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June 22, 2020 0

Diagnostic Methods as a Category of Patent-Ineligible Subject Matter

(Source) The authority to grant to patents arises from Article Eight of the United States Constitution. Specifically, Clause Eight grants Congress the power to “promote the Progress of Science and useful Arts, by securing for limited Times to Authors and inventors the exclusive right to their respective Writings and Discoveries.” Through this clause, Congress is empowered by the Constitution to grant copyrights and patents. Under this authority, Congress has enacted and promulgated various statutes in furtherance of promoting the progress of science and the useful arts. One such statute is 35 U.S.C. § 101, whose interpretation has been embroiled in controversy over the past decade. The statute delineates the types of subject matter that are patentable. Section 101 renders patentable “any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof.” Laws of nature and natural phenomena are prima facie unpatentable. Additionally, a mathematical formula is unpatentable because it “is merely a statement of a law of nature.” Similarly, medical diagnostic processes should be deemed as a category of patent-ineligible subject matter for numerous reasons. First, courts have repeatedly struck down patent claims to medical diagnostic processes unless they include a step of [read more]
June 19, 2020 0

Fraud and Shortages in the PPE Market and the Failures of the Trump Administration

(Source)   It has been five months since the first COVID-19 case was reported in Seattle, the epicenter of the outbreak in the US. As the virus spread, patients flooded into hospitals as hundreds of people got sick. The US soon realized that hospitals, healthcare facilities, nursing homes, and the government alike were short of the gear that would keep the healthcare workers at the frontline of the pandemic alive and healthy. At a time when their expertise and care were paramount, their lives were put at risk in a way that was unprecedented in recent history. Suddenly, the government and healthcare facilities across the nation were in a frenzy, hurrying to find personal protective equipment (“PPE”) for healthcare workers. What they faced were empty warehouses, factories at capacity, and a market ridden with fraud. This supply chain shortage and fraud in the PPE market is unrelenting and has left practitioners finding alternative means to protect themselves. In March, nurses at Mount Sinai hospital were spotted wearing trash bags fashioned as protective gear. Medical practitioners around the country were forced to reuse PPE, even though the FDA has reported that “protective capabilities of [reused] single-use PPE cannot be assured.” One [read more]
June 15, 2020 0

Today’s Media Landscape: Legal Protections For The Press From Arrest and Police Violence

(Source) Journalism is often referred to as the Fourth Estate because of the central role it plays in the political system. From the beginning of the United States, the importance of a free press has been recognized and given special consideration. From Thomas Jefferson’s famous words: “[W]ere it left to me to decide whether we should have a government without newspapers or newspapers without a government, I should not hesitate a moment to prefer the latter[,]” the importance of a free press has been repeatedly affirmed by the nation’s leaders. The importance of journalism to our society is never more visible than during periods of civil unrest. Brave journalists risking their safety to tell the stories of protestors is essential to achieving wide-reaching change through protest. The work of journalists in these situations both amplifies the voices of the protestors and serves as a check on the government’s ability to limit the rights of the protestors. In many cases, police officers who commit violent misconduct would not face consequences if not for video evidence recorded by journalists or ordinary citizens. However, for journalists to serve their essential role during acts of protest, their constitutional right to report must not be [read more]
May 29, 2020 0

Separating Federal Immigration Enforcement from Community-Oriented Policing: How the COPS Grant Program Misses the Mark

(Source) Combating illegal immigration has become a cornerstone of the Trump administration’s agenda. President Trump has frequently touted the allegedly threatening impact of immigration on crime and the economy to justify ramping up federal immigration enforcement efforts. However, many jurisdictions have adopted an implicit policy of obstructing such efforts by refusing to disclose information on suspected undocumented or illegal immigrants. These “sanctuary cities” have been embroiled in numerous legal battles with the Trump administration. Cases involving the denial of federal grant funding to sanctuary cities have proven especially controversial and continue to play out today. The COPS Grant Program Created under the Violent Crime Control and Law Enforcement Act of 1994 (“the Act”) and under the supervision of the Department of Justice (DOJ), the Community Oriented Policing Services (COPS) Program aims to “advance community policing in all jurisdictions across the United States” by awarding grants to state, local, and tribal law enforcement agencies. Congress initially funded the program to hire more street-level law enforcement officers, also known as beat cops, during the Clinton administration. The COPS Program issues competitive grants, as opposed to formula grants, meaning that state, local, and tribal governments must apply for access to a limited pool [read more]
May 25, 2020 0

Punishing the Victim: IRC §162(m) and the Limitation on Deducting Executive Compensation

(Source) The phenomenon of punishing the victim is unfortunately a familiar one. Too often, a person in need of protection discovers that those whose ostensible task it is to assist not only do not offer the necessary protection but in fact exacerbate the harm. Here is a current example. Section 162(m) of the Internal Revenue Code provides that a publicly held corporation may not deduct compensation in excess of $1,000,000 paid to its principal executive office, its principal financial officer, or any of its three other most highly compensated employees (if the compensation paid to that employee is required to be reported to its shareholders under the Securities Exchange Act of 1934). Until 2017, IRC §162(m) was fairly easy to avoid as it did not apply to performance-based compensation: bonuses, stock options, and so forth. However, the 2017 Tax Cuts and Jobs Act eliminated this escape route. Today, regardless of how the compensation package is structured, the corporation can deduct a maximum of $1,000,000 for each of its covered employees. Underlying IRC §162(m) is the concern that the entrenched power of corporate management and the lack of effective oversight foster excessive executive compensation. The issue addressed by this provision is [read more]
May 15, 2020 0

