Articles by mjlst

Culpability in Criminal Law and the Emerging Field of Neuroscience

February 26, 2016
Criminal Law, Neuroscience

Daniel Mensching, MJLST Staffer

Criminal law has long held that people are accountable for their behavior and that most behavior is intentional and conscious. This is necessary for the legal system to determine culpability and therefore warrant punishment. In his article Blaming the Brain, Seven K. Erickson explores how the still young field of cognitive neuroscience is beginning to challenge traditional notions of free will independent action and potential legal consequences of this shift in understanding. While the implications for emerging understandings of neuroscience are far-reaching and delve into areas such as psychology and philosophy, viewing human actions as mechanical and absent of free will raises serious questions in the field of law as well, especially criminal law.

Cognitive neuroscience, though still in its infancy, holds the potential to explain all human behavior as a result of involuntary processes occurring within the brain. According to Erickson, cognitive neuroscience leads us to the view that “we are a passive audience to the electrical cadence of neuronal firings buried deep within our heads” and that “what we perceive as the mind is nothing more than a cognitive adaptation established by our brains to allow higher-ordered behavior.” This view is entirely incompatible with the notion of human agency that holds that people evaluate their environments and make choices.

Many exceptions are already made, both in the legal system and in general, for people with certain mental defects. While some defects are obvious, the list of recognizable mental disorders is growing rapidly. The number of official diagnosable mental disorders has increased by almost 300% in the past 50. Behaviors that were once considered indicative of poor character are now considered medical disorders. What could have been considered laziness or immaturity 50 years ago can now be treated with a prescription for amphetamines, a drug considered addictive and dangerous and is therefore illegal for the general public. Many of these diagnoses are made based on inherently subjective criteria. Criminal law already contains the affirmative defense of insanity, and cognitive neuroscience begs the question of how and to what extent neurological conditions should influence culpability and punishment.

But the criminal system is not aimed solely at punishing for the sake of justice. Another main goal of criminal law is to reduce crime in society, both by deterring would-be criminals and by reducing recidivism. While understanding human behavior as simple mechanics may make punishment seem irrational, cognitive neuroscience aims to ameliorate the criminal justice system by understanding the causes of criminal behavior and therefore being able to effectively predict crime and rehabilitate offenders.

3D Food Printing and Its Legal Complications

February 17, 2016
3-D Printing, Food and Agriculture

Riley Conlin, MJLST Staffer

According to a recent article in Bloomberg, the FDA has recently approved the use of a drug that was 3D printed for the first time. The first drug the FDA approved is Spritam, which was created by Aprecia Pharmaceuticals. The drug is to be administered orally to treat adults and children for epilepsy. The 3D printing process supposedly allows the pill to dissolved quickly, which means it will enable the pill to act faster in the case of an oncoming seizure. When this approval occurred several attorneys voiced concern, because of the intellectual property issues related to 3D printing. First, it would be difficult to determine the manufacturer of the drug, making the assignment of IP rights quite challenging. Second, because it would be difficult to determine the manufacturer, it would also be difficult to identify liable parties in potential litigation.

While there are undoubtedly legal issues related to 3D printing, a forthcoming article in the Minnesota Journal of Law Science and Technology Symposium argues that the benefits far outweigh potential legal issues that could slow the adoption of 3D technology in the area of food production. Symposium author, Jasper Tran, notes that there are “endless possibilities” associated with 3D food printing. First, the ability to print food has the potential to significantly impact the global food shortage crisis, because healthy food can be mass-produced via 3D printers. He also argues that 3D printing has the potential to reduce environmental harms associated with current food production. However, he does note that there are legal liability issues with 3D printing, including (1) short-term food poisoning on an individual scale or mass scale and (2) long term impacts of food printing. Despite these concerns, Tran argues the legal risks are far outweighed by the potential global benefits of mass-producing food via 3D printers.

As discussed in the Bloomberg article and in Tran’s note, 3D food and drug printing is the future. It is the responsibility of government organizations to take a proactive approach and attempt to enact rules and regulations that anticipate the new legal issues and challenges associated with the process.

