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TL;DR TL;DR Background: Policymakers on both sides of the Atlantic are contemplating new regulations on standard-essential patents (SEPs). While the European Union (EU) is attempting to . . .
Background: Policymakers on both sides of the Atlantic are contemplating new regulations on standard-essential patents (SEPs). While the European Union (EU) is attempting to pass legislation toward that end, U.S. authorities like the Department of Commerce and U.S. Patent and Trademark Office are examining the issues and potentially contemplating their own reforms to counteract changes made by the EU.
But… These efforts would ultimately hand an easy geopolitical win to rivals like China. Not only do the expected changes risk harming U.S. and EU innovators and the standardization procedures upon which they rely, but they lend legitimacy to concerning Chinese regulatory responses that clearly and intentionally place a thumb on the scale in favor of domestic firms. The SEP ecosystem is extremely complex, and knee-jerk regulations may create a global race to the bottom that ultimately harms the very firms and consumers they purport to protect.
In April 2023, the EU published its “Proposal for a Regulation on Standard Essential Patents.” The proposal seeks to improve transparency by creating a register of SEPs (and accompanying essentiality checks), and to accelerate the diffusion of these technologies by, among other things, implementing a system of nonbinding arbitration of aggregate royalties and “fair, reasonable, and non-discriminatory” (FRAND) terms.
But while the proposal nominally applies only to European patents, its effects would be far broader. Notably, the opinions on aggregate royalties and FRAND terms would apply worldwide. European policymakers would thus rule (albeit in nonbinding fashion) on the appropriate royalties to be charged around the globe. This would further embolden foreign jurisdictions to respond in kind, often without the guardrails and independence that have traditionally served to cabin policymakers in the West.
Chinese policymakers have long considered the SEPs to be of vital strategic importance, and have taken active steps to protect Chinese interests in this space. The latest move came from the Chongqing First Intermediate People’s Court in a dispute between Chinese firm Oppo and Finland’s Nokia. In a controversial December 2023 ruling, the court limited the maximum FRAND royalties that Nokia could charge Oppo for use of Nokia’s SEPs pertaining to the 5G standard.
Unfortunately, the ruling appears obviously biased toward Chinese interests. In calculating the royalties that Nokia could charge Oppo, the court applied a sizable discount in China. It’s been reported that, in reaching its conclusion, the court defined an aggregate royalty rate for all 5G patents, and divided the proceeds by the number of patents each firm held—a widely discredited metric.
The court’s ruling has widely been seen as a protectionist move, which has elicited concern from western policymakers. It appears to set a dangerous precedent in which geopolitical considerations will begin to play an increasingly large role in the otherwise highly complex and technical field of SEP policy.
Leaving aside how China may respond, the EU’s draft regulation will likely be detrimental to innovators. The regulation would create a system of government-run essentiality checks and nonbinding royalty arbitrations. The goal would be to improve transparency and verify that patents declared “standard essential” truly qualify for that designation.
This system would, however, be both costly and difficult to operate. It would require such a large number of qualified experts to serve as evaluators and conciliators that it may prove exceedingly difficult (or impossible) to find them. The sheer volume of work required for these experts would likely be insurmountable, with the costs borne by industry players. Inventors would also be precluded from seeking out injunctions while arbitration is ongoing. Ultimately, while nonbinding, the system may lead to a de facto royalty cap that lowers innovation.
Finally, it’s unclear whether this form of coordinated information sharing and collective royalty setting may give rise to collusion at various points in the value chain. This threatens both to harm consumers and to deter firms from commercializing standardized technologies.
In short, these kinds of top-down initiatives likely fail to capture the nuances of individualized patents and standards. They may also add confusion and undermine the incentives that drive affordable innovation.
The bottom line is that the kinds of changes under consideration by both U.S. and EU policymakers may undermine innovation in the West. SEP entrepreneurs have been successful because they have been able to monetize their innovations. If authorities take steps that needlessly imbalance the negotiation process between innovators and implementers—as Chinese courts have started to do and Europe’s draft regulation may unintendedly achieve—it will harm both U.S. and EU leadership in intellectual-property-intensive industries. In turn, this would accelerate China’s goal of becoming “a cyber great power.”
