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A Machete for the Patent Thicket: Using Noerr-Pennington Doctrine’s Sham Exception to Challenge Abusive Patent Tactics by Pharmaceutical Companies
Get PDFOutrageous drug prices have dominated news coverage of the American healthcare system for years. Yet despite widespread condemnation of skyrocketing drug prices, nothing seems to change. Pharmaceutical companies can raise drug prices with impunity because they hold patents on their drugs, which give them monopolies. These monopolies are only supposed to last twenty years, and then competing lower-cost drugs like generics can enter the market, driving down the costs of pharmaceuticals for all. But pharmaceutical companies have created “patent thickets,” dense webs of overlapping patents surrounding one drug, which have artificially extended the companies’ monopolies for years or even decades after a drug’s initial patent expires. These problems will only be exacerbated as the pharmaceutical industry increasingly focuses on biologic drugs, which already provide more opportunities to acquire multiple patents on one drug than traditional small-molecule drugs.
Patent law’s weapons in the fight against patent thickets, namely litigation and inter partes reviews (an abbreviated process for challenging patent validity), have proven to be inadequate-—a scalpel when the public needs a machete. Antitrust law, which polices anticompetitive behavior and corrects market failures, is the ideal weapon to fight the pharmaceutical industry’s exploitation of patent law. The Noerr-Pennington doctrine, which immunizes parties from antitrust liability when a party “petitions” the government, currently stands in the way of an antitrust solution to the patent-thicket problem. “Petitions” eligible for Noerr-Pennington antitrust immunity include patent applications and patent-infringement lawsuits, so the pharmaceutical industry can wield the Noerr-Pennington doctrine as a sword against potential antitrust challenges. The Noerr-Pennington doctrine has a narrow “sham exception,” where Noerr-Pennington antitrust immunity is pierced when a party’s petitions are “mere shams” to interfere with the operations of a competitor. Unfortunately, after two Supreme Court decisions about the sham exception, the circuit courts have disagreed on the sham exception’s operation, leaving potential antitrust plaintiffs, such as consumers and government regulators, with uncertain prospects for challenging patent thickets under antitrust law.
This Note proposes that courts adopt an approach to reconcile the Supreme Court decisions wherein courts apply a stricter standard for invoking the sham exception when an antitrust plaintiff challenges a single sham petition and a looser standard when an antitrust plaintiff challenges a pattern of sham petitions. Further, this Note proposes a general framework for analyzing patent proceedings under the looser pattern standard. This solution strikes a balance between protecting parties First Amendment petitioning right and discouraging abuse of the patent law system for anticompetitive effect. If successful, antitrust challenges can lead to quicker market entry for lower-cost drugs and allow more people to benefit from innovative and life-altering drugs
Solving for Law Firm Inclusion: The Necessity of Lawyer Well-Being
Get PDFChances are, in a room of one hundred law firm partners in the United States, at most, one Black woman would be present. Statistically, if there were a Black, Latinx, or Asian woman in that room, she would be the only one. Women of color make up only 3.79 percent of all partners, counting equity and nonequity partners. The percentage of Black women among all partners has remained solidly under one percent—0.57 percent in 2009 and 0.80 percent in 2020. And so, women of color lawyers starting at law firms inevitably enter spaces that are overwhelmingly white and male—spaces where their well-being is not understood, much less prioritized. These same spaces are also home to a significant level of stress, substance abuse, and depression, rendering the law firm business ill-equipped to be welcoming and supportive. Attrition ensues and underrepresentation continues.
To evolve into truly inclusive workplaces, law firms must act to embed lawyer well-being as an institutional piece of their diversity, equity, and inclusion efforts. For law firms, the “racial reckoning” and the COVID-19 pandemic of 2020–2021, with negative impacts falling disproportionately on women of color lawyers, have only complicated diversity, equity, and inclusion (DEI) and well-being challenges. This Article proposes that law firms take concrete steps to solidify a holistic, interconnected approach to well-being and inclusion. Part II will provide an overview of the state of lawyer well-being and the representation of women of color lawyers at law firms. Part III will explore the impact of the events of 2020–21 on women of color lawyers. Part IV will highlight and critique recent law firm efforts on well-being and DEI. Part V will chart a path forward for law firms that treats well-being as inextricable from inclusion
Impact of Returning Unsolicited Genomic Results to Nongenetic Health Care Providers in the eMERGE III Network
No full textAs genomic sequencing becomes more common, medically actionable secondary findings will increasingly be returned to health care providers (HCPs), who will be faced with managing the resulting patient care. These findings are generally unsolicited, ie, unrelated to the sequencing indication and/or ordered by another clinician.
To understand the impact of receiving unsolicited results, we interviewed HCPs who received genomic results for patients enrolled in the Electronic Medical Records and Genomics (eMERGE) Phase III Network, which returned results on \u3e100 actionable genes to eMERGE participants and HCPs.
