Digital Commons Network^™

Data Exclusivities In The Age Of Big Data, Biologics, And Plurilaterals, Peter K. Yu

Peter K. Yu

The past decade has seen many new developments impacting the intellectual property system. The introduction of big data analytics has transformed the fields of biotechnology and bioinformatics while ushering in major advances in drug development, clinical practices, and medical financing. The arrival of biologics and personalized medicines has also revolutionized the healthcare and pharmaceutical industries. In addition, the emergence of bilateral, regional, and plurilateral trade agreements have raised serious, and at times difficult, questions concerning the evolution of domestic and international intellectual property standards.

One topic linking all three developments together concerns the establishment of international standards to protect clinical …

The Rutabaga That Ate Pittsburgh: Federal Regulation Of Free Release Biotechnology, Michael P. Vandenbergh

Michael Vandenbergh

When the Environmental Protection Agency (EPA) first approved a field test of a bioengineered microbe,' one EPA official remarked: "We're not expecting this to be the rutabaga that eats Pittsburgh.' 2 But regulators cannot afford to be wrong. Bioengineered microbes may serve many useful purposes, but they may also cause harm to the environment and to human health.3 Although the risks of an accident stemming from the deliberate release of bioengineered microbes into the environment may be low, the resulting damage could be substantial. This note examines the possible consequences of two recent trends in biotechnology-the development of bioengineered microbes …

Emerging Drivers And Business Models For Equipment Reuse And Remanufacturing In The Us Lessons From The Biotech Industry-2017.Pdf, Vesela R. Veleva, Gavin Bodkin

Vesela Veleva

Preparing The Groundwork For A Responsible Debate On Stem Cell Research And Human Cloning, O. Carter Snead

O. Carter Snead

The debate over both cloning and stem cell research has been intense and polarizing. It played a significant role in the recently completed presidential campaign, mentioned by both candidates on the stump, at both parties' conventions, and was even taken up directly during one of the presidential debates. The topic has been discussed and debated almost continuously by the members of the legal, scientific, medical, and public policy commentariat. I believe that it is a heartening tribute to our national polity that such a complex moral, ethical, and scientific issue has become a central focus of our political discourse. But, …

Opinion Letter As To The Patentability Of Certain Inventions Associated With The Identification Of Partial Dna Sequences, Rebecca S. Eisenberg, Robert P. Merges

Robert P Merges

No abstract provided.

Reply To Comments On The Patentability Of Certain Inventions Associated With The Identification Of Partial Cdna Sequences, Rebecca S. Eisenberg, Robert P. Merges

Robert P Merges

No abstract provided.

Genetically Engineered Plant Pesticides: Recent Developments In The Epa's Regulation Of Biotechnology, Mary Jane Angelo

Mary Jane Angelo

This paper examines the EPA's new policy regulating plant pesticides and presents the legal, scientific and policy issues surrounding the regulation of genetically engineered plants. Part I introduces the concepts covered in this paper. Part II.A. discusses products that have originated from biotechnology. Part II.B. describes the EPA's legal authority for regulating plant pesticides and other biotechnology products. Part II.C. presents the history of federal regulation of biological pesticides and biotechnology products. Part III examines the controversy surrounding the use of genetically engineered plants, including the potential risks and benefits of genetically engineered plants and the public's perception of these …

Is The Turkey Halal? Genetically Modified Animal Feed Regulation Where East Meets West, Jennifer Spreng

Jennifer E Spreng

Turkey’s Biosafety Law (2010) imposes some of the world’s most stringent restrictions on the import, release and marketing of genetically modified foodstuffs. The Biosafety Board has not approved a single food event; the Council of State has suspended approval of MON 810; Turks have endured meat and milk price spikes; herders are going bankrupt for lack of affordable feed; and importers have been arrested and prosecuted for trace contamination with unapproved GMOs. It’s a pox an all their houses: Turks want nothing do with GM foodstuffs.

The culprit? The “precautionary principle,” which authorizes taking precautions in the face of scientific …

Maintaining Competition In Copying: Narrowing The Scope Of Gene Patents, Oskar Liivak

Oskar Liivak

In supporting gene patents, the patent office, the courts and other supporters have assumed that gene discoveries are identical to traditional inventions and therefore the patent system should treat them as identical. In other words, they have assumed that the relatively broad claims that are used for traditional inventions are also appropriate for encouraging gene discovery. This article examines this assumption and finds that gene discoveries are critically different from traditional inventions and concludes that the patent system cannot treat them as identical.

