Thursday, March 3, 2022

How do we encourage innovation on “long COVID”?

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

Since the pandemic began, numerous recovered COVID-19 patients have reported having “long COVID”: COVID-19 symptoms persisting well beyond the underlying viral infection period. Whether such a condition is specific to COVID-19, or more generally a form of “post-acute sequelae”—or even a discernable condition—has bedeviled scientists and clinicians alike. The fact remains, though, that likely millions of people in the U.S. alone will continue to report a variety of challenging symptoms more than 6 months after they’re infected. Despite this magnitude of reports, confusion regarding defining the condition and identifying its etiological basis has presented significant challenges to innovating treatments for it. In this post, we explore some of the current evidence surrounding “long COVID,” some of the difficulties in developing long COVID treatments, and how policymakers can move things along.

Wednesday, February 9, 2022

Motorola v. Hytera: Why Might Government Bring a Criminal Trade Secrets Case After a Successful Civil One?

A federal indictment was unsealed yesterday in the Northern District of Illinois, charging Hytera, a Chinese maker of radio transceivers and radio systems, with conspiracy to commit theft of trade secrets under the Economic Espionage Act. The indictment alleges that Hytera conspired with former employees of Motorola, who were working for Motorola Malaysia at the time, to steal digital mobile radio (DMR) technology developed by Motorola.  The indictment brings criminal trade secrets claims under various provisions of 18 U.S.C. § 1832, including Sections 1832(a)(2) (copies, communicates, downloads, etc.), (a)(3) (possession), 1832(a)(4) (attempt), and 1832(a)(5) (conspiracy).

It is not necessarily uncommon for the government to bring a criminal case after a civil case.  Recall in the Waymo v. Uber case, the judge in the civil case actually referred the case to the US Attorney for investigation, and he did so very early in the case, a long time before the actual trial.  Sometimes the civil plaintiff can even lose or settle the civil case, and the government still brings the criminal case anyway. That happened to Anthony Levandowski in the Uber/Wayo dispute. He was indicted and convicted, even after the companies settled the civil case.  (Trump pardoned him).

But here, Motorola had a very big win in the civil case. The Illinois district court case (Judge Norgle presiding) was decided after a full jury trial. Motorola won a massive verdict of over $700M in damages, more than half of which were punitive. See Motorola Sols., Inc. v. Hytera Commc'ns Corp., 495 F. Supp. 3d 687, 695 (N.D. Ill. 2020). (This was thereafter reduced by ~ $200M).

One might think: "isn't that enough?" Why should the government bother to pursue a criminal claim now? I will not dwell here on the obvious political motive: "We think China is stealing US trade secrets and we need to make an example of them..." even if that is probably there.  I'll put that hot potato aside and instead highlight several practical reasons why the government might be getting involved after the victorious civil case.

Friday, January 21, 2022

What are the challenges in developing information around mixing-and-matching COVID-19 vaccines and therapies?

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

The FDA has now authorized three vaccines and several treatments (including both monoclonal antibodies and small-molecule drugs) for the prevention and treatment of COVID-19. But the initial evidence supporting these products’ introduction into the market did not include information about how they might work together. Nevertheless, information about mixing-and-matching COVID-19 vaccines and therapies would be highly valuable not only to physicians and their patients, who must already make decisions about what treatment options to pursue under conditions of uncertainty (if the treatments are available), but also for policymakers, who want to know what products to prioritize for investment. Why is it so difficult to obtain this information? How can policymakers encourage its development? 

Wednesday, January 12, 2022

Jessica Litman: Who Cares What Edward Rogers Thought About Trademark Law?

Professor Jessica Litman has a fascinating forthcoming book chapter on the history of the Lanham Act and the influence of Edward S. Rogers, "Edward S. Rogers, the Lanham Act, and the Common Law. " Litman tells the history of the drafting of the Lanham Act of 1946 through the lens of Edward S. Rogers, detailing how his advocacy and drafting work influenced the final statutory text. 

