Volume 15, Issue 1 (Winter 2014)

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The Fight Against Oppression in the Digital Age: Restructuring Minnesota’s Cyberbullying Law to Get with the Battle
(Minnesota Journal of Law, Science and Technology, 2014-02-20) Morben, Bryan
This Note will explore some of the difficulties in dealing with cyberbullying, the importance of finding a better solution, and how Minnesota’s current cyberbullying law can be drastically improved by analyzing pending legislation. Minnesota amended its bullying statute back in 2007 to include “electronic forms” of bullying in an attempt to deal with the increasing cyberbullying problem. This attempt has done little, except cause more confusion for local schools that are supposed to adopt their own policies. The U.S. Department of Education studied the bullying statutes of every state that had one in 2011. The Department introduced eleven key components that it found were part of most state legislation and that experts agreed were important to effective laws against bullying and cyberbullying. The latest bill to go through the Minnesota Legislature, H.F. 826, would completely reconstruct the Minnesota bullying statute and would provide much more guidance and instruction to local schools that want to create a safer learning environment for all. The author hopes this Note creates more awareness of the need for an updated cyberbullying law in Minnesota and helps raise the support needed to effect this change.
Accuracy or Efficiency: Has Grain Processing Made a Difference?
(Minnesota Journal of Law, Science and Technology, 2014-02-20) Kidd, George David
Since the Federal Circuit’s adoption of Panduit’s causation standard for establishing entitlement to lost profits damages in patent litigation, application of its noninfringing alternatives prong has lacked consistency. The court’s decision in Grain Processing Corp. v. American Maize-Products Co., however, created an additional contribution to the Panduit standard, thereby raising the evidentiary bar while significantly altering the noninfringing-alternative inquiry. Grain Processing has given the infringer a potentially powerful defensive mechanism in an area in which patentees are generally favored, even when some infringement may be socially desirable. Grain Processing allows for the potential avoidance of lost profit damages, so long as the alleged infringer shows that it had the necessary equipment, know-how, and experience to produce an acceptable, noninfringing substitute during the alleged infringement period. The Grain Processing decision, however, raises some debate. As a judicially interjected gloss on damages, the added ability to limit damage awards to a reasonable royalty could have been too drastic. A closer look demonstrates a precarious policy balance. On the one hand, increases in patent litigation might justify implementing an additional hurdle to potential damage awards in order to further incentivize innovation. Added rigor provided by Grain Processing may deter frivolous and expensive litigation that might be asserted by patentees to keep new innovators out of the market. But on the other hand, if a market participant does unlawfully infringe, it is certainly reasonable to believe that the infringer should pay appropriate damages for the encroachment on another’s intellectual property. Grain Processing’s lost-profit-limiting defense against a patentee’s claim of entitlement to lost profits damages may serve to deter potentially useful innovation by increasing costs shouldered by patentees in defending their patent rights. This Note analyzes six Federal Circuit cases appealing lost profits determinations, decided both before and after Grain Processing, and attempts to discern the impacts that Grain Processing has had on patentees’ entitlements to lost profits. This Note is organized in four parts. Part I provides the historical and substantive context necessary to understand the Grain Processing decision and examines important statutory changes, especially their subsequent interpretation, both before and after Grain Processing. Part II summarizes three pre-, as well as three post-Grain Processing cases. Parts III and IV dissect and analyze the holdings in these cases and evaluate Grain Processing’s impact on patent damages.
Biologics Price Competition and Innovation Act: Striking a Delicate Balance Between Innovation and Accessibility
(Minnesota Journal of Law, Science and Technology, 2014-02-20) Lu, Ude
The Biologics Price Competition and Innovation Act of 2009 (BPCIA, also known as the Biosimilar Act) was signed into law in 2010 by President Barack Obama as part of the healthcare reform bill. The central mission of the BPCIA is two-fold: (1) providing sufficient incentives for continuous innovations in biologic therapies (i.e., promoting innovation); and (2) lowering the price of biologic therapies (i.e., promoting accessibility). To promote innovation, the BPCIA provides twelve-year Food and Drug Administration (FDA) exclusivity to innovator biologics. This twelve-year FDA exclusivity prevents generic biologics, also known as follow-on biologics (FOBs), from being approved. To promote accessibility, the BPCIA provides an abbreviated pathway for FOBs—the abbreviated biologic license application (ABLA). The ABLA allows FOB manufacturers to cut short the time and the expensive cost of clinical testing by referring to innovator biologics’ clinical data to establish safety and efficacy. The goal of this Note is to discuss the advantages and drawbacks of the mechanisms established in the BPCIA and to suggest modifications to strike a better balance between innovation and accessibility. Part I of this Note introduces the legal and scientific background of the BPCIA and Hatch-Waxman Act in order to engage in further analyses. Part II of this Note analyzes the competing interests of innovation and accessibility and suggests a novel six-year data exclusivity and a six-to-twelve-year market exclusivity regulatory scheme. This Note concludes that the current design of the BPCIA tips too favorably toward innovation and compromises accessibility. The suggested six-year data exclusivity and six-to-twelve-year market exclusivity regulatory scheme potentially strike a better balance between innovation and accessibility.
