Articles by mjlst

Mechanical Curation: Spotify, Archillect, Algorithms, and AI

October 15, 2017
Artificial Intelligence, Copyrights, Intellectual Property

Jon Watkins, MJLST Staffer

 

A great deal of attention has been paid recently to artificial intelligence. This CGPGrey YouTube video is typical of much modern thought on artificial intelligence. The technology is incredibly exciting- until it threatens your job. This train of thought has led many, including the video above, to search for kinds of jobs which are unavoidably “human,” and thereby safe.

 

However, any feeling of safety that lends may be illusory. AI programs like Emily Howell, which composes sheet music, and Botnik, which writes jokes and articles, are widespread at this point. What these programs produce is increasingly indistinguishable from human-created content- not to mention increasingly innovative. Take, as another example, Harold Cohen’s comment on his AARON drawing program: “[AARON] generates objects that hold their own more than adequately, in human terms, in any gathering of similar, but human-produced, objects. . . It constitutes an existence proof of the power of machines to do some of the things we had assumed required thought. . . and creativity, and self-awareness.”

 

Thinking about what these machines create brings up more questions than answers. At what point is a program independent from its creator? Is any given “AI” actually creating works by itself, or is the author of the AI creating works through a proxy? The answer to these questions are enormously important, and any satisfying answer must have both legal and technical components.

 

To make the scope of these questions more manageable, let’s limit ourselves to one specific subset of creative work- a subset which is absolutely filled with “AI” at the moment- curation. Curation is the process of sorting through masses of art, music, or writing for the content that might be worth something to you. Curators have likely been around as long as humans have been collecting things, but up until recently they’ve been human. In the digital era, most people likely carry a dozen curators in their pocket. From Spotify and Pandora’s predictions of the music you might like, to Archillect’s AI mood board, to Facebook’s “People You May Know”, content curation is huge.

 

First, the legal issues. Curated collections are eligible for copyright protection, as long as they exhibit some “minimal degree of creativity.” Feist v. Rural Telephone Co., 499 U.S. 340, 345 (1991). However, as a recent monkey debacle clarified, only human authors are protected by copyright. This is implied by § 102 of the Copyright Act, which states in part that copyright protection subsists “in original works of authorship.” Works of authorship are created by authors, and authors are human. Therefore, at least legally, the author of the AI may be creating works through a proxy. However, as in the monkey case above, some courts may find there is no copyright-eligible author at all. If neither a monkey, nor a human who provides the monkey with creative tools is an author, is a human who provides a computer with creative tools an author? Goldstein v. California, a 1973 Supreme Court case, has been interpreted as standing for the proposition that computer-generated work must include “significant input from an author or user” to be copyright eligible. Does that decision need to be updated for a different era of computers?

 

The answer to this question is where a technical discussion may be helpful, because the answer may involve a simple spectrum of independence.

 

On one end of the spectrum is algorithmic curation which is deeply connected to decisions made by the algorithm’s programmer. If a programmer at Spotify writes a program which recommends I listen to certain songs, because those songs are written by artists I have a history of listening to, the end result (the recommendation) is only separated by two or three steps from the programmer. The programmer creates a rigid set of rules, which the computer implements. This seems to be no less a human work of authorship than a book written on a typewriter. Just as a programmer is separated from the end result by the program, a writer may be separated from the end result by various machinery within the typewriter. The wishes of both the programmer and the writer are carried out fairly directly, and the end results are undoubtedly human works of authorship.

 

More complex AI, however, is often more independent. Take for example Archillect, whose creator stated in an interview “It’s not reflecting my taste anymore . . .I’d say 60 percent of the things [she posts] are not things that I would like and share.” The process involved in Archillect, as described in the same interview, is much more complex than the simple Spotify program outlined above- “Deploying a network of bots that crawl Tumblr, Flickr, 500px, and other image-heavy sites, Archillect hunts for keywords and metadata that she likes, and posts the most promising results. . .  her whole method of curation is based on the relative popularity of her different posts.”

 

While its author undoubtedly influenced Archillect through various programming decisions (which sites to set up bots for, frequency of posts, broad themes), much of what Archillect does is what we would characterize as judgement calls if a human were doing the work. Deeply artistic questions like “does this fit into the theme I’m shooting for?” or “is this the type of content that will be well-received by my target audience?” are being asked and answered solely by Archillect, and are answered- as seen above- differently from how Archillect’s creator would answer them.

Even closer to the “independent” end of the spectrum, however, even more complex attempts at machine curation exist. This set of programs includes some of Google’s experiments, which attempt to make a better curator by employing cutting-edge machine learning technology. This attempt comes from the same company which recently used machine learning to create an AI which taught itself to walk with very little programmer interaction. If the same approaches to AI are shared between the experiments, Google’s attempts at creating a curation AI might result in software more independent (and possibly more worthy of the title of author) than any software yet.