COVID-19 and the Criminal Justice System: How Prisons and Prisoners are Impacted

  (Source)   “The closest thing I can equate it with is…when you’re locked in a cell in a giant, old, deteriorating jailhouse, is the fear that there will be a fire and no one will come in and unlock your cell. What caught my attention about this virus is that it really feels like there’s a fire in this prison.” An inmate at Washington State describes the inevitability of COVID-19 and the powerlessness he feels at remaining incarcerated as the virus rapidly spreads. When prisoners routinely lack access to soap, and when hand sanitizer is considered contraband in prisons, it is easy to imagine the rapid proliferation of the infection. Lack of access to sanitation is only part of the conditions that make prisoners particularly vulnerable to COVID-19. Close quarters, frequently used communal spaces, and lack of adequate medical care are just a few other factors that make prisons and jails petri dishes for the spread of disease. Indeed, these factors have caused a huge spike in the number of COVID-19 cases over the past months. As the number of cases rise in the general United States population, the number of cases in prison skyrockets. Though New York City [read more]
May 1, 2020 0

“Smile! You’re on Camera” – The Implications of the Use of Facial Recognition Technology

(Source) What is the first thing that comes to mind when you hear the phrase ‘facial recognition technology’? Is it a TV show or movie scene where law enforcement is staring at computer monitors as faces in a database cycle through as a software program looks for a match to an image of a suspect, victim, or witness in the case? Many associate the phrase ‘facial recognition technology’ with the government and law enforcement; an association which is reinforced by the way in which numerous procedural TV shows (such as FBI, Hawaii Five-0, Blue Bloods, and Law and Order: SVU) display facial recognition in their episodes. For many Americans, those TV and movie scenes are their primary exposure to facial recognition, resulting in the stronger association of facial recognition as a law enforcement aid. While facial recognition technology (also known as facial recognition or FRT) is certainly a tool used by government and law enforcement officials, its uses and capabilities span far beyond what is depicted by the entertainment industry. The concept of facial recognition originally began in the 1960s with a semi-automated system, which required an administrator to select facial features on a photograph before the software calculated and [read more]
April 27, 2020 0

Is There a Way Out of the U.S. Military if You Morally Object to Your Job?

(Source)   On January 3, 2020, so many people visited the Selective Service webpage that it crashed. The crash came hours after the announcement that Quasem Soleimani was killed by a U.S. airstrike ordered by President Donald Trump. In light of threats of a World War III and fear of a looming draft, the hashtag #WorldWarIII was one of the top trends on Twitter that day. Operated under the United States government, the Selective Service System’s mission is “[t]o register men and maintain a system that, when authorized by the President and Congress, rapidly provides personnel in a fair and equitable manner while managing an alternative service program for conscientious objectors.” In January, the Selective Service webpage read in red, “THERE IS NO MILITARY DRAFT.” While the possibility of another world war frightens many U.S. citizens, beliefs about war prior to service are taken seriously in most instances. However, beliefs about war that are the result of military-linked experiences are more complex. Ignoring the possibility of a draft, which does not appear to be coming, what happens when an individual freely signs a contract with the military and then changes their mind, claiming to be a conscientious objector? Current military [read more]
April 24, 2020 0

Kids & Teens in Quarantine: Considerations for Navigating Co-Parenting During COVID-19

(Source) On April 9th, the ABA Center on Children and the Law, ABA Commission on Youth at Risk, and ABA Section of Civil Rights and Social Justice hosted a webinar regarding the COVID-19 pandemic’s impact on child welfare cases. The webinar primarily focused on the federal Children’s Bureau’s March 27th guidance on how family courts and family law practitioners should proceed during these uncertain times. Now, more than ever, courts and practitioners play an integral role in ensuring the safety and welfare of children in our country. The Children’s Bureau’s guidance was written in part in response to concerns regarding court closures, postponement of hearings, and complications regarding visitation. Across the country, and even in the Q&A sidebar of the webinar, parents have expressed concern that their co-parenting arrangements will be disregarded by ex-spouses amidst the stay-at-home orders coming down left and right. The isolation and social distancing that the COVID-19 pandemic requires may give parents a greater ability to damage the other parents’ parent-child relationship through explicit and implicit behavior, which may ultimately contribute to a child’s estrangement from both parents. Damaging behavior can include denigrating the other parent in front of the child, encouraging the child to take [read more]
April 20, 2020 0

The Doctrine of Equivalents: A Barrier to Cheaper Biologics?

(Source)   The benefit of biosimilar drugs is clear—biosimilars provide the U.S. market with drastic cost-saving alternatives, with estimates of a reduction in spending on biologic drugs from 2017 to 2026 of $54 billion dollars. Biologics are pharmaceutical drugs designed from or involving biological process/materials such as proteins, DNA, carbohydrates, and triglycerides. They include vaccines such as your common flu shot to drugs taken to boost a patient’s white blood cell count during chemotherapy. To illustrate the direct benefit, Neupogen, a popular biologic drug used to combat low white blood cell count in the blood, currently costs about $1,750 dollars at a CVS pharmacy for a supply lasting 83 days while Zarxio, the biosimilar copy of Neupogen, costs about $1,440 dollars at the same pharmacy for the same amount. But with the introduction of biosimilars to the U.S. market in 2015 with Neupogen, an emphasis has been placed on how the patent law doctrine of equivalents will play into patent infringement litigation. The doctrine of equivalents has the potential of hindering the benefits that biosimilars provide to the drug market and act as a barrier to entry for biosimilars. This piece will discuss the doctrine of equivalents itself, the difficulty with its application to biologics, and the problems associated [read more]

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