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A New Sheriff in the Wild West: How the Cryptocurrency Industry’s Failure to Neutralize Hacking Threats Has Rendered Federal Regulation a Necessity

Dan O’Dea, MJLST Staffer

In today’s financial world, few things are more captivating than the rapidly evolving cryptocurrency space. It has been a wild twelve months for the cryptocurrency industry, and specifically for Bitcoin owners. Bitcoin doubled its value in 2021 and peaked at just over $68,000/coin, only to erase nearly all of those gains when the crypto market crashed in January 2022. The crash was largely prompted by fears that the Federal Reserve would withdraw stimulus from the market by raising interest rates. In the process, the crypto market lost over $1 trillion in market value, and an asset class that many have called a “hedge opportunity” for investors against inflation crashed down with the stock market as a whole.

But extreme market volatility is not the only risk investing in cryptocurrency poses for its some 300 million investors. Hackers and thieves have been wreaking havoc on the Decentralized Finance (De-Fi) industry, with their latest exploit coming in the form of a $320 million theft of Ethereum from Wormhole, one of the most popular bridges linking the blockchains of the popular Ethereum and Solana coins. These blockchains are of great use, as they are capable of developing “smart contracts” to replace banks and lawyers in certain business transactions. Blockchain “bridges” like Wormhole are important facilitators for these contracts. Unfortunately, in the process, bridges like Wormhole have become a target for cyberattacks due to fundamental limits on their security as they house hundreds of millions of dollars of assets in escrow. This latest theft on Wormhole is not even the largest in the De-Fi crypto space’s history, where a $600 million theft from a platform called Poly Network takes the cake. Interestingly, the hacker’s goal in that theft was simply to open a dialogue with the platform about security issues on the blockchain, and ultimately all funds were returned. Attacks have not been limited to the platform level, as smaller-time thieves have turned to phishing scams and SIM Swap schemes (in which an individual misrepresents their identity to your cell phone provider in an effort to intercept dual-factor authentication messages and gain access to your crypto accounts) to steal from individual investors. Unfortunately, victims of the vast majority of cryptocurrency thefts are extremely unlikely to recoup their funds once they have been stolen, due to the anonymity afforded to wallet holders on the blockchain, who in some cases can reveal no identifiable details about themselves while transacting cryptocurrency.

It is important to note that when a cryptocurrency platform loses money, it is not the platform alone that incurs a loss. Rather, the clients whose accounts were pillaged by hackers bear the entire loss, or, if the platform collapses from the theft and liquidators are appointed, every user on the platform will bear the loss to some degree. So what recourse do the victims of cryptocurrency theft have? While Cryptocurrency platforms such as Coinbase attempt to educate users about the types of scams they may encounter, if a theft occurs, victims are usually on their own. While state prosecutor’s offices and federal enforcement agencies like the FBI will investigate and prosecute identifiable criminals, and individual plaintiffs can bring private civil actions against them, the largest challenge faced by victims of cryptocurrency theft is identifying the thieves in the first place. In an effort to identify perpetrators, both the FBI and private parties with deep pockets have begun to contract with private tech firms specializing in tracking down stolen crypto, such as CipherTrace. While working with a crypto-tracking firm gives an aggrieved individual the best chance of tracking down their thieves, it is still unlikely that the parties will ever be identified and funds ever recouped.

Security requirements are far from standardized across the crypto industry—true to its nickname, the “Decentralized Finance” (De-Fi) industry, operates essentially free from regulatory constraints in the United States. The Financial Industry Regulatory Authority (FINRA) has cautioned investors of the risks posed by cryptocurrency investments relating to hacking and volatility, but because the space is not subject to federal securities regulation requirements, investors often enter the world of cryptocurrency investing underinformed as to its true risks. The U.S. Securities and Exchange Commission (SEC) has begun to wade into the fray of regulating cryptocurrency platforms, most recently with the introduction of a proposal that some are calling a “trojan horse” regulatory tool to be wielded against the crypto industry. The proposal contains an expansive definition of the term “treasury platforms” that would likely allow the SEC to issue protocols for cryptocurrency and De-Fi platforms. The trojan horse notwithstanding, the SEC has been vocal about its plans to introduce formal regulatory guidelines and procedures for the cryptocurrency industry in the long term. Even the White House has waded into the crypto regulatory waters, with the Biden administration set to release an executive order designed to create a government-wide strategy to regulate the cryptocurrency industry that could release as soon as mid-February, 2022. The proposal comes on the heels of the FTC’s release of data showing cryptocurrency scams have skyrocketed, and as concern levels over crypto money laundering schemes rise.

While many have scoffed at the idea that the decentralized finance industry should be regulated, it is likely that the prospect of federal regulation actually represents a good thing for a cryptocurrency market that has been referred to as “The Wild West,” and that has drawn comparisons to the late 2000s subprime mortgage market. Federal regulation of the cryptocurrency industry will prompt new protocols for its platforms designed to enhance risk disclosures made to prospective crypto investors and strengthen the security measures protecting investments. Further, regulation is likely to prompt registration and reporting requirements that will make it easier to catch crypto thieves by providing greater information to law enforcement agencies. The crypto industry continues to prove it cannot protect itself from the threat of hacking, and investors are largely bearing the costs of these failures. Just as the SEC stepped in to protect investors from being burned by highly speculative and worthless securities in the 1930s, aiding its regulatory hand to the cryptocurrency industry in a non-burdensome manner should again provide investors with a new set of protections in 2022.


Legal Personhood and Cocaine Hippos: Animals as “Interested Persons” and Their Rights in Court

Douglas Harman, MJLST Staffer

On October 15, 2021, a federal magistrate judge ruled that a group of hippos in Colombia can be recognized as “interested persons” per federal statute for the purposes of deposing two Ohio Wildlife experts. These hippos are the descendants of hippos illegally imported to Colombia by drug kingpin Pablo Escobar. When Escobar was killed, the hippos were not relocated and were left to their own devices in Colombia. Since then, the hippos have multiplied and present significant environmental challenges. The issue in the US arose from litigation in Colombia concerning the fate of the hippos, which resulted in a request to depose the two Ohio experts. These hippos will be referred to as the “cocaine hippos” because that seems to be the term most commonly associated with them (and, quite frankly, it’s amusing).

