Law Commons^™

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 …

The Biotechnology Process Patent Act Of 1995: Providing Unresolved And Unrecognized Dilemmas In U.S. Patent Law, Becca Alley

Journal of Intellectual Property Law

No abstract provided.

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 …

Bioprospect Theory, James Ming Chen

Akron Intellectual Property Journal

Conventional wisdom treats biodiversity and biotechnology as rivalrous values. The global south is home to most of earth's vanishing species, while the global north holds the capital and technology needed to develop this natural wealth. The south argues that intellectual property laws enable pharmaceutical companies and seed breeders in the industrialized north to commit biopiracy. By contrast, the United States has characterized calls for profit-sharing as a threat to the global life sciences industry. Both sides magnify the dispute, on the apparent consensus that commercial exploitation of genetic resources holds the key to biodiversity conservation.

Both sides of this debate …

The Mayo Framework Is Bad For Your Health, Christopher M. Holman

Faculty Works

This Article begins by providing a brief historical retrospective of the development of the patent eligibility doctrine, and then delves into the related questions of: (1) what are the Supreme Court’s policy objectives for the recent reinvigoration of the patent eligibility doctrine; and (2) has it achieved those objectives? The article then discusses three important out-standing questions regarding the application of the new test for patent eligibility: (1) what constitutes a natural phenomenon; (2) what constitutes an inventive step; and (3) what, if any, role does preemption play in the analysis? The article then provides four examples of recent lower …

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. This finding contextualizes …

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

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.

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 …

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.

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

Other Publications

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

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.

Intellectual Property And Biofuels: The Energy Crisis, Food Security, And Climate Change, Matthew Rimmer, Griffith Hack

Matthew Rimmer

In light of larger public policy debates over intellectual property and climate change, this article considers patent practice, law, and policy in respect of biofuels. This debate has significant implications for public policy discussions in respect of energy independence, food security, and climate change. The first section of the paper provides a network analysis of patents in respect of biofuels across the three generations. It provides empirical research in respect of patent subject matter, ownership, and strategy in respect of biofuels. The second section provides a case study of significant patent litigation over biofuels. There is an examination of the …

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.

The Critical Role Of Patents In The Development, Commercialization And Utilization Of Innovative Genetic Diagnostic Test And Personalized Medicine, Christopher M. Holman

Faculty Works

Arguments in favor of reining in the availability of effective patent protection in the area of genetic diagnostic testing are based largely on two fundamental misconceptions regarding the role of patents in this important area of technological innovation. The first is the mistaken assumption that patents negatively impact patient access to genetic diagnostic testing by preventing research that might lead to new or improved versions of a genetic test and by increasing the cost of testing services. The second is the failure to appreciate the substantial positive role patents play in in the development and utilization of genetic diagnostic tests. …

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 intellectual property …

Developments In Synthetic Biology Are Altering The Ip Imperatives Of Biotechnology, Christopher M. Holman

Vanderbilt Journal of Entertainment & Technology Law

While the accomplishments of the biotechnology industry have been substantial, recent technological advances promise to dramatically increase the power and utility of the discipline over the coming years. The term "synthetic biology" has been coined to describe the application of these powerful new tools to the engineering of synthetic genetic sequences and organisms. In essence, synthetic biology represents the next iteration in the ongoing evolution of biotechnology, and hopes run high that in time, the fruits of synthetic biology will dwarf the past successes of conventional biotechnology. There is, however, some concern that the current patent-centric approach to Intellectual Property …

Developments In Synthetic Biology Are Altering The Ip Imperatives Of Biotechnology, Christopher M. Holman

Faculty Works

While the accomplishments of the biotechnology industry have been substantial, recent technological advances promise to dramatically increase the power and utility of the discipline over the coming years. The term “synthetic biology” has been coined to describe the application of these powerful new tools to the engineering of synthetic genetic sequences and organisms. In essence, synthetic biology represents the next iteration in the ongoing evolution of biotechnology, and hopes run high that in time, the fruits of synthetic biology will dwarf the past successes of conventional biotechnology. There is, however, some concern that the current patent-centric approach to Intellectual Property …

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.

Do Biotech Patent Lawsuits Really “Overwhelmingly Lose?”: A Response To Our Divided Patent System, Christopher M. Holman

Faculty Works

On October 14, 2014, Stanford’s Professor Mark Lemley tweeted “My new study with Allison & Schwartz shows that software and biotech patent lawsuits overwhelmingly lose.” He was referring to an article entitled Our Divided Patent System, co-authored by Lemley and two other prominent law professors. Taken at face value, the assertion that “biotech patent lawsuits overwhelmingly lose” would seem to hold troubling implications for biotechnology. In order to better understand the basis for Lemley’s assertion, I reanalyzed the underlying data and found that the situation is not nearly as bleak as his tweet might suggest. My significantly different interpretation of …

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

Oskar Liivak

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 …

Patents, Genetically Modified Foods, And Ip Overreaching, Elizabeth A. Rowe

Elizabeth A Rowe

Genetically engineered plants and animals have become and will continue to constitute a large part of the food we consume. The United States is the world's largest producer of genetically modified foods, making American consumers the most exposed population to these products. Agricultural biotechnology patents spur and support innovation. Accordingly, patent law is one of the main contributors to this phenomenon that has changed not only the kinds of food we eat, but the nature of the agri-business industry that produces these foods. This Article takes on an area of concern involving the patenting of food that has remained unexplored: …

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 …

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 …

Anticipating The Storm: Predicting And Preventing Global Technology Conflicts, Sabrina Safrin

Sabrina Safrin

This article helps lay the foundation for a new field of international law — International Law and Technology — and opens novel avenues of inquiry in law and technology and intellectual property more broadly. It analyzes as a starting point why some technologies generate global conflicts while others do not. Technologies that face international resistance can trigger a barrage of international legal responses, ranging from trade bans and WTO disputes to international regulatory regimes and barriers to patenting. Agricultural biotechnology triggered all of these legal flashpoints, while the cellphone, a technology that grew up alongside it, triggered none. Why?

Understanding …

Patent Trolling--Why Bio & Pharmaceuticals Are At Risk, Robin C. Feldman, W. Nicholson Price Ii

Robin C Feldman

The Empire Of Cancer: Gene Patents And Cancer Voices, Matthew Rimmer

Matthew Rimmer

In his book, The Emperor of All Maladies, Siddhartha Mukherjee writes a history of cancer — ‘It is a chronicle of an ancient disease — once a clandestine, “whispered-about” illness — that has metamorphosed into a lethal shape-shifting entity imbued with such penetrating metaphorical, medical, scientific, and political potency that cancer is often described as the defining plague of our generation’.Increasingly, an important theme in the history of cancer is the role of law, particularly in the field of intellectual property law. It is striking that a number of contemporary policy debates over intellectual property and public health have concerned …

Patents And The University, Peter Lee

Peter Lee

This Article advances two novel claims about the internalization of academic science within patent law and the concomitant evolution of “academic exceptionalism.” Historically, relations between patent law and the university were characterized by mutual exclusion, based in part on normative conflicts between academia and exclusive rights. These normative distinctions informed “academic exceptionalism”—the notion that the patent system should exclude the fruits of academic science or treat academic entities differently than other actors—in patent doctrine. As universities began to embrace patents, however, academic science has become internalized within the traditional commercial narrative of patent protection. Contemporary courts frequently invoke universities’ commercial …