Readers may be surprised to learn that Litman started research on the topic as a law student in the 1980s, while writing a student note on trade dress infringement. She went into the stacks of the Columbia Law Library and started reading bound copies of legislative history. She noticed it seemed like Rogers was everywhere, from 1932 all that way up to 1946, and that the chairs of the committees were deferring to him.  That was really interesting, she thought.  But after the note was done, she kind of forgot about it.

Now, forty years later, Litman is a professor at the very institution Rogers attended, the University of Michigan. She was surprised to find no one seemed to remember Rogers had been at Michigan, even though he "earned three law degrees and was a member of the adjunct faculty for 18 years" (3). In this book chapter, Litman is making up for that, returning to the topic of Rogers and his legacy. She's found her notes from 1981. She's read everything he wrote, and all his cases, starting in 1895 all the way until his death in 1949.

The result is a remarkably personal history of Rogers' involvement in the development of trademark law, full of contemporary details and selected quotes from Rogers' own writings. Litman's chapter, which engages extensively with the secondary literature as well as the primary sources, adds a tremendous amount to this history and to the many excellent recent articles touching on this subject, including The Lost Unfair Competition Law by Christine Haight Farley, The Erie/Sears/Compco Squeeze: Erie's Effects Upon Unfair Competition and Trade Secret Law by Sharon Sandeen, In the Shadow of the Trade-Mark Cases: The 1881 Trademark Act and the Supreme Court by Zvi Rosen, Mark McKenna's book chapter, Trademark Law's Faux Federalism, and many others.

My interview with Litman is transcribed in this post. The interview significantly deepened my knowledge of the subject and I am excited to share it with readers.

Monday, December 6, 2021

How does pregnancy factor into COVID-19 innovation?

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

Pregnant people are at increased risk of severe illness from COVID-19, but they have been largely excluded from clinical trials, the process of testing vaccines’ and treatments’ safety and efficacy. They’re consequently left in a bind: there’s not great evidence about the safety and efficacy of products they can take to be safe from COVID-19. This lack of information might be part of the explanation for low vaccine uptake among pregnant people, particularly women of color. And while this lack of data isn’t particularly novel with respect to drug development, generally—we’re historically bad at generating robust safety data for pregnant people—failing to do so for COVID-19 seems to have outsized public health consequences. What’s behind this ongoing exclusion? And how should policymakers consider including pregnant people in COVID-19 clinical trials and beyond?

Friday, November 5, 2021

Molnupiravir may become the first COVID-19 pill. What took so long?

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

On October 1, the developers of the COVID-19 antiviral molnupiravir issued a press release announcing positive Phase 3 clinical trial results, with a 50% reduction in the risk of hospitalization or death. On November 4, the UK’s Medicines and Healthcare products Regulatory Agency authorized molnupiravir for use in the UK. While the results have yet to be reviewed by a scientific journal, they have generated excitement not only because of the potential lives saved but also because molnupiravir can be taken orally in tablet form, greatly reducing the difficulty and cost of administration. (Monoclonal antibodies require intravenous administration, as do the less promising treatments remdesivir and plasma therapy.) While it remains to be seen whether molnupiravir is as effective a weapon as its namesake Mjölnir (Thor’s hammer), the news so far is promising. But why, in a global pandemic where vaccines could be pushed through in record-breaking time, were new treatments like molnupiravir so much slower to find? (It’s worth noting that molnupiravir isn’t the only drug in this situation; as this post was going to press on November 5, Pfizer announced that its experimental antiviral, Paxlovid, reduced COVID-19-related hospital admissions for high-risk adults by 89%.)

In this post, we explore the role of innovation policy in molnupiravir’s development, the FDA’s role in balancing access to promising treatments with the need to generate evidence of their efficacy, questions about molnupiravir access, and the implications for antiviral innovation going forward, for COVID-19 and beyond.

Sunday, October 10, 2021

Courtney Cox on Trade Secrets and Lying

Courtney Cox, a professor at Fordham University Law School, has a very interesting trade secret law article forthcoming in George Washington Law Review called "Legitimizing Lies." The article can be downloaded on SSRN

Cox argues, in short, that trade secret law could generate an unexpected incentive for trade secret holders to "lie." The reason is that federal and state trade secret statutes require anyone who wishes to own a trade secret to take "reasonable" measures to keep that information secret, and in some instances deception—including deception effectuated by lies—may be the most reasonable way to keep something secret.  For example, companies sometimes use "deception technology" in their cybersecurity systems "to trick hackers into thinking they are getting close to critical data.” (25). Cox highlights increasing use of a cybersecurity device, affectionately called the "honeypot," which operates as a decoy computer system that can lure away would-be hackers. (24).