For more on this issue, see the ICLE issue brief “FRAND Determinations Under the EU SEP Proposal: Discarding the Huawei Framework,” as well as the “ICLE Comments to USPTO on Issues at the Intersection of Standards and Intellectual Property.”
Popular Media The Oregon Senate earlier this month approved SB 1596, the so-called “right to repair” bill. This legislation now awaits consideration in the Oregon House, with . . .
The Oregon Senate earlier this month approved SB 1596, the so-called “right to repair” bill. This legislation now awaits consideration in the Oregon House, with a hearing of the House Committee on Business and Labor scheduled for Wednesday.
While motivated by good intentions, this legislation risks unintended consequences that could ultimately harm consumers. Lawmakers should proceed cautiously.
Read the full piece here.
Popular Media My last post provided an overview of my draft article The Cost of Justice at the Dawn of AI and explained the basic logic of Baumol’s cost disease for . . .
My last post provided an overview of my draft article The Cost of Justice at the Dawn of AI and explained the basic logic of Baumol’s cost disease for the practice of law. Just as in any other market, if the productivity of lawyers increases at a slower rate than the rest of the economy, legal services will become more expensive. And if a technology like artificial intelligence leads legal productivity to increase at a faster rate than the rest of the economy, then legal services will become cheaper.
Scholarship Summary This chapter contributes to the literature on legal transition by offering a perspective on the “attenuation policy.” The attenuation policy invites the lawmaker to . . .
This chapter contributes to the literature on legal transition by offering a perspective on the “attenuation policy.” The attenuation policy invites the lawmaker to adjust its decisions to the contingent status of the parties, which might be favorable (high benefits/low costs) or unfavorable (small benefits/high costs). The attenuation policy provides parties with insurance, with a negligible impact on efficiency. The chapter puts the attenuation policy in perspective and compares it to other transition tools.
Popular Media It has been a while since my last post on the Volokh Conspiracy. In 2021, I became associate dean at George Washington and did not . . .
It has been a while since my last post on the Volokh Conspiracy. In 2021, I became associate dean at George Washington and did not have time to write. Last year, I switched associate dean roles and my portfolio became smaller, so I was fortunate to have some time to return to scholarship and to complete several articles. I’ll begin my return to blogging by writing a series of posts offering shorter versions of the key arguments in a recently completed article that I have now submitted to law reviews, entitled The Cost of Justice at the Dawn of AI.
Scholarship Abstract Enrolling financiers is critical to new venture success. Building on the challenges of communicating novel and complex projects under Knightian uncertainty, we describe two . . .
Enrolling financiers is critical to new venture success. Building on the challenges of communicating novel and complex projects under Knightian uncertainty, we describe two approaches—the opportunity discovery path vis-à-vis the effectuation/bricolage path—entrepreneurs and financiers can use to resolve alternative sources of uncertainty sequentially rather than simultaneously.
ICLE Issue Brief Executive Summary Vaccines for the SARS-CoV-2 virus saved countless lives and are a modern science miracle. But they had risks, were not as effective as . . .
Vaccines for the SARS-CoV-2 virus saved countless lives and are a modern science miracle. But they had risks, were not as effective as originally claimed, and were effectively forced onto many people in order for them to work, attend school, or travel. There is early evidence that these and other factors may currently be contributing to heightened vaccine hesitancy, with potentially serious consequences for public health.
To better understand the extent and causes of vaccine hesitancy, we surveyed 124 physicians in Montgomery County, Pennsylvania. They reported that most patients (nearly all adults and most children and infants) took the initial COVID-19 vaccines in the winter of 2021. Take-up among adults declined over the proceeding months and was much lower by the second half of 2023 (and almost non-existent among infants). This shift in vaccine uptake was especially prevalent in the more staunchly Republican-voting areas of Montgomery County. It is noteworthy, however, that at-risk populations continue to receive vaccine boosters.
