Letter to U.S. Senate Committee on the Judiciary Concerning Inter Partes...
A summary of data concerning the intersection of inter partes review challenges of Orange Book-listed patents. Data available at Harvard's Dataverse under keyword "sherkow."
View ArticleThe History of Patenting Genetic Material
The US Supreme Court’s recent decision in Association for Molecular Pathology v. Myriad Genetics, Inc. declared, for the first time, that isolated human genes cannot be patented. Many have wondered how...
View ArticlePatent Law's Reproducibility Paradox
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...
View ArticleDescribing Drugs: A Response to Professors Allison and Ouellette
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...
View ArticleProtecting Products versus Platforms
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...
View ArticlePursuit of Profit Poisons Collaboration
The CRISPR–Cas9 patent battle demonstrates how overzealous efforts to commercialize technology can damage science.
View ArticleThe Changing Life Science Patent Landscape
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...
View ArticleWho Owns Gene Editing? Patents in the Time of CRISPR
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...
View ArticleCancer's IP
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...
View ArticlePatents, Promises, and Reproducibility
Cutting-edge scientific research faces a global reproducibility crisis: scientists often cannot faithfully reproduce their colleagues’ experiments. Several domestic patent law doctrines would appear to...
View ArticleCRISPR, Surrogate Licensing, and Scientific Discovery
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...
View ArticleInventive Steps: The CRISPR Patent Dispute and Scientific Progress
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...
View ArticlePatent Pools for CRISPR Technology — Response
In response to a letter from Lawrence Horn, MPEG LA, suggesting patent pools for CRISPR licensing, we respond that while patent pools have been successfully deployed in the consumer electronics and...
View ArticlePatent Protection for Microbial Technologies
Microbial technologies often serve as the basis of fundamental research tools in molecular biology. These presents challenges, as well as ethical, legal and social issues, concerning their patenting....
View ArticleKey Challenges in Bringing CRISPR-Mediated Somatic Cell Therapy into the Clinic
Genome editing using clustered regularly interspersed short palindromic repeats (CRISPR) and CRISPR-associated proteins offers the potential to facilitate safe and effective treatment of genetic...
View ArticleBridges II: The Law–STEM Alliance & Next Generation Innovation
This contribution to the Northwestern University Law Review's Bridge II micro-symposium discusses collaborations between the law and STEM fields and real-world examples of where such collaborations...
View ArticlePatent Protection for CRISPR: An ELSI Review
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...
View ArticleCRISPR, Patents, and the Public Health
Patent issues surrounding CRISPR, the revolutionary genetic editing technology, may have important implications for the public health. Patents maintain high prices for novel therapies, limiting patient...
View ArticleThe Science of Substitution: A Response to Carrier and Minniti
In Biologics: The New Antitrust Frontier, Michael A. Carrier and Carl J. Minniti provide an overview of potential antitrust harms in the newly enacted biologic drug approval and litigation regime, the...
View ArticleIntellectual Property, Surrogate Licensing, and Precision Medicine
The fruits of the biotechnology revolution are beginning to be harvested. Recent regulatory approvals of “precision medicine” therapies target patients’ specific genetic, physiological and...
View ArticleAIRR Data Under the E.U. Trade Secrets Directive: Aligning Scientific...
Whether the E.U. Trade Secrets Directive sufficiently and appropriately covers cutting-edge complex technologies is of critical interest to policy-makers, scientists, and commercial developers alike....
View ArticleThe Pick-and-Shovel Play: Bioethics for Gene-Editing Vector Patents
Concerns over patent protection covering new forms of gene-editing have largely focused on the intellectual property covering the editing mechanism itself, most notably CRISPR (clustered regularly...
View ArticleControlling CRISPR Through Law: Legal Regimes as Precautionary Principles
Since its advent in 2012, CRISPR has spawned a cottage industry of bioethics literature. One principal criticism of the technology is its virtually instant widespread adoption prior to deliberative...
View ArticleDifferential Requirements for Mcm Proteins in DNA Replication in Drosophila...
The MCM2-7 proteins are crucial components of the pre replication complex (preRC) in eukaryotes. Since they are significantly more abundant than other preRC components, we were interested in...
View ArticleIs It 'Gene Therapy'?
What, exactly, is "gene therapy"? Crystallizing a modern definition of "gene therapy" has now become critically important on several fronts. Following the recent of passage the 21st Century Cures Act,...
View ArticleInferred Allelic Variants of Immunoglobulin Receptor Genes: A System for...
Immunoglobulins or antibodies are the main effector molecules of the B-cell lineage and are encoded by hundreds of variable (V), diversity (D), and joining (J) germline genes, which recombine to...
View ArticleThe CRISPR-Cas9 Patent Appeal: Where Do We Go From Here?
An appellate court in the United States affirmed the Patent Office’s finding that the Broad Institute’s patents covering eukaryotic applications of CRISPR-Cas9 was separately patentable over the...
View ArticleThe CRISPR Patent Landscape: Past, Present, and Future
The development of CRISPR depends, in part, on the patents — past, present, and future — covering it. As for the past, the origins of the CRISPR patent landscape predate its use as a gene editing...
