Law Commons^™

What's Not Natural Phenomena? Let's Consider A Three-Step Innovative Concept Test For Composition Of Matter Claims, Sydney Hancock

IP Theory

Biotechnology innovation is rapidly growing, especially in the realm of biotech. This growth leads to questions about patent subject matter eligibility of natural phenomena. For example, currently the human genome and microbiome are being extensively studied, bacteriophages are being edited, animals are being cloned, and CRISPR is widespread. Additionally, composition of matter patent claims give the most protection to patent holders. Therefore, knowing when a natural phenomenon veers into human innovation is important for courts, lawyers, and innovators in the era of biotechnology and genetic engineering.

Part I discusses the history of Supreme Court cases on natural phenomena subject matter …

The Code Of Life And Death, Braden R. Leach

Notre Dame Journal on Emerging Technologies

Biotechnology is advancing at an astonishing clip, but our safeguards are decades behind. Given new technologies and economies of scale, it is possible for nefarious actors to assemble deadly viruses from scratch using synthetic DNA ordered off the internet. The Select Agents statute helps to prevent malicious actors from acquiring dangerous pathogens, but the Department of Health and Human Services has interpreted it to not cover synthetic DNA. Recognizing the gap, HHS issued guidance recommending that gene synthesis companies verify their customers to ensure their legitimacy and screen genetic sequences for matches to pathogen sequences. Unsurprisingly, voluntary guidance has not …

Patenting Genetic Information, David S. Olson, Fabrizio Ducci

Indiana Law Journal

The U.S. biotechnology industry got its start and grew to maturity over roughly three decades, beginning in the 1980s. During this period genes were patentable, and many gene patents were granted. University researchers performed basic research— often funded by the government—and then patented the genes they discovered with the encouragement of the Bayh-Dole Act, which sought to encourage practical applications of basic research by allowing patents on federally funded inventions and discoveries. At that time, when a researcher discovered the function of a gene, she could patent it such that no one else could work with that gene in the …

Crispr, Like Any Other Technology: Shedding Determinism & Reviving Athens, Jon Khan

Canadian Journal of Law and Technology

This article examines current narratives surrounding CRISPR (clustered regularly interspaced short palindromic repeats) and the current Canadian treatment of this novel biotechnology. It argues that Canada’s current approach to genetic research and CRISPR appear to have succumbed to the false narrative of technological determinism. It argues that Canada must buck the narrative and alter the current status quo in two principal ways: Canada should pursue more somatic CRISPR clinical trials in humans and permit pre-clinical germline editing. To design a regulatory regime for clinical germline editing and better guidance on somatic CRISPR clinical trials, Canada should engage Deliberative Polling to …

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, …

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 …

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 Note …

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 economic priorities; …

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 …

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 of …

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

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 property …

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 …

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

Georgia Journal of International & Comparative Law

No abstract provided.

Genome Editing And The Jurisprudence Of Scientific Empiricism, Paul Enriquez

Vanderbilt Journal of Entertainment & Technology Law

Humankind has reached, in tow by the hand of a scientific breakthrough called CRISPR, the Rubicon of precise genetic manipulation first envisioned over fifty years ago. Despite CRISPR's renown in science and its power to transform the world, it remains virtually unaddressed in legal scholarship. In the absence of on-point law, the scientific community has attempted to reach some consensus to preempt antagonistic regulation and prescribe subjective standards of use under the guise of a priori scientific empiricism. Significant and complex legal issues concerning this technology are emerging, and the void in legal scholarship is no longer tolerable.

This Article …

Useless Information: Genetic Patenting, The Usefulness Requirement, And The Effect On The “Big Freeze”, David T. Bennett

Journal of the National Association of Administrative Law Judiciary

This note considers the current state of affairs regarding patentability in the field of biotechnology, especially that of genes and DNA. Part II gives a brief background of patents in general, including the requirements that must be met for a patent to be granted, the way in which the patent process works, and the options available to a patent holder once a patent has been granted. Part III explores the history of biotechnology patents. Part IV takes a look at the relationship between patents and biotechnology, and sheds light on some of the common arguments both in favor of and …

The Human Genome: A Patenting Dilemma, Pamela Docherty

Akron Law Review

This Comment will address the conflict between the U.S. patent laws and biotechnology by focusing on the NIH patent application.

