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Courts Revisit Tough Question: Can Genes Be Patented?

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To laypeople, the idea of having a gene patented may sound impossible. However, an amendment to federal patent legislation could allow pharmaceutical and biotech companies to patent genes, a decision that would have significant consequences for a variety of industries, medical care providers, and patients.

New Amendment Could Change Legal Precedent

Legal precedent was established in 2013 when Myriad filed a patent for BRCA1 and BRCA2 genes. These genes are utilized in diagnostic tests for breast and ovarian cancer. The company argued that they had the right to patent these genes because they were the company to isolate them. The U.S. Supreme Court ruled that human genes cannot be patented, since they are a product of nature.

This new bill, which was introduced in Congress in May of 2019, would allow companies to patent human genes and associations between diseases and genes.

What This Means for Researchers, Companies, and Patients

If this bill passes, it could seriously impact the pharmaceutical industry, as well as companies that specialize in biotech and medical research. A company that patents a gene would have full rights to any experimentation on that gene, as well as the development of diagnostic tests and treatment options. In some situations, perhaps this would be advantageous. Companies with a truly philanthropic interest in the treatment of specific diseases could potentially have more resources to dedicate to the isolation of genes and the subsequent development of testing and treatment options.

The more likely scenario, however, is far less palatable for consumers and biotech development as a whole. Large companies with extensive funding could essentially dominate the field by focusing exclusively on gene isolation and securing patents. Once they successfully patent various genes and connections with diseases, they would be able to conduct research on their own schedule and at their leisure. In the meantime, other companies—including companies that could possibly develop cutting-edge testing and treatment options—would be unable to do any research with the patented gene. This is disastrous for smaller biotech companies and research facilities. It’s likely that they’d be unable to isolate genes as quickly as much larger companies, which would significantly limit the type and amount of research they could do. Consequently, they’d have a difficult time hiring talented researchers who want to discover new treatment options. Larger pharmaceutical and biotech companies could quickly develop a monopoly in several diseases.

Perhaps the most disastrous implication of this legal decision would be the effect on patients. Patients with debilitating or even fatal diseases do not have extra time to wait for a patent-holding company to decide that their disease is profitable enough to research. By limiting who can study and experiment on specific genes, legislators could leave thousands of patients waiting for cures or treatment options that may not come or may come too late.

Opinions Across Various Industries

Lawyers representing professionals across many different industries have voiced their opposition to this measure. At least 169 different organizations representing medical professionals, patients, and researchers have come out in strong opposition to the bill. The ACLU is one organization that has expressed concern over this bill. Kate Ruane, senior legislative counsel for the ACLU, said, “Congress should not upend years of settled law to grant corporations exclusive rights to examine our genes and hinder much-needed genetic research, testing and treatments for a range of diseases.”

Attorneys have outlined the potential fallout of this bill. They note that BRCA gene patents caused significant issues in the past, with Myriad’s monopoly on testing protocols leading to the shutdown of other labs that also conducted ovarian and breast cancer screenings. Myriad dramatically increased its testing prices when it held the patent, leading to serious issues for patients.

This bill could go one of several ways. It could pass if it gets the necessary votes or it could die on the legislative table if it doesn’t receive enough votes. If it passes, it’s likely that numerous advocacy groups and professionals organizations will fight it, possibly leading to another Supreme Court case.

The Difficulties with Risk Assessment Software in Sentencing

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For many years, criminal courts throughout the United States have struggled with a critically important issue: how do you fairly determine whether a particular defendant is a good risk for bail, probation, or a light prison sentence? Many jurisdictions today turn to predictive risk assessment software to help guide such decisions. There’s a catch, however — the algorithms that translate input data into risk assessment scores are proprietary software, and neither courts nor lawyers know just how such scores are generated.

Obvious issues of fairness in sentencing and due process lurk behind the use of proprietary software in bail and sentencing decisions, but for the moment, they will remain matters for academic debate. On June 26, the U.S. Supreme Court denied a petition for further review in Loomis v. Wisconsin, where a man who pleaded guilty to lesser charges of fleeing an officer and operating a vehicle without authorization received a six-year sentence for his role behind the wheel in a drive-by shooting that resulted in no injuries.

The prosecution alleged that Loomis drove the car during the shooting, while the defendant maintained that he only drove the vehicle afterward. Either way, the charge was dropped as part of the plea negotiation, but all five of the original charges, including weapons offenses, were in the record at the time of sentencing. Loomis also was identified as a high-risk offender through Northpointe Inc.’s COMPAS risk assessment software.

