The Comment on the Note “Best Practices for Establishing Georgia’s Alzheimer’s Disease Registry” of Volume 17, Issue 1

April 27, 2016
Biotechnology, Data, Ethics, Healthcare, Privacy, Public Health

Jing Han, MJLST Staffer

Alzheimer’s disease (AD), also known just Alzheimer’s, accounts for 60% to 70% of cases of dementia. It is a chronic neurodegenerative disease that usually starts slowly and gets worse over time. The cause of Alzheimer’s disease is poorly understood. No treatments could stop or reverse its progression, though some may temporarily improve symptoms. Affected people increasingly rely on others for assistance, often placing a burden on the caregiver; the pressures can include social, psychological, physical, and economic elements. It was first described by, and later named after, German psychiatrist and pathologist Alois Alzheimer in 1906. In 2015, there were approximately 48 million people worldwide with AD. In developed countries, AD is one of the most financially costly diseases. Before many states, including Georgia, South Carolina, passed legislation establishing the Registry, many private institutions across the country already had made tremendous efforts to establish their own Alzheimer’s disease registries. The country has experienced an exponential increase of people who are diagnosed with Alzheimer’s disease. More and more states have begun to have their own Alzheimer’s disease registry.

From this Note, the Registry in Georgia has emphasized from the outset, the importance of protecting the confidentiality of patent date from secondary uses. This Note explores many legal and ethical issues raised by the Registry. An Alzheimer’s disease patient’s diagnosis history, medication history, and personal lifestyle are generally confidential information, known only to the physician and patient himself. Reporting such information to the Registry, however, may lead to wider disclosure of what was previously private information and consequently may arouse constitutional concerns. It is generally known that the vast majority of public health registries in the past have focused on collection of infectious disease data, registries for non-infectious diseases, such as Alzheimer’s disease, diabetes, and cancer have been recently created. It is a delicate balance between the public interest and personal privacy. It is not a mandatory requirement to register because Alzheimer is not infectious. After all, people suffering from Alzheimer’s often face violations of their human rights, abuse and neglect, as well as widespread discrimination from the other people. When a patient is diagnosed as AD, the healthcare provider, the doctor should encourage, rather than compel patients to receive registry. Keeping all the patients’ information confidential, enacting the procedural rules to use the information and providing some incentives are good approaches to encourage more patients to join the registry.

Based on the attention to the privacy concerns under federal and state law, the Note recommend slightly broader data sharing with the Georgia Registry, such as a physician or other health care provider for the purpose of a medical evaluation or treatment of the individual; any individual or entity which provides the Registry with an order from a court of competent jurisdiction ordering the disclosure of confidential information. What’s more, the Note mentions there has the procedural rules designated to administer the registry in Georgia. The procedural rules involve clauses: who are the end-users of the registry; what type of information should be collected in the registry; how and from whom should the information be collected; and how should the information be shared or disclosed for policy planning for research purpose; how the legal representatives get authority from patient.

From this Note, we have a deep understanding of Alzheimer’s disease registry in the country through one state’s experience. The registry process has invoked many legal and moral issues. The Note compares the registry in Georgia with other states and points out the importance of protecting the confidentiality of patient data. Emphasizing the importance of protection of personal privacy could encourage more people and more states to get involved in this plan.

The Federal Government Wants Your iPhone Passcode: What Does the Law Say?

April 21, 2016
Constitutional Law, Cyber Security, Data, Law Enforcement

Tim Joyce, MJLST Staffer

Three months ago, when MJLST Editor Steven Groschen laid out the arguments for and against a proposed New York State law that would require “manufacturers and operating system designers to create backdoors into encrypted cellphones,” the government hadn’t even filed its motion to compel against Apple. Now, just a few weeks after the government quietly stopped pressing the issue, it almost seems as if nothing at all has changed. But, while the dispute at bar may have been rendered moot, it’s obvious that the fight over the proper extent of data privacy rights continues to simmer just below the surface.

For those unfamiliar with the controversy, what follows are the high-level bullet points. Armed attackers opened fire on a group of government employees in San Bernardino, CA on the morning of December 2, 2015. The attackers fled the scene, but were killed in a shootout with police later that afternoon. Investigators opened a terrorism investigation, which eventually led to a locked iPhone 5c. When investigators failed to unlock the phone, they sought Apple’s help, first politely, and then more forcefully via California and Federal courts.

