Rebecca S. Eisenberg

Genomics in the public domain: strategy and policy

The public domain has been conspicuous in media accounts of public and private sector initiatives to complete the sequence of the human genome. The issue of whether the human genome will be freely available to the public or privately held as a proprietary resource has captured the attention of the scientific, trade and popular press, the financial markets, and even heads of state. Although some media commentary has framed the issue as a conflict between ethics and greed, strategic considerations go a long way towards explaining the timing and quality of information disclosures on both sides of the public–private divide.

Bayh-Dole reform and the progress of biomedicine

A method for the hydrolysis of only the lacto-N-biosidic (Gal beta 1-3GlcNAc beta 1-) linkages at the non-reducing termini of sugar compounds, characterized by the use of glycosidase that is specific for only the lacto-N-biosidic linkage in said sugar compounds. And disclosed is a reagent for use in hydrolysis of only the lacto-N-biosidic linkage at the non-reducing termini of sugar compounds.

Why the gene patenting controversy persists.

Apuzzling aspect of the controversy over patenting genes has been its timing. Other controversies over patenting new subject matter—such as microorganisms, animals, software, and business methods—have typically erupted promptly upon the allowance of patents in these areas, and then diminished as people and institutions got used to it. By contrast, public controversy over patenting genes initially trailed patenting practice by a decade or more, yet it has remained remarkably robust ever since, despite many years of experience with gene patents. Throughout the 1980s, while Congress and commentators focused concerned attention on the patenting of living things, the practice of patenting genes was becoming well established beneath the radar of media attention. The first significant public controversy over patenting DNA sequences did not erupt until the early years of the Human Genome Project, when the National Institutes of Health (NIH) filed patent applications on the first few hundred expressed sequence tags (ESTs) identified in the laboratory of Dr. Craig Venter. But if critics of gene patenting were slow in launching public discussion of the issue, they have certainly been persistent in keeping the controversy alive. What accounts for this peculiar pattern of delayed, yet enduring, controversy? Although at a formal level patenting genes looks like an established practice, the interests that it implicates have shifted over time, bringing different stakeholders forward and raising different concerns and arguments that were not salient in the early days. In particular, in recent years the patenting of genes has raised evolving issues concerning (1) the patenting of DNA diagnostic products that are the object of mixed clinical and research use; (2) the patenting of ‘‘upstream’’ discoveries that are still some distance away from endproduct development but are nonetheless of immediate scientific interest to researchers; and (3) the patenting of routine research results obtained through a mechanized process requiring no more than ordinary skill on the part of the inventors. Each of these issues has cast a new light upon the practice of patenting genes as science and technology move forward, bringing into focus questions that were neither raised nor resolved in the prior course of gene patenting.

Intellectual Property Issues in Genomics

Controversy over intellectual property rights in the results of large-scale cDNA sequencing raises intriguing questions about the roles of the public and private sectors in genomics research, and about who stands to benefit (and who stands to lose) from the private appropriation of genomic information. While the US Patent and Trademark Office has rejected patent applications on cDNA fragments of unknown function from the National Institutes of Health, private firms have pursued three distinct strategies for exploiting unpatented cDNA sequence information: exclusive licensing, non-exclusive licensing and dedication to the public domain.

Harnessing and Sharing the Benefits of State-Sponsored Research: Intellectual Property Rights and Data Sharing in California's Stem Cell Initiative

In recent years data-sharing has been a recurring focus of struggle within the scientific research community as improvements in information technology and digital networks have expanded the ways that data can be produced, disseminated, and used. Information technology makes it easier to share data in publicly accessible archives that aggregate data from multiple sources. Such sharing and aggregation facilitate observations that would otherwise be impossible. But data disclosure poses a dilemma for scientists. Data have long been the stock in trade of working scientists, lending credibility to their claims while highlighting new questions that are worthy of future research funding. Some disclosure is necessary in order to claim these benefits, but data disclosure may also benefit ones research competitors. Scientists who share their data promptly and freely may find themselves at a competitive disadvantage relative to free riders in the race to make future observations and thereby to earn further recognition and funding. The possibility of commercial gain further raises the competitive stakes. This article discusses data sharing in Californias stem cell initiative against the background of other data sharing efforts and in light of the competing interests that the California Institute for Regenerative Medicine (CIRM) is directed to balance. We begin by considering how IP law affects data-sharing. We then assess the strategic considerations that guide the IP and data policies and strategies of federal, state, and private research sponsors. With this background, we discuss four specific sets of issues that public sponsors of data-rich research, including CIRM, are likely to confront: (1) how to motivate researchers to contribute data; (2) who may have access to the data and on what conditions; (3) what data get deposited and when do they get deposited; and (4) how to establish database architecture and curate and maintain the database.

