Friday, April 9, 2021

How can Congress create infrastructure for the next pandemic?

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

After approximately 200 Infrastructure Weeks, policymakers now appear to be actually talking about passing legislation about infrastructure! Congress also seems like it might take action to lay the groundwork for combatting the next pandemic; bipartisan efforts are underway. Putting the two together: how should Congress think about creating innovation infrastructure, broadly defined, to help combat the next pandemic? 

Even before COVID-19, experts were sounding alarms about insufficient infrastructure to address the foreseeable risk of a global pandemic. In 2019, an expert group convened by the World Bank and WHO concluded that “[t]he world is not prepared” for the “very real threat of a rapidly moving, highly lethal pandemic of a respiratory pathogen,” among other things because “[t]oo many places lack even the most rudimentary health-care infrastructure.” COVID-19 has magnified these global health inequalities. But inadequate infrastructure investment is not just a problem in low-income countries: COVID-19 has also drawn increased attention to long-apparent weaknesses in many U.S. infrastructure sectors. We suggest priorities for three types of infrastructure: physical infrastructure, knowledge infrastructure, and human infrastructure (recognizing that these categories may overlap).

Tuesday, April 6, 2021

Google v. Oracle - The Final Shoe Drops

The Supreme Court ruled yesterday in Google v. Oracle that Google did not infringe Oracle's copyright in its APIs by virtue of fair use. The vote was 6-2, with Justice Breyer writing for the Court, and Justices Thomas and Alito dissenting. 

The opinion was straightforward and went to great lengths to attempt to explain the technology at issue. I thought it did a decent job of it (definitely more Godot than Guffman), even as the opinion continued to struggle for a good analogy. The Court adopted the file cabinet/drawer/folder analogy presented in Google's brief, which I thought was a terrible analogy...so I guess there's no accounting for taste (or winning advocacy). The court's fair use analysis was influenced by Judge Boudin's concurrence in Lotus v. Borland, though that concurrence didn't actually call it fair use, but instead "privileged use."

Others have and will surely write about the fair use aspects and what this means for software APIs. Contrary to Oracle's ridiculous and vitriolic press statement yesterday, this case will likely not change the way anyone in the industry behaves in the least. APIs have been used and reused for decades, and will continue to be. And contrary to being a barrier to entry, reuse of APIs allows for competitive inroads and entry, including by Oracle, in its mimicry of Amazon's AWS API. (Indeed, the hubris of Oracle's statement in light of its implementation of another company's API is stunning, assuming it was unlicensed-I've been unable to verify one way or the other.)  

The opinion also has some nuggets for other fair use - discussion of transformation and art, definition of markets for determining harm, another reaffirmation of Campbell v. Acuff-Rose Music, fair use as a mixed question of law and fact (something I discussed in a prior blog post), and so forth.

Instead, I will focus on my hobby horse-whether the APIs are copyrighted, and if so how we get to non-infringement. The Supreme Court explicitly decided that the copyrightability of APIs is a third-rail and did not attempt to touch the issue. There are two ways to read the tea leaves. First, perhaps a majority of the court thought they were uncopyrightable, but feared the effects of saying so. Second (and my guess), perhaps a majority of the court (or a 4-4 split) thought that they were copyrightable, but fair use was an acceptable compromise. The second possibility is why I wrote and submitted my amicus brief, which was intended to give a path to non-infringement even if the APIs were copyrightable.

Alas, the court did not buy into the abstraction/filtration argument I made, which I believe was doctrinally appropriate, nor did the brief get a cite, as many that discussed the importance of APIs did. However, in a sense, the court adopted the methodology I suggested. From my brief:

But the copyrightability of an entire work does not answer the question of whether any particular portion of it, if used by another, is infringing. That analysis requires determining whether the defendant has taken too much expression and not ideas, systems, methods of operation, or the like. And such a determination cannot be made outside of the infringement analysis. Any functionally required aspects—including any expression necessary to practice the idea—should be removed from the comparison. 

What remains should then be compared. The advantage of this approach is that it recognizes that while entire software programs may be copyrightable in some contexts, their pieces might not be infringed in others. There need be no zero-sum game, but only a recognition that the scope of copyright depends, as it always has, on the accused’s use of the copyrighted work. 

...

[T]he Court need not decide whether any part of Oracle’s code is copyrightable standing alone. It should only determine that the scope of its copyright in the Java source code cannot extend to infringement through the reuse of declaring functions necessary to create a compiler or interpreter that accepts the same commands and parameter names to allow programmers to use the Java programming language.

The primary pushback on this argument that I received from smart colleagues asked this question: why should context matter in the infringement analysis? Justice Thomas's dissent is replete with this same concern. My answer was always the same - because use in a functional context may be a use of the idea/method, whereas use in a different context might not be.

