertile ground for the use of artificial intelligence and machine learning in medicine. AI offers the tantalizing possibility of solutions and recommendations when scientists don’t understand what’s going on—and that is sometimes exactly what society needs in the pandemic. The lack of oversight and wide deployment without much in the way of validation, however, raise concerns about whether researchers are actually getting it right. 

Trade Secrets and Prior Art

I have published an article entitled "The Trade Secrecy Standard for Patent Prior Art," co-authored with Sharon K. Sandeen. 

The article, which is forthcoming in American University Law Review, argues that patent prior art cases can be explained using concepts of publicness and secrecy that match those used in trade secret law. In other words, what counts as prior art against a patent pursuant to 35 U.S.C. § 102 (2011) is informed by the definition of a trade secret pursuant to 18 U.S.C. § 1839 (3) (2016).

The paper can be downloaded here. I've posted an excerpt below, applying the trade secrecy standard for patent prior art to the Supreme Court's interpretation of a "public use" in Egbert v. Lippman.

The origin of [the Federal Circuit's] seemingly counterintuitive notion of what makes a use “public” is usually traced to the Supreme Court’s holding in Egbert v. Lippman. In Egbert, the inventor of an improved corset spring (Samuel Barnes) gave two samples of the invention to Francis Lee Egbert (Mr. Barnes’ then girlfriend and eventual wife). She wore them for more than two years before Mr. Barnes applied for a patent; and they allegedly showed and explained the corset spring to a friend, Joseph Sturgis, who came over to Mr. Barnes’ house for dinner. Even though the spring was sewn into a corset and therefore, by its nature, was not visible to the public, the Court held it was in “public use” because it was given “to another” (to Frances and to Mr. Sturgis) “to be used” by them “without limitation or restriction, or injunction of secrecy.”

This holding baffled the dissenting Justice Miller, who wrote rhetorically that “[i]f the little steep spring inserted in a single pair of corsets, and used by only one woman, covered by her outer-clothing, and in a position always withheld from public observation,” was a “public use,” then he was “a loss to know the line between a private and a public use.”

But the trade secrecy standard explains how the Egbert Court drew “the line between a private and a public use.” The Court’s concept of a “public use” was, in its own words, any sharing of the invention with another for use, without placing them under an “injunction of secrecy[.]” The Court’s use of this phrase, “injunction of secrecy,” is unlikely to be coincidence. This phrase appeared in contemporary trade secret cases to refer to a duty of confidentiality that might give rise to an injunction.

In trade secret law, a court might have found that—although the corset spring was neither generally known in the industry nor readily ascertainable by proper means—it had not been the subject of reasonable efforts to maintain its secrecy, given how liberally Barnes shared it with his girlfriend and house guests, without placing them under contractual or other restrictions that would have imposed an obligation of confidentiality. 

We might debate whether this was the right decision, from the perspective of trade secret law and modern domestic relationships. In trade secret law, a duty to maintain secrecy does not necessarily have to be written down. It depends upon the circumstances. Even if not expressly stated, a duty to maintain secrecy can be inferred if, among other things, “the trade secret was disclosed to the person under circumstances in which the relationship between the parties to the disclosure” indicates an intent to keep the information confidential. That standard might have been met in Egbert, because the most public part of the disclosure was to Frances, who was at the time the inventor’s domestic partner. ...  

In any case, even if the Egbert Court may have reached the wrong factual conclusion, it is hard to argue with the fact that the standard being applied was a trade secrecy one. Other cases from the same period indicate courts thought of secrecy in a similar way—deliberate, beyond the ordinary efforts to conceal the invention was needed to keep something out of the public eye.

For example, just a few years later, in Hall v. Macneale, the Court again denied a patent for an improved design for a safe that the inventors had used more than two years prior to filing a patent. Citing its opinion in Egbert, the Court held that—even though the inventive design feature was effectively “hidden from view,” since it was inside the safe, and revealing it would have required a “destruction of the safe”—the inventors had not made deliberate efforts at concealment. Like Mr. Barnes, they’d simply relied on the inherent nature of the safe designs to maintain the secrecy of the invention. Like in a trade secret case, where zero efforts to maintain secrecy will disqualify an owner from enforcing their trade secrets, this simply was not enough.

The trade secrecy standard—if not being kept as a trade secret, then patent prior art—sheds still more light when prior art activity arises within an employment setting, where courts must assess whether the company has exercised sufficient secrecy precautions with respect to its own employees. ..."