Health in the Fast Lane: FDA’s Effort to Streamline Digital Health Technology Approval

October 7, 2017
FDA, Health, Regulatory, Uncategorized

Alex Eschenroeder, MJLST Staffer

 

The U.S. Food and Drug Administration (FDA) is testing out a fast-track approval program to see if it can accommodate the pace of innovation in the technology industry and encourage more ventures into the digital health technology space. Dr. Scott Gottlieb M.D., Commissioner of the FDA, announced the fast-track pilot program—officially named the “Pre-Cert for Software Pilot Program” (Program)—on July 27, 2017. Last week, the FDA announced the names of the nine companies it selected out of more than 100 applicants to participate in the Program. Companies that made it onto the participant list include tech giants such as Apple and Samsung, as well as Verily Life Sciences—a subsidiary of Alphabet, Inc. The FDA also listed smaller startups, indicating that it intends to learn from entities at various stages of development.

The FDA idea that attracted applicants from across the technology industry to the Program is roughly analogous to the TSA Pre-Check Program. With TSA Pre-Check certification, travelers at airports get exclusive access to less intensive pre-boarding security procedures because they submitted to an official background check (among other requirements) well before their trip. Here, the FDA Program completes extensive vetting of participating technology companies well before they bring a specific digital health technology product to market. As Dr. Gottlieb explained in the July Program announcement, “Our new, voluntary pilot program will enable us to develop a tailored approach toward this technology by looking first at the . . . developer, rather than primarily at the product (as we currently do for traditional medical products).” If the FDA determines through its review that a company meets necessary quality standards, it can pre-certify the company. A pre-certified company would then need to submit less information to the FDA “than is currently required before marketing a new digital health tool.” The FDA even proposed the possibility of a pre-certified company skipping pre-market review for certain products, as long as the company immediately started collecting post-market data for FDA to confirm safety and effectiveness.

While “digital health technology” does not have a simple definition, a recently announced Apple initiative illustrates what the term can mean and how the FDA Program could encourage its innovation. Specifically, Apple recently announced plans to undertake a Heart Study in collaboration with Stanford Medicine. Through this study, researchers will use “data from Apple Watch to identify irregular heart rhythms, including those from potentially serious heart conditions like atrial fibrillation.” Positive research results could encourage Apple, which “wants the Watch to be able to detect common heart conditions such as atrial fibrillation”, to move further into FDA regulated territory. Indeed, Apple has been working with the FDA, aside from the Program, to organize the Heart Study. This is a critical development, as Apple has intentionally limited Watch sensors to “fitness trackers and heart rate monitors” to avoid FDA regulation to date. If Apple receives pre-certification through the Program, it could issue updates to a sophisticated heart monitoring app or issue an entirely different diagnostic app with little or no FDA pre-market review. This dynamic would encourage Apple, and companies like it, to innovate in digital health technology and create increasingly sophisticated tools to protect consumer health.

Congress, Google Clash Over Sex-Trafficking Liability Law

September 29, 2017
Internet, Public Health, Social Media

Samuel Louwagie, MJLST Staffer

Should web companies be held liable when users engage in criminal sex trafficking on the platforms they provide? Members of both political parties in Congress are pushing to make the answer to that question yes, over the opposition of tech giants like Google.

The Communications Decency Act was enacted in 1934. In the early 1990s, as the Internet went live, Congress added Section 230 to the act. That provision protected providers of web platforms from civil liability for content posted by users of those platforms. The act states that in order to “promote the continued development of the internet . . . No provider of an interactive computer service shall be treated as the publisher or speaker of any information provided by another information content provider.” That protection, according to the ACLU, “defines Internet culture as we know it.”  

Earlier this month, Congress debated an amendment to Section 230 called the Stop Enabling Sex Traffickers Act of 2017. The act would remove that protection from web platforms that knowingly allow sex trafficking to take place. The proposal comes after the First Circuit Court of Appeals held in March of 2016 that even though Backpage.com played a role in trafficking underage girls, section 230 protected it from liability. Sen. Rob Portman, a co-sponsor of the bill, wrote that it is Congress’ “responsibility to change this law” while “women and children have . . . their most basic rights stripped from them.” And even some tech companies, such as Oracle, have supported the bill.

Google, meanwhile, has resisted such emotional pleas. Its lobbyists have argued that Backpage.com could be criminally prosecuted, and that to remove core protections from internet companies will damage the free nature of the web. Critics, such as New York Times columnist Nicholas Kristof, argue the Stop Enabling Sex Traffickers Act was crafted “exceedingly narrowly to target those intentionally engaged in trafficking children.”

The bill has bipartisan support and appears to be gaining steam. The Internet Association, a trade group including Google and Facebook, expressed a willingness at a Congressional hearing to supporting “targeted amendments” to the Communications Decency Act. Whether Google likes it or not, eventually platforms will be at legal risk if they don’t police their content for sex trafficking.

In Doge We Trust

September 29, 2017
Economy, International Law, Internet

Richard Yo, MJLST Staffer

Despite the closure of virtually all U.S.-based Bitcoin exchanges in 2013 due to Congressional review and the uncertainty with which U.S. banks viewed its viability, the passion for cryptocurrencies has remained strong, especially among technologists and venture capitalists. This passion reached an all-time high in 2017 when one Bitcoin exchanged for 5000 USD.** Not more than five years ago, Bitcoin exchanged for 13 USD. For all its adoring supporters, however, cryptocurrencies have yet to gain traction in mainstream commerce for several reasons.