As a doctrinal matter, this article applies the generally overlooked constitutional requirements of inventorship and originality and …

Patents, Genetically Modified Foods, And Ip Overreaching, Elizabeth A. Rowe

Elizabeth A Rowe

Genetically engineered plants and animals have become and will continue to constitute a large part of the food we consume. The United States is the world's largest producer of genetically modified foods, making American consumers the most exposed population to these products. Agricultural biotechnology patents spur and support innovation. Accordingly, patent law is one of the main contributors to this phenomenon that has changed not only the kinds of food we eat, but the nature of the agri-business industry that produces these foods. This Article takes on an area of concern involving the patenting of food that has remained unexplored: …

Transgenesis In Animal Agriculture: Addressing Animal Health And Welfare Concerns, Michael Greger

Michael Greger, MD, FACLM

The US Food and Drug Administration’s final Guidance for Industry on the regulation of transgenesis in animal agriculture has paved the way for the commercialization of genetically engineered (GE) farm animals. The production-related diseases associated with extant breeding technologies are reviewed, as well as the predictable welfare consequences of continued emphasis on prolificacy at the potential expense of physical fitness. Areas in which biotechnology could be used to improve the welfare of animals while maintaining profitability are explored along with regulatory schema to improve agency integration in GE animal oversight.

Trait Selection And Welfare Of Genetically Engineered Animals In Agriculture, Michael Greger

Michael Greger, MD, FACLM

The release of the Final Guidance from the US Food and Drug Administration on the commercialization of genetically engineered animals has sparked renewed discussion over the ethical, consumer, and regulatory implications of transgenesis in animal agriculture. Animal welfare critiques have focused on unexpected phenotypic effects in animals used in transgenic research, rather than on the health and welfare implications of the intended productivity enhancement. Unless breeding goals are redefined to reflect social concerns, the occurrence and magnitude of undesirable side effects may increase and consumer confidence in the nascent technology may be undermined.

A False Start? The Impact Of Federal Policy On The Genotechnology Industry, Michael J. Malinowski, Maureen A. O'Rourke

Michael J. Malinowski

No abstract provided.

Globalization Of Biotechnology And The Public Health Challenges Accompanying It, Michael J. Malinowski

Michael J. Malinowski

No abstract provided.

Anticipating The Storm: Predicting And Preventing Global Technology Conflicts, Sabrina Safrin

Sabrina Safrin

This article helps lay the foundation for a new field of international law — International Law and Technology — and opens novel avenues of inquiry in law and technology and intellectual property more broadly. It analyzes as a starting point why some technologies generate global conflicts while others do not. Technologies that face international resistance can trigger a barrage of international legal responses, ranging from trade bans and WTO disputes to international regulatory regimes and barriers to patenting. Agricultural biotechnology triggered all of these legal flashpoints, while the cellphone, a technology that grew up alongside it, triggered none. Why?

Understanding …

Patent Trolling--Why Bio & Pharmaceuticals Are At Risk, Robin C. Feldman, W. Nicholson Price Ii

Robin C Feldman

Understanding Biopharmaceutical Employment Growth In North Carolina: A "Working Regions" Approach, Laura Wolf-Powers

Laura Wolf-Powers

Scholars of the life sciences industry argue that spatial linkages between research and production have been critical to the growth of the biotechnology and biopharmaceutical sectors. (Feldman and Ronzio, 2001, 2006; Pisano, 1997). More recently, work by Jennifer Clark has suggested that firms in innovation-intensive industries gain competitive advantage from localized supply chains and close control over the manufacturing process. Clark contends that the co-location of design and production makes for regional economies that are innovative and resilient as well as more socially equitable (2013).

Because it has been difficult to understand spatial relationships between manufacturing and R&D using establishment …

Patents For Chemicals, Pharmaceuticals And Biotechnology: Fundamentals Of Global Law, Practice And Strategy By Philip W. Grubb, Michael J. Malinowski

Michael J. Malinowski

No abstract provided.

Taking Genomics To The Bio Bank: Access To Human Biological Samples And Medical Information, Michael J. Malinowski

Michael J. Malinowski

No abstract provided.

