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COVID-19 as an Example of Why Genomic Sequence Data Should Remain Patent Ineligible
The researchers who determined the genomic sequence of the SARS-CoV-2 virus did not seek to patent it, but instead released it in the publicly-accessible GenBank data repository. Their release of this critical data enabled the scientific community to mobilize rapidly and conduct research on a range of diagnostic, vaccine, and therapeutic applications based on the viral RNA sequence. Had the researchers sought patent protection for their discovery, as earlier research teams had during the SARS, H1N1 and H5N1 outbreaks, global research relating to COVID-19 would have been less efficient and more costly. One of the reasons that patents are no longer sought on genomic sequences is the U.S. Supreme Court’s decision in Association for Molecular Pathology v. Myriad Genetics, Inc., which established that a sequence of naturally-occurring nucleotides is an unpatentable “product of nature” (Association for Molecular Pathology v. Myriad Genetics, 2013). Yet, in the midst of the COVID-19 crisis, patent advocates are calling on Congress to overturn the Myriad decision and once again allow patenting of genomic sequences. This Chapter argues that the COVID-19 pandemic illustrates why the “product of nature” exclusion under patent law, which prevents the patenting of genomic sequence data, should be preserved and strengthened under U.S. law. This paper was prepared as part of the COVID-19 Policy Playbook: Legal Recommendations for a Safer, More Equitable Future, a comprehensive report published by Public Health Law Watch in partnership with the de Beaumont Foundation and the American Public Health Association
Freedom of Thought in the United States: The First Amendment, Marketplaces of Ideas, and the Internet
Freedom of thought is not directly protected as a right in the United States. Instead, US First Amendment law protects a range of rights that may allow thoughts to be expressed. Freedom of speech has been granted especially robust protection. US courts have extended this protection to a wide range of commercial activities judged to have expressive content. In protecting these rights, US jurisprudence frequently relies on the image of the marketplace of ideas as furthering the search for truth. This commercial image, however, has increasingly detached expressive rights from the understanding of freedom of thought as a critical forum for individual autonomy. Indeed, the commercialization of US free speech doctrine has drawn criticism for “weaponizing” free speech to attack disfavoured economic and regulatory policies and thus potentially affecting freedom of thought adversely. The Internet complicates this picture. This paper argues that the Supreme Court’s expansion of the First Amendment for the benefit of commercial actors lies in the problematic tension with the justification for individual freedom of thought resting in personal self-direction and identity
Proceedings of the 2020 Lee E. Teitelbaum Utah Law Review Symposium
In the autumn of 2020, the Utah Law Review, in cooperation with the S.J. Quinney College of Law Center for Law and Biomedical Sciences, convened a twoday virtual symposium exploring “The Law and Ethics of Medical Research.” On November 13th, leading scholars from across the country joined us for a panel discussion titled “Sharing Medical Research Data: Privacy and Confidentiality.” On November 20th, a second set of distinguished scholars and practitioners gathered virtually for three more panel discussions: “Clinical Trials—Legal and Ethical Issues in the Age of COVID-19,” “Intellectual Property and Medical Research,” and “Medical Research as a Public Health Initiative.”
The pages that follow present summaries of those conversations prepared by S.J. Quinney College of Law students. Full video recordings of the panel discussions are posted on the S.J. Quinney College of Law YouTube channel located at https://perma.cc/LKF2-CKQ5
A Balanced Consideration of the Federal Circuit’s Choice-of-Law Rule
The Federal Circuit’s jurisdiction is unique. Unlike the jurisdiction of all other U.S. courts of appeals, the Federal Circuit’s jurisdiction is defined not by its geographical boundaries, but rather by the subject matter of the original claims and compulsory counterclaims. The court has appellate jurisdiction over final decisions from all U.S. district courts if a plaintiff’s claim or a party’s counterclaim arises under the patent laws. From this unusual jurisdictional grant, the Federal Circuit has concluded that, as a policy matter, it should apply and develop its own law only if the legal issue pertains to patent law. For all other legal issues, the Federal Circuit defers to the law of the court of appeals in which the case originated—i.e., it applies the procedural law and the non-patent substantive law of the regional circuits.
