
|
VOLUME 8 ISSUE 1 WINTER 2006 |
|
|
|
| ARTICLES |
|
Patent Reform and Differential Impact
This article presents a new method of analyzing patent reform proposals through the use of differential impact analysis. Congressional efforts to address the crisis of confidence in the U.S. patent system have failed up to the present day. If Congress is to have any hope of passing much needed legislative reform to the Patent Act, the supporters of patent reform will have to unite behind a streamlined set of proposals that directly address the most pressing and unambiguous defects of the current patent system. To that end, the authors have proposed applying a test of differential impact to enable Congress to prioritize those reforms which will discourage the acquisition and assertion of bad patents without unduly prejudicing the interests of the holders of good patents. The differential impact approach elucidated in this article has at least three distinct advantages over other efforts to rewrite the patent system from the ground up. First, the differential impact approach provides a mechanism by which to evaluate competing claims for legislative resources. Second, the differential impact approach is an appropriate response to the empirical uncertainty surrounding optimal patent scope. Third, differential impact is consistent with the need to take the legitimate expectations of current stakeholders into account.
|
[ download full text pdf ]
|
Kurt Rohde
Matthew Sag
| 1 |
|
|
Curing Confusion: An Overview of the Regulatory Complexities of Obtaining Pharmaceutical Trademarks and a Prescription for Reform
The United States Patent and Trademark Office (PTO) is entrusted with reviewing and approving proposed trademarks. Similarly, the Food and Drug Administration (FDA) is entrusted with reviewing and approving pharmaceutical drugs. Although each agency has the exclusive jurisdiction to regulate the federal registration of trademarks and approve prescription drugs for commercial use respectively, jurisdictional lines are blurred when the FDA extends its authority to regulate misleading drug labeling into the multi-million dollar industry of drug trademarks. In seemingly wasteful and repetitive fashion, both the FDA and PTO must conduct an independent "likelihood of confusion" analysis. While the PTO must ensure that a proposed trademark does not confuse consumers about the product's commercial source, the FDA must ensure that proposed drug trademarks do not make false, misleading, or suggestive promises. More important, the FDA must ensure that drug trademarks are sufficiently discernable from one another to reduce the likelihood of prescription and drug administration errors.
This article argues that the current system under which the FDA and PTO evaluate proposed drug trademarks, although necessary, lacks efficiency, specificity, and fails to provide drug manufacturers with clear and predictable guidelines for obtaining drug trademark approval. Although maintaining public safety must remain the primary concern regardless of how the FDA and PTO review drug names, this end can be achieved more appropriately and more efficiently by requiring both agencies to develop and implement clear, integrated, and workable guidelines for reviewing proposed pharmaceutical trademarks.
|
[ download full text pdf ]
|
Dana M. Herberholz
| 97 |
|
|
Potentially Reduced Exposure Cigarettes: The Need for a Public Health Policy
[ download full text pdf ]
|
Christopher N. Banthin
| 127 |
|
[ download full text pdf ]
|
Peter Curwen
Jason Whalley
| 149 |
|
| SYMPOSIUM |
|
Colloquy: Moving Forward in Food Safety & Defense
The risk of intentional contamination in the food supply poses a real and potentially catastrophic threat to homeland security, pointing to a critical need to strengthen our capabilities for preparedness and response in relation to the food system. Given the wide range of potential vulnerabilities in the farm-to-table food supply chain, intentional contamination could cause devastating and far-reaching health and economic effects, including direct morbidity and mortality, disruption of supply chain distribution, loss of consumer confidence in the food industry, major business failures, trade restrictions, and damaging effects on the national economy. This colloquy, which is derived from a roundtable discussion among academic, government, industry, and audience participants at this Conference, highlights many of the leading challenges in food defense: the need to anticipate risks, assess safety, and respond to threats and foodborne disease outbreaks, as well as the importance of maintaining public trust in the food system and recognizing the ethical and legal issues that may arise from threats or incidents of deliberate contamination.
|
[ download full text pdf ]
|
Julie Ostrowsky
| 175 |
|
|
Food Protection and Defense: Preparing for a Crisis
Recent catastrophes, such as the events of September 11, 2001 and Hurricane Katrina serve as key examples of the importance of emergency preparedness. While federal agencies prepare plans to deal with terrorist attacks or natural crises, significant gaps remain in the safety of our nation's food supply. Critical areas of food protection, including food safety risk assessment, laboratory testing, import inspections, and tracing and alert systems, are ill-equipped to deal with large-scale food safety emergencies. With food safety being managed by a dozen federal agencies, the nation's food supply remains vulnerable to both intentional and accidental contamination. Improved coordination between federal agencies and a single food agency will strengthen our capacity to ensure the safety of our food.
