2019

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.

Wearable, Shareable, Terrible? Wearable Technology and Data Protection

November 5, 2019
Data, Healthcare, Privacy

Alex Wolf, MJLST Staffer

You might consider the first wearable technology of the modern-day to be the Sony Walkman, which celebrates its 40th anniversary this year. After the invention of Bluetooth 1.0 in 2002, commercial competitors began to realize the vast promise that this emergent technology afforded. Fifteen years later, over 265 million wearable tech devices are sold annually. It looks to be a safe bet that this trend will continue.

A popular subset of wearable technology is the fitness tracker. The user attaches the device to themselves, usually on their wrist, and it records their movements. Lower-end trackers record basics like steps taken, distance walked or run, and calories burned, while the more sophisticated ones can track heart rate and sleep statistics (sometimes also featuring fun extras like Alexa support and entertainment app playback). And although this data could not replace the care and advice of a healthcare professional, there have been positive health results. Some people have learned of serious health problems only once they started wearing a fitness tracker. Other studies have found a correlation between wearing a FitBit and increased physical activity.

Wearable tech is not all good news, however; legal commentators and policymakers are worried about privacy compromises that result from personal data leaving the owner’s control. The Health Insurance Portability and Protection Act (HIPAA) was passed by Congress with the aim of providing legal protections for individuals’ health records and data if they are disclosed to third parties. But, generally speaking, wearable tech companies are not bound by HIPAA’s reach. The companies claim that no one else sees the data recorded on your device (with a few exceptions, like the user’s express written consent). But is this true?

A look at the modern American workplace can provide an answer. Employers are attempting to find new ways to manage health insurance costs as survey data shows that employees are frequently concerned with the healthcare plan that comes with their job. Some have responded by purchasing FitBits and other like devices for their employees’ use. Jawbone, a fitness device company on its way out, formed an “Up for Groups” plan specifically marketed towards employers who were seeking cheaper insurance rates for their employee coverage plans. The plan allows executives to access aggregate health data from wearable devices to help make cost-benefit determinations for which plan is the best choice.

Hearing the commentators’ and state elected representatives’ complaints, members of Congress have responded; Senators Amy Klobuchar and Lisa Murkowski introduced the “Protecting Personal Health Data Act” in June 2019. It would create a National Task Force on Health Data Protection, which would work to advise the Secretary of Health and Human Services (HHS) on creating practical minimum standards for biometric and health data. The bill is a recognition that HIPAA has serious shortcomings for digital health data privacy. As a 2018 HHS Committee Report noted, “A class of health records that can be subject to HIPAA or not subject to HIPAA is personal health records (PHRs) . . . PHRs not subject to HIPAA . . . [have] no other privacy rules.”  Dena Mendolsohn, a lawyer for Consumer Reports, remarked favorably that the bill is needed because the current framework is “out of date and incomplete.”

The Supreme Court has recognized privacy rights in cell-site location data, and a federal court recognized standing to sue for a group of plaintiffs whose personally identifiable information (PII) was hacked and uploaded onto the Dark Web. Many in the legal community are pushing for the High Court to offer clearer guidance to both tech consumers and corporations on the state of protection of health and other personal data, including private rights of action. Once there is a resolution on these procedural hurdles, we may see firmer judicial directives on an issue that compromises the protected interests of more and more people.

 

When It Comes to Running Shoes, How Fast Is Too Fast?

November 4, 2019
New Technology, Sports Law

Molly Woodford, MJLST Staffer

On October 12, 2019, Eliud Kipchoge made headlines for running a marathon in 1:59:41 in Vienna. A day later, Brigid Kosgei broke Paula Radcliffe’s long-standing women’s marathon world record by over a minute, recording a time of 2:14:04 at the Chicago Marathon. Nike sponsors both athletes. Kipchoge’s run does not count as an official world record for a number of reasons, including a rotating phalanx of pacemakers and a pace car, but he holds the official world record of 2:01:39 set at the Berlin Marathon in 2018. Two weeks before Kipchoge’s historic sub-two-hour run, Kenenisa Bekele, the world record holder at 5000m and 10,000m, missed Kipchoge’s world record by a mere two seconds at the 2019 Berlin Marathon. Nike also sponsors Bekele. All of these record-setting athletes wore some version of the Nike VaporFly during their races.

This spate of record-setting performances has reinvigorated a debate in the running community about whether these shoes confer an unfair advantage to competitors who wear them and should, therefore, be banned. The first iteration of the Nike VaporFly, later dubbed the 4%, first appeared on the feet of elite athletes in early 2016, at the U.S. Olympic Marathon Trials. The shoe became available to the public in July 2017, retailing at $250. Several studies (1, 2) have shown that, true to its name, the Nike VaporFly 4% makes wearers approximately 4% more efficient compared to other racing shoes (which make the wearers ~1.9% faster). Nike has since released an updated version, the Next%, which was worn by Kosgei in Chicago and Bekele in Berlin, as well as by Kipchoge’s entire rotating phalanx of pacers in his sub-2 attempt. Next%, now also available to the public for $250, is certainly intended to, and based on recent performances may actually, confer a benefit of more than 4% to its wearers. But is that fair? Other companies are racing to compete, but none appear to have caught up to Nike just yet. And, whether or not it is fair, is it legal?

In April 2017, the IAAF significantly modified its rule regarding shoes, apparently due to “speculation and the increased interest in the development” of the 4% and other shoes. Before the rule change, “[a]ll types of competition shoes [had to] be approved by IAAF.” After the change IAAF appears to approve the shoes post hoc, and only “[w]here evidence is provided to the IAAF that a type of shoe being used in competition does not comply with the Rules or the spirit of them” at which point “it may refer the shoe for study and if there is non-compliance may prohibit such shoes from being used in competition.” In response to the advantage conferred by the Nike VaporFly, IAAF released a statement in mid-October stating that its technical committee had established a working group to look into the issue.