The request was for Apple to create an authenticated version of its iOS operating system which would enable the FBI to access the stored data on the phone. In essence, the government asked Apple to create a universal hack for any iPhone operating that particular version of iOS. As might be predicted, Apple was less than inclined to help crack its own encryption software. CEO Tim Cook ran up the banner of digital privacy rights, and re-ignited a heated debate over the proper scope of government’s ability to regulate encryption practices.

Legal chest-pounding ensued.

That was the situation until March 28, when the government quietly stopped pursuing this part of the investigation. In its own words, the government informed the court that it “…ha[d] now successfully accessed the data stored on [the gunman]’s iPhone and therefore no longer require[d] the assistance from Apple Inc…”. Apparently, some independent governmental contractor (read: legalized hacker) had done in just a few days what the government had been claiming from the start was impossible without Apple’s help. Mission accomplished – so, the end?

Hardly.

While this one incident, for this one iPhone (the iOS version is only applicable to iPhone 5c’s, not any other model like the iPhone 6), may be history, many more of the same or substantially similar disputes are still trickling through the courts nationwide. In fact, more than ten other federal iPhone cases have been filed since September 2015, and all this based on a 227 year old act of last resort. States like New York are also getting into the mix, even absent fully ratified legislation. Furthermore, it’s obvious that legislatures are taking this issue seriously (see NYS’s proposed bill, recently returned to committee).

Although he is only ⅔ a lawyer at this point, it seems to this author that there are at least three ways a court could handle a demand like this, if the case were allowed to go to the merits.

  1. Never OK to demand a hack – In this situation, the courts could find that our collective societal interests in privacy would always preclude enforcement of an order like this. Seems unlikely, especially given the demonstrated willingness in this case of a court to make the order in the first place.
  2. Always OK to demand a hack – Similar to option 1, this option seems unlikely as well, especially given the First and Fourth Amendments. Here, the courts would have to find some rationale to justify hacking in every circumstance. Clearly, the United States has not yet transitioned to Orwellian dystopia yet.
  3. Sometimes OK to demand a hack, but scrutiny – Here, in the middle, is where it seems likely we’ll find courts in the coming years. Obviously, convincing arguments exist on each side, and it seems possible reconcile infringing personal privacy and upholding national security with burdening a tech company’s policy of privacy protection, given the right set of facts. The San Bernardino shooting is not that case, though. The alleged terrorist threat has not been characterized as sufficiently imminent, and the FBI even admitted that cracking the cell phone was not integral to the case and they didn’t find anything anyway. It will take a (probably) much more scary scenario for this option to snap into focus as a workable compromise.

We’re left then with a nagging feeling that this isn’t the last public skirmish we’ll see between Apple and the “man.” As digital technology becomes ever more integrated into daily life, our legal landscape will have to evolve as well.
Interested in continuing the conversation? Leave a comment below. Just remember – if you do so on an iPhone 5c, draft at your own risk.

Policy Proposals for High Frequency Trading

April 21, 2016
Business Law, Competition, Economics, Securities Law

Steven Graziano, MJLST Staffer

In his article, The Law and Ethics of High Frequency Trading, which was published in the Minnesota Journal of Law, Science, and Technology Issue 17, Volume 1, Steven McNamara examines the ethics of high frequency trading. High frequency trading is the use of high-speed algorithms to take advantage of minor inefficiencies in trading technologies, and in doing so gain large market returns. McNamara looks into ethical, economic, and legal aspects of high frequency trading. In the course of his discussion McNamara determines that: high frequency trading is a term that actually describes an assortment of different practices; the amount of dollars involved in high frequency trading is declining, but is still a concern for certain types of investors and regulators; a proper analysis of high frequency trading requires use of expectation-based, deontological moral theory; and that modern technology may call into question the use of the Regulation National Market System regime. McNamara concludes that even though high frequency trading may lower costs to most investors, many practices associated with high frequency trading support the position that high frequency trading is not fair.

