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Are Pig Kidneys Patentable? The Legal Landscape Around The First Genetically Engineered Pig Kidney Transplant

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By: Bethany Butler

Last month, doctors at Massachusetts General Hospital successfully transplanted a genetically engineered pig kidney into a 64-year-old patient. Scientists removed porcine genes and added human genes via the CRISPR-Cas 9 gene editing technology. In total, sixty-nine of the pig’s genes were modified prior to transplantation. The surgery took approximately four hours, with the kidney functioning almost immediately after transplantation. eGenesis, a biotechnology company focused on genetically engineered, human-compatible organs, invented this procedure and the resulting genetically engineered kidney. This novel procedure may help to alleviate critical organ shortages in the US, with more than 100,000 Americans currently on the transplant wait list. Scientists hope this procedure will pave the way to more research and clinical applications that may help to alleviate the organ transplant shortage. 

The Legal Landscape

Novel research and clinical applications surrounding xenotransplantation, the transplanting of animal cells/organs to humans, have the potential to revolutionize access to life saving therapies. However, the legal landscape surrounding this science is far from settled. While areas of xenotransplantation of pig organs into humans have been granted patents, the procedure itself has not been approved by the FDA. These procedures, like the one used for the modified pig kidney transplant, are only currently able to move forward using “compassionate use” exceptions granted by the FDA. These exceptions apply to patients with life-threatening conditions where there is no alternative for treatment. 

Another important aspect of the law surrounding xenotransplantation is informed consent. Informed consent is a protection provided by the Health and Human Services regulation, 45 CFR Part 46. The regulation requires that important information, including any risks, be disclosed to the patient before he or she decides to participate in any trials or undergo treatment. Xenotransplantation procedures carry unique risks, such as zoonotic infections and the need for lifelong monitoring and intervention due to the nature of the procedure. Patients must be informed of and consent to all of the unique risks involved with these types of treatments. 

Xenotransplantation and Patent Law

Biological patents are generally utility patents, which allow the patent holder to exclude others from making, selling, using, or importing their biological invention for a specified period of time, currently twenty years in the United States. Companies like eGenesis can own biological patents for genetically modified animal organs and associated methods for xenotransplantation. Currently, these types of patents are protected by law, provided the claimed subject matter is not naturally occuring. US patent law has exceptions to patentable subject matter that are laws of nature, natural phenomena, and products of nature. The Supreme Court found, in the landmark case Association for Molecular Pathology v. Myriad Genetics, Inc., that “a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated.” The case concerned whether the BRCA1 and BRCA2 genes can be patent eligible when isolated. These genes are responsible for tumor suppression and mutations in these genes commonly lead to the development of breast cancer. If the Supreme Court had ruled that Myriad Genetics could patent these gene sequences, that ruling would have effectively prevented any other company from offering diagnostic testing for these genes, thereby monopolizing the breast cancer diagnostic market. The Supreme Court’s decision relied on the statutory provisions in 35 U.S.C. § 101, which addresses patentable subject matter. The court has found exceptions to what is patentable, including laws of nature and natural phenomena. In terms of biological material, if the invention or process is something that naturally occurs, then it is ineligible for patent protection. 

Some eligible biological patents granted in the past include the PCR process and transgenic animals – an animal whose genome has been edited to contain genes from another species. The first transgenic mammal patented was the Harvard Oncomouse, developed by Harvard in the 1980s. This mouse was genetically modified to be more likely to develop cancerous tumors, making it a valuable cancer research subject, and patent eligible. 

Innovation for novel developments in the transplant space, like the genetically modified pig kidney, is encouraged by the patent protection of inventions utilized for xenotransplantation technology. eGenesis has received a number of patents related to the xenotransplantation process, including utility patents for the methods to generate genetically modified animals/cells and for genetically modified animals/tissue/cells used for xenotransplantation.  

