How are COVID-19 vaccine developers and regulators responding to variants?

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

The remarkable news of record-breaking COVID-19 vaccine development has been clouded by the increasing emergence of new variants of the SARS-CoV-2 virus. Like other viruses, SARS-CoV-2 mutates over time, due to random errors in copying its genetic sequence. When one of these mutations helps the virus survive and reproduce—such as by making the virus more transmissible—that variant will spread more rapidly than the original virus through natural selection. The global effort to control the pandemic has thus been framed as a race between the vaccines and the variants: can the world be vaccinated before the virus evolves to evade the vaccines? In this post, we examine how COVID-19 vaccine developers are responding to the spread of variants, how the FDA plans to regulate updates to the vaccines, and other innovation policies governments should consider to combat the variant spread.

Advice about the patent bar for current and prospective law students

Guest post by Professor Eric E. Johnson (ericejohnson.com)

I recently asked fellow intellectual property professors and others about advice for law students interested in taking the patent bar. The IP community generously responded, and I have synthesized their wisdom and opinions here, with some of my own advice sprinkled in. Of course, opinions differ and things change, so students should consider this post as a jumping-off point for doing their own research and asking their own questions.

Waiting for Google

Google v. Oracle was argued (after being reset last term for additional briefing) on October 7, during the first week of this term. We still don't have an opinion, and the time delay makes me worry that the opinion(s) will be more Guffman than Godot.

While we wait (and it could be any time), I wanted to point to a recent case that illustrates the concern at issue in this case if Oracle wins. The facts of this case are remarkably similar to my remote control analogy, which I continue to think is the best analogy to date (and which I hope some Supreme Court clerk happened to read).

The case is Pyrotechnics Management, Inc. v. XFX Pyrotechnics LLC and FireTEK, a W.D. Pa. case that just issued a preliminary injunction. The facts for our purposes are not complicated. Both parties make a device used to control fireworks displays. The device issues and responds to commands, which are basically numbers sent along the wire. It's called a protocol by the plaintff (and anyone else familiar with this kind of technology). It's functionally no different than an API like that in Google v. Oracle - it's a set of commands that tells devices to do something.

Here, the copyrighted work isn't even software. The registration deposit materials is a manual that describes the protocol - send this command (number) with these optional parameters (more numbers) and things will happen. Here is the briefest of examples:

In other words, send a 12-byte message containing (in this case) 3 actual bytes of information. 0x23, 0x23,0x46, plus a CRC check (a common error check practice). Like the remote control in my analogy, it's sending 1s and 0s down the wire, in a particular order.

The plaintiff's expert said the copyrighted work must have been copied because how else could you make a device that sent these same numbers? The defendant's device sent and received these same numbers down the wire. There's not even a claim that the numbers were generated in the same way.

And the court agreed. It said the selection of numbers required originality, and there was no reason for a competitor to use the same numbers. Furthermore, the fact that the deposit wasn't even software didn't mean that it couldn't be copied in software if the same numbers were implemented. In short, the plaintiff now owns the set of remote control codes and nobody else can make a compatible remote control.

If you don't see why this is problematic, then nothing else I write will convince you otherwise - you are basically OK using copyright to obtain a 100 year backdoor patent on any device that sends and receives an arbitrary set of commands. But this is not a good result. Copyright policy - let alone the statute - simply should not allow for this outcome that uses copyright to limit functional information sharing in computer programs and electronic devices. 

As I advocated in my amicus brief and many other blog posts, I've got no quarrel with the argument that the set of numbers collected by the plaintiff may be copyrighted.  But that copyright cannot extend to enforcement against the method of using those numbers to operate devices. So, you can't copy the description of the protocol verbatim, perhaps, but it is not infringing to send numbers down a wire. The statute couldn't be more plain on this - methods of operation cannot be protected, no matter the form in which they are expressed. What else can the statute mean, if not this narrow meaning?

