Regulatory

Ways to Lose Our Virtual Platforms: From TikTok to Parler

January 31, 2021
Cyber Security, Data Privacy, Regulatory

Mengmeng Du, MJLST Staffer

Many Americans bid farewell to the somewhat rough 2020 but found the beginning of 2021 rather shocking. After President Trump’s followers stormed the Capitol Building on January 6, 2021, major U.S. social media, including Twitter, Facebook, Instagram, and Snapchat, moved fast to block the nation’s president on their platforms. While everybody was still in shock, a second wave hit. Apple’s iOS App stores, Google’s Android Play stores, Amazon Web Services, and other service providers decided to remove Parler, an app used by Trump supporters in the riot and mostly favored by conservatives. Finding himself virtually homeless, President Trump relocated to TikTok, a Chinese owned short-video sharing app   relentlessly sought to ban ever since July 2020. Ironically but not unexpected, TikTok banned President Trump before he could even ban TikTok.

Dating back to June 2020, the fight between TikTok and President Trump germinated when the app’s Chinese parent company ByteDance was accused of discreetly accessing the clipboard content on their users’ iOS devices. Although the company argued that the accused technical feature was set up as an “anti-spam” measure and would be immediately stopped, the Trump administration signed Executive Order 13942 on August 6, 2020, citing national security concerns to ban the app in five stages. TikTok responded swiftly , the District Court for the District of Columbia issued a preliminary injunction on September 27, 2020. At the same while, knowing that the root of problem lies in its “Chinese nationality,” ByteDance desperately sought acquisition by U.S. corporations to make TikTok US-owned to dodge the ruthless banishment, even willing to give up billions of dollars and, worse, its future in the U.S. market. The sale soon drew qualified bidders including Microsoft, Oracle, and Walmart, but has not advanced far since September due to the pressure coming from both Washington and Beijing.

TikTok, in the same Executive Order was another Chinese app called WeChat. If banning TikTok means that American teens will lose their favorite virtual platform for life-sharing amid the pandemic, blocking WeChat means much more. It heavily burdens one particular minority group––hundreds and thousands of Chinese Americans and Chinese citizens in America who use WeChat. This group fear losing connection with families and becoming disengaged from the social networks they have built once the vital social platform disappears. For more insight, this is a blog post that talks about the impact of the WeChat ban on Chinese Students studying in the United States.

In response to the WeChat ban, several Chinese American lawyers led the creation of U.S. WeChat Users Alliance. Supported by thousands of U.S. WeChat users, the Alliance is a non-profit organization independent of Tencent, the owner of WeChat, and was formed on August 8, 2020 to advocate for all that are affected by the ban. Subsequently, the Alliance brought suit in the United States District Court for the Northern District of California against the Trump administration and received its first victory in court on September 20, 2020 as Judge Laurel Beeler issued a preliminary injunction against Trump’s executive order.

Law is powerful. Article Two of the United States Constitution vested the broad executive power in the president of this country to discretionally determine how to enforce the law via issuance of executive orders. Therefore, President Trump was able to hunt a cause that seemed satisfying to him and banned TikTok and WeChat for their Chinese “nationality.” Likewise, the First Amendment of the Constitution and section 230 of the Communication Decency Act empowers private Internet forum providers to screen and block offensive material. Thus, TikTok, following its peers, finds its legal justification to ban President Trump and Apple can keep Parler out of reach from Trump supporters. But power can corrupt. It is true that TikTok and WeChat are owned by Chinese companies, but an app, a technology, does not take on nationality from its ownership. What happened on January 6, 2021 in the Capitol Building was a shame but does not justify removal of Parler. Admittedly, regulations and even censorship on private virtual platforms are necessary for national security and other public interest purposes. But the solution shouldn’t be simply making platforms unavailable.

As a Chinese student studying in the United States, I personally felt the of the WeChat ban. I feel fortunate that the judicial check the U.S. legal system puts on the executive power saved WeChat this time, but I do fear for the of internet forum regulation.

 

Becoming “[COVID]aware” of the Debate Around Contact Tracing Apps

December 6, 2020
COVID-19, Data Privacy, Public Health, Regulatory

Ellie Soskin, MJLST Staffer

As COVID-19 cases continue to surge, states have ramped up containment efforts in the form of mask mandates, business closures, and other public health interventions. Contact tracing is a vital part of those efforts: health officials identify those who have been in close contact with individuals diagnosed with COVID-19 and alert them of their potential exposure to the virus, while withholding identifying information. But traditional contact tracing for a true global pandemic requires a lot of resources. Accordingly, a number of regions have looked to smartphone-based exposure notification technology as an innovative way to both supplement and automate containment efforts.

