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Biotechnology

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Full-Text Articles in Law

Adapting Federal Regulatory Approaches To Advances In Agricultural Biotechnology, Alan Sachs Jan 2021

Adapting Federal Regulatory Approaches To Advances In Agricultural Biotechnology, Alan Sachs

Maryland Law Review Online

No abstract provided.


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 (DIY) genomic ...


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 ...


The Gmo/Ge Debate, Joanna K. Sax Jan 2017

The Gmo/Ge Debate, Joanna K. Sax

Faculty Scholarship

The scientific community and the public sphere are having different debates about the application of genetic engineering to improve our food supply. Many that are deeply steeped in the science view genetically engineered food as a more precise way to accomplish what we have been doing for centuries, which is genetically modifying our food supply. Some members of the public view genetically engineered food with skepticism especially as it relates to health, safety and the environment. A disconnect between the scientific consensus and public perception is not a new phenomenon. This Article attempts to bridge this gap by explaining what ...


Intellectual Property Rights And The Ascent Of Proprietary Innovation In Agriculture, Matthew S. Clancy, Giancarlo Moschini Jan 2017

Intellectual Property Rights And The Ascent Of Proprietary Innovation In Agriculture, Matthew S. Clancy, Giancarlo Moschini

CARD Working Papers

Biological innovations in agriculture did not enjoy protection by formal intellectual property rights (IPRs) for a long time, but the recent trend has been one of considerable broadening and strengthening of these rights. We document the nature of these IPRs and their evolution, and provide an assessment of their impacts on innovation. We integrate elements of the institutional history of plant IPRs with a discussion of the relevant economic theory and a review of applicable empirical evidence. Throughout, we highlight how the experience of biological innovation mirrors, or differs from, the broader literature on IPRs and innovation. We conclude with ...


Crispr, Surrogate Licensing, And Scientific Discovery, Jorge Contreras, Jacob S. Sherkow Jan 2017

Crispr, Surrogate Licensing, And Scientific Discovery, Jorge Contreras, Jacob S. Sherkow

Other Publications

Several research institutions are embroiled in a legal dispute over the foundational patent rights to CRISPR-Cas9 gene-editing technology, and it may take years for their competing claims to be resolved. But even before ownership of the patents is finalized, the institutions behind CRISPR have wasted no time capitalizing on the huge market for this groundbreaking technology by entering into a series of licensing agreements with commercial enterprises. With respect to the potentially lucrative market for human therapeutics and treatments, each of the key CRISPR patent holders has granted exclusive rights to a spinoff or "surrogate" company formed by the institution ...


Inventive Steps: The Crispr Patent Dispute And Scientific Progress, Jacob S. Sherkow Jan 2017

Inventive Steps: The Crispr Patent Dispute And Scientific Progress, Jacob S. Sherkow

Other Publications

Recent decisions by patent offices in the USA and Europe concerning the revolutionary gene-editing technology, CRISPR/Cas9, have shed light on the importance — and puzzles — of one particular area of patent law: “nonobviousness”, as it known in the USA, or, in Europe, the “inventive step”. Patent law does not always neatly align itself with the realities of biological research. But these competing decisions from the U.S. Patent and Trademark Office and the European Patent Office have put those differences on parade. Unpacking these standards for CRISPR tell us a lot about how advances in biology are actually made — and ...


Patent Pacifism, Clark D. Asay Jan 2017

Patent Pacifism, Clark D. Asay

Faculty Scholarship

Over the last decade, much of the patent law literature has focused on the problem of “patent trolls,” or patent owners who don’t make products, but sue others that do. The basic complaint against these types of entities is that they impose a tax on innovation without providing offsetting societal benefits. Furthermore, their patent assertions have been on the rise, with a significant percentage of patent suits now attributable to them. In short, the troll phenomenon suggests a problem of excessive patent assertions.

But despite the importance of the troll phenomenon, the fact remains that most patents are never ...