Cryptocurrencies, particularly Bitcoin, have been notoriously linked to dark web locales such as the now-defunct Silk Road. A current holder of Bitcoin, Litecoin, or Monero, would be hard pressed to find a completely legal way to spend his coins or tokens without second guessing himself. A few legitimate enterprises, such as Microsoft, will accept Bitcoin but only with very strict limitations, effectively scrubbing it of its fiat currency-like qualities.

The price of your token can take a volatile 50% downswing or 3000% upswing in a matter of days, if not hours. If you go to the store expecting to purchase twenty dollars’ worth of groceries, you want to be sure that the amount of groceries you had in mind at the beginning of your trip is approximately the amount of groceries you will be able to bring back home.

After the U.S. closures, cryptocurrency exchanges found havens in countries with strong technology bases. Hotbeds include China, Russia, Japan, and South Korea, among others. However, the global stage has recently added more uncertainty to the future of cryptocurrency. In March 2017, the Bank of Japan declared Bitcoin as an official form of payment. Senators in Australia are attempting to do the same. China and Russia, meanwhile, are home to most Bitcoin miners (Bitcoin is “mined” in the sense that transactions are verified by third-party computers, the owners of which are rewarded for their mining with Bitcoins of their own) due to low energy costs in those two nations and yet are highly suspicious of cryptocurrencies. China has recently banned the use of initial coin offerings (ICOs) to generate funds and South Korea has followed suit. Governments are unsure of how best to regulate, or desist from regulating, these exchanges and the companies that provide the token and coins. There’s also a legitimate question as to whether a cryptocurrency can be regulated given the nimbleness of the technology.

On this issue, some of the most popular exchanges are sometimes referred to as “regulated.” In truth, this is usually not in the way that consumers would think a bank or other financial institution is regulated. Instead, the cryptocurrency exchange usually imposes regulations on itself to ensure stability for its client base. It requires several forms of identification and multi-factor authentication that rivals (and sometimes exceeds) the security provided by traditional banks. These were corrections that were necessary after the epic 2014 failure of the then-largest cryptocurrency exchange in the world, Mt. Gox.

Such self-adjustments, self-regulation, and stringency are revealing. In the days of the Clinton administration when internet technology’s ascent was looming, the U.S. government adopted a framework for its regulation. That framework was unassuming and could possibly be pared to a single rule: we will regulate it when it needs regulating. It asked that this technology be left in the hands of those who understand it best and allow it to flourish.

This seems to be the approach that most national governments are taking. They seem to be imposing restrictions only when deemed necessary, not banning cryptocurrencies outright.

For Bitcoin and other cryptocurrencies, the analogous technology may be the “blockchain” that underlies their structure, not the tokens or coins themselves. The blockchain is a digital distributed ledger that provides anonymity, uniformity, and public (or private) access, using complex algorithms to verify and authenticate information. When someone excitedly speaks about the possibilities of Bitcoin or another cryptocurrency, they are often describing the features of blockchain technology, not the coin.

Blockchain technology has already proven itself in several fields of business and many others are hoping to utilize it to effectuate the efficient and reliable dissemination and integration of information. This could potentially have sweeping effects in areas such as medical record-keeping or title insurance. It’s too early to know and far too early to place restrictions. Ultimately, cryptocurrencies may be the canary that gets us to better things, not the pickaxe.

 

*Dogecoin is the cryptocurrency favored by the Shina Inu breed of dog, originally created as a practical joke, but having since retained its value and now used as a legitimate form of payment.

**The author holds, or has held, Bitcoin, Ether, Litecoin, Ripple, and Bitcoin Cash.

Invisible Cryptography: Should Quantum Communications Be Subjected to Legal Restraint?

September 23, 2017
New Technology, Patents

Jacob Weindling, MJLST Staffer

Sending secret messages across the world has traditionally required sending messages that risked interception or eavesdropping by unintended recipients. Letters sent on horseback, telegraphs sent over wires, and radio transmissions through the atmosphere were all theoretically capable of interception in transit between the sender and the receiver. This problem was particularly pronounced in World War II, when the Allies easily intercepted secret Axis transmissions and vice versa. To ensure secrecy the messages were consequently encoded, resulting in seemingly random jumbles of characters to unintended recipients.

Message encoding in World War II operated on two separate principles. For particularly sensitive messages, ‘one-time pads’ were created using (theoretically) random values as starting points. This technique for encryption, while essentially ‘unbreakable’ without access to a copy of the one-time pad, required both the sender and the recipient to hold identical copies of the pads. The second method used machines to transform plaintext messages into code. This second method, famously employed by Nazi Germany’s Enigma machine, substituted true randomness for a complicated but non-random algorithm that provided convenience and reliability. While Enigma proved a sufficient safeguard against traditional pen-and-paper codebreakers, early computers proved adept at quickly defeating the encryption, as dramatically highlighted in “The Imitation Game,” the recent film detailing Alan Turing’s invention of a codebreaking computer during World War II.