The first part of this Comment discusses the objectives and statutory requirements of the patent system, which the NIH application purportedly did not meet. Next, this Comment focuses on the debate between NIH and its detractors. It explains NIH's reasons for its actions and discusses the criticisms leveled at the agency. Finally, this Comment presents solutions to the problems that have been uncovered by this debate regarding the patentability of genes.

International Trade Law And The U.S.-Eu Gmo Debate: Can Africa Weather This Storm?, Michelle K. Mcdonald

Georgia Journal of International & Comparative Law

No abstract provided.

After Myriad: Reconsidering The Incentives For Innovation In The Biotech Industry, Daniel K. Yarbrough

Michigan Telecommunications & Technology Law Review

35 U.S.C. § 101 allows a patent for “any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof.” Recently, the Supreme Court issued several key decisions affecting the doctrine of patentable subject matter under § 101. Starting with Bilski v. Kappos (2011), and continuing with Mayo Collaborative Services, Inc. v. Prometheus Laboratories (2012), Association for Molecular Pathology v. Myriad Genetics (2013) and, most recently, Alice Corporation Pty. Ltd. v. CLS Bank International (2014), every year has brought another major change to the way in which the Court assesses patentability. In Myriad, the …

Expanding Horizons: Scientific Frontiers, Legal Regulation And Globalization, Belinda Bennett

Indiana Journal of Global Legal Studies

In the six decades since the discovery of the double helix structure of DNA by Watson and Crick in 1953, developments in genetic science have transformed our understanding of human health and disease. These developments, along with those in other areas such as computer science, biotechnology, and nanotechnology, have opened exciting new possibilities for the future. In addition, the increasing trend for technologies to converge and build upon each other potentially increases the pace of change, constantly expanding the boundaries of the scientific frontier. At the same time, however, scientific advances are often accompanied by public unease over the potential …

Will Gene Patents Derail The Next-Generation Of Genetic Technologies?: A Reassessment Of The Evidence Suggests Not, Christopher M. Holman

UMKC Law Review

Judge Bryson recently asserted in Association for Molecular Pathology v. US Patent and Trademark Office (dissenting-in-part) that human gene patents "present a significant obstacle to the next generation of innovation in genetic medicine — multiplex tests and whole-genome sequencing." His concern over the impact of gene patents on genetic testing, which coincides with his position that certain gene patents should be declared patent ineligible, reflects a widely held misperception that 20% of human genes are patented in a manner that would necessarily result in infringement by whole genome sequencing and other forms of genetic testing. In fact, the myth that …

Exhausted Or Unlicensed: Can Field-Of-Use Restrictions In Biotech License Agreements Still Prevent Off-Label Use Promotion After Quanta Computer?, Kristal M. Wicks

The University of New Hampshire Law Review

[Excerpt] “In the biotechnology (biotech) industry, companies must be increasingly aware of their intellectual property and how their licensing strategies can impact their rights. When licensing patented technology, it is common practice for biotech companies to include restricted field-of-use provisions in their license agreements. Such provisions permit a licensee to only use licensed technology in a defined field and restrict use or development in another field. This licensing strategy plays an important role within the biotech industry because it allows companies to more effectively control their intellectual property and to more efficiently research and develop pharmaceutical products.

A problem that …

Restoring The Genetic Commons: A Common Sense Approach To Biotechnology Patents In The Wake Of Ksr V. Teleflex , Anna Bartow Laakmann

Michigan Telecommunications & Technology Law Review

In this Article, I argue that a new approach to biotechnology patenting is necessary to fully realize the tremendous potential of recent advances in our understanding of the human genome. Part I places the gene patenting debate in context by highlighting the key landmarks that have shaped the biotechnology industry and outlining the products and stakeholders that comprise the industry. Part II describes the current state of the law on biotechnology patents, summarizing the Federal Circuit's application of the various doctrines that collectively define the patent landscape's parameters. In this Part, I explain how the Federal Circuit's jurisprudence is tied …