Minnesota is one of the latest states to adopt this approach: on November 23rd, the state released “COVIDaware” a phone application designed to notify individuals if they’ve been exposed to someone diagnosed with COVID-19. Minnesota’s application utilizes a notification technology developed jointly by Apple and Google, joining sixteen other states and the District of Columbia, with more expected to roll out in the coming weeks. The nature of the technology raises a number of complex concerns over data protection and privacy. Additionally, these apps are more effective the more people use them and lingering questions remain as to compliance and the feasibility of mandating use.

The joint Apple/Google notification software used in Minnesota is designed with an emphasis on privacy. The software uses anonymous identifying numbers (“keys”) that change rapidly, does not solicit identifying information, does not provide access to GPS data, and only stores data locally on each user’s phone, rather than in a server. The keys are exchanged via localized Bluetooth connection operating in the background. It can also be turned off and relies wholly on self-reports. For Minnesota, accurate reports come in the form of state-issued verification codes provided with positive test results. The COVIDaware app checks daily to see if any keys contacted within the last 14 days have recorded positive test results. Minnesota policymakers, likely aware of the intense privacy concerns triggered by contact tracing apps, have emphasized the minimal data collection required by COVIDaware.

The data privacy regulatory scheme in the United States is incredibly complex, as there is no single unified federal data protection policy. Instead, the sphere is dominated by individual states. Federal law enters into the picture primarily via the Health Insurance Portability and Accountability Act (“HIPAA”), which does not apply to patients voluntarily giving health information to third parties. In response to concerns over contact tracing app data, multiple data privacy bills were introduced to Congress, but even the bipartisan “Exposure Notification Privacy Act” remains unpassed.

Given the decentralized nature of the internet, applications tend to be designed to comply with all 50 states’ policies. However, in this case, state-created contact tracing applications are designed for local use, so from a practical perspective states may only have to worry about compliance with neighboring states’ data privacy acts. The Minnesota Government Data Practices Act passed in 1974 is the only substantive Minnesota state statute affecting data collection and neighboring states’ (Wisconsin, Iowa, North Dakota, and South Dakota) laws have similarly limited or dated schemes. In this specific case, the privacy-focused Apple/Google API that forms the backbone of COVIDaware and the design of the app itself, described briefly above, likely keep it complaint. In fact, some states have expressed frustration at the degree of individual privacy afforded by the Apple/Google API, saying it can stymie coordinated public health efforts.

Of course, one solution to even minimal data privacy concerns is simply not to use the application. But the efficacy of contact tracing apps depends entirely on whether people actually download and use them. Some countries have opted for degrees of mandatory use: China has mandated adoption of its contact tracing app for every citizen, utilizing unprecedented government surveillance to flag individuals potentially exposed, and India has made employers responsible for ensuring every employee download its government-developed contact tracing app. While a similar employer-based approach is not legally impossible in the United States, any such mandate would be legally complex, and anyone following the controversy over mask mandates should instinctively recognize that a mandated government tracking app is a hard sell (to put it lightly).

But mandates may not even be necessary. Experts have emphasized that universal compliance isn’t necessary for an app to be effective: every user helps. Germany and Ireland have not mandated use, but have download rates of 20% and 37% respectively. Some have proposed small, community-focused launches of tracking apps, similar to successful start-ups. With proper marketing and transparency, states need not even enter the sticky legal mess that is mandating compliance.

Virtually every policy response to COVID in the United States has been met with heated controversy and tracking apps are no different. As these apps are in their infancy, legal challenges have yet to emerge, but the area in general is something of a minefield. The limited and voluntary nature of Minnesota’s COVIDaware app likely places it out of the realm of significant legal challenges and significant data privacy concerns, at least for the moment. The general conversation around contact tracing apps is a much larger one, however, and has helped put data privacy and end user control into the global conversation.

 

 

 

 

 

Extracting Favors: Fossil-Fuel Companies are Using the Pandemic to Lobby for Regulatory Rollbacks and Financial Bailouts

October 17, 2020
Climate Change, COVID-19, Energy Law, Environment, Environmental Law, Regulatory

Christopher Cerny, MJLST Staffer

In the waning months of World War II, Winston Churchill is quoted, perhaps apocryphally, as saying, “[n]ever let a good crisis go to waste.” It seems fossil-fuel companies have taken these words to heart. While in the midst of one of the greatest crises of modern times, oil, gas, and coal companies are facing tremendous economic uncertainty, not only from the precipitous drop in demand for gasoline and electricity, but also from the rise of market share held by renewable energy. In response, industry trade groups and the corporations they represent are engaged in an aggressive lobbying campaign aimed at procuring financial bailouts and regulatory rollbacks. The federal government and some states seem inclined to provide assistance, but with the aforementioned rise of renewable energy, many see the writing on the wall for some parts of the fossil-fuel industry.