This decision, though hailed by animal rights groups as groundbreaking, is likely more a technicality than a guiding precedent. Specifically, the ruling comes because Colombia treats animals as “sentient beings” with certain rights. Because the suit by the hippos is permitted in Colombia, US law treats the hippos as “interested persons” for the purposes of deposing US experts on ethical sterilization methods. Regardless of the breadth or technicality of the decision in question, it nonetheless represents a significant step to affix the title of “person” to a non-homosapien, and it has not happened in a US court before, despite repeated efforts by animal rights organizations. However, other countries do recognize various degrees of animal sentience.

The Legal Concept of Non-Human “Personhood”

The issue of whether animals should be considered “persons” has a variety of scientific, psychological, and philosophical elements. This blog post is not here to debate whether animals should be considered persons in terms of political theory or philosophy; plenty of ink has been spent in that pursuit elsewhere. This discussion focuses on how non-persons may receive limited rights to sue in court and perform certain legal functions as if they were persons, like the deposition of experts in the matter of the cocaine hippos.

 The implications of animal consciousness are relevant because growing understanding of animal cognition and consciousness has informed a discussion of whether animals, and other non-humans like trees or natural areas, should be allowed to have their own rights vindicated in court. That is to say, there are a number of ongoing legal discussions about obligations owed to non-humans that governments are obligated to respect, and how those rights are allowed to be vindicated in court. It is this narrower, legal version of non-human “personhood” that was granted to Colombia’s cocaine hippos in the present action.

History of Non-Human “Personhood” Debate in the US

Although the court ruling in the cocaine hippos matter is the first time a US court has attached “person” status to an animal, it is not the first time the issue has been discussed. Attempts to give animals legal status and treat them as “persons” in certain legal areas developed from the animal rights movement, which has a long history in the US and Great Britain. In the last several years, several courts have referred to animal legal rights in the context of personhood, albeit rather obliquely at times. One of the biggest ongoing debates concerns the rights of Happy the Elephant; animal rights activists are pursuing a writ of habeas corpus for Happy, arguing she deserves to be treated as a person in the eyes of the law.

Non-human personhood is not without precedent. Courts have allowed corporations to be considered “artificial persons” in limited circumstances in court since the 1600s. Jurisprudence has since developed in the United States towards increasing “personhood” of corporations, referring to a railroad as a person for the purposes of the 14th amendment in 1886. Today corporations have near-total personhood, including the right to make religious objections to laws and practice free speech.

There is also some precedent for inanimate objects holding “personhood” status under the law. Every law student (and a great many other Americans, it is to be imagined) have discussed or at least heard of the Tree that Owns Itself (while it almost certainly does not own itself as a technical matter, it certainly does in the public mind and in the official statements of the local government). Additionally, Justice William O. Douglas in his dissent in Sierra Club v. Morton argued that standing doctrine should be amended to allow organizations to sue on behalf of inanimate things, including land, rivers, trees, etc. This opinion essentially lays out an idea of legal personhood for inanimate objects, and would presumably also extend with relative ease to animals.

As a factual matter, the reality of non-human personhood, while remarkably developed for corporations in the United States, has relatively little real applications to animals today. This is one of the main reasons that the attachment of the “interested persons” label to the Colombian hippos felt significant to many in the animal rights movement.

Recognition of Non-Human “Personhood” in Other Countries

While animals have not commonly been granted legal rights in the United States, they do in many other countries. Spain recognized animals as “sentient beings” and have greater standing than inanimate objects. In doing so, it joined about 32 other countries that do the same, including France, the U.K., the Netherlands, Sweden, New Zealand, and Tanzania. South Korea is doing something similar in granting animals legal status.

South America is also moving on the front on non-human rights. In 2014, a court in Argentina recognized the basic rights of Sandra the Orangutan, and agreed that she was being detained illegally in the Buenos Aires Zoo. Additionally, Colombia, the state in which the cocaine hippos case originates, has vested portions of the Amazon Rainforest with legal rights, and, as mentioned, recognizes animal sentience and limited legal rights.

What This Means for Colombia’s Cocaine Hippos (and Other Animals)

In the immediate term, the magistrate judge’s recognition of the cocaine hippos as “interested persons” has allowed for the expert deposition sought by the Colombian lawyers advocating on the hippos’ behalf. Effort is now under way to chemically sterilize the hippos, rather than cull or surgically castrate them.

More broadly, there appears to be more references to the inherent rights of animals in American jurisprudence, rather than simply their function as property. The act of classifying the hippos as “interested persons” did not rock the legal boat (in fact, the magistrate judge remains quite well regarded by her colleagues). Those interested in animal rights will doubtless be heartened by increased use of personhood and rights language used with respect to animals. Hopefully, the treatment of Pablo Escobar’s rogue cocaine hippos in US court is indicative of progressive trend in the law’s treatment of animals.


The Mysterious Disappearance of Deference: What Is the Supreme Court’s Current Relationship to Federal Agencies?

Carly Michaud, MJLST Staffer

The Supreme Court has had no shortage of administrative law cases in the (possibly) final sessions of one of the Court’s administrative law scholars, Justice Stephen Breyer. Yet, Breyer has found himself and his ideological compatriots in the opposition on the topic in which he situates his expertise. In the recent case regarding OSHA’s ability to require COVID-19 vaccines, Breyer’s dissent repeated discusses the proper deference an agency’s determination should be given by the Supreme Court.

Notably absent from the case is any mention of the previous key to the relationship between the courts and federal agencies: Chevron deference. In fact, Chevron U.S.A., Inc. v. National Resources Defense Council, was, (as of a 2014 analysis in the Yale Journal on Regulation) the “Most Cited Supreme Court Administrative Law decision”. While previously considered a niche area, administrative law is now so ubiquitous in practice that as of July 2021, 55 law schools require students take a course in administrative law or one of its mainstays: legislation or statutory interpretation.