The Threat of Antibiotic Resistance: The Use of Antibiotics in Animal Agriculture and Proposed Regulations to Increase the Involvement of the Food and Drug Agency

February 17, 2016
FDA, Food and Agriculture

Jody Ferris, MJLST Staffer

Antibiotic resistance purportedly caused by the immoderate use of antibiotics in animals raised for human consumption is currently a hot button issue in the news today. It is an issue important to human health and to the food and agriculture industries.   In her note, Slowing Antibiotic Resistance by Decreasing Antibiotic Use in Animals, Jennifer Nomura discusses this issue and makes recommendations regarding which government agency should regulate antibiotic use in animals and how it should best be regulated.

According to Nomura, antibiotics that had been used to treat animal diseases are also being utilized for growth purposes. She says that, “it is now common in the United States for farm animals to be fed low doses of antibiotics on a daily basis.” The species in which antibiotic use is most common are pigs and poultry. She states that “[b]ecause farmers have been feeding antibiotics to animals for so many years, animals are becoming resistant to the effects of these drugs.”   She also states that it is also possible for the antibiotic resistant bacteria in animals to pass to humans and that, “as humans become resistant to antibiotics, health care for treatable diseases becomes more costly. Antibiotic resistance can lead to hospitalization, longer-term care, and potentially even death.” However, despite the grave risk that antibiotic resistance poses, Nomura states that “no direct connection has been established” between antibiotic use in animals and antibiotic resistance in humans. Some studies have showed a causal link between the two.

Over the course of her note, Nomura argues convincingly that the primary authority for the regulation of antibiotic use is the Food and Drug Agency in connection with the United States Department of Agriculture and the Center for Disease Control, along with the World Health Organization and the European Union. She proposes that the Food and Drug agency should enact a full scale ban on the animal use of any antibiotic that is also used in the human population. Her note also suggests that the Food and Drug Agency should then establish a monitoring program to keep an eye out for any threats posed to human health through the continued use of antibiotics that would not be covered by the ban.

One regulation that has since been promulgated by the Food and Drug Agency since Nomura authored her note, is the Veterinary Feed Directive rule. This rule will require agricultural producers to get prescriptions for the animal use of antibiotics “considered important to human health, such as penicillin or sulfa” (see Nikki Work’s article Veterinary Feed Directive Will Impact Whole Livestock Industry, But Many Aren’t Aware of the Regulation at http://www.greeleytribune.com/news/20358154-113/veterinary-feed-directive-will-impact-whole-livestock-industry#). The rule will be fully implemented on Jan. 1, 2017.

While the above regulation does not go so far as Nomura’s proposal to ban all antibiotic use in animals when the medications may also used for human health purposes, it is a step in the direction of increased oversight of antibiotic use by the Food and Drug Agency. It will certainly be interesting to follow future regulations in this area as they appear on the horizon, and how the Veterinary Feed Directive impacts antibiotic use and food production.

Name That Star

February 17, 2016
Space Law

Quang Trang, MJLST Staffer

For space lovers out there, the opportunity to name a star after a loved one sounds like a nice romantic gift for Valentine’s Day. The issue of whether this is actually allowed is somewhere between yes and no.

The main authority in naming astronomical objects is the International Astronomical Union (IAU). The goal of the IAU when formed in 1919 is to “to promote and safeguard the science of astronomy in all of its aspect through international cooperation.” Part of the IAU’s authority in its scientific mission promoting and safeguarding astronomy is the duty of being “the arbiter of planetary and satellite nomenclature.” In normal English, the IAU is the organization that decided Pluto does not qualify to be a planet.

Although the IAU is the leading authority in astronomical nomenclature, the organization still refuses to commercialize outer space by selling the rights to name space objects, such as stars. Due to the IAU being an international scientific organization, it does not have the authority nor the interest in outlawing such a practice. There are many services that would allow you to pick an unregistered star and name it for a fee. However, these multiple services are unrelated and have different databases. Essentially, a star you named with one service may be already be registered under a different name with a different service. Prominent star-naming services such as the International Star Registry are aware of its unofficial status. Rocky Mosele of ISR said “I think people are OK that it’s not official. I’m sure of it. I know because customers call again and again and again.” The ISR’s claims to not mislead any of its customers because it never once claimed to be official.