The ongoing COVID-19 pandemic continues to inflict immeasurable havoc on a global scale. The virus and the mitigation efforts designed to curb its spread have dramatically changed the way humankind interacts with each other and the world around us. In the United States, nearly all states at one time or another implemented mandatory shelter-at-home orders to restrict movement and prevent the further spread of the novel coronavirus. These orders have, in many ways, completely restructured society and the economy, with perhaps no sector being more impacted than transportation. At the peak of the virus in the United States, air travel was down 96% and, in April 2020, passenger road travel was down 77% from 2019. Similarly, the pandemic has altered America’s energy consumption. For example, the Midcontinent Independent System Operator reports a decrease in daily weekday demand in March and April of up to 13% and a national average decline of as much as 7% for the same time frame. A secondary impact of these market disruptions is on the fossil-fuel industry. The decrease in electricity demand has further diminished the already declining coal market, while the fall off in travel and transportation has radically impacted oil prices.

On April 20, a barrel of oil traded for a loss for the first time ever when demand fell so low that the cost storing oil exceeded its sale price. While the price of a barrel of oil, the world’s most traded commodity, has since improved, as of October 1st, the U.S. stock index for domestic oil companies remains down 57% in 2020. Similarly, coal consumption in the United States is projected to decline 23% this year. Natural gas remains resilient, with U.S. demand only dropping 2.8% between January and May of 2020. However, much of natural gas’s buoyancy comes at the expense of lower prices. These numbers are dire, especially for coal and oil, two domestic industries already on the decline due to the rise in renewable energy.

Fossil-fuel companies have gone on the offensive. The oil and gas industry is responding to these calamitous figures and grim financials by lobbying state and federal lawmakers for financial bailouts and the relaxation of environmental regulations. The California Independent Petroleum Association, an oil and gas trade group, requested an extension for compliance with an idle well testing plan that would push 100% program compliance from 2025 to 2029. Further, the trade group asked California to scale back on Gov. Gavin Newsom’s plan to increase the staff of the California Energy Management Division, the state agency charged with oversight of oil and gas drilling. In Texas, the Blue Ribbon Task Force on Oil Economic Recovery, created at the behest of the state oil and gas regulatory body and composed of representatives and leaders of Texas’s oil and gas trade groups, recommended the suspension of particular environmental testing and extensions for environmental reporting to the state agency. The Louisiana Oil and Gas Association asked Louisiana Gov. John Bel Edwards to suspend the state’s collection of severance taxes.

On the national stage, the Independent Petroleum Association of America asked the Chairman of the Federal Reserve to support changes to the Main Street Lending Program, a part of the CARES Act, to expand the eligibility requirements to include many oil and gas producers. The American Fuel and Petrochemical Manufacturers, a refiners trade association, called on the Trump administration and the Environmental Protection Agency (EPA) to waive biofuel policies that mandate the blending of renewable corn-derived ethanol in petroleum refining. The American Petroleum Institute also reached out to the Trump administration seeking the waiver of record keeping and training compliance.

Not to be left behind, the coal industry ramped up its lobbying as well. In an opinion piece, the CEO of America’s Power, a coal trade group extolled the virtues of the fleet of coal power plants and their necessity in the recovery from the COVID-19 pandemic. The National Mining Congress, the coal industry’s lobbying arm, sent a letter to the Trump administration and Congressional leaders asking for an end to the industry’s requirements to pay into funds for black lung disease and polluted mine clean-up

These lobbying efforts are being met with varied levels of success. In a move that garnered criticism from the Government Accountability Office, the Department of the Interior through the Bureau of Land Management cut royalties on oil and gas wells leased by the federal government, saving the industry $4.5 million. The EPA scaled back enforcement of pollution rules, instead relying on companies to monitor themselves. The Governors of Texas, Utah, Oklahoma, and Wyoming sent a letter asking the EPA to waive the biofuel blending regulations in support of the refiners trade group. In September, the EPA denied the request. The Governor of Louisiana agreed to delay the collection of the severance tax, a revenue source for the state that can normally bring in $40 million per month. The Louisiana state legislature later voted to reduce the severance tax on oil and gas from 12.5% to 8.5% for the next eight years. The EPA finalized a rule that it is not “appropriate and necessary” to regulate certain hazardous air pollutants, including mercury, emitted from coil and oil fired power plants.