The narrowing of biological patents to non-naturally occurring subject matter allows for companies like eGenesis to obtain patents for biological innovations while still protecting research and development efforts, particularly diagnostic testing of carrier genes. Patent eligibility of biological and natural phenomena is currently being addressed in Congress. On June 22, 2023, the US Senate released the Patent Eligibility Reform Act of 2023 (“PERA”). If passed, this act would clarify patent-eligible subject matter and potentially allow for the patenting of solely isolated genes, possibly overriding the Myriad decision. 

While patent eligibility of biological subject matter has the potential to allow for greater innovations, like modified organ transplants, expanding patent-eligible material may lead to negative downstream impacts. Granting monopolies can lead to access issues for diagnostic testing and increasing costs to use isolated genes in research and development efforts. Granting patent protection to biological patents is important and the right balance is necessary to further innovation and facilitate problem solving medical solutions. While patent law is complicated and evolving, novel advancements like the pig kidney transplant are largely driven by innovation incentives and a greater need for medical solutions to the transplant wait list issue.

Not So Golden Handcuffs

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By: Bella Hood

Wunderkind Sam Bankman-Fried, otherwise known as “SBF”, was sentenced to 25 years in prison and ordered to pay $11 billion on March 28, 2024. A federal court convicted SBF in November on seven counts of fraud, conspiracy, money laundering, and conspiracy to commit commodities and securities fraud.

The former 32-year-old billionaire is the son of two Stanford law professors. After graduating from the Massachusetts Institute of Technology, he worked at Jane Street Capital, a quantitative trading firm. FTX, an abbreviation of “Futures Exchange” was founded by SBF in 2018 as a centralized cryptocurrency exchange supporting futures for all major cryptocurrencies. At his height, SBF’s net worth was said to be around $26 billion. For reference, Beyonce’s is roughly $800 million. SBF also founded his own hedge fund, Alameda Research, which would go on to be a key player in his scheme to defraud investors.

In November 2022, FTX filed for Chapter 11 bankruptcy (handled by Sullivan & Cromwell) which requires the reorganization of the company’s assets and liabilities but does not kill the company outright. Even so, FTX is dead for all intents and purposes and announced in January it would not reopen its exchange and would liquidate all assets.

A New York jury found SBF guilty of all seven criminal counts, including wire fraud and conspiracy to commit wire fraud against FTX customers. Against Alameda Research lenders the court found SBF guilty of conspiracy to commit securities fraud, conspiracy to commit commodities fraud against FTX investors, and conspiracy to commit money laundering.

Congress enacted the wire fraud statute in 1952 as an extension of the 1872 mail fraud statute. In 1987, the Supreme Court broadly held in McNally v. United States that the statute applied to any act “designed to defraud by representations as to the past or present, or suggestions and promises as to the future.” Securities fraud refers to illegal activities that involve the deception of investors or the manipulation of financial markets. The Securities and Exchange Commission is the primary securities regulator in the U.S.

Commodities fraud is the sale or purported sale of a commodity through illegal means and often goes hand in hand with securities fraud. Since 2019, the Fraud Section of the Criminal Division of the U.S. Department of Justice has entered six corporate resolutions relating to violations of the commodities laws with a combined total monetary amount of over $1 billion. Money laundering is the act of disguising financial assets so they can be used without detection of the illegal activity that produced them.

Bernie Madoff, orchestrator of the biggest Ponzi scheme in history, was convicted of 11 federal felony counts, including securities fraud, wire fraud, mail fraud, and money laundering, which earned him a sentence of 150 years in prison.  His net assets in 2009 prior to sentencing totaled at least $823 million. It is estimated that he stole as much as $65 billion. In comparison, SBF was found to have cheated customers and investors of at least $10 billion. Jeffrey Skilling, the failed CEO of Enron at the time of its implosion, was convicted of an impressive 19 crimes, including 12 counts of securities fraud. Skilling was ultimately sentenced to 14 years in prison and ordered to pay $42 million in restitution to victims of the fraud. The energy and commodities trading holding company held $63.4 billion in assets before its stocks tanked.