Loomis unsuccessfully challenged his sentence all the way to the Wisconsin supreme court, which upheld the trial court’s decision, even though neither the sentencing judge, the prosecution, nor the defense attorney knew just how proprietary risk assessment software processed the answers to a 137-question survey completed by corrections officers and Loomis himself.

The basis of the appeal was denial of due process through the use of a proprietary risk assessment tool that could not be examined or challenged for scientific validity, due to its guarded proprietary nature. While the Wisconsin supreme court recognized that a criminal defendant has the right to be sentenced on the basis of accurate information, the court also observed that the same sentence would have been ordered anyway. Nevertheless, both the prosecution and the court made frequent reference to the COMPAS risk assessment during the arguments in court.

Wisconsin’s high court implicitly found that the sentencing judge correctly followed the instructions that accompanied the risk assessment tool, including this caveat: “It is very important to remember that risk scores are not intended to determine the severity of the sentence or whether an offender should be incarcerated.”

The sentencing judge pointed to several factors that supported a heavy sentence apart from the high-risk scores that the COMPAS tool assigned Loomis. The state supreme court therefore held that because other information in the record was sufficient to support the sentence, the use of the proprietary software to characterize the defendant’s risk was not a violation of his due process rights.

Eric Loomis might not have been the most sympathetic felon to have challenged the use of proprietary risk assessment software in sentencing decisions. He was a registered sex offender with a long rap sheet, including four arrests while on probation. The broader point, however, that closely guarded algorithms can determine the fate of criminal defendants, continues to generate vigorous legal and public policy debate around the country.

One version of nonproprietary risk assessment software has been found to reduce incarceration with no cost to public safety in Virginia, where fewer defendants are being sent to prison after conviction. Elsewhere, a controversial study of the COMPAS software in Broward County, Florida was found to understate the reoffense risk of white defendants while overstating that of African-Americans, even though no racial data is used in generating the risk assessment scores. Subsequent research has challenged the findings and methods of the Florida study.

As the dependence of American society on Big Data continues to deepen, the use of proprietary software in court decisions concerning bail, incarceration, or release can be expected to increase. What remains in question is the willingness of policymakers and courts to make sure that such decisions are made without excessive reliance on computer systems that lack transparency or external validation.

SCOTUS Strikes Down North Carolina Social Media Restriction for Registered Sex Offenders

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SCOTUS Exterior

In Packingham v. North Carolina, the United States Supreme Court invalidated a North Carolina statute prohibiting certain social media use by registered sex offenders. The decision is widely regarded as the Court’s acknowledgment that social media use is a practical necessity in 21st-century American society as well as a platform for the free expression protected by the First Amendment.

At the time of his sex offense in 2002, Lester Packingham was a 21-year-old college student who was convicted of indecent liberties with a child — he had sex with a 13-year-old girl. Packingham had no prior criminal record, and received a suspended sentence of 10 to 12 months of incarceration with a 24-month period of supervised release. He was, however, required to register as a sex offender for at least ten years.

In 2008, about halfway through Packingham’s minimum registration period, North Carolina enacted its social media restrictions for sex offenders. The new statute made it a felony for a registered sex offender, if aware that minors might use them as well, to use social media websites with the following characteristics: 1) generating revenue via advertising or otherwise, 2) facilitating contact between users, 3) allowing users to create profiles, and 4) providing ways for users to communicate with each other through message boards, chatrooms, e-mail, or other means. More than 1,100 people have been charged with violating this statute in North Carolina.

It is not known whether Packingham was specifically advised of this legislative action. He had completed his probation several years previously, and he apparently led his life as a law-abiding citizen until he was stopped and cited for a traffic violation in 2010. When he showed up for the hearing, he discovered to his delight that the charge had already been dismissed. So, there was nothing else to do but post this triumph on Facebook!

Unbeknownst to Packingham, a local police officer was monitoring the social media accounts of registered sex offenders and obtained a warrant to search Packingham’s computer. It was discovered that Packingham was in at least technical violation of North Carolina’s new sex offender social media restrictions, and he was indicted and charged accordingly.

Packingham challenged the prosecution on First Amendment grounds as an unreasonable restriction on his free speech rights. The trial court rejected the challenge, the state court of appeals upheld it, and the North Carolina supreme court rejected the First Amendment challenge again, upholding the state law as “constitutional in all respects.” Packingham was ultimately convicted and given a suspended sentence. The U.S. Supreme Court granted his petition for review, and unanimously struck down the North Carolina statute.