Cox suggests that, to the extent deception-based information security becomes the most effective option for protecting secrets in a certain industry or context, then trade secret law may require taking that deceptive act. This is because the trade secret statutes, at the federal and state level, include taking "reasonable" measures to preserve secrecy as a necessary element of a plaintiff's trade secret case. Thus, the law encourages, or at least gives its blessing, to "lying."

Monday, September 27, 2021

How would the proposed American Pandemic Preparedness Plan help address underinvestment in pandemic-related innovation?

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

Historically, the United States’ preparedness for a pandemic is like Charles Dudley Warner’s aphorism on the weather: everybody talks about it but no one ever does anything. Before COVID-19 struck, it was clear that the threat of a pandemic was real and that the world was not ready. As one of many examples, a September 2019 report from the Global Preparedness Monitoring Board (GPMB)—an expert group convened by the World Bank and WHO—concluded that “there is a very real threat of a rapidly moving, highly lethal pandemic of a respiratory pathogen killing 50 to 80 million people and wiping out nearly 5% of the world’s economy.” Perhaps the tragedy of the current crisis will provide sufficient motivation to better prepare for next time.

As a step in this direction, earlier this month the Biden administration released a twenty-seven page American Pandemic Preparedness Planwith a $65 billion price tag—to provide the United States with “broad and deep protection against biological threats, ranging from the ongoing and increasing risk of pandemic disease, to the possibility of laboratory accidents and the deliberate use of bioweapons.” These include, of course, several innovation policy commitments to encourage the development of pandemic-related tools for COVID-19 and beyond. What are those commitments? How do they work—or would have worked—for COVID-19? And what does this say about innovation policy more generally?

Friday, August 27, 2021

How does the CDC’s Advisory Committee on Immunization Practices impact innovation and access to COVID-19 vaccines?

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

In previous blog posts in this series, we have explored the roles different federal agencies, including the NIH, FDA, and CMS, play in the development and distribution of new healthcare technologies in the fight against COVID-19. But we have devoted much less attention to the CDC and its Advisory Committee on Immunization Practices (ACIP), which has a key role to play in the distribution of vaccines, including those against COVID-19. In this post, we explain the role played by ACIP, discuss several important COVID-19 vaccine decisions ACIP has been involved in, and consider what ACIP’s processes might teach policymakers more generally about innovation and access to health technologies.

Friday, July 30, 2021

What’s happening with proposals for a WTO waiver of COVID-related IP?

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

If COVID-19 were a pandemic movie, we’d be very close to the end since we’ve identified several excellent vaccines; the conventional biomedical innovation narrative often ends with the product being fully developed. But we’ve still got a long way to go with COVID-19, and the biggest challenge is getting the vaccines to billions more people (and getting them to take the vaccines, but that’s a separate topic). Only 0.3% of global doses have been administered in low-income countries, many of which are confronting severe outbreaks. A staggering 1 million infections were reported in Africa in just one month, with few vaccines in sight. By some estimates, much of the world’s population won’t be vaccinated until well into 2023. Amid pledges of sharing vaccines, perhaps the most prominent policy debate today is about waiving intellectual property rights to COVID-19 technologies, including vaccines. In this post we explain what’s being proposed, what’s happening with the waiver negotiations, and what impact these negotiations might have.

Monday, July 12, 2021

New Free Patent Casebook by Masur & Ouellette

As previously announced, I have been writing a new free patent law casebook with Prof. Jonathan Masur (Chicago Law), and we're very grateful to everyone who has provided helpful comments on the beta edition over the past year.

