Articles by mjlst

Three’s a Crowd: Identifying the Shifting Parental Rights in Three-Parent Babies

October 3, 2016
Ethics, FDA, New Technology, Regulatory

Daniel Green, MJLST Staffer

Once again, science is spurring the law to adapt in ways it never could have predicted. A baby boy was recently born with genetic material of three different people. Aside from being born slightly premature, the now three-month-old child is very healthy. Even though three-parent techniques have been used before, this child marked the first healthy birth.

Given the obvious religious, safety, and ethical disputes behind such a medical procedure it may seem unclear as to why anyone would want to go through with it. The answer, however, avoids the arguments that the procedure is simply done to “play God” or for polyamorous relationships. The mother underwent the treatment to ensure both the happiness of parents and the health the child.

In this instance, the mother carried genetic defects identified to cause Leigh syndrome. This disorder which affects the brain resulted in the mother having had four pregnancy losses in addition to the death of two previous children at the ages of 8 months and 6 years. Leigh syndrome is caused by defects in a cells mitochondria, and the three-parent treatment was able to bypass the damaged mitochondrial DNA.

The process involves implanting the mother’s DNA into an egg from a donor. The egg has the donor’s main genetic DNA removed prior. The egg is then fertilized with sperm from the father. This process allows the DNA from the mother to pass down virtually unchanged since “mitochondrial DNA makes up less than 1% of the total cellular DNA.” However, small amounts of the donor’s mitochondrial DNA are still left throughout the child’s body.

The treatment was done in Mexico involving a team of fertility specialists from the United States and Great Britain. The procedure took place in Mexico since the treatment used has not yet been approved in the United States by the Food and Drug Administration, but this may not be the case for long due, in part, to recent successes. Another indicator of this possible change is that the treatment has already been approved in Britain.

Given this rapidly changing landscape, the law, in particular regarding parental rights, needs to somehow catch up quickly on an incredibly complex topic. As the donor parent will only be contributing 37 genes out of the total 22,000, it is likely that a donor’s right will be the most contested. Given the precedent already set forth, courts may adopt one of several strategies if and when three-parent babies are no longer barred in the United States.

  1. The donor parent has no legal claims: This would be similar to the mostly commonly accepted view concerning to sperm donors. In most states, if a sperm is donated through a licensed medical professional then the donor loses all legal claims to the child unless the parents are married. It seems logical that the treatment of an egg donor, in a three-parent situation, would be similar given what the term “donor” implies. Great Britain, which has already approved the three-parent treatment, has already adopted a stance similar to this. However, states are in contention regarding of parental rights and even custody of traditional style egg donors. Given the distribution of DNA it may be easier for a court to rule against the egg donor, but this is still very unclear.
  1. The donor parent has an equal claim to the child: California has already passed a version of a three-parent law, but this was mainly for same-sex couples who wish to have the donor on the birth certificate as well. However, the process leaves the door open for unintended parents, such as the donors, to assert claims over a child. In such a case, a court may find that, despite the objections of two parents, the donor has a right to be considered as a parent. Instances of this have already come up in traditional sperm and egg donation. Such conflicts could create a great degree of instability for the life of the child.
  1. The parties agree through a contract prior to the treatment as to what claims exist: The last apparent possibility is that parties may be able to contractually agree what their family is to look like. This would likely create the most amiable way to go about the process, but it is time-consuming and still may run into problems with the existing laws of certain states.

Clearly, there is no solid answer regarding three-parent babies even though three-parent birth certificates are already becoming more common in the United States. It seems like it is only a matter of time before three-parent babies are introduced into the culture as well. This leaves the question as to whether the law will be ready in time so as to hopefully create a circumstance that, whatever the family may look like, is best for the child.

Westward (And Then Some) Expansion: One Theory of Property Rights on the Moon and Mars

September 28, 2016
International Law, Property Law, Space Law

Jordan Rude, MJLST Staffer

Recently a friend of mine received, for his birthday, a deed to one acre of land on Mars. That’s right—he is the proud owner of property located approximately 34 million miles from Earth. This is possible thanks to the efforts of various (and often interconnected) websites such as Buy Mars, Buy Planet Mars, Lunar Registry, and Lunar Land. While selling extraterrestrial property is not a recent development (see here and here), and there does not appear to be any recent lawsuits regarding this practice, these methods still deserve scrutiny. With the rapid advancement of technology in recent decades and increasing participation by private companies in space programs (SpaceX recently tested a Mars-capable rocket), human settlement on the Moon and Mars is becoming a possibility (albeit a distant one) within our lifetimes. At that point, property ownership will become an important and possibly contentious issue. For the millions of people who have bought land on the Moon and Mars, the question of whether their claims will be recognized in such a situation is a not insignificant one.