Perhaps unsurprisingly, cryptographic systems were added to the State Department’s International Traffic in Arms Regulations (“ITAR”) Munitions List shortly after World War II. Thus, while the U.S. government was severely limited in its ability to shield secret messages from foreign adversaries, it categorized the tools, methods, and development of cryptographic systems as munitions and severely regulated their export to foreign entities. While today the Department of State has narrowed the scope of cryptography to exclude civilian products, regulations remain on specialized military applications. A key assumption of this regulatory regime is that sensitive diplomatic and military information will be transmitted ‘in the clear’ for all who happen to have access to the channel of communications. While today many communications have moved from radio waves to fiberoptic cables, both systems remain vulnerable to surveillance over the air and online.

Last year however, China took a major step toward a vast departure in the philosophy of secret communication. With the launch of the Quess satellite, China hopes to enable quantum entanglement communication between two ground sites. The satellite would in principle transmit a photon to the ground, while retaining a photon that is ‘entangled’ with the released photon. Any changes to the photon on the satellite would thus be reflected in the photon on the ground, serving as a rudimentary method for transmitting binary information. This test comes on the heels of an experiment at Delft University of Technology in the Netherlands, which demonstrated the transmission of information between two electrons separated by a distance of 17 kilometers.

A unique feature of this mode of transmission is that information is not propagated from the sender to the receiver via radio waves, which can be intercepted, but rather via the principle of quantum entanglement. Any attempt to eavesdrop would theoretically be perfectly detectable, as the act of observing the photons being transmitted would potentially change their state and render the communication either unreadable or otherwise obviously tampered with. A system could therefore be developed to automatically cut off communications if disturbances are detected.

Interestingly enough, the U.S. Patent and Trademark Office has granted a patent that describes a similar method for transmitting information via quantum entanglement. The invention, claimed by Zhiliang Yuan and Andrew James Shields on behalf of Toshiba Corporation, was filed with the PTO on September 8, 2006 and published August 7, 2012. This patent builds on prior art that envisioned quantum cryptography, much of which was quietly filed with the PTO during the preceding two decades. Nevertheless, neither Congress nor the Department of State has acted to incorporate any reference to quantum communications into law, perhaps reflecting an unwillingness to address emerging technology that sounds like science fiction, as with self-driving cars and cyberspace before it.

Despite Congress’ history of lethargy in addressing new innovations and the State Department’s regulatory silence on the matter, legislative action or regulation may yet be premature. China has claimed its satellite has successfully sent a ‘hack-proof’ communication from its satellite, but the results have not been studied by the scientific community. Furthermore, no public demonstration has been made of a practical, non-laboratory quantum entanglement communication product. Even if the technology were to be brought to market, any early application will likely have severely low bandwidth by today’s standards, more closely resembling the telegraph than a gigabit internet connection. But with organizations around the world exploring ground- and space-based experiments with quantum communications, the technology appears poised to exit science fiction and enter practical application. Within the next generation, the codebreaking arms race may ultimately become obsolete, and Congress will be faced with a need to address the new secret communication regime.

Scents: The Unconventional Potential for Trademarks

September 14, 2017
Trademark Law, Uncategorized

Amber Peterson, MJLST Staffer

Trademarks are intended to create an immediate brand recognition in the consumer’s mind. Consumers who are satisfied with a product must have a way to easily distinguish it from nearly identical or similar products from competitors. Thus, trademarks play a powerful role in branding and marketing as seen in the Nike “swoosh” and the Target bullseye. These traditional marks or logos are what are typically thought of when thinking about trademarks. However, unconventional trademarks such as the catch phrase “Hasta la Vista Baby” from the film, “The Terminator” and the red color of Christian Louboutin soles can be just as effective to identify a product or service.

The key requirement is distinctiveness. If a product can be thought of as inherently distinctive, it can be trademarked. Thus, the United States Patent and Trademark Office allows the trademarking of a scent since scent is distinctive in that it is deeply tied to memory recognition. Although this option is available, few have accomplished the task since the Patent and Trademark Office has put strict boundaries around what smells qualify.

First, the scent must serve no important practical function other than to help identify and distinguish the brand. This means that those smells whose only purpose is smell-related, such as perfumes and air fresheners, cannot receive scent trademark protection. Second, a detailed written description of the non-visual mark is required to complete the registration process. The problem with scents is the subjective nature of them. The perception of smell can be very different among a number of noses and is thus open to interpretation. This creates difficulty in successfully representing the scent graphically which is required to determine whether something is or is not appropriate for a trademark.

To date, there are only about 12 scent trademarks in the United States (e.g., the flowery musk smell in Verizon Wireless stores and the pina colada scent that a ukulele company scents its ukuleles with). As evidenced, the process of registering a scent can be challenging. However, there are marketing advantages that may make it worthwhile if the product or service resonates more deeply with a consumer compared to a typical visual mark or logo trademark.

Artificial Wombs and the Abortion Debate

September 12, 2017
Health, New Technology, Reproductive Health

Henry Rymer, MJLST Staffer

In a study published in the latter part of April 2017, a group of scientists reported that they had created an “extra-uterine system” that assisted in the gestation, and eventual birth, of several fetal lambs. This device, which houses the fetus in a clear plastic bag, is filled with a synthetic amniotic fluid that flows in and out of the bag through a pump system. While inside this artificial womb, the fetus is attached to a machine outside of the bag by its umbilical cord. This machine is used for several purposes: providing nutrition to the fetus, giving the fetus necessary medication, providing the blood of the fetus with a blend of air, oxygen and nitrogen, and removing carbon dioxide from the bloodstream. The scientists report that in housing the premature lamb fetuses in this system, the scientists were able to “maintain stable haemodynamics, have normal blood gas and oxygenation parameters, and maintain patency of the fetal circulation” within the fetuses. Additionally, the scientists report that the fetal lambs subject to this test were able to demonstrate “normal somatic growth, lung maturation and brain growth and myelination.” The scientists’ report that they believe that this extra-uterine system would not be relegated only to animal use, as they believe that the device could support a premature human infant “for up to four weeks.”

