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Full-Text Articles in Law

Intellectual Property, Surrogate Licensing, And Precision Medicine, Jacob S. Sherkow, Jorge L. Contreras Apr 2018

Intellectual Property, Surrogate Licensing, And Precision Medicine, Jacob S. Sherkow, Jorge L. Contreras

IP Theory

The fruits of the biotechnology revolution are beginning to be harvested. Recent regulatory approvals of a variety of advanced therapies—Keytruda (pembrolizumab), Kymriah (tisagenlecleucel), and patisiran—have ushered in an age of “precision medicine” treatments that target patients’ specific genetic, physiological, and environmental profiles rather than generalized diagnoses of disease. Therapies like these may soon be supplemented by gene editing technologies such as CRISPR, which could enable the targeted eradication of deleterious genetic variants to improve human health. But the intellectual property (IP) surrounding precision therapies and their foundational technology remain controversial. Precision therapies ultimately rely—and are roughly congruent with—basic scientific information …


Judging Adaptive Management Practices Of U.S. Agencies, Robert L. Fischman, J. B. Ruhl Apr 2016

Judging Adaptive Management Practices Of U.S. Agencies, Robert L. Fischman, J. B. Ruhl

Articles by Maurer Faculty

All U.S. federal agencies administering environmental laws purport to practice adaptive management (AM), but little is known about how they actually implement this conservation tool. A gap between the theory and practice of AM is revealed in judicial decisions reviewing agency adaptive management plans. We analyzed all U.S. federal court opinions published through 1 January 2015 to identify the agency AM practices courts found most deficient. The shortcomings included lack of clear objectives and processes, monitoring thresholds, and defined actions triggered by thresholds. This trio of agency shortcuts around critical, iterative steps characterizes what we call AM-lite. Passive AM differs …


No Ordinary Fish Tale: Working Toward A Transnational Solution To The Cod Crisis In The Gulf Of Maine, Michael Ruderman Dec 2015

No Ordinary Fish Tale: Working Toward A Transnational Solution To The Cod Crisis In The Gulf Of Maine, Michael Ruderman

Indiana Law Journal

In response to a National Oceanic and Atmospheric Administration (NOAA) survey that showed “record-low levels of abundance” of groundfish in the Gulf of Maine (“Gulf”), local fisherman Brian Pearce asserted: “It concerns [me] that what [NOAA is] saying and what we [the local fishermen] are seeing is such a contrast . . . . Who sees more fish in the ocean than the fishermen?” Despite Mr. Pearce’s skepticism, the state of the cod fishery in the Gulf of Maine—home to “critical” and “legendary" fishing grounds in Canadian and American territories—is, in fact, dire. According to the NOAA survey, conducted in …


Lessons From Pollution Control: Response To Heller And Hobbs 2014, Robert L. Fischman, James Salzman Jun 2015

Lessons From Pollution Control: Response To Heller And Hobbs 2014, Robert L. Fischman, James Salzman

Articles by Maurer Faculty

Heller and Hobbs (2014) provide an incisive analysis of the challenges inherent in setting endpoint states as conservation goals. The social construct of nature, nonequilibrium ecosystems, global climate change, large-scale transformations of the landscape, and increasing population and economic activity confound efforts to establish conservation goals. Stakeholders often disagree on endpoint targets, whereas competing notions of historic fidelity and future flexibility frustrate our ability to articulate success, never mind actually achieve it. As Heller and Hobbs describe, this leaves managers in the bind of finding the “balance between future-looking management emphasizing change and past-looking management emphasizing persistence.” As a result, …


Learning From Conservation Planning For The U.S. National Wildlife Refuges, Robert L. Fischman, Vicky J. Meretsky Oct 2014

Learning From Conservation Planning For The U.S. National Wildlife Refuges, Robert L. Fischman, Vicky J. Meretsky

Articles by Maurer Faculty

The U.S. National Wildlife Refuge System has nearly completed its first round of unit-level, comprehensive conservation plans (CCPs) and will soon begin required revisions. Laws and policies governing refuge planning emphasize ecological integrity, landscape-scale conservation, and adaptive management. We evaluated 185 CCPs completed during 2005–2011, which cover 324 of 555 national wildlife refuges. We reviewed CCP prescriptions addressing 5 common conservation issues (habitat and game, nongame, imperiled, and invasive species) and 3 specialized topics (landscape-scale conservation, climate change, and environmental quality). Common conservation issues received prescriptions in >90% of CCPs. Specialized topics received more variable treatment. Prescriptions for aquatic connectivity, …


Will Gene Patents Impede Whole Genome Sequencing?: Deconstructing The Myth That 20% Of The Human Genome Is Patented, Christopher M. Holman Feb 2012

Will Gene Patents Impede Whole Genome Sequencing?: Deconstructing The Myth That 20% Of The Human Genome Is Patented, Christopher M. Holman

IP Theory

No abstract provided.