Results: In total, 16 HCPs across 3 eMERGE sites were interviewed about their experience of receiving a positive (likely pathogenic or pathogenic), negative, or variant of uncertain significance result for a patient enrolled in eMERGE Phase III and about managing their patient on the basis of the result. Although unsolicited, HCPs felt responsible for managing the patient’s resulting medical care. HCPs indicated that clinical utility depended on the actionability of results, and whereas comfort levels varied, confidence was improved by the availability of subspecialist consults. HCPs were concerned about patient anxiety, insurability, and missing an actionable result in the electronic health record.
Conclusion Our findings help inform best practices for return of unsolicited genomic screening findings in the future
Gambling on the Blockchain: How the Unlawful Internet Gambling Enforcement Act Has Opened the Door for Offshore Crypto Casinos
Get PDFOnline cryptocurrency casinos have seen a dramatic rise in popularity over the past thirty years as the rate of ownership of cryptocurrencies has risen almost as quickly as the US monetary value of a single Bitcoin. Current US laws and regulations are outdated; the only piece of federal legislation that provides oversight in the area of virtual gambling originated in 2006, more than fifteen years before the publication of this Note. Previous scholarship suggests that a lack of federal action has resulted in a surge of criminal activity, such as money laundering and tax evasion, as well as significant missed opportunities now that cash-strapped states are seeking to fill falling tax revenues in the aftermath of the COVID-19 pandemic. This Note expands on these arguments and offers a real and tangible solution that provides clarity to innocent gamblers and puts organized crime syndicates on notice.
Since federal and state legislatures in the United States have failed to address the use of cryptocurrencies as a gambling medium, this Note illustrates why leaving the virtual gambling space largely unregulated is a net-negative for American society. By exploring this gap in the law, this Note aims to inform both federal and state legislators about the importance of governmental oversight in cryptocurrency gambling
The Divergent Designs of Mandatory Takeovers in Asia
Get PDFOptimal takeover regulation aims to promote efficient changes of corporate control while curbing inefficient takeovers. Viewed from a comparative perspective, the Anglo-American prototypes of takeover regulation spearhead not only the discourse but also the dissemination of takeover regulation globally. At one end of the spectrum, the law in the United States follows the market rule, whereby transfers of corporate control benefit from a regulatory free hand. At the other end of the spectrum lies the mandatory bid rule (MBR), epitomized by takeover regulation in the United Kingdom. Under the United Kingdom\u27s version of the MBR, an acquirer who acquires de facto control over a target must make a general offer to the remaining shareholders to acquire all of their shares at the same price it paid to acquire the controlling block.
This Article aims to analyze how and why six significant Asian jurisdictions adopted the MBR and its variants. This is puzzling given that the jurisdictions display considerable divergence in terms of structural, legal, and institutional foundations, not only with their Anglo-American counterparts but also among themselves. This Article challenges the prevailing notion that the binary Anglo-American approach constitutes the framework for the dissemination of takeover regulation worldwide.
The Article claims that because of the political economy of takeover regulation in the Asian jurisdictions, the choice to adopt various intermediate positions is by design and not by accident. Considering that the market rule provides suboptimal protection to minority shareholders and the MBR curbs the market for corporate control, the intermediate positions aim to balance these somewhat conflicting objectives. This study contributes to the wider debate surrounding the appropriate takeover regulation and, more specifically, the claims made by the proponents of the market rule on the one hand and the MBR on the other
Comparative Cybersecurity Law in Socialist Asia
Get PDFThis Article is a comparative study of the cybersecurity laws adopted in China and Vietnam in 2017 and 2018, respectively. The two laws both converge and diverge. Their convergences include the stringent regulation of banned acts, network operators, critical infrastructure, data localization, and personal data. These are all shaped by the immediate diffusion of China\u27s Cybersecurity Law in Vietnam and broader structural factors: namely, the common features of the socialist state, socialist legality, and the statist approach to human rights. The foundational divergence is between the Chinese notion of cybersecurity sovereignty and the Vietnamese notion of national cyberspace, which is due to the global diffusion of cybersecurity law in Vietnam and the differences in technological infrastructure and developmental approaches-Chinese exceptionalism and Vietnamese universalism. This Article has implications for comparative law generally and comparative cybersecurity law particularly
Money Grab: How The G20/OECD Inclusive Framework for Taxation Could Unnecessarily Disrupt Corporate Incentives and Misallocate Taxing Rights