Slowing Antibiotic Resistance by Decreasing Antibiotic Use in Animals
(Minnesota Journal of Law, Science and Technology, 2014-02-20) Nomura, Jennifer
Antibiotic resistance in humans is a health concern; it can lead to long, expensive hospital stays and an increased risk of death. Antibiotic use in animals has increased over the years, and it is now commonplace in the United States for farm animals to be fed low doses of antibiotics on a daily basis. Because of the high use of antibiotics in animals, the animals can develop antibiotic-resistant bacteria. The antibiotic-resistant bacteria in farm animals can pass to humans through meat and poultry consumption, and therefore, antibiotic use in animals needs to be more stringently regulated. Currently, the FDA is working with the CDC and the USDA to monitor antibiotic use in animals and the spread of antibiotic resistance in humans. The FDA has decided to employ a wait-and-see approach and continues to perform research, through NARMS, to determine how big of a threat antibiotic use in animals actually is to humans. It seems the FDA is looking for a direct link before it acts. Antibiotic resistance is a major health concern that needs to be prevented. Because antibiotic resistance poses such a large threat to human health, the better solution is to act now before antibiotic resistance spreads even more. The FDA should coordinate its regulation efforts with domestic agencies (the USDA and the CDC) and international groups (the WHO and the EU). Then, the FDA should enact a ban on all antibiotics that are used in human health care. Finally, the FDA can continue to monitor the remaining antibiotics used in animals in order to determine whether these drugs also pose a threat to human health.
Responsible, Renewable, and Redesigned: How the Renewable Energy Movement Can Make Peace with the Endangered Species Act
(Minnesota Journal of Law, Science and Technology, 2014-02-20) Robbins, Kalyani
One of the most promising routes to a sustainable energy future, as well as climate change mitigation, is the development of renewable energy sources such as wind, solar energy, and hydropower. Indeed, scientists have proposed plans to move completely (100 percent!) to these energy sources within a couple of decades. Mark Z. Jacobson and M.A. Delucchi, scientists from Stanford and U.C. Davis, have outlined a plan to achieve this goal, thereby “eliminating all fossil fuels.” Hydroelectric power already provides almost one-fifth of the world’s electricity, and wind and solar development is rapidly picking up as well. However, before we leave our worries behind and celebrate, we must resolve one potentially difficult issue for renewable energy, especially these three favored brands. They conflict with another important goal, that of protecting biodiversity. Wind, solar, and hydro energy all have one thing in common: they destroy habitat as well as directly kill wildlife, including listed endangered species and their habitat. Can these problems be reconciled with the movement toward renewable energy, allowing us to partake of its many benefits? At least for now, we regularly see renewable energy progress impeded by the need for Endangered Species Act compliance. The ESA has presented itself as a potentially catastrophic obstacle to renewable energy development. The time has come to think about how we might maximize our access to renewable energy while minimizing its impacts on vulnerable species. This Essay will first review the existing conflicts between endangered species and these three sources of renewable energy. This will be followed by analysis of the potential for harmonizing each energy source with the dictates of the Endangered Species Act, concluding with specific proposals for redesigning our methods of harvesting these forms of renewable energy. As one example, innovators have designed impressive new wind-harvesting technologies that are less dangerous to birds and bats without sacrificing efficiency. I propose that the U.S. Fish & Wildlife Service incorporate a preference for wildlife-protective technologies into the regional incidental take permitting requirements, at least for certain higher-risk landscapes. The ultimate goal of the piece is to analyze the extent to which it is possible to use each form of renewable energy without significant ecosystem impacts, to generate somewhat of a ranking of preferred modes of development, and to seek the best path (in relation to wildlife) to a renewable energy future. Such a future is itself essential to biodiversity, so the interests must be harmonized.