The full paper can be downloaded here.  

 

What did we learn from last week’s FDA vaccine advisory committee meeting?

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

On October 22, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) met to discuss the development, authorization, and licensure of COVID-19 vaccines. The meeting was not focused on any particular vaccine candidate; rather, it gave the FDA an opportunity to seek more general guidance about the process from outside experts. In this post, we explain what advisory committees like VRBPAC do, what happened at the meeting last week, and what this means for the COVID-19 vaccine timeline.

Excerpt from Masur & Ouellette's Free Patent Law Casebook (Forthcoming Summer 2021)

In January 2020, Jonathan Masur (Chicago Law) and I decided to write a free patent law casebook, which has turned out to be a rewarding pandemic project. As James Grimmelmann has documented, there are now many inexpensive and open-access IP and technology law casebooks, but none focused on patent law. Jonathan and I plan to pilot our casebook with our own patent law courses in spring 2021, and we will release the casebook in summer 2021 for free download online and in print on an at-cost, royalty-free basis through Amazon.

For a sample of what we've been working on, you can now download Patent Law: Cases, Problems, and Materials – Chapter II.A Novelty from SSRN. And in a win for future patent law students, instructors looking for a free patent casebook will soon have more than one option—Sarah Burstein, Sarah Rajec, and Andres Sawicki also have one in development, with an excerpt available here.

To help instructors use active-learning pedagogical strategies, our casebook emphasizes problems and practical exercises that ask students to apply patent doctrine to situations from recent cases. We are also attempting to make the book as concise and conceptually clear as possible, with graphical illustrations to summarize the doctrine and manageable reading assignments focused on the details of modern patent practice and policy.

We will provide adopting instructors with corresponding PowerPoint slides and a Teacher's Manual containing suggested answers to the practice problems and discussion questions. If you are teaching patent law in 2021–22 and are interested in seeing the Teacher's Manual, providing feedback on this chapter, or receiving further updates, please contact us at jmasur@uchicago.edu and ouellette@law.stanford.edu.

What is—and should be—the military’s role in COVID-19 research?

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

A recent STAT News report found that Operation Warp Speed—the government’s Manhattan Project-style effort to quickly develop a COVID-19 vaccine—has substantial military involvement. Although it might initially seem counterintuitive to think of the virus as a military issue, the military’s involvement is part of a long history of government military spending on public health aims. What has been the role of military involvement and spending on preventing and treating diseases with pandemic potential? What’s different, if anything, for COVID? And what should policymakers and scholars be focused on going forward?

Google v. Oracle and the search for an analogy

I had the pleasure of listening to the Supreme Court oral argument in near real-time from the comfort of my desk last Wednesday, one of the few positives to come out of this pandemic. There's a lot to say about it, but I won't do a full recap here or make any predictions. I'll likely follow-up after the opinion.

But one thing that struck me was the Court's struggle to find an analogy. I'm not the only person to point this out, of course, because it was palpable. Google used a filing cabinet as an analogy in its briefing, and that fell flat, never mentioned during argument. Other analogies, including essential facilities, football playbooks, qwerty keyboards, telephone switchboards, and grocery organizations had varying degrees of success in capturing the issues at play in the case.

It occurred to me that perhaps an appropriate analogy would have been a remote control - this is something that uses APIs, but that the Court could have wrapped its collective mind around. 

Consider a television set. It has an infrared detector that receives various a series of pulses that coincide with different functions: on, off, volume up, volume down, input selection, etc. The remote control has a list of these commands built into its memory. When the appropriate button is pressed, a lookup command finds the proper set of pulses, and sends them. I realize that this may be done via hardware, but not necessarily and even if so, the analogy still works to illustrate the consequences.

Let's assume now that this group of pulses took some creativity. There was a lot of work to make sure that the pulses didn't match other devices, and they could have been created any other way. But this collection of pulses is original, even highly so.

Now, along comes your cable box, and you want to turn the channel on cable, while powering on your TV and changing the TV's volume using a single remote. We've all been there, right? In order to do this, the cable box remote must include a collection of the pulses needed to do those things. Indeed, it will need the collection of pulses from every television manufacturer. Mind you, not every pulse will be needed. Cable box remotes won't have a "setup" button, for example. The universal remote can generate the compatible pulses in any number of ways, but the pulses will always be the same, or else the remote won't work.