Though a long line of financial fraudsters paved the way for SBF, the use of cryptocurrency to achieve such scale was largely unheard of. Bitcoin was the first cryptocurrency created and is younger than SBF himself, having launched in 2009. The public should expect to see the federal government go after an increasing number of crypto king copycats in the future in an attempt to strengthen guardrails on the industry.

In September of 2023, a cofounder of OneCoin, a now defunct cryptocurrency exchange, was sentenced to 20 years in prison for creating and promoting a phony cryptocurrency. Just this past month, OneCoin’s former head of legal and compliance, Irina Dilkinska was sentenced to four years in prison and ordered to forfeit over $111 million. Dilkinska pled guilty in November of 2023 to one count of conspiracy to commit wire fraud and one count of conspiracy to commit money laundering. March of 2024 was a busy month for the U.S. government because a jury also found the founder of Terraform Labs, a Singapore-based blockchain protocol and payment platform, liable for defrauding investors in 2021. Binance is yet another example of a cryptocurrency exchange riddled with fraud. In November of 2023 (sensing a trend?), the company and founder pleaded guilty to money laundering and other crimes, costing the company over $4 billion.

Treasury Secretary Janet Yellen set the tone when she told the industry: “Let me be clear, we’re also sending a message to the virtual currency industry more broadly – today and for the future, the virtual currency exchanges and financial technology firms wish to realize the tremendous benefits of being part of the US financial system they must play by the rules. If they do not, the US government will take action.” SBF’s sentence serves as a harbinger of the U.S. government’s approach to cryptocurrency fraud and the harsh punishments to come.

The Legal Battle Behind an Olympic Figure Skating Doping Controversy May Change Anti-Doping Rules

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Photo by Thomas Laukat on Pexels.com

By: Bethany Butler

2022 Olympic Women’s Singles Figure Skating Doping Controversy 

The 2022 Winter Olympics in Beijing were overshadowed by an intense doping scandal in the women’s singles figure skating event. In February 2022, Kamila Valieva, a 15-year-old Russian figure skater (competing under the ROC “Russian Olympic Committee” due to Russia’s previous doping issues), participated in the Olympic figure skating team event. With the help of Valieva’s top scores, the ROC placed first in this event, followed by the United States in second, Japan in third, and Canada in fourth. At the time, the medal ceremony was delayed for this competition. It was later revealed that the results of Valieva’s drug test from the Russian championship a few months prior in December 2021 was the reason behind the delay. Valieva’s sample from the December 2021 competition was found to contain detectable amounts of trimetazidine (“TMZ”), which is a World Anti-Doping Agency banned substance that is thought to help with endurance and recovery. The timing and reporting of this doping violation was unfortunate as it led to issues regarding the results of the team event, and questions of whether Valieva would be allowed to compete in the individual competition. Quickly after the drug testing results came out, the Court of Arbitration for Sport decided that Valieva was ultimately allowed to compete in the individual event in part due to her protected status as a minor and the “untimely notification” of the anti-doping results. In the individual competition Valieva placed fourth while her Russian teammates, Anna Scherbakova and Sasha Trusova, earned the gold and silver medals respectively. Following the Olympics, the main unanswered question was whether Valieva’s scores would be disqualified, and if so, what would happen to the team event standings. 

Legal Battle and Ruling

The legal and procedural landscape surrounding Olympic sports and anti-doping policies involve the International Olympic Committee (“IOC”), the World Anti-Doping Agency (“WADA”) and the Court of Arbitration for Sport (“CAS”). WADA is a foundation initiated by the IOC and coordinates anti-doping efforts across nations. CAS is a mediator in anti-doping cases which handles WADA appeals “under the jurisdiction of World Anti-Doping Code signatories (Code).” In addition, CAS “provides for services to facilitate the settlement of sport-related disputes” and eventually handled the case between Valieva, the Russian Anti-Doping Agency (“RUSADA”), the International Skating Union (“ISU”), and WADA. 