It is difficult to discern what impact these industry efforts and resulting government actions will have in the long term. The financial measures may have propped up an industry that otherwise would have suffered permanent damage and bankruptcies without the influx of relief and capital. However, environmental groups are more concerned with the regulatory rollbacks. For example, after the EPA chose to allow companies to self-monitor pollution, there was a year-over-year decline of 40% in air emissions tests at industrial facilities and over 16,500 facilities did not submit required water quality reports. The ramifications of the state and federal acquiescence to the fossil-fuel industry’s requested regulatory non-compliance may end up costing the American tax payers millions of dollars, causing irreparable immediate harm to the environment, and delaying critical action needed to mitigate anthropogenic climate change.

Zoinks! Can the FTC Unmask Advertisements Disguised by Social Media Influencers?

February 25, 2020
FDA, Regulatory, Social Media

Jennifer Satterfield, MJLST Staffer

Social media sites like Instagram and YouTube are filled with people known as “influencers.” Influencers are people with a following on social media that use their online fame to promote products and services of a brand. But, with all that power comes great responsibility, and influencers, as a whole, are not being responsible. One huge example of irresponsible influencer activity is the epic failure and fraudulent music festival known as Fyre Festival. Although Fyre Festival promised a luxury, VIP experience on a remote Bahamian island, it was a true nightmare where “attendees were stranded with half-built huts to sleep in and cold cheese sandwiches to eat.” The most prominent legal action was against Fyre’s founders and organizers, Billy McFarland and Ja Rule, including a six-year criminal sentence for wire fraud against McFarland. Nonetheless, a class action lawsuit also targeted the influencers. According to the lawsuit, the influencers did not comply with Federal Trade Commission (“FTC”) guidelines and disclose they were being paid to advertise the festival. Instead, “influencers gave the impression that the guest list was full of the Social Elite and other celebrities.” Yet, the blowback against influencers since the Fyre Festival fiasco appears to be minimal.

According to a Mediakix report, “[i]n one year, a top celebrity will post an average of 58 sponsored posts and only 3 may be FTC compliant.” The endorsement guidelines specify that if there is a “material connection” between the influencer and the seller of an advertised product, this connection must be fully disclosed. The FTC even created a nifty guide for influencers to ensure compliance. While disclosure is a small burden and there are several resources informing influencers of their duty to disclose, these guidelines are still largely ignored.

Evens so, the FTC has sent several warning letters to individual influencers over the years, which indicates it is monitoring top influencers’ posts. However, a mere letter is not doing much to stop the ongoing, flippant, and ignorant disregard toward the FTC guidelines. Besides the letters, the FTC rarely takes action against individual influencers. Instead, if the FTC goes after a bad actor, “it’s usually a brand that[] [has] failed to issue firm disclosure guidelines to paid influencers.” Consequently, even though it appears as if the FTC is cracking down on influencers, it is really only going after the companies. Without actual penalties, it is no wonder most influencers are either unaware of the FTC guidelines or continue to blatantly ignore them.

Considering this problem, there is a question of what the FTC can really do about it. One solution is for the FTC to dig in and actually enforce its guidelines against influencers like it did in 2017 with CSGO Lotto and two individual influencers, Trevor Martin and Thomas Cassell. CSGO Lotto was a website in which users could gamble virtual items called “skins” from the game Counter-Strike: Global Offensive. According to the FTC’s complaint, Martin and Thomas endorsed CSGO Lotto but failed to disclose they were both the owners and officers of the company. CSGO Lotto also paid other influencers to promote the website. The complaint notes that numerous YouTube videos by these influencers either failed to include a sponsorship disclosure in the videos or inconspicuously placed such disclosures “below the fold” in the description box. While the CSGO Lotto action was a huge scandal in the video game industry, it was not widely publicized to the general population. Moreover, Martin and Cassell got away with a mere slap on the wrist—“[t]he [FTC] order settling the charges requires Martin and Cassell to clearly and conspicuously disclose any material connections with an endorser or between an endorser and any promoted product or service.” Thus, it was not enough to compel other influencers into compliance. Instead, if the FTC started enforcement actions against big-name influencers, other influencers may also fear retribution and comply.

On the other hand, the FTC could continue its enforcement against the companies themselves, but this time with more teeth. Currently, the FTC is preparing to take further steps to ensure consumer protection in the world of social media influencers. Recently, FTC Commissioner Rohit Chopra acknowledged in a public statement that “it is not clear whether our actions are deterring misconduct in the marketplace, due to the limited sanctions we have pursued.” Although Chopra is not interested in pursuing small influencers, but rather the advertisers that pay them, it is possible that enforcement against the companies will cause influencers to comply as well.

