Technology Transfer and the Genome Project: Problems with Patenting Research Tools

Professor Eisenberg argues against a system providing for federally-sponsored inventions to be patented if any associated person so desires. She believes that the system does not adequately weigh the possibility that the greatest social return from genome research will require some discoveries to be in the public domain

Harnessing and Sharing the Benefits of State Sponsored Research

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 one\u27s 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 California\u27s 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

Academic Freedom and Academic Values in Sponsored Research

In this Article I examine the traditional American conception of academic freedom and analyze its implications for universities formulating policies on the acceptance of sponsored research. I begin by reviewing the basic policy statements of the American Association of University Professors (AAUP) on academic freedom to identify both the academic values implicit in those statements and the assumptions about institutional relationships and individual incentives underlying their prescriptions for advancing those values. I then evaluate the validity of those underlying assumptions in contemporary sponsored research and argue that academic freedom as traditionally conceived might no longer effectively advance academic values in externally sponsored research. Against this background, I examine recent policies of thirty-nine universities on the acceptance of classified and proprietary research and analyze the roles of academic freedom and academic values in formulating university research policy

Reaching Through the Genome

The past two decades have been a period of rapid evolution in the science of biotechnology and therefore in patent strategies, if not in patent law itself. Patent law takes a long time to catch up with science, and commentators take a long time to catch up with the law, but patent lawyers don’t have that luxury. They have to keep ahead of the game, figuring out claiming strategies that allow their clients to capture the value of future discoveries. I want to discuss some of these strategies today

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

Diagnostics Need Not Apply

Diagnostic testing helps caregivers and patients understand a patient\u27s 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 statutory categories of patentable subject matter to a finite list repeatedly articulated in the Court\u27s own prior decisions for laws of nature, physical phenomena, and abstract ideas, while declining to embrace other judicial exclusions that were never expressed in Supreme Court opinions. The result has been a series of decisions that, while upending a quarter century of lower court decisions and administrative practice, purport to be a straightforward application of ordinary principles of stare decisis. As the implications of these decisions are worked out, the Court\u27s robust understanding of the exclusions for laws of nature and abstract ideas seems to leave little room for patent protection for diagnostics. This Article reviews recent decisions on patent-eligibility from the Supreme Court and the Federal Circuit to demonstrate the obstacles to patenting diagnostic methods under emerging law. Although the courts have used different analytical approaches in recent cases, the bottom line is consistent: diagnostic applications are not patent eligible. I then consider what the absence of patents might mean for the future of innovation in diagnostic testing

Analyze This: A Law and Economics Agenda for the Patent System

Legal scholars and economists might enhance the value and impact of their work by making more effective use of each other\u27s knowledge and capabilities. Legal scholars can offer a more nuanced understanding of the legal rules that underlie the patent system and the doctrinal levers that might be manipulated in furtherance of public policy goals. Economists bring to bear a set of analytical and methodological tools that could shed considerable light on what these doctrinal levers are doing and which of them we ought to be manipulating. Together, we have a better chance of asking the right questions and thinking about them in a useful way. Towards that end, this Essay provides an overview of issues of patent doctrine that might be illuminated by good work in law and economics. It is important not only to identify the levers in the patent system that are available for manipulation, but also to understand which policy choices are best addressed through the manipulation of each of these levers. Economic analysis that is grounded in a better understanding of patent doctrine can better inform us about the most effective use of the levers that control the operation of the patent system

Wisdom of the Ages or Dead-Hand Control? Patentable Subject Matter for Diagnostic Methods After In Re Bilski

In 1980, the Supreme Court gave a reassuring signal to the then-nascent biotechnology industry about the availability of patent protection for the fruits of its research when it upheld the patentability of a genetically modified living organism in Diamond v. Chakrabarty. Twenty-five years later, the Court seemed poised to reexamine the limits of patentable subject matter for advances in the life sciences when it granted certiorari in Laboratory Corporation v. Metabolite. But the Federal Circuit had not addressed the patentable subject matter issue in Laboratory Corporation, and the Court ultimately dismissed the certiorari p etition as improvidently granted. Five years later, two pending cases in which the issue of patentable subject matter has been fully litigated in the lower courts provide opportunities for the Court to resolve some of the uncertainties exposed in Laboratory Corporation

The Problem of New Uses

Discovering new uses for drugs that are already on the market seems like it ought to be the low-lying fruit of biopharmaceutical research and development (R&D). Firms have already made significant investments in developing these drugs and bringing them to market, including testing them in clinical trials, shepherding them through the FDA regulatory approval process, building production facilities, and training sales staff to market them to physicians. By this point, the drugs have begun to enjoy goodwill among patients and physicians and casual observations in the course of clinical experience may point to potential new uses. One might expect that firms would be well-motivated to invest in the further clinical trials necessary to market their products for new uses. But in practice, the legal and economic environment for drug development complicates firms\u27 incentives to pursue this research. Examining the problem of motivating firms to invest in rigorous testing of new uses for previously approved drugs provides an interesting window on this environment

Prometheus Rebound: Diagnostics, Nature, and Mathematical Algorithms

The Supreme Court’s decision last Term in Mayo v. Prometheus left considerable uncertainty as to the boundaries of patentable subject matter for molecular diagnostic inventions. First, the Court took an expansive approach to what counts as an unpatentable natural law by applying that term to the relationship set forth in the challenged patent between a patient’s levels of a drug metabolite and the indication of a need to adjust the patient’s drug dosage. And second, in evaluating whether the patent claims add enough to this unpatentable natural law to be patent eligible, the Court did not consult precedents concerning the patentability of claims involving natural laws and natural products. Instead, it turned to two seemingly inconsistent decisions that reached opposing conclusions concerning the patent eligibility of industrial methods that used mathematical algorithms. The Court’s analysis invites challenges to many issued patents, while offering little guidance for resolving them. This Term, in the Association for Molecular Pathology case, the Court has another opportunity to clarify the meaning of its exclusion of natural phenomena from patent eligibility