What if the TV manufacturer says that its pulses are protected by copyright? It's not far-fetched. the pulses are 10011101001 - original expression. The longer the pulse, the more likely it is to be original. Should it be able to stop cable box manufacturers from including the list of pulses in its remote controls? Should it be able to stop competing televisions (or maybe sound bar makers) from including a list of those pulses so that a single volume change affects multiple devices at once?

Now this, I suggest, is an analogy that the Court can get its arms around. I am certain that every justice has worked a remote control, and a universal remote control. I would posit that most of them know how very different the world is when you have 5 different remote controls--one for each device--rather than a single universal remote.

This analogy, I submit, brings into focus the competing policy arguments. Google argues that competing remote control manufacturers must be able to have a list of all the pulse commands in their programming if they are to communicate with the TV.  It doesn't really matter how famous the TV is - if the TV maker gets to own the collection of pulses, then society is left with only one remote control possibility. Further, if other device makers cannot include the list of pulses to work with the TV's remote--and so only the TV maker can make devices that work with its remote--then consumers must use a different remote if they want to turn up the stereo or sound bar with a remote control.

Oracle, on the other hand, says that its collection of pulses, being original, is owned by the TV manufacturer, and as a result universal remotes and compatible sound bars are just riding its coattails. People are free to make up their own collection of pulses, but if that means nobody's remote control works with its TV's and nobody can used its remote control on competitor sound bars or televisions, that's just fine.

When put this way, I think the issue comes into stark resolution. 

• Was copyright meant to regulate remote control compatibility, even if the collection of pulses is original? I don't think so. 
• Is the sending of a message to turn up the volume from a remote control to a television a method of operating the television, not withstanding the originality of the pulse collection? Yes - the pulse is making the television do something. 
• Does allowing sound bar manufacturers (and even rival television manufacturers) to reuse the pulse collection so that they can respond to pulse commands from the original TV remote put the copyrightability of all the other original and creative functionality inside the original TV at risk?  No. APIs really are different. 
• Does this fit into copyright doctrine? Yes. As I noted in my amicus brief, the TV manufacturer is entitled to copyright protection in all of its code, including the collection of pulses. But when the pulses are reused to obtain a functional goal - namely remote to television compatibility, then we should filter them out. Whether you call it merger, idea/expression, or method of operation doesn't really matter. From a doctrinal point of view, we are saying that the commands necessary for one device/program to control another cannot be asserted as part of the copyright scheme. In Baker v. Selden, the court was clear that such use is allowed, even if copying of some expression is incident to it.
  

In sum, it is maddening to me how little mention Bateman v. Mnemonics has received in this case and its briefing. That case, decided at about the same time as Lotus v. Borlad 25 years ago, deals with nearly identical issues as this case, and quite easily disposes of the issues by filtering out common interface as function in an infringement analysis. 

As I note in my brief: "According to Westlaw, Bateman is cited in nearly 1/3 more cases than Lotus about (240:170), but only in about half as many secondary sources (about 450:950)." In other words, the straightforward application of filtration is not as sexy as ruling something is completely uncopyrightable as a method of operation. But it makes a whole lot more sense to courts, who have been using the methodology for nearly 25 years.

 

How are COVID-19 vaccine manufacturers aiming to encourage trust in the FDA’s approval process?

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

In recent weeks, a number of articles have reported great concern around the politicization of the approval process for future COVID-19 vaccines. Public trust in public health agencies is arguably at an all-time low. After several missteps, the FDA has been working publicly to shore up public confidence in an approved vaccine once it comes out. But pharmaceutical companies themselves are now also engaging the public themselves in an attempt to build trust in their products. This is an unusual step for, of course, unusual times. What are vaccine developers doing, how should policymakers think about these efforts, and how can we encourage these lines of communication in the future?

What are the innovation challenges to scaling vaccine manufacturing?

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

Many worries dog the race for a COVID-19 vaccine. Is the FDA going to bow to political pressure and possibly approve a vaccine prematurely? How much will a vaccine be rewarded by governments and how will it be allocated to patients? How will distribution work, when the world faces potential supply-chain shortages ranging from glass vials to low-temperature freezers to manage the challenging cold chain? Will enough people take the vaccine to reach herd immunity? Can the government overcome the understandable skepticism of many Black Americans toward a vaccine produced by a medical system with a long history of systemic racism? 