Some of these websites claim to have legal standing for their ownership of property on Mars. Consider Buy Mars (owned by Lunar Land). Under the heading “Lunar Land’s Legal Right To Offer Planet Mars Land,” the site makes reference to the U.N. Outer Space Treaty of 1967 as well as the tradition “dating back to early U.S. settlers” of staking a claim on surveyed land through the U.S. Office of Claim Registries. The Outer Space Treaty has been previously discussed by this blog (in a different context). Suffice it to say that this treaty prohibits countries from claiming ownership of land on Mars and other extraterrestrial property, but says nothing about individuals or corporations. Thus, the argument would be that Buy Mars, because it is not a sovereign nation, is not subject to the treaty specifically prohibiting claims of ownership on Mars.

Beyond the lack of a direct prohibition, Buy Mars also claims historical precedent as an affirmative justification. This reference to historical precedent is problematic for two reasons: first, the U.S. Office of Claim Registries does not exist, and likely never existed; and second, this is not an accurate statement of the process by which the West was settled. In fact, the federal government sold the land—first as townships and other large plots, and later in smaller, more affordable plots, before finally offering land for free under the Homestead Act of 1862 (see Michael C. Blumm & Kara Tebeau, Antimonopoly in American Public Land Law, 28 Geo. Envtl. L. Rev. 155, 165–71 (Winter 2016)). That is, the federal government owned the land it sold to speculators and other settlers (though this ownership came more or less from the government declaring it to be so, not dissimilar to what Buy Mars has done). So, because the U.S. government does not own land on Mars that it could sell to Buy Mars (to then sell to us), on its face the claimed historical precedent is not in fact proof of the legality of the process.

However, setting aside the flaws in Buy Mars’ formulation of the argument, let’s assume that the principles of westward expansion can be applied to property on Mars—would this type of claim survive a legal challenge?

Most likely it would not. Construing the westward expansion analogy narrowly, the U.S. government would have to first own land on Mars and then distribute it to corporations like Lunar Land or individuals. This is clearly prohibited by the Outer Space Treaty. That being said, if a company like SpaceX lands on Mars, the Outer Space Treaty would potentially not restrict its ability to claim land. At that point, it is unclear what the legal policies governing ownership would be. In that situation, a process loosely similar to westward expansion could be utilized, wherein a larger entity (in this case a large company) distributes land to newcomers. The key difference between the Buy Mars argument and SpaceX landing on Mars would be the latter company’s physical presence on the planet—an important aspect of making such property claims and the most likely way to get around the Outer Space Treaty. This could be extremely lucrative for SpaceX but problematic for those who have already purchased land on Mars. Ultimately, the websites currently offering land on the Moon or Mars do not have legal standing to do so, and any person who bought such land is unlikely to find legal protections should the need arise. The law in this field is very uncertain, if it exists at all, and the day may come where a true answer is needed.

Of course, the legal implications of this process should not deter you from investing in extraterrestrial property for the fun of it. My friend’s deed comes from Buy Planet Mars, whose website makes quite clear, in the FAQ section, that the deed is “a novel gift and for entertainment purposes only.”

Halo Electronics v. Pulse Electronics: More Discretion of District Courts in Granting Enhanced Damages

September 25, 2016
Intellectual Property, Litigation, Patents

Tianxiang (Max) Zhou, MJLST Staffer

The recent US Supreme Court case, Halo Electronics v. Pulse Electronics, grants district courts more discretion in determining “enhanced damages.” The previous clear standard of the enhanced damages became murkier after this case and left much room for lower courts to decide what constitutes enhanced damages.

Section 284 of the Patent Act provides that, in a case of infringement, courts “may increase the damages up to three times the amount found or assessed.” Enhanced damages are appropriate only when the patentee proves, by clear and convincing evidence, that the infringer “willfully” infringed the patent. Prior to Halo, courts adopted a bifurcated approach to enhanced damages established in In re Seagate: First, the patentee must show the infringer’s recklessness by clear and convincing evidence, that “the infringer acted despite an objectively high likelihood that its actions constituted infringement of a valid patent.” If the objective standard of recklessness is satisfied, then patentee must demonstrate that the risk was either known or so obvious that it should have been known to the accused infringer.