Securities and Exchange Commission Chair Mary Jo White has recently commented on the legality, and potential ways to approach, high frequency trading. White, while testifying before the Senate Appropriations Subcommittee on Financial Services and General Government, informed the Congressional Committee that “You don’t paint with the broad brush all high-frequency traders — they have very different strategies.” This sentiment mirrors McNamara’s assertion that the term high-frequency trading actually involves various practices. However, White is seemingly defending some practices, while McNamara has a more negative view.

Differing still from these two views are the results of a study done by United Kingdom’s Financial Conduct Authority. That study concluded with the conclusion that high-frequency trade technologies are not rapidly predicting marketable orders and then trading those orders. However, the study examined practices in Europe, which has less market participants and a slower moving market than the United States.

In conclusion, Steven McNamara offers a very insightful, encompassing look at high frequency trading. His analysis resonates through both White’s testimony, and in the results of the study from the Financial Conduct Authority. Although all three perspectives seemingly stand for somewhat different propositions, what is clear from all three sources is that the practice of high-frequency trading is extremely complex and requires in-depth analysis before making any conclusive policy decisions.

Biosimilar Licensing

April 14, 2016
Biotechnology, Food and Drug Law, Intellectual Property, Regulatory

Jeff Simon, MJLST Staffer

On February 18th, Sandoz filed a petition for certiorari appealing to the supreme court to revisit the Federal Circuit’s holding in Amgen v. Sandoz. Prior to Sandoz’s petition for certiorari, the Federal Circuit denied a rehearing of the case en banc back on October 16th. Sandoz is seeking the Supreme Court to review the Federal Circuit’s holding that it could not market Zarxio, the biosimilar equivalent of Amgen’s patented biologic Neupogen, until 180 days after Zarxio received FDA approval.

Sandoz will most likely take the stance that the Federal Circuit misinterpreted the BPCIA and particularly 42 U.S.C § 262(l)(8)(A). This paragraph states that a subsection (k) biosimilar applicant seeking approval under the BPCIA shall provide notice of marketing to the reference product sponsor (biologic brand manufacturer) not later than 180 days before the date of the first commercial marketing of the licensed biological product. According to Sandoz, the Federal Circuit incorrectly held that notice shall not be given prior to FDA approval of the biosimilar. The Federal Circuit noted that the statute uses the term “licensed” biologic product, implying that the biosimilar must first obtain FDA licensure before notice of commercial marketing can be given. Sandoz argued that the statute does not require the biosimilar applicant to stay notice until 180 days of licensure, and that such an interpretation would grant the reference product sponsor a six-month extension of exclusivity on the biologic product. Accordingly, Sandoz contends that such an interpretation would result in consequences unintended by the drafters of the Biologics Price Competition and Innovation Act, stating that if such was the intention of Congress, the BPCIA would have been drafted to include a fourteen-and-a-half-year exclusivity period. It’s important to note that the Federal Circuit was unanimous regarding its decision on 180-day notice of commercial marketing.

Earlier, Amgen declined to seek a petition of certiorari regarding the Federal Circuit’s holding that the Patent Dance provisions of the BPCIA are not mandatory. However, on March 24, 2016, Amgen asked the Supreme Court to review both portions of the Federal Circuit’s opinion, including its holding regarding the Patent Dance provisions of the Act. Amgen’s cross petition came in response the Sandoz’s petition for certiorari. In its opinion, the Federal Circuit held that the information exchange and patent dispute resolution mechanisms of the BPCIA were not mandatory, and that a subsection (k) applicant may avoid these provisions subject to the consequences contemplated by the BPCIA.

Amgen v. Sandoz was the first case regarding these provisions of the BPCIA as Neupogen was the first marketed biologic to come of patent since the passing of the BPCIA. If the Supreme Court is to review the decision of the Federal Circuit, it may elect to delay until the decision of pending cases such as Amgen v. Apotex. Regardless, the possible grant of certiorari has important implications for the biotechnology and pharmaceutical industries, as a looming patent cliff is set for the biologics industry in the next 5 years.

