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

February 7, 2020
New Technology, Public Safety, Regulatory

Alex Wolf, MJLST Staffer

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

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

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

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

Elections? There’s an App for That.

February 5, 2020
Elections, New Technology

Jacob Hauschild, MJLST Staffer

Clay Aiken won. We true believers don’t care what FOX had to say about it. When the phone systems were allegedly logjammed on that 2003 day, millions of American Idolaters had their faith in the democratic vote shattered. As one author wrote, “Technology is thwarting democracy. . .”

Yet, even as our democracy has been so thwarted by encroaching technology, one Washington district believes there Ain’t No Need to Worry. Instead of protecting voters from technology’s perils, the King Conservation District of Washington is embracing technology in the democratic process, allowing roughly 1.2 million Seattle area voters to vote online, via a smartphone, tablet, or computer, in an election for a board of supervisor position. Last year, the King Conservation District had only a 0.2% participation rate in its Board of Supervisors’ election. By allowing voters to vote this year from their couches, administrators hope more residents will participate, strengthening the district’s democratic capacity.

Of course, such an expansion to voter accessibility is no laughing matter. On one hand, voter turnout in the United States is concerningly low. Of no help are the 24 states who have introduced heightened voting restrictions over the last decade. On the other hand, these kinds of restrictions are, in theory, meant to make our elections more secure, as recent elections have quite notoriously resulted in claims of voter fraud and international interference. And experts have major concerns about the effects of online voting, which include challenges in voter authentication, risks to ballots in transit (i.e. ballots that are manipulated while transferred between the voter and the election office), and the threat of malware infiltrating electoral systems.

Online voting advocates are responsive to these issues. Many believe that blockchain, the technology behind bitcoin, may be the magic key to these security concerns. Others are far more cautious. Plus, in addition to security risks, there is the ever-present possibility that the voting technology fails to function as expected. For its part, the King Conservation District is utilizing a mobile voting platform through Democracy Live, which has FedRAMP certification, providing a government standardized approach to security assessment, authorization, and monitoring of cloud services.

For now, other voting districts aren’t exactly lining up to make similar changes to voting accessibility. Washington Secretary of State Kim Wyman recently indicated after consultation with cyber experts from the FBI and Department of Homeland Security that “electronic transmission [is] far too risky for voting and could leave voter information and election infrastructure impaired.” Even Julie King, the Elections Director for King County itself, announced that mobile voting is “not technology [she’ll] be rolling out for King County in upcoming elections.”

Will this technology grow more widespread in the future? And if so, how does that affect the legitimacy of our democracy? For a glimpse of that future, we need only wait until February 16. Or, if you don’t intend to tune into the American Idol premiere, you can opt instead to observe mobile voting’s impact as early as February 11, when the King Conservation District polls close. That election’s success—or failure—could fundamentally change how Americans vote in coming elections.

Foodborne Illness Law: E. Coli, Salmonella, and More

February 3, 2020
Food and Drug Law, Product Liability, Public Health, Torts Law

Katherine Nixon, MJLST Staffer

Sometime in the fall of 2018, I walked into Chipotle hoping for a nice savory burrito bowl. The best burrito bowl—at least in my opinion—is made up of the following: brown rice, chicken, cheese, lettuce, hot salsa, sour cream, and guacamole. One ingredient missing can throw off the whole experience. Well, I walked into Chipotle only to find a printed sign on the glass in front of the various ingredients. Let’s be honest, that never means anything good. The sign notified customers that Chipotle would not currently be offering romaine lettuce due to an E. coli outbreak. At first, all I could think was “Noooo, not my beloved burrito bowl. What will it be like without the crunchy lettuce?”

In looking past my immediate concern over the negative effect that a lettuceless burrito bowl would have on my taste buds, I was ultimately thankful I had not eaten the romaine lettuce. Big picture things. It was discovered that the romaine lettuce came from a farm in Santa Barbara County, California. It was distributed through many avenues and not just to food establishments like Chipotle. Unfortunately, people became very sick. According to the Center for Disease Control and Prevention (CDC), 62 people were infected from 16 states and the District of Columbia. Further, 25 people were hospitalized and 2 people developed a form of kidney failure. This ended up being a big deal. That particular outbreak began in October 2018 and wasn’t declared over until January 9, 2019.

Believe it or not, E. coli outbreaks occur with some frequency. A massive outbreak that began in September 2019 was just declared over by the CDC on January 15, 2020. Again, the source of that outbreak was romaine lettuce. Other outbreaks in 2019 came from ground bison, flour, and ground beef. Aside from E. coli, there are other types of outbreaks as well. For instance, in 2019, there were several Salmonella outbreaks related to food items such as papayas and frozen raw tuna. Many people fell sick.