Alongside these concerns is another substantial challenge: how are firms going to make hundreds of millions—eventually billions—of doses quickly and effectively? As one of us (NP) recently discussed in work with Professors Arti Rai and Timo Minssen, vaccine manufacturing is hard, and the world needs it to happen fast. How should innovation policy scholars and policymakers think about this issue?

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.

Sean O'Connor's Historical Take on Different Types of Intellectual Property

I truly enjoyed Sean O'Connor's new paper, forthcoming in the George Mason Law Review, called "Distinguishing Different Kinds of Property in Patents and Copyrights." It is somewhat sui generis. But I guess I would describe it as a 'legal-historical take on how people perceived intellectual property in the past, with theoretical implications for IP today.'

How can policymakers encourage the expansion of at-home diagnostic testing for COVID-19?

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

As we have previously discussed, fighting the COVID-19 pandemic will require a massive expansion of testing. Diagnostic tests for who is currently infected are particularly important. Given a limited number of health-care providers and testing sites, at-home testing has emerged as an important route to expand diagnostic testing capability. But developing at-home diagnostic tests that are affordable, reliable, effective, and able to be administered by untrained individuals presents a number of challenges. How should policymakers encourage the development and deployment of such tests?

Why is at-home COVID-19 testing needed?

Currently, the vast majority of testing for active infection (principally by RT-PCR) requires a health-care worker trained to collect samples. In large part, this requirement arises because samples are collected using a nasopharyngeal swab—something like a very long Q-tip which is inserted through the nostril as far back as the ear. The task is unpleasant for the patient and requires training to do right. It can also be dangerous to the health-care worker, because patients often sneeze or cough in reaction to the swab, potentially exposing the worker to SARS-CoV-2.

As a result, getting tested for COVID-19 requires traveling to a testing site, whether a hospital, a clinic, or a drive-through site. Today, availability is still limited; appointments are often required, and some sites are limited to residents of a particular area. Getting to a testing site also requires actually getting to the site, which can be difficult for those without cars or ready access to public transportation (which itself brings risks). Unfortunately, the populations most vulnerable to COVID-19 frequently overlap with those lacking good access to personal transportation. 

At-home testing could ease the path to substantially increased testing, allowing more frequent testing of more people and readier access across different populations. At-home testing could lessen friction from transportation and site access and circumvent bottlenecks due to the limited availability of health-care workers.

Nonexcludable Innovations and COVID-19

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

Some of the most widely discussed COVID-19 interventions include vaccines, drugs, and medical devices—typical interventions for many diseases, whether the cause of a pandemic or not. These interventions share a further similarity—they’re all generally excludable. That is, the owner of a particular invention can generally exclude others from practicing it without permission. In a classic account of IP, it is this excludability that encourages their development in the first instance. But as Professors Amy Kapczynski and Talha Syed have explained, some knowledge goods are more excludable than others. In this post, we describe why many successful COVID-19 interventions—washing hands, wearing face masks, even the proning of patients in a hospital setting—are generally nonexcludable and thus likely to be underincentivized by IP-based market rewards. Policymakers tasked with encouraging COVID-19 innovation should attempt to correct for this asymmetry in excludability.

Remdesivir Part II: Allocating Access

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

Last week, we focused on incentives for developing clinical evidence supporting the use of remdesivir for COVID-19 and analyzed the FDA’s grant of an emergency use authorization (EUA) for the drug. This week, we consider mechanisms for allocating access to the drug, including distribution, payment, and patents. Importantly, many of these issues are relatively uncommon to encounter in the prescription drug space. The government does not usually control the allocation and distribution of new drugs after marketing authorization has been granted, although it is doing so for remdesivir. These novel issues raise opportunities, but also concerns, for law and policy.

Remdesivir Part I: Incentivizing Antiviral Innovation

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

The antiviral drug remdesivir, developed by California-based biopharmaceutical company Gilead Sciences in collaboration with government scientists, has emerged as the new standard of care for COVID-19 patients. The drug has also been beset by controversy, from Gilead’s withdrawn orphan drug application to conflicting reports of clinical trial results to an opaque and haphazard distribution process. We examine the role of legal institutions in the remdesivir rollout in two posts focused on the two (separable) parts of innovation policy. This week focuses on the innovation incentives for producing information about remdesivir and other COVID-19 treatments, including the FDA’s role in deciding whether and under what conditions a new drug can reach the market. Next week we will turn to pharmaceutical allocation mechanisms, including payment and distribution.