Sustainable Communities and Wind Energy Project Acceptance in Massachusetts
(Minnesota Journal of Law, Science and Technology, 2014-02-20) Petrova, Maria A.
o The State of Massachusetts is one of the most progressive U.S. states in advancing sustainability through energy conservation and renewable energy. The Green Communities Act, signed into law by Governor Deval Patrick in 2008, has awarded 110 communities with the title “Green Communities” in the last five years. The title is earned after communities achieve “five clean energy benchmarks,” two of which are the provision of “as-of-right” siting for renewable/alternative energy generation and the adoption of an expedited application and permitting process for “as-of-right” energy facilities. The expedited “as-of-right” siting is one of the policy tools designed to encourage communities to speed up the siting of renewable energy projects—particularly wind and solar—as the State has a goal of obtaining 20% of its electricity capacity from renewable energy projects by 2020. Despite the fact that high-ranking energy officials in the State are of the opinion that Massachusetts is able to continue on the path of a “‘clean energy revolution . . . in large part because of leadership at the local level,’” the State has had many difficulties implementing renewable energy projects locally, and many projects have met with strong public resistance. This paper examines the relationship between the “Green Community” designation and the level of acceptance of wind energy projects in the State. Results from surveys conducted in Spring 2012 in three Massachusetts towns—one of which is a designated “Green Community”—are used to show how residents’ perceptions of the siting process, project familiarity, and opportunities to participate in the siting decision affect project support. The paper also discusses the policy implications for renewable energy facilities.
Transitioning a Community Away from Fossil-Fuel Generation to a Green Economy: An Approach Using State Utility Commission Authority
(Minnesota Journal of Law, Science and Technology, 2014-02-20) Ramo, Alan; Behles, Deborah
A transition is starting throughout the nation as renewable energy resources are developed and older fossil-fuel facilities retire. The communities that bear the brunt of fossil-fuel pollution will also likely bear this transition’s economic impacts. Yet, there is no guarantee that these communities will share in the transition’s economic benefits—in particular, the building, operation, and ownership of new renewable energy resources. Renewable energy laws generally do not consider these types of impacts when determining where to site new resources. The California Public Utilities Commission (CPUC), in a case involving Native Americans in Arizona affected by the operations and closure of a recently retired coal-fired power plant, developed a novel plan to generate a revenue stream from a closed power plant to assist an impacted community with a transition to renewable energy. The CPUC’s decision provides an important roadmap for other states to consider communities impacted by the operation and closure of fossil-fuel facilities as the energy grid transitions into green resources. The CPUC’s creative approach provides a framework for considering how to transition a community away from fossil fuel generation. Other state utility commissions have similar authority as the CPUC, and creative disbursements like this can provide the necessary incentive to spur critical green development in impacted areas. Consideration of the equities, as the CPUC has illustrated, can be done consistent with an agency’s jurisdictional authorities in a way that does not undercut ratepayer or other potential interests.
The Fifth Dimension: Legal Infrastructure, Cracks, and Governance
(Minnesota Journal of Law, Science and Technology, 2014-02-20) Ferrey, Steven
There is a substantial need for sustainable electric power development. It is the key infrastructure that will determine the future carbon footprint. And the current sustainable energy policy is largely implemented at the state, rather than federal, level of government. Many of these state policies are confronting Supremacy and dormant Commerce Clause constitutional challenges. It is not that we lack energy infrastructure; rather, we lack legally smart implementation of energy infrastructure. It is enough to note that the challenges are several, raise significant legal issues, and are ongoing. This Article explores the Five Dimensions of U.S. federal and state sustainable energy policy and through the legal cracks in its infrastructure and governance. States have sculpted sustainable energy policy around five dimensions of legal and policy initiatives: Net metering: In 86% of states; Renewable portfolio standards: In 58% of states; Renewable system benefit charges: In 30% of states; Carbon and greenhouse gas (GHG) regulation: In 24% of states; Feed-in tariffs: In 14% of states.