At this point, you might be wondering—what does this all have to do with law? It turns out there is a whole body of law generally referred to as “foodborne illness law.” I know—you definitely don’t learn about that in your normal law school curriculum. Yet, the name is somewhat self-explanatory. As succinctly put by the Public Health Law Center at Mitchell Hamline School of Law, “[A] person who is injured as a result of a foodborne illness may bring a civil cause of action against another by claiming that the other individual is legally liable for the harm caused by the foodborne illness.” Sometimes, there is even strict liability.

Overall, this type of law can be highly technical and usually involves the help of experts. It also can be quite difficult. Including the difficulty that often comes in discovering the source of a certain outbreak as well as the manufacturer of that source. It can be like piecing a giant puzzle together. However, once the pieces start to fit together, it all begins to make sense. If you have a science background, especially biology, this may be an area of law for you to consider. Next time you are at a family gathering and Uncle Eddy asks what you want to do, tell him you want to specialize in foodborne illness law. That will surely grab his attention.

 

 

Orange Book, Purple Book, Complex Products, and Process Patents

December 23, 2019
Biotechnology, Intellectual Property, Patents

Philip E. Alford, Ph.D., MJLST Staffer

Complex Products and Process Claims

The most economically important pharmaceutical innovations of the past decade have centered around biologics and complex non-biologic products. Biologics are a diverse class of therapeutic products, typically produced via biotechnology or obtained from biological sources. Biologics often contain complex mixtures or large, elaborate molecules that are intricately folded into a specific desired conformation. In many respects, we do not yet have the technology to characterize all the functional elements of these products fully, and sometimes it is not possible to make the products synthetically or according to alternative processes. Even minor variations in biologic manufacturing can result in a product having different properties. Since the manufacturing process may be one of the most accurate ways to describe a biologic, patent strategies for biologics typically give extra emphasis around process patents. Indeed, biologic process claims have proven to be a powerful tool, and process patents have been at the core of the first waves of biosimilar litigation.

Non-biologic drugs can also be so complex as to defy characterization and reproduction. Such products are now referred to as complex products or non-biological complex drugs (NBCDs), as well as “nanomedicine” or “synthetic biologics.” Like biologics, many complex products have the challenge that different manufacturing processes can result in the product having divergent properties. Thus, manufacturing aspects are uniquely important to both complex products and biologics. Where the patent system is involved in the regulatory framework, process patents should play a central role in protecting complex products from generic entry. Yet for complex drug products, FDA does not integrate process patents into the generic entry process.

Despite being difficult to truly reproduce, complex products are nonetheless susceptible to market pressure under Hatch-Waxman-type generic entry 21 USC 355(b)(2) and 355(j), i.e., via Food Drug & Cosmetic Act 505(b)(2) and 505(j) applications. The Hatch-Waxman Act, discussed in more detail below, ingeniously incorporated the patent system as a secondary gatekeeper in FDA’s generic drug approval process. The so-called Orange Book is the nexus uniting two separate regulatory regimes. However, FDA has interpreted that the Orange Book and Hatch-Waxman provisions invoke only on the types of patents that were important for determining infringement of traditional, small molecule drugs, namely, drug and therapeutic use claims. The Orange Book expressly excludes process patents. 21 C.F.R. §314.53.

Although product-by-process claims can be permitted, the resulting product must be novel, and product-by-process claims are not interchangeable with process claims. (For example, see, MPEP 2113 and Judge Newman’s dissent in Abbott Labs. v. Sandoz, Inc, suggesting that process claims and product-by-process claims are held to different validity standards.)

Hatch-Waxman as a political bargain.

When Congress passed the Hatch-Waxman Act was passed in 1984, the Act represented a classic political bargain. The hope was to strike a balance between innovation and competition by strengthening the golden years of brand drugs while facilitating subsequent generic entry. Pioneers of approved new drugs were given up to 5 years of data exclusivity during which FDA would not approve a generic of the drug. Additionally, one of the pioneer’s patents could be extended up to 5 additional years to compensate for lost patent term consumed while seeking FDA approval. In turn, the Act provided a new, streamlined process for drug makers to obtain approval of generic drugs.

