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

Patenting the Human Genome

The increasing promise of federal funding for mapping and sequencing the human genome has brought with it renewed attention in the research science community to issues of intellectual property protection for products of biotechnology research. Echoing concerns raised a decade ago in the debate over commercialization of academic biomedical research, scientists have called for the free availability of all information generated through the Human Genome Project and have argued against allowing private intellectual property rights in such knowledge. Meanwhile, private parties have quietly been obtaining patents on bits and pieces of the human genome from the Patent and Trademark Office (PTO). Notwithstanding the willingness of the PTO to issue these patents, the patents may still be vulnerable to challenges to their validity in the courts. Patent claims to human DNA sequences raise unresolved issues under traditional patent doctrine. Moreover, even if the patent claims are valid under existing law, one might question the wisdom of issuing patents on DNA sequences in the human genome to private parties, particularly at a time .when the government is devoting public resources to a concerted research effort to generate this information. This Article examines some of these issues

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

A Functional Approach to Judicial Review of PTAB Rulings on Mixed Questions of Law and Fact

The Court of Appeals for the Federal Circuit (“Federal Circuit”) has long relied on active appellate review to bring uniformity and clarity to patent law. It initially treated the PTO the same as the federal district courts, reviewing its factual findings for clear error and its legal conclusions de novo. Following reversal by the Supreme Court in Dickinson v. Zurko, the Federal Circuit began giving greater deference to PTO factual findings. But it continued to review the PTO’s legal conclusions de novo, while coding an expansive list of disputed issues in patent cases as legal conclusions, even when they rest on subsidiary factfinding. Congress expanded the role of the PTO in adjudicating challenges to patent validity in the Leahy–Smith America Invents Act of 2011 (“AIA”), authorizing new adjudicatory proceedings before the Patent Trial and Appeal Board (“PTAB”) as an alternative to federal district court litigation. The AIA provides for Federal Circuit review of PTAB decisions, without specifying standards of review. The scope of review could determine the success of these proceedings as a quicker, cheaper, and more expert alternative to district court litigation of patent challenges. The Federal Circuit applies the same standards of review to PTAB decisions in AIA proceedings that it applies to other PTO rulings, reviewing legal conclusions de novo and factual findings for substantial evidence. It also follows the same characterizations of issues as legal or factual that it has long used in the context of court/court review. In the past, by maximizing the scope of appellate review, these characterizations allowed the Federal Circuit to exercise greater quality control over generalist trial courts with limited competence to resolve patent matters. The net benefits are more dubious as applied to decisions of expert PTAB panels in AIA adjudications. Yet reversal rates at the Federal Circuit are essentially the same for PTAB decisions as for decisions of district courts in patent cases, threatening to frustrate a system designed to improve patent quality while limiting litigation costs. This Essay reconsiders the proper scope of judicial review of PTAB rulings on two issues that the Federal Circuit codes as legal conclusions with factual underpinnings: nonobviousness and claim interpretation. Drawing on a functional approach to judicial review of mixed questions of law and fact, it argues for more deferential review of PTAB rulings on nonobviousness and claim interpretation given the expertise of the administrative tribunal and the case-specificity of the rulings. The Federal Circuit would do better to confine de novo review to generalizable legal rulings that provide guidance in future matters rather than replicating the work of the PTAB from the appellate bench on routine case-specific rulings

The Supreme Court and the Federal Circuit: Visitation and Custody of Patent Law

The U.S. Supreme Court’s relationship to patent law sometimes seems like that of a non-custodial parent who spends an occasional weekend with the kids. The custodial parent is, of course, the U.S. Court of Appeals for the Federal Circuit. The Federal Courts Improvement Act of 1982 consolidated intermediate appellate jurisdiction over patent law cases in this single court, which hears appeals from the U.S. Patent and Trademark Office (“PTO”), the U.S. District Courts, the U.S. Court of Federal Claims, and the U.S. In-ternational Trade Commission. Day to day it is the Federal Circuit that reviews contested decisions of the institutions that administer the patent sys-tem. Congress created the Federal Circuit in order to achieve national uniformity, doctrinal stability, and predictability in patent law—leaving some question as to the appropriate role for the Supreme Court. The Su-preme Court controls the frequency of its patent law visits, and it is free to grant certiorari more often if it is unhappy with the Federal Circuit’s stew-ardship. But the Supreme Court has other work to do; it is an extraordinary year when it manages to review as many as three patent cases, as it did this past term. When each of these Supreme Court visits eventually comes to an end and everyday life resumes, it becomes plain once again that the Federal Circuit is, for all practical purposes, the parent in charge. The increasing propensity of the Supreme Court to grant review in pat-ent cases suggests that it is concerned about how good a job the Federal Circuit is doing. But the consolidation of intermediate appellate jurisdiction in a single court presents special challenges for Supreme Court review. First, how does the Court decide which cases to review without circuit splits to signal important and contested issues? Second, what benchmarks can it use to evaluate the jurisprudence of a court that stands alone in its field? Third, how can it control future decisions of an expert court that disagrees with it