Law Commons^™

What's Not Natural Phenomena? Let's Consider A Three-Step Innovative Concept Test For Composition Of Matter Claims, Sydney Hancock

IP Theory

Biotechnology innovation is rapidly growing, especially in the realm of biotech. This growth leads to questions about patent subject matter eligibility of natural phenomena. For example, currently the human genome and microbiome are being extensively studied, bacteriophages are being edited, animals are being cloned, and CRISPR is widespread. Additionally, composition of matter patent claims give the most protection to patent holders. Therefore, knowing when a natural phenomenon veers into human innovation is important for courts, lawyers, and innovators in the era of biotechnology and genetic engineering.

Part I discusses the history of Supreme Court cases on natural phenomena subject matter …

Patenting Genetic Information, David S. Olson, Fabrizio Ducci

Indiana Law Journal

The U.S. biotechnology industry got its start and grew to maturity over roughly three decades, beginning in the 1980s. During this period genes were patentable, and many gene patents were granted. University researchers performed basic research— often funded by the government—and then patented the genes they discovered with the encouragement of the Bayh-Dole Act, which sought to encourage practical applications of basic research by allowing patents on federally funded inventions and discoveries. At that time, when a researcher discovered the function of a gene, she could patent it such that no one else could work with that gene in the …

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 …

A Comparative Study Of Gmo Labeling And Liability Systems In The Us, Eu, And South Korea: The Circumstances And A Future Potential For Harmonization, Moonsook Park

Maurer Theses and Dissertations

With the remarkable development of GMOs, GMO trade has also increased. The different attitudes on GMOs among the countries all over the world, specifically the US, EU, and South Korea, have the potential to create international trade conflicts. In order to mediate the conflicts, reasonable labeling and liability systems need to be established to prevent potential GMO risks. The Biosafety Protocol regarding the transboundary movement of GMOs exists to resolve such tensions, but it fails to sufficiently solve the problems and provide clear regulations concerning GMO labeling and liability systems.

A successful GMO labeling and liability system should emphasize the …

Expanding Horizons: Scientific Frontiers, Legal Regulation And Globalization, Belinda Bennett

Indiana Journal of Global Legal Studies

In the six decades since the discovery of the double helix structure of DNA by Watson and Crick in 1953, developments in genetic science have transformed our understanding of human health and disease. These developments, along with those in other areas such as computer science, biotechnology, and nanotechnology, have opened exciting new possibilities for the future. In addition, the increasing trend for technologies to converge and build upon each other potentially increases the pace of change, constantly expanding the boundaries of the scientific frontier. At the same time, however, scientific advances are often accompanied by public unease over the potential …

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

Indiana Law Journal

No abstract provided.

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.

Biotechnology And Agriculture: The Common Wisdom And Its Critics, Mark Sagoff

Indiana Journal of Global Legal Studies

No abstract provided.

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

Indiana Journal of Global Legal Studies

No abstract provided.

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

Indiana Law Journal

No abstract provided.

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

Indiana Law Journal

No abstract provided.

Introduction: Emerging Paradigms In Bioethics Symposium, Roger B. Dworkin

Indiana Law Journal

Symposium: Emerging Paradigms in Bioethics

A Response To Beauchamp, David H. Smith

Indiana Law Journal

Symposium: Emerging Paradigms in Bioethics

Principles And Particularity: The Role Of Cases In Bioethics, John D. Arras

Indiana Law Journal

Symposium: Emerging Paradigms in Bioethics

Bioethics With A Human Face, Carl E. Schneider

Indiana Law Journal

Symposium: Emerging Paradigms in Bioethics

Paradigms And Our Shrinking Bioethics, Peter Cherbas

Indiana Law Journal

Symposium: Emerging Paradigms in Bioethihcs

Society And The Balance Of Professional Dominance, And Patient Autonomy In Medical Care, Bernice A. Pescosolido

Indiana Law Journal

Symposium: Emerging Paradigms in Bioethics

Are Principles Ever Properly Ignored? A Reply To Beauchamp Or Bioethical Paradigms, Karen Hanson

Indiana Law Journal

Symposium: Emerging Paradigms in Bioethics

Narrative And Casuistry: A Response To John Arras, Richard B. Miller

Indiana Law Journal

Symposium: Emerging Paradigms in Bioethics