Law Commons^™

Patently Obvious: A Dual Standard Solution To The Diverging Needs Of The Information Technology And Pharmaceutical Patent Industries, Andrew Moody

Golden Gate University Law Review

This Comment proposes the use of a specifically tailored obviousness standard as a new solution to the IT and pharmaceutical patent industries' divergent needs. Part I summarizes the obviousness standard's history in patent law. Part II illustrates how the IT and pharmaceutical industries have divergent needs. Part III describes why using a single standard for the obviousness inquiry is inadequate to meet the needs of both the IT and pharmaceutical industries. Part IV illustrates why the obviousness standard needs to be specifically tailored for the IT and pharmaceutical industries. Finally, Part V concludes that a dual standard for obviousness is …

Bridging The Gap: How United States V. Munn Correctly Interprets The Legislative Intent Of Amendment 706 Addressing The Disparity Between Crack And Cocaine Offenses, Alyn Goodson

North Carolina Central Law Review

No abstract provided.

One False Move: The History Of Organic Agriculture And Consequences Of Non-Compliance With The Governing Laws And Regulations, Sara N. Pasquinelli

Golden Gate University Environmental Law Journal

This Article provides an overview of the types of factors that may lead to the decertification of organic products, and the current regulatory scheme to evaluate and adjudicate potential violations. The underlying rationale for the enforcement of the Organic Foods Production Act of 1990 may lie in protection of the integrity of the product, as well as protection of the environmental system that is integral to its production. However, the risk factors for transitioning the U.S. food economy to a larger market share in order for organic food to reach a broader population could be an unintended disincentive. Part II …

Different Endings: Lethal Injection, Animal Euthanasia, Humane Slaughter, And Unregulated Slaugter, Jeff Welty

Golden Gate University Environmental Law Journal

This Article compares the laws and regulations that govern the termination of life in several contexts: lethal injection of condemned inmates; the euthanasia of companion animals; the slaughter of farmed animals covered by the Humane Methods of Slaughter Act; and the slaughter of farmed and other animals not covered by the Act.

A Reconsideration Of Agricultural Law: A Call For The Law Of Food, Farming, And Sustainability, Susan A. Schneider

William & Mary Environmental Law and Policy Review

American agricultural policy has evolved from its early focus on agricultural development and expansion to its current focus on economic and political support for the agricultural sector. Agricultural law as a discipline has tracked this policy, with agricultural law scholars debating the origins and the validity of the special treatment of agriculture under the law. This article reviews these debates and calls for a reconsideration of agricultural law and policy to address the unique aspects of agricultural production, the fragility of the environment, and the fundamental need for healthy food. Transforming the special law of agriculture to a new more …

Keeping Agriculture Alive In The Shadow Of A Uranium Mine: Potential Effects And Regulatory Solutions For Virginia, Maggy J. Lewis

William & Mary Environmental Law and Policy Review

No abstract provided.

How Many Patents Does It Take To Make A Drug - Follow-On Pharmaceutical Patents And University Licensing, Lisa Larrimore Ouellette

Michigan Telecommunications & Technology Law Review

As described by Professors Dan Burk and Mark Lemley, drugs are[...] special because of the low number of patents per product: "In some industries, such as chemistry and pharmaceuticals, a single patent normally covers a single product. Much conventional wisdom in the patent system is built on the unstated assumption of such a one-to-one correspondence." Although many have repeated this one-patent, one-drug assumption, there has been little empirical analysis of how many patents actually protect each drug. In fact, most small-molecule drugs are protected by multiple patents. The average was nearly 3.5 patents per drug in 2005, with over five …

It Is Time: Why The Fda Should Start Disclosing Drug Trial Data, Mustafa Ünlü

Michigan Telecommunications & Technology Law Review

Although [drug] manufacturers bear the cost of research data generation, it is oftentimes a worthwhile investment that also confers significant commercial advantages. Consequently, they have argued that research data should be considered a trade secret and kept confidential. The FDA's longstanding position has been to accept this proposition. Even when Congress appeared to mandate disclosure or weaken the underlying rationale for secrecy, the FDA has continued to treat research data as confidential. A strong argument against a default posture of confidentiality is that research data disclosure would promote broad public interests by eliminating the societal costs brought about by keeping …

Re-Stocking The Shelves: Policies And Programs Growing In Food Deserts, Tess Feldman

Public Interest Law Reporter

No abstract provided.

Obama Administration Withholds Funds For Drug War In Mexico Pending Human Rights Reform, Christina Mcmahon

Public Interest Law Reporter

No abstract provided.