A key provision of the Act directs the drug pioneer to identify its patents in the Orange Book. The listed patents must (1) claim the new drug, or (2) claim a method of using the drug, in so far as a claim of infringement could reasonably be asserted if another engaged in the manufacture, use, or sale of the drug. 21 U.S.C. §355(b)(1)(G). The Orange Book thus represents an essential part of the Hatch-Waxman political bargain. Process (manufacturing) patents are expressly excluded from the Orange Book, as are patents relating to packaging, metabolites, or intermediates. 21 C.F.R. §314.53.

The Orange Book lists these patents alongside each FDA approved drug. Before obtaining approval of a generic, the generic drug maker must certify to FDA that the patents listed in the Orange Book are expired, invalid, or will not be infringed by its generic. 21 U.S.C. §355(b)(2)(A) and 21 U.S.C. 355(j)(2)(vii). Under 35 U.S.C. § 271(e)(2), such certifications of invalidity or non-infringement constitutes an act of infringement permitting the pioneer to sue the generic drug maker before the generic ever reaches the market. Prompt litigation can trigger a stay on the generic’s approval. In this manner, the Orange Book serves not only as a mechanism for transparency (informing the public of patent and regulatory exclusivities), but also as a mechanism for litigation. The Orange Book has served both causes well.

As blockbuster biologics began to approach the end of the foreseeable patent life, FDA created a compendium of BLA-approved biological products loosely mirroring the Orange Book, but for biologics instead of drugs. Reverently, FDA named this volume the Purple Book. Unlike the Orange Book, the Purple Book has had no reason to list patents because the generic drug provisions of the Hatch–Waxman Act apply only to drug approvals under 21 U.S.C. §355(b) and 21 U.S.C §355(j). The Biologics Price Competition and Innovation Act of 2009 (BPCIA) provides a framework for approving biosimilars and resolving patent disputes. Instead of referring to a book of approvals and patents, the BPCIA invokes a so-called patent dance exchange of patent information. 42 USC § 262 (l). This patent information includes not only composition and use claims, but also process of manufacture claims. Conceptually, the dance was expected to lead the parties to agree on an initial set of patents to litigate and thus control the tempo and scope of litigation. However, the parties soon recognized that dancing is optional. Sandoz Inc. v. Amgen Inc., 137 S. Ct. 1664. Dance or no dance, the parties ultimately litigate their patent disputes, which often center the methods of manufacturing the biologic product.

As new biologics and complex drug products come to market, process claims are likely to be increasingly important.

Possible Legislation to the Orange Book and Purple Book

This year, Congress considered legislation sponsored by members of the House Committee on Energy and Commerce proposing changes to the way the Purple Book and Orange Book function.

The Purple Book Continuity Act of 2019 proposes that the purple book be updated to list patents generated during the ‘patent dance’ of 42 USC § 262 (l), which would include process patents or any other patent likely to be important in an infringement claim. Any such patents listed in the Purple Book would not function as a regulatory gatekeeper for generics since no mechanism yet exists for the Purple Book to do so. Still, from a transparency point-of-view, it seems like a reasonable choice to have the Purple Book act at least as a compendium of relevant patents. The Orange Book Transparency Act of 2019 proposes a requirement to list the drug substance, drug product, and method of use patents, while also requiring removal of any patents that are improperly listed (presumably including process patents absent any change to 21 C.F.R. §314.53). Although the House Committee on Energy and Commerce sponsored both acts, each take differing approaches to process patents. It seems illogical to insert process patents into the Purple Book, while more tightly excluding process patents from the Orange Book at a time when process claims are increasingly more important to modern therapeutics.

Indeed, FDA has expressly focused on the manufacturing process when trying to understand how a generic relates to a reference complex product. For example, FDA explained that a central part of their inquiry was whether the generic is made according to the same process as the original®, a non-biologic complex product, FDA explained that a central part of their inquiry was whether the generic is made according to the same process as the original. See, also, Bell et al., which discusses FDA’s criteria for approving a generic even when there is no physicochemical or biological characterization technique to establish active ingredient sameness. If such an inquiry is part of FDA’s analysis for permitting the sale of a generic drug, then it should be more than enough to justify listing process patents in the orange book.

If Congress revisits either of these matters, it should adjust the code to include process patents in both the Orange Book and the Purple Book. Listing process patents in the Orange Book would serve a public good, namely, that of transparency, but also would notify competitors of the manufacturing space the pioneer drug company intends to protect. Delaying such litigation until after a possible generic approval is messy for all parties involved. As more medications become too complex to manufacture by alternative routes, the importance of process patents in complex biologic and nonbiologic drugs will only increase.

 

“Open Up It’s the Police! . . . and Jeff Bezos?”

