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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 …


Halted Innovation: The Expansion Of Federal Jurisdiction Over Medicine And The Human Body, Myrisha S. Lewis Dec 2018

Halted Innovation: The Expansion Of Federal Jurisdiction Over Medicine And The Human Body, Myrisha S. Lewis

Faculty Publications

Modern medical innovations are blurring the line between medical practice and medical devices and drugs. Historically, many techniques have been developed in medicine, without any interference from the federal government, as medical practice is (and has historically been) an area of state jurisdiction. Over the past two decades, however, the U.S. Food and Drug Administration (FDA) has been exerting jurisdiction over the human body and the practice of medicine by targeting new medical techniques for oversight and subjecting the continued use of those treatments to onerous and legally questionable regulatory requirements that hinder the use of those treatments in practice. …


Charting The Contours Of Copyright Regime Optimized For Engineered Genetic Code, Christopher M. Holman Jan 2017

Charting The Contours Of Copyright Regime Optimized For Engineered Genetic Code, Christopher M. Holman

Faculty Works

There is a growing disconnect between the traditional patent-centric approach to protecting biotechnological innovation and the emerging intellectual property imperatives of “synthetic biology,” a promising new manifestation of biotechnology that enables the design and construction of artificial biological pathways, organisms or devices, as well as the redesign of existing natural biological systems. As explained in previous articles, one way to deal with this disconnect would be to expand the scope of copyrightable subject matter to encompass engineered genetic sequences, much in the way that copyright was expanded in the 1970s and 1980s to include computer programs. The present article expands …


Use Of Facial Recognition Technology For Medical Purposes: Balancing Privacy With Innovation, Seema Mohapatra Jun 2016

Use Of Facial Recognition Technology For Medical Purposes: Balancing Privacy With Innovation, Seema Mohapatra

Pepperdine Law Review

Imagine applying for a job, and as part of your application process, your prospective employer asks for a photograph. You, as an eager candidate, comply with the request and, unbeknownst to you, the employer runs your picture through a software program that scans you for any common genetic diseases and that estimates your longevity. Alas, your face indicates that you may die young. No job for you. Although this sounds like science fiction, we may not be that far off from this scenario. In June 2014, scientists from Oxford reported that they have developed a facial recognition program that uses …


Describing Drugs: A Response To Professors Allison And Ouellette, Jacob S. Sherkow Jan 2016

Describing Drugs: A Response To Professors Allison And Ouellette, Jacob S. Sherkow

Articles & Chapters

Profs. Allison and Ouellette’s Article, How Courts Adjudicate Patent Definiteness and Disclosure, 65 Duke L.J.609 (2015), on courts’ adjudication of certain patent disputes presents some surprising data: pharmaceutical patents litigated to judgment fare substantially worse on written-description analyses if they are not part of traditional pioneer-generic litigation. This Response engages in several hypotheses for this disparity and examines the cases that make up Allison and Ouellette’s dataset. An analysis of these cases finds that the disparity can be best explained by technological and judicial idiosyncrasies in each case, rather than larger differences among pharmaceutical patent cases. This finding contextualizes …


Are Engineered Genetic Sequences Copyrightable?: The U.S. Copyright Office Addresses A Matter Of First Impression, Christopher M. Holman, Claes Gustafsson, Andrew W. Torrance Jan 2016

Are Engineered Genetic Sequences Copyrightable?: The U.S. Copyright Office Addresses A Matter Of First Impression, Christopher M. Holman, Claes Gustafsson, Andrew W. Torrance

Faculty Works

In spite of the compelling logic that would support extending copyright to engineered DNA sequences, copyright protection for genetic code has not been legally recognized in the US, or as far as we know anywhere. The Copyright Act is silent on the point, the courts do not appear to have ever addressed the question, and the Copyright Office has taken the position that an engineered genetic sequence is not copyrightable subject matter. In an attempt to advance the conversation, we submitted an engineered DNA sequence to the Copyright Office for registration, and then appealed the Office’s decision refusing to register …


Developments In Synthetic Biology Are Altering The Ip Imperatives Of Biotechnology, Christopher M. Holman Jan 2015

Developments In Synthetic Biology Are Altering The Ip Imperatives Of Biotechnology, Christopher M. Holman

Faculty Works

While the accomplishments of the biotechnology industry have been substantial, recent technological advances promise to dramatically increase the power and utility of the discipline over the coming years. The term “synthetic biology” has been coined to describe the application of these powerful new tools to the engineering of synthetic genetic sequences and organisms. In essence, synthetic biology represents the next iteration in the ongoing evolution of biotechnology, and hopes run high that in time, the fruits of synthetic biology will dwarf the past successes of conventional biotechnology. There is, however, some concern that the current patent-centric approach to Intellectual Property …