Deadly Delay / Postponed Pills, 10 J. Marshall Rev. Intell. Prop. L. 254 (2010), Christopher R. Walker

UIC Review of Intellectual Property Law

Since 1984, generic pharmaceuticals have continued to grow, and are an important element in our national struggle to increase affordable health care options in the United States. The Hatch-Waxman Act has played a pivotal role in helping to create a regulatory environment that fosters the development of generic pharmaceuticals, thereby increasing access to lower-cost alternatives to more expensive drugs. An important part of balancing the interests of the generic manufacturers against those of the primary pharmaceutical makers is the thirty-month stay provision of the Hatch-Waxman Act. This comment begins by taking a look at the history of the Hatch-Waxman Act …

Volume 10 Issue 3, Sustainable Development Law & Policy

Sustainable Development Law & Policy

No abstract provided.

Livestock Animal Cloning: This Steak Is Giving Me Déjà Vu, Blake M. Mensing

Sustainable Development Law & Policy

No abstract provided.

Wyeth V. Levine: What Does It Mean And Where Do Pharmaceutical Companies Go From Here, Clay Landa

Richmond Journal of Law and the Public Interest

Therefore, one approach for a drug maker, knowing of a potential hazard, would be to unilaterally strengthen their warning without prior FDA approval under current regulations to head off any state tort claims for failure to warn. If the FDA ultimately determines not to approve the strengthened label, under explicit authority granted by Congress in the FDCA, drug makers have a strong argument that implicit conflict preemption now applies. As another avenue, drug makers may include a potential warning amounting to a prohibition of the drug's use or method of delivery when seeking initial approval of the warning label. Again, …

Are You Covered? The Need For Improvement In Insurance Coverage For Autism Spectrum Disorder, 44 J. Marshall L. Rev. 291 (2010), Marissa Mazza

UIC Law Review

No abstract provided.

Wine Wars: How We Have Painted Ourselves Into A Regulatory Corner, Rachel M. Perkins

Vanderbilt Journal of Entertainment & Technology Law

A private citizen can violate the Constitution in two ways. The first is by enslaving another person, an atrocious act that should be proscribed by the highest law in the land. The second is by transporting alcohol across a state line in violation of the laws of that state. The two actions are hardly of the same magnitude.

The history of alcohol regulation has been a litany of failed attempts--on both the state and federal levels. Each new layer of legislation created additional problems. Most are familiar with the infamy of Prohibition, the federal ban on the manufacture or sale …

Allocating Liability For Deficient Warnings On Generic Drugs: A Prescription For Change, Sarah C. Duncan

Vanderbilt Journal of Entertainment & Technology Law

Brand-name pharmaceutical companies create pioneer drugs that cure diseases around the world. However, because research and development costs are very high, brand-name drugs are expensive. In response to escalating costs, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 ("Hatch-Waxman Act") to promote generic competition. As generics become more prominent in the pharmaceutical marketplace, individuals injured by generic drugs are suing the manufacturers with more frequency. The cases often turn on which company should bear the liability for failing to warn--the brand-name manufacturer or the generic drug maker. Although the injured person took the generic drug, …

Making Changes: Generic Drug Labeling And The Case Against Federal Preemption, Lesley A. Stout

Kentucky Law Journal

No abstract provided.

Wyeth V. Levine: What Does It Mean And Where Do Pharmaceutical Companies Go From Here, Clay Landa

Richmond Public Interest Law Review

In the recent landmark decision in Wyeth v. Levine, the Supreme Court put drug manufacturers on notice that they can and should be liable for state tort claims for the harm their products cause regardless of Federal Drug Administration ("FDA") approval of the drug's use and warning labels. Part II of this paper analyzes the history and background of federal preemption to give context to the current environment after Wyeth. Part III analyzes the Supreme Court's decision in Wyeth, holding that the FDCA and corresponding regulations do not preempt state tort claims. Finally, Part IV discusses and analyzes what drug …

Between Starvation And Globalization: Realizing The Right To Food In India, Lauren Birchfield, Jessica Corsi

Michigan Journal of International Law

This Article evaluates People's Union for Civil Liberties v. Union of India & Others (PUCL) through multiple lenses, examining: (1) the necessary factors that contributed to the success of the Public Interest Litigation (PIL) and its enforcement and (2) both the implications and limitations of PUCL as it relates to India's larger economic policy framework. We argue that the development and success of the PUCL litigation have depended in part on provisions of the Indian Constitution amenable to the incorporation and promotion of economic and social rights as well as on a unique relationship between civil society and judicial institutions. …

Liberty Lost: The Moral Case For Marijuana Law Reform, Eric Blumenson, Eva Nilsen

Indiana Law Journal

Marijuana policy analyses typically focus on the relative costs and benefits of present policy and its feasible alternatives. This Essay addresses a prior, threshold issue: whether marijuana criminal laws abridge fundamental individual rights, and if so, whether there are grounds that justify doing so. Over 700, 000 people are arrested annually for simple marijuana possession, a small but significant proportion of the 100 million Americans who have committed the same crime. In this Essay, we present a civil libertarian case for repealing marijuana possession laws. We put forward two arguments corresponding to the two distinct liberty concerns implicated by laws …