With each registration costing as much as fifty dollars, one might ask why the IAU does not participate in such a business. The organization would be an industry leader with the ability to give these registered names official status. The proceeds could be used to fund various projects. After receiving many requests to from private individuals to name stars, the IAU explains its policy to stay out of such an enterprise: Thus like true love and many other of the best things in human life, the beauty of the night sky is not for sale, but is free for all to enjoy.

The Affordable Care Act, Meant to Increase Medical Care Accessibility, May in Practicality Hurt That Accessibility Through Narrow Networks

January 28, 2016
Competition, Healthcare, Healthcare Reform

Natalie Gao, MJLST Staffer

The Patient Protection and Affordable Care Act (PPACA) continues to perpetuate some of the issues of medical inaccessibility it was meant to fix. The PPACA uses insurers’ desire to dodge risk to make health insurance more widely available, preventing insurers from refusing coverage based on preexisting conditions and requires they guarantee renewalability without too extensive a waiting period. Although PPACA disincentive insurance companies to risk-select, insurance companies found new ways to compete.

Narrow Networks, the Very Sick, and the Patient Protection and Affordable Care Act: Recalling the Purpose of Health Insurance and Reform by Valarie Blake discusses the creation of narrow networks by insurance companies as new ways to compete, where insurance companies agree to better rates with a narrow group of providers. This allows them to give better prices and premiums to its customers, even if the potential consequences is that the customers actually end up with more restrictive coverage. PPACA theoretically regulates networks, guaranteeing network adequacy of by a minimum standard of care and that the network be with essential community providers. But PPACA does not require network adequacy of providers. Practically, narrow networks can affect the availability of specialize services that some patients need, and the quality and experience of those providers. Even if the need to compete for patients might also ensure that narrow networks never compromise the necessary care, tertiary and specialty care, and the quality of care and connection due the provider, can easily be limited.

“Network adequacy,” states Blake, “is not a debate about access of health insurance but rather access of healthcare.” One way to measure whether or not our health care system is doing what it is supposed to is to measure the health of the very sick, and it brings up the question of whether or not PPACA guarantees all the right of healthcare or the right to be healthy. And what does count as sufficient access and who should be responsible for paying the healthcare costs associated with that sufficient access? These questions evoke analysis for consumer choice and consumer rights. The article recommends that network adequacy standard in both State and Federal law include tertiary and specialized care, and not extra cost be added onto out-of-network care, and the article recommends a special standard for tertiary care be adopted into law. On principle and based the cases that have occurred already around PPACA, narrow networks can easily become an issue that, if left unregulated, can create the very thing it was meant to solve.

USPTO to Decide Who Will Own the Pioneer Gene Editing Patent for the Next Billion-Dollar Industry

January 28, 2016
Biotechnology, Competition, Intellectual Property

Na An, MJLST Staffer

Earlier this month, the United States Patent and Trademark Office (USPTO) declared an interference to determine which one of the two research groups will be awarded the patent protection of one of the most important scientific discoveries in the past decade: CRISPR technology. This technology enables deletion, repair or replacement of genes in such a precise fashion that it could be worth billions of dollars in human health, agriculture and biotechnology industries.

Clustered regularly-interspaced short palindromic repeats system (CRISPR) is a mechanism used by the immune system to resist invading viruses by recording their genetic information and then specifically target these exogenous genetic elements in bacteria, mammals and other organisms. It provides a reliable and precise tool for editing genes. Upon its discovery, CRISPR has been adopted for a wide range of applications from creating animal models with human cancers and turning specific genes on and off to genetically modifying plants.

In 2015, companies rushed to invest and occupy early markets of this potentially billion-dollar industry. The first was Novartis, who signed two deals with gene-editing start-ups to use CRISPR for engineering immune cells and blood stem cells, and as a tool for drug discovery. Soon after, AstraZeneca shook hands with the Wellcome Trust Sanger Institute, the Innovative Genomics Initiative, the Broad and Whitehead Institutes, and Thermo Fisher Scientific to identify and validate new targets in preclinical models with CRISPR. Simultaneously, immunotherapy firm Juno Therapeutics made deals with Editas and Vertex Pharmaceuticals to create anticancer immune cell therapies with an agreement that could be valued at $2.6 billion.