In spite of this, Chevron appears nowhere in the discussion of OSHA’s vaccine mandate, nor in the court’s earlier revocation of the CDC’s eviction moratorium. This absence suggests that perhaps this Court has become a body of health experts, relying on their own understanding of COVID-19 to determine whether these agency-created regulations are effective in their mission. Both cases center on whether an agency action to prevent the spread of COVID-19 is within the purview of their empowering statute, and, despite the broad statutory authorities of these agencies to protect the health of Americans, both actions were deemed beyond that authority.

But back to Chevron, has it been abandoned as a standard? Not yet, although there was some discussion of this proposition during the oral argument of American Hospital Association v. Becerra last November. The Court has not released an opinion yet on this case, however the Court of Appeals had previously upheld HHS’s ability to set reembursement rates, per its statutory authority.

In a final thrust of irony, the death knell for Chevron deference may come from a case challenging the very statute and the very agency whose decision-making was at issue in Chevron: the EPA and the Clean Air Act. This is particularly ironic as the EPA administrator whose decision-making was being challenged in Chevron was Anne Gorsuch, the mother of Supreme Court justice and noted antagonist of agency authority: Neil Gorsuch. Yes, in a tale mirroring Hamlet, Neil Gorsuch seems determined to destroy the administrative state that had entangled his mother in various administrative scandals. The latest edition of this showdown between the Gorsuchs and EPA is scheduled for Monday February 28, which will see the Supreme Court hearing arguments in West Virginia v. EPA and its consolidated cases.

This behavior by the Court belies a grave concern both about the continued disempowerment of federal agencies—which have been empowered directly by Congress—at the hands of the unelected judiciary. Further, the most cynical of us may see this as a direct assault on the authority of agencies that some justices may politically disagree with, further disregarding the knowledge of learned experts to push their own political agendas.


Billionaire Space Race: How Blue Origin’s Attempt to Stall SpaceX’s Lunar Program May Lead to China Beating the USA to the Moon

Henry Killen, MJLST Staffer

The days of mega billionaires like Jeff Bezos, Elon Musk, and Richard Branson being content with their private islands and mega yachts are over. The latest mega rich trend is owning a space company. Blue Origin, SpaceX, and Virgin Galactic are all leaders in space exploration and are all owned by billionaires. The space race is on! The privatization of space travel has led to innovative developments in the industry. Both Blue Origin and SpaceX now have reusable rockets that cut the cost of a launch by at least 50 percent compared to a nonreusable rocket. Virgin Galactic has developed its own unique technology, which uses an aircraft to fly their space vehicle to an altitude of 50,000 feet before releasing it.

In 2017, then President Trump signed an order directing NASA to partner with the private sector with the goal of putting astronauts on the moon by 2024. The project, known as Artemis, will return astronauts to the moon for the first time in over 50 years. Perhaps the most important part of going to the moon, is the lunar landing vehicle. Both Blue Origin and SpaceX have demonstrated that their rockets can safely and effectively travel into space, but neither has ever successfully landed a vehicle on the moon. Developing lunar landing technology is certainly expensive, so NASA solicited proposals from private companies who want to lead the lunar landing project.  In 2020, NASA awarded almost a billion dollars combined to SpaceX, Blue Origin, and Dynetics (long considered a dark horse) to begin researching and developing a lunar landing vehicle. After the initial funding, NASA was expected to select two of the three companies, so they would have a backup if one company failed, and then fully fund the completion of each company’s lunar landing program. In April 2021, NASA selected only SpaceX to build the lunar landing system because of a lack of funding. Blue Origin immediately filed a protest with the US Government Accountability Office, but its protest was promptly denied. Then, Blue Origin sued NASA in federal court in an attempt to remedy the flaws in the acquisition process found in NASA’s Human Landing System. Blue Origin’s main issue is that NASA was expected all along to select two companies, and that they would have revised their proposal had they known only one would be selected. Released court filings show that SpaceX’s final proposal was $2.9 billion, while Blue Origin’s was $5.9 billion. On November 4th, a federal judge rejected Blue Origin’s argument because the company was not able to show how the process was unfair. Though the judge’s opinion is yet to be publicly released, we do know that the case was dismissed under rules 12(b)(1) lack of subject matter jurisdiction and 12(b)(6) failure to state a claim upon which relief can be granted. It appears Blue Origin has accepted defeat because Jeff Bezos took to twitter writing in part, “we respect the court’s judgment, and wish full success for NASA and SpaceX on the contract.”

Perhaps the biggest loss stemming from this lawsuit is time. SpaceX and NASA’s work was put on hold during this litigation. Ultimately, they were unable to communicate about the Artemis program for nearly seven months, and have now delayed humans returning to moon until at least 2025. As America’s billionaires litigated and delayed this monumental project, America’s biggest rival on the global stage has made its own strides for putting humans back on the moon. China is now rapidly developing its own lunar program. China publicized timeline for landing its astronauts on the moon is slated for 2028, but China has a history of world-class innovation. Most recently, China has successfully tested the most advanced missiles in history. In 2020, China used a drone to raise a flag on the moon, becoming the only nation besides America to have a flag standing on the moon. General Mark Milley, who is the Chairman of the Joint Chiefs, said China’s new weapons are close to a ‘sputnik moment.’ The sputnik moment Milley is referring to is when the Soviet’s put the first satellite in orbit during the Cold War, shocking the USA and giving the Soviet’s an early lead in the space race. America ended up beating Russia to the moon after the sputnik moment, but the 21st century’s moon race is still up for grabs. It remains to be seen if America’s billionaire-run space companies can compete with a country like China. One thing is certain, SpaceX and Blue Origin’s resources are better off innovating than litigating.