A Thousand Tiny Pieces: The Federal Circuit’S Fractured Myriad Ruling, Lessons To Be Learned, And The Way Forward, Jonathan R. K. Stroud Jan 2012

A Thousand Tiny Pieces: The Federal Circuit’S Fractured Myriad Ruling, Lessons To Be Learned, And The Way Forward, Jonathan R. K. Stroud

IP Theory

No abstract provided.


Patents Fettering Reproductive Rights, Scott A. Allen Jan 2012

Patents Fettering Reproductive Rights, Scott A. Allen

Indiana Law Journal

No abstract provided.


Preserving Field Notes On Songbird Biology At Indiana University, Eric Snajdr, Ellen D. Ketterson Jun 2011

Preserving Field Notes On Songbird Biology At Indiana University, Eric Snajdr, Ellen D. Ketterson

Val Nolan Jr. (1976 Acting; 1980 Acting)

No abstract provided.


Statutory Reform To Protect Migrations As Phenomena Of Abundance, W. William Weeks, Jeffrey B. Hyman, Andrea Need Jan 2011

Statutory Reform To Protect Migrations As Phenomena Of Abundance, W. William Weeks, Jeffrey B. Hyman, Andrea Need

Articles by Maurer Faculty

Animal migrations capture the human mind and heart like few other natural phenomena. Migrations provide ecological, psychological (e.g., aesthetic), cultural, and economic benefits. Increasingly, though, migrations are being recognized as threatened phenomena-that is, spectacular aspects of the life history of animal species often involving large numbers of individuals, but which are threatened with impoverishment or demise, even though the species per se may not be in peril. Migration phenomena are themselves worthy of protection, as a category of biodiversity Yet, conserving migratory populations and their migrations is particularly problematic. Migratory animals are especially vulnerable to a variety of threats because …


A Tradable Conservation Easement For Vulnerable Conservation Objectives, W. William Weeks Jan 2011

A Tradable Conservation Easement For Vulnerable Conservation Objectives, W. William Weeks

Articles by Maurer Faculty

The critical conservation objectives in some conservation easements will probably be compromised by the effects of climate change in the relatively near future. Prompted to consider that likelihood, we can similarly predict that landscape fragmentation, invasive species, and other catastrophes— anthropogenic and natural—may also seriously diminish the capacity of particular parcels of land to serve narrowly defined conservation purposes, and especially, the conservation of a particular element of biodiversity.


Economics, Behavioral Biology, And Law, Jeffrey E. Stake, Owen D. Jones, Erin O'Hara O'Connor Jan 2011

Economics, Behavioral Biology, And Law, Jeffrey E. Stake, Owen D. Jones, Erin O'Hara O'Connor

Articles by Maurer Faculty

This article compares the relevance to law of two unexpectedly similar fields: economics and behavioral biology. It first examines the assumptions, core concepts, methodological tenets, and emphases of the two fields. It then compares the interdisciplinary fields of law and economics, on one hand, with law and behavioral biology, on the other-highlighting not only important similarities but also important differences. The article subsequently explores ways that biological perspectives on human behavior may, among other things, improve economic models and the behavioral insights they generate. The article concludes that although there are important differences between the two fields, the overlaps between …


Law, Biology Professor Val Nolan Dies Mar 2008

Law, Biology Professor Val Nolan Dies

Val Nolan Jr. (1976 Acting; 1980 Acting)

No abstract provided.


Combining The Components Of Life: The Application Of Patent Extraterritoriality Doctrine To Biotechnology, Jennifer L. Schuster Jan 2008

Combining The Components Of Life: The Application Of Patent Extraterritoriality Doctrine To Biotechnology, Jennifer L. Schuster

Indiana Law Journal

No abstract provided.


Technological Change And The Design Of Plant Variety Protection Regimes, Mark D. Janis, Stephen Smith Jan 2007

Technological Change And The Design Of Plant Variety Protection Regimes, Mark D. Janis, Stephen Smith

Articles by Maurer Faculty

No abstract provided.


Rules V. Standards For Patent Law In The Plant Sciences, Mark D. Janis Jan 2006

Rules V. Standards For Patent Law In The Plant Sciences, Mark D. Janis

Articles by Maurer Faculty

This article argues that US patent jurisprudence as applied to the plant sciences is moving to a second stage that will be characterized by more by incremental calibration than by spectacular change. The article discusses two doctrines of patent scope that are likely to be implicated in calibrating the utility patent system for the plant sciences: enablement and experimental use. It considers how those doctrines may be refined to serve as calibration tools in the application of patent law to the plant sciences.


Balancing Ease And Accuracy In Assessing Pharmaceutical Exclusion Payments, Mark D. Janis, Herbert Hovenkamp, Mark A. Lemley Jan 2004

Balancing Ease And Accuracy In Assessing Pharmaceutical Exclusion Payments, Mark D. Janis, Herbert Hovenkamp, Mark A. Lemley

Articles by Maurer Faculty

No abstract provided.