November 24, 2019
Criminal Law, New Technology, Privacy

Noah Cozad, MJLST Staffer

Amazon’s Ring company posted a series of Instagram posts around Halloween, including a video of children trick or treating, and statistics about how many doorbells were rang on the night.  What was probably conceived as a cute marketing idea, quickly received backlash. It turns out people were not enamored by the thought of Ring watching their children trick or treat.  This is not the first time Ring’s ads have drawn criticism. In June of this year, social media users noticed that Ring was using images and footage from their cameras in advertisements. The posts included pictures of suspects, as well as details of their alleged crimes. Ring called these “Community Alerts.” Customers, it seems, have agreed to exactly this use of data. In Ring’s terms of service agreement, customers grant Ring the ability to “use, distribute, store .  . . and create derivative works from such Content that you share through our Service.”

The backlash to Ring’s ads gets to a deeper concern about the Amazon company and its technology: the creation of a massive, privately owned surveillance network. Consumers have good reason to be wary of this. It’s not fully understood what exactly Ring does with the images and videos this network creates. Earlier this year, it was reported that Ring allegedly gave their Ukrainian R&D team unlimited access to every video and image created by any Ring camera. And Ring allegedly allowed engineers and executives unlimited access to some customers cameras as well, including Ring’s security cameras made for indoor use. Ring has denied these allegations. There are not many specifics, but the company is said to have “minimum security standards” in general, and appears not to encrypt the storage of customer data. Though data is now encrypted “in transit.”

The legal and civil rights concerns from this technology all seem to come to a head with Ring’s partnerships with local police departments. Six hundred plus police departments, including the Plymouth and Rochester departments, have partnered with Ring. Police departments encourage members of their community to buy Ring, and Ring gives police forces potential access to camera footage. The footage is accessed through a request to the customer, which can be denied, otherwise, police usually require a warrant to force Ring to hand over the footage. California departments though allege they have been able to sidestep the customer, and simply threaten Ring with a subpoena for the footage. If true, there is effectively little stopping Ring from sharing footage with police. Ring has claimed to be working hard to protect consumers privacy but has not answered exactly how often they give police footage without the approval of the customer or a warrant.

How legislatures and regulators handle this massive surveillance network and its partnerships with law enforcement is up in the air at this point. Despite continual backlash to their services, and 30 civil rights groups speaking out against Ring’s corporate practices, there has been little movement on the Federal level it seems, besides a letter from Senator Markey (D-Mass) to Amazon demanding more information on their services. Recently, Amazon replied to Senator Markey, which shed some light on how police can receive and use the data. Amazon stated that police can request 12 hours of footage from any device within a 0.5 mile radius of the crime. Amazon further stated that it does not require police to meet any evidentiary standard before asking for footage.

Despite the relative lack of governmental action currently, it is almost assured some level of government will act on these issues in the near future. For now, though, Ring continues to expand its network, and along with it, concerns over due process, privacy, and law enforcement overreach.

Information Sharing: Tesla and the Open Patent Framework

November 23, 2019
Intellectual Property, New Technology, Patents

Bernard Cryan, MJLST Staffer

Information Sharing: Tesla and the Open Patent Framework

By Bernard Cryan

Patents offer powerful protection of intellectual property, i.e., inventions. Patents confer the patent owner the right to exclude others from making, using, or selling the patented invention for a limited time. In return for a limited monopoly, the inventor must disclose the invention. This is the classic quid pro quo of the patent system—a limited monopoly granted by the government to an inventor in exchange for revealing helpful information to society. Tesla owns many patents on its electric vehicle technology. Under Elon Musk’s direction, Tesla has decided to allow others to use its patented technologies to “accelerate sustainable transport.”

The Patent System

The patent system often works as expected—the patent owner practices the patented invention and prevents others from doing so. Sometimes, however, the patent system can behave oddly. For example, contrary to popular belief, patents do not grant the patent owner automatic permission to practice the invention. This situation can occur in the pharmaceutical industry. For instance, a drug maker can acquire a patent on a pharmaceutical not yet approved by the Food and Drug Administration (FDA). As a result, the drug company cannot itself make, use, or sell the drug—even though it owns a patent on the drug. Therefore, a patent alone is insufficient to practice the invention. An additional inquiry is required, i.e., is the patent owner allowed to make, use, or sell the patented invention?

An opposite oddity can also occur. One can practice an invention that is patented by another. This occurs through either a formal license agreement or an open patent framework. A license, in the patent context, is simply an agreement between the patent owner and another party granting legal permission to use the patented invention. The more interesting framework, however, is the use of an open patent system. An open patent is a patent that is intentionally not enforced. In other words, the owner of the patent allows others to use the invention and actively avoids filing an infringement lawsuit—which is the main platform to enforce patent rights.

