Tuesday, January 12, 2021

What can policymakers learn from the disastrously slow COVID-19 vaccine rollout?

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

In the middle of a record number of COVID-19 infections and deaths—and continued evidence of racial disparities in the pandemic’s effects—December brought some good news to the fight against the pandemic: the FDA’s emergency use authorizations (EUAs) for the Pfizer-BioNTech and Moderna vaccines and the ensuing nationwide rollouts. The record-breaking vaccine development timeline and the videos of healthcare workers receiving early vaccines are worth celebrating. But the subsequent distribution has been tragically slow—echoing distribution challenges for COVID-related goods ranging from PPE to diagnostics. On Dec. 29, Dr. Leana Wen noted that at the initial vaccination rate, it would take 10 years to vaccinate the roughly 80% of Americans needed to achieve herd immunity. According to Bloomberg’s vaccine tracker, as of today, fewer than 10 million vaccines have been administered in the United States. States are still sitting on nearly two-thirds of the doses they have received, and the federal government is holding half the U.S. supply in reserve. In this post we explain what went wrong and how policymakers can correct course for COVID-19 and avoid such disasters in the future.

Friday, December 18, 2020

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.

Tuesday, December 15, 2020

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.  ...  

Monday, November 30, 2020

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.

Saturday, November 21, 2020

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. 

Monday, November 2, 2020

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.  


Friday, October 30, 2020

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.

Thursday, October 29, 2020

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.

Monday, October 12, 2020

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.


Friday, October 2, 2020

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?

Thursday, September 10, 2020

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?

Tuesday, August 25, 2020

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?

Wednesday, August 19, 2020

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.

Tuesday, August 18, 2020

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.