With the advent of this new piece of neonatal technology, specifically with the implications of what this invention (and others like it) would have on fetal development for humans, the artificial womb poses the power to completely shift the paradigm in regards to how the abortion debate is framed. In particular, the impact that this invention will have when combined with American jurisprudence will surely be a new point of contention between Pro-Abortion activists and their Anti-Abortion counterparts.

With the Supreme Court case of Planned Parenthood v. Casey, SCOTUS re-enshrined the thesis of Roe v. Wade: namely that women have the right to have an abortion prior to the viability of the fetus. Planned Parenthood of Southeastern Pa. v. Casey, 505 U.S. 833, 846. The Casey court also stated that states have the power to “restrict abortions after fetal viability, if the law contains exceptions for pregnancies which endanger the woman’s life or health” and that the “State has a legitimate interest from the outset of the pregnancy in protecting the health of the woman and the life of the fetus that may become a child.” Id.

The arguments that arise from the advent of an artificial womb in conjunction with case law flows from the notion of what a “viable” fetus would be after extra-uterine systems become more mainstream and sophisticated. If these machines develop to a point in which they can take a fetus the moment after conception and develop it for its entire gestation period, will abortion procedures become completely outlawed? Will “viability” remain the measure by which a fetus is distinguished from a human, or will a new metric be invented to replace “viability?” Additionally, will this be a problem that the courts will have to answer? The legislature? Or a combination of both? The invention of artificial wombs seems to be a periphery legal issue that will not have to be answered for some time yet. However, there are many questions that need to be answered as technology improves and develops, and the abortion debate will not be a topic that will remain untouched as humanity moves into the future.

The Future of AI in Self-Driving Vehicles

September 11, 2017
Autonomous Vehicles, Public Safety, Regulatory

Kevin Boyle, MJLST Staffer

 

Last week, artificial intelligence (AI) made a big splash in the news after Russian President Vladimir Putin and billionaire tech giant Elon Musk both commented on the subject. Putin stated that whoever becomes the leader in artificial intelligence (AI) will become “the ruler of the world.” Elon Musk followed up Putin’s comments by declaring that competition for AI superiority between nations will most likely be the cause of World War III. These bold predictions grabbed the headlines; but in the same week, Lyft announced a new partnership with a company that produces AI for self-driving cars and the House passed the SELF DRIVE Act. The Lyft deal and the House bill are positive signs for investors of the autonomous vehicle industries; however, the legal landscape remains uncertain. As Putin and Musk have predicted, AI is certain to have a major impact on our future, but current legal hurdles exist before AI’s applications in self-driving vehicles can reach its potential.

 

One of the legal hurdles that currently exists is the varying laws between state and federal authorities. For example, Companies such as Google and Ford would like to introduce cars with no pedals or steering wheels that are operated entirely by AI. However, most states still require that a human driver be able to take “active physical control” of the car to manually override the autonomous vehicle. This requires a steering wheel and brakes, which would make those cars illegal to operate. At the federal level, the FAA requires that commercial drones be flown by certified operators, not computers or AI. Requiring operators instead of AI to steer drones for deliveries severely limits the potential of this innovative technology. Furthermore, international treaties, including the Geneva Convention, need to be addressed before we see fully autonomous cars.

 

The bipartisan SELF DRIVE Act recently passed by the House attempts to address most of the issues created by the patchwork of local, state, and federal regulations so that AI in self-driving cars can reach its potential. The House bill proposed clear guidelines for car manufacture guidelines, clarified the role of the NHTSA in regulating automated driving systems, and detailed cybersecurity requirements for automated vehicles. The Senate, however, is drafting its own bill for the SELF DRIVE Act. This week, the Senate Commerce, Science, and Transportation Committee will convene a hearing on automated safety technology in self-driving vehicles and the potential impacts on the economy. The committee will hear testimony from car manufacturers, public interest groups, and labor unions. Some of these groups will inevitably lobby against this bill and self-driving technology for fear of the potentially devastating impact on jobs in some industries. But ideally, the Senate bill will stick to the fundamentals from the House bill, which focuses on prioritizing safety, strengthening cybersecurity, and promoting the continued innovation of AI in autonomous vehicles.

 

Several legal obstacles still exist that are preventing the implementation of AI in automated vehicles. Congress’ SELF DRIVE Act has the potential to be a step in the right direction. The Senate needs to maintain the basic elements of the bill passed in the House to help advance the use of the innovative AI technology in self-driving cars. Unlike Musk, Mark Zuckerberg has taken a stance similar to those in the auto industry, and believes AI will bring about countless “improvements in the quality of our lives,” especially in the application of AI in self-driving vehicles.