|
[ download full text pdf ]
|
Caroline Smith DeWaal
| 187 |
|
|
Role of Regulation in Minimizing Terrorist Threats Against the Food Supply: Information, Incentives, and Penalties
This article discusses the crucial role that government regulation plays in protecting against terrorist threats to the food supply. This regulatory role is defined largely by the meshing of a patchwork food-safety regulatory system developed over time with recent regulation enacted in response to terrorist threats. The result is a regulatory response to terrorist threats that is largely predicated upon the effective coordination amongst regulatory authorities and between these regulatory authorities and the food industry. This article evaluates the effectiveness of this regulatory system to terrorist threats and makes recommendations by focusing on its delivery of information, incentives, and penalties.
|
[ download full text pdf ]
|
Michael T. Roberts
| 199 |
|
|
Modeling the Public Health System Response to a Terrorist Event
The objective of this research is to develop a mathematical model which describes the behavior of the public health system in response to a contamination event. This model will be able to predict the effect of different interventions which might be attempted in the middle of an event, and to predict the effect of these interventions, and the resulting estimated reductions in morbidity and mortality. We expect that the model will be useful for deliberate contamination events, but may also have value in understanding and mitigating the effect of accidental contamination as well.
The current model has been developed in Analytica, and simulates 60 dose-events (i.e. contaminated servings), consumed over 50 days. The dose-response model is a simple one, consisting of a single probability of illness, which may manifest with 3 different severities. The current model uses the concept of a disease outbreak "detection constant" where the probability that the public health system actually detects an ongoing outbreak is related to both the detection constant, as well as the number of cases, where those cases are weighted by severity, such that more severe cases are more likely to be detected.
|
[ download full text pdf ]
|
Donald W. Schaffner
| 225 |
|
|
The Public Health Tesseract: Managing the Multiplicative Threat
The public health community has had a tendency to approach and plan for issues separately – bioterrorism separate from antibiotic-resistant tuberculosis separate from obesity separate from influenza, etc. This has occurred – understandably – because the requirements for dealing with each of many different public health issues can be complex and unique. In effect, we have taken the tangled strands of health-related challenges – pulled them apart to identify and deal with them individually – and then forgotten that we not only have to deal with these individual strands, but the problems that the entire tangle presents as well. Additionally, the threats to the public's health are multiplicative, and they demand both measured and multidimensional approaches be used to deal with them. The public health threat-management model left the second and third dimensions behind long ago – and should now be based upon the tesseract, (the four dimensional analog of the cube which serves as a better model for our thinking and actions. The combined threat of both pandemic influenza (naturally-occurring) and bioterrorism (human-generated) supports the use of this model. In geometry, the tesseract is to the cube what the cube is to the square. As public health professionals, we must entertain the notion of a tesseract to broaden our thinking, and manage the complex interactions between and among the various cubicle cells (there are eight), faces (there are 24), edges (there are 32), and vertices (there are 16). This is not a case of making way for the public health community to take a leadership role in managing multiplicative threats. The community is already there, and by mission and for professional and organizational survival, it must use the assets, resources, organizational acumen, analyses, and operational expertise that possesses beyond all others to deal with the threat. The public health tesseract will enable us to respond to the threat successfully.
|
[ download full text pdf ]
|
Asha M. George
| 237 |
|
| BOOK REVIEWS |
|
Our Agriculture Policy Dilemma: The Omnivore's Dilemma: A Natural History of Four Meals by Michael Pollan (2006)
Michael Pollan's book, The Omnivore's Dilemma: A Natural History of Four Meals, (2006) ("Omnivore's Dilemma"), invites readers to follow Pollan as he uncovers the origins of four vastly different meals. The conceit enables Pollan to explore the complicated food systems on which Americans rely for their daily bread. Pollan explores four food supply systems in particular: industrial, big organic, small organic, and hunter-gatherer. This book review focuses on the industrial food supply, and the "small" organic alternative. In so doing, the review discusses agriculture policy and explores what has become in some ways a national fixation on "family farms." The review seeks to expose the disparity between how we eat—most of our calories provided through the industrial agricultural sector, and how we like to think we eat–our food coming fresh from "family farms." The review also discusses some of the paradoxes, or absurdities, that Pollan identifies in the food supply system as we have evolved from hunters-gatherers to consumers of convenience. In some ways, The Omnivore's Dilemma is an unquestionable success, and this review duly notes those successes. The review also addresses a topic raised but not exhausted by Pollan: that is, our national romanticism of the "family farm," including an explanation of the status of such farms today. The industrial agriculture food system is implicated in what has become known as the hunger-obesity paradox. The review next explores this paradox and concludes where Pollan begins by asking, though not attempting to answer, "What's for dinner?"
