Biotechnology Commons^™

Patenting Ai Discoveries In Life Sciences: Overcoming Eligibility, Disclosure, And Inventorship Challenges, Dhohyung Kim, Ryan P. Hiler

IP Theory

The pharmaceutical and biotechnology industries face transformative opportunities through artificial intelligence and machine learning integration. However, these technological advances create distinct patent law complications that traditional drug development does not encounter. This article analyzes three interconnected obstacles: establishing eligible subject matter under 35 U.S.C. § 101, meeting disclosure standards under § 112(a), and determining proper inventorship when AI systems contribute substantially to claimed inventions. Drawing from recent USPTO guidance and Federal Circuit precedent, this analysis offers evidence-based strategies for patent practitioners, research scientists, and business leaders seeking robust intellectual property protection for AI-integrated pharmaceutical innovations.

Agricultural Biotechnology In The Courts: Judicial Opinions And Commentary, Drew L. Kershen

Faculty Articles

Seven jurisdictions from around the world have issued judicial opinions that address fundamental issues about the governance and regulatory systems of agricultural biotechnology. This article summarizes these legal proceedings and describes their impact upon agricultural biotechnology. The article then provides a commentary and critique of the legal proceedings and resulting judicial opinions.

Let’S Be Cool About It: Anticipating Proper, Whole-Human Cryopreservation And The Necessary Oversight For Adequate Consumer Protection, Peter Lyon

Minnesota Journal of Law, Science & Technology

No abstract provided.

Genetic Property Rhetoric And The Public Domain, Dave Fagundes

Texas A&M Journal of Property Law

Among the many themes that illuminate Jorge Contreras’s The Genome Defense, this Essay focuses on property. It considers the rhetorical role played by property in convincing both courts and the public that patenting genetic data was legally and ethically objectionable. This Essay begins by locating property—and public property—as a major theme in the dialogue surrounding the Myriad litigation. It then situates this rhetorical move in the context of property-talk generally, highlighting the distinctiveness of leveraging public rather than private ownership as a means of accessing moral intuitions. Finally, this Essay reflects on what the use of public property rhetoric …

Revitalizing Biotechnological Advancement In The United States: Patent Eligibility Reform To Promote Innovation While Preserving Morality, Sydney Virtue

West Virginia Law Review

Patent protection has long been recognized as a key part of promoting innovation; however, current patent eligibility law in the United States often produces the exact opposite result. While the basic framework for patent eligibility is provided by the Patent Act, the United States Supreme Court has crafted several significant exceptions to patent eligibility—laws of nature, natural phenomena, and abstract ideas. These judicial exceptions have created a crisis in patent law and impeded biotechnological innovation, as they are too vague to be properly confined and carry tests that are too ambiguous for predictable application. To promote and retain world leadership …

Reducing Food Scarcity: The Benefits Of Urban Farming, S.A. Claudell, Emilio Mejia

Journal of Nonprofit Innovation

Urban farming can enhance the lives of communities and help reduce food scarcity. This paper presents a conceptual prototype of an efficient urban farming community that can be scaled for a single apartment building or an entire community across all global geoeconomics regions, including densely populated cities and rural, developing towns and communities. When deployed in coordination with smart crop choices, local farm support, and efficient transportation then the result isn’t just sustainability, but also increasing fresh produce accessibility, optimizing nutritional value, eliminating the use of ‘forever chemicals’, reducing transportation costs, and fostering global environmental benefits.

