Jacob S. Sherkow

What If Extinction Is Not Forever

Although new technologies may make it possible to bring extinct species back to life, there are ethical, legal, and social ramifications to be addressed A 1930s film shows a dog running and jumping inside a fenced enclosure (1)—except that the dog has a strange-shaped head, odd stripes, and a rigid tail that can only move side-to-side. The “dog” is actually one of the last thylacines, a marsupial predator also called the Tasmanian tiger. The film was taken shortly before humans extinguished the species forever. Or did we? Recently, new technologies have made it plausible to try to revive many recently extinct species. Scientists around the world are discussing, and working toward, “de-extinction” (2).

23andMe, the Food and Drug Administration, and the Future of Genetic Testing

On November 22, 2013, the US Food and Drug Administration (FDA) effectively halted health-related direct-to-consumer genetic testing in the United States by sending a warning letter to 23andMe, the leading company in the field, directing it to stop providing such testing. The FDA acted as the era of widespread, clinical use of DNA sequencing rapidly approaches. The agency’s action will contribute to changes in which genetic tests are offered to patients and how testing is provided.

Law, History and Lessons in the CRISPR Patent Conflict

Predicting the outcome of the ongoing patent disputes surrounding genome-editing technology is equal parts patent analysis and history.

CRISPR, Surrogate Licensing, and Scientific Discovery

Have research universities abandoned their public focus? Several 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 (1–4). 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 license agreements with commercial enterprises (see the figure). 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 and one of its principal researchers (5, 6). Although this model, in which a university effectively outsources the licensing and commercialization of a valuable patent portfolio to a private company, is not uncommon in the world of university technology transfer, we suggest it could rapidly bottleneck the use of CRISPR technology to discover and develop useful human therapeutics.

The rise of the ethical license

The Broad Institutes 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.

The Future of Gene Patents and the Implications for Medicine

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?

Patent Pools for CRISPR Technology — Response

It appears that Horn concurs with our assessment of the potential development bottlenecks arising from the current CRISPR licensing model. We welcome his creative thinking about further ways to open CRISPR technology to a broader market. We are aware that patent pools have been successfully

Inventive 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 patent law: “nonobviousness”, as it known in the USA, or, in Europe, the “inventive step”. In February 2017, the US Patent Trial and Appeal Board (PTAB) found that the work of Feng Zhang, a researcher at the Broad Institute in Cambridge, MA, USA, constituted a “nonobvious” advance over the celebrated work of Jennifer Doudna of the University of California, Berkeley (USA) and Emmanuelle Charpentier, then at Umea University, Sweden [1]. As a consequence, the Broad Institute will be able to keep its US patents covering the technology irrespective of how Doudna and Charpentiers patent application proceeds. By contrast, the European Patent Office (EPO) announced that it had granted Doudna and Charpentiers European patent application covering broad uses of CRISPR/Cas9 in essentially any cell type, despite the US Patent Offices decision to the contrary [2]. Other parties—including the Broad Institute—will be able to challenge Doudna and Charpentiers European patent. But for now, the EPOs decision is an implicit recognition that Doudna and Charpentiers work was, itself, a major “inventive step” over the work that came before it. Patent law does not always neatly align itself with the realities of biological research. But these competing decisions have put those differences on parade. The US decision in particular—and even the nature of the controversy between the two US research institutions—has been widely criticized by scientists. One prominent researcher, Michael Eisen from the University of California, Berkeley, has taken particular issue with the PTABs articulation of the typical manner in which molecular biologists adapt discoveries to different cell systems. “[O]ne can believe that it was obvious that CRISPR would work in eukaryotic cells, …

The 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 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.

Key challenges in bringing CRISPR-mediated somatic cell therapy into the clinic

Editorial summaryGenome editing using clustered regularly interspersed short palindromic repeats (CRISPR) and CRISPR-associated proteins offers the potential to facilitate safe and effective treatment of genetic diseases refractory to other types of intervention. Here, we identify some of the major challenges for clinicians, regulators, and human research ethics committees in the clinical translation of CRISPR-mediated somatic cell therapy.