Following delays from the RUSADA investigation into the Valieva case, WADA put the agency on notice that they will appeal the case to CAS if a resolution is not released. Eventually, RUSADA, the ISU, and WADA all appealed the case to CAS which resulted in closed hearings at CAS’s headquarters in Lausanne, Switzerland.  

In January of 2024, almost two years after the 2022 Winter Olympic Games, CAS ruled that Valieva was guilty of an anti-doping violation for her positive TMZ sample. The ruling resulted in a four year ban, retroactive to December 25, 2021, the date of Valieva’s positive test at the 2021 Russian Championship. Valieva’s Olympic results were subsequently disqualified due to this ban, which led many to speculate how the IOC would handle the figure skating team event results. 

Ultimately, the IOC decided to remove Valieva’s results from the cumulative team score and keep all other scores the same. This led to the US and Japan teams moving to the first and second spots, with the ROC team dropping to third, rather than disqualifying the entire team results and moving Canada to the third spot. So far four appeals to CAS, three from Russia and one from Canada, were filed challenging the ISU’s amended team event standings.  

The handling of Valieva’s case led to many criticisms, primarily related to using a teenage athlete as a scapegoat in a flawed system. Valieva was the only one punished in this case, even though she was 15 years old at the time. Many believe the testing delay was inappropriate and she should have never been in this situation to begin with, while others believe her coaching staff should be at fault. This case has led WADA officials to indicate their desire to update the anti-doping code “before the 2026 Winter Olympics in Italy to give more powers to investigate athlete entourages.” The head of the IOC, Thomas Bach, expressed concerns over the Valieva case and stated that “doping is very rarely done alone with the athletes,” indicating a need to hold athletes’ support teams accountable. 

The World Anti-Doping Code “is the core document that harmonizes anti-doping policies, rules and regulations within sport organizations and among public authorities around the world,” and is updated every six years with the next global review set in late 2025. This review is when anti-doping violation rules may be overhauled in response to the Valieva case, especially to take into account various agencies’ requirements to investigate minor athletes’ support teams. Some changes have already been implemented since the Valieva case. Approximately four months after the 2022 Olympic Games in June 2022, the ISU voted to gradually increase the age limit for senior competitive skaters from 15 to 17. The 17 year age limit will be in effect for the 2026 Winter Olympic Games in Italy. This decision was largely believed to be in response to the Valieva controversy and an effort to better protect minors in the sport. The age limit increase is just the beginning of the overhaul in procedures and safeguards needed to protect athletes in the sport. The legal and procedural decisions by CAS, WADA, and other agencies in the coming years prior to the 2026 Winter Olympic Games are vital for the sport of figure skating to continue in a clean, fair, and legal manner.

The Strippers’ Bill of Rights: a Revolution in Adult Entertainment

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By: Karina Paup Byrnes

On March 24, 2024, Washington’s State Governor, Jay Inslee, signed into law the “Strippers’ Bill of Rights” (SB 6105/ HB 2036), which provides adult dancers with increased safety protections in the workplace. Adult entertainers employed at strip clubs across Washington state are now legally entitled to safeguards such as keypad entrances to dressing rooms, panic buttons in private room where employees are alone with customers, mandatory sexual harassment training for all employees, and security guard staffing on site. However, this bill represents more than just a win for workers’ safety and financial security. The legislation importantly recognizes that adult entertainers should be afforded the same rights and protections as any other employee, allowing dancers to more freely and safely participate in the creative expression of their profession.

Strippers Are Workers

The Strippers’ Bill of Rights movement was spearheaded by the dancer-led organization known as Strippers are Workers (“SAW”). SAW “fights to empower the dancers of Washington state so that they can strip safely, positively, and lucratively.” Established in 2018, the organization has been a leader in calling for greater regulation of the adult entertainer industry in Washington. SAW has successfully advocated for reductions in industry practices that are harmful to dancers. Its work has enabled dancers to gain protective measures that are both essential for maintaining a safe work environment and crucial for reducing stigmas and other barriers that adult entertainers face.