How is regulatory policy influencing the development and marketing of antibody testing for COVID-19?

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

Over the last few weeks, dozens of companies have begun marketing tests intended to determine whether someone has antibodies directed to SARS-CoV-2, the virus that causes COVID-19. These tests indicate likely immunity to COVID-19 and are different from diagnostic tests to determine whether someone is currently infected. However, recent evaluations have shown that these antibody tests are often failing to deliver accurate results. Last week, the House Oversight Committee called for more information from these companies about the accuracy of their tests, and the FDA has now responded by increasing its oversight over antibody tests. But why did the FDA’s initial stance toward these tests differ so strongly from its stance toward COVID-19 diagnostics, and what lessons should policymakers draw from these experiences going forward?

How does the law impact the use of 3D printing to address COVID-19 production shortages?

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

Health systems worldwide are facing shortages of crucial medical supplies, including personal protective equipment (PPE), diagnostic testing components including kits and nasal swabs, and even ventilators or ventilator parts. Enter 3D printing. A growing network of hobbyists, small-scale makers, 3D printing firms themselves, and even larger companies with some 3D printing capacity are using the technology to help address ongoing shortages in the COVID-19 response.

What kinds of COVID-19-related products are being 3D printed?

3D printing, also called additive manufacturing, involves building a 3D form from the bottom up by adding one thin layer of material at a time. (Here’s a handy Congressional Research Service overview.) Many materials can be used, including plastic, metal, or resin. The printer is controlled by a computer which prints based on a computer-assisted design (CAD) file. 3D printers have been used for rapid prototyping or by hobbyists for years, but are more recently being used at larger scale.

3D printing is being used to create a host of products potentially relevant to COVID-19. PPE is perhaps the most common example; many people are producing the headbands of protective face shields; some are printing masks. Nasal swabs are also being printed in substantial numbers (the swabby bit at the end is a bristled resin structure, not cotton fibers like you’d find in a Q-Tip), and have been evaluated by, among others, Beth Israel Deaconess Medical Center. Printing has also been used for more complex components of medical devices, such as ventilator valves or splitters so that patients can share a ventilator—or even most of the components of emergency open-source ventilators.

Who’s Afraid of Section 1498?: Government Patent Use as Versatile Policy Tool

Guest post by Christopher Morten & Charles Duan

Chris Morten (@cmorten2) is the Clinical Teaching Fellow and Supervising Attorney in NYU’s Technology Law and Policy Clinic. Charles Duan (@Charles_Duan) is Director of Technology and Innovation Policy at the R Street Institute.

From vaccines to ventilators to diagnostic tests, technology has dominated response strategies to the ongoing COVID-19 pandemic. Where technology leads, patent law and policy follow. Recently, some attention has turned to federal government patent use under 28 U.S.C. § 1498. Jamie Love of KEI has called on the federal government to explore use of section 1498 in its response to COVID-19, to reduce prices, expand supplies, and ensure widespread, equitable access to patented technologies. (We have, too.) There is a long line of scholarship, including Amy Kapczynski and Aaron Kesselheim, Hannah Brennan et al., Dennis Crouch, Daniel Cahoy, and others discussing the relevance of section 1498 in a variety of contexts.

Yet others have encouraged the government to “tread lightly” and described use of section 1498 as a “nuclear option”—potent but dangerous—because it can be used to make massive interventions in the market for patented products—e.g., by issuing compulsory licenses to patents on high-priced brand-name drugs, “breaking” patent monopolies and accelerating the entry of numerous generic competitors. One recent example: a few years ago, Gilead’s high prices on hepatitis C drugs exacerbated a different public health crisis and prompted a chorus of voices, including Senator Bernie Sanders and the New York Times editorial board, to call on the federal government to exercise its section 1498 power to “break” Gilead’s patents in just this way, which might have saved tens of billions of dollars in public spending. (The federal government did not do so.)

Irrespective of the merits of 1498 as a general matter, in the context of a crisis such as the COVID-19 pandemic we see real value in bold, “nuclear option” use of section 1498 to save billions on high-priced prescription drugs and maximize their availability. But that is not the only way section 1498 can be used. It can also be used in modest, incremental, unexceptional ways—it can be as much as a scalpel or a Swiss Army knife as a nuclear weapon, and some of its virtues in this regard have gone underappreciated.