Get PDFThe Organisation of Economic Co-operation and Development (OECD) is proposing a dramatic shift to international corporate taxation that both sets a floor for corporate tax rates across the globe and transforms how countries obtain taxing rights over large multinational corporations. This Note focuses on the proposed framework for re-allocating taxing rights over corporations away from the traditional requirement of a physical presence in a country to mere revenues in a country. This Note identifies problems with the proposal as it relates to artificially altering corporate incentives and structures, as well as the proposal\u27s incompatibility with theories of taxation- including Adam Smith\u27s views on the necessity and evaluation of taxes. To resolve these problems, this Note suggests modifying the OECD proposal by removing the segmentation rule for companies that would not otherwise qualify for Pillar One taxation and allocating taxing rights to countries based on jurisdiction-specific profits, not revenues. While the OECD proposal will face obstacles, these suggestions should reduce the obstacles by limiting the proposal\u27s disruptive impact on US corporations and addressing legislators\u27 concerns about disproportionate impact on the United States
The Future of Law and Neuroscience
Get PDFI was asked to speculate about where the field of Law and Neuroscience may be ten years from now. In that spirit (and while recognizing that the future rarely complies with our predictions) I attempt here some extrapolations. I first consider potential advances in the technologies for monitoring and manipulating brain states, the techniques for analyzing brain data, and the efforts to further integrate relevant fields. I then consider potential neurolaw developments relevant to: (1) detecting things law cares about; (2) individualizing developmental states and brain states; (3) evidence-based legal reforms; (4) legal decision-making; and (5) brain-brain interfaces
A Modern Reconceptualization of Copyrights as Public Rights
Get PDFCopyright law is at a crossroads. In the wake of Oil States Energy Servs., LLC v. Greene’s Energy Grp., LLC, the patent, copyright, and intellectual property regimes as a whole, are primed for a modern reconceptualization. At the heart of this reconceptualization is the distinction between public rights, those vindicated by public offices for the public good, and private rights, those vindicated by private citizens for their exclusive government-granted monopolies. Thanks to Oil States, patent rights now exist in two separate bundles-—a public bundle including the patent grant itself and a private bundle consisting of a patent owner’s exclusivity rights.
Similar to patents, copyrights exist between a nuanced and delicate tug of war between creator incentive and public benefit. Necessarily, Congress continually legislates around potential market failures that threaten to thwart that delicate balance to keep both creators incentivized to create and the public able to access those creations. Reshaping the current copyright regime into two separate bundles would help Congress continue their market-correcting efforts. Just as with patents, a private bundle would include a copyright owner’s exclusivity rights. However, in addition to copyright grants, copyright’s public bundle of rights would also include conceptualizing copyrights as public rights under the Takings Clause of the Fifth Amendment. While seemingly chipping away at a copyright holder’s exclusive rights over their creative monopoly, conceptualizing copyrights as public rights under the Takings Clause ensures that copyright holders see guaranteed economic incentives to create while allowing the public to access those creations at the copyright holder’s discretion
The Politics of Deference
Get PDFLike so much else in our politics, the administrative state is fiercely contested. Conservatives decry its legitimacy and seek to limit its power; liberals defend its necessity and legality. Debates have increasingly centered on the doctrine of Chevron deference, under which courts defer to agencies’ reasonable interpretations of ambiguous statutory language. Given both sides’ increasingly entrenched positions, it is easy to think that conservatives have always warned of the dangers of deference, while liberals have always defended its virtues. Not so. This Article tells the political history of deference for the first time, using previously untapped primary sources including presidential and congressional archives, statements by interest groups, and partisan media sources. It recounts how the politics of deference have varied over time, even though the issue is often framed in terms that resist evolutionary analysis. As the administrative state grew in the 1970s, conservatives in Congress sought to rein in deference, while liberals defended it. These positions reversed in the 1980s, as the Reagan Administration relied on flexible readings of statutes in service of its deregulatory efforts, including in the Chevron case itself. After a period of political détente, the 2010s witnessed a resurgence of conservative opposition to and liberal support for Chevron, driven largely by the ascendance of libertarian interests in the Republican Party and the increasingly central role of administrative policymaking to the Democratic Party’s agenda.
The Article then develops a framework for understanding the shifting politics of deference. It argues that the politics of deference are the politics of regulation: for nearly a half century, partisans and interest groups have viewed doctrinal debates as inexorably tied to interests in policy outcomes. Positions about Chevron have varied based on which party controls the presidency and the ideological makeup of the federal courts. But the parties are also asymmetrically reliant on the administrative state, and thus on judicial deference. Liberals depend on deference to advance their regulatory goals in the face of an often-gridlocked Congress, while conservatives have many paths to accomplishing their deregulatory ends. The conservative turn against the so- called “deep state” and Chevron’s nonapplication in areas where conservatives most favor deference (such as national security) further exacerbate the partisan split on the doctrine. And, apart from its real-world impacts, Chevron has become a rhetorical cudgel in broader debates about the legality and legitimacy of the administrative state as a whole. Unless these dynamics change, Chevron deference will continue to have a political valence. And so long as the doctrine is understood to create winners and losers, partisans and interest groups will fight to ensure its survival or hasten its demise