Tesla’s Pledge

Elon Musk believes the carbon crisis calls for joint efforts amongst all automakers to build electric vehicles. In 2014, Tesla pledged that it would not file patent infringement lawsuits against companies that use, in good faith, Tesla’s electric vehicle patented technology. In Tesla’s words:

“What this pledge means is that as long as someone uses our patents for electric vehicles and doesn’t do bad things, such as knocking off our products or using our patents and then suing us for intellectual property infringement, they should have no fear of Tesla asserting its patents against them.”

The Good

Another car company can use Tesla’s patented technology instead of spending resources developing similar electric vehicle technology. Tesla is the leading seller of electric vehicles and has sold more than 380,000 electric vehicles (as of April 2019). There is still opportunity for electric vehicle development as the electric vehicle market share is small (1.8% as of March 2019). As a result, Tesla’s pledge is significant because it encourages the sharing and use of powerful information in the auto industry, which should accelerate society’s move toward electric vehicles. The use of proven technology can facilitate a start-up company’s path to success or focus an established automaker’s efforts to develop electric vehicles. Further, Toyota has followed Tesla’s approach with respect to its hydrogen fuel cell technology. This open patent framework is not limited to only the auto industry. Google, for example, has pledged to open some of its patents directed at encryption technologies.

The Bad

While Tesla’s pledge may appear revolutionary, it has drawbacks. Some companies may fear the legal tools to enforce Tesla’s pledge are insufficient. As a result, automakers may be reluctant to use the patented technology out of fear that Tesla will not follow through on its promise. While a formal license agreement to use patented technology is enforceable through reliable legal tools, an informal pledge posted in blog format by a CEO on the company website may not carry the force of law. Is Tesla required to follow through with its pledge? Maybe, under the legal doctrine of estoppel. Will Tesla withdraw its pledge? It is unlikely as Elon Musk recently reminded the world of Tesla’s pledge. Nevertheless, Tesla’s pledge may have only limited impact if other automakers lack confidence to legally enforce the pledge.

The Takeaway

This open patent framework has enormous potential to facilitate innovation by concentrating companies’ efforts to build on each other’s prior work, rather than around it. Time will reveal the true impact of open patent pledges like Tesla’s. Most recently, XPeng, a Chinese automaker inspired by Tesla, has secured a $400M investment.

Perhaps the biggest impact of Tesla’s pledge is not the acceleration of the electric vehicle use, but rather teaching the world that openly sharing valuable information is priceless. This reminder may encourage other industries to adopt similar pledges, thereby accelerating all kinds of innovation.

Forget About Quantum Computers Cracking Your Encrypted Data, Many Believe End-to-End Encryption Will Lose Out as a Matter of Policy

November 16, 2019
Cyber Security, Data, Privacy

Ian Sannes, MJLST Staffer

As reported in Nature, Google recently announced they finally achieved quantum supremacy, which is the point when computers that work based on the spin of qubits, rather than how all conventional computers work, are finally able to solve problems faster than conventional computers. However, using quantum computers is not a threat to encryption any time soon according to John Preskill, who coined the term “quantum supremacy,” rather such theorized uses remain many years out. Furthermore, the question remains whether quantum computers are even a threat to encryption at all. IBM recently showcased one way to encrypt data that is immune to the theoretical cracking ability of future quantum computers. It seems that while one method of encryption is theoretically prone to attack by quantum computers, the industry will simply adopt methods that are not prone to such attacks when it needs to.

Does this mean that end-to-end encryption methods will always protect me?

Not necessarily. Stewart Baker opines there are many threats to encryption such as homeland security policy, foreign privacy laws, and content moderation, which he believes will win out over the right to have encrypted private data.

The highly-publicized efforts of the FBI in 2016 to try to force Apple to unlock encryption on an iPhone for national security reasons ended in the FBI dropping the case when they hired a third party who was able to crack the encryption. This may seem like a win for Silicon Valley’s historically pro-encryption stance but foreign laws, such as the UK’s Investigatory Powers Act, are opening the door for government power in obtaining user’s digital data.

In October of 2019 Attorney General Bill Barr requested that Facebook halt its plans to implement end-to-end encryption on its messaging services because it would prevent investigating serious crimes. Zuckerberg, the CEO of Facebook, admitted it would be more difficult to identify and remove harmful content if such an encryption was implemented, but has yet to implement the solution.