Patents And The University, Peter Lee

Peter Lee

This Article advances two novel claims about the internalization of academic science within patent law and the concomitant evolution of “academic exceptionalism.” Historically, relations between patent law and the university were characterized by mutual exclusion, based in part on normative conflicts between academia and exclusive rights. These normative distinctions informed “academic exceptionalism”—the notion that the patent system should exclude the fruits of academic science or treat academic entities differently than other actors—in patent doctrine. As universities began to embrace patents, however, academic science has become internalized within the traditional commercial narrative of patent protection. Contemporary courts frequently invoke universities’ commercial …

Politicizing Patents - Patenting Biotechnology In The Wake Of Section 33, Prometheus, And Cls Bank, Jonathan R. K. Stroud

Jonathan R. K. Stroud

Tucked into the America Invents Act is the first statutory exemption for any patentable subject matter. Section 33 renders unpatentable all claims “encompassing a human being.” By recognizing a vague subject matter – exception for human beings despite the fact that internal policies had long militated against such patent claims, Congress has politicized the patent law to an unheard-of degree. While textually consistent with internal USPTO policy, the passage of § 33 should not be seen as an invitation to litigators to expand § 101 unpatentable-subject-matter challenges to validity by including arguments that medical methods, genetic tests, biological chimeras, or …

“The Problem Of Science” In Nietzsche And Heidegger, Babette Babich

Babette Babich

Nietzsche and Heidegger pose important philosophical questions to science and its technological projects. The resultant contributes to what may be called a continental philosophy of science and I argue that only such a rigorously critical approach to the question of science permits a genuinely philosophical reflection on science. The resultant contributes to what may be called a continental philosophy of science and I argue that only such a rigorously critical approach to the question of science permits a genuinely philosophical reflection on science. More than a thoughtful reflection on science, however, the heart of philosophy is also at stake in …

Human-Capital-Centred Regionalism In Economic Development: A Case Of Analytics Outpacing Institutions?, Laura Wolf-Powers

Laura Wolf-Powers

Identification Of Stable Genetic Networks Using Convex Programming, Michael M. Zavlanos, A. Agung Julius, Stephen P. Boyd, George J. Pappas

George J. Pappas

Gene regulatory networks capture interactions between genes and other cell substances, resulting in various models for the fundamental biological process of transcription and translation. The expression levels of the genes are typically measured in mRNA concentrations in micro-array experiments. In a so called genetic perturbation experiment, small perturbations are applied to equilibrium states and the resulting changes in expression activity are measured. This paper develops a novel algorithm that identifies a sparse stable genetic network that explains noisy genetic perturbation experiments obtained at equilibrium. Our identification algorithm can also incorporate a variety of possible prior knowledge of the network structure, …

Identification Of Stable Genetic Networks Using Convex Programming, Michael M. Zavlanos, A. Agung Julius, Stephen P. Boyd, George J. Pappas

George J. Pappas

Gene regulatory networks capture interactions between genes and other cell substances, resulting in various models for the fundamental biological process of transcription and translation. The expression levels of the genes are typically measured in mRNA concentrations in micro-array experiments. In a so called genetic perturbation experiment, small perturbations are applied to equilibrium states and the resulting changes in expression activity are measured. This paper develops a novel algorithm that identifies a sparse stable genetic network that explains noisy genetic perturbation experiments obtained at equilibrium. Our identification algorithm can also incorporate a variety of possible prior knowledge of the network structure, …

Identification Of Stable Genetic Networks Using Convex Programming, Michael M. Zavlanos, A. Agung Julius, Stephen P. Boyd, George J. Pappas

George J. Pappas

Gene regulatory networks capture interactions between genes and other cell substances, resulting in various models for the fundamental biological process of transcription and translation. The expression levels of the genes are typically measured in mRNA concentrations in micro-array experiments. In a so called genetic perturbation experiment, small perturbations are applied to equilibrium states and the resulting changes in expression activity are measured. This paper develops a novel algorithm that identifies a sparse stable genetic network that explains noisy genetic perturbation experiments obtained at equilibrium. Our identification algorithm can also incorporate a variety of possible prior knowledge of the network structure, …

Whose Body Is It Anyway? Human Cells And The Strange Effects Of Property And Intellectual Property Law, Robin C. Feldman

Robin C Feldman

Medical Alert: Alarming Challenges Facing Medical Technology Innovation, Lawrence M. Sung

Lawrence M. Sung

No abstract provided.

Gene Probes As Unpatentable Printed Matter, Andrew Chin

Andrew Chin

In this Article, I argue that the most problematic kind of gene patents — those claiming short DNA molecules used to probe for longer gene sequences — should be held invalid as directed to unpatentable printed matter. This argument, which emerges from recent developments in biotechnology and information technology, is grounded in the printed matter doctrine’s structural role of obviating patentability inquiries directed to inapposite information-management considerations. Where the inventive contribution in a claimed gene probe subsists solely in stored sequence information, these inapposite considerations lead the novelty and nonobviousness analyses to anomalous results that the printed matter doctrine was …

The Intellectual Property Landscape For Ips Cells, Robin C. Feldman

Robin C Feldman