The Australian Carbon Pricing Mechanism: Promise and Pitfalls on the Pathway to a Clean Energy Future
(Minnesota Journal of Law, Science and Technology, 2014-02-20) Peel, Jacqueline
A major issue facing efforts to transition from high carbon to low carbon (“clean energy”) sources in the United States is the lack of well-developed legal and policy “infrastructure” to facilitate this transition. This Article considers the lessons for developing such infrastructure from Australia’s recent experience in introducing and implementing a national carbon pricing mechanism. This mechanism was intended to be the keystone of broader national policy arrangements to secure a “clean energy future” for the nation. Although there are significant differences between the legal arrangements governing energy generation and distribution in the United States and Australia (for example, the latter has a national electricity market supported by cooperative federal-state laws), there are yet many similarities between the two countries that enhance the potential for cross-jurisdictional learning. In particular, both countries are leading per capita emitters of greenhouse gases (GHGs), with significant emissions sourced from their respective energy sectors, which remain heavily dependent on fossil fuels (coal, natural gas, and petroleum) for energy supply. In addition, both countries have legal systems based upon common law foundations, embedded within a federal matrix of national and state laws relevant to issues of energy production, environmental protection, and climate change.
Solar Skyspace B
(Minnesota Journal of Law, Science and Technology, 2014-02-20) DuVivier, K.K.
The cleanest source of electricity is that generated from photovoltaic solar panels (PV). Unlike fossil fuels, PV does not require extraction and does not burn, so it emits no carbon. Unlike hydropower, it does not require the damming of natural rivers and the destruction of upstream areas through flooding. Unlike industrial-scale concentrating solar thermo-electric power, it does not consume water to generate electricity. Finally, when placed on existing rooftops in developed areas, distributed solar PV does not require long-term dedication of public lands to an industrial use, does not disrupt native habitat (a potential problem with all of other energy generation resources), and provides power right where it is needed without requiring the construction of new transmission lines. Because of PV’s advantages, one might think that state legislators or courts would give fledgling solar PV some of the many property law benefits that older energy sources have enjoyed. In fact, the current legal system does just the opposite—creating hurdles to the deployment of solar PV by placing all burdens on the solar-energy host side of the scale. This Article will first explain the technological need for solar access. Next it will review the rise and fall of U.S. laws addressing the problem from the late 1970s until today. Finally, it will examine property law regimes that could strengthen protections for this valuable right. While the common law could provide some remedies, the most efficient remedies appear to be through legislative action—either through federal or state statutes, or local government regulations or ordinances. Because grid-connected solar provides broad social benefits beyond those just to the property upon which solar collectors are installed, throughout this Article, I will use the neutral terminology of “Solar Host” for the property on which a grid-connected solar PV array is directly sited and “Southern Property” for a neighboring property to the south of the Solar Host which is within the solar skyspace of an array.
Mitigating the Impacts of the Renewable Energy Gold Rush
(Minnesota Journal of Law, Science and Technology, 2014-02-20) Morris, Amy Wilson; Owley, Jessica
This Article questions where the push for utility-scale solar energy development in the California desert leaves endangered species preservation. We begin in Part I by providing some general context for the boom in renewable energy projects and outlining the main mechanisms for expediting endangered species permitting. Part II details offsite mitigation requirements for recently approved projects. Finally, in Part III, we draw some conclusions about the challenges posed by the current strategies for balancing renewable energy development and endangered species protection, and we make recommendations for strengthening mitigation outcomes. Our research highlights general concerns with perpetual off-site mitigation and the lack of oversight and information about mitigation projects. Through examining the development of two specific solar power facilities in the California desert (Ivanpah and Genesis), we demonstrate the mitigation choices, the time lag between project approval and developed mitigation plans, and the roles scientific uncertainty plays in making project decisions. Overall, the picture we paint is a disturbing one where decisions regarding desert development are made without full consideration or understanding of the mitigation measures. The urge to approve projects and get them operational quickly increases this problem. In such an uncertain realm, infusing concepts of reevaluation and adaptive management can provide routes to incorporate new information and alter mitigation or development plans as necessary. Current efforts at consolidated landscape-level planning may help ameliorate some of these concerns, but a better solution may be to slow down the pace of project approval to enable better understanding of the desert ecosystem and full evaluation of mitigation prior to plant construction.
Introduction: Envisioning Legal and Policy Pathways for Energy Innovation
(Minnesota Journal of Law, Science and Technology, 2014-02-20) Osofky, Hari M.
