November 2021

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.

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.

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.

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.