We are excited to be releasing the 1st edition. You can download a free PDF or purchase an at-cost color printed copy through Amazon here: https://www.patentcasebook.org/

We've tried to achieve a number of goals with this project beyond simply lowering the cost of course materials:

  • The casebook is heavily problem-focused, including problems that can be used for out-of-class assignments, in-class multiple-choice polls, and small-group activities. Some problems are drawn from real cases, while others are hypotheticals constructed to isolate and explain difficult concepts.
  • A key goal was bringing conceptual clarity to the details of modern patent practice, which means that cases are very heavily edited, some topics are presented through means other than case excerpts, and we have many diagrams and notes to help explain the points that are most likely to trip students up.
  • Finally, we have worked to place patent law in its social context, including by surfacing issues of race and gender and exploring the connections between patent law and inequality among innovators and inequality in access to innovations.

For adopting instructors, we have an accompanying slide deck (including many multiple-choice questions and figures from the patents at issue in excerpted cases) and a teacher's manual with answers to practice problems and suggestions for Q&A with students about cases. We are also happy to share a Word version of the casebook.

The casebook is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License. We are likely willing to authorize many derivative uses; please contact us to discuss.

If you have questions, suggestions, or interest in adopting the casebook, please let us know at ouellette@law.stanford.edu and jmasur@uchicago.edu.

We're delighted that patent law instructors will have multiple free course materials to choose from for the coming academic year. For those looking for free or low-cost options across different areas of IP, James Grimmelmann maintains a helpful compilation here.

Thursday, July 1, 2021

Rob Merges Guest Post: Who Gives a Hoot About Minerva? The Patent Act and the Common Law of Patents

Guest Post by Rob Merges, UC Berkeley

In the immediate, practical sense, the Minerva opinion registers like the mildest tremor on the landscape of patent law. With a few tweaks of the standard patent assignment agreement, and putting aside the potential that the Federal Circuit will bollix up the follow-through, the opinion changed very little.

But, sometimes, a ripple on the surface denotes more dramatic movement in the deep crust. So it may be with this prosaic little case of assignor estoppel. Justice Barrett’s dissent signals a potentially radical reappraisal of the many common law rules that supplement, permeate and modify the body of operational U.S. patent law. If the signals are portents, then many settled doctrines of patent law – and other fields of IP law as well – have been quietly but surely put into play.

Wednesday, June 30, 2021

Why do differences in clinical trial design make it hard to compare COVID-19 vaccines?

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

The number of COVID-19 vaccines is growing, with 18 vaccines in use around the world and many others in development. The global vaccination campaign is slowly progressing, with over 3 billion doses administered, although the percentage of doses administered in low-income countries remains at only 0.3%. But because of differences in how they were tested in clinical trials, making apples-to-apples comparisons is difficult—even just for the 3 vaccines authorized by the FDA for use in the United States. In this post, we explore the open questions that remain because of these differences in clinical trial design, the FDA’s authority to help standardize clinical trials, and what lessons can be learned for vaccine clinical trials going forward.

Friday, June 4, 2021

What Does it Mean to Exceed Authorized Access?

After years of debate and prosecutorial overreach, the Supreme Court has now narrowed the Computer Fraud and Abuse Act (CFAA). In Van Buren v. U.S., the Court ruled that obtaining information by "exced[ing] authorized access" is limited to information on the computer that one is not authorized to access at all, rather than to information simply gathered for an improper purpose.

To explain, consider the facts of Van Buren. Van Buren had rightful access to a database of DMV license plate information. He accessed that database using valid credentials, but looked up information for an improper purpose. He was convicted under the CFAA for exceeding his authorized access. I have blogged about this issue before. The broad reading that sent him to jail is a really scary interpretation of the statute, one in which many ordinary people could go to jail for innocuous use of the internet.

The Court narrowed the meaning, and held that the language of the statute: "to access a computer with authorization and to use such access to obtain or alter information in the computer that the accesser is not entitled so to obtain or alter.” cannot be read to cover the purpose of gathering the information. Instead, "entitled so to obtain" must mean entitled to obtain in the manner prior referenced, which means obtained by access to a computer with authorization. Based on this reading, Van Buren cannot be guilty because he accessed records that he was already entitled to access. But he might have been guilty if he looked at personnel files on the same computer.