Imagine Doris, who is …

Brief For Professors Mary Ann Glendon And O. Carter Snead As Amici Curiae In Support Of Petitioners, Heather Gebelin Hacker, O. Carter Snead

Court Briefs

No. 19-1392
Thomas E. Dobbs v. Jackson Women's Health Organization

On Writ of Certiorari to the United States Court of Appeals for the Fifth Circuit

From the Summary of Argument

Mississippi’s 2018 Gestational Age Act, which prohibits abortions after 15 weeks gestational development (with exceptions for medical emergency or fetal abnormality) is quite modest in impact, more permissive than the vast majority of the laws on abortion around the world (including in all but three European nations), and appears to be broadly popular. But it seems to clearly violate the Supreme Court-made law of abortion, which forbids the State from …

Suspicion Encoded: Women Of Color And Biometric Technology In The United States, Lilith A. Saylor

sprinkle: an undergraduate journal of feminist and queer studies

This paper explores the commodification of privacy through biometric technology in the United States. It examines the impact of this technology on poor women of color (WOC), arguing that poor WOC face intersectional discrimination based on the convergence of sex, race, and class in their identities. I highlight the unique and powerful intrusion of biometric technology into the lives of poor WOC, and argue that the connection between data and the physical body created through biometric data has formed an environment in which the state wields unrestricted control in all spheres over the privacy of poor WOC.

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

DePaul Journal of Health Care Law

No abstract provided.

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 …

Same-Sex Marriage And The Baby Carriage: A Post-Obergefell Analysis Of Art Funding For Same-Sex Couples In The United States, Charmaine Mech

Georgia Journal of International & Comparative Law

No abstract provided.

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 with—basic scientific information …

Building Capacity For A Global Genome Editing Observatory: Institutional Design, Krishanu Saha, J. Benjamin Hurlbut, Sheila Jasanoff, Aziza Ahmed, Anthony Appiah, Elizabeth Bartholet, Francoise Baylis, Gaymon Bennett, George Church, I. Glenn Cohen, George Daley, Kevin Finneran, William Hurlbut, Rudolf Jaenisch, Laurence Lwoff, John Paul Kimes, Peter Mills, Jacob Moses, Buhm Soon Park, Erik Parens, Rachel Salzman, Abha Saxena, Hilton Simmet, Tania Simoncelli, O. Carter Snead, Kaushik Sunder Rajan, Robert D. Truog, Patricia Williams, Christiane Woopen

Journal Articles

A new infrastructure is urgently needed at the global level to facilitate exchange on key issues concerning genome editing. We advocate the establishment of a global observatory to serve as a center for international, interdisciplinary, and cosmopolitan reflection.

Building Capacity For A Global Genome Editing Observatory: Conceptual Challenges, J. Benjamin Hurlbut, Sheila Jasanoff, Krishanu Saha, Aziza Ahmed, Anthony Appiah, Elizabeth Bartholet, Francoise Baylis, Gaymon Bennett, George Church, I. Glenn Cohen, George Daley, Kevin Finneran, William Hurlbut, Rudolf Jaenisch, Laurence Lwoff, John Paul Kimes, Peter Mills, Jacob Moses, Buhm Soon Park, Erik Parens, Rachel Salzman, Abha Saxena, Hilton Simmet, Tania Simoncelli, O. Carter Snead, Kaushik Sunder Rajan, Robert D. Truog, Patricia Williams, Christiane Woopen

Journal Articles

A new infrastructure is urgently needed at the global level to facilitate exchange on key issues concerning genome editing. We advocate the establishment of a global observatory to serve as a center for international, interdisciplinary, and cosmopolitan reflection.

Advanced Biotechnology Tools For Invasive Species Management, Invasive Species Advisory Committee

National Invasive Species Council

Increasingly, genetic tools are being used to detect and solve pressing environmental, social, and health-related challenges. It is clear that investments in technology innovation can be game changing, as advances in biotechnology may provide new methods to protect the nation’s resources from the negative impacts of invasive species. The current toolbox of management options is recognizably insufficient to deal with many of the high-impact species that have been introduced. However, “surrendering” to these species is generally not a viable option from ecological, health, economic, socio-cultural, or political perspectives. Cost-efficient solutions to these “grand invasive species challenges” need to be found. …

Plant Variety In The Republic Of Korea: Seed Industry Law, Yoonjin Buyn

Oklahoma Journal of Law and Technology

No abstract provided.