Amid the fast surge of research and commercial opportunities, a patent fight over CRISPR simmers in the background, which raises great uncertainties of the future market structure and commercial potential. The UC Berkeley team, lead by chemist Jennifer Doudna, filed a patent application (No. 13/842,859) on March 15, 2013 with a priority date of May 25, 2012. The application contained broad claims to CRISPR technology, but described only “genetically modified cells that produce Cas9,” an enzyme crucial to CRISPR mechanism, and “Cas9 transgenic non-human multicellular organisms.” On October 15, 2013, the MIT researcher Feng Zhang filed his own patent application (No. 14/054,414) with a priority date of December 12, 2012. Unlike the Doudna application, Zhang contemplated specifically adapting CRISPR in eukaryotic cells. Through Accelerated Examination, USPTO granted Zhang a patent on April 15, 2014, even though Doudna had an earlier invention date and filing date. After several amendments to Doudna application in response to two third-party submissions, the world has been waiting on the USPTO to make a decision. On January 19, 2016, the patent office finally agreed to conduct an interference to decide who was the rightful applicant to award the patent protection on CRISPR.

Since both applications have priority dates prior to March 16, 2013, the patent will be granted on a “first to invent” basis. Interference cases are historically rare and could stretch out for years, considering the high probability that the losing party will appeal the decision. It is unclear what the result will be. Mari Serebrov, regulatory editor at Thomson Reuters BioWorld, said “if the courts rule the technology isn’t patentable, it could chill investment. On the other hand, if one group is allowed the patent, it could result in a monopoly and will probably make licenses more expensive or discourage research because the patents could lock up the field, depending on how broadly they are written.” Faced with the great uncertainty, Monsanto has limited CRISPR’s applications until a decision is made. Tom Adams, vice president of global biotechnology at Monsanto, said “until we understand the intellectual property it’s hard to do much.”

As more capital is pouring in and risks skyrocketing, companies and researchers need to use caution in their inventive and investment activities relating to CRISPR.

Long-Term Success of Autonomous Vehicles Depends on Its First-Generation Market Share

January 25, 2016
Autonomous Vehicles, Business Law, Competition

Vinita Banthia, MJLST Articles Editor

In its latest technology anticipations, society eagerly awaits a functional autonomous car. However, despite the current hype, whether or not these cars will be ultimately successful remains a question. While autonomous cars promise to deliver improved safety standards, lower environmental impacts, and greater efficiency, their market success will depend on how practical the first generation of autonomous vehicles are, and how fast they are adopted by a significantly large portion of the population. Because their usability and practicality depends inherently on how many people are using them, it will be important for companies to time their first release for when they are sufficiently developed and can infiltrate the market quickly. Dorothy J. Glancy provides a detailed account of the legal questions surrounding autonomous cars in Autonomous and Automated and Connected Cars Oh My! First Generation Autonomous Cars in the Legal Ecosystem. This blog post responds to Glancy’s article and suggests additional safety and regulation concerns that Glancy’s article does not explicitly discuss. Finally, this post proposes certain characteristics which must be true of the first generation of autonomous vehicles if autonomous vehicles are to catch-on.

Glancy thoroughly covers the expected benefits of autonomous cars. Autonomous cars will allow persons who are not otherwise able to drive, such as visually impaired people, and the elderly, to get around conveniently. All riders will be able to save time by doing other activities such as reading or browsing the internet during their commute. And in the long run, autonomous vehicles will allow roads and parking lots to be smaller and more compact because of the cars’ more precise maneuvering abilities. Once enough autonomous vehicles are on the road, they will be able to travel faster than traditional cars and better detect and react to dangers in their surroundings. This will decidedly lead to fewer crashes.

On the contrary, several other features may discourage the use of autonomous vehicles. First, because of the mapping systems, the cars will likely be restricted to one geographic region. Second, they might be programmed to save the most number of people during a car crash, even if that means killing the occupant. Therefore, many prospective buyers may not buy a car that is programmed to kill him or her in the event of an inevitable crash. In addition, initial autonomous cars may not be as fast as imagined, depending on whether they can detect faster moving lanes, frequently change lanes, and adapt to changing speed limits. Until there are significant numbers of autonomous cars on roads, they may not be able to drive on longer, crowded roads such as highways, because vehicles will need to interact with each other in order to avoid crashes. Some argue that other car-service provides will suffer as taxis, Ubers, busses, and trails become less relevant. However, this change will be gradual because people will long continue to rely on these services as cheap alternatives to car-ownership.