 

 

Snortable Chocolate Fails the Smell Test, but What Exactly Is It?

July 13, 2017
Drug Policy, FDA, Food and Agriculture

Tommy Tobin, MJLST Guest Blogger

 

Snorting chocolate does not sound like a good idea. In fact, it sounds downright crazy. Enter the aptly named “Coco Loko.”

As reported by the AP, Coco Loko is a cocktail of cacao powder and common energy-drink ingredients, such as guarana and taurine. Marketed by a company called Legal Lean, the product makes several bold claims and promises, including feelings similar to ecstasy and “a steady rush of euphoric energy that is great for party goers to dance the night away without a crash.” Oddly, that promised effect is juxtaposed with promises of “calm focus” and “natural relaxation.”

Legal Lean advises users to “consume responsibly.” Warnings include the all too familiar boilerplate that product statements have not been evaluated by FDA and that the products are not intended to diagnose or treat any disease. A notable product warning also advises potential customers that Coco Loko is “not recommended for children or pregnant women.” Legal Lean also notes that the product “may impair your ability to drive a car or operate machinery, and may cause health problems.” It is certainly helpful that the company recognizes that snorting a chocolate concoction up one’s nose may result in health issues and is warning potential consumers accordingly. Self magazine summarized the situation succinctly: “If it sounds like a bad idea to snort what basically amounts to glorified hot chocolate mix, you’re right.”

As the Huffington Post recently put it, “snortable chocolate exists now, for some reason.” The mere fact that this product exists raises myriad questions, not least of which is what the product actually is and how it will be regulated.

According to ABC News, FDA is currently weighing whether the product falls within its jurisdiction and is currently “not prepared to issue a determination regarding whether and how this product is subject to FDA jurisdiction at this time. In reaching that decision, FDA will need to evaluate the product labeling, marketing information, and/or any other information pertaining to the product’s intended use.”

While the intricacies of regulatory classifications are enough to make one crazy, Coco Loko’s regulatory future remains to be seen. As the administrative law bloodhounds at FDA continue their work sniffing out the proper classification for this product, here are some preliminary thoughts.

 

Is Coco Loko a Food?

Strictly speaking, probably not. The statutory definition of food, 21 U.S.C. § 321 (f), is not tremendously helpful here. The statute’s most applicable definition defines “food” as an article used for food or drink for man or other animals. Snorting something through one’s nose is not generally how most people consume their food or drink, especially as the nose is woefully devoid of taste buds.

Legal Lean may argue that an alternative use of the product is as a hot chocolate mix. Presumably, the Coco Loko powder could be used as a drink when dissolved in hot water. Even so, the company markets the product as “infused raw cacao snuff.”

The product’s marketing as “snuff” is highly suggestive that the company does not consider that the product is meant to be food, given that “snuff” is taken through the nose. Put differently, the company may huff and puff that the product is a “food,” but in the end, the stuff is “snuff” by their own admission.

 

Is it a Drug?

Possibly. Coco Loko is likely not a “drug” under 21 U.S.C. § 321 (g). One applicable definition of “drug” includes items “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals.” Such an intention is expressly disclaimed by the makers of Coco Loko.

Another definition of “drug” applies to “articles (other than food) intended to affect the structure or any function of the body of man or other animals,” with a carve-out for foods and dietary supplements. Coco Loko does promise a rush of serotonin and endorphins, as well as “increased overall happiness.”

The structure or function claims made by Coco Loko could make it a “drug” if it is found to be neither a food nor dietary supplement. Put another way, the product appears to be an inhaled stimulant, and regulators could plausibly put it in the category of “drug” given the claims the product is making, in the case that the product does not fit in other categories.

 

Is it a Dietary Supplement?

It depends. Regulators could label Coco Loko as a “dietary supplement” under 21 U.S.C. § 321 (ff). Just as the definition of “food” was quite broad, so too is the statutory definition of “dietary supplements,” which helpfully notes that the term:

 

“1) means a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients:

(A) a vitamin;

(B) a mineral;

(C) an herb or other botanical;

(D) an amino acid;

(E) a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or

(F) a concentrate, metabolite, constituent, extract, or combination of any ingredient described in clause (A), (B), (C), (D), or (E).”

 

Given the inclusion of cacao in the product, a colorable claim could be that Coco Loko contains a dietary substance used by man to supplement the diet. That said, is someone actually supplementing their diet by inhaling through their nose? Not being a doctor myself, I can only surmise that the snorted chocolate may have a circuitous path from the nose to one’s stomach—if it ends up there at all.

More on the nose, US News & World Report notes that the product’s label includes B vitamins, ginkgo biloba, blood flow-improving amino acid L-Arginine, as well as energy drink staples guarana and taurine. So, it would seem that Coco Loko would meet the vitamin and amino acid test.

Other aspects of the “dietary supplement” definition in 21 U.S.C. § 321 (ff) include that the item must not represent itself for use as a conventional food or as a sole item of a meal or the diet. “Dietary supplements” must also be labeled as such. If its labeling does not call it a “dietary supplement,” Coco Loko cannot be a “dietary supplement.” According to Ars Technica, Legal Lean is already marketing Coco Loko as a “dietary supplement.”

