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Full-Text Articles in Law

United States Food Law Update: Moving Toward A More Balanced Food Regulatory Regime, A. Bryan Endres, Nicholas R. Johnson Jul 2021

United States Food Law Update: Moving Toward A More Balanced Food Regulatory Regime, A. Bryan Endres, Nicholas R. Johnson

Journal of Food Law & Policy

For decades, the federal government has played a significant role in promoting healthy eating. In the early 1900s, the United States Department of Agriculture (USDA) promoted a foundational diet of milk, proteins, fruits and vegetables, and grains. Most Americans are at least somewhat familiar, although perhaps confused, with the more nuanced healthy eating recommendations contained in the food pyramid - first employed in 1992. And virtually every American has experienced the federally supported school lunch program. In the first half of 2011, these two iconic programs underwent significant change as part of a stepped-up effort to improve the health of the ...


Association For Molecular Pathology V. Myriad Genetics: A Critical Reassessment, Jorge L. Contreras Jan 2021

Association For Molecular Pathology V. Myriad Genetics: A Critical Reassessment, Jorge L. Contreras

Michigan Technology Law Review

The Supreme Court’s 2013 decision in Association for Molecular Pathology v. Myriad Genetics is an essential piece of the Court’s recent quartet of patent eligibility decisions, which also includes Bilski v. Kappos, Mayo v. Prometheus, and Alice v. CLS Bank. Each of these decisions has significantly shaped the contours of patent eligibility under Section 101 of the Patent Act in ways that have been both applauded and criticized. The Myriad case, however, was significant beyond its impact on Section 101 jurisprudence. It was seen, and litigated, as a case impacting patient rights, access to healthcare, scientific freedom, and ...


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.


Feeding The World: How Changes In Biotech Regulation Can Jump-Start The Second Green Revolution And Diversify The Agricultural Industry, John A. Erwin, Robert Glennon May 2020

Feeding The World: How Changes In Biotech Regulation Can Jump-Start The Second Green Revolution And Diversify The Agricultural Industry, John A. Erwin, Robert Glennon

William & Mary Environmental Law and Policy Review

As the Earth’s population climbs from 7.7 billion in 2019 to almost 10 billion by mid-century, farmers will need to increase food production by 70 percent. This Article analyzes the tools available to achieve this demanding goal. We assess changes in agriculture related to both the organic industry and the high-tech sector that are enabling farmers to become more efficient. Critically, biotechnology offers great promise to hasten the pace of increased agricultural efficiency through genetic engineering. While genetic modification has been controversial, we cannot exclude any viable policy option, especially one with so much promise. Yet the current ...


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 ...


Biotechnology Patent Law Top Ten Of 2018 Broad Wins, Sovereignty Loses, And Patent Dance, Kevin E. Noonan, Andrew W. Torrance Jul 2019

Biotechnology Patent Law Top Ten Of 2018 Broad Wins, Sovereignty Loses, And Patent Dance, Kevin E. Noonan, Andrew W. Torrance

Akron Law Review

In this article, we discuss what we consider to be the ten important and influential biotechnology patent law judicial decisions of 2018. These hinged on a variety of patent doctrines. An abbreviated new drug application (ANDA) for the multiple sclerosis drug Ampyra set the stage for the Acorda Therapeutics, Inc. v. Roxane Laboratories, Inc. (Fed. Cir. 2018) decision, in which the Court of Appeals for the Federal Circuit (Federal Circuit) provided guidance on how to conduct an obviousness analysis (35 U.S.C. §103). The Berkheimer v. HP Inc. (Fed. Cir. 2018) decision, although addressing a software invention, provided valuable ...


Data Exclusivities In The Age Of Big Data, Biologics, And Plurilaterals, Peter K. Yu Mar 2019

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 ...


Is Dna Really A Natural Product? It's Time To Separate Fact From (Legal) Fiction: An Examination Of Dna Patentability As A Biological Algorithm In The Post-Myriad Era, Nicholas Ulen Feb 2019

Is Dna Really A Natural Product? It's Time To Separate Fact From (Legal) Fiction: An Examination Of Dna Patentability As A Biological Algorithm In The Post-Myriad Era, Nicholas Ulen

Chicago-Kent Law Review

In 2013, the United States Supreme Court delivered its landmark decision in Ass’n for Molecular Pathology v. Myriad Genetics, Inc., holding isolated DNA unpatentable, thereby invalidating the claims of thousands of DNA patents in the process. The opinion, delivered by Justice Thomas, reasoned that the act of separating DNA from the body did not sufficiently transform the molecule beyond what naturally exists. Yet the Court found that line to be crossed when it held certain artificially synthesized complementary DNA molecules coding for the exact same gene patentable. Unlike the Federal Circuit, the Court focused its analysis not on the ...


