The battle over global drug markets: enforcement of pharmaceutical patents in the United States, Europe and Japan

Legal context: Pharmaceutical patent litigation is on the rise. The focal pointof this increasingly contentious area of litigation is the surgein pharmaceutical patent challenges mounted by generic drugmanufacturers. Pharmaceutical companies need to identify viableenforcement strategies that can survive these challenges andeffectively manage the life cycle of their pharmaceutical productsaround the world. Key points: The degree to which pharmaceutical companies can capitalizeupon the value of their second generation patents to extendthe protection given to existing drug products depends in parton the patent landscape, country by country, and also on theregulatory landscape for generic drug products and their entryinto the marketplace.This paper will examine the patent laws,drug approval regulations, and court decisions on the validityand enforceability of later stage or second generation patentsdirected to combination compounds, selection inventions, andnew indications, in three major jurisdictions: The United States,Europe/UK, and Japan. Practical significance: Successful pharmaceutical companies can maintain a competitiveadvantage in the global pharmaceutical industry by evaluatingand strengthening the way existing drug products are protectedand, in many cases, changing the nature of protection underthe patent laws by improving upon the pharmaceutical productitself.     

The good, the bad, and the ugly: how the due process clause may limit comprehensive health care reform

This article examines atopic which has receivedlittle attention from the media or other scholarly publications: The due process concerns that arise when engaging in comprehensive federal health care reform and regulation. First, the article provides a background discussion detailing the factors necessitating health care reform in the United States. Second, it analyzes whether a constitutionally protected right to make personal health care decisions exists under the Fifth and Fourteenth Amendments' Due Process Clauses. Finally, the article analyzes the susceptibility of government-sponsored health care-specifically proposals which include a public option-to due process challenges and makes suggestions to avoid any potential fundamental rights violations.     

The competitive effects of health maintenance organizations: another look at the evidence from Hawaii, Rochester, and Minneapolis/St. Paul

There has been much discussion about the potential cost-containing impact of HMOs upon the local medical care market. Three areas have been identified by various observers as experiencing such beneficial effects: Hawaii, after the development of Kaiser in the late 1950s; Rochester, New York, which experienced rapid HMO growth and declining Blue Cross hospital use in the late 1970s; and Minneapolis/St. Paul, which has been the focus of vigorous HMO competition in the last decade. While comprehensive data on health care expenditures are not available, bits of evidence can be pieced together to develop case studies of each area. Careful review of the available data often identifies internal inconsistencies and contradictions, but in none of the three sites is there a reduction in hospital use that is most plausibly attributed to HMO competition. Instead, the reported reductions are in each case attributable to other factors--including biases in data, long-term trends predating HMOs, indirect effects of other policy changes, and other forms of competition.     

The Priority of Politics and Procedure over Perfectionism in Penal Law, or, Blackmail in Perspective

Criminal law theory concerns itself with the justification of punishment. Conflicting moral theories of punishment will be held in liberal democracies. The positive law therefore neither will nor should reflect exclusively a single moral theory of punishment. Like the institutions for making law, the institutions for enforcing it will cause punishments imposed to deviate from what pure moral theory might prescribe. These claims are illustrated by the debate over blackmail prohibition. The best rationale for prohibition is not the moral argument that blackmailers culpably cause harm, but the political argument that blackmailers threaten the state’s claimed monopoly on punishing crime.