Science and Technology Law Commons^™

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

Other Publications

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

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 …

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 from …

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.

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.

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.

A Comparative Study Of Gmo Labeling And Liability Systems In The Us, Eu, And South Korea: The Circumstances And A Future Potential For Harmonization, Moonsook Park

Maurer Theses and Dissertations

With the remarkable development of GMOs, GMO trade has also increased. The different attitudes on GMOs among the countries all over the world, specifically the US, EU, and South Korea, have the potential to create international trade conflicts. In order to mediate the conflicts, reasonable labeling and liability systems need to be established to prevent potential GMO risks. The Biosafety Protocol regarding the transboundary movement of GMOs exists to resolve such tensions, but it fails to sufficiently solve the problems and provide clear regulations concerning GMO labeling and liability systems.

A successful GMO labeling and liability system should emphasize the …

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 …

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

Celebrating WCL Student Authors

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 …

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 …

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 …

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 …

The "Reasonable Plant" Test: When Progress Outruns The Constitution, Max Oppenheimer

All Faculty Scholarship

No abstract provided.

Maintaining Competition In Copying: Narrowing The Scope Of Gene Patents, Oskar Liivak

Cornell Law Faculty Publications

In supporting gene patents, the patent office, the courts and other supporters have assumed that gene discoveries are identical to traditional inventions and therefore the patent system should treat them as identical. In other words, they have assumed that the relatively broad claims that are used for traditional inventions are also appropriate for encouraging gene discovery. This article examines this assumption and finds that gene discoveries are critically different from traditional inventions and concludes that the patent system cannot treat them as identical.

As a doctrinal matter, this article applies the generally overlooked constitutional requirements of inventorship and originality and …

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 …

Is The Eli Lilly Written Description Requirement A Paper Tiger?: A Comprehensive Assessment Of The Impact Of Eli Lilly And Its Progeny In The Courts And Pto, Christopher M. Holman

ExpressO

In University of California v. Eli Lilly, decided by the Federal Circuit in 1997, the court established for the first time a new form of patent law’s written description requirement, apparently targeted specifically at biotechnology. To this day, the conventional wisdom is that the so-called Lilly written description requirement (“LWD”) exists as a biotechnology-specific “super-enablement” requirement, substantially more stringent than the enablement requirement (the conventional standard for patentability), and standing as an impediment to effective patent protection for biotechnology inventions. My objective in writing this article was to test this conventional wisdom, by conducting a comprehensive search for all LWD …

Stealing What's Free: Exploring Compensation To Body Parts Sources For Their Contribution To Profitable Biomedical Research, Jo-Anne Yau

ExpressO

It is undisputed in the biotechnology industry that human body parts play a vital role in research. The body parts donors, referred to as "Sources" in this article, are subjected to physical and financial exploitation. Forbidding the explosion of profits from trickling down to the Source presents an irrational inequity. Despite established law, it is evident from case analysis, prevailing social practices, and constitutional interpretation that Source compensation is a plausible solution.

This article proposes a model of compensation for Sources, whereby Sources are compensated based on a proportionate share of the research profits set aside for the Source as …

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 …

The Story Of Diamond V. Chakrabarty: Technological Change And The Subject Matter Boundaries Of The Patent System, Rebecca S. Eisenberg

Book Chapters

Technological change often exposes unstated assumptions lurking in the law and makes them problematic, and patent law is no exception. Although the core mission of the patent system is to promote technological progress, path-breaking new technologies have not always been easily assimilated within its boundaries. The first wave of patent applications on advances in biotechnology in the 1970s illustrate some of the difficulties. Before that time, living organisms had generally been assumed to fall outside the range of patent-eligible subject matter under a timehonored exclusion for "products of nature." But genetically engineered organisms, although derived from naturally occurring life forms, …

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 …

Preparing The Groundwork For A Responsible Debate On Stem Cell Research And Human Cloning, O. Carter Snead

Journal Articles

The debate over both cloning and stem cell research has been intense and polarizing. It played a significant role in the recently completed presidential campaign, mentioned by both candidates on the stump, at both parties' conventions, and was even taken up directly during one of the presidential debates. The topic has been discussed and debated almost continuously by the members of the legal, scientific, medical, and public policy commentariat. I believe that it is a heartening tribute to our national polity that such a complex moral, ethical, and scientific issue has become a central focus of our political discourse. But, …

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 …

Protein Similarity Score: Simplified Version Of The Blast Score As Superior Alternative To Percent Identity For Claiming Genuses Of Related Protein Sequences, Christopher M. Holman

Faculty Works

Recombinant proteins form the basis for most of the products of biotechnology, including drugs, diagnostics, research reagents, genetically modified organisms and industrial enzymes. However, the nature of proteins and the rules of patentability conspire to make it difficult to achieve adequate patent protection for novel proteins and the polynucleotides that encode them. Narrow patent claims limited to protein sequences sharing a high degree of structural identity can generally be designed around by introducing structural changes in the claimed protein, thereby avoiding the patent without substantially altering the protein's function. However, inventors are generally restricted in their ability to broadly claim …

Biotechnology Law: A Tale Of Peptides And Lasers: Is Integra Lifesciences I, Ltd. V. Kgaa The End Of The Experimental Use Defense For Biomedical Innovation, Or Does § 271(E)(1) Of The Patent Act Save The Day, Melissa J. Alcorn Ph.D.

Oklahoma Law Review

No abstract provided.