The SAW’s work has enabled more financial freedom for dancers, seen best in one critical aspect of the Strippers’ Bill of Rights. Currently, dancers must pay a set club fee for every shift they work, whether or not they make money during the shift. Thus, unpaid fees carry over from previous shifts. After its passage, the bill caps these fees at $150 or 30% of the total amount the employee earned during their shift, whichever is less. Additionally, the legislation bars clubs from carrying over unpaid fees. Impeding clubs from imposing predatory financial constraints over their employees will lessen dancers’ burdens to work with potentially hazardous clients and give them greater financial independence.

Increased Revenue, Safety, and Freedom

A key component of the legislation involved repealing the prohibition of alcohol sales in strip clubs. Prior to the bill’s passage, Washington was the only state that imposed an absolute ban on alcohol sales in strip clubs. This restriction limited the revenue of dancers and clubs and put pressure on dancers to engage with guests, even when such guests arrived at the club highly intoxicated or were known to be violent. The purpose behind allowing strip clubs to apply for alcohol licenses is to prevent abuse of dancers and to enable greater financial mobility for employers and employees. Additionally, with the increased revenue generated through alcohol sales, clubs should be able to afford the safety protections as required by the Act.

The Strippers’ Bill of Rights signals that mandated safety measures in strip clubs are long overdue. Proponents of the legislation are celebrating the reform of adult entertainer establishments not just for the increased physical safety and potential positive financial effects, but also for the validation of dancers as employees who deserve respect and autonomy in the workplace. These protective measures empower dancers and enable them to retain the self-expression that is an important element of their work.On a larger scale, the bill also demonstrates the growing movement towards the decriminalization of sex work. SAW’s campaign manager stated that “there needs to be more of a national push for a more radical and revolutionary way of establishing labor rights, because, you know, it is 2024 and it’s time to do things differently.” As the Washington State Department of Labor and Industries starts drafting and implementing the new rules and guidelines for adult entertainment clubs over the next year, many will be looking at how the work environment for dancers will begin to change for the better. Protecting the rights and interests of dancers participating in sex work has garnered more attention by lawmakers, and advocates hope that other states will follow in Washington’s steps.

Emulation or Piracy for Profit? Nintendo Says No.

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By: Kevin Vu

Nintendo, the developer of various beloved video games and consoles, was recently in the news for its lawsuit against, and subsequent settlement with, Tropic Haze, the developers of the Nintendo Switch emulator “Yuzu.” In the initial complaint, Nintendo alleged that “[w]ith Yuzu in hand, nothing stops a user from obtaining and playing unlawful copies of virtually any game made for the Nintendo Switch, all without paying a dime to Nintendo or any of the hundreds of other game developers and publishers making and selling games for the Nintendo Switch. In effect, Yuzu turns general computing devices into tools for massive intellectual property infringement of Nintendo and others’ copyrighted works.” In essence, Nintendo alleged that Tropic Haze “facilitate[d] piracy at a colossal scale.”

Nintendo’s battles against piracy are nothing new. The company has a storied history of filing lawsuits against various forms of piracy – including individuals who sold Nintendo Switch-hacking devices and international cases against Nintendo game copy-holding websites. But some commentators argue that emulation is not piracy – which might explain why Nintendo has yet not filed similar lawsuits against other emulators like “Dolphin” (which emulates the Nintendo Wii). 

Emulation or Piracy?

Emulation, as commonly referred to in this context, means a computer program that “imitates a video game console.” At first blush, it is easy to see why such programs would be an issue for first-party developers like Nintendo. Emulation programs might disincentivize consumers from buying the latest video game console to play their video games for example.  The historic answer to criticisms like that is that emulation falls under fair use. 