Incorporated by reference into the § 321 (ff) definition of “dietary supplements” is the requirement that the product be intended for ingestion under 21 U.S.C. § 350 (c)(1)(B). That section requires products be “intended for ingestion in tablet, capsule, powder, softgel, gelcap, or liquid form.” While Coco Loko is a powder, it is unlikely that it is “ingested” in the typical meaning of that term. The statutory provision also provides an alternative definition for items “not intended for ingestion in such a form” that are otherwise “not represented as conventional food and is not represented for use as a sole item of a meal or of the diet.” Both incorporated definitions are predicated on “ingestion,” and Coco Loko’s method of intake is unlikely to fit the plain meaning of “ingestion.”

By analogy, a suppository also bypasses the mouth when they are taken into the body. Even so, suppositories generally go into one end of the alimentary canal—rather than the sinuses or the lungs. Moreover, neither suppositories nor this inhaled chocolate are “ingested.” No less an authority than the Oxford English Dictionary includes a definition of “ingest” that equates ingestion with the introduction of material into the stomach or mouth.

Coco Loko faces an uphill battle getting a “dietary supplement” label given that is probably not “ingested” or intended for ingestion. According to the FDA Law Blog, “FDA has consistently taken the position that articles not intended for ingestion do not qualify as dietary supplements.” In the end, FDA may find that “ingestion” is distinct from insufflation, or the act of breathing something into the body.

Even if Coco Loko is labeled as a “dietary supplement” and met other aspects of the § 321 (ff) definition, the Secretary of Health and Human Services, pursuant to 21 U.S.C. § 342 (f), could conceivably find that it presents a “significant or unreasonable risk of illness or injury.” While unlikely, the Secretary has the authority to declare a dietary supplement so unsafe that it poses “an imminent hazard to public health or safety.” That said, do not hold your breath for such a declaration—if you do, it’d be harder to inhale the chocolate.

 

Concluding Thoughts

While the safety and propriety of snorting crystalline chocolate powder through one’s nostrils is up for debate, FDA is hard at work sniffing out the proper regulatory classification of Coco Loko.

My preliminary thought is that Coco Loko might be labeled a “dietary supplement,” given its ingredients. On the other hand, its method of delivery—through the nasal passage—is not one typically seen in dietary supplements and is unlikely to fit the “intended for ingestion” prong of the incorporated statutory definition.

Alternatively, FDA may label the product a “drug,” especially with its “structure or function” claims. Either way, if you think I’m going to go snort chocolate anytime soon—you’re loko.

U of M Asserts Sovereign Immunity Prevents USPTO From Invalidating Its Patents

July 11, 2017
Constitutional Law, Patent Infringement Damages, Patents

Prof. Richard Stern, MJLST Guest Blogger

The University of Minnesota owns a number of patents on cell phone signal processing technology that was invented by Professor Georgios Giannakis of U of M’s Department of Electrical and Computer Engineering and his colleagues. The U of M claims that AT&T, Sprint, T-Mobile, and Cellco Partnership (a joint venture between Verizon and Vodaphone, doing business as Verizon Wireless) are infringing five of these patents, and in 2014 it sued the companies in Minnesota federal district court for patent infringement. The U of M is “a great research university,” President Eric Kaler said, and “must vigorously protect our faculty, [their] discoveries and the overall interests of our university.” (The U collects about $40 million annually in royalties from licensing and the commercialization of faculty work.) Apparently, the cell phone carriers infringed the patents by utilizing Ericsson radio chips that code signals for wireless transmission and practicing patented methods the chips performed.

 

The case was assigned to Chief Judge John R. Tunheim in Minneapolis, who denied the defendants’ motion to dismiss the case for defective pleading, in September 2015. He did reject the U’s claim, however, that the defendants engaged in “willful blindness” in infringing the patents. Judge Tunheim said that the U “alleges no actions that would constitute deliberate avoidance of knowledge” that they were infringing, although they did know of the patents and they “actively entice[d] their customers through advertising, marketing and sales activity to use [their] infringing products.”

 

Ericsson, the wireless carriers’ equipment supplier, then acted to protect its defendant customers against the U by intervening in the Minnesota infringement suit. Ericsson then filed inter partes review (IPR) proceedings in the USPTO to invalidate the U of M patents on which the U was suing the carriers. An IPR is a new type of administrative proceeding that the recent America Invents Act established to provide a swifter and supposedly cheaper way for small companies to resist demands by trolls that they pay patent tribute. Instead of engaging in district court litigation, an aggrieved party can seek an IPR before the USPTO, which then employs its patent expertise to determine whether the patents it issued are invalid, and (if so) consequently relieving the aggrieved party from infringement liability (an invalid patent cannot be infringed).