Risk Regulation And Innovation: The Case Of Rights-Encumbered Biomedical Data Silos, Arti K. Rai Jan 2017

Risk Regulation And Innovation: The Case Of Rights-Encumbered Biomedical Data Silos, Arti K. Rai

Faculty Scholarship

Recent Supreme Court cases on patent-eligible subject matter are likely to exacerbate the longstanding problem of biomedical data fragmentation. For each data silo, multiple overlapping legal claims and claimants must be addressed to achieve the benefits of pooling.

Commentators who have discussed the data aggregation challenge have generally focused on possibilities created through public funding, through collective action by research participants, or through pressure by payers. This Article emphasizes the important role of risk regulators, most notably the precedent offered by risk regulation in the area of clinical trial data.

While U.S. risk regulators have taken some positive steps ...


Re-Framing Biotechnology Regulation, Alison Peck Jan 2017

Re-Framing Biotechnology Regulation, Alison Peck

Law Faculty Scholarship

Biotechnology is about to spill the banks of federal regulation. New genetic engineering techniques like CRISPR-Cas9 promise revolutionary breakthroughs in medicine, agriculture, and public health-but those techniques would not be regulated under the terms of the Coordinated Framework for Regulation of Biotechnology. This revolutionary moment in biotechnology offers an opportunity to correct the flaws in the framework, which was hastily patched together at the advent of the technology. The framework has never captured all relevant technologies, has never satisfied the public that risk is being effectively managed, and has never been accessible to small companies and publicly-funded labs that increasingly ...


Who Owns Gene Editing? Patents In The Time Of Crispr, Jacob S. Sherkow Jan 2016

Who Owns Gene Editing? Patents In The Time Of Crispr, Jacob S. Sherkow

Other Publications

New gene-editing technologies, like CRISPR, promise revolutionary advances in biology and medicine. However, several patent disputes in the USA and UK may have complicated who can use CRISPR. What does this mean for the future of gene editing?


Pursuit Of Profit Poisons Collaboration, Jacob S. Sherkow Jan 2016

Pursuit Of Profit Poisons Collaboration, Jacob S. Sherkow

Other Publications

The CRISPR–Cas9 patent battle demonstrates how overzealous efforts to commercialize technology can damage science.


Pursuit Of Profit Poisons Collaboration, Jacob S. Sherkow Jan 2016

Pursuit Of Profit Poisons Collaboration, Jacob S. Sherkow

Other Publications

The CRISPR–Cas9 patent battle demonstrates how overzealous efforts to commercialize technology can damage science.


Protecting Products Versus Platforms, Jacob S. Sherkow Jan 2016

Protecting Products Versus Platforms, Jacob S. Sherkow

Articles & Chapters

Patents have long been the most important legal assets of biotech companies. Increasingly, however, biotech firms find themselves on one side of a divide: as either traditional product companies or platform companies. Given the differences between these two types of business models, the merits of intellectual property (IP) protection vary between them. This article explores how those differences relate to biotech startups and entrepreneurs seeking to protect their inventions.


The Changing Life Science Patent Landscape, Arti K. Rai, Jacob S. Sherkow Jan 2016

The Changing Life Science Patent Landscape, Arti K. Rai, Jacob S. Sherkow

Articles & Chapters

Over the past two decades, patent law in the life sciences has been buffeted by numerous controversies. With courts, legislatures and patent offices all responding, one could be forgiven for believing that the main constant has been change. In the following article, we look back at some of the major events in life science intellectual property (IP) law and business practice over the past 20 years and then suggest where IP practice in the life sciences may be heading in the coming years.


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 ...