Introduction to special symposium edition (Issue 15.1) of the Minnesota Journal of Law, Science & Technology, which emerged from the conference Legal and Policy Pathways for Energy Innovation organized by the Consortium on Law and Values in Health, Environment & the Life Sciences at the University of Minnesota on April 24–25, 2013. The conference brought together leading scholars, practitioners, policymakers, and business people to discuss how to make critical progress on energy law and policy. The issue contains contributions from several conference participants, who highlight the complexity of energy transition and possibilities for creative, practical solutions.
Dumping the “Anti-Dumping” Law: Why EMTALA Is (Largely) Unconstitutional and Why It Matters
(Minnesota Journal of Law, Science and Technology, 2014-02-20) Morreim, E.H.
EMTALA—the Emergency Medical Treatment and Active Labor Act requiring hospital emergency departments to screen and stabilize emergency patients, regardless of ability to pay— has played a pivotal and peculiar role in American health care, as the only assured access to care for millions of people. Curiously, although EMTALA imposes enormous costs on hospitals, neither the Supreme Court nor any circuit courts have addressed its constitutionality. This Article argues that, particularly in the paradigm case of an indigent patient at a for-profit hospital, EMTALA violates the Fifth Amendment’s Takings Clause: the government takes property for public use without just compensation. All the elements of a taking are readily established: property, taking, and public use. Here, the property is not the hospital as such—this is not a case of land use regulation. Rather, the hospital is the “person” from whom property is taken, including: [1] personal property such as costly pharmaceuticals, medical devices, and paid staff time; and [2] physical invasion of spaces such as the emergency room, operating suites, and intensive care beds. Such destruction or transfer of personal property and invasion of physical spaces constitute per se takings. Regulatory takings analysis, ordinarily invoked for regulating real property, is inapplicable. These takings’ public use is to ensure immediate emergency care, regardless of ability to pay. All three elements of a taking are thus satisfied. As this Article further argues, EMTALA’s broad economic coercion of hospitals cannot be justified as simply a condition of participation in Medicare. In the end, the problem is not that EMTALA mandates takings, but rather that it fails to provide adequately for just compensation. For-profit hospitals often receive no compensation whatever. Even not-for-profit hospitals can quickly cross the threshold from “compensated” (e.g., via tax exemption) into uncompensated care. Where compensation is insufficient, EMTALA’s takings are unconstitutional. The substantial constitutional impairment of EMTALA could trigger an interesting predicament. Historically, EMTALA has been a “fig leaf” obscuring the nation’s less-than-universal access to care. After all, the uninsured can always go to the emergency room. Going forward, EMTALA may be an “enabler,” encouraging healthy people to forego insurance until they become ill. The Affordable Care Act (ACA) permits anyone, even those with preexisting conditions, to buy insurance at the same cost as anyone else and, although it mandates that everyone be insured, the “tax” for noncompliance is modest and not strongly enforceable. Refusal to buy insurance until after one is ill may thus be attractive because, after all, the emergency room cannot demand advance assurance of payment. If the cost of insurance thereby spirals out of control because too few healthy people buy it, the Fifth Amendment’s Takings Clause could actually salvage the ACA’s mandate. Although this Article neither endorses nor disparages the idea, the individual mandate could be re-cast as a constitutionally proper act of eminent domain: the “property” being taken is the citizen’s money; the “just compensation” is a health insurance policy; and the “public use” is to save private health insurance as Congress’ chosen avenue for broadening access to care. Perhaps most interestingly, the mandate as an exercise of eminent domain need not satisfy the Commerce Clause. Per a long line of Supreme Court rulings, acts of eminent domain need only satisfy the rational basis test.