Biopiracy And Beyond: A Consideration Of Socio-Cultural Conflicts With Global Patent Policies, Cynthia M. Ho

University of Michigan Journal of Law Reform

This Article provides afresh and multi-dimensioned approach to a long-standing claim of biopiracy patents made by developing countries and communities. The basic principles of patent law and policy are first established to provide a foundation from which to evaluate the claim that genetic resources and traditional knowledge from developing countries are being misappropriated in a variety of ways that are loosely referred to as biopiracy. The Article distinguishes rhetoric from reality in examining biopiracy allegations from the perspective of national patent laws, as well as international agreements. In addition, the Article explains the underlying conflicts, misconceptions, and historical biases that …

Supporting Innovation In Targeted Treatments: Licenses Of Right To Nih-Funded Research Tools, Tanuja V. Garde

Michigan Telecommunications & Technology Law Review

Support for new drug development has taken some interesting turns in current patent law jurisprudence. Beginning with the severe curtailment of scope of the common law experimental use doctrine in Madey v. Duke University, and culminating with the recent Supreme Court decision in Merck KGaA v. Integra Lifesciences I, Ltd., broadening the scope of the statutory research exemption, the freedom to conduct experimental research using another's patented inventions becomes dependent in part on the purpose of the research. That the patent at issue in Merck was characterized by the Federal Circuit as being directed to a research tool raised the …

Biotechnology Unglued: Science, Society, And Social Cohesion By Michael D. Mehta, Ed. (Vancouver: Ubc Press, 2005), Chidi Oguamanam

Canadian Journal of Law and Technology

In Biotechnology Unglued, Mehta and his thirteen-member interdisciplinary team, comprising mainly of social scientists using a number of ‘‘case studies’’, explore in nine essays ‘‘how advances in agricultural, medical, and forensic biotechnology may threaten the social cohesiveness of different kinds of communities and at different scales’’. In a way, the project is a successful attempt to underscore the theme of (and imperative for) social accountability of science and bio/technological innovations. This 208-page collection of nine essays in a corresponding number of chapters is a remarkable effort. It is a departure from the traditional concerns regarding biotechnology innovations which, hitherto, emphasized …

Planting A Standard: Proposing A Broad Reading Of In Re Elsner, Alicia L. Frostick

Michigan Law Review

This Note will show that one can read Elsner broadly to encompass both plant-type and widget-type inventions, and that applying Elsner to both plants and widgets is within the current statutory framework and case law. Such a reading would change the § 102 bar for inventions patentable under § 10i29 (hereinafter referred to as "widgets") as well as for plants. Part I of this Note argues that congressional sources require a flexible test-one that does not prejudice any objects under the Patent Act. Part II discusses the judicial interpretation of the Patent Act prior to Elsner in order to argue …

The Experimental Purpose Doctrine And Biomedical Research, Tao Huang

Michigan Telecommunications & Technology Law Review

The experimental use doctrine is a common law rule in patent law that until a few years ago excused accused infringers who made and used patented products or processes on the basis of an experimental, educational, or nonprofit purpose when there was de minimis economic injury to the patent owner and de minimis economic gain to the infringer. While the application of the experimental purpose doctrine was always narrow, two recent Federal Circuit decisions indicate that there is not much left under its aegis. In Madey v. Duke University, the Federal Circuit strictly limited the application of the experimental purpose …

An Examination Of Patents, Licensing, Research Tools, And The Tragedy Of The Anticommons In Biotechnology Innovation, Michael S. Mireles

University of Michigan Journal of Law Reform

The continued development of and affordable access to potentially life saving pharmaceuticals, gene therapies and diagnostics is unquestionably a socially important issue. However, crafting government policy to encourage the development of and allowing affordable access to those services and products is difficult. On one hand, the development of those services and products requires a large investment of funds because of the complexity, collaborative nature, and uncertainty of the development of those products and services. Accordingly, investors require the safety of strong and stable patent rights to ensure a return on their investment in the development of a commercial end-product or …