Diagnostics Need Not Apply, Rebecca S. Eisenberg Sep 2015

Diagnostics Need Not Apply, Rebecca S. Eisenberg

Articles

Diagnostic testing helps caregivers and patients understand a patient's condition, predict future outcomes, select appropriate treatments, and determine whether treatment is working. Improvements in diagnostic testing are essential to bringing about the long-heralded promise of personalized medicine. Yet it seems increasingly clear that most important advances in this type of medical technology lie outside the boundaries of patent-eligible subject matter. The clarity of this conclusion has been obscured by ambiguity in the recent decisions of the Supreme Court concerning patent eligibility. Since its 2010 decision in Bilski v. Kappos, the Court has followed a discipline of limiting judicial exclusions ...


Law, History And Lessons In The Crispr Patent Conflict, Jacob S. Sherkow Mar 2015

Law, History And Lessons In The Crispr Patent Conflict, Jacob S. Sherkow

Articles & Chapters

Predicting the outcome of the ongoing patent disputes surrounding genome-editing technology is equal parts patent analysis and history.

Genome-editing technology based on clustered, regularly interspaced, short palindromic repeats (CRISPR) and CRISPR associated protein 9 (Cas9) has generated great excitement in both academia and industry. But a potential patent dispute between two sets of inventors has left the biotech community pondering its fate. Understanding several facets of patent law and history may provide some lessons about the probable — and best — outcome for the dispute.


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.


Agricultural Biotechnology: Drawing On International Law To Promote Progress, J. Janewa Oseitutu Jan 2015

Agricultural Biotechnology: Drawing On International Law To Promote Progress, J. Janewa Oseitutu

Faculty Publications

In Bowman v. Monsanto, the Supreme Court declined to apply the principle of exhaustion to limit the patentee’s ability to control the reproduction of self-replicating inventions. This decision was justified from a patent law perspective on the basis that patent holder has a right to prevent others from making the invention. But what happens when we take other perspectives into account? For instance, a farmer might have human rights or other rights that may need to be balanced against the patentee’s right. Since globalized intellectual property standards were established through international agreements and much of the resistance to ...


When Condoms Fail: Making Room Under The Aca Blanket For Prep Hiv Prevention, Jason Potter Burda Jan 2015

When Condoms Fail: Making Room Under The Aca Blanket For Prep Hiv Prevention, Jason Potter Burda

Faculty Publications

Given the alarming upward trend in HIV infection rates and the downward trend in condom usage, we need a new approach to HIV prevention in the United States. One such approach, HIV Pre-Exposure Prophylaxis (commonly known as “PrEP”), has the potential to significantly reduce HIV incidence. The FDA recently approved a daily dose of Truvada® — an antiretroviral drug that suppresses the virus in HIV-positive individuals — for daily use by high-risk HIV-negative individuals to prevent infection. Despite an effectiveness above ninety percent and significant regulatory momentum, this pharmacological prevention modality has proven difficult to implement. In this Article, I address the ...


Myriad Stands Alone, Jacob S. Sherkow, Christopher T. Scott Jul 2014

Myriad Stands Alone, Jacob S. Sherkow, Christopher T. Scott

Articles & Chapters

Myriad took no prisoners on its way to the top of the molecular diagnostics field. That strategy is unlikely to endure.

Myriad Genetics began in 1991 as a small University of Utah startup interested in the then-novel arena of diagnostic genetic testing. After winning a highly publicized race to sequence the BRCA1 and BRCA2 breast cancer genes, the company obtained patents on the gene sequences and methods of using them to determine cancer risk. The patents were broad and interlocking, covering BRCA genomic DNA, cDNA, methods of diagnosis and systems detecting mutations. Myriad also filed for diagnostic 'toolbox' patents, including ...


The Costs Of Changing Our Minds, Nita A. Farahany Jan 2014

The Costs Of Changing Our Minds, Nita A. Farahany

Faculty Scholarship

This isn’t quite a draft yet – it’s a concept paper. You’ll see after the first 10 pages a good bit of text in brackets, which are primarily notes for me, but it’ll give you a sense of the content of those sections. I’d like to talk through the concept – the “duty” to mitigate emotional distress damages and how courts have struggled with it, as a foray into a broader dichotomy that I see in a number of areas of law that suggest an implicit value in “cognitive liberty.” This is a smaller version of a ...