|
[ download full text pdf ]
|
Morgan L. Holcomb
| 249 |
|
| NOTES |
|
Dad Was Born A Thousand Years Ago? An Examination of Post-Mortem Conception and Inheritance with a Focus on the Rule against Perpetuities
In, "Are You My Daddy? An Examination of Post-Mortem Conception and Inheritance, With a Focus on the Rule Against Perpetuities" I examine the issues that arise from the increasingly common practice of cryopreserving (freezing) sperm, and the possibility that this may be used to inseminate a woman after a man's death. Port-mortem conception not only removes the presumption of paternity which is a key factor in most of our inheritance laws, but also reeks havoc when intertwined with the surviving rules against perpetuities. After a detailed analysis of the issues, I propose a solution that attempts to meet some basic criteria which are laid out in the article.
|
[ download full text pdf ]
|
Joshua Greenfield
| 277 |
|
|
Chaos Worth Having: Irreducible Complexity and Pragmatic Jurisprudence
A judge's assumptions about the ability of empirical methods to model and predict complex systems is likely to influence his or her decision making philosophy. An overly simplistic view of the ability of science to deal with complex systems may undermine the value of such a philosophy. This Note examines how the growing field of complexity theory may aid in the analysis of jurisprudential theories. Using a tripartite classification developed by Professor Roy Books, judicial temperaments may be roughly divided into positivism, pragmatism, and nominalism. Three concepts from complexity theory suggest the superiority of pragmatic judicial temperaments, at least to the extent that they reflect an appropriate view of empirical methods. First, Gödel's Incompleteness Theorem suggests limitations on formal decision making methods that undermine positivist assumptions, but not to an extent that supports a nominalist approach; pragmatism strikes a more appropriate balance. Second, challenges in modeling the behavior of chaotic systems suggest weaknesses in the rigidity of positivist decision making, but again not to an extent that supports a nominalist reaction. Finally, the intractability of some types of computational problems offers similar reasons for favoring pragmatism. By undertaking this type of analysis, we can gain a clearer understanding of the limitations of jurisprudence while leaving room for vigorous debate on those questions further from the reach of scientific inquiry.
|
[ download full text pdf ]
|
Byron Holz
| 303 |
|
| RECENT DEVELOPMENTS |
|
Metabolite Labs and Patentable Subject Matter: A Review of Federal Circuit and PTO Precedent was Narrowly Averted but for How Long?
The United States Supreme Court granted certiorari to hear Lab. Corp. of Am. Holdings v. Metabolite Labs on the issue of whether claim 13 of Competitive Technologies, Inc.'s ("CTI", the patent holder) patent recited patentable subject matter, or whether the claim was invalid as reciting nothing more than a natural phenomenon. Claim 13 recited "a method for detecting a deficiency of cobalamin or folate in warm-blooded animals comprising the steps of: assaying a body fluid for an elevated level of total homocysteine; and correlating an elevated level of total homocysteine in said body fluid with a deficiency of cobalamin or folate." The Court invited the Solicitor General to submit a brief stating its view on whether the claim recited patentable subject matter. The Solicitor General, as well as CTI/Metabolite Labs argued the Court should dismiss the case, because the issue of whether claim 13 recited patentable subject matter was not argued below. LabCorp failed to directly argue subject matter in the lower courts, and ultimately the Supreme Court dismissed the writ as improvidently granted in June 2006. Justice Breyer, however, joined by Justices Stevens and Souter, wrote an emphatic dissent. Breyer argued that the case was not a difficult one, that the claim impermissibly attempted to claim a natural phenomenon, and that the legal and medical community would benefit from clarity in this area sooner rather than later. Some interested parties, including the Solicitor General, argued finding claim 13 invalid would call into question an untold number of existing patents, while others argued that allowing claim 13 to stand essentially nullifies the judicially created exclusions to patentable subject matter.
|
[ download full text pdf ]
|
Michelle E. Dawson
| 345 |
|
|
|