Insurance for broad genomic tests in oncology

Insurance coverage should precede rather than follow clinical validation of broad genomic testing in oncology Tests based on DNA sequencing methods are redefining diagnostic categories in oncology and providing a rational basis for the development and use of new cancer therapies, especially the many drugs targeted against mutant proteins that drive malignant growth (1). The medical and economic value of identifying specific genetic abnormalities in cancers has been established by the evidence-based use of targeted drugs and immunotherapies in cancer patients (see the figure for an example). For some cancer therapies, the U.S. Food and Drug Administration (FDA)–approved label calls for the use of a companion diagnostic test for the presence or absence of certain genetic changes before initiating treatment. Most recently, the FDA approved the use of the immunotherapeutic pembrolizumab for treatment of tumors that show a defect in DNA repair called microsatellite instability, irrespective of the tissue of origin; although an FDA-approved test for microsatellite instability is not yet available, many clinical laboratories are using assays for the relevant biomarkers (2).

Obvious to Whom - Evaluating Inventions from the Perspective of PHOSITA

I. IN TRO D UCTION ....................................................................................................... 885 II. THE DIMINISHED ROLE OF PHOSITA IN JUDICIAL DECISIONS ............................... 889 III. W HAT PH O SITA KNow s ....................................................................................... 897 IV . CONSULTING PH O SITA ......................................................................................... 899

Reaching through the genome

Advances in genomics research have called forth new strategies for patenting DNA sequences. Gene patenting, which began inconspicuously in the early days of the biotechnology industry in the 1970s and 1980s, did not generate significant public controversy until the advent of high-throughput DNA sequencing in the 1990s. By this point, it was such a well-established practice that categorical challenges to the patentability of DNA seemed quaint and out of touch. Yet something was plainly different. In the early days, patenting genes looked like patenting drugs. By the early 1990s, it looked more like patenting scientific information. We have a reasonably clear story about why we should issue patents on drugs; the case for issuing patents on scientific information is less clear. Patents on research discoveries arising far upstream from end-product development threaten the interests of research scientists, who fear impediments to the free use and dissemination of new discoveries, and of downstream product developers, who fear that they will be foreclosed from pursuing certain research and development (R&D) pathways or that their profits will be diluted by the claims of upstream predecessors. At the same time, it is not obvious how upstream patent owners might use patents to capture the value that their discoveries contribute to downstream product development, particularly in the face of concerted resistance to sharing the wealth. This strategic challenge is leading upstream innovators to pursue novel patent claiming and licensing approaches that raise unresolved doctrinal and policy questions.

One Size Fits All, After Tailoring

Claiming that serious problems arise from current U.S. patent law applying the same set of rules across all industries, Burk and Lemley argue for giving the courts the power to interpret and apply the law so as to treat different types of businesses differently. Claiming that serious problems arise from current U.S. patent law applying the same set of rules across all industries, Burk and Lemley argue for giving the courts the power to interpret and apply the law so as to treat different types of businesses differently.

Promoting Healthcare Innovation on the Demand Side

Abstract Innovation policy often focuses on fortifying the incentives of firms that develop and sell new products by offering them lucrative rights to exclude competitors from the market. Regulators also rely on these same firms—and on similar incentives—to develop information about the effects of their products in patients, despite their obvious conflict of interest. The result may be a distorted understanding that leads to overuse of expensive new medical technologies. Recent technological advances have put healthcare payers in an excellent position to play a larger role in future innovation to improve healthcare and reduce its costs. Insurance companies and integrated healthcare providers have custody of treasure troves of data about healthcare provision and outcomes that can yield valuable insights about the effects of medical treatment without the need to conduct costly clinical trials. Some integrated healthcare systems have seized upon this advantage to make notable discoveries about the effects of particular products that have changed the standard of care. Moreover, to the extent that healthcare payers can profit from reducing costs, they will seek to avoid inappropriate use of costly technologies. Greater involvement of payers in healthcare innovation thus offers a potential counterweight to the incentives of product sellers to promote excessive use of costly new products. In recent years, the federal government has sought to promote innovation through analysis of healthcare records in a series of initiatives; some picture insurers as passive data repositories, while others provide opportunities for insurers to take a more active role in innovation. In this paper, we examine the role of health insurers in developing new knowledge about the provision and effects of healthcare—what we call ‘demand-side innovation’. We address the contours of this underexplored area of innovation and describe the behavior of participating firms. We examine the effects of current legal rules on demand-side innovation, including insurance regulation, intellectual property rules, privacy protections, and FDA regulation of new healthcare technologies. Throughout, we highlight many policy tools that government can use and is using to facilitate payer innovation outside the traditional toolkit of patents and exclusive rights.