The Large Effect of Food Advertising on Children

April 6, 2016
Agriculture, Food and Drug Law, Public Health

Zach Berger, MJLST Staffer

The goal of advertising is to persuade consumers to purchase the advertised product. Advertising, as a form of commercial speech, is given considerable legal protection. Despite these protections, and with the rise of obesity in the you of America, advertising has become a topic of debate in the past several decades. As discussed in the Minnesota Journal of Law, Science & Technology article Food Advertising and Childhood Obesity: A Call to Action for Proactive Solutions by Roseann B. Termini, Thomas A. Roberto, and Shelby G. Hostetter, many theorists believe food advertising targets children “who are too young an immature to distinguish advertising puffery from truth.” Children have limited cognitive abilities, and assume the advertised food products are healthy. Without government regulation or parental intervention, these children can maintain these misconceptions and carry the unhealthy habits they developed at a young age into adulthood.

Unfortunately, the percentage of obese children has only gone up since the aforementioned article was written. According to a recent study, 20.5% of twelve to nineteen year olds are considered obese in the U.S., as well as 17.7% of children age six to eleven. As mentioned by Termini et al., food advertising can contribute to childhood obesity in several different ways: Time spent watching TV detracts from time that could be engaged in exercise, food advertisements encourage unhealthy choices, food products partnering with TV/movie characters encourages children to buy unhealthy products, and children snack excessively while watching TV. Although some companies have attempted to self-regulate, these attempts are not always successful.

Termini et al. suggested several solutions to limited the damage done to children by unhealthy food advertisements. These included: banning fast-food advertising on child-targeted TV, regulating food advertisements directed at children as well as the companies that produce them, eliminating tax breaks for food advertising, and increasing parental intervention. One such solution was recently reintroduced with the announcement of the Stop Subsidizing Childhood Obesity Act. This law would amend the tax code by eliminating tax deductions for advertising that is directed at children and which promotes unhealthy food and drink. The revenue this law would bring will go towards funding the U.S. Department of Agriculture’s “Fresh Fruit and Vegetable Program.” As the name states, this program provides fresh fruit and vegetables to all students at participating schools.

Overwhelming evidence suggests that the programs children watch on TV influences their eating habits. Although some of the onus is on the parents to supervise what their children eat, more consistent regulation of food advertising can help reduce childhood obesity. There is still a long way to go, but we need to be proactive if we want to have any chance of halting childhood obesity in its tracks.

Bottom-Up Approach to Climate Change

April 6, 2016
Energy Law, Environmental Law

Allison Kvien, MJLST Managing Editor

Most often, climate change is discussed on the global, top-down level: what changes may happen all around the world as a result of increasing global temperatures and greater fluctuations in weather events. There are very interesting maps that can show you just how much coastline will be underwater depending on different levels of sea level rise. To see just how much sea level rise it would take to put any city in the world underwater, you can use this mapping tool. There are also plenty of articles discussing hundreds of other effects of global climate change, such as food production, human health, endangered species, and the global economy.

We talk about climate change from a bottom-up perspective far less often, but it is a perspective that really does deserve our attention. Myanna Dellinger, in a recent article published in 2013 by the Minnesota Journal of Law, Science, and Technology, discusses and analyzes “bottom-up, polycentric developments within national and international environmental and human rights law in general.” This approach to viewing the large issue of climate change could be very beneficial because, as Dellinger points out, “waiting for national- and supranational-level actors to reach a broadly based and substantively effective agreement on climate change mitigation is like waiting for Godot—unlikely to happen, at least at a substantively early enough point in time.” Dellinger’s article argues that bottom-up approaches could be very viable alternatives to waiting for the unlikely global, top-down action to occur. Read her interesting and novel article here.

Renewable Energy Accounts for Majority of New Energy Technology Installed in 2015 but Remains a Minority Producer Overall

April 6, 2016
Energy Law, Environmental Law

John Biglow, MJLST Staffer

According to a United Nations Environment Programme report titled “Global Trends in Renewable Energy Investment 2016,” 2015 was a record setting year for global investment in renewable energy. A record $286 Billion dollars was invested in renewable energy technology in 2015. Furthermore, for the first time in history, renewable energy technologies made up more than half of the total gigawatt capacity of all newly installed energy technologies. Significantly, it was developing countries that led the way, with China, South Africa, Mexico, India, and Chile all showing an increase in investment. China itself accounted for over 1/3 of the total global investment with $102.9 billion invested.

According to a UNEP publication concerning this report, these developments are indicative of a structural change happening in the global energy system in the article Complexity in Global Energy-Environment Governance, Andrew Long discusses and describes the global energy system and the ways it reacts to change. Long argues that viewing the global energy system in the same manner that we study other complex systems will allow for a better understanding of how the system works and how it could be changed.