The Ethics Of Big Data In Genomics: The Instructive Icelandic Saga Of The Incidentalome, Donna M. Gitter Jan 2019

The Ethics Of Big Data In Genomics: The Instructive Icelandic Saga Of The Incidentalome, Donna M. Gitter

Washington University Global Studies Law Review

DeCODE Genetics, Inc., a pioneering Icelandic biotech firm, recently introduced a free website that permits Icelanders to learn whether they carry mutations in the BRCA2 gene that are known to increase cancer risk, even if these citizens have never participated in genetic testing. Approximately five thousand Icelanders have elected thus far to receive their status. This site is made possible by the consanguinity of Icelandic citizens, who number fewer than 350,000, and their detailed genealogical records dating back centuries, a set of circumstances that presents a unique opportunity to study genetic mutations and the medical disorders associated with them ...


Data Exclusivities In The Age Of Big Data, Biologics, And Plurilaterals, Peter K. Yu Jan 2019

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

Texas A&M Law Review

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 Dec 2018

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 ...


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 ...


A Prescription For Biopharmaceutical Patents: A Cure For Inter Partes Review Ailments, Alex A. Jurisch Sep 2018

A Prescription For Biopharmaceutical Patents: A Cure For Inter Partes Review Ailments, Alex A. Jurisch

Seattle University Law Review

The patent system in the United States was forever changed with the introduction of the Leahy-Smith America Invents Act (AIA) in September of 2011. The AIA brought sweeping changes to American patent law in order to align the U.S. with much of the rest of the world by changing the invention priority from a “first to invent” to a “first to file” system. The first section of this note will provide a brief overview of the substance of inter partes reviews and some of the most critical negatives that have become apparent since 2013. The second section of this ...


Emerging Governance Of Mitochondrial Replacement Therapy: Assessing Coherence Between Scientific Evidence And Policy Outcomes, Katherine Drabiak May 2018

Emerging Governance Of Mitochondrial Replacement Therapy: Assessing Coherence Between Scientific Evidence And Policy Outcomes, Katherine Drabiak

DePaul Journal of Health Care Law

In the fall of 2016, media headlines reported news of several births of children born through “three parent IVF” or mitochondrial replacement therapy (MRT). MRT refers to an experimental procedure that entails removing the nuclear DNA from the mother’s egg or fertilized zygote and transferring it to a donor’s egg or fertilized zygote. This procedure constitutes a modification of the human germline, which has been prohibited by numerous declarations, directives, and laws promulgated by the United Nations, the Council of Europe, and other nations. In 2016, the Human Fertilisation and Embryology Authority in the United Kingdom was the ...


State Biotechnology Oversight: The Juncture Of Technology, Law, And Public Policy, Christine C. Vito Ph.D. May 2018

State Biotechnology Oversight: The Juncture Of Technology, Law, And Public Policy, Christine C. Vito Ph.D.

Maine Law Review

In a 1980 landmark decision, the Supreme Court of the United States ruled that genetically engineered lifeforms such as bacteria were patentable. The significance of this decision to the emerging biotechnology industry—an industry predicated on intellectual property rights—was incalculable. The characteristically research-intensive, capital-intensive biotechnology industry now had the economic incentive to push the technology of genetic engineering to previously unimagined extremes. The genetic engineering and recombinant DNA applications pursued by the biotechnology industry over the past ten years have engendered a spectrum of perplexing inquiries concerning ethical and moral values; agricultural, ecological and environmental matters; global competitiveness and ...


