Browsing by Author "Nomura, Jennifer"
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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 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.