Accordingly, we highlight four particularly valuable features of government patent use under section 1498 in a crisis like the present one: (1) speed, (2) flexibility, (3) ex post determination of the appropriate compensation, and (4) determination of that compensation by an impartial adjudicator. In particular, we compare section 1498 with an alternative policy tool, patent buyouts, which can also expand public access to patented technologies, and identify several reasons why section 1498 may be the preferable tool.

Regulatory Responses to N95 Respirator Shortages

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

Our recent posts have highlighted shortages in three COVID-19-related knowledge goods: testing, drugs (such as those needed to put patients on ventilators), and clinical trial information about effective treatments. This week we focus on the role of legal regulators in another critical shortage: N95 respirators, one of the key forms of personal protective equipment (PPE) for healthcare workers. We explain how N95 regulation, like COVID-19 testing, presented an interagency coordination problem. The FDA has successfully removed key regulatory hurdles—though the problem should have been anticipated earlier, and much more needs to be done to ensure an adequate supply.

What are N95 respirators?

N95 respirators are a specialized subset of face masks (here’s a handy NY Times explainer with photos). A normal surgical mask (what you see, for example, in a typical medical TV show) fits fairly loosely around the face; it blocks splashes and relatively large droplets, but not tiny particles. An N95 respirator, on the other hand, is relatively rigid rather than being flexible, and is designed to fit closely to the face and create a tight seal—tightly enough that the masks don’t work with certain beards (or for children). The “95” in N95 refers to the requirement that the mask block at least 95% of 0.3 micron particles (about a thousandth the width of a human hair). Both types of masks are meant to be single-use.

N95 masks are meant to keep droplets that include the SARS-CoV-2 virus out. They’re not perfect, but if they’re well fitted, they are effective at protecting the wearer (most crucially right now, the healthcare providers who are caring for patients and are themselves still getting sick in droves). Surgical masks, on the other hand, do a worse job of keeping the virus out. Cloth masks even less so. But cloth masks can help keep droplets in—that is, if someone is sick, wearing a cloth mask may keep them from projecting droplets that can infect other people. The CDC now recommends that everyone wear a face mask when in public, to avoid infecting other people (because even asymptomatic individuals can infect others, and the lack of testing means it’s very hard for most people to know whether they have been infected). However, surgical masks and especially N95 masks are in very short supply, and should be reserved for medical professionals.

N95s were initially developed for industrial uses including mining. The key feature—and what makes N95s harder to manufacture than other masks—is that the masks are made using what’s called “melt-blown” fabric. A polymer (such as polystyrene, polyurethane, or nylon), is melted then blown through small nozzles; it forms a matrix of tiny fibers with many holes (think: cotton candy), which can capture particles. But the machines to make this fabric are complex and expensive, and manufacturers of the fabric are struggling—and failing—to meet demand.

How can innovation and regulatory policy accomplish robust COVID-19 testing?

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

It’s now clear that expansive, population-wide testing is part-and-parcel of every successful COVID-19 containment strategy. But US testing efforts, from the beginning of the pandemic until now, have been widely criticized as lacking. Perhaps as a direct consequence of this failure, the US now leads the world in COVID-19 cases and deaths. What are these tests and what’s our capacity to test; why is it important to test; how have the FDA and other administrative agencies addressed the issue; and what can we do about it?

What is the status of US testing capacity?

It is important to distinguish between two types of COVID-19 tests: reverse transcription polymerase chain reaction (RT-PCR) tests for SARS-CoV-2, the virus that causes COVID-19; and serological tests for the body’s immune response to SARS-CoV-2. The tests are not interchangeable: RT-PCR tests detect the presence of the virus’s genome, itself, and thus determine whether someone is currently infected. Someone who was once infected and has since recovered will return a negative result. A serological test, by contrast, detects whether the body has produced antibodies to the virus; that’s useful to determine whether someone has been infected for long enough to mount an immune response.

To date, virtually all of the testing has been of the RT-PCR type, useful for answering the question: Is the patient infected now? Testing centers in the US are currently running approximately 135,000 tests a day—far fewer per capita than in other countries. The US’s maximum, overall testing capacity is unclear and is, in any event, a moving target given that new tests are now being cleared by the FDA with some frequency. But it’s widely acknowledged that testing is not at the level that it needs to be to accurately assess the number of people infected with SARS-CoV-2.