I'll end by noting that the district court here did not even mention Baker v. Selden, which explicitly endorses this rule - that the expression of a method is not infringed when others use the method:

The fact that the art described in the book by illustrations of lines and figures which are reproduced in practice in the application of the art, makes no difference. Those illustrations are the mere language employed by the author to convey his ideas more clearly. Had he used words of description instead of diagrams (which merely stand in the place of words), there could not be the slightest doubt that others, applying the art to practical use, might lawfully draw the lines and diagrams which were in the author's mind, and which he thus described by words in his book.

The copyright of a work on mathematical science cannot give to the author an exclusive right to the methods of operation which he propounds, or to the diagrams which he employs to explain them, so as to prevent an engineer from using them whenever occasion requires.

Furthermore, we will accept some copying of expression if that's the only way to use the idea:

And where the art it teaches cannot be used without employing the methods and diagrams used to illustrate the book, or such as are similar to them, such methods and diagrams are to be considered as necessary incidents to the art, and given therewith to the public; not given for the purpose of publication in other works explanatory of the art, but for the purpose of practical application.

Baker v. Selden also provides a direct analogy on the facts - there, the bookkeeping system was described in a document, but the plaintiff could not stop others from practicing the system. That rings true here, where the copyright is in a document explaining the system of numbers; from Selden: "The use of the art is a totally different thing from a publication of the book explaining it." Here, the commands were described in a document, but the plaintiff should not be able to stop others from practicing the commands: 

As an author, Selden explained the system in a particular way. It may be conceded that Baker makes and uses account-books arranged on substantially the same system; but the proof fails to show that he has violated the copyright of Selden's book, regarding the latter merely as an explanatory work; or that he has infringed Selden's right in any way, unless the latter became entitled to an exclusive right in the system.

The court's failure here to mention Baker v. Selden is problematic. I hope the same is not true in Google v. Oracle.

 

Charles Tait Graves: Idea Submission Cases, Desny Claims, and Trade Secret Law

I thoroughly enjoyed Charles Tait Graves new article: Should California’s Film Script Cases Be Merged into Trade Secret Law?, which was recently published in The Columbia Journal of Law & the Arts.  Graves is a partner at Wilson Sonsini and teaches trade secret law at UC Hastings Law.   

The article deals with so-called "idea submission" cases. The fact pattern is as follows. Plaintiff, who is sometimes called the "idea man" in older cases, shares an idea with Defendant, hoping for monetary compensation even though there's no express contract stating terms of payment. Defendant subsequently takes the idea and commercializes it without paying Plaintiff. (There's an excellent discussion of the idea submission cases in Chapter 4 of Elizabeth Rowe and Sharon Sandeen's Trade Secret Law casebook). 

At least in California, the Plaintiff-idea person will likely have two distinct types of legal claims in this scenario: (1) a claim for breach of an implied-in-fact contract, which in California is called a Desny claim; and (2) a claim for civil trade secret misappropriation, which since 2016 can be brought under both state law (e.g. under the California Uniform Trade Secret Act) and federal law via the Defend Trade Secrets Act (DTSA). Graves recounts in tremendous detail how these two different legal regimes developed on separate ends of the map of California, in Southern and Northern California, respectively. Graves' thesis is that, even though these two areas of law have been historically addressed separately, they have a lot in common and can learn a lot from one another.   

I interviewed Graves about the article, transcribed below.

Are patents the cause of—or solution to—COVID-19 vaccine innovation problems? (No!)

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

Are patents the cause of—or solution to—COVID-19 vaccine innovation problems? A number of recent commentaries have suggested as much, and have advocated for either weakening or strengthening patents covering various aspects of COVID-19 vaccines. Turning to patent law to address innovation problems may seem natural, as legal scholars conventionally view patent law as “our primary policy tool to promote innovation.” But there is a reason we have written over thirty posts on COVID-19 innovation issues without a single post focused on patent law (until now): many other legal institutions have turned out to be far more important. This is particularly true for vaccines. In this post, we explain why either eliminating or strengthening patents would have little effect on the rollout of vaccines for this pandemic, and why non-patent institutions will play a far more important role than patent law in incentivizing innovation for the next pandemic.