Law Commons^™

Cancer's Ip, Jacob S. Sherkow

Articles & Chapters

The state of publicly funded science is in peril. Instead, new biomedical research efforts — in particular, the recent funding of a “Cancer Moonshot” — have focused on employing public-private partnerships, joint ventures between private industry and public agencies, as being more politically palatable. Yet, public-private partnerships like the Cancer Moonshot center on the production of public goods: scientific information. Using private incentives in this context presents numerous puzzles for both intellectual property law and information policy. This Article examines whether—and to what extent — intellectual property and information policy can be appropriately tailored to the goals of public-private partnerships. …

Patent Law's Reproducibility Paradox, Jacob S. Sherkow

Articles & Chapters

Clinical research faces a reproducibility crisis. Many recent clinical and preclinical studies appear to be irreproducible; their results cannot be verified by outside researchers. This is problematic for not only scientific reasons but legal ones: patents grounded in irreproducible research appear to fail their constitutional bargain of property rights in exchange for working disclosures of inventions. The culprit is likely patent law’s doctrine of enablement. Although the doctrine requires patents to enable others to make and use their claimed inventions, current difficulties in applying the doctrine mitigate or even actively dissuade reproducible data in patents. This Article assesses the difficulties …

Trust: A Model For Disclosure In Patent Law, Ari Ezra Waldman

Articles & Chapters

How to draw the line between public and private is a foundational, first-principles question of privacy law, but the answer has implications for intellectual property, as well. This project is the first in a series of papers about first-person disclosures of information in the privacy and intellectual property law contexts, and it defines the boundary between public and non-public information through the lens of social science — namely, principles of trust.

Patent law’s “public use” bar confronts the question of whether legal protection should extend to information previously disclosed to a small group of people. I present evidence that shows …

The Rise Of Ethical License, Christi Guerrini, Margaret Curnette, Jacob S. Sherkow, Christopher Scott

Other Publications

The Broad Institute's recent licensing of its gene editing patent portfolio demonstrates how licenses can be used to restrict controversial applications of emerging technologies while society deliberates their implications.

Patent Protection For Crispr: An Elsi Review, Jacob S. Sherkow

Articles & Chapters

The revolutionary gene-editing technology, CRISPR, has raised numerous ethical, legal, and social concerns over its use. The technology is also subject to an increasing patent thicket that raises similar issues concerning patent licensing and research development. This essay reviews several of these challenges that have come to the fore since CRISPR’s development in 2012. In particular, the lucre and complications that have followed the CRISPR patent dispute may affect scientific collaboration among academic research institutions. Relatedly, universities’ adoption of “surrogate licensors” may also hinder downstream research. At the same time, research scientists and their institutions have also used CRISPR patents …

Inventive Steps: The Crispr Patent Dispute And Scientific Progress, Jacob S. Sherkow

Other Publications

Recent decisions by patent offices in the USA and Europe concerning the revolutionary gene-editing technology, CRISPR/Cas9, have shed light on the importance — and puzzles — of one particular area of patent law: “nonobviousness”, as it known in the USA, or, in Europe, the “inventive step”. Patent law does not always neatly align itself with the realities of biological research. But these competing decisions from the U.S. Patent and Trademark Office and the European Patent Office have put those differences on parade. Unpacking these standards for CRISPR tell us a lot about how advances in biology are actually made — …

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 …

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.

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.

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.

Administrating Patent Litigation, Jacob S. Sherkow

Articles & Chapters

Recent patent litigation reform efforts have focused on every branch of govemment-Congress, the President, and the federal courts-save the fourth: administrative agencies. Agencies, however, possess a variety of functions in patent litigation: they serve as "gatekeepers" to litigation in federal court; they provide scientific and technical expertise to patent disputes; they review patent litigation to fulfill their own mandates; and they serve, in several instances, as entirely alternative fora to federal litigation.