Accordingly, Chopra’s next steps include: (1) “[d]eveloping requirements for technology platforms (e.g. Instagram, YouTube, and TikTok) that facilitate and either directly or indirectly profit from influencer marketing;” (2) “[c]odifying elements of the existing endorsement guides into formal rules so that violators can be liable for civil penalties under Section 5(m)(1)(A) and liable for damages under Section 19; 7;” and (3) “[s]pecifying the requirements that companies must adhere to in their contractual arrangements with influencers, including through sample terms that companies can include in contracts.” By pushing some of the enforcement duties onto social media platforms themselves, the FTC gains more monitoring and enforcement capabilities. Furthermore, codifying the guidelines into formal rules gives the FTC teeth to impose civil penalties and creates tangible consequences for those who previously ignored the guidelines. Finally, by actually requiring companies to adhere to these rules via their contract with influencers, influencers will be compelled to follow the guidelines as well. Therefore, under these next steps, paid advertising disclosures on social media can become commonplace. But only time will really tell if the FTC will achieve these steps.

Electric Scooter Regulations in Winter: Why the “Brake” in Service?

February 17, 2020
Public Safety, Regulatory, Transportation

Warren Cormack, MJLST Staffer

In the summer of 2018, the city of Minneapolis began a pilot project to introduce 600 electric rental scooters, primarily to the downtown area. The city approved operations for Jump, Lyft, Spin, and Lime in 2019. Two thousand scooters were slated to hit the Minneapolis streets, but the companies deployed less than one thousand to Minneapolis for much of the 2019 season. Still, half a year ago, ride-share scooters from the 2019 authorization could be found all over the streets of Minneapolis and users “racked up about 225,000 rides.”

Minneapolis is a city with a strong winter biking tradition. Yet in February, with winter in full swing, electric scooters are nowhere to be seen. What happened?

The short answer is that Minneapolis’ second pilot program for electric scooters ended in November 2019. When we dig deeper, though, some interesting dynamics affect the use of electric scooters in winter.

Though scooter companies initially targeted warm-weather cities, now colder cities like Milwaukee,  Boston, and Minneapolis face challenges associated with operating electric scooters in colder weather. For example, when snow emergencies hit, cities may have to ask companies to remove scooters from the roads.

An important concern for cities is safety. This was a major reason why Minneapolis ended the 2019 scooter pilot in late November. Minneapolis scooter companies agreed that 6 to 10 inches of snow was too much to operate safely. Scooter companies are already being sued for the injuries that they cause, and the odds that someone might injure themselves while riding on snowy ground is higher than when the streets are clear. Still, scooter companies have shown a desire to keep their scooters running unless a winter storm hits.

Though Denver’s weather is not as cold as Minneapolis, it does snow there. Denver’s scooters arrived in May 2018 and the city regulated their numbers within two months. Still, the city did not regulate the months within which the scooters would be available for use. A spokeswoman for Denver Public Works reportedly said: “I think riders are going to have to make their own choices if they want to ride an electric scooter in the winter months.” Denver’s comparable warmth may affect how the city balances safety concerns.

The cold weather is not only an issue for riders. “Scooter companies are still learning how their vehicles perform in various weather conditions and from regular use.” Scooters generally either operate on bike lanes or sidewalks. In either location, the small wheels and limited batteries of scooters can negatively impact their winter-weather suitability. The major scooter models currently in use have minimum operating temperatures of fourteen degrees Fahrenheit. Possibly in response to the limits of popular scooters, Bird (one of the major scooter companies) designed a scooter with more battery and pronounced tire treads. Tier is another company developing scooters that can handle cold weather. The effects of winter may be over-hyped, however. According to a scooter expert, scooters may become slower during the winter, but the cold does not damage their battery.

A final winter issue is simply a lack of riders. Even for European scooter companies that operate throughout the year, about half of the riders stop riding during the winter. Minneapolis data also reflect a roughly 50% decrease from summer’s peak to November. College riders leave home for winter break, prompting companies to reduce the number of deployed scooters. A lack of winter riders caused Lime to ramp down operations in Milwaukee. Though riders in relatively snowy cities like Denver have found that people use scooters through the winter, scooter companies facing higher maintenance costs and lower ridership may be wise to reduce their fleet size.

Scooters may leave for the winter due to safety, maintenance, or lower ridership. This may be caused by city policy or by the companies themselves. If the companies continue to make their scooters more capable of enduring the winter, cities may begin to find themselves at odds with electric scooter companies’ desire to stay open for business.