Some believe legislators may simply force software developers to create back doors to users’ data. Kalev Leetaru believes content moderation policy concerns will allow governments to bypass encryption completely by forcing device manufacturers or software companies to install client-side content-monitoring software that is capable of flagging suspicious content and sending decrypted versions to law enforcement automatically.

The trend seems to be headed in the direction of some governmental bypass of conventional encryption. However, just like IBM’s quantum-proof encryption was created to solve a weakness in encryption, consumers will likely find another way to encrypt their data if they feel there is a need.

Pacemakers, ICDs, and ICMs – Oh My! Implantable Heart Detection Devices

November 16, 2019
Bioethics, Data, Healthcare, Privacy

Janae Aune, MJLST Staffer

Heart attacks and heart disease kill hundreds of thousands of people in the United States every year. Heart disease affects every person differently based on their genetic and ethnic background, lifestyle, and family history. While some people are aware of their risk of heart problems, over 45 percent of sudden heart cardiac deaths occur outside of the hospital. With a condition as spontaneous as heart attacks, accurate information tracking and reporting is vital to effective treatment and prevention. As in any market, the market for heart monitoring devices is diverse, with new equipment arriving every year. The newest device in a long line of technology is the LINQ monitoring device. LINQ builds on and works with already established devices that have been used by the medical community.

Pacemakers were first used effectively in 1969 when lithium batteries were invented. These devices are surgically implanted under the skin of a patient’s chest and are meant to help control the heartbeat. These devices can be implanted for temporary or permanent use and are usually targeted at patients who experience bradycardia, a slow heart rate. These devices require consistent check-ins by a doctor, usually every three to six months. Pacemakers must also be replaced every 5 to 15 years depending on how long the battery life lasts. These devices revolutionized heart monitoring but involve significant risks with the surgery and potential device malfunctioning.

Implantable cardioverter defibrillators (ICD) are also surgically implanted devices but differ from pacemakers in that they deliver one shock when needed rather than continuous electrode shocks. ICDs are similar to the heart paddles doctors use when trying to stimulate a heart in the hospital – think yelling “charge” and the paddles they use. These devices are used mostly in patients with tachycardia, a heartbeat that is too fast. Implantation of an ICD requires feeding wires through the blood vessels of the heart. A subcutaneous ICD (S-ICD) has been newly developed and gives patients who have structural defects in their heart blood vessels another option of ICDs. Similar to pacemakers, an ICD monitors activity constantly, but will be read only at follow-up appointments with the doctor. ICDs last an average of seven years before the battery will need to be replaced.

The Reveal LINQ system is a newly developed heart monitoring device that records and transmits continuous information to a patient’s doctor at all times. The system requires surgical implantation of a small device known as the insertable cardiac monitor (ICM). The ICM works with another component called the patient monitor, which is a bedside monitor that transmits the continuous information collected by the ICM to a doctor instantly. A patient assistant control is also available which allows the patient to manually mark and record particular heart activities and transmit those in more detail. The LINQ system allows a doctor to track a patient’s heart activity remotely rather than requiring the patient to come in for the history to be examined. Continuous tracking and transmitting allow a patient’s doctor to more accurately examine heart activity and therefore create a more effective treatment approach.

With the development of wearable technology meant to track health information and transmit it to the wearer, the development of devices such as the LINQ system provide new opportunities for technologies to work together to promote better health practices. The Apple Watch series 4 included electrocardiogram monitoring that records heart activity and checks the reading for atrial fibrillation (AFB). This is the same heart activity pacemakers, ICDs, and the LINQ system are meant to monitor. The future capability of heart attack and disease detection and treatment could be massively impacted by the ability to monitor heart behavior in multiple different ways. Between the ability to shock your heart, continuously monitor and transmit information about it, and report to you when your heart rate may be experiencing abnormalities from a watch it seems as if a future of decreased heart problems could be a reality.

With all of these newly developed methods of continuous tracking, it begs the question of how all of that information is protected? Health and heart behavior, which is internal and out of your control, is as personal as information gets. Electronic monitoring and transmission of this data opens it up to cybersecurity targeting. Cybersecurity and data privacy issues with these devices have started to be addressed more fully, however the concerns differ depends on which implantable device a patient has. Vulnerabilities have been identified with ICD devices which would allow an unauthorized individual to access and potentially manipulate the device. Scholars have argued that efforts to decrease vulnerabilities should be focused on protecting the confidentiality, integrity, and availability of information transmitted by implantable devices. The FDA has indicated that the use of a home monitor system could decrease the potential vulnerabilities. As the benefits from heart monitors and heart data continue to grow, we need to be sure that our privacy protections grow with it.