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

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

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

Oklahoma Journal of Law and Technology

No abstract provided.

The Impact Of Novartis On The European Patent Convention's Exception To Patentability For "Plant Varieties", Katrina Mcclatchey

Oklahoma Journal of Law and Technology

No abstract provided.

Agricultural Biotechnology: United States Case Law, Jo Lynn Jeter

Oklahoma Journal of Law and Technology

No abstract provided.

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

Oklahoma Journal of Law and Technology

No abstract provided.

Adapting To The Changing World Of Biotechnology: Syngenta Ag Mir162 Corn Litigation As Regulation By Litigation, Paul Goeringer

Texas A&M Law Review

Agriculture has relied on plant breeding to improve genetics since the first domestication of agricultural plants 10,000 years ago. More recently, Gregor Mendel and his hybridization experiments on peas led to what we know as modern genetics. The rise in recombinantDNA technology has opened up many possibilities in plant breeding, including Roundup Ready technology and crop varieties designed to resist a number of pests. At the same time, governments and the private sector have sought to institute regulations for handling the releases of new biotechnology to ensure the technologies will have limited environmental impacts and provide safe foods to the …

The Gmo/Ge Debate, Joanna K. Sax

Texas A&M Law Review

We live longer and healthier lives because advances in science create easier and better ways to sustain and survive. Society has an intricate relationship with biotechnology. Vaccines save lives. Fluoridated water decreases dental issues. Antibiotics treat bacterial infections. Nuclear power is a form of clean energy. With any emerging technology, the benefits do not exist in a vacuum, thus, negative consequences result as well. Our widespread uses of antibiotics are creating antibiotic-resistant strains of bacteria. Our research into nuclear energy also facilitated the creation of nuclear bombs. Perhaps it is human nature to use scientific advances for good and for …

Recognizing Challenges And Opportunities In The Quest To End Hunger, Jennifer Williams Zwagerman

Texas A&M Law Review

As an attorney and professor that does not focus on intellectual property law, I was a bit apprehensive about providing a keynote address for a Symposium focusing on “Agriculture, Intellectual Property, and Feeding the World in the 21st Century.” As I thought about this topic, knowing that there were other speakers who would focus more on the IP issues and technical aspects of various topics, I kept coming back to the importance of technology as we worktowards the goal of feeding the world, and the many ways in which innovation plays a role in meeting that goal. It also brought …

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 …

Bio-Piracy: Creating Proprietary Rights In Plant Genetic Resources, James O. Odek

Journal of Intellectual Property Law

No abstract provided.

Manufacturing Barriers To Biologics Competition And Innovation, W. Nicholson Price Ii, Arti K. Rai

Faculty Scholarship

As finding breakthrough small-molecule drugs gets harder, drug companies are increasingly turning to “large molecule” biologics. Although biologics represent many of the most promising new therapies for previously intractable diseases, they are extremely expensive. Moreover, the pathway for generic-type competition set up by Congress in 2010 is unlikely to yield significant cost savings.

In this Article, we provide a fresh diagnosis of, and prescription for, this major public policy problem. We argue that the key cause is pervasive trade secrecy in the complex area of biologics manufacturing. Under the current regime, this trade secrecy, combined with certain features of FDA …

Can Dna Be Speech?, Jorge R. Roig

Cardozo Arts & Entertainment Law Journal

DNA is generally regarded as the basic building block of life itself. In the most fundamental sense, DNA is nothing more than a chemical compound, albeit a very complex and peculiar one. DNA is an information-carrying molecule. The specific sequence of base pairs contained in a DNA molecule carries with it genetic information and encodes for the creation of particular proteins. When taken as a whole, the DNA contained in a single human cell is a complete blueprint and instruction manual for the creation of that human being.

This Article discusses a myriad of current and developing ways in which …