In Halo, the jury in the district court found a high probability that the infringement was willful. However, the district court refused to grant an enhanced damages based on the two-part test, and found as a matter of law, that the patentee did not prove objective recklessness of the infringer. The Federal Circuit Court affirmed the decision.

However, the Supreme Court reversed the Appeal Court’s decision, and rejected the two-part test set forth in In re Seagate. Specifically, the Supreme Court, citing Octane Fitness LLC v. ICON Heath & Fitness, Inc, found that the test is “unduly rigid, and it impermissibly encumbers the statutory grant of discretion to district courts.” Though rejecting the two-part test, the Supreme Court did not give a clear guideline for lower courts to follow. Halo provides that, “[a]s with any exercise of discretion, courts should continue to take into account the particular circumstances of each case in deciding whether to award damages, and in what amount.” According to the Supreme Court, district courts are “‘to be guided by [the] sound legal principles’ developed over nearly two centuries of application and interpretation of the Patent Act.” Besides, the Supreme Court found that the prior two-part test, which requires a finding of objective recklessness, excludes discretionary punishment of “wanton and malicious pirate” who intentionally infringes another’s patent, and a district may grant enhanced damages even in the absence of a finding such objective recklessness.

Overall,  Halo broadened district courts’ discretion in evaluating facts of patent infringement and granting enhanced damages. While the Halo decision will definitely increase the unpredictability of patent infringement lawsuits, it is still unclear whether the broad discretion of district courts will open the gate of flood of enhanced damages. Besides, before we think about the standard of enhanced damages, it is also worthy to consider the policy implications of enhanced damages, and to ask whether and when enhanced damages are appropriate. Anyway, it would be exciting to see a clearer standard of enhanced damages in future cases, or amendments of laws and regulations.

A View to the Development of the FAA’s Ban on the Use of Galaxy 7 Phones on Airplanes.

September 25, 2016
Law Enforecement, Public Safety, Regulatory

Joshua Wold, MJLST Staffer

Samsung’s Galaxy Note 7 has problems. Under normal charging and use conditions, the battery in some devices can start on fire. As of September 1, Samsung reported that 35 of these problems had come to its attention, and more have been reported since that time. Samsung has already begun a recall—officially a “replacement program”—offering to replace the potentially dangerous devices with new ones. At the same time, US government agencies are also moving to prevent the harm that a malfunction from these devices could cause.

The Federal Aviation Administration (FAA) has not banned the device from airplanes. According to Matt Novak at Gizmodo, the FAA stated on September 6th that it was “working on guidance related to this issue,” and said, “If the device is recalled by the manufacturer, airline crew and passengers will not be able to bring recalled batteries or electronics that contain recalled batteries in the cabin of an aircraft, or in carry-on and checked baggage.” On September 8th, the FAA issued a statement “strongly” advising airline passengers to keep the devices off, not charge them while aboard, and to keep them out of checked baggage.

Then, on September 9th the Consumer Product Safety Commission (CPSC) put out a press release urging Galaxy Note 7 owners to power off the device, and not to charge or use it. The press release indicated that it was cooperating with Samsung “to formally announce an official recall of the devices, as soon as possible.”

Based on the comments made to Gizmodo, the FAA appeared unwilling to ban the device until the official recall was put into effect. This is understandable. Cell phones are a significant part of modern life. Nearly every person getting onto a plane is carrying at least one. TSA would thus be forced to distinguish between types of cell phones. Its task would be complicated by cases and other types of personalization which obscure the appearance of a cell phone.

Even more challenging, however, is the fact that some versions of the Note 7 have a battery which is not prone to overheating, and poses no threat. Unless these safe phones were to also be banned, security personnel would need to determine which battery was in a phone in order to know if it were permissible. People want to have their phones when they get wherever they are flying to, and banning a safe phone because it looks like an unsafe phone seems like a sure recipe for passenger dissatisfaction.

It may seem that a ban is be appropriate despite the difficulties. Certainly, the potential for harm is significant. A widely circulated photo of a Jeep engulfed in flames is evocative of the threat, and airline passengers have gotten used to restrictions on items which seem to pose even less risk than an exploding phone. FAA’s suggestion that those with Note 7 phones simply turn them off and not charge them may have had the potential to eliminate the threat. On the one hand, it was only a strong recommendation, and not a rule. On the other hand, with airlines repeating the FAA’s warning, it seems unlikely that many people would have failed to take it seriously.

On the 15th of September, the situation changed further, as the CPSC announced an official recall. With that decision, the ground mentioned to Gizmodo for not instituting a ban disappeared. Considering  some data (which can be found here), suggesting that people aren’t really taking Samsung’s warnings seriously, it seemed very likely that the FAA would decide to strengthen their recommendation against use to a prohibition on use, or even a prohibition on flying with the phones at all.

