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Full-Text Articles in Law
Minding The Gaps In Regulation Of Do-It-Yourself Biotechnology, Barbara J. Evans
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
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
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 …
Describing Drugs: A Response To Professors Allison And Ouellette, Jacob S. Sherkow
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
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 …
Stem Cell Patents After The America Invents Act, Jacob S. Sherkow, Christopher Scott
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.
Developments In Synthetic Biology Are Altering The Ip Imperatives Of Biotechnology, Christopher M. Holman
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 …
Federal Trade Commission V. Actavis, Inc. And Reverse-Payment Or Pay-For-Delay Settlements, Jacob S. Sherkow
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.
The Misperception That Bioethics And The Law Lag Behind Advances In Biotechnology, David Orentlicher
The Misperception That Bioethics And The Law Lag Behind Advances In Biotechnology, David Orentlicher
Scholarly Works
No abstract provided.