There are myriad reasons for this deficit in testing: an initially slow ramp-up of tests approved by the FDA; difficulties in speeding manufacturing of kits used to conduct the tests; a shortage of reagents to conduct the tests, including solutions, primers, and even the swabs used to collect samples from patients; the capacity of clinical laboratories to run tests and return results; and less technical hang-ups like patients’ difficulties in finding or physical getting to testing sites and questions concerning who will pay for such testing.

How can the US address coronavirus drug shortages?

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

The escalating pandemic has caused devastating shortages not only of ventilators and personal protective equipment like masks, but also of essential medicines needed to treat COVID-19 patients. As detailed by STAT and the New York Times, prescriptions for painkillers, sedatives, anesthetics, and antibiotics are up, but the rate at which prescriptions are filled and shipped to hospitals is down. The FDA helpfully tracks drug shortages, but this doesn’t solve the problem. With the sudden spike in hospitalized patients with COVID-19 symptoms, physicians are using these drugs faster than manufacturers are making them.

What is causing these drug shortages?

Drug shortages are frighteningly common even in the best of times. A 2019 FDA report noted that from 2013 to 2017, at least 163 drugs went into shortage. (The actual number is likely much higher.) That report blamed “economic forces”—namely, price-eroding generic competition, a lack of incentives to make quality generic manufacturing more efficient, and supply chain difficulties that made the continued manufacture of older generics unprofitable. These problems are now exacerbated by the sudden demand spikes caused by COVID-19 patients. As just one example: propofol, an important drug for sedating patients who need intubation—and, historically, already in waxing and waning states of shortage—has seen prescriptions shoot up about 100%.

Supply has been slow to meet COVID-19-related demand—but slower still because of the outbreak’s disruption to the global supply chain. Many pharmaceutical ingredients are manufactured in China, which has seen slowdowns (and in some cases, shutdowns) in manufacturing sectors across the country. Furthermore, because drugs do expire, they’re not stockpiled when there’s a surplus. In some instances, countries have banned the export of drug products important for treating COVID-19 to ensure adequate supply for their own citizens. India, for example, has banned exports on hydroxychloroquine in the event the drug proves useful in treating COVID-19. It’s a wicked problem: the very thing causing the sudden spike in demand is shutting down the means of supply.

What does it mean that Oracle is partnering with the Trump administration to study unproven COVID-19 drugs?

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

One of the dizzying stream of innovation and health law stories to emerge last week is Oracle’s partnership with the White House to study unproven pharmaceuticals for treating COVID-19. We decided to unpack this story for ourselves and then to collectively share our thoughts in a short explainer.

What are the drugs being studied?

The initial stories about Oracle’s platform mention its use for two older drugs approved to treat malaria—chloroquine and hydroxychloroquine—that are now being tested to treat COVID-19. Both drugs are quite old: chloroquine was first approved by the FDA in 1949 and sold, until recently, under the brand name Aralen. Hydroxychloroquine, which is also used to treat lupus and rheumatoid arthritis, is sold under the brand Plaquenil and was first approved in 1955.

The impetus behind studying these two drugs stems from in vitro studies following the 2005 SARS-CoV-1 outbreak. Those studies suggested the drugs could inhibit some types of coronaviruses from both entering cells and replicating after infection—potentially serving as a preventative and a treatment. But the studies were small, in cell culture rather than living animals, and not conducted against the virus that causes COVID-19, SARS-CoV-2. Some early work with the drugs against SARS-CoV-2 may be promising but it, too, has been done in a test tube rather than an animal model.

Does Gilead's (withdrawn) orphan designation request for a potential coronavirus treatment deserve your outrage?

Many commentators were outraged by the FDA's announcement on Monday that Gilead received orphan drug designation for using the drug remdesivir to treat COVID-19. The backlash led to a quick about-face by Gilead, which announced today that it is asking the FDA to rescind the orphan designation. For those trying to understand what happened here and the underlying policy questions, here's a quick explainer:

How could the Orphan Drug Act possibly apply to COVID-19?

Under 21 U.S.C. § 360bb(a)(2), a pharmaceutical company can request orphan designation for a drug that either (A) treats a disease that "affects less than 200,000 persons in the United States" at the time of the request or (B) "for which there is no reasonable expectation that the cost of developing and making available in the United States a drug for such disease or condition will be recovered from sales in the United States of such drug." An ArsTechnica explainer suggests that remdesivir received orphan designation under option (B), but this email from the FDA indicates that it was option (A).