In his article, Long argues that the current global energy system shows both resilience and adaptation. By adaptation, he is referring to the system’s ability to incorporate new aspects into itself without experiencing an entire overhaul and shift in trajectory. The UNEP’s report which indicates the increasing role of renewable energy in the global energy system is demonstrative of this adaptation. By resilience, Long is referring to the entrenched nature and dominance of fossil fuels in the global energy system. Despite the major, and indeed record setting, strides made in 2015 in regards to renewable energy investment, it still only accounts for around 10% of total global energy production, as stated in UNEP’s recent report.

It is unclear what to make of the UNEP report at this juncture; on the one hand, if our goal is to increase the use of environmentally friendly energy sources, as it undoubtedly should be, then it appears we are on track. However, questions remain as to whether we are moving fast enough down that track. In his article, Long stated that in complex systems, occasionally small scale changes to the system can cause a system-wide shift and alteration, though he stressed that the occurrence of this is rare. Whether or not the increase of renewable energy use is indicative of a trend which will eventually de-trench the entrenched fossil fuel energy production is unclear at this point. Overall, the UNEP report seems to indicate a promising trend towards increased renewable energy usage, but if the global energy system is to undergo any drastic shifts, it seems that more countries will have to follow China’s example and invest heavily in new eco-friendly energy technologies.

Five-Year Extension May “Put the Falls Back in River Falls”

April 6, 2016
Energy Law, Environmental Law

Katie Cumming, MJLST Lead Note & Comment Editor

A March 17, 2016 decision by the Federal Energy Reserve Commission (FERC) may “put the falls back in River Falls.” This is good news for community groups and environmental stewards, as this decision overturns FERC’s December 9, 2015 decision originally denying a five-year extension for the continued operation of the River Falls two hydroelectric dams (the River Falls Project). After the initial denial, the City released a letter stating that it would “pursue the extension through whatever means” available. FERC heard and ultimately granted the City’s extension because it “found that the unique circumstances in this case, such as the unanimous stakeholder support for the extension, the river corridor plan, and the size of the project, all demonstrate that a five-year extension of the license is in the public interest.” As a result of the recent decision the City effectively ended its relicensing efforts and is refocusing its resources on planning for the Kinnickinnic River Corridor. The five-year extension gives the City and stakeholders “breathing room to decide about the fate of the two dams.” City Management Analyst, Ray French, said “The benefit is that the five-year (license) extension pushes back the regulatory filing and process deadline in order to give the community time to engage in a river corridor planning process that will provide a vision for this central area and beyond. . . .” Re-evaluating the use of rivers as a resource is not unique to the Kinnickinnic River. As many dams age and become obsolete, communities are re-evaluating the economic and environmental costs of these dams. Kinnickinnic stakeholders have created a movement to “put the falls back in River Falls.” On April 5, 2016, River Falls will hold an election for City Council and Mayor. With the river’s fate to be determined, the result of this election will undoubtedly have an effect on whether the falls are put back in River Falls.

“What’S in a Name?” Billions of Dollars, That’s What

March 22, 2016
International Law, Trademark Law

Travis Waller, MJLST Staffer

Cease-and-desist letters have long been one of the most commonly used, and perhaps more potent, of the tools relied upon by organizations and legal counsel to cut short unauthorized 3rd party use of material relating to that company’s trademarks. In 2013, Marcella David published a fascinating article in vol. 14 of the Minnesota Journal of Law, Science & Technology entitled “Trademark Unraveled: The U.S. Olympic Committee Versus Knitters of the World”. This article discussed the “scandal” surrounding the U.S Olympic Committee’s (USOC) harshly worded cease-and-desist letter sent to the operators of a website for knitters, called ravelry.com. What did ravelry.com do to receive this response? Ravelry.com hosted a kind of knitting competition, which it called the “ravelmpics”, in which the site would promote various events (such as the afghan marathon) and award “blog badges” to the winner of these events. Ravelry.com even had commemorative pins made up to memorialize the event.