For example, in Sony Computer Entertainment v. Connectix Corp., 203 F.3d 596, 609 (9th Cir. 2000), the Ninth Circuit determined that an emulator for Sony’s PlayStation did not infringe on Sony’s copyright because that emulator fell under fair use. Courts typically consider four factors for determining whether fair use applies: (1) the purpose and character of the use, (2) the nature of the copyrighted work, (3) the amount and substantiality of the portion used in relation to the copyrighted work as a whole, and (4) the effect of the use upon the potential market value of the copyrighted work. 17 U.S.C. § 107. Under the Ninth Circuit’s precedence at the time, fair use preserved the public’s access to elements in copyrighted computer codes. Sony Comput. Ent., 203 F.3d at 603. The court determined that the second factor weighed in favor of fair use because Sony’s program was not publicly available such that the defendant’s process of reverse engineering Sony’s program was necessary to replicate the program. Id. at 603-04. As to the first and fourth factors, the court concluded that the defendant’s emulation program was transformative because it “afford[ed] opportunities for game play in new environments” such that “the [emulator was] a legitimate competitor in the market for platforms on which Sony and Sony-licensed games [could] be played.” Id. at 606-07. Accordingly, the court concluded that the emulation of Sony’s PlayStation was protected under fair use. Id. at 609.

That reverse engineering approach was codified by the Digital Millennium Copyright Act (DMCA) as 17 U.S.C. § 1201(f), which generally allows for reverse engineering of a computer program “for the sole purpose of . . . achiev[ing] interoperability of an independently created program[.]” 

In contrast, piracy is understood as “[t]he illegal reproduction and distribution of copyrighted material on the Web.” That definition is distinguishable from the situation in the Sony Computer Entertainment case because there, the emulator was essentially a reverse engineered PlayStation that did not wholly copy Sony’s program. But, as some proponents have argued, emulation naturally leads to piracy because emulators do not have anti-piracy safeguards. The idea behind this is that a video game console, like the Nintendo Switch, will have safeguards that disallow someone from using a pirated copy of a game, but emulators do not have that same protection. Because emulators can run on pirated games, the argument is that emulators support piracy by doing so, resulting in lost profits for the developers of both games and consoles. In contrast, however, some argue that emulation is necessary to preserve the history of video games, along with letting people enjoy games or video game systems that are no longer produced or supported.

Why Yuzu was Targeted.

Many individuals have theorized that Yuzu was targeted because the program emulated a current-generation console in the Nintendo Switch, as opposed to other emulators which are focused on older consoles that are no longer supported. Others have pointed out that Nintendo’s original complaint did not explicitly argue that the Yuzu emulator was illegal, but rather because Yuzu’s developers showed how to break into Nintendo’s game files or even a Nintendo Switch. Additionally, the complaint also noted that Yuzu had a Patreon page (a website that allows people to support creators by donating on a monthly subscription basis) that provided subscribers with early access and unreleased features to the public – in short, that Tropic Haze was profiting from Yuzu. 

Whatever the reason, Nintendo’s actions have already had wide effects on other emulators. For example, Tropic Haze was also developing “Citra,” a 3DS emulator, but under their settlement agreement with Nintendo, Citra has also been discontinued. Another Nintendo console emulator, “DraStic” (for the Nintendo DS), used to be a paid app on Google Play but has since been free to download. 

All of this is a signal that Nintendo, and perhaps other companies, may seek to be more litigious with emulators. Although the DMCA and case law may allow certain forms of emulation, clearly Nintendo is looking at other strategies to fight emulators. For example, when the Dolphin emulator was seeking to be added to the Steam storefront, Nintendo told Steam that Dolphin did not comply with the DMCA because Dolphin used Nintendo’s encryption keys. Dolphin disputed that determination, but Steam refused to allow Dolphin on its storefront until Dolphin and Nintendo could reach an agreement. Currently, Dolphin is still available on the Internet for download and use. Whatever the case, individuals and emulators should be wary about Nintendo’s – and other video game company’s – recent efforts in combating emulation and privacy.