Can This Marriage Be Saved? Federalism and the Future of U.S. Health Policy Under the Affordable Care Act
(Minnesota Journal of Law, Science and Technology, 2014-02-20) Rosenbaum, Sara
As with all transformational laws, the Patient Protection and Affordable Care Act, hereinafter referred to by its popular name, the Affordable Care Act (ACA or the Act), derives its power from the extent to which it realigns prior relationships and from adding new rights and duties: Between individuals and government through the creation of a right to accessible, affordable health insurance and a concomitant “personal responsibility” to secure it; between the insurance industry and the government through reforms aimed at assuring access to affordable coverage; between larger employers and workers through the Act’s “shared responsibility” requirements; and between health care providers and public and private insurers through provisions aimed at long-term restructuring in how health care is organized and paid for. But it is fair to say that no relationship within the health care system is more affected by the Act than that between the federal government and state governments. Indeed, the ACA establishes a legal approach to national health reform that, at its core, rests on the shoulders of this relationship. First, the Act expands the pre-existing federal-state partnership in the regulation of health insurance while establishing a new Marketplace for affordable coverage. Second, the Act expands the joint federal-state investment in health care for the poor (this time, with the lion’s share coming from the federal partner) through an expanded Medicaid program. As of May 2013, the Congressional Budget Office (CBO) has estimated that by 2022, twenty-five million Americans will gain coverage as a result of this recalibrated set of relationships. This Article takes a closer look at the two federalism relationships—one regulatory, the other investment—that lie at the heart of the Act. I surmise that even if sputtering and fragile, the regulatory partnership actually is built to weather current conditions and that ultimately, it will enable full implementation of the market reforms that the Act sets in motion. I also conclude, however, that at least where coverage of poor adults and their families is concerned, the Medicaid relationship is sufficiently under water to necessitate a federal fallback system, comparable in spirit to the federal fallback that has been designed for the regulatory side of the ledger. Creating such a fallback is essential if the nation is to avert the terrible spectacle of allowing any individual state to exclude its poorest residents from coverage.
The Role of State Antitrust Law in the Aftermath of Actavis
(Minnesota Journal of Law, Science and Technology, 2014-02-20) Samp, Richard A.
Reverse payment patent litigation settlements, wherein the payments flow from plaintiff brand name drug companies to defendant generic competitors, often including agreements that the generic companies will delay market entry, have evaded consistent legal treatment and divided courts for over a decade. In December 2012, the United States Supreme Court granted the Federal Trade Commission’s petition for writ of certiorari to review FTC v. Watson Pharmaceuticals. In Watson, the Eleventh Circuit found that, absent sham litigation or fraud, reverse payment settlements are legal under antitrust law as long as the settlement agreement falls within the exclusionary scope of the patent. The Watson decision was followed mere months later by the Third Circuit’s In re K-DUR decision, concluding that reverse-payment settlements should be deemed presumptively unlawful under a quick-look rule of reason approach. Because “different courts have reached different conclusions” regarding the legality of reverse-payment settlements, the Supreme Court endeavored to resolve the circuit split in FTC v. Actavis, Inc. On June 17, 2013, with Justice Breyer writing the majority opinion in a 5-3 decision, the Supreme Court reversed the Eleventh Circuit, holding that governments and private plaintiffs have a cause of action under the antitrust laws against brand name and generic pharmaceutical companies engaging in reverse payment settlements. The Court directed lower courts reviewing such claims to apply a full rule of reason analysis to drug companies’ potentially anticompetitive conduct. In the spring of 2013, in anticipation of the Court’s decision, the Minnesota Journal of Law, Science & Technology invited scholars and practitioners who have analyzed and developed the jurisprudence of reverse payment settlements to respond to FTC v. Actavis, Inc. This article is a response piece that will digest the opinion, critique both Justice Breyer’s majority opinion and Chief Justice Roberts’ dissent, and provide direction for courts and practitioners in navigating the new legal landscape of reverse-payment settlements in the wake of FTC v. Actavis, Inc.
Implications of FTC v. Actavis: A Reasonable Approach to Evaluating Reverse Payment Settlements
(Minnesota Journal of Law, Science and Technology, 2014-02-20) Bieri, Diane E.
Reverse payment patent litigation settlements, wherein the payments flow from plaintiff brand name drug companies to defendant generic competitors, often including agreements that the generic companies will delay market entry, have evaded consistent legal treatment and divided courts for over a decade. In December 2012, the United States Supreme Court granted the Federal Trade Commission’s petition for writ of certiorari to review FTC v. Watson Pharmaceuticals. In Watson, the Eleventh Circuit found that, absent sham litigation or fraud, reverse payment settlements are legal under antitrust law as long as the settlement agreement falls within the exclusionary scope of the patent. The Watson decision was followed mere months later by the Third Circuit’s In re K-DUR decision, concluding that reverse-payment settlements should be deemed presumptively unlawful under a quick-look rule of reason approach. Because “different courts have reached different conclusions” regarding the legality of reverse-payment settlements, the Supreme Court endeavored to resolve the circuit split in FTC v. Actavis, Inc. On June 17, 2013, with Justice Breyer writing the majority opinion in a 5-3 decision, the Supreme Court reversed the Eleventh Circuit, holding that governments and private plaintiffs have a cause of action under the antitrust laws against brand name and generic pharmaceutical companies engaging in reverse payment settlements. The Court directed lower courts reviewing such claims to apply a full rule of reason analysis to drug companies’ potentially anticompetitive conduct. In the spring of 2013, in anticipation of the Court’s decision, the Minnesota Journal of Law, Science & Technology invited scholars and practitioners who have analyzed and developed the jurisprudence of reverse payment settlements to respond to FTC v. Actavis, Inc. This article is a response piece that will digest the opinion, critique both Justice Breyer’s majority opinion and Chief Justice Roberts’ dissent, and provide direction for courts and practitioners in navigating the new legal landscape of reverse-payment settlements in the wake of FTC v. Actavis, Inc.