More worryingly, physicians also report an increase in patient distrust for non-COVID vaccines and a more generalized increase in concern about and distrust of public-health advice among their patients. Even some physicians are concerned about governmental public-health advice.
Future research will need to establish whether vaccine uptake has changed and, if so, how it has changed, and what this may mean for public health. If these data are replicated in larger surveys and a trend becomes identifiable, the implications for public health could be serious, indeed.
Vaccines are among the most powerful interventions in the field of public health, plausibly saving and improving more lives than anything other than good sanitation and diet. Historically, however, vaccines have typically taken years to develop. When effective vaccines were developed for COVID within a year of the pandemic’s emergence, many were surprised and awed. Amazingly and, in retrospect, incredibly, the makers of the first mRNA vaccines to be granted emergency use authorization by the U.S. Food and Drug Administration (FDA) claimed more than 90% efficacy in trials. This is much higher than the efficacy of vaccines for many other diseases, including influenza, although this level of efficacy was expected to wane over time. For all of these reasons, COVID vaccines were greeted as truly remarkable public-health interventions.
Uptake of COVID vaccines was initially very high. This was likely primarily because of the protection they afforded against a potentially deadly disease. But it was also partly because, for many, vaccination became a requirement for work, travel, and most other social interactions.
But concerns about the vaccines soon arose. While many of these purported risks were plainly false, some—most notably, the risk of myocarditis and pericarditis among the young—were supported by data. It also emerged that the vaccines were far less effective and shorter lived than originally touted. Moreover, they do not completely prevent disease transmission, although they probably reduce transmission by reducing viral loads. As the virus has mutated over time, it has generally become more virulent, but less dangerous, which also likely has informed the calculus of those considering whether to take further vaccine boosters.
Despite these concerns, state and federal authorities have recommended and, in many cases, demanded vaccination. These mandates were applied even to those who had just had COVID. This appeared illogical, given that the natural immunity provided by a disease is usually greater than the passive immunity from vaccination. This appears to be true of COVID, as well.
U.S. vaccine policy is comprehensive and promotes vaccinations for all ages. It also continues to promote COVID vaccines for everyone over six months old. But skeptics have claimed all sorts of dangers from the vaccines, and most people report their experiences are that the vaccines really only prevented death for the old, obese, or those with other co-morbidities. This has resulted in reactive vaccine hesitancy, especially in more Republican-leaning areas. We hypothesize that this is partly because many elected Republicans vocally opposed vaccine mandates and some even voted to prohibit private requirements. Such actions likely influenced opinion in these Republican-voting areas.
The aim of this research is to examine vaccine uptake and patient opinions about vaccines in Montgomery County, Pennsylvania. If, as expected, COVID-vaccine refusal and more general vaccine hesitancy has increased over the past few years, reasons for this will be discussed.
Primary physicians oversee many vaccinations and also address many questions from patients about vaccines, including about efficacy and safety. We undertook a survey of primary physicians in order to obtain information about changes in vaccine uptake, physicians’ interpretations of patients’ opinions about vaccines, and their own opinions about vaccines.
The survey was undertaken in Montgomery County, Pennsylvania, which ranges from the Northeast suburbs of Philadelphia into more rural areas. It has three members of the U.S. House of Representatives, including two Democrats (Reps. Madeleine Dean and Mary Scanlon) and one Republican (Rep. Brian Fitzpatrick).
Physicians were surveyed in the three constituencies. To assess uptake of, and opinions about, vaccines across the political divide, it made sense to find the few Republican-voting areas and compare them to the rest. The two most strongly Republican-voting of the county’s14 Pennsylvania House of Representatives districts are District 147 and District 131, both of which have 30% more registered Republican voters than Democrats. In many of the other state House districts, there are more than twice as many Democrats as Republicans registered to vote. From within the overall sample, physicians from these two Republican-leaning districts were compared to the other 12 state House districts. The tables in the appendix show all relevant political data.
The survey, titled “Vaccine Questionnaire” and republished in full below, was kept short to ensure full participation by physicians. It was undertaken for two weeks starting in mid-January 2024, with responses collected online, over the phone, or in-person.