Soon after the announcement of the “ravelmpics”, the USOC sent a cease-and-desist letter to ravelry.com. The outrage surrounding the USOC’s cease-and-desist letter (which complained that the “ravelympics” made light of Olympic athlete’s lifetime of training and dedication, among other things) was immediate and intense, so much so that the USOC actually apologized to ravelry.com for the letter twice, as well as blamed the contents of the letter on an over-zealous summer associate within the organization’s legal department.

While this event may mark the upper limits of the strange when it comes to brand protection, the Olympic committees appear to have not lost their appetite for using their trademark rights in the word “Olympic” as a sword, as the International Olympic Committee recently carved up the name of a Portland charcuterie shop, now known as Olympia Provisions.

Bologna, right? Not necessarily. (Olympia Provisions prides itself on it’s salami). While organizations like the USOC’s actions against these companies may seem harsh – even ridiculous – at first blush, there can be very real harms to an organization’s branding efforts and trademark protection if prevention of unauthorized use is not vigorously enforced. Remember Aspirin? Linoleum? Trampoline? These names, which have now fallen into common use as terms for items, used to be trademarks. That is, aspirin used to denote a brand of acetylsalicylic acid, made by the company Bayer, and branded as “aspirin”.

This loss of rights is due to an aspect of trademark law that allows the expiration of trademark protection for certain marks that lose their status as “source identifiers”. While it may be difficult now to imagine the word “Olympic” as ever losing its connection to the Olympic Games, words have a funny way of changing meaning simply through their usage over time. To this point, consider “literally”, which today is synonymous with both “actually” and “figuratively” (“literally” antonyms of each other).

Aside from the USOC, the NFL is another large entity that actively enforces it’s use of the “SUPER BOWL” mark through cease-and-desist letters, and does so out of many of the same fears that the USOC uses in justifying it’s strict enforcement of it’s marks.

To bring this discussion to a head, cease-and-desist letters are probably more a tool of necessity than an expression of corporate malice. While there may be the rare occasion of an “over-zealous summer associate” or two, the astronomical economic value associated with the trademarks of many of the worlds most famous brands provides ample incentive to stymie even the most negligible 3rd party uses, strong likelihood of confusion or not. This is because, like it or not, language is slippery, and far is the fall to “generic”.

The Path of Pollutants Under the Clean Water Act

March 19, 2016
Administrative Law, Environmental Law

Ted Harrington, MJLST Staffer

In 1972, the Clean Water Act set forth a lofty goal—to “[r]estore and maintain the chemical, physical, and biological integrity of the nation’s waters.” (33 U.S.C. §1251(a)). Yet, the Clean Water Act only regulates point sources that discharge pollutants into navigable waters (33 U.S.C. §1251(a)(1)). As a result, many forms of water pollution escape federal jurisdiction, most notably, groundwater. This is because CWA regulation depends on how a pollutant reaches navigable water, instead of focusing on the end result. This added constraint is hardly logical when juxtaposed against the stated goal.

For example, if a pollutant is discharged into groundwater, and eventually reaches navigable Water Body B, the CWA does not have the ability to regulate the groundwater. In other terms, if the polluted effluent passes through groundwater, considered a “nonpoint source,” before it reaches Water Body B, no CWA regulation occurs.

To combat this issue, Federal District Courts in Hawai’i, North Carolina, and Pennsylvania have begun adopting the “Conduit Theory” (See Allison Kvien note Volume 16). The conduit theory states that if a body of water (groundwater) simply acts as a conduit, it should be viewed as an extension of the point source from which it is receiving the pollutant. This theory directs its attention to the ultimate result—the pollution of Water Body B. It is only logical that if Water Body B is being polluted, the source should fall under CWA jurisdiction. Why should we leave a source of pollution unregulated simply because the effluent isn’t being directly discharged into a navigable water? As the Court in Rapanos v. United States noted, “The [Clean Water] Act does not forbid the ‘addition of any pollutant directly to navigable waters from any point source,’ but rather the ‘addition of any pollutant to navigable waters.’”

The issue of groundwater as a pollutant is receiving increasing attention in the courts. In the Northern District of Iowa, a case concerning the discharge of groundwater through tile drains is currently in litigation‑ Board of Water Works v. Sac County Board of Supervisors. This could be an opportunity for Iowa to take one of the first stances on the conduit theory in the 8th Circuit. Stay tuned!

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