Hatch-Waxman Patent Case Settlements—The Supreme Court Churns the Swamp
(Minnesota Journal of Law, Science and Technology, 2014-02-20) Bernard, Kent
Reverse payment patent litigation settlements, wherein the payments flow from plaintiff brand name drug companies to defendant generic competitors, often including agreements that the generic companies will delay market entry, have evaded consistent legal treatment and divided courts for over a decade. In December 2012, the United States Supreme Court granted the Federal Trade Commission’s petition for writ of certiorari to review FTC v. Watson Pharmaceuticals. In Watson, the Eleventh Circuit found that, absent sham litigation or fraud, reverse payment settlements are legal under antitrust law as long as the settlement agreement falls within the exclusionary scope of the patent. The Watson decision was followed mere months later by the Third Circuit’s In re K-DUR decision, concluding that reverse-payment settlements should be deemed presumptively unlawful under a quick-look rule of reason approach. Because “different courts have reached different conclusions” regarding the legality of reverse-payment settlements, the Supreme Court endeavored to resolve the circuit split in FTC v. Actavis, Inc. On June 17, 2013, with Justice Breyer writing the majority opinion in a 5-3 decision, the Supreme Court reversed the Eleventh Circuit, holding that governments and private plaintiffs have a cause of action under the antitrust laws against brand name and generic pharmaceutical companies engaging in reverse payment settlements. The Court directed lower courts reviewing such claims to apply a full rule of reason analysis to drug companies’ potentially anticompetitive conduct. In the spring of 2013, in anticipation of the Court’s decision, the Minnesota Journal of Law, Science & Technology invited scholars and practitioners who have analyzed and developed the jurisprudence of reverse payment settlements to respond to FTC v. Actavis, Inc. This article is a response piece that will digest the opinion, critique both Justice Breyer’s majority opinion and Chief Justice Roberts’ dissent, and provide direction for courts and practitioners in navigating the new legal landscape of reverse-payment settlements in the wake of FTC v. Actavis, Inc.
Implementing Actavis: Three Tips for Future Courts Assessing Reverse Patent Settlements Under Rule of Reason Analysis
(Minnesota Journal of Law, Science and Technology, 2014-02-20) Krueger, Alexander
Reverse payment patent litigation settlements, wherein the payments flow from plaintiff brand name drug companies to defendant generic competitors, often including agreements that the generic companies will delay market entry, have evaded consistent legal treatment and divided courts for over a decade. In December 2012, the United States Supreme Court granted the Federal Trade Commission’s petition for writ of certiorari to review FTC v. Watson Pharmaceuticals. In Watson, the Eleventh Circuit found that, absent sham litigation or fraud, reverse payment settlements are legal under antitrust law as long as the settlement agreement falls within the exclusionary scope of the patent. The Watson decision was followed mere months later by the Third Circuit’s In re K-DUR decision, concluding that reverse-payment settlements should be deemed presumptively unlawful under a quick-look rule of reason approach. Because “different courts have reached different conclusions” regarding the legality of reverse-payment settlements, the Supreme Court endeavored to resolve the circuit split in FTC v. Actavis, Inc. On June 17, 2013, with Justice Breyer writing the majority opinion in a 5-3 decision, the Supreme Court reversed the Eleventh Circuit, holding that governments and private plaintiffs have a cause of action under the antitrust laws against brand name and generic pharmaceutical companies engaging in reverse payment settlements. The Court directed lower courts reviewing such claims to apply a full rule of reason analysis to drug companies’ potentially anticompetitive conduct. In the spring of 2013, in anticipation of the Court’s decision, the Minnesota Journal of Law, Science & Technology invited scholars and practitioners who have analyzed and developed the jurisprudence of reverse payment settlements to respond to FTC v. Actavis, Inc. This article is a response piece that will digest the opinion, critique both Justice Breyer’s majority opinion and Chief Justice Roberts’ dissent, and provide direction for courts and practitioners in navigating the new legal landscape of reverse-payment settlements in the wake of FTC v. Actavis, Inc.
