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Minding The Gaps In Regulation Of Do-It-Yourself Biotechnology, Barbara J. Evans Jan 2020

Minding The Gaps In Regulation Of Do-It-Yourself Biotechnology, Barbara J. Evans

UF Law Faculty Publications

This Symposium confronts the reality that genetic technologies – not just genetic tests, but tools for altering plant, animal, and human genomes – are rapidly becoming and indeed already are consumer technologies. People can experiment with and apply these technologies in disintermediated formats, potentially without the involvement of national research funding agencies, professional scientists, physicians, genetic counselors, regulators, and traditional medical product manufacturers. The framework of 20th -century medical product and practice regulations assigned each of these parties a role in promoting ethical, safe, and effective biomedical research and health care. Do-it-yourself biotechnology (DIYbio), which includes direct-to-consumer (DTC) and do-it-yourself …


Constitutionalizing Nature's Law: Dignity And The Regulation Of Biotechnology In Switzerland, James Toomey Jan 2020

Constitutionalizing Nature's Law: Dignity And The Regulation Of Biotechnology In Switzerland, James Toomey

Elisabeth Haub School of Law Faculty Publications

The Swiss Constitution was amended by referendum in 1992 to include two unique provisions: Article 119, which imposes strict limits on genetic and reproductive technologies in humans in order to protect ‘human dignity’, and Article 120, which commits the Swiss federal government to limiting genetic technologies in non-human species on the basis of the ‘dignity of the creature’. This article analyzes the role of ‘dignity’ as a limit on biotechnologies in the Swiss constitutional order. It concludes that the understanding of dignity the constitution embraces codifies a contestable metaphysical theory of value at the constitutional level. Specifically, the Swiss constitutional …


Ajinomoto V. Itc, The Doctrine Of Equivalents, And Biomolecule Claim Limitations At The Federal Circuit, Christopher M. Holman Jan 2020

Ajinomoto V. Itc, The Doctrine Of Equivalents, And Biomolecule Claim Limitations At The Federal Circuit, Christopher M. Holman

Faculty Works

The doctrine of equivalents (DOE) allows a court to hold an accused infringer liable for patent infringement in spite of the fact that the accused product (or process) does not fall within the literal scope of the asserted patent claim(s). Prosecution history estoppel (PHE), which can be triggered by a narrowing amendment of a patent claim during patent prosecution, or by arguments made during prosecution, imposes significant constraints on the ability of a patentee to assert the DOE. The 1990s and early 2000’s saw a proliferation of legal commentary postulating that the DOE would play an important role in protecting …