The Court leaves open the question whether access to other information must be barred by code or merely policy. In the hypo above, if Van Buren bypasses a password on the computer to which he has access in order to obtain the personnel records, there's no question that such conduct would be barred. But what if the files were there for all to see if they merely looked, and it was simply policy that barred access? The court leaves that question open. The legislative history, which I discuss here, makes clear that the policy based bar was contemplated at the time of the statute, because "exceeds authorized access" was left out of some provisions of the CFAA to keep unwary employees from being ensnared: "It is not difficult to envision an employee or other individual who, while authorized to use a particular computer in one department, briefly exceeds his authorized access and peruses data belonging to the department that he is not supposed to look at. This is especially true where the department in question lacks a clear method of delineating which individuals are authorized to access certain of its data." (S. Rep. 99-472)

This brings me to my discomfort with the opinion. I'm thrilled at the outcome. The CFAA is much too broad, and this is one way to narrow the scope of it. Otherwise, it made all sorts of innocuous activity illegal. But from a textual standpoint, I've never been convinced that this is the proper reading of the words of the statute.

So long as the Court allows policy-based access restrictions (which is not crazy given the legislative history, even if it's not great policy), my view continues to be that the actual statutory interpretation part of it is not nearly as clear as the Court would have it. 

As noted above, the Court envisions two situations: 

    1. You may access the computer. You may access file A but (by policy) not file B, even though technically your access to the computer allows you to download file B. This exceeds authorized access. 

    2. You may access the computer. You may access file A, but (by policy) only for a particular purpose, even though technically your access to the computer allows you to download file A for any purpose. This does not exceed authorized access. 

For many policy reasons this is a better outcome than saying No. 2 exceeds authorized access. But the Court offers little support for the conceptual (or textual) notion that these two scenarios are distinct. There is nothing in the “entitled so to obtain” discussion that differentiates what is entitled by access once given and what is not. Both of these scenarios are types of information you could get with your access, but have no right to get under the terms of your access. 

The only difference is that as a matter of policy we don’t want to impose a purpose based limitation on that right. Even if you accept the Court’s reading of the statute wholesale, you do not get to (quoting the Court's new rule): “an individual 'exceeds authorized access' when he accesses a computer with authorization but then obtains information located in particular areas of the computer—such as files, folders, or databases—that are off limits to him.”  So long as “off-limits” is not code based, this is a common law gloss rather than a textual one. I’m fine with that, but would rather the Court say that, or alternatively limit liability for all policy based breaches.

To illustrate the point that we cannot differentiate policy limits, as I noted in this post years ago: what is to stop everyone from rewriting their agreements conditionally: "Your access to this server is expressly conditioned on your intent at the time of access. If your intent is to use the information for nefarious purposes, then your access right is revoked." Problem solved, Van Buren goes to jail. If this seems far-fetched, consider Google's terms of service at the time of the Nosal case:  "You may not use the Services and may not accept the Terms if . . . you are not of legal age to form a binding contract with Google . . . .”  That sounds like an access restriction to me. I can see everyone rewriting policy to match; but this shows the folly of it all.

As a final note, the Court's appeal to the civil provisions is unavailing – standard hacking, captcha breaking, password guessing and any number of other things that might give unauthorized access to information are illegal yet cause no damage or loss as the Court describes those provisions. Further, the Court ignores the ridiculous, “we spent money finding the leak and that’s loss” that lower courts have upheld. That type of loss would apply to a broader definition of "exceeds authorized access" as well. 

In sum, this is a good outcome even if I'm not entirely convinced it's the technically proper one. I'm good with that.

Thursday, June 3, 2021

What’s the difference between vaccine approval (BLA) and authorization (EUA)?

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

Recently, Pfizer and BioNTech and Moderna announced that they are seeking full FDA approval for their mRNA COVID-19 vaccines—filing, in FDA parlance, a Biologics License Application (BLA). Johnson & Johnson plans to file its own BLA later this year. But currently, all three vaccines are being distributed under a different FDA mechanism, the Emergency Use Authorization (EUA). What’s the difference, under the hood, between these two mechanisms? Why would these companies want to go through the BLA process? And what tools can policymakers use to make the EUA to BLA shift better?