Convergence?
(Minnesota Journal of Law, Science and Technology, 2014-02-20) Ghosh, Shubha
Reverse payment patent litigation settlements, wherein the payments flow from plaintiff brand name drug companies to defendant generic competitors, often including agreements that the generic companies will delay market entry, have evaded consistent legal treatment and divided courts for over a decade. In December 2012, the United States Supreme Court granted the Federal Trade Commission’s petition for writ of certiorari to review FTC v. Watson Pharmaceuticals. In Watson, the Eleventh Circuit found that, absent sham litigation or fraud, reverse payment settlements are legal under antitrust law as long as the settlement agreement falls within the exclusionary scope of the patent. The Watson decision was followed mere months later by the Third Circuit’s In re K-DUR decision, concluding that reverse-payment settlements should be deemed presumptively unlawful under a quick-look rule of reason approach. Because “different courts have reached different conclusions” regarding the legality of reverse-payment settlements, the Supreme Court endeavored to resolve the circuit split in FTC v. Actavis, Inc. On June 17, 2013, with Justice Breyer writing the majority opinion in a 5-3 decision, the Supreme Court reversed the Eleventh Circuit, holding that governments and private plaintiffs have a cause of action under the antitrust laws against brand name and generic pharmaceutical companies engaging in reverse payment settlements. The Court directed lower courts reviewing such claims to apply a full rule of reason analysis to drug companies’ potentially anticompetitive conduct. In the spring of 2013, in anticipation of the Court’s decision, the Minnesota Journal of Law, Science & Technology invited scholars and practitioners who have analyzed and developed the jurisprudence of reverse payment settlements to respond to FTC v. Actavis, Inc. This article is a response piece that will digest the opinion, critique both Justice Breyer’s majority opinion and Chief Justice Roberts’ dissent, and provide direction for courts and practitioners in navigating the new legal landscape of reverse-payment settlements in the wake of FTC v. Actavis, Inc.
Activating Actavis: Economic Issues in Applying the Rule of Reason to Reverse Payment Settlements
(Minnesota Journal of Law, Science and Technology, 2014-02-20) Addanki, Sumanth; Butler, Henry N.
Reverse payment patent litigation settlements, wherein the payments flow from plaintiff brand name drug companies to defendant generic competitors, often including agreements that the generic companies will delay market entry, have evaded consistent legal treatment and divided courts for over a decade. In December 2012, the United States Supreme Court granted the Federal Trade Commission’s petition for writ of certiorari to review FTC v. Watson Pharmaceuticals. In Watson, the Eleventh Circuit found that, absent sham litigation or fraud, reverse payment settlements are legal under antitrust law as long as the settlement agreement falls within the exclusionary scope of the patent. The Watson decision was followed mere months later by the Third Circuit’s In re K-DUR decision, concluding that reverse-payment settlements should be deemed presumptively unlawful under a quick-look rule of reason approach. Because “different courts have reached different conclusions” regarding the legality of reverse-payment settlements, the Supreme Court endeavored to resolve the circuit split in FTC v. Actavis, Inc. On June 17, 2013, with Justice Breyer writing the majority opinion in a 5-3 decision, the Supreme Court reversed the Eleventh Circuit, holding that governments and private plaintiffs have a cause of action under the antitrust laws against brand name and generic pharmaceutical companies engaging in reverse payment settlements. The Court directed lower courts reviewing such claims to apply a full rule of reason analysis to drug companies’ potentially anticompetitive conduct. In the spring of 2013, in anticipation of the Court’s decision, the Minnesota Journal of Law, Science & Technology invited scholars and practitioners who have analyzed and developed the jurisprudence of reverse payment settlements to respond to FTC v. Actavis, Inc. This article is a response piece that will digest the opinion, critique both Justice Breyer’s majority opinion and Chief Justice Roberts’ dissent, and provide direction for courts and practitioners in navigating the new legal landscape of reverse-payment settlements in the wake of FTC v. Actavis, Inc.