View ArticleFortune and Hindsight: Gene Patents’ Muted Effect on Medical Practice
Physicians have long worried about gene patents’ potential to restrict their medical practices. Fortune and hindsight have proven these worries exaggerated both in the UK and elsewhere. Neither current...
View ArticlePatent Eligibility Reform and the Public Health
The 2013 decision by the Supreme Court of the United States in Association for Molecular Pathology v. Myriad Genetics, Inc. was seen by many as a triumph for public health. The opinion declared human...
View ArticleGene Editing Sperm and Eggs (not Embryos): Does it Make a Legal or Ethical...
Heritable, human genome editing constitutes one of the most contentious issues facing science policy. This was starkly illustrated by Dr. He’s unsafe, unethical, and irresponsible editing of twin...
View ArticleRegulatory Sandboxes and the Public Health
Recently, administrative agencies around the world have engaged in a grand experiment to regulate new technologies: regulatory sandboxes. Regulatory sandboxes allow developers, in cooperation with an...
View ArticleEpiPen, Patents, and Life and Death
Drug pricing disputes, while significant public health concerns, are not typically immediate life or death matters. But they may be for certain emergency medicines, medicines used for potentially...
View ArticleInnovation Institutions and COVID-19
The COVID-19 crisis has starkly illustrated both the strengths and limitations of U.S. biomedical innovation institutions as deployed to fight a pandemic. These innovation institutions include not just...
View ArticleEthical, Legal, and Social Issues in the Earth BioGenome Project
The Earth BioGenome Project (EBP) is an audacious endeavor to obtain whole genome sequences of representatives from all eukaryotic species on earth. In addition to the Project’s technical and...
View ArticleInnovation Law and COVID-19: Promoting Incentives and Access for New...
As the devastating COVID-19 pandemic first swept the globe, it posed a crucial test of biomedical innovation institutions. Containing the virus required developing new technologies including diagnostic...
View ArticleThe Role of Patents and Licensing in the Governance of Human Genome Editing:...
On 12 July 2021 the World Health Organization (WHO) Expert Advisory Committee on Developing Global Standards for Governance and Oversight of Human Genome Editing published a set of reports entitled...
View ArticleModels of Technology Transfer for Genome-Editing Technologies
Many of the fundamental inventions of genome editing, including meganu- cleases, zinc finger nucleases (ZFNs), transcription activator-like effector nucleases (TALENs), and CRISPR, were first made at...
View ArticleThe FDA De Novo Medical Device Pathway, Patents, and Anticompetition
The interaction between patents and FDA’s De Novo and 510(k) regulatory pathways has the potential to threaten follow-on innovation for medical devices.
View ArticlePresidential Administration and FDA Guidance: A New Hope
Assessments of a President’s first 100 days in office typically focus on legislative priorities and executive orders. Less attention is paid to early victories achieved via guidance and other informal...
View ArticleBiological Controls for Standardization and Interpretation of Adaptive Immune...
Use of adaptive immune receptor repertoire sequencing (AIRR-seq) has become widespread, providing new insights into the immune system with potential broad clinical and diagnostic applications. However,...
View ArticleGovernance Choices of Genome Editing Patents
There are a variety of governance mechanisms concerning the ownership and use of patents. These include government licenses, compulsory licenses, march-in rights for inventions created with federal...
View ArticleThe Antibody Patent Paradox
Antibodies constitute a staggering $145 billion annual market—an amount projected to almost double by 2026. Consequently, patents covering antibodies are among the most valuable in the patent system....
View ArticlePreprint Servers and Patent Prior Art
The use of preprint servers to rapidly disseminate research results has exploded since the start of the COVID-19 pandemic. But such disclosures may make obtaining patent protection on the results quite...
View ArticleInnovation Institutions and COVID-19, Part II
The COVID-19 crisis has starkly illustrated both the strengths and limitations of U.S. biomedical innovation institutions as deployed to fight a pandemic. These innovation institutions include not just...
View ArticleWriting Definitions in Rewriting Nature: Lessons from FDA Law
Paul Enríquez’ book Rewriting Nature fits neatly within what has become a cottage industry of legal takes on genome editing. It is also something that many books in this area are not: fun; an...
View ArticleFamilial Searches, The Fourth Amendment, and Genomic Control
In recent years, police have increasingly made use of consumer genomic databases to solve a variety of crimes, from long-cold serial killings to assaults. They do so frequently without judicial...
View ArticleThe Myth of DNA Trade Secrecy
Are DNA sequences subject to trade secrecy protection? At least two decades of scholarship has assumed so. But, in fact, there are very few reported decisions directly on point and no explicit...
View ArticleBrief of Patent Law Professors as Amicus Curiae Supporting the Appellant and...
Antibodies—as large, complex, and almost incalculably diverse molecules—have long been technically difficult to disclose in a patent application and appropriately claim. And as antibody technology has...
View ArticlePutting the C Back in IRAC
Read a law school exam these days, and you're likely to find one of the IRAC elements given short-shrift: the conclusion, C. That's unfortunate because conclusions in legal writing are important for...
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