Justice Kennedy wrote the five-justice majority opinion, which essentially points out that so many websites offer the features North Carolina prohibits for sex offenders that the statute represented an unreasonable restriction on free expression rights. Justice Kennedy observed that the statute would prohibit a registered sex offender from visiting Amazon, WebMD, or the Washington Post online. The majority opinion specifically protected the ability of states to restrict sex offender Internet use more narrowly, thereby balancing the state interest in protecting minors with the interest of past offenders in legitimate Internet use.

One of the more interesting aspects of the Packingham decision is found in Justice Alito’s concurring opinion, joined by Chief Justice Roberts and Justice Thomas. While Justice Alito agreed with the result, he criticized the majority for its “undisciplined dicta” in the form of “musings that seem to equate the entirety of the internet with public streets and parks.” Then Justice Alito indulged in some undisciplined dicta of his own:

Repeat sex offenders pose an especially grave risk to children. “When convicted sex offenders reenter society, they are much more likely than any other type of offender to be rearrested for a new rape or sexual assault.” (Citations omitted.)

This is simply not true, according to the Washington Post Fact Checker. Sex offenders are actually among the least likely felons to reoffend with a similar crime. Only 5.6 percent of those convicted of rape or sexual assault were arrested for another sex offense within five years after release, according to a 2014 Bureau of Justice Statistics report. Far more likely candidates for recidivism on similar charges are persons convicted of drug crimes (51.2 percent), larceny or car theft (41.4 percent) assault (34.4 percent), or fraud or forgery (29.7 percent).

If Justice Alito had used his own unrestricted access to the Internet to find this data, perhaps he would not have made such an undisciplined and ill-informed statement in his concurring opinion.

SCOTUS to address privacy vs. technology debate

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Cell phones, laptops, credit cards, emails, tablets. Today’s technology is ubiquitous, and increasingly uses monitoring software to provide better service by storing information about consumer movement in computer databases. Information that can tell a precise, coherent narrative about a person’s location at a particular time is invaluable information to law enforcement, but is it constitutional for them to access that information without first acquiring a warrant?

It’s this burning question that elevates a Washington, DC drug dealer’s case to the Supreme Court. Though the DC Police Department’s use of a GPS tracker to monitor  drug trafficking suspect Antoine Jones in 2005 (the result was the seizure of 100 kilograms of cocaine and $1 million) is the specific instance, what’s really at question is to what degree the Fourth Amendment protects citizens from warrantless tracking and monitoring in an age in which private businesses have access this valuable information.

Groups like the ACLU have sued the Department of Justice in an effort to force the government to disclose how it determines which suspects do not require a warrant to track, and by which technologies.

In 1961, the Supreme Court ruled that police needed a warrant before placing a bug in the heating duct of a suspect’s home. Then, six years later, in Katz v. U.S., the court said authorities violated the Fourth Amendment by tapping a bookie’s calls without warrant, even though the suspect made them from a public telephone booth.

Justice Potter Stewart wrote that the issue was not whether the activity, like using a payphone or driving on the streets, happened in public view, but whether the activity was intended to be private.

“The Fourth Amendment protects people, not places,” he wrote. “What a person knowingly exposes to the public, even in his own home or office, is not a subject of Fourth Amendment protection. But what he seeks to preserve as private, even in an area accessible to the public, may be constitutionally protected.”

It’s legal for police to monitor a suspect by following him or her in a cruiser, but unless law enforcement stays on the tail 24/7, there’s no comparison to the amount of data and information relayed by simply using a GPS tracker. There are now more efficient and effective means of doing something the police can legally do, but those advantages create a violation of privacy, according to U.S. Court of Appeals of the District of Columbia.

What is likely maddening to law enforcement involved in the Jones case is that they actually received a warrant—they had probable cause–but used the GPS device after it had expired.

However this case is about far more than a night club owner and drug dealer in Washington DC. The ruling from this case will constitute a starting point for balancing new, aggressive monitoring technologies with the protections allowed in the Fourth Amendment.

Supreme Court Sends Mixed Signals on EPA Enforcement

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Supreme Court justices are notoriously opaque when it comes to detailing why they take up some cases but reject seemingly similar appeals. This trait was pushed front and center this week as the Supreme Court decided to hear debate on EPA enforcement of the Clean Water Act despite rejecting a similar case brought by General Electric Co. just three weeks earlier, reports the New York Times. Both cases claimed that the EPA routinely violates due process under the Fifth Amendment, but environmental lawyers predict the Supreme Court decided to hear Sackett v. EPA because it included the question of wetlands regulation, to which the Court has previously shown “overt hostility.”

