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.

Thursday, August 13, 2020

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. 

Wednesday, August 5, 2020

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


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.

Thursday, July 30, 2020

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


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.

Wednesday, July 22, 2020

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


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.

Friday, July 10, 2020

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


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.