E-Bikes: Protections, Safety and Liability on the Road

February 7, 2020
New Technology, Public Safety, Regulatory

Alex Wolf, MJLST Staffer

E-bikes, or electronic bikes, are kind of a hybrid between an electric scooter and a regular bicycle. In appearance, they’re no different than your normal two-wheeled bike, but e-bikes have a motor that lets the rider reach brisk speeds without much pedaling effort. There are two classes of motors, hub motors and mid-drive motors. Hub motors are installed in the hub gear and mid-drive motors are installed between the pedals at the bottom bracket of the bike. The usual advice for e-bike newbies is to start with a hub motor; it is simpler to install and it has fewer working parts (creating less risk of a slip/accident and lasting longer). However, the mid-drives have now outpaced the hubs in popularity; for biking enthusiasts, the gear shifts feel more natural and the extra power is great for terrain or mountain biking.

E-bikes are on the streets, so states and localities need to decide how to regulate them. Wisconsin Governor Tony Evers recently signed a law that incorporates e-bikes into an existing law governing safety regulations for bicycles. The law creates a three-tiered “e-bike class” system, based on the maximum speed the e-bike can reach with its motor. Although e-bike riders don’t need any license or permit to operate, riders must be 16 years or older to ride e-bikes that can reach 28 mph. These regulations are similar to those previously enacted in Illinois and Michigan.

Like electronic scooters, e-bikes pose more safety issues than non-mechanized transportation. Reliable data is very hard to find (as e-bikes are new on the scene), but news reports indicate that older bikers are getting injured at higher rates than others. New York Governor Andrew Cuomo vetoed a bill that would’ve reauthorized electronic scooters and e-bikes on paths and bike lanes. He said that he believed the bill lacked important safety requirements, namely helmet use. However, Governor Phil Murphy of neighboring New Jersey eagerly signed a bill permitting scooters and e-bikes, hoping that “By bringing our motor vehicle laws into the 21st century, we will enable the rollout of e-bikes in Jersey City’s bike share program and expand the transportation options available to New Jerseyans.”

What can we expect for e-bikes in the near future? The annual e-bike market has surpassed $1.5 billion, with recognizable brands like BMW and Harley-Davidson jumping headfirst into this exciting commercial domain. We might soon see the statistic of the number of Americans who bike to work, currently about 1%, tick upwards. Minneapolis’ Nice Ride is leading the way for e-bikes in Minnesota, working with Lyft to bring 2,000 e-bikes to the city sometime in 2020. Minnesota law does not require either a license or a special motorized bicycle permit, but it does have other safety precautions like headlight use and an adult riding along if a minor is operating. So, if you’ve got the means, let it ride!

Impact of China’s Generics Push on Innovator Drug Companies

November 12, 2018
Food and Drug Law, Intellectual Property, Regulatory

Sherrie Holdman, MJLST Staffer

With a population of 1.42 billion, China presents a large market for both innovator manufacturer and generic drug companies.  Currently, about 95% of marketed drugs are sold by generics. However, many patients in China opt to use more expensive, imported, brand-name drugs.  In an effort to address this problem, China’s State Council has announced its “Opinions Concerning Reforms of Policies to Improve the Supply and Utilization of Generics” to encourage the people of China to use generic drugs early this year.  As a regulatory document, the Opinion shed light on the future direction of China’s generic market.

The Opinion identifies three important suggestions to guide implementation. The first suggestion is to promote research and development of generic drugs in China.  The Opinion proposes a drug list to be compiled that identifies drugs for which generic counterparts don’t exist yet. The Opinion also encourages the government to develop key technologies in manufacturing generics.  The second suggestion aims to improve the quality and efficacy of generic drugs. Generics will only be approved if their quality and efficacy are equivalent to the original drugs.  To facilitate this goal, the State Council proposes speeding up the conformity assessment of quality and efficacy of generic drugs and improving the quality management of generic drugs.  The third suggestion is to provide policy incentives for generics development, including implementation of a tax policy for generic manufacturers. Under this policy, a generic manufacturer, once designated as a “high technology enterprise,” will have a preferential tax rate of 15%, compared to the 25% rate for other companies.  In order to be a “high technology enterprise,” the generic manufacturer will need to meet certain qualifications. Meanwhile, the Opinion encourages patentees to voluntarily grant compulsory licenses to Chinese generic manufacturers when there is “a serious threat to the public health.”  However, despite its long existence in Chinese patent law and regulation, the compulsory licenses are historically rare in practice, partly because of the difficulty in defining what constitutes a “serious threat to the public health.”    