General Electric v. Jackson resulted from GE’s lengthy campaign to contest the EPA’s authority to implement the Superfund statute without giving the company enough opportunity for judicial review. But the case essentially boiled down to the same due process concern cited in Sackett. “It’s hard to understand why they took this case and not the GE case,” said Seth Jaffe of the Foley Hoag law firm. He added that the Court may have chosen Sackett because it involves “some small persecuted guy,” rather than a giant corporation.

What’s more likely, said UC Berkeley environmental law professor Holly Doremus, is that Superfund cleanup projects require urgent responses to “an emergency situation.” When it comes to Clean Water Act regulations, on the other hand, the Court has signaled in past decisions that regulation of potentially contaminated wetlands does not constitute an urgent need. In the 2006 case Rapanos v. United States, for example, Justice Anthony Kennedy sided with the Court’s plurality that regulation requires contamination that “significantly affect the chemical, physical, and biological integrity of other covered waters.” That’s more difficult to prove than what the EPA deems significant contamination at Superfund sites.

At issue in Sackett is whether Michael and Chantell Sackett had their due process rights violated by the EPA when it halted construction on their house due to fill material placed too close to wetlands, a violation of the Clean Water Act. A federal judge and the 9th Circuit Court of Appeals both dismissed the complaint because they had the opportunity to contest the EPA claims in court. But the Sacketts’ attorneys at the Pacific Legal Foundation argue that this creates an “impossible situation” because the Sacketts “must either run the risk of ruinous penalties or imprisonment.” Their lawyers say this process could cost more than 200,000, which exceeds the price of the property.

Some environmental lawyers are predicting that the Supreme Court will side with the Sacketts, due to the apparently hostile view of wetlands regulation adopted in Rapanos. But the fact that the Supreme Court decided to hear this case as opposed to the General Electric case indicates a larger message that the Court may be more sympathetic to individuals, like Rapanos and Sackett, than major corporations when it comes to EPA enforcement.

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Supreme Court Rejects Wal-Mart Class Action Lawsuit

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In a controversial decision in mid-June, the Supreme Court rejected class action status for 1.6 million women who sought to sue mega-store Wal-Mart for employment discrimination in what would have been history’s largest class action lawsuit. More than a year earlier, the 9th Circuit Court of Appeals approved the lawsuits, arguing that the #1 company on Fortune’s list of 500 largest companies must address claims that women are paid less than men for the same jobs and are less likely to receive promotions. But by a 5-4 vote, the Supreme Court said it was a stretch to decide the fate of 1.6 million discrimination lawsuits at once, a major set back for Wal-Mart discrimination plaintiffs.

This all began back in 2000, when Betty Dukes, a “store greeter” at a California Wal-Mart said she was refused the chance for a promotion despite six years of glowing performance reviews because she was a woman. In her complaint, Dukes reported that despite making up 80 percent of Wal-Mart’s low-pay jobs, women hold less than 15 percent of the company’s management positions. But Dukes’ case, when combined with 1.6 million other sexual discrimination lawsuits, was struck down by the country’s highest court, which said the class action included too many women in a diverse array of positions and salary levels to fall under one class action lawsuit.

The Court’s ruling has ignited concerns that the plaintiffs’ attorneys may have cast too wide a net in attempting to combine 1.6 million discrimination complaints into one lawsuit. This view was represented in the Court’s majority opinion, which chided the plaintiffs for trying “to sue literally millions of employment decisions at once.” For the majority, Justice Antonin Scalia wrote that “without some glue holding the alleged reasons for all those decisions together, it will be impossible to say that examination of all the class members’ claims for relief will produce a common answer to the crucial question why was I disfavored.”

The court’s minority dissent, penned by Justice Ruth Bader-Ginsburg, said the majority opinion “disqualifies the class at the starting gate,” and puts too much burden on the plaintiffs to prove that their individual claims are similar enough for class action status. Senate Judiciary Committee Chairman Sen. Patrick Leahy said the ruling marked a major setback for employees at major corporations nationwide. In a statement following the ruling, Leahy said the Supreme Court “decision will undoubtedly make some wonder whether the Supreme Court had now decided that some corporations are too big to be held accountable.

The major impact of this decision is likely that it makes it more difficult for groups of employees to sue for workplace discrimination against a major corporation. “Only workers who have a truly common legal claim may sue as a group,” wrote Lyle Denniston of SCOTUSblog, “and, even that claim will require rigorous proof that every single worker suffered from the same sort of bias.” That’s a tough hurdle for large class action lawsuits, and means future plaintiffs will likely seek to limit their numbers before taking on major corporations like Wal-Mart.

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