Inventions Ex Machina, Patents Dantur Hominibus

Chase Webber, MJLST Staffer

In the last year, a United States Patent and Trademark Office (USPTO) and a US federal district court opinion answered many questions on the issue of who (or what) should get the patent when AI is responsible for an invention?   The take-away from these new sources is that AI cannot be named as the “inventor” for a patent, but the human developers of the AI will qualify as joint inventors.  Future courts (including the appeal of Thaler v. Hirshfeld, the recent AI “inventor” case) may consider whether an invention created by an AI may be practically unpatentable because no “natural person” could qualify as the inventor.  However, according to the USPTO report, humans’ significant contributions to the AI in all existing instances of AI invention qualify them as the “joint inventors” to obtain a patent.  There is no need to change the patent laws today for AI.  It is essential to consider, however, which humans will qualify as inventors.

Stephen Thaler applied for a patent on behalf of his AI, DABUS, for two inventions generated by DABUS.  The inventions are inconceivable by human minds; for example, a beverage container designed using fractal geometry.  Thaler named DABUS the “sole inventor” when filing for a patent.  On DABUS’s behalf, Thaler assigned all DABUS’s patent rights and benefits to himself.  The USPTO refused to issue the patent to DABUS because an “inventor” must be a “natural person.”  Facing an insurmountable obstacle of basic statutory interpretation, Thaler argues policy:  The USPTO’s interpretation disincentivizes innovation and devalues human inventorship – both of which threaten the purpose of the Patent Act.  Thaler’s arguments do not persuade the court or this author.

Who really cares?  The outcome seems to be the same for Thaler – whether he is assigned DABUS’s patent rights or awarded the patent for DABUS’s invention.  The public commentary in the USPTO report, published before the case and referenced by the court in Thaler, seems to agree.  There is no apparent injustice in a human taking credit for the AI’s invention.  However, the outcome of Thaler is important when considering who is responsible for (and therefore profits from) AI inventions.

Thaler claims that the AI is the rightful “inventor,” although, practically, someone besides the AI will profit no matter the outcome of Thaler.  But who?  Is it the owner of the AI machine?  Or the developers who created the AI (assuming these are separate people)?  Both the AI owners and developers?  According to the USPTO report, it’s more likely to be the developer, but it may be both.  Joint inventorship is determined by considering whether a person’s contribution to the invention was significantin the scope of the entire invention.  AI developers easily qualify for joint inventorship.  However, AI owners may only claim joint invention if they can show that their contribution to the AI (e.g., the introduction of crucial data which the AI used in its invention process) was significant to the AI’s invention.  These issues are determined on a case-by-case basis.  Thaler, for example, is the owner and developer of DABUS, therefore, Thaler would be the “sole inventor” on the patent application for DABUS’s inventions.

Future plaintiffs in AI “inventor” cases should frame their case around joint ownership, instead of sole ownership.  In this way, the court would consider which humans could profit from AI inventions instead of AI personhood, a theory doomed by philosophical reasoning if not only textualism.  Using the “significant contribution” standard, the AI owner can never legally be named “sole inventor” in exclusion of the AI developers as joint inventors.  In contrast, naming the AI itself as “sole inventor” (as Thaler proposes) allows the AI owner to assign patent rights to himself and exclude the AI developers from benefitting.

A court could be more generous if it compares the implication of Thaler’s proposal to the Patent Act goals in the context of joint inventorship.  Using the USPTO’s interpretation, if AI machines are marketed to numerous owners, the developers profit from patents earned by each individual machine, whether or not any individual owner will profit.  Under Thaler’s interpretation, the one who owns the AI and applies for a patent will benefit from the AI’s invention.  In that case, the developers will only profit from the initial sale of the machine, not from the patent of any AI inventions.  The implication of the USPTO’s interpretation may threaten innovation, as a plaintiff of Thaler’s position might argue, because the individual owners have little incentive to produce valuable and innovative AI-generated inventions if they likely cannot profit from the patents of those inventions.

What happens if no humans can show that they made significant contributions to the AI?  According to public comments summarized by the USPTO, there is no such legal circumstance now.  To some, there never will be.  When the Patent Act says, “Whoever invents . . . may obtain a patent . . .” (emphasis added), it refers to he who contributes significantly to an AI invention (explained above).  AI is legally only a tool used by a natural person, who is himself the inventor.  The non-AI computer is a familiar example of a tool that can be used for invention, where it is obvious that the computer itself is not the “inventor.”  Thaler seems to imply that since no human could conceive DABUS’s inventions (e.g., the fractal geometry), DABUS is no longer a tool but the inventor himself.  Philosophically – and, as the court determines by statutory interpretation, legally – it seems clear that DABUS is only a tool used by Thaler, especially when considering that Thaler (and not DABUS, as he concedes) stands to profit.

AI (including DABUS) is limited to “narrow, application-specific objectives” in contrast to artificial general intelligence (AGI) which resembles human intelligence.  To picture AGI, imagine the AI portrayed in sci-fi movies, e.g., Ex Machina, AI that can pass The Turing Test.  Could AGI hypothetically graduate from “tool” to “inventor”?  The public opinion gathered by the USPTO is split on this question:  One side argues “no.”  Even AGI, they claim, has the same practical human origins as AI; there is no legal difference in patent law.  The other position is “who cares?”  To argue whether AGI is an “inventor” is to claim AGI’s moral personhood, a question best left for the field of philosophy that far exceeds the scope of this discussion.  One day, we may confront this issue in legal or technological reality.  For now, AGI is still a matter of imagination and cinema.


You Can Design Your Clothes, but Can You “Design” a Baby? Ethical Objections to Genetic Modification of Embryos and the Prevention of Diseases in the Unborn

Zanna Tennant, MJLST Staffer

The term “designer babies” has been thrown around quite a bit by those who find the genetic modification of babies to be morally repugnant. However, these fears are often blown out of proportion considering the benefits that such genetic testing and modification can give to babies in utero. The age-old debate of science versus religion is evident here, as scientists argue that genetic alteration can save lives while many with religious or spiritual backgrounds fear the ethical implications. How the world and the law should react to this newer science is still very much a controversial topic. Many countries have banned genetic modification of embryos altogether, while some are still unsure how to proceed. Despite these fears, genetic alteration should not be completely abandoned. It has the potential to prevent genes for diseases from passing from parent to child and save lives. It should not, however, be completely unregulated. While it is difficult to say precisely how to regulate and who should be in charge of such regulations, this is something that governments and the world as a whole must decide. This is exactly the challenge genetic testing faces today, especially from those who oppose it on religious or ethical grounds.