In order to balance the interests of innovator and generic drug companies, the Opinion provides recommendations for strengthening the enforcement of intellectual property rights.  For example, the Opinion proposes establishing an “early warning patent system” to prevent generic manufacturers from infringing on valid patents and thus mitigating the risk of infringement.  Moreover, the State Council proposed to enhance accessibility of innovative drugs, especially imported oncology drugs, by applying no tariffs on imported new drugs. A five-year patent extension for new drugs was also proposed to enhance the intellectual property protection of innovator drugs.

Following the announcements promulgated in the Opinion, on April 25, 2018, China Food and Drug Administration (CFDA) released its “Public Comment Draft of Pharmaceutical Data Exclusivity Implementing Rules (provisional).” The Draft proposes that “innovative new drugs” will enjoy six years of data protection and “innovative therapeutic biologics” will enjoy 12 years of data protection.  By proposing data protection for new drugs, China encourages multinational corporations to include China in international multicenter clinical trials and to concurrently apply for market introduction in China.  Even if the new drug is introduced to China at a later time, the drug will still be entitled to a data protection period (e.g., from one to five years). The public comment period for the Draft was closed on May 31, 2018 and the final rule is expected soon.  

Facing China’s generics push, innovator drug makers can strengthen their IP strategy in numerous ways.  For example, companies should disclose information about the patents in the drug list in a timely manner, making the public and government aware of the patents.  Further, companies should also establish a multi-directional scheme for IP rights protection including not only patent, but also knowhow, trade secret, design, trademark and copyright.

Tesla: Can the Electric Car Company Overcome its CEO’s Erratic (and sometimes illegal) Behavior?

November 12, 2018
Corporate Ethics, Regulatory, Securities Law

Joe Hallman, MJLST Staffer 

Elon Musk, the ingenious and at times controversial CEO of Tesla, Inc., has been a fixture in the national news cycle of late with many questioning his erratic behavior. Musk has garnered negative attention recently for incidents ranging from publicly smoking marijuana to hurling wild accusations against critics on Twitter. However, Musk’s most significant faux pas in recent months was likely a tweet that resulted in him being charged with securities fraud by the Securities and Exchange Commission (“SEC”).

On August 7, 2018, Musk tweeted “Am considering taking Tesla private at $420. Funding secured.” The SEC sued Musk in federal court on September 27 for misleading investors with his tweet. Musk settled with the SEC two days later on September 29. The terms of the settlement required Musk to pay a $20 million personal fine and step down as chairman for three years, although he was allowed to remain CEO of the company. Although not charged with fraud, Tesla also settled with the SEC for $20 million.

Tesla’s stock price plummeted shortly after the SEC’s lawsuit was filed. Tesla shares were trading at about $305 prior to the lawsuit and on September 28, the day after the SEC filed suit, Tesla’s shares dropped to about $269. However, after that initial dip Tesla’s stock rebounded, eventually closing at $341.06 on November 6.

Many have questioned Tesla’s viability as a company over the years and it has been a common short sell among investors. However, considering Musk’s curious recent behavior, the stock price has been resilient. Meanwhile, on October 24, Tesla released its 2018 third-quarter earnings report showing surprise profits and positive cash flow. The earnings report is good news for shareholders who eagerly wait to see if Musk’s electric car company can eventually turn the corner and achieve a significantly higher market cap as Musk has promised.

Although Tesla seems to have been largely unaffected by the SEC’s lawsuit and other strange behavior by Musk, other top executives of publicly traded companies will likely take notice and learn from Tesla’s tumultuous past few months. Going forward, I would expect CEO’s of high-profile companies like Tesla to be careful about Twitter usage and seek to avoid negative attention in the press.

PyeongChang: The Opening Ceremony

February 16, 2018
Drones, New Technology, Regulatory

MJLST Staffer, Amber Peterson

 

The opening ceremony of the Olympics is always a big show and the 2018 Winter Olympics’ opening ceremony in PyeongChang, South Korea was no exception. Intel created a display that featured a world-record setting 1,218 drones. The display featured drone murmurations that depicted images of a snowboarder that morphed into the Olympic rings using four billion color combinations enabled by onboard LEDs. This display surpassed Intel’s previous Shooting Star drone world record which flew 500 drones simultaneously in Germany in 2016.

Intel’s Shooting Star drones are each about a foot-long, weigh eight ounces, and can fly in formation for up to 20 minutes given the limitations of current lithium-ion battery technology.

While the show is certainly impressive, from a software perspective, it is very much similar to flying a smaller, 300-drone show. The additional drones simply increase the resolution and quality of the images to create more depth. Every drone is operated from a central computer system, which tweaks things such as individual battery life and GPS signal. The drones communicate with this central computer instead of with each other. After animators draw up the show using 3D design software, each individual drone acts as an aerial pixel to fill the night sky.