TERMINAL DISCLAIMERS: QUICK FIX or SIMPLE RUIN?

November 12, 2019
Intellectual Property, Patents

Amanda Jackson, MJLST Staffer

Terminal disclaimers, a limit on patent term of a patent that is substantially similar to another co-owned patent, are often thought of as a quick and easy way for a patent applicant to overcome a non-statutory double patenting rejection.  Non-statutory double patenting rejections arise when the claimed subject matter is not patentably distinct from the subject matter claimed in a commonly owned patent.  This judicially created doctrine arose to prevent extension of a patent term by filing subsequent patent applications claiming substantially similar subject matter as earlier applications.  In addition, non-statutory double patenting rejections seek to prevent multiple lawsuits against an alleged infringer by multiple assignees of the patentably indistinct patents (e.g., in the case where the patentably indistinct patents were assigned to different entities).

To overcome a non-statutory double patenting rejection, patent applicants can cancel the rejected claims, amend the claims to be patentably distinct, argue against the rejection, or file a terminal disclaimer.  By filing a terminal disclaimer, the patent applicant agrees that the later-filed patent (if granted) expires when the first patent does (the patent that resulted in the double patenting rejection).  Moreover, in order to alleviate the concerns of harassment by multiple assignees, 37 C.F.R. § 1.321 requires that a terminal disclaimer, to obviate a non-statutory double patenting rejection, must “[i]nclude a provision that any patent granted on that application . . . shall be enforceable only for and during such period that said patent is commonly owned with the application or patent which formed the basis for the judicially created double patenting.”  The patent office makes fulfilling that requirement easy by providing applicants with a standard terminal disclaimer form that states, “[t]he owner hereby agrees that any patent so granted on the instant application shall be enforceable only for and during such period that it and the prior patent are commonly owned.”  The terminal disclaimer runs with any patent granted from the application.

Seems harmless, right?  As long as the applicant does not have a problem with a reduced patent term, including any patent term adjustment, terminal disclaimers seem like a relatively painless fix to a non-statutory double patenting rejection.  Terminal disclaimers might also be appealing to avoid characterizing prior work by the applicant (e.g., putting statements on the record construing aspects of the prior work that could be limiting in litigation).  It may also be difficult to overcome non-statutory double patenting rejections by arguments alone.  However, terminal disclaimers can render patents invalid or unenforceable, many times without the patent owner realizing it.

As a first example, when less than all of the patents attached to a terminal disclaimer are owned by one entity, the patent may be rendered unenforceable.  In Voda v. Medtronic, Inc., Voda had filed a terminal disclaimer linking three patents together.  At the time of filing the terminal disclaimer, Voda owned all three patents.  Voda later assigned two of the patents to another entity.  One of those patents was reassigned to Voda, but the other remained owned by the third party.  Medtronic asserted that the patent at issue was unenforceable because Voda did not own one of the patents included in the terminal disclaimer.  Dismissing Voda’s argument that the patents only had to be commonly owned during the period of infringement, the court stated,

Terminal [d]isclaimers, however, do not speak in terms of ownership during times of infringement; rather, they require common ownership for enforceability. . . . To enforce the ‘195 patent, plaintiff must not only own all three patents for the period he seeks enforcement of the ‘195 patent he must also own all three patents during the period he files suit to do so. As it is undisputed that plaintiff does not own the ‘625 patent, the ‘195 patent is unenforceable as a matter of law under the plain language of the [t]erminal [d]isclaimers.

When a patent owner fails to have common ownership of terminally disclaimed patents, some courts have held that the plaintiff lacks Article III standing.  However, other courts have held the opposite, namely that “enforceable title” is required to have standing to bring a patent infringement suit, but that “enforceable title” is not the same as “enforceability” (e.g., with respect to lack of common ownership of terminally disclaimed patents).

As another example, terminal disclaimers involving patents (or applications) that are not commonly owned at the time of filing the terminal disclaimer may be invalid due to non-statutory double patenting.  For example, in In re Fallaux, the court asserted that “[i]f the Fallaux application and the Vogels patents were commonly owned, the terminal disclaimer filed in this case would have been effective to overcome the double patenting rejection. We note that this defect was of the applicant’s creation as through assignment it allowed ownership of the applications to be divided among different entities.”  Joint ownership and ownership by subsidies may also present enforceability issues with respect to terminal disclaimed patents.

Thus, patent owners and practitioners should be a little more weary in filing terminal disclaimers to overcome non-statutory double patenting rejections.  And if a terminal disclaimer is filed, patent owners should pay close attention to patents that have a terminal disclaimer, as well as to the patents to which the patent is terminally disclaimed.  This is especially important in licensing agreements and assignments, when patents—even in different patent families—may be unknowingly linked by terminal disclaimers.