Even if IAAF eventually determines that Nike’s technological advances are too advantageous, Nike seems to be the main beneficiary, thus far, of IAAF’s rule change. Nike has received an enormous amount of free press, this blog included, because of the recent spate of record-breaking performances, and the surrounding controversy. However, a group that could benefit are up-and-coming, innovative, shoe manufacturers. In the late aughts, a company called Spira built a marketing campaign around being banned by USATF and IAAF because of springs in their shoes. Whether or not Spira was ever actually banned appears to be an open question—USATF repeatedly stated that Spira was not banned, and three runners wore Spira shoes in the 2008 Olympics. However, Spira filed a lawsuit against USATF and IAAF, alleging that the organizations had violated antitrust laws. Spira voluntarily dismissed the suit. Although there is other evidence that USATF believed that Spira did not comply with the IAAF shoe rules.

Spira still exists today, though they never took off as a serious running shoe brand. Whether the Spira controversy was completely authentic or drummed up for publicity, the next Spira could benefit from IAAF’s rule change. Instead of worrying about when and if they’ll receive IAAF approval, a new company and its shoe will only be scrutinized by IAAF if “evidence is provided to the IAAF that a type of shoe being used in competition does not comply with the Rules or the spirit of them.”

Death of a Gravesite: Alternatives to the Traditional Burial Practice

October 29, 2019
Uncategorized

Jennifer Novo, MJLST Staffer

Halloween is often a time for ghosts, the dead, and for some, is the perfect time to make a trip to a local graveyard or cemetery. The obvious association with death as the final resting place for many makes graveyards an inherently spooky destination. Burial is just one of the many methods used for the final disposition of human remains around the world and is a common practice in the United States. However, considering environmental and economic factors, it may be time to consider alternative forms of final disposition.

In the United States, there is a presumed right to a decent burial under common law. Beyond that, different jurisdictions within the United States have their own regulations for the disposal of dead bodies and the reporting of deaths and final dispositions of the remains. For example, Minnesota Statute § 149A outlines regulations with the purpose of “regulat[ing] the removal, preparation, transportation, arrangements for disposition, and final disposition of dead human bodies for purposes of public health and protection of the public.” This chapter outlines license requirements, safety standards, and guidelines for a number of disposition practices, not just burial.

There are a number of negatives, from environmental to economic, to the modern burial. Modern burials consist of burying a casket containing embalmed remains. This practice has serious environmental effects. Embalming is used to delay the decay of a body, and the chemicals used for embalming include formaldehyde, phenol, methanol, and glycerin, all of which are irritants and some of which are carcinogenic or toxic. Over time, once the body and the casket have decomposed, these chemicals will seep into the soil and water table of the surrounding area and pose a health risk to the living. Burials also negatively affect the environment by using a large amount of resources to create caskets (hundreds of thousands of tons of various metals and concrete as well as millions of board feet of wood). Another primary negative environmental impact that burial has is that graveyards use up a lot of space (as of late 2018, there are a little under 145,000 graveyards across the United States totaling to approximately 1 million acres of land). This land requires a lot of maintenance, water, and fertilizer to keep green. In addition to the environmental effects, burials are expensive. By 2017, funeral expenses increased 227.1% and the cost of burial caskets rose by 230% since 1986. The current cost of a traditional full-service burial in North America is between $7,000 and $10,000.

In 2017, a report by the National Funeral Directors Association (NFDA) found that for the first time, more Americans were cremated than buried. Researchers ascribed this change to shifting religious beliefs and generational differences. Economically, cremations are less expensive than traditional burials. Additionally, cremation removes the need for large swaths of land required by burials. However, like burials, cremation has negative environmental impacts. For example, studies have suggested that the high level of energy required to cremate a body damages the environment. Additionally, the cremation process releases various chemicals (such as carbon monoxide, sulfur dioxide, and mercury) and soot into the atmosphere, and the resulting sterile ashes lack nutrients that could contribute to ecological cycles.

As people are becoming more aware of the downsides to traditional burial and cremation, other methods of final disposition have been created and adopted that address some of these concerns.

One alternative comparable to a traditional burial is a natural or green burial, in which a body is buried either in a shroud or a biodegradable container without going through the embalming process. Some types of natural burial (conservation burial) take this a step further in that some of the fees associated with the burial go towards protecting the land through a conservation easement.

One alternative comparable to traditional cremation is a flameless cremation process known as alkaline hydrolysis, in which the body is dissolved, leaving bone powder and a liquid that can then be “recycled” in a local wastewater treatment plant. Only a handful of states, including Minnesota, have formally adopted regulations for this final disposition process.

A number of states, including Minnesota, do not have many (or any) restrictions on remains post-cremation, so a number of alternatives focus on ways cremated remains can be used to negate the negative environmental effects of the traditional cremation process. Some examples include sending ashes in a concrete ball to the ocean floor to promote the growth of coral reefs, placing ashes in a pod that will eventually grow into a tree, and mixing ashes with fertilizer to feed a particular tree in lieu of having a gravestone.

Death is frightening and uncomfortable to think about, and contemplating the treatment of a loved one’s (or one’s own) remains is depressing. However, decisions on these matters have lasting effects for friends, family, and even the general population. There is a lot of legal leeway surrounding final disposition, so it never hurts to consider the options before it’s too late.

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