Specialized Trial Courts: Concentrating Expertise on Fact

In the absence of a specialized patent trial court with expertise in fact-finding, the Court of Appeals for the Federal Circuit often reviews de novo the many factual questions that pervade patent law. De novo review of fact by an appellate court is problematic. In the area of patent law, as in other areas of law, there are sound institutional justifications for the conventional division of labor that gives trial courts primary responsibility for questions of law. This Article identifies the problems created by de novo appellate review of fact and argues for the creation of a specialized trial court to which the Federal Circuit would feel compelled to defer on questions of fact. It also discusses how such a court would be designed, focusing on the manner in which trial court judges could use the court-appointed advisors to evaluate competing factual claims

Who’s Afraid of the Federal Circuit?

In this brief Essay, Professor Rai responds to Professor Jonathan Masur\u27s Yale Law Journal article Patent Inflation. Professor Masur\u27s argument rests on the assumption that U.S. Patent and Trademark Office ( PTO ) behavior is determined almost entirely by a desire to avoid reversal by the Federal Circuit. Although the PTO is certainly a weak agency over which the Federal Circuit has considerable power, Masur overestimates the extent to which high-level PTO administrators are concerned about Federal Circuit reversals and underestimates institutional influences that are likely to operate in a deflationary direction. The PTO is influenced not only by the Federal Circuit but also by executive branch actors, industry players, and workload concerns that can push in a deflationary direction

Unstandard Standardization: The Case of Biology

How applicable are the approaches adopted by information and communication technology standards-setting organizations to biological standards? Most engineering-based industries construct products from standard, well understood components. By contrast, despite the early attachment of the moniker “genetic engineering” to biotechnology, standardization in the biological sciences has been relatively rare

Biomedical Patents at the Supreme Court: A Path Forward

Although most would argue that software patents pose a bigger challenge, the U.S. Supreme Court has recently focused on biomedical patents. Two of the Court\u27s recent decisions scaling back such patents, Mayo v. Prometheus and AMP v. Myriad, have provoked justifiable anxiety for those concerned about biomedical innovation, particularly in the area of personalized medicine. While acknowledging significant limitations in the Court\u27s reasoning in both cases, this Essay sketches a reading that is consistent with the results and innovation-friendly

A Brief History of BioPerl

Large-scale open-source projects face a litany of pitfalls and difficulties. Problems of contribution quality, credit for contributions, project coordination, funding, and mission-creep are ever-present. Of these, long-term funding and project coordination can interact to form a particularly difficult problem for open-source projects in an academic environment. BioPerl was chosen as an example of a successful academic open-source project. Several of the roadblocks and hurdles encountered and overcome in the development of BioPerl are examined through the telling of the history of the project. Along the way, key points of open-source law are explained, such as license choice and copyright. The BioPerl project current status is then analyzed, and four different strategies typically employed by traditional open-source projects at this stage are analyzed as future directions. Strategies such as soliciting donations, securing grants, providing dual-licenses to enhance commercial interest, and the paid provision of support have all been employed in various traditional open-source projects with success, but each has drawbacks when applied to the academy. Finally, the construction of a successful long-term strategy for BioPerl, and other academic open-source projects, is proposed so that such projects can navigate the difficulties

Synthetic Biology: Caught Between Property Rights, the Public Domain, and the Commons

Synthetic biologists aim to make biology a true engineering discipline. In the same way that electrical engineers rely on standard capacitors and resistors, or computer programmers rely on modular blocks of code, synthetic biologists wish to create an array of modular biological parts that can be readily synthesized and mixed together in different combinations. Synthetic biology has already produced important results, including more accurate AIDS tests and the possibility of unlimited supplies of previously scarce drugs for malaria. Proponents hope to use synthetic organisms to produce not only medically relevant chemicals but also a large variety of industrial materials, including ecologically friendly biofuels such as hydrogen and ethanol. The relationship of synthetic biology to intellectual property law has, however, been largely unexplored. Two key issues deserve further attention. First, synthetic biology, which operates at the confluence of biotechnology and computation, presents a particularly revealing example of a difficulty that the law has frequently faced over the last 30 years -- the assimilation of a new technology into the conceptual limits around existing intellectual property rights, with possible damage to both in the process. There is reason to fear that tendencies in the way that the law has handled software on the one hand and biotechnology on the other could come together in a perfect storm that will impede the potential of the technology. Second, synthetic biology raises with remarkable clarity an issue that has seemed of only theoretical interest until now. It points out a tension between different methods of creating openness. On the one hand, we have intellectual property law\u27s insistence that certain types of material remain in the public domain, outside the world of property. On the other, we have the attempt by individuals to use intellectual property rights to create a commons, just as developers of free and open source software use the leverage of software copyrights to impose requirements of openness on future programmers, requirements greater than those attaching to a public domain work

Structuring U.S. Innovation Policy: Creating a White House Office of Innovation Policy

This article begins with a discussion of innovation’s importance to the future well-being of American society. The authors then discuss limitations of the current federal framework for making innovation policy. Specifically, the relative absence of innovation from the agenda of Congress and many relevant federal agencies manifests the confluence of two regulatory challenges: first, the tendency of political actors to focus on short-term goals and consequences; and second, political actors’ reluctance to threaten powerful incumbent actors. Courts, meanwhile, lack sufficient expertise and the ability to conduct the type of forward-looking policy planning that should be a hallmark of innovation policy. Ultimately, their analysis leads to a proposal that President Obama (or Congress, if Congress is willing) create a White House OIP that would have the specific mission of being the “innovation champion” within these processes. The authors envision OIP as an entity that would be independent of existing federal agencies and that would have more than mere hortatory influence. It would have some authority to push agencies to act in a manner that either affirmatively promoted innovation or achieved a particular regulatory objective in a manner least damaging to innovation. We also envision OIP as an entity that would operate efficiently by drawing upon, and feeding into, existing interagency processes within OIRA and other relevant White House offices (e.g., the Office of Science and Technology Policy)