Women or others who may be having trouble conceiving or are concerned about possible hereditary diseases are among those likely to pursue in-vitro fertilization, a process by which a sperm and an egg are combined in a lab. This process results in an embryo. “Designer babies” are babies that come from embryos created by in-vitro fertilization (IVF) and are specifically selected because of the presence of “good” genes like intelligence, or the absence of “bad” genes, such as BRCA 1.  The genes of the embryos are then altered through the process of heritable genome altering, whereby scientists alter the DNA of the egg, sperm or any other cells involved in the process in order to achieve a desired result.For example, suppose an embryo has the gene for sickle cell anemia. Diseases often show up in DNA in the form of a genetic alteration, such as the presence of an extra chromosome or the absence of one. The embryo in this example would be taken to a lab where a scientist could alter it to get rid of the gene for sickle cell anemia. Heritable genome altering could prevent life-altering disabilities and diseases in children who otherwise may not survive.

Despite the enormous lifesaving potential, there is a large movement against genetic alteration of embryos. One of the biggest challenges genetic alteration faces is whether it is ethical to alter the genes of an unborn child. Many fear that this genetic alteration would be used to change what they consider to be superficial genes, such as hair or eye color. They think this is man’s way of “playing God” and is unnatural. Factors such as religion and spirituality heavily influence what people think about gene altering of babies. Some see the altering of embryos as going against God’s wishes.  Along with this issue, people who believe that life begins at conception are concerned with the rights of the embryos. Similar to the controversial topics of reproductive rights and abortion, there are those who think that altering the genes of an embryo violates the human rights of what they perceive to be a living child. They see the embryo as already being alive and having the same rights as any post-birth child. On the other side, there are those, including many scientists, who do not conflate the embryo with a human child and find their beliefs in line with those who support the right to choose. People are also concerned about the unknown effects of gene alteration since it is a more recent development and scientists believe that the genetic alerting of DNA might affect future generations in unknown ways. There is also concern about increasing socio-economic inequality due to the high price tag that comes with genetic alteration. In vitro fertilization on its own is expensive, but genetic alteration is upwards of $500,000. Should this technology become available to the public, only the very wealthy would be able to afford it, thereby increasing the divide between the rich and the poor.  Because of the controversy surrounding heritable genome altering, legal systems in different countries are often unsure what to do.

Some forty countries, such as China and Japan , have completely banned heritable genetic altering. In 2019, a biophysicist in China was criminally charged with illegal medical practice and sentenced to three years in prison after he edited genes of two embryos which later became baby girls. He used a new tool, CRISPR, which allows scientists to more easily edit genes and DNA. He was universally condemned, save for the scientific community. There are other countries, however, that have not banned heritable genome altering. Rather, they have placed strict regulations on how it is to be used. In the United Kingdom, they have banned all forms of genetic alteration except for the modifications of nuclear mitochondrial DNA, which are heavily regulated. Mitochondrial DNA testing focuses on diseases in the mitochondria of a cell that can be passed down from mother to child. This testing allows potential families to determine if the mitochondria in the embryo has a disease and allows them to replace the defective part of the mitochondria with a healthy part. Clinical trials for mitochondrial replacement therapy are allowed in the UK, but they are only allowed for medical purposes. Similarly, mitochondrial replacement therapy is offered on a case by case basis only to those who meet the necessary medical criteria. Even in the few countries which have not outright banned genetic alteration, there is still strict regulation and strong public criticism.

As in the rest of the world, genome editing is controversial in the United States. Although it is not technically illegal, it is regulated under the FDA and the National Health Institute. Any genetic testing must be approved by the FDA, which is no easy task. Generally, the editing of somatic cells is allowed, while the editing of germline cells is still very much up for debate. Somatic cells are those cells which have already been differentiated as blood cells or liver cells, while germline cells are those in the egg, sperm, or embryo. Alerting somatic cells is akin to altering the function of cells. Germline editing, on the other hand, is the controversial case of actually altering the genes that determine who a person is. There are clinical trials that have been approved for the use of CRISPR in somatic cell editing.  Recently, the FDA stated that the use of federal money cannot be used to research germline editing, but it can go towards funding for somatic cell editing. While the US has yet to actually ban germline editing, there is essentially a moratorium on its use as it is disfavored by many government officials. However, the US does permit the use of preimplantation genetic screening (or diagnosis), which is either heavily regulated or banned in other countries. Preimplantation genetic screening is a process used to test embryos for genetic abnormalities that could indicate a disease and help parents to find a healthy embryo to use. It is used in the course of IVF and can help parents to increase the likelihood that their child will make it to term and be healthy. PGS raises similar ethical concerns to genetic alteration due to its focus on finding the best embryo and using science to change DNA, which is why it is banned in some countries.

Despite the numerous, and admittedly (mostly) valid concerns, it would be contrary to human progress to completely rule out heritable genome testing. This process can save the lives of thousands of children yet to be born and could even erase a disease from a family’s hereditary line. Although there are certain inherent risks, the only way for the world to move forward with this achievement is to allow, within reason, clinical trials to take place so that scientists can better understand how best to alter genes. The federal government should, with regulations enacted, encourage the use of gene altering. Although states have admittedly said very little about gene editing, they, too, should support its use. Only through controlled, regulated tests can the best practices and the unknown consequences of gene editing be discovered. The focus of gene editing should be on how it can progress the medical field. People’s fear that gene editing will be used for superficial purposes is unfounded, scientists claim, as there is not a one for one ratio between a gene and, say, the trait for blue eyes. Scientists can better predict hair or eye color, but they cannot determine these traits with one hundred percent certainty, nor can they easily find and gene and determine that it is the gene for intelligence.The government could also easily limit gene editing for health reasons and medical research, thereby making this fear irrelevant. The US government, unlike other countries, has yet to really take a stand one way or the other when it comes to gene editing. It is time that the federal government get behind this scientific wave that could potentially erase diseases altogether from the human population.