This Article undertakes a thorough evaluation of the Federal Circuit’s choice-of-law rule. It examines how the rule compares against the congressional objectives reflected in the court’s enabling statute as well as against possible alternative rules. In addition, it considers how the court’s rule causes the court to depart from the trans-substantivity principle of procedural law and a related principle of equity in a nontransparent manner, and, in doing so, engage in substantive lawmaking that may be beyond the court’s authority. Finally, this Article contemplates solutions beyond a mere change in the court’s choice-of-law rule
Assessing the Performance of Voluntary Environmental Programs
In recent years, government agencies have increasingly relied on voluntary programs to achieve a variety of goals, from improving worker safety to creating healthier living conditions in urban areas. This type of government initiative is based on a bargain between the agency and private citizens: the government provides certain incentives—economic or otherwise—and private actors voluntarily adopt behaviors that benefit the public. One example is cleaning up a contaminated site and building an affordable housing project.
While agencies have made substantial progress since the creation of the first voluntary programs, much work remains. To move forward in this area, and especially with voluntary environmental programs, two critical questions must be answered: First, how should we evaluate the performance of voluntary environmental programs? And second, how do wedetermine the appropriate level of government—federal, state, or local—that should be in charge of implementing them? These two questions have not been satisfactorily addressed to date.
This Article addresses these lingering questions by evaluating the performance of a sophisticated local voluntary cleanup program. The resulting analysis uncovers some of the shortcomings in how agencies and scholars have previously assessed voluntary programs, yielding four contributions to the literature. First, the Article offers a deeper understanding of how data can and should affect the design and improvement of regulatory programs. Second, the examination of a local voluntary cleanup program provides much-needed empirical support for a common argument raised in the environmental federalism literature: that the need to tailor programs to local conditions can justify a strong municipal role. The need for a strong local government is especially important where state legislation creates what this Article refers to as “local regulatory gaps.” Third, while efficiency is a desirable feature of any government initiative, it becomes a necessity in the context of voluntary programs. Delays and other inefficiencies in the operation of avoluntary program can deter potential enrollees from participating in it. Without enrollees, voluntary cleanup programs simply cannot operate. Lastly, injecting unnecessary complexity into the design of voluntary programs by trying to address too many policy challenges at once can be counterproductive
Kansas v. Boettger: On Petition for a Writ of Certiorari to the Supreme Court of the State of Kansas
This amicus brief in support of Kansas’ petition for certiorari in Kansas v. Boettger discusses the important issue of whether the First Amendment require proof of specific intent to criminally punish violent threats. The brief argues that the First Amendment does not contain any such requirement and that creating any such requirement would interfere with effective prosecution of domestic violence. The Kansas Supreme Court’s decision over which review is being sought required the state to prove that an abuser had a specific intent to cause fear. If allowed to stand, the decision will make prosecuting and preventing domestic violence even more challenging, without any corresponding benefit. In domestic violence cases, there is rarely direct evidence of specific intent, and domestic-violence victims often struggle to confront their abusers in court. Indeed, the impact of abusers’ psychological, emotional, and physical abuse is often so severe that victims frequently struggle even to seek help. The Kansas Supreme Court’s decision to impose a specific intent requirement in a case involving violent threats is inconsistent with decisions from other courts, the law in over a dozen states, the Model Penal Code, and the history and tradition of the First Amendment. This amicus brief concludes that the Supreme Court should grant certiorari to review the decision below and reverse it
A Formalist Theory of Contract Law Adjudication
Formalism has a bad name. It is often seen as a naïve and unsophisticated approach to the adjudication of legal disputes. This negative view of formalism is widespread in American legal culture and has been particularly influential in contract law. This Article challenges this prevailing view and argues that a formalist theory of adjudication is the best approach to resolve contractual disputes.
The argument of this Article starts from the assumption that contract law is not morally justified because of its enforcement of promissory rights or some other dimension of interpersonal morality. Instead, like contemporary law and economics, this Article assumes as its starting point that the law of contracts is an instrumentally justified legal institution (i.e., an institution justified because of its valuable social consequences). Starting from this assumption, this Article asks what approach to the adjudication of contractual disputes facilitates the achievement of contract law’s instrumental goals. Against the common assumption, the answer is that a formalist approach—the specific contours of which are set out below—would be instrumentally best. This is because formalism, with its commitment to an ex-post, rule-bound, doctrinalist, and modest approach to legal adjudication, has important instrumental benefits. Formalism contributes to simple, generalizable, and cost-effective decision-making; it is consistent with the institutional competence of courts; reduces the risks and overall costs of legal mistakes; and increases predictability, protecting contractual parties’ legitimate expectations. Moreover, formalism is an adequate means to deal with value pluralism and is consistent with the main values served by the law of contracts, such as autonomy and efficiency.