The only minor tweak that Intel had to make to the design of the drone was to the rotor cages to account for the cold and windy conditions in Pyeongchang. Intel ran test flights in Finland, which has a similar climate to Pyeongchang, to make sure the drones could handle the climate.

This record for the “most unmanned aerial vehicles airborne simultaneously” may have an asterisk however, since the display was pre-recorded after a last minute logistical issue which prevented the record setting drones from flying live at the ceremony. The show that was pre-recorded last December was instead broadcast during the event.

The South Korean laws and regulations that Intel had to comply with are as follows: 1) the maximum height that a drone can fly is 492 feet and if the flights are higher than this distance, government approval is required; 2) drones can only be flown during the day unless government approval has been given; 3) drones must be operated in a range that is viewable from the naked eye; 4) certain zones are banned for drone flights; and 5) drones must always yield to manned aircraft.

Drone law has developed from the explosion of online shopping in Korea. Korean privacy laws however, are some of the strictest in the world so a vexing issue remains as to how to deal with the invasion of privacy from drones. Maintaining a balance between supporting technological advances and being cognizant of protecting safety and individual rights remains an issue that requires further debate.

Changing Families: Time for a Change in Family Law?

February 12, 2018
Family Law, Healthcare, Regulatory, Reproductive Health

MJLST Staffer, Hannah Mosby

 

Reproductive technology allows individuals to start families where it may not otherwise have been possible. These technologies range from relatively advanced procedures—those using assisted reproductive technology (or “ART,” for short)—to less invasive fertility treatments. ART encompasses procedures like in vitro fertilization—in fact, the CDC defines ART as including “all fertility treatments in which both eggs and embryos are handled” (Link to: https://www.cdc.gov/art/whatis.html)—while other kinds of reproductive assistance range from artificial insemination to self-administered fertility drugs. In a study published by the CDC, the number of ART procedures completed in 2014 in the U.S. alone was almost 170,000. As scientific knowledge grows and new procedures develop, that number will undoubtedly increase.

Individuals choosing to utilize these reproductive technologies, however, can find themselves in legal limbo when it comes to determining parentage. In instances where an individual uses a donor gamete (a sperm or an egg) to conceive, that donor could be a legal parent of the offspring produced—even if that result wasn’t intended by the any of the parties involved. For example, the 2002 version of the Uniform Parentage Act—variations of which have been adopted by many states—provides for the severance of the parental rights of a sperm donor in the event of consent by the “woman,” as well as consent or post-birth action by the “man” assuming paternal rights. If statutory conditions aren’t met, the donor could retain his parental rights over any offspring produced by the procedure. To further complicate things, the use of gendered terms makes it unclear how these statutes apply to same-sex couples. A new version of the Act was proposed in 2017 to comply with the Supreme Court’s recognition of marriage equality in Obergefell v. Hodges, but it has yet to be adopted by any state . Even murkier than the laws governing donor gametes are those governing surrogacy contracts, which some states still refuse to legally recognize. Overall, these laws create an environment where even the most intentional pregnancies can have unintended consequences when it comes to establishing legal parentage.

For further illustration, let’s revisit artificial insemination. Jane and John, a Minnesotan couple, decide to undergo an artificial insemination procedure so that Jane can become pregnant. However, they aren’t married. Pursuant to Minn. Stat. 257.56, the couple’s marriage is a necessary condition for the automatic severance of the sperm donor’s parental status—therefore, since Jane and John aren’t married, the sperm donor retains his parental rights. The statute also requires that the procedure be performed “under the supervision of a licensed physician” in order for severance to occur. If there was no doctor present, then the sperm donor—and not John—would have legal parental status over the offspring produced. The example becomes more complicated if the couple is same-sex rather than heterosexual, because the statute requires the consent of the “husband” to the procedure. Further still, if Jane lived in a different state, the sperm donor might be able to establish parental rights after the fact—even if they were initially severed—by maintaining a relationship with the child. As one can imagine, this makes the use of known donors (rather than anonymous donors) particularly complicated.

Ultimately, ART and related procedures provide opportunities for individuals to create the families they want, but could not otherwise have—an enormously impactful medical development. However, utilization of these procedures can produce legal consequences that are unforeseen—and, often, unwanted—by the parents of children born using these procedures. The state law that exists to govern these procedures is varied and lagging. In the age of marriage equality and donor gametes, such laws are highly inadequate. . . In order for society to reap the biggest benefit from these life-creating technologies, the legal world will have to play a serious game of catch-up.

 

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