Relieving a Pain Management Crisis: How Medical Cannabis May Help the Prescription Opioid Epidemic

David C. Edholm, MJLST Staffer

“The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human . . . drugs.” To no surprise, near the top of the FDA’s list of current priorities is ameliorating the prescription opioid epidemic. More than 14,000 deaths in 2019 are attributed to prescription opioid overdoses. (See fig. 4 of hyperlink). Celebrity opioid overdoses have raised public awareness of the crisis, however, hundreds of millions of opioid prescriptions are written each year to treat “moderate-to-severe” pain. The epidemic continues today, begging the question of whether any reasonable alternatives to prescription opioids exist, perhaps medical cannabis.

California became the first state to legalize medical cannabis through a ballot initiative in 1996; since then, 35 states and four territories followed. Although the Department of Health and Human Services and the FDA have expressed skepticism about safety and efficacy due to a lack of quality research, legalization in a recreational capacity is becoming more popularized. Recent systematic studies on high-potency cannabis products have shown a cause for concern, however, studies on substituting medical cannabis for prescription opioids remain inconclusive, leaving the door open to this future possibility.

In order for medical cannabis to legitimately contend with prescription opioids, quality safety and efficacy data are required. But the public stands by as FDA has yet to approve a medical use and “marihuana” remains a Schedule I controlled substance. 18 U.S.C. § 812(1) (2018). Recent federal efforts push for decriminalization, but historically the federal government has adopted a “hands off” approach, giving states choice on cannabis regulation. There is coast-to-coast differentiation on cannabis legalization with most states permitting medical use and a growing number permitting recreational use, but due to its current state of being under-researched, it is substantially less controversial to leave the political choice for legalization to the states as long as safety and efficacy are opaque.

The benefit of state choice is articulated through efforts from states like California and Minnesota that aid the national effort to clarify safety and efficacy in legitimate ways. California, for example, allows medical and recreational use, as a result providing a vast data cohort. The state senate bill reads, “[i]t is the intent of the legislature that the state commission objective scientific research by . . . the University of California, regarding the safety and efficacy of administering cannabis as part of medical treatment.” Additionally, Minnesota, which permits medical use and submitted a bill for recreational approval now pending in the senate, created a medical cannabis patient registry that accumulates data, generates reports, and submits the reports to legislature and prominent medical journals that are available to the public. These states are among others providing similar efforts.

Medical cannabis may be an alternative for prescription opioids, yet there remain several questions about safety and efficacy that must be answered in order for the FDA to move on any milestone cannabis regulation. It seems that severe risks posed by cannabis are extremely rare, and are not a public health threat requiring immediate attention. Prescription opioids remain standard treatment post-operation or post-physical trauma and are usually prescribed for short-term use, but 20% of post-op patients still use opioids three months after surgery, despite an increased risk of addiction after only a few days of use. It seems the opioid epidemic is here to stay as long as prescribing practices remain the same, at least until an effective alternative arises. Maybe cannabis will be a solution. It depends on the data.


Quantum Computing: Ready to Be Patented!

Shuang Liu, MJLST Staffer

In June 2021, IBM presented its newest and most powerful quantum computer—Q System One. This news highlighted people’s continuing confidence and resolution in the research and development of quantum computing. As a matter of fact, several countries and leading high-tech corporations are investing from millions to billions in various aspects of quantum computing technology, and filing patent applications to protect their research achievement.

(Q System One at Fraunhofer-Gesellschaft, Germany)

This article attempts to provide a brief introduction of quantum computing technology (Part I), a potentiometric analysis of the high-tech corporations in quantum computing industry (Part II), and a discussion of potential legal challenges in obtaining patents related to quantum software (Part III).

I. The Quantum Computing Technology and Its Potential Applications

The world’s most famous cat, Schrödinger’s cat, is both alive and dead until it is observed. A quantum bit (“qubit”) behaves similarly—it is both 0 and 1 until it is measured. A classical computer transmits and processes n-bit information with n bits. In contrast, since a qubit represents 0 and 1 at the same time (that is, a superposition of 0 and 1), a quantum computer transmits and processes 2n-bit information with n qubits. Therefore, if a good algorithm is found and the superposition property is utilized properly, a quantum computer can compute exponentially faster than a classical computer.

However, algorithms for quantum computers (hereinafter “quantum algorithms”) are not easy to find and algorithms for classical computers (hereinafter “classical algorithms”) cannot be readily applied on quantum computers. After all, classical algorithms solve problems in a deterministic way (where bits are either 0 or 1), while a quantum computer by its nature processes probabilistic information (where bits are superpositions of 0 and 1). It took people decades to develop the first quantum algorithm that showed capability of solving real-life problems. To date, although quantum algorithms are still far from enough, the available ones do show a great potential of applications.

The first, surest application is cryptanalysis. Integer factorization plays a key role in cryptanalysis. The Shor’s algorithm, one of the most famous quantum algorithms, is able to factor all integers in polynomial time, which has not been made possible by classical algorithms so far.

Another promising application is predicting new chemicals and materials having certain properties. Properties of chemicals and materials usually depend on a variety of factors and can be too complicated for a classical computer to make simulations. A quantum computer, with a stronger computation power, is expected to be able to make such simulations. To be noted, researchers are hopeful to use a quantum computer to find a way to build materials that can be superconducting at room temperature.

Complex processes, such as biological processes, economic development modelling, energy allocation optimization, and big data processing, are also good candidates for which a quantum computer can use its exceptional computation power.

II. Patent Landscape of Leading Corporations

People’s confidence in the potential of quantum computing leads to a race in patents. In the last five years, nearly a thousand patent applications related to quantum computing have been filed in the US, and a little bit fewer before the WIPO.

The figures below show the number of applications filed by leading corporations related to quantum computing and the number of applications related to specific areas. Among them, IBM is the first active patent applicant, leading other corporations by big margins and showing interest in almost every aspect of quantum computing. Other leading applicants are interested in different aspects of quantum computing. For example, Microsoft is mainly working on the software side (machine learning and optimization), while Intel devotes its most energy on the hardware side (quantum circuits). It is also worth noting that Bank of America has filed many applications in the cryptology aspect of quantum computing—it is endeavoring to be the first to use quantum security keys to protect its data.