The aim of this short survey is to find out about opinions and uptake of key vaccines in your practice. And to note whether there have been changes in either opinions or uptake of vaccines over the past few years.
Nearly everyone, most, few, almost none
COVID – positive, the same, negative about the vaccines.
Other vaccines – positive, the same, negative.
Thank you for your time.
In all, 124 physicians in Montgomery County who had been in their practice for more than four years replied in full to the survey. Rep. Dean’s constituency is the largest, and this was reflected by having the most physicians surveyed (48), compared with Fitzpatrick (37) and Scanlon (39). 19 physicians came from the two most Republican-leaning Pennsylvania House Districts.
The data we obtained are imprecise, because they are primarily based on the recall (of up to four years) of busy physicians, each of whom deal with dozens of patients. Small differences over time or between districts may well be the result of poor recall or biases due to survey design. Nevertheless, significant differences are probably reliable and based on identifiable trends.
As expected, most physicians reported very high initial uptake of the COVID vaccine among all groups, especially adults. Figure 1 represents the number of responses (Y axis) against time (2021 or 2023) and vaccine-recipient type (adult, child, infant). As the chart demonstrates, most physicians reported nearly every adult receiving a vaccine when first offered (a few may have had medical exemptions to vaccinations).
As noted above, when the mRNA COVID vaccines were first rolled out in late 2020 and early 2021, they were touted as more than 90% effective and that they would (or, at least, might) reduce transmission. Vaccines were also required for many jobs and for travel, etc. By late 2023, when the latest booster was made available, fewer adults were taking it, as well as far fewer children and almost no infants.
Perhaps this can be explained by a greater appreciation that the vaccines were less effective than originally touted, did not appreciably reduce transmission, were no longer required for jobs or travel, and that the side effects more widely explained. Additionally, the disease itself changed, becoming more contagious, but less deadly (though the long-term trajectory remains indeterminant). By lowering viral loads, vaccines probably lowered transmission, but many vaccinated individuals still got the disease. Many patients may also regard the side effects of vaccination—such as a sore arm and the possibility of feeling bad for a day or two—as not worthwhile, given that the disease itself appears little worse than a bad cold. Several physicians mentioned this as among the plausible reasons for declining uptake.
There was very little difference across the three U.S. House districts. While uptake was marginally lower in the Republican Rep. Fitzpatrick’s district, the difference was not statistically significant. In the two most Republican-leaning Pennsylvania House districts, however, there was a notable difference, as can be seen in Figure 2 and Figure 3. Initial uptake was not as great in these two districts, and it is almost non-existent for the most recent booster. This is noteworthy, given that Montgomery County follows Centers for Disease Control and Prevention (CDC) advice that everyone over six months old should receive the latest booster. The vast majority of these districts’ patients are ignoring CDC advice.
COVID is one disease among many. Other diseases that require vaccinations obviously have not disappeared. Question 4 sought to gather information about the uptake of these other vaccines over the same period (early 2021 to late 2023). Here, the data are significant, as demonstrated in Figure 4. Not one physician reported an increase in vaccine uptake for these other diseases. While approximately a third reported no change, fully two-thirds (slightly more in the Republican areas) have seen a decrease in vaccination uptake.
This is a very broad measure and far more detailed surveys are required to understand exactly which vaccines are being missed—i.e., whether it is the annual (and not particularly effective) flu vaccines, or the far more important and less-frequent (often a one-off in childhood) vaccines for diseases such as measles, polio, or tuberculosis. The data below also do not show by how much vaccine rates are falling.
Nevertheless, that rates are falling is potentially worrying and deserving of attention.
The latter questions in the survey refer to opinions about vaccines and, where quantifiable, how they have changed, as well as specific comments made by patients (and the parents of patients) and physicians about vaccines. These responses do not rise much above anecdotes, but they may provide some insight into patient and physician concerns. These comments could also help to design more detailed surveys in the future.