On the next day, September 16th, the FAA banned use of the phone on airplanes, but not the phones themselves. This new policy fits with the reality of modern cellphone use, that people rely on their phones, even if they are fire hazards. While this move takes the pressure off the TSA (which is probably a good move in terms of the overall happiness of air travelers), the regulation (which can be found here) doesn’t specifically mention the Galaxy Note 7, but refers instead to “defective or recalled” lithium batteries.

Of course, this creates the same sort of enforcement problems as appeared with earlier recommendations: can airline staff identify a Galaxy Note 7 with such “defective or recalled” lithium batteries? The FAA itself notes that it is difficult to distinguish between phones which have had the battery replaced and those which are still risked. The FAA’s recommendation on how to manage this problem is pretty general, and it essentially boils down to training of airline staff, and provision of information to airline passengers. One hopes that this is sufficient.

Who Owns Your Tattoos?

September 15, 2016
Uncategorized

Zachary Berger, MJLST Executive Editor

Tattoos are more common today than they have ever been. More than 20 percent of Americans have at least one tattoo, and among millennials nearly 40 percent have at least one tattoo. Most people probably assume that they are the owners of their tattoos. After all, tattoos are part of your body. How can you not own them? However, the answer is a bit more complicated than that. There have been a number of lawsuits relating to tattoo ownership over the years, but a recent one has brought the issue back into the news.

Take-Two Interactive Software is the parent company of 2k Sports and developer Visual Concepts, who create the popular NBA 2K video game series. Solid Oak Sketches is a company that is claiming ownership over a number of tattoos that appear in the game on several prominent players, including LeBron James and Kobe Bryant. Take-Two has licenses to the players’ likenesses, but Solid Oak claims they alone have the right to license the tattoos, which appear on the players in the game. Tattoos are very prominent in the NBA, and if the players had to appear without them, it would break the sense of realism the game is attempting to convey.Suits such as this one have occurred before, most notably in 2011 when Mike Tyson’s facial tattoo appeared on Ed Helms in the movie The Hangover Part II. However, all of these cases have settled, leaving tattoo ownership in a murky place.

In order to be eligible for copyright protection, a creation must meet three requirements. It must be a work of authorship, it must be fixed in a tangible medium of expression, and it must be original. It is up for debate whether tattoos meet all of these requirements but many believe they do.

The more interesting question, I think, is once that tattoo is finished, who owns it? Does it belong to the artist or patron? As is frequently the case in the legal field, the answer likely is that “it depends.” The default rule in copyright is that ownership is given to the artist. The University of Minnesota Law School’s own Professor Thomas Cotter is coauthor of one of the earliest and most extensive forays into the question of tattoo ownership. He concluded that there are three possibilities: 1) the artist owns the tattoo in the same way a painter owns what he or she paints on a canvas, 2) the work is a joint work, meaning that “it is prepared by two or more authors with the intention that their contributions be merged into inseparable or interdependent copyrightable expression,” or 3) the work is a work for hire. As explained by Timothy C. Bradley of the Coats & Bennet law firm, a “work for hire” applies when the work is 1) prepared by an employee within the scope of his or her employment or 2) specially ordered or commissioned for use in certain circumstances. A “work for hire” is owned by the party that commissions the work.

Take-Two recently won a dismissal of a potentially large damages claim when Judge Laura Taylor dismissed Solid Oak’s statutory damage claim because the tattoo designs Solid Oak claims ownership to were not registered with the U.S. Copyright Office until 2015, but Take-Two first used them in 2013 with the release of NBA 2k14. In order to be able to obtain statutory damages, a plaintiff must have registered their copyright before the alleged infringement. Solid Oak argued that each new 2K game is a separate instance of infringement, but the judge disagreed.

However, Solid Oak is still able to seek actual damages, so the case will continue. In their answer and counterclaim, Take-Two is relying in particular on the defenses of  de minimis use and fair use. De minimis is Latin for “minimal things” and essentially means that the infringement was insignificant and not worthy of judicial scrutiny. Fair use is an affirmative defense that allows limited copying without the copyright owner’s permission for the purposes such as criticism, comment, news reporting, teaching, scholarship, etc. The following factors (from 17 U.S.C. § 107) are used to analyze fair use:

(1) the purpose and character of the use, including whether such use is of a commercial nature or is for nonprofit educational purposes;

(2) the nature of the copyrighted work;

(3) the amount and substantiality of the portion used in relation to the copyrighted work as a whole; and

(4) the effect of the use upon the potential market for or value of the copyrighted work.