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Figure 1

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Figure 2

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Figure 3

Turning our eyes to the world, we can see that Huawei, a Chinese telecommunication company, has filed a large number of quantum computing related applications before the World Intellectual Property Office (WIPO). Its major interests reside in quantum communication and securing such communication with cryptographs. NEC, a Japanese electronics corporation is also an active global patent applicant. It mainly focuses on building a quantum computer itself.

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Figure 4

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Figure 5

III. Potential Legal Issues

In the process of obtaining a patent, the most common substantive rejections are novelty and obviousness rejections. For a quantum software application, a patent-eligibility rejection is also likely. The subsections below discuss patent-eligibility and obviousness challenges especially for quantum software applications.

A. Patent Eligibility

The case law on patent eligibility of software has been unclear and inconsistent. This subsection does not attempt to, nor can it, predict the patent eligibility of quantum software. But at least there are more arguments available for patent eligibility of quantum software than those of classical software.

Courts tend to find a software claim ineligible if it is “not tied to any particular novel machine or apparatus, only a general-purpose computer.” From a policy perspective, such claims are disfavored by courts because “[they] would risk disproportionately tying up the use of the underlying ideas and . . . pose . . . risk of pre-emption.”

To facilitate discussion and avoid confusion, the remainder of this and next subsection will discuss with claim 1 ofU.S. Pat. No. US10990677B2 (hereinafter “‘677 claim 1”):

“A method, comprising:

programming a quantum computing device to implement quantum circuits that perform a machine learning technique using one or more qubits of the quantum computing device, wherein the machine learning technique employs principal component analysis based on at least one median estimate stored as a quantum bit string . . . .”

In a nutshell, ‘677 claim 1 recites a machine learning technique implemented by a quantum computing device. It was drafted in a way that it is closely tied to the quantum computing device, in contrast to “a general-purpose computer.” Therefore, if challenged, the patentee can always argue that this method is closely tied to “a particular novel machine,” and can’t possibly preempt all use of the underlying concept in the claim.

It is worth noting that, instead of simply claiming a machine learning method implemented by a quantum computer, the claim ties the implementation with “quantum circuits” and “one or more qubits.” When drafted this way, the patentee has a strong argument that this claim is not an abstract idea under the commonly used pen and paper test,because a human cannot implement quantum circuits and/or use qubits either mentally or by a pen and a piece of paper.

Other quantum software or algorithm patents might have other arguments available. For example, the patent eligibility of an error correction algorithm patent can be supported by the fact that it greatly improved the performance of a quantum computer, which is a common theme of the current case law of patent eligibility.

B. Obviousness

As can be expected, ‘677 claim 1 has been challenged under 35 U.S.C. §103. In the Non-Final Office Action, the Examiner asserted Mork et al. in view of Kappor et al. in further view of Kerner et al. renders the claim obvious, wherein Mork discloses a classical computer implementing a similar machine learning technique, Kerner discloses a quantum computing device, and Kappor recites that “[t]he machine learning acceleration hardware . . . may comprise . . . a quantum computing device” without providing any details. Such a combination of references can be a recipe for obviousness rejections against quantum software claims.

The key for this rejection to stand is the “connecting” reference (in this example, Kappor), that is, how the classical algorithm can be connected to a quantum computing device. As discussed in Section I of this article, it’s not just that the computation powers of a classical computer and a quantum computer are different; the ways they compute are not at all the same.

Accordingly, for this specific example, the rejection is erroneous because Kappor does not provide any details of how to apply its machine learning process to a quantum computing device, let alone providing teachings of how to apply the machine learning technique disclosed by Mork to a quantum computer. In general, a reference that motivates and teaches to apply a classical algorithm on a quantum computer can be extremely difficult to find. That is because, there is few, if any, classical algorithm can be readily applied on a quantum computer!

Therefore, it is fair to say that a reference in the classical software domain is almost never effective to defeat the patentability of a quantum software.

Conclusion

Although quantum computing technology is still in its infancy, people are very confident in its potential. Corporations in the industries of communication, computing, electronics, and even finance have joined the patent race of quantum computing related technologies. The patent space of quantum computing technology is still quite sparce, and a patent on quantum computing can be obtained much more easily now than later.


Kids’ Choice? COVID-19 Shots

Carly Michaud, MJLST Staffer

At the end of October, the CDC broadened the eligibility for COVID-19 vaccines by adding booster shots for people with specific risk factors who have already been vaccinated, and the long-awaited authorization of shots for children ages 5-11. But with eligibility expanding, the fights over public-school vaccine mandates are sure to increase in intensity. The ultimate question is who has the final say on the health and safety of children in public school: the educators, the parents, or perhaps the students themselves. In addition to the rights of public schools and parents to make decisions around childhood vaccinations, states and public health experts have started to endorse legal processes for teens to consent to vaccination without parental consent.

School Authority

School districts can issue and enforce vaccine mandates through a delegation of state police powers. Through the doctrine of parens patriae, the state holds the power to intervene to protect citizens, including children when the parent is not adequately assuring their health and safety. However, in comparison to the broadness of parens patriae, schools have traditionally had a duty to protect children via the doctrine of in loco parentis, which gives the school the authority of the parents while the child is attending. Schools districts retain authority because of the need to protect the health of children and staff at their facility.

All states have some required vaccinations for children attending public schools, including MMR, Tdap, and varicella (aka. Chickenpox). MMR and Tdap are both combination vaccines protecting against measles, mumps, rubella, (MMR) and diphtheria, tetanus, and pertussis (Tdap). Vaccination mandates are a common public health measure taken particularly for those who are considered medically vulnerable populations and those who work with those populations. Children are considered medically vulnerable due to a variety of factors, including  psychological development, behavioral development, and significantly more daily person-to-person social contacts, making them unique from adults.