Thus, encouraging judges to make socially optimal decisions in contractual disputes might not be the optimal strategy. The overall socially optimal outcome might, instead, be achieved through a decision procedure that directs judges to decide by applying pre-existing doctrine and expanding it incrementally. If that is the case, then, despite their disagreement about contract law’s foundations, instrumentalist and formalist theorists might agree about the narrower question of how judges should decide contractual disputes
Show Me the (Data About the) Money!
Information about consumers, their money, and what they do with it is the lifeblood of the flourishing financial technology (“FinTech”) sector. Historically, highly regulated banks jealously protected this data. However, consumers themselves now share their data with businesses more than ever before. These businesses monetize and use the data for countless prospects, often without the consumers’ actual consent. Understanding the dimensions of this recent phenomenon, more and more consumer groups, scholars, and lawmakers have started advocating for consumers to have the ability to control their data as a modern imperative. This ability is tightly linked to the concept of open banking—an initiative that allows consumers to control and share their banking data with service providers as they see fit. But in the U.S., banks have threatened to block the servers of tech companies and data aggregators—business entities that serve as the middlemen connecting FinTech companies and banks, enabling consumers to get more financial services—from accessing their customers’ data even if the customers agree to it. With no regulation or accepted standards for the ethical gathering and use of data, banks argue that limiting access helps them protect their clients’ privacy, improve their accounts’ safety, and promote consumer protection principles. Banks claim that FinTech apps collect more data than needed, store it insecurely, and sell it to others.
But the motivation of the big banks in advocating for such limitations may not be so pure. Banks do not want to relinquish competitive advantages, lose customers, or be held liable for data or fund losses. Witnessing resistance, tech companies are not sitting idly by waiting for banks to limit their data access. Instead, they are working on ways to outsmart banks’ blocking technology and use data aggregation services as a middleman. They also extended the fight into Washington, where regulators such as the Federal Trade Commission (FTC) and the Consumer Financial Protection Bureau (CFPB) are noticing how technology impacts consumer data flows and credit reporting issues. Advocating for consumers’ rights to control data, tech companies lobby for open banking
U.S. v. Briggs: Brief of Members of Congress As Amici Curiae in Support of Petitioner
This amicus brief filed in the U.S. Supreme Court case of United States v. Briggs on behalf of a bipartisan group of thirteen members of Congress discusses the absence of any statute of limitation for rape prosecutions within the military. It argues that the Constitution entrusts Congress with authority over military discipline, including the authority to determine what (if any) statutes of limitations apply to crimes that occur within the military. By classifying rape as an “offense punishable by death” and stipulating that “offenses punishable by death” are not subject to statutes of limitations, Congress entrenched the policy that rape within the military is not subject to any statute of limitations at all. Whether the death penalty can be constitutionally imposed for the rape of an adult—an open question in the specialized military context—is wholly irrelevant to the key question in the case: Whether Congress determined that the death penalty is warranted for rape in the military. Congress’ policy judgment—that rape within the military is so heinous and so damaging to military effectiveness that no temporal restriction should be placed on its prosecution—is entitled to respect. Rape in the military has devastating effects on survivors individually and military readiness generally. And the military’s hierarchical command structure can exacerbate the understandable reluctance of rape survivors to come forward and report the crimes committed against them. In light of those considerations, the provisions in the Uniform Code of Military Justice that address rape in the military have been understood for decades to reflect Congress’ intent that those who commit the crime of rape should not be permitted to escape justice by hiding behind the passage of time
Sometimes FRAND Does Mean License-to-All
FRAND commitments are creations of written policy documents and contract law. Accordingly, the existence of a “License to All” obligation under a FRAND commitment must arise from the relevant policy language. Numerous SDO policies expressly impose “License to All” requirements. Some SDO policies are ambiguous with respect to this requirement and such ambiguities should be resolved based on an examination of extrinsic evidence including the intentions of policy drafters, the shared understandings of SDO participants, and the historical precedents for such policies. In many cases, an examination of these factors should lead to the conclusion that “License to All” is, indeed, required by the relevant policies. The only sure way to prevent the imposition of “License to All” obligations on SDO participants is to draft clear policy language expressly disavowing such obligations and permitting level discrimination in SEP licensing