 

Here is where the complications set in. The 11th Amendment preserves state sovereign immunity against suit—“The Judicial power of the United States shall not be construed to extend to any suit in law or equity, commenced or prosecuted against one of the United States . . . .” Thus, when a patent owner sued a Florida state agency that provided college tuition payment plans, for patent infringement, the Supreme Court held the law subjecting states to infringement liability unconstitutional under the 11th Amendment. Florida Prepaid Postsecondary Ed. Expense Bd. v. College Savings Bank, 527 U.S. 627 (1999). Accordingly, in two January 2017 IPR cases, the USPTO held that the 11th Amendment required it not to allow proceedings before it against Maryland and Florida. Neochord, Inc. v. Univ. of Maryland, Baltimore and Harpoon Medical, Inc., IPR2016-00208 (May 23, 2017), http://www.ptablitigationblog.com/wp-content/uploads/2017/06/IPR2016-00208.pdf; Covidien LP v. University of Florida Research Found. Inc., IPR2016-01274 (Jan. 25, 2017), http://www.finnegan.com/files/upload/LES_Insights_Column/2017/CovidienvUFIPRNos20160126476.pdf. Although waiver was urged, the USPTO said it was inapplicable because the 11th Amendment is jurisdictional—it deprived the tribunal of any jurisdiction to act, so that jurisdiction could be considered at any time. Waiver requires an affirmative act of invoking federal jurisdiction in the relevant tribunal, and that had not occurred.

 

Ericsson argued, in support of its claim that there was jurisdiction to hear its IPR challenges, that the U had waived its 11th Amendment immunity by suing Ericsson’s customers in the Minnesota district court. Ericsson said that the U “has consented to jurisdiction,” when it sued Ericsson’s customers in the district court, because by filing lawsuits against Ericsson’s customers, “it could surely anticipate” that Ericsson would bring an IPR case at the USPTO to invalidate the patents asserted against its customers for using its products. The U has now urged the USPTO to dismiss Ericsson’s IPR cases, insisting that it has not waived its sovereign immunity by suing the phone carriers—not Ericsson, a third party to the U’s patent infringement suits.

 

The U argues that the law is clear that a waiver must be personal, i.e., filing a lawsuit or counterclaims in the same action and in the same forum. Thus, in Regents of Univ. of New Mexico v. Knight, 321 F.3d 1111, 1125 (Fed. Cir. 2003), the Federal Circuit held that it would be unfair to let New Mexico sue in federal court to enforce a right to ownership of patents arising from contracts “and, at the same time, to claim immunity from liability [in the same case] for royalties or other compensation arising from those same contracts and conduct.” The court added, “Moreover, because a state as plaintiff can surely anticipate that a defendant will have to file any compulsory counterclaims [in the same case] or be forever barred from doing so, it is not unreasonable to view the state as having consented to such counterclaims.” Id. at 1126. On the other hand, the Federal Circuit has held that “a state that files a [patent infringement] lawsuit in one district court does not waive its immunity in a related [invalidity declaratory judgment] lawsuit filed by a party in another district court.” Board of Regents of the Univ. of Wis. Sys. v. Phoenix Int’l Software, Inc., 653 F.3d 448, 462 (7th Cir. 2011) (citing Tegic Communications Corp. v. Board of Regents of the Univ. of Texas Sys., 458 F.3d 1335, 1342 (Fed. Cir. 2006)).

 

In the Tegic case, in which UT sued Tegic’s customers for patent infringement in Texas, the Federal Circuit held that UT waived its immunity against a declaratory judgment counterclaim in Texas. But UT did not waive immunity against the separate declaratory judgment action that Tegic wanted to bring in Washington (where Tegic resided). The court said that if Tegic wanted to litigate patent validity, it could intervene in the Texas case and subject itself to infringement liability if the patent was valid and infringed. This is consistent with the Supreme Court’s concept in the College Savings Bank that the 11th Amendment is more about where a state is willing to be sued than whether it can be sued—for example, most states allow suits against them in their own courts of general jurisdiction. (But they don’t want to be sued in another jurisdiction.)

 

Based on this case law, the U argued: “IPR petitions are [not] counterclaims nor adjudicated in the same forum—they are a different action brought in a different forum.” Further, “a state that files an infringement action does not waive its immunity from a different action challenging the patent in a different forum.” The USPTO had said previously that it was not passing on what would happen if the patentee did file a patent infringement suit, as U of M did here. Furthermore, Ericsson did intervene in the Minnesota district court patent infringement suit, as the Tegic court said the equipment seller should if it wanted to challenge validity. But the Minnesota district court has stayed the federal patent action (at Ericsson’s request) to await the result in the IPR case, as district courts usually do in order to let the experts in the USPTO resolve the patent issues for them. (Presumably, the court will vacate its stay if the IPR case is dismissed.)

 

The U quoted the Federal Circuit opinion in Tegic that insisted that Tegic could not show that adjudication of its claim of invalidity was “not available in the Texas action,” and the U then argued, “Similarly, Ericsson cannot show that adjudication of invalidity counterclaims is not available in the Minnesota court,” where the U has (constructively) waived its immunity. There is a serious conflict here between the respective policies of the 11th Amendment that states should not be subjected to forums not of their choice and of the America Invents Act that a cheap, fast, expert determination of patent validity should be available in lieu of litigation in courts. Like the College Savings Bank case, this case may well end up in the Supreme Court. One important issue, not raised or resolved so far, is whether Congress may constitutionally impose, as a condition of the statutory right to acquire the benefit of a patent, and thus make as an integral element of the patent right, that the patent is subject to validity determination in IPR proceedings. Or would the 11th Amendment make that an unconstitutional condition on a benefit, as applied to a state, rather than a legitimate part of the statutory definition of a patent right?

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