Solid Oak v. 2k Games may be the first tattoo copyright infringement suit to settle on the merits rather than out of court and thus will be a very interesting case to watch going forward. The case is Solid Oak Sketches v. 2K Games and Take-Two Interactive Software, No. 16-CV-724-LTS (S.D.N.Y. filed Feb. 1, 2016).

 

Solar Climate Engineering and Intellectual Property

April 27, 2016
Climate Change, Data, Environmental Law, Intellectual Property

Jesse L. Reynolds 

Postdoctoral researcher, and Research funding coordinator, sustainability and climate
Department of European and International Public Law, Tilburg Law School

Climate change has been the focus of much legal and policy activity in the last year: the Paris Agreement, the Urgenda ruling in the Netherlands, aggressive climate targets in China’s latest five year plan, the release of the final US Clean Power Plan, and the legal challenge to it. Not surprisingly, these each concern controlling greenhouse gas emissions, the approach that has long dominated efforts to reduce climate change risks.

Yet last week, an alternative approach received a major—but little noticed—boost. For the first time, a federal budget bill included an allocation specifically for so-called “solar climate engineering.” This set of radical proposed technologies would address climate change by reducing the amount of incoming solar radiation. These would globally cool the planet, counteracting global warming. For example, humans might be able to mimic the well-known cooling caused by large volcanos via injecting a reflective aerosol into the upper atmosphere. Research thus far – which has been limited to modeling – indicates that solar climate engineering (SCE) would be effective at reducing climate change, rapidly felt, reversible in its direct climatic effects, and remarkably inexpensive. It would also pose risks that are both environmental – such as difficult-to-predict changes to rainfall patterns – and social – such as the potential for international disagreement regarding its implementation.

The potential role of private actors in SCE is unclear. On the one hand, decisions regarding whether and how to intentionally alter the planet’s climate should be made through legitimate state-based processes. On the other hand, the private sector has long been the site of great innovation, which SCE technology development requires. Such private innovation is both stimulated and governed through governmental intellectual property (IP) policies. Notably, SCE is not a typical emerging technology and might warrant novel IP policies. For example, some observers have argued that SCE should be a patent-free endeavor.

In order to clarify the potential role of IP in SCE (focusing on patents, trade secrets, and research data), Jorge Contreras of the University of Utah, Joshua Sarnoff of DePaul University, and I wrote an article that was recently accepted and scheduled for publication by the Minnesota Journal of Law, Science & Technology. The article explains the need for coordinated and open licensing and data sharing policies in the SCE technology space.

SCE research today is occurring primarily at universities and other traditional research institutions, largely through public funding. However, we predict that private actors are likely to play a growing role in developing products and services to serve large scale SCE research and implementation, most likely through public procurement arrangements. The prospect of such future innovation should be not stifled through restrictive IP policies. At the same time, we identify several potential challenges for SCE technology research, development, and deployment that are related to rights in IP and data for such technologies. Some of these challenges have been seen in regard to other emerging technologies, such as the risk that excessive early patenting would lead to a patent thicket with attendant anti-commons effects. Others are more particular to SCE, such as oft-expressed concerns that holders of valuable patents might unduly attempt to influence public policy regarding SCE implementation. Fortunately, a review of existing patents, policies, and practices reveals a current opportunity that may soon be lost. There are presently only a handful of SCE-specific patents; research is being undertaken transparently and at traditional institutions; and SCE researchers are generally sharing their data.

After reviewing various options and proposals, we make tentative suggestions to manage SCE IP and data. First, an open technical framework for SCE data sharing should be established. Second, SCE researchers and their institutions should develop and join an IP pledge community. They would pledge, among other things, to not assert SCE patents to block legitimate SCE research and development activities, to share their data, to publish in peer reviewed scientific journals, and to not retain valuable technical information as trade secrets. Third, an international panel—ideally with representatives from relevant national and regional patent offices—should monitor and assess SCE patenting activity and make policy recommendations. We believe that such policies could head off potential problems regarding SCE IP rights and data sharing, yet could feasibly be implemented within a relatively short time span.

Our article, “Solar Climate Engineering and Intellectual Property: Toward a Research Commons,” is available online as a preliminary version. We welcome comments, especially in the next couple months as we revise it for publication later this year.

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

April 27, 2016
Bioethics, Data, 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 Enforecement

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, FDA, Intellectual Property

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.

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