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.
Friday, October 30, 2020
Thursday, October 29, 2020
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 email@example.com and firstname.lastname@example.org.
Monday, October 12, 2020
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?
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
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?