Intellectual Property, Surrogate Licensing, And Precision Medicine, Jacob S. Sherkow, Jorge L. Contreras Apr 2018

Intellectual Property, Surrogate Licensing, And Precision Medicine, Jacob S. Sherkow, Jorge L. Contreras

IP Theory

The fruits of the biotechnology revolution are beginning to be harvested. Recent regulatory approvals of a variety of advanced therapies—Keytruda (pembrolizumab), Kymriah (tisagenlecleucel), and patisiran—have ushered in an age of “precision medicine” treatments that target patients’ specific genetic, physiological, and environmental profiles rather than generalized diagnoses of disease. Therapies like these may soon be supplemented by gene editing technologies such as CRISPR, which could enable the targeted eradication of deleterious genetic variants to improve human health. But the intellectual property (IP) surrounding precision therapies and their foundational technology remain controversial. Precision therapies ultimately rely—and are roughly congruent ...


Patent Infringement In Personalized Medicine: Limitations Of The Existing Exemption Mechanisms, Jiyeon Kim Jan 2018

Patent Infringement In Personalized Medicine: Limitations Of The Existing Exemption Mechanisms, Jiyeon Kim

Washington University Law Review

Mr. X suffers from recurrent glioblastoma, a type of deadly brain cancer. One of his physicians reads a study reporting a novel immunotherapy, which uses the chimeric antigen receptor T cell (CAR-T) technology, leading to regression of glioblastoma in a small number of patients. Although the therapy has recently been approved by the U.S. Food and Drug Administration (FDA) and is now offered by two major pharmaceutical companies, it is only approved for certain hematological cancers. In addition, Mr. X’s cancer does not express the biomarker that is necessary for the CAR-T therapy used in the published glioblastoma ...


The Uneasy Case For Patent Law, Rachel E. Sachs Jan 2018

The Uneasy Case For Patent Law, Rachel E. Sachs

Michigan Law Review

A central tenet of patent law scholarship holds that if any scientific field truly needs patents to stimulate progress, it is pharmaceuticals. Patents are thought to be critical in encouraging pharmaceutical companies to develop and commercialize new therapies, due to the high costs of researching diseases, developing treatments, and bringing drugs through the complex, expensive approval process. Scholars and policymakers often point to patent law’s apparent success in the pharmaceutical industry to justify broader calls for more expansive patent rights.

This Article challenges this conventional wisdom about the centrality of patents to drug development by presenting a case study ...


Open Source Approaches In Biotechnology: Utopia Revisited, Yann Joly Nov 2017

Open Source Approaches In Biotechnology: Utopia Revisited, Yann Joly

Maine Law Review

Tracing its origin to Greek antiquity, intellectual property has become an institution in modern legal systems worldwide. This growing importance of intellectual property was confirmed with the 1994 adoption of the Trade-Related Aspects of Intellectual Property Rights Agreement by the World Trade Organization (WTO), which harmonized the rules of intellectual property amongst the various members of the international community on the model of developed countries. However enshrined in the legal tradition, intellectual property law has also had its share of detractors and has recently come under severe criticism. The exercise of intellectual property rights in such diverse fields of creation ...


A Virtue-Centered Approach To The Biotechnology Commons (Or, The Virtuous Penguin), David W. Opderbeck Nov 2017

A Virtue-Centered Approach To The Biotechnology Commons (Or, The Virtuous Penguin), David W. Opderbeck

Maine Law Review

The instrumentalist emphasis of the current biotechnology intellectual property rights (IPR) debate is not surprising. In the American tradition, intellectual property law has long been justified primarily by instrumentalist concerns. Thomas Jefferson famously acceded to the “embarrassment of patent and copyright monopolies because he believed a limited monopoly would encourage the production of new scholarship and inventions. The framers' willingness to allow this embarrassment for the greater good is enshrined in the Intellectual Property Clause of the U.S. Constitution. Countless judicial opinions refer to intellectual property law as a tool that provides necessary incentives to creators and innovators. Intellectual ...


Adoption Of The Bayh-Dolye Act In Developed Countries: Added Presure For A Broad Research Exemption In The United States?, Michael S. Mireles Nov 2017

Adoption Of The Bayh-Dolye Act In Developed Countries: Added Presure For A Broad Research Exemption In The United States?, Michael S. Mireles

Maine Law Review

Numerous developed countries, most if not all members of the Organization of Economic Cooperation and Development (OECD), including Japan, France, the United Kingdom, Germany, Austria, Denmark, Norway, Portugal, Spain, and Finland, have or are considering adopting legislation similar to the Bayh-Dole Act. These countries apparently believe that passage of legislation similar to the Bayh-Dole Act will lead to the transfer of government funded research results from the university laboratory to the marketplace and other economic activity. In the United States, the birthplace of the Bayh-Dole Act (the Act), it is not entirely clear whether its passage is the direct result ...


