Volume 15, Issue 1 (Winter 2014)
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Item 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, SaraAs 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.Item 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, DeborahA 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.Item Actavis, the Reverse Payment Fallacy, and the Continuing Need for Regulatory Solutions(Minnesota Journal of Law, Science and Technology, 2014-02-20) Crane, Daniel 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.Item FTC v. Actavis, Inc.: When Is the Rule of Reason Not the Rule of Reason?(Minnesota Journal of Law, Science and Technology, 2014-02-20) Cotter, Thomas F.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.Item Foreword: The Future of Reverse Payments in the Wake of FTC v. Actavis, Inc.(Minnesota Journal of Law, Science and Technology, 2014-02-20) Marsili, Caroline; Palmen, Brandon; Desai, Sarvesh; Connell, Ryan; Punia, Savir; Ferrell, Elliot; Kidd, George; Maloney, Eric; Nomura, Jennifer; Lu, Ude; Suresh, Maya; DeRuyter, Katelyn; Parker, Nihal; Morben, BryanReverse 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. The following eleven response pieces 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.Item Mitigating the Impacts of the Renewable Energy Gold Rush(Minnesota Journal of Law, Science and Technology, 2014-02-20) Morris, Amy Wilson; Owley, JessicaThis 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.Item Anticompetitive Patent Settlements and the Supreme Court’s Actavis Decision(Minnesota Journal of Law, Science and Technology, 2014-02-20) Hovenkamp, HerbertReverse 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.Item 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.Item Convergence?(Minnesota Journal of Law, Science and Technology, 2014-02-20) Ghosh, ShubhaReverse 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.Item 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.Item 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, BryanThis 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.Item 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, JacquelineA 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.Item Ending Patent Exceptionalism and Structuring the Rule of Reason: The Supreme Court Opens the Door for Both(Minnesota Journal of Law, Science and Technology, 2014-02-20) Feldman, RobinReverse 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.Item Slowing Antibiotic Resistance by Decreasing Antibiotic Use in Animals(Minnesota Journal of Law, Science and Technology, 2014-02-20) Nomura, JenniferAntibiotic 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.Item 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.Item 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, AlexanderReverse 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.Item Hatch-Waxman Patent Case Settlements—The Supreme Court Churns the Swamp(Minnesota Journal of Law, Science and Technology, 2014-02-20) Bernard, KentReverse 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.Item 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, UdeThe 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.Item 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.Item 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.