When these cars are available, in order to promote autonomous cars to enter the market rapidly, manufacturers should make the cars most attractive to potential buyers, instead of making them good for society as a whole. For example, instead of programming the car to injure its own occupants, it should be programmed to protect its occupants. This will encourage sales of autonomous cars, reducing the number of car crashes in the long run.

Glancy also states that the first generation of autonomous vehicles will be governed by the same state laws that apply for conventional vehicles, and will not have additional rules of their own. However, this is unlikely to be true, and specific state and possibly even federal laws will most likely affect autonomous vehicles before they may be driven on public roads and sold to private individuals. Because autonomous cars will co-exist with traditional vehicles, many of these laws will address the interaction between autonomous and conventional cars, such as overtaking, changing lanes, and respecting lane restrictions.

In the end, the success of autonomous cars depends widely on how practical the first fleet is, how many people buy into the idea and how fast, as well as the car’s cost. If they are successful, there will be legal and non-legal benefits and consequences, which will only be fully realized after a few decades of operation of the cars.

Are News Aggregators Getting Their Fair Share of Fair Use?

January 20, 2016
Copyrights, Internet, Social Media

Mickey Stevens, MJLST Note & Comment Editor

Fair use is an affirmative defense to copyright that permits the use of copyrighted materials without the author’s permission when doing so fulfills copyright’s goal of promoting the progress of science and useful arts. One factor that courts analyze to determine whether or not fair use applies is whether the use is of a commercial nature or if it is for nonprofit educational purposes—in other words, whether the use is “transformative.” Recently, courts have had to determine whether automatic news aggregators can invoke the fair use defense against claims of copyright infringement. An automatic news aggregator scrapes the Internet and republishes pieces of the original source without adding commentary to the original works.

In Spring 2014, MJLST published “Associated Press v. Meltwater: Are Courts Being Fair to News Aggregators?” by Dylan J. Quinn. That article discussed the Meltwater case, in which the United States District Court for the Southern District of New York held that Meltwater—an automatic news aggregator—could not invoke the defense of fair use because its use of copyrighted works was not “transformative.” Meltwater argued that it should be treated like search engines, whose actions do constitute fair use. The court rejected this argument, stating that Meltwater customers were using the news aggregator as a substitute for the original work, instead of clicking through to the original article like a search engine.

In his article, Quinn argued that the Meltwater court’s interpretation of “transformative” was too narrow, and that such an interpretation made an untenable distinction between search engines and automatic news aggregators who function similarly. Quinn asked, “[W]hat if a news aggregator can show that its commercial consumers only use the snippets for monitoring how frequently it is mentioned in the media and by whom? Is that not a different ‘use’?” Well, the recent case of Fox News Network, LLC v. TVEyes, Inc. presented a dispute similar to Quinn’s hypothetical that might indicate support for his argument.

In TVEyes, Fox News claimed that TVEyes, a media-monitoring service that aggregated news reports into a searchable database, had infringed copyrighted clips of Fox News programs. The TVEyes database allowed subscribers to track when, where, and how words of interest are used in the media—the type of monitoring that Quinn argued should constitute a “transformative” use. In a 2014 ruling, the court held that TVEyes’ search engine that displayed clips was transformative because it converted the original work into a research tool by enabling subscribers to research, criticize, and comment. 43 F. Supp. 3d 379 (S.D.N.Y. 2014). In a 2015 decision, the court analyzed a few specific features of the TVEyes service, including an archiving function and a date-time search function. 2015 WL 5025274 (S.D.N.Y. Aug. 25, 2015). The court held that the archiving feature constituted fair use because it allowed subscribers to detect patterns and trends and save clips for later research and commentary. However, the court held that the date-time search function (allowing users to search for video clips by date and time of airing) was not fair use. The court reasoned that users who have date and time information could easily obtain that clip from the copyright holder or licensing agents (e.g. by buying a DVD).

While the court’s decision did point out that the video clip database was different in kind from that of a collection of print news articles, the TVEyes decisions show that the court may now be willing to allow automatic news aggregators to invoke the fair use defense when they can show that their collection of print news articles enables consumers to track patterns and trends in print news articles for research, criticism, and commentary. Thus, the TVEyes decisions may lead the court to reconsider the distinction between search engines and automatic news aggregators established in Meltwater that puts news aggregators at a disadvantage when it comes to fair use.