Understanding administrative agencies' functions in managing or directing, i.e., "administrating," patent litigation sheds both descriptive and normative insight on several aspects of patent reform. These include several problems …

Administering Patent Litigation, Jacob S. Sherkow

Articles & Chapters

Recent patent litigation reform efforts have focused on every branch of government — Congress, the President, and the federal courts — save the fourth: administrative agencies. Agencies, however, possess a variety of functions in patent litigation: they serve as “gatekeepers” to litigation in federal court; they provide scientific and technical expertise to patent disputes; they review patent litigation to fulfill their own mandates; and they serve, in several instances, as entirely alternative fora to federal litigation. Understanding administrative agencies’ functions in managing or directing, i.e., “administrating,” patent litigation sheds both descriptive and normative insight on several aspects of patent reform. …

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 …

The Natural Complexity Of Patent Eligibility, Jacob S. Sherkow

Articles & Chapters

It has long been assumed that the doctrine of patent eligibility’s prohibition of patents on “laws of nature,” “natural phenomena,” and “products of nature” rests on legalistic interpretations of those terms. But there is good reason to doubt this assumption. Since the doctrine’s inception, the Supreme Court has yet to provide any framework, formula, or factors explaining these “natural” terms. Rather, the Court has increasingly fixated on a list of scientific tropes, such as gravity, the heat of the Sun, and extracted metals, that it believes are true examples of “natural laws,” “phenomena,” and “products.”

An actual examination of scientific …

And How: Mayo V. Prometheus And The Method Of Invention, Jacob S. Sherkow

Articles & Chapters

The Mayo Court's novel test for patent eligibility — whether or not an invention involves “well-understood, routine, conventional activity, previously engaged in by researchers in the field” — focuses on how an invention is accomplished rather than what an invention is. That concern with the method of invention poses several normative, statutory, and administrative difficulties. Taken seriously, the “how” requirement will likely have broad effects across all levels of patent practice.

Patent Infringement As Criminal Conduct, Jacob S. Sherkow

Articles & Chapters

Criminal and civil law differ greatly in their use of the element of intent. The purposes of intent in each legal system are tailored to effectuate very different goals. The Supreme Court’s recent decision in Global-Tech Appliances, Inc. v. SEB S.A., 131 S. Ct. 2060 (2011), however, imported a criminal concept of intent — willful blindness — into the statute for patent infringement, a civil offense, despite these differences. This importation of a criminal law concept of intent into the patent statute is novel and calls for examination. This Article compares the purposes behind intent in criminal law with 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.

What If Extinction Is Not Forever?, Jacob S. Sherkow

Other Publications

No abstract provided.

The Future Of Gene Patents And The Implications For Medicine, Jacob S. Sherkow, Henry Greely

Other Publications

The Supreme Court decision in Myriad Genetics struck down the patenting of human genomic DNA. What will this mean for genetic testing and medicine, more broadly?

Negativing Invention, Jacob S. Sherkow

Articles & Chapters

Since 1952, the patent statute has forbidden courts from discriminating against, or “negativing,” inventions according to how they were made, be it “long toil and experimentation” or a “flash of genius.” Now, in addressing whether an invention is “obvious,” courts must only examine whether the invention was obvious according to the arts pertinent to that invention — the “analogous” rather than “nonanalogous” arts. This article shows that this dichotomy has actually promoted method-of-invention discrimination in patent law because the subjectivity of the analogous art inquiry has increasingly “analogized” wide fields of prior art as technology has progressed. This, in turn, …

Competition Within Intellectual Property Regimes: The Instance Of Patent Rights, Rudolph J.R. Peritz

Articles & Chapters

No abstract provided.

Three Statutory Regimes At Impasse: Reverse Payments In Pay-For-Delay Settlement Agreements Between Brand-Name And Generic Drug Companies, Rudolph J.R. Peritz

Articles & Chapters

No abstract provided.

Peer To Peer Meets The World Of Legal Information: Encountering A New Paradigm, Ethan Katsh, Beth Simone Noveck

Articles & Chapters

The authors describe a proposed system for patent application reviews that uses new technologies to access information-community peer reviews. By allowing examiners to "mine for data" in the heads of experts rather than in libraries or databases, the proposal illustrates how new technology could change the boundaries of legally authoritative and relevant information and make it possible to identify legitimate authority from new sources.

Peer To Patent: Collective Intelligence And Intellectual Property Reform, Beth Simone Noveck

Articles & Chapters

No abstract provided.