Stem Cell Patents After The America Invents Act, Jacob S. Sherkow, Christopher Scott Jan 2015

Stem Cell Patents After The America Invents Act, Jacob S. Sherkow, Christopher Scott

Articles & Chapters

Under the newly passed Leahy-Smith America Invents Act (AIA), the U.S. Patent and Trademark Office may hear new challenges to stem cell patents. Here, we explore how the new law affects challenges to stem cell patents, focusing on two recent cases, and discuss the future of stem cell patent disputes.


Federal Trade Commission V. Actavis, Inc. And Reverse-Payment Or Pay-For-Delay Settlements, Jacob S. Sherkow Jan 2013

Federal Trade Commission V. Actavis, Inc. And Reverse-Payment Or Pay-For-Delay Settlements, Jacob S. Sherkow

Articles & Chapters

An imminent US Supreme Court ruling should resolve one of the thorniest legal issues facing pharmaceutical companies today.


23andme Inc.: Patent Law And Lifestyle Genetics, Matthew Rimmer Dec 2012

23andme Inc.: Patent Law And Lifestyle Genetics, Matthew Rimmer

Matthew Rimmer

The venture, 23andMe Inc., raises a host of issues in respect of patent law, policy, and practice in respect of lifestyle genetics and personalised medicine. The company observes: ‘We recognize that the availability of personal genetic information raises important issues at the nexus of ethics, law, and public policy’. 23andMe Inc. has tested the boundaries of patent law, with its patent applications, which cut across information technology, medicine, and biotechnology. The company’s research raises fundamental issues about patentability, especially in light of the litigation in Bilski v. Kappos, Mayo Collaborative Services v. Prometheus Laboratories Inc. and Association for Molecular Pathology …


Could A Hub And Spoke, Homegrown Ceo Strategy Boost The Success Of University Start-Ups?, Brendan O. Baggot, Martin R. Graf Phd Mar 2012

Could A Hub And Spoke, Homegrown Ceo Strategy Boost The Success Of University Start-Ups?, Brendan O. Baggot, Martin R. Graf Phd

Brendan O. Baggot

How can universities make more money with their spinout company (SpinCo)‐suitable technologies? By “growing” their own CEOs to improve both the quality and quantity of startup company leaders available, that’s how. Surprisingly, however, at most universities little or no effort is made to interweave this critical need into tech transfer efforts.


Medical Alert: Alarming Challenges Facing Medical Technology Innovation, Lawrence M. Sung Apr 2011

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

Lawrence M. Sung

No abstract provided.


A Submission To The Senate Community Affairs Committee Inquiry Into Gene Patents, Matthew Rimmer Mar 2009

A Submission To The Senate Community Affairs Committee Inquiry Into Gene Patents, Matthew Rimmer

Matthew Rimmer

I am a senior lecturer and the associate director for research at the Australian National University College of Law based in Canberra, Australia. I am also an associate director of the Australian Centre for Intellectual Property in Agriculture (ACIPA). I have a BA (Hons) and a University Medal in literature, and a LLB (Hons) from the Australian National University, and a PhD in law from the University of New South Wales. I am a member of the Copyright and Intellectual Property Advisory Group of the Australian Library and Information Association, and a director of the Australian Digital Alliance. I am …


Stealing What's Free: Exploring Compensation To Body Parts Sources For Their Contribution To Profitable Biomedical Research, Jo-Anne Yau May 2006

Stealing What's Free: Exploring Compensation To Body Parts Sources For Their Contribution To Profitable Biomedical Research, Jo-Anne Yau

ExpressO

It is undisputed in the biotechnology industry that human body parts play a vital role in research. The body parts donors, referred to as "Sources" in this article, are subjected to physical and financial exploitation. Forbidding the explosion of profits from trickling down to the Source presents an irrational inequity. Despite established law, it is evident from case analysis, prevailing social practices, and constitutional interpretation that Source compensation is a plausible solution.

This article proposes a model of compensation for Sources, whereby Sources are compensated based on a proportionate share of the research profits set aside for the Source as …


The Misperception That Bioethics And The Law Lag Behind Advances In Biotechnology, David Orentlicher Jan 1999

The Misperception That Bioethics And The Law Lag Behind Advances In Biotechnology, David Orentlicher

Scholarly Works

No abstract provided.