Douglas J. Sylvester

What Does the History of Technology Regulation Teach Us About Nano Oversight

As policy makers struggle to develop regulatory oversight models for nanotechnologies, there are important lessons that can be drawn from previous attempts to govern other emerging technologies. Five such lessons are the following: (1) public confidence and trust in a technology and its regulatory oversight is probably the most important factor for the commercial success of a technology; (2) regulation should avoid discriminating against particular technologies unless there is a scientifically based rationale for the disparate treatment; (3) regulatory systems need to be flexible and adaptive to rapidly changing technologies; (4) ethical and social concerns of the public about emerging technologies need to be expressly acknowledged and addressed in regulatory oversight; and (5) international harmonization of regulation may be beneficial in a rapidly globalizing world.

A Framework Convention for Nanotechnology

With nanotechnology now a major funding priority for governments and industry around the world, devising the manner and timing of regulation presents a challenge. Too much regulation too soon could hinder development of beneficial technologies, while too little regulation too late may allow dangerous technologies to enter the market. Kenneth Abbott, Gary Marchant, and Douglas Sylvester argue that any solution to this regulatory dilemma must have four basic characteristics: the solution must be flexible, innovative, international, and official. In this Article, they advocate a framework convention on nanotechnology as a regulatory tool meeting these four requirements. The authors use a series of case studies to reveal framework convention best practices, and conclude with a summary of how a nanotechnology framework convention might be structured.

International harmonization of regulation of nanomedicine

Nanomedicine holds enormous promise for the improved prevention, detection and treatment of disease. Yet, at the same time, countervailing concerns about the potential safety risks of nano-technologies generally, and nanomedical products specifically, threaten to derail or at least delay the introduction and commercial viability of many nanomedicine applications. All around the globe, national governments are struggling with balancing these competing benefits and risks of nanotechnology in the medical and other sectors. It is becoming increasingly clear that reasonable, effective and predictable regulatory structures will be critical to the successful implementation of nanotechnology. The question examined in this paper is whether there are mechanisms of international harmonization or cooperation that can facilitate the development of more effective and efficient regulatory regimes for nanomedicine?Part I of this paper briefly summarizes the promise of nanomedicine as well as potential concerns about the risks of nanomedical applications that will require regulatory oversight. In Part II, we analyze the various factors weighing for and against attempts to harmonize regulatory requirements at the international level. Finally, in Part III we identify some specific existing or feasible mechanisms that may be useful for fostering international harmonization in the regulation of nanomedicine.

Navigating the Patent Landscapes for Nanotechnology: English Gardens or Tangled Grounds?

The patent landscape, like a garden, can tell you much about its designers and users: their motivations, biases, and general interests. While both patent landscapes and gardens may appear to the casual observer as refined and ordered, an in-depth exploration of the terrain is likely to reveal unforeseen challenges including, for example, alien species, thickets, and trolls. As this chapter illustrates, patent landscapes are dynamic and have been forced to continually evolve in response to technological innovation. While emerging technologies such as biotechnology and information communication technology have challenged the traditional patent landscape, the overarching framework and design have largely remained intact. But will this always be the case? The aim of this chapter is to highlight how nanotechnology is challenging the existing structures and underlying foundation of the patent landscape and the implications thereof for the technology, industry, and public more generally. The chapter concludes by asking the question whether the current patent landscape will be able to withstand the ubiquitous nature of the technology, or whether nanotechnology will be a catalyst for governments and policy makers for overhauling the current landscape design.

Returning to the Patent Landscapes for Nanotechnology: Assessing the Garden that It Has Grown Into

The patent landscape, like a garden, can tell you much about its designers and users; their motivations, biases, and general interests. While both patent landscapes and gardens may appear to the casual observer as refined and ordered, an in-depth exploration of the terrain is likely to reveal unforeseen challenges including, for example, alien species, thickets, and trolls. As this Chapter illustrates, patent landscapes are dynamic and have been forced to continually evolve in response to technological innovation. While emerging technologies, such as biotechnology and information communication technology have challenged the traditional patent landscape, resulting in the pruning of certain elements here and there, the overarching framework and design has largely remained intact. But will this always be the case? As the field of nanotechnology continues to evolve and mature, the aim of this Chapter is to map how the technology has evolved and grown within the confines of existing structures and underlying foundation of the patent landscape and the implications thereof for the technology, industry, and the public more generally. The Chapter concludes by asking the question whether the current patent landscape will be able to withstand the ubiquitous nature of the technology, or whether nanotechnology, in combination with other emerging technologies, will be a catalyst for governments and policy makers to completely redesign the patent landscape.

English Garden or Tangled Grounds? Navigating the Nanotechnology Patent Landscape

The patent landscape, like a garden, can tell you much about its designers and users; their motivations, biases and general interests. And while both patent landscapes and gardens may appear to the casual observer as refined and ordered, an in depth exploration of the terrain is likely to reveal unforeseen challenges including, for example, alien species, thickets and trolls. As this article illustrates, patent landscapes are dynamic and have been forced to continually evolve in response to technological innovation. Emerging technologies, such as biotechnology and information communication technology, have challenged the traditional patent landscape, the overarching framework and design has largely remained intact. But will this always be the case? The aim of this article is to highlight how nanotechnology is challenging the existing structures and underlying foundation of the patent landscape and the implications thereof for the technology, industry and the public more generally. The article concludes by asking the question whether the patent landscape will be able to withstand the ubiquitous nature of the technology, or whether nanotechnology will be a catalyst for governments and policy makers to overhaul the current landscape design. In the end, we suggest that nanotechnology may be the final push for cross-national harmonization of patent laws and administration.