Ecophilosophy And Communalist Utopian Novels: Do Bicycles And Biotechnology Go Together?, Anne L. Melano Jan 2013

Ecophilosophy And Communalist Utopian Novels: Do Bicycles And Biotechnology Go Together?, Anne L. Melano

Faculty of Law, Humanities and the Arts - Papers (Archive)

The period of social change from the 1960s to the 1980s saw a flowering of utopian novels, from Huxley's Island (1962) and Le Guin's The Dispossessed (1964) through to Callenbach's Ecotopia (1975) and Piercy's Woman on the Edge of Time (1976). These works were infused with a vision of an ideal world structured as a decentralised network of small villages or precincts. In each novel, local, participatory decision-making was the key to a utopian "good place" both for people and for ecological communities as a whole. The need to reharmonise with ecological systems saw a rejection ...


Is Anyone Regulating?: The Curious State Of Gmo Governance In The United States, Rebecca Bratspies Jan 2013

Is Anyone Regulating?: The Curious State Of Gmo Governance In The United States, Rebecca Bratspies

Publications and Research

No abstract provided.


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.


Politicizing Patents - Patenting Biotechnology In The Wake Of Section 33, Prometheus, And Cls Bank, Jonathan R. K. Stroud Jul 2012

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

Articles in Law Reviews & Journals

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 emerging cell and ...


Patents And Regulatory Exclusivity, Rebecca S. Eisenberg Apr 2012

Patents And Regulatory Exclusivity, Rebecca S. Eisenberg

Book Chapters

This article reexamines the sources of exclusivity for drugs, considers their limitations, and evaluates exclusivity under the new biologics legislation in light of these limitations. The current overlapping legal protections for exclusivity in the pharmaceutical marketplace reflect a series of political compromises, repeatedly renegotiated to correct for unintended consequences in the previous version of the rules. Patents and patent challenges play a central role in this system of protection, and many of the patents at stake are ultimately held invalid in litigation. It is not easy to untangle a complex legal regime that allocates billions of dollars of profits. But ...


Wisdom Of The Ages Or Dead-Hand Control? Patentable Subject Matter For Diagnostic Methods After In Re Bilski, Rebecca S. Eisenberg Jan 2012

Wisdom Of The Ages Or Dead-Hand Control? Patentable Subject Matter For Diagnostic Methods After In Re Bilski, Rebecca S. Eisenberg

Articles

In 1980, the Supreme Court gave a reassuring signal to the then-nascent biotechnology industry about the availability of patent protection for the fruits of its research when it upheld the patentability of a genetically modified living organism in Diamond v. Chakrabarty. Twenty-five years later, the Court seemed poised to reexamine the limits of patentable subject matter for advances in the life sciences when it granted certiorari in Laboratory Corporation v. Metabolite. But the Federal Circuit had not addressed the patentable subject matter issue in Laboratory Corporation, and the Court ultimately dismissed the certiorari p etition as improvidently granted. Five years ...


Patent Eligible Medical And Biotechnology Inventions After Bilski, Prometheus, And Myriad, Joshua Sarnoff Feb 2011

Patent Eligible Medical And Biotechnology Inventions After Bilski, Prometheus, And Myriad, Joshua Sarnoff

College of Law Faculty

In Bilski v. Kappos, the U.S. Supreme Court continued to require that patentable subject matter eligibility determinations under Section 101 be made by reference to three historic, categorical exclusions, for scientific principles, natural phenomena, and abstract ideas. This excluded subject matter must be treated as if already known even when newly discovered by the applicant. Unlike in other jurisdictions, the excluded subject matter thus cannot contribute creativity to the claimed inventions, either for eligibility or for patentability evaluations. The Federal Circuit has reluctantly applied eligibility doctrine after Bilski, holding in Prometheus v. Mayo that claims to treatment methods applying ...