Mandatory vaccination has been a common public health practice since the turn of the 20th century and the widespread development and availability of vaccines. In 1905 the Supreme Court upheld a smallpox vaccine mandate enforced by a municipal Board of Health in Massachusetts as a reasonable exercise of state police power. As vaccine availability grew the Supreme Court also affirmed the applicability of vaccine mandates for school children in Zucht v. King. This doctrine has remained well-settled even to the present day, as mere days ago the Supreme Court denied injunctive relief to stop a state level vaccine mandate for health care workers.

Parent/Guardian Authority

The parent or guardian is automatically assumed to care for their child and have a right to do so in the way the parent or guardian sees fit, which is protected under the Fourteenth Amendment’s fundamental rights of parents. The state has been deferential to parental rights under the Fourteenth Amendment, however that deference has not extended to unvaccinated children attending schools without a legally approved exception. Despite the legal control parents have over their children, school districts are able to use their authority to compel students attending their facility to be vaccinated against certain diseases.

Self-Authorizing?

Due to the COVID-19 pandemic, more jurisdictions in the United States have given children ages 11 or 12 and older the ability to consent to vaccinations without parental consent. Ethicists have affirmed this policy noting that as children develop autonomy, it is reasonable to rely on their ability to consent to high benefit and low risk health decisions. This policy has been in place in a variety of states and municipalities for numerous years for other vaccines and medical decisions. Now it is being utilized by teens for COVID-19 vaccines.

The American Medical Association is in favor of autonomous teen vaccination as it “maximize[s] immunization opportunities for children” and is already the standard for teens who are effectively independent due to homelessness, unaccompanied status, or military service. This policy also offers protection for teens who do not want to inform a parent of their desire to receive specific preventable or immediate medical care. Many of these laws exist to allow teenagers to choose to receive contraception and the HPV vaccine.

While teens are able to make some health decisions for themselves, the majority of children in the United States are between the ages of 0 and 11. The most recent authorization applies to children in the age 5-11 group, who are still reliant on school vaccine mandates to protect their health and stop the spread of COVID-19 in schools.

Vaccine mandates in schools protect the health of students, faculty and the larger community from the spread of disease. In the case of COVID-19, the Pfizer-BioNTech vaccine has been approved for children ages 5-11 and is over 90% effective, and for children ages 12-15 and has the same efficacy as the original vaccine for adults. (Children ages 16-18 were included in the original Emergency Use Authorization for Pfizer’s vaccine, which is over 95% effective). It is vital schools maintain the power to require student vaccinations to prevent the unnecessary death of students and teachers from a lack of vaccine access and acceptance.


With Lull in Deepfake Legislation, Questions Loom Large as Ever

Alex O’Connor, MJLST Staffer

In 2019 and 2020, remarkably realistic forged politically motivated content went viral on social media. The content, known as “deepfakes,” included photorealistic images of world leaders such as Kim Jong Un, Vladimir Putin, Matt Gaetz, and Barack Obama. Also in 2019, a woman was conned out of nearly $300,000 by a scammer posing as a U.S. Navy Admiral using deepfake technology. These stories, and others, catapulted online forgeries to the front page of newspapers, as observers were both intrigued and frightened by this novel technology. 

While the potential for deepfake technology to deceive political leaders and provoke conflict helped bring deepfakes into the public consciousness, individuals — and particularly women — have been victimized by deepfakes since as early as 2017. Even today, research suggests that 96% of deepfake content available online is nonconsensual pornography. While early targets of deepfakes were mostly celebrity women, nonpublic figures have been victimized as well. Indeed, deepfake technology is becoming increasingly more sophisticated and user friendly, giving anyone inclined the ability to forge pornography using a woman’s photograph transposed over explicit content in order to harass, blackmail, or embarrass. For example, one deepfake app allowed users to strip a subject’s clothing from photos, creating a photorealistic nude image. After widespread outcry, the developers of the app shut it down only hours after its launch. 

The political implications of deepfakes alarmed lawmakers as well, and congress leapt into action. Beginning in 2020, the National Defense Authorization Act (NDAA) included a requirement that the Department of Homeland Security (DHS) issue an annual report on the threats that deepfake technology poses for national security. The following year, the NDAA broadened the DHS report to include threats to individuals as well. Another piece of legislation, the Identifying Outputs of Generative Adversarial Networks Act, directed the National Institute of Standards and Technology to support research for developing standards related to deepfake content. 

A much more controversial bill went beyond mere research and committees. The DEEP FAKES Accountability Act would require any producer of deepfake content to include a watermark over the image notifying viewers that it was a forgery. If the content contains “sexual content of a visual nature,” producers of unwatermarked content would be subject to criminal penalties. Meanwhile, anyone who merely violates the watermark requirement would be subject to civil penalties of $150,000 per image. 

While many have celebrated the bill for its potential to protect individuals and the political process, others have criticized it as an overbroad and ineffective infringement on free speech. Producers of political satire in particular may find the watermark requirement a joke killer. Further, some worry that the pace of deepfake technology development could expose websites to interminable litigation as the proliferation of deepfake content renders enforcement of the act on platforms impossible. Originally introduced in June 2019 by Representative Yvette Clarke, [D-NY-9], the bill languished in committee. Representative Clarke reintroduced the bill in April of this year before the 117th Congress, and it is currently being considered by three committees: Energy and Commerce, Judiciary, and Homeland Security.

The flurry of legislative activity at the federal level was mirrored by engagement by states as well. Five states have enacted deepfake legislation to combat political interference, nonconsensual pornography, or both, while another four states have introduced similar legislation. As with the federal legislation, opposition to the state deepfake laws is grounded in First Amendment concerns, with defenders of civil liberties such as the ACLU sending a letter to the California governor asking him to veto the legislation. He declined.

Deepfake related legislative activity has stalled during the Coronavirus pandemic, but the questions around how to craft legislation that strikes the right balance between privacy and dignity on the one hand, and free expression and satire on the other loom large as ever. These questions will only become more relevant with the rapid growth of deepfake technology and growing concerns about governmental overreach in good-faith efforts to protect citizens’ privacy and the democratic process.