A large NIH survey about vaccination opinions among 737 physicians was undertaken in May 2021, when COVID vaccines were taken in vast numbers. The summary findings were that “10.1% of primary care physicians do not agree that, in general, vaccines are safe, 9.3% do not agree they are effective, and 8.3% do not agree they are important.” Evidently, the vast majority of physicians accepted their safety, efficacy, and importance, but it is both interesting and relevant that a small minority did not. One reason reported was that the pharmaceutical industry is not widely trusted and that some vaccinations, such as for flu, are often not that effective.
To ensure rapid distribution of COVID vaccines, pharmaceutical producers were given (temporary) immunity from liability related to vaccine-induced harm, which probably fueled some additional skepticism (a point physicians said a few patients made when refusing COVID vaccines). This is obviously a tricky area, as the manufacturers might not have agreed to sell the vaccines in the United States without such protections.
By mid-2023, federal vaccine mandates as a requirement for federal jobs and international travel had been removed. It is therefore not that surprising that the uptake of COVID vaccine boosters collapsed among infants and children, and fell markedly amongst adults. One comment made by a few physicians was that uptake was close to zero, as well, for adults under 40, while being nearly universal among adults over 70, or with co-morbidities. This likely demonstrates that those most at-risk were, indeed, reading the scientific situation correctly and taking the vaccine.
It is important not to overinterpret these results. The data could be the result of faulty recollections by busy physicians. Even if entirely accurate, they may reflect a temporary shift, rather than an actual trend in increased vaccine resistance. But these data are worrying if they are sustained and reflective more broadly than in one county in Pennsylvania.
The development of COVID vaccines was a truly remarkable phenomenon. Within one year of the pandemic’s start, pharmaceutical companies had developed multiple vaccines, while the previous record for the fastest vaccine developed (for mumps) took four and half years. These vaccines saved hundreds of thousands of lives, especially among the old and those with comorbidities who were most at risk from severe COVID.
But the vaccines were oversold, were not as effective as first touted, did not fully prevent transmission and, like most vaccines, posed some risks. By making them mandatory for jobs and travel, people who were disinclined to take them appear to have become more hostile to vaccines in general. The exact reasons for the downturn in COVID vaccination are myriad. Some are due to vaccine failings, some to inappropriate political demands, but some are related to the disease changing to a more virulent but less harmful form, making vaccination less attractive.
Further research should establish whether the results in this survey are replicated over time and in larger groups. More importantly, there is a need to establish whether vaccine hesitancy applies across all vaccines or whether it is limited to COVID and seasonal vaccines with weak efficacy (such as influenza).
Data from most recent U.S. Census and election for Montgomery County, Pennsylvania.
Data for the two Republican-leaning Pennsylvania House districts.
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Scholarship Abstract While modern mathematical models of settlement bargaining in litigation generally seek to identify perfect Bayesian Nash equilibria, previous computational models have lacked game theoretic . . .
While modern mathematical models of settlement bargaining in litigation generally seek to identify perfect Bayesian Nash equilibria, previous computational models have lacked game theoretic foundations. This article illustrates how computational game theory can complement analytical models. It identifies equilibria by applying linear programming techniques to a discretized version of a cutting-edge model of settlement bargaining. This approach makes it straightforward to alter some assumptions in the model, including that the evidence about which the parties receive signals is irrelevant to the merits and that the party with a stronger case on the merits also has better information. The computational model can also toggle easily to explore cases involving liability rather than damages and can incorporate risk aversion. A drawback of the computational model is that bargaining games may have many equilibria, complicating assessments of whether changes in equilibria associated with parameter variations are causal.
Read at SSRN.
TOTM Ahalf-dozen lawsuits have been filed to date challenging the digital-discrimination rules recently approved by the Federal Communications Commission (FCC). These cases were consolidated earlier this month and will now . . .
Ahalf-dozen lawsuits have been filed to date challenging the digital-discrimination rules recently approved by the Federal Communications Commission (FCC). These cases were consolidated earlier this month and will now be heard by the 8th U.S. Circuit Court of Appeals.