Requiring Backdoors Into Encrypted Cellphones

January 20, 2016
Constitutional Law, Cyber Security, Data, First Amendment, Privacy

Steven Groschen, MJLST Managing Editor

The New York State Senate is considering a bill that requires manufacturers and operating system designers to create backdoors into encrypted cellphones. Under the current draft, failure to comply with the law would result in a $2,500 fine, per offending device. This bill highlights the larger national debate concerning privacy rights and encryption.

In November of 2015, the Manhattan District Attorney’s Office (MDAO) published a report advocating for a federal statute requiring backdoors into encrypted devices. One of MDAO’s primary reasons in support of the statute is the lack of alternatives available to law enforcement for accessing encrypted devices. The MDAO notes that traditional investigative techniques have largely been ineffective. Additionally, the MDAO argues that certain types of data residing on encrypted devices often cannot be found elsewhere, such as on a cloud service. Naturally, the inaccessibility of this data is a significant hindrance to law enforcement. The report offers an excellent summary of the law enforcement perspective; however, as with all debates, there is another perspective.

The American Civil Liberties Union (ACLU) has stated it opposes using warrants to force device manufacturers to unlock their customers’ encrypted devices. A recent ACLU blog post presented arguments against this practice. First, the ACLU argued that the government should not require “extraordinary assistance from a third party that does not actually possess the information.” The ACLU perceives these warrants as conscripting Apple (and other manufacturers) to conduct surveillance on behalf of the government. Second, the ACLU argued using search warrants bypasses a “vigorous public debate” regarding the appropriateness of the government having backdoors into cellphones. Presumably, the ACLU is less opposed to laws such as that proposed in the New York Senate, because that process involves an open public debate rather than warrants.

Irrespective of whether the New York Senate bill passes, the debate over government access to its citizens’ encrypted devices is sure to continue. Citizens will have to balance public safety considerations against individual privacy rights—a tradeoff as old as government itself.

Patent Damages

January 20, 2016
Competition, Intellectual Property, Patents

Tianxiang (Max) Zhou, MJLST Staffer

In Dec. 2015, almost five years after Apple sued Samsung for infringing a smartphone design patent, Samsung agrees to pay Apple $548 million. Apple is now demanding Samsung pay an additional $180 million for the patent dispute. Besides the huge amounts of damages, the case is not over and it continues raising fundamental issues of how to evaluate values of design patent infringements.

In the petition for writ of certiorari challenging the $400 million that it has paid for infringing Apple’s design patent, Samsung writes, “The questions presented are: . . . Where a design patent is applied to only a component of a product, should an award of infringer’s profits be limited to those profits attributable to the component?”

The second issue stated in the writ is noteworthy. Under the current rule, the awards in a design patent infringement case to the patent owner are the whole profits from the sale of the infringing products. This rule has created and will create massive jury verdicts in design patent infringement cases, and the Supreme Court has not reviewed the rule. As Samsung writes in the petition, “the Supreme Court has not reviewed a design-patent case in more than 120 years.” With the new development of the industries and various design patents, it is doubted whether the awards of whole profits are reasonable.

Although statistically the Supreme Court will not take the case, the issue of design patent awards raised heated discussions. In 2014, a group of 27 law professors submitted an amicus brief in support of Samsung urging the Federal Circuit to interpret the relevant statutory provision to limit the award of profits in design patent infringement cases. The amicus brief stated: “the Court should require proof of some connection between the patented design and the defendant’s profits, the order the district court to remit the award of profits to the extent it exceeds those profits attributable to the patented designs.” The professors argued the origin and context of the controlling statute Section 289, and that awarding a defendant’s entire profits makes no sense in the modern world, and to prevent disgorgement of profits.

As stated above, the Supreme Court has not reviewed the issue for over one hundred years. With the unsettled dispute between Samsung and Apple continuing, we could look forward to whether the Supreme Court would take the case and redefine Section 289. However, a question posed to the judges is, if the awards to the design patent infringement are not the whole profits of the sale, then what proportion of the profits should be awarded? Judges should figure out a reasonable standard to evaluate the amount attribute to the infringed design.

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