Salmon With A Side Of Genetic Modification: The Fda’S Approval Of Aquadvantage Salmon And Why The Precautionary Principle Is Essential For Biotechnology Regulation, Kara M. Van Slyck Oct 2017

Salmon With A Side Of Genetic Modification: The Fda’S Approval Of Aquadvantage Salmon And Why The Precautionary Principle Is Essential For Biotechnology Regulation, Kara M. Van Slyck

Seattle University Law Review

This Note seeks to address the issues concerning the FDA’s approval of genetically modified salmon for consumption, arguing that the FDA did not properly vet AquAdvantage salmon, as well as relied on inappropriate criteria in their approval of its market use. Part I provides a brief history of AquAdvantage salmon’s introduction to U.S. markets and the legal actions taken in response to the FDA ruling. Part II discusses the statutes and regulations fundamentally relevant to GE products, as well as a critique of the way each regulation was used to approve AquAdvantage. Part III offers a comparison ...


Balancing Open Source Paradigms And Traditional Intellectual Property Models To Optimize Innovation, Lisa M. Mandrusiak Oct 2017

Balancing Open Source Paradigms And Traditional Intellectual Property Models To Optimize Innovation, Lisa M. Mandrusiak

Maine Law Review

Copyrights and patents grant property rights to creators and inventors in order to spur further innovation through the dual approach of increasing the amount of material in the public domain and rewarding inventors and creators for their efforts. However, in recent years, it has been postulated that extensive granting of copyrights and patents may in fact stifle additional creation and development. This led to a revolt in the computer programming industry and spawned the open source movement, which provides software with its source code and a license allowing for free creation and distribution of works. This movement attempts to spur ...


The European Patent Office And The European Patent: An Open Avenue For Biotechnologists And "Living Inventions", Katrina Mcclatchey Sep 2017

The European Patent Office And The European Patent: An Open Avenue For Biotechnologists And "Living Inventions", Katrina Mcclatchey

Oklahoma Journal of Law and Technology

No abstract provided.


Agricultural Biogechnology: United States Statutory Law, Jo Lynn Jeter Sep 2017

Agricultural Biogechnology: United States Statutory Law, Jo Lynn Jeter

Oklahoma Journal of Law and Technology

No abstract provided.


The International Treaty On Plant Genetic Resources For Food And Agriculture: Friend Of The International Farmer, Steven M. Ruby Sep 2017

The International Treaty On Plant Genetic Resources For Food And Agriculture: Friend Of The International Farmer, Steven M. Ruby

Oklahoma Journal of Law and Technology

No abstract provided.


The Effect Of The "Onco-Mouse" Decisions On The Exception To Patentability For "Animal Varieties" Under The European Patent Convention, Katrina Mcclatchey Sep 2017

The Effect Of The "Onco-Mouse" Decisions On The Exception To Patentability For "Animal Varieties" Under The European Patent Convention, Katrina Mcclatchey

Oklahoma Journal of Law and Technology

No abstract provided.


Do The Evolution: The Effect Of Ksr V. Teleflex On Biotechnology, Josh Harrison Sep 2017

Do The Evolution: The Effect Of Ksr V. Teleflex On Biotechnology, Josh Harrison

Oklahoma Journal of Law and Technology

No abstract provided.


Patent Arbitration: The Underutilized Process For Resolving International Patent Disputes In The Pharmaceutical And Biotechnology Industries, Alessandra Emini Aug 2017

Patent Arbitration: The Underutilized Process For Resolving International Patent Disputes In The Pharmaceutical And Biotechnology Industries, Alessandra Emini

Arbitration Law Review

No abstract provided.


"Playing God?": An Examination Of The Legality Of Crispr Germline Editing Technology Under The Current International Regulatory Scheme And The Universal Declaration On The Human Genome And Human Rights, Brooke Elizabeth Hrouda Jun 2017

"Playing God?": An Examination Of The Legality Of Crispr Germline Editing Technology Under The Current International Regulatory Scheme And The Universal Declaration On The Human Genome And Human Rights, Brooke Elizabeth Hrouda

Georgia Journal of International & Comparative Law

No abstract provided.