Estate Planning in the Digital Age: What Every Millennial Needs to Know

November 12, 2019
Property Law, Trusts and Estates

Nicole Petrow, MJLST Staffer

As our society becomes increasingly tied to digital technologies, the world of estate planning is faced with novel questions. Today, many people own significant digital assets, including anything from electronically stored photos and videos to valuable domain names and cryptocurrency. The field of estate planning is evolving with law of digital property as well as the digitization of the will drafting process.

How is estate planning complicated by advancing technologies?

After death, accessing a loved one’s digital presence can be a significant way by which grieving loved ones preserve cherished memories. There are over 2.5 quintillion bytes of data created each day, many of these through communication platforms, social media, online storage, and other digital mediums. However, passwords, data encryption, criminal laws, and data privacy laws complicate how to plan for the eventuality of passing these assets.

Social media presents interesting challenges for proper planning, because simply sharing account passwords may not always be proper. Using another person’s password to access an account, even if freely given, is potentially punishable under the federal Computer Fraud and Abuse Act as it may violate the account’s Terms of Service agreement by “exceeding authorized access.” Platforms have various methods of handling the deaths of users: Facebook and Instagram have options to “memorialize” accounts after death, while other platforms such as Twitter and LinkedIn allow account deactivation.

Data privacy laws add an additional wrinkle in accessing a loved one’s online accounts after death. Until recently, the privacy protections ensured by the Stored Communications Act prevented a duly appointed fiduciary from accessing the contents of a deceased user’s online account. In response to this problem, the Uniform Law Commission promulgated the Revised Uniform Fiduciary Access to Digital Assets Law (RUFADAA), which has been adopted in 44 jurisdictions. The RUFADAA is significant for many reasons, particularly because it formally recognizes digital property as a property right that can be managed and accessed by third parties after death.

Proper planning is also essential for anyone with digital assets of significant financial value. Problems arise when owners of domain names or cryptocurrency die without having identified their assets, or planned for their transfer.

Why should I care?

 For the average Millennial and Gen Zer, death planning may feel like a morbid project, better suited for the wealthy and elderly. A 2019 survey shows that only 1 in 5 of 18-34 year olds have an estate plan in place. However, there are many reasons to prepare an estate plan regardless of wealth, age, or family status.

Primarily, estate planning allows a person to direct what happens to their money and property after their death. But this is not the entire equation. Estate plans allow you to:

  • Outline and identify your online assets. Proper planning ensures that your loved ones will be able to identify, access, and preserve any online presence you may have. This includes social media accounts, personal blogs, and anything of financial value. If no one knows of your online presence, it may be lost after death.
  • Plan for the transfer of your debts. Depending on the type of loan you have, your debt may not die with you. Certain private loans will transfer to your co-signer in the event of your death.
  • Outline your desired end of life care. Drafting Health Care Directives and Powers of Attorney allow you to express your desired medical treatment in the event of your incapacitation.
  • Make things easier on your loved ones. Clearly expressing your desires for your end of life care, as well as outlining your intended asset distribution, will help your grieving loved ones make big decisions without the stress of wondering “what you would have wanted.”
  • Avoid unwanted “intestate” succession. If you die without a will, your state’s intestate succession laws will determine who receives and controls your assets. These may not reflect your desires – drafting a simple will can avoid this issue.
  • Arrange the guardianship of any minor children. Planning for this potential is essential for any parent, particularly if your state’s intestate succession statute does not reflect your desires for your children.

What about the will drafting process itself?

Technological advancements are changing the ways estate planning documents themselves are being drafted and admitted to probate courts around the world. Modern cases are asking new questions of previously settled law: is a will written on the iPhone Notes app sufficient? In Microsoft Word? What about a will hand-written by stylus on a tablet?

In response to questions such as these, the Uniform Law Commission drafted the Uniform Electronic Wills Act to accommodate electronic aspects of will executing. This act primarily encourages the validity of electronically signed and cloud-stored wills. Some commentators suggest that these electronic wills are likely to work best for young people with fewer assets and simple succession plans.

The law of wills and trusts is likely to continue evolving rapidly in order to keep pace with technological development. To preserve any Instagram masterpieces or bitcoin troves for those that will appreciate them in the future it is important to stay informed of the status of the law and have a plan in place. If this is your first time thinking about an estate plan, take stock of your assets, your family situation, and your state’s intestacy laws, and consider contacting a professional to plan for the future.

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