Supplemental Forms Of Intellectual Property Protection For Plants, Mark D. Janis Jan 2004

Supplemental Forms Of Intellectual Property Protection For Plants, Mark D. Janis

Articles by Maurer Faculty

A new hierarchy of intellectual property protection for plant innovation is emerging. Utility patent protection is poised to become the dominant intellectual property mechanism for plants in the U.S. and perhaps elsewhere. Plant breeder's rights systems continue to garner a dedicated following, especially in developing countries, as a means for complying with international intellectual property treaty obligations. But while utility patent and plant breeder's rights regimes have come to occupy the first tier of the intellectual property hierarchy for plants, other forms of intellectual property protection remain important, albeit in a supplemental role. This article surveys supplemental intellectual property strategies …


Intellectual Property Issues In Plant Breeding And Plant Biotechnology, Mark D. Janis Jan 2002

Intellectual Property Issues In Plant Breeding And Plant Biotechnology, Mark D. Janis

Articles by Maurer Faculty

No abstract provided.


Cases And Guidelines In Genetics, Roger B. Dworkin Jan 2002

Cases And Guidelines In Genetics, Roger B. Dworkin

Articles by Maurer Faculty

No abstract provided.


Patenting Resources: Biotechnology And The Concept Of Sustainable Development, Yvonne Cripps Oct 2001

Patenting Resources: Biotechnology And The Concept Of Sustainable Development, Yvonne Cripps

Indiana Journal of Global Legal Studies

No abstract provided.


A "Frozen Exception" For The Frozen Embryo: The Davis "Reasonable Alternatives Exception", Jennifer L. Medenwald Apr 2001

A "Frozen Exception" For The Frozen Embryo: The Davis "Reasonable Alternatives Exception", Jennifer L. Medenwald

Indiana Law Journal

No abstract provided.


Making Sense Out Of Antisense: The Enablement Requirement In Biotechnology After Enzo Biochem V. Calgene, Matthew D. Kellam Jan 2001

Making Sense Out Of Antisense: The Enablement Requirement In Biotechnology After Enzo Biochem V. Calgene, Matthew D. Kellam

Indiana Law Journal

No abstract provided.


Hard Cases For Autonomy, Respect, And Professionalism In Medical Genetics, Roger B. Dworkin Jan 2001

Hard Cases For Autonomy, Respect, And Professionalism In Medical Genetics, Roger B. Dworkin

Articles by Maurer Faculty

No abstract provided.


Bridging The Gap Between Life Insurer And Consumer In The Genetic Testing Era: The Rf Proposal, Christopher M. Keefer Oct 1999

Bridging The Gap Between Life Insurer And Consumer In The Genetic Testing Era: The Rf Proposal, Christopher M. Keefer

Indiana Law Journal

No abstract provided.


Balancing Interests In Frozen Embryo Disputes: Is Adoption Really A Reasonable Alternative?, David L. Theyssen Apr 1999

Balancing Interests In Frozen Embryo Disputes: Is Adoption Really A Reasonable Alternative?, David L. Theyssen

Indiana Law Journal

No abstract provided.


The Human Genome Project's Implications For Autonomy, Respect, And Professionalism In Medical Genetics, Roger B. Dworkin Jan 1999

The Human Genome Project's Implications For Autonomy, Respect, And Professionalism In Medical Genetics, Roger B. Dworkin

Articles by Maurer Faculty

No abstract provided.


Beyond The Harvard Mouse: Current Patent Practice And The Necessity Of Clear Guidelines In Biotechnology Patent Law, Carrie F. Walter Jul 1998

Beyond The Harvard Mouse: Current Patent Practice And The Necessity Of Clear Guidelines In Biotechnology Patent Law, Carrie F. Walter

Indiana Law Journal

No abstract provided.


Pregnant With Ambiguity: Credibility And The Pto Utility Guidelines In Light Of Brenner, Andrew T. Kight Jul 1998

Pregnant With Ambiguity: Credibility And The Pto Utility Guidelines In Light Of Brenner, Andrew T. Kight

Indiana Law Journal

No abstract provided.


The Role Of Riparian Water Law In Protecting Biodiversity: An Indiana (Usa) Case Study, Robert L. Fischman Jan 1997

The Role Of Riparian Water Law In Protecting Biodiversity: An Indiana (Usa) Case Study, Robert L. Fischman

Articles by Maurer Faculty

This article discusses how the rules affecting the use of surface water ground water in a typical riparian state, Indiana, can promote the conservation biological diversity. The article first surveys the basic water laws that apply to surface water, diffused surface water, underground streams, and ground water. The rules governing the uses of these waters originate in common law property doctrines and substantially clarified by state legislation. Next the article considers state administration of water. The article examines regulatory tools and administrative opportunities control uses of water in a manner that protects biodiversity. Programs requiring permits for construction in floodplains, …