The designation seems correct based on the plain language of the relevant statute and regulations: As of Monday, there were 44,183 cases diagnosed in the United States (and even fewer at the time of Gilead's request), and the Orphan Drug Act regulations indicate that orphan designation "will not be revoked on the ground that the prevalence of the disease . . . becomes more than 200,000 persons." But given the CDC's low-end estimates of 2 million Americans eventually requiring hospitalization, commentators have noted that this feels like a loophole that gets around the purpose of the Orphan Drug Act.

What benefits would Gilead have received from an orphan designation?

The main effect would have been a tax credit for 25% of Gilead's expenses for the clinical trials it is running to figure out whether remdesivir is actually effective for treating COVID-19. (The tax credit was 50% when the Orphan Drug Act became effective in 1983, but was reduced to 25% by the December 2017 tax reform.)

Challenging what we think we know about "market failures" and "innovation"

I really enjoyed the final version of Brett Frischmann and Mark McKenna's article, "Comparative Analysis of Innovation Failures and Institutions in Context." The article was published in Houston Law Review in 2019. But I initially encountered it when the authors presented an early draft at the 2012 Yale Law School Information Society Project's "Innovation Beyond IP Conference," conceived and brought together by Amy Kapczynski and Written Description's Lisa Ouellette. The conference explored mechanisms and institutions besides federal intellectual property rights (IP) that government uses, or could use, in order to achieve some of IP's stated goals. Examples explored include research grants, prizes, and tax credits, among countless others.

Deepa Varadarajan on Trade Secret Injunctions and Trade Secret "Trolls"

I wrote some previous posts about eBay in trade secret law, and in particular Elizabeth Rowe's empirical work. Rowe found not all trade secret plaintiffs actually ask for injunctions, even after prevailing at trial, along with many other fascinating findings. I would be remiss if I did not flag a characteristically excellent discussion of this issue by Deepa Varadarajan, in a piece that may have flown under readers' radars.

Google v. Oracle: Amicus Briefing

Hello again, it's been a while. My administrative duties have sadly kept me busy, limiting my blogging since the summer. But since I've blogged consistently about Google v. Oracle (fka Oracle v. Google) about every two years, the time has come to blog again.

I won't recap the case here -my former post(s) do so nicely. I'm just reporting that 20+ amicus briefs were filed in the last week, which SCOTUSblog has nicely curated from the electronic filing system.

There are many industry briefs. They all say much the same thing - an Oracle win would be bad for industry, and also inconsistent with the law (The R Street brief -and prior op ed-describes how Oracle has copied Amazon's cloud based API declarations). But since I'm an academic, I'll focus on those briefs:

1. Brief of IP Scholars (Samuelson & Crump): Merger means that the API declarations cannot be protected
2. Brief of IP Scholars (Tushnet): Fair Use is warranted
3. Brief of Menell, Nimmer, Balganesh: Channeling dictates that API declarations are not protected
4. Brief of Lunney: Infringement only occurs if whole work is copied; protection does not promote the progress
5. Brief of Snow, Eichhorn, Sheppard: Fair Use jury verdict should not be overturned
6. Brief of Risch: Protection should be viewed through the lens of abstraction, filtration, and comparison

My brief is listed last, but it's certainly not least. Indeed, I think it's a really good brief. But of course I would say that. If you've read my prior blog posts on this (including the one linked above), you'll note that my brief puts into legal terms what I've been complaining about for eight or so years: by framing this case as a pure copyrightability question, the courts have lost sight of the context in which we consider the protection of the API declarations. There might be a world where the declarations, if published as part of a novel and reprinted in a pamphlet made by Google, are eligible for copyright registration. But in the context of filtration, which neither the district court nor the Federal Circuit performed, the declarations are not the type of expression that can be infringed by a competing compiler. Give it a read. It's better than Cats (and not just the new movie), you'll read it again and again.

An even better summary of all the briefs is here.

I conclude with a paragraph from the brief, which I think sums things up:

This case boils down to [the] question: can a company own a programming language through copyright? Oracle would say yes, but the entire history of compatible language compilers, compatible APIs, compatible video games and game systems, and other compatible software says no. Michael Risch, How Can Whelan v. Jaslow and Lotus v. Borland Both Be Right? Reexamining the Economics of Computer Software Reuse, 17 The J. Marshall J. Info. Tech. & Priv. L. 511, 539–44 (1999) (analyzing economics of switching costs, lock-in, de facto standards, and competitive need for compatibility).