But Justice Breyer has sidestepped this question to essentially reach the same result using fair use. The one place where we can be sure that context matters is fair use. The nature and character of the use is one of the factors, after all. The Court's analysis tracks many of the same issues in my brief - the functionality of the APIs, their use as a de facto standard, switching costs, etc.

And so the Court's final resolution is not that far off from what I had asked. Rather than excluding the APIs from infringement by filtering them out, the Court would instead exclude them from infringement under a fair use analysis that considers many of the same factors. I can live with this solution--way back in 1999, I published a paper that argued that "courts have been able to determine efficient economic outcomes based on the cases before them, but they have been unable to settle on a rule that definitely determines how much reuse to allow in each case." The article lays out a variety of economic factors that predict how cases come out, and you'll be shocked to find out that they favor Google in this case (e.g. switching costs, de facto standards, lack of slavish copying of the implementation, no breach of an underlying economic duty, public benefits of compatibility). Perhaps that's a reason this case has stuck in my craw for so long: it's about the only one that didn't fit with my 20+ year old model.

Despite my doctrinal sanguinity, the downside of the court's approach is that it might still lead to framing issues in the future. Litigants might still be subjected to juries asked to simply decide whether the APIs were used (for infringement) and then hope to rely on fair use as a defense. Then again, a judicial fair use inquiry might keep the question from ever getting to a jury, which is basically the same result I've advocated. But this case went to a jury, by appellate order, and it's unclear that it should have. It was certainly costly. However, the strong language of this opinion may apply the next time, as in the case I recently blogged about with control codes.


The end is near for my Oracle and Google blogging, a 9 year expedition. But I do have one more in me, a more technical post in a week or so about the so-called 170 lines of code that supposedly all that are necessary to implement Java.

Thursday, March 25, 2021

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.

Thursday, March 18, 2021

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.

Wednesday, March 17, 2021

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.

 

Wednesday, March 10, 2021

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.

Thursday, March 4, 2021

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.

Thursday, February 18, 2021

How can policymakers overcome the hurdles to scaling up antibody manufacturing?

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

In our last post, we introduced some of the clinical evidence supporting the use of therapeutic antibodies against COVID-19—including Regeneron’s casirivimab and imdevimab and Eli Lilly’s bamlanivimab—and analyzed the existing problems in the distribution and administration of those therapies. Even in just the last few weeks, further clinical evidence has supported the use of these technologies, leading the FDA to issue an additional emergency use authorization for Lilly’s bamlanivimab and etesevimab cocktail. In the near future, though, problems in administering our existing supply of these new drugs may give way to problems producing enough of them—a challenge that is also affecting the vaccine rollout. In this post, we consider the difficult manufacturing issues involved in the therapeutic antibody context (a subject we’ve previously explored regarding vaccines), and what might be done to address them.

Friday, January 29, 2021

Why aren’t therapeutic antibodies being used more to treat COVID-19?

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

When former President Donald Trump contracted COVID-19 in fall 2020, he was treated with monoclonal antibodies, touted as potentially miraculous treatments. Unlike other treatments so touted, there is some rigorous evidence to support these assertions: antibody drugs look like the best treatments currently available to prevent COVID cases from progressing to hospitalization. But months later, the drugs are in limited use and seem to be only a moderately important part of the COVID-19 response. Why aren’t antibodies making more of a difference for ordinary Americans?

Wednesday, January 27, 2021

Irene Calboli: Trademarking COVID

Irene Calboli, professor of law at Texas A&M University School of Law, has written a new empirical article reporting that "the COVID-19 pandemic has led to a veritable tsunami of trademark applications" for COVID, QUARANTINE, SOCIAL DISTANCING, and other pandemic-related terms.  Indeed, Calboli concludes that trademarking of COVID-related terms is unusually rampant, even when compared to past tragedies and disasters such as 9/11, Hurricane Katrina, and Ebola. "Ultimately," Calboli writes, "probably only the HIV/AIDS pandemic can be compared with COVID-19 in terms public awareness, societal fears, and strong emotions," and even "the beginning of the HIV/AIDS pandemic did not see a similar rush to trademark filings" that we have seen with COVID. While several practitioners have also noted the large number of applications filed for these terms in the past month, Calboli's paper is the first to survey these applications comprehensively and in detail. 

The full article, Trademarks and the COVID-19 Pandemic: An Empirical Analysis of Trademark Applications Including the Terms “COVID,” “Coronavirus,” “Quarantine,” “Social Distancing”, “Six Feet Apart,” and “Shelter in Place, can be downloaded on SSRN.  The data are included as an appendix to the paper.  The article will be published in the Akron Law Review's IP Symposium Issue as part of the Annual Akron Law IP Scholars Conference. (The other scholars publishing in this year's IP issue are Margaret Chon, Robert Merges, Kristen Osenga, and Sharon Sandeen.) 

I interviewed Professor Calboli on her findings. The interview is transcribed in this post.  To follow along, here is one of the many beautiful tables and informational graphics in the article, included with Calboli's permission.

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.