Much of EPA's focus over the past several years has been aimed at filling information gaps and gathering more data regarding the potential risks associated with nanomaterials, mostly through voluntary programs and agency-funded research. Recently, EPA has moved to quicken the pace of its regulatory efforts, through a series of actions taken under the authority of the Toxic Substances Control Act (TSCA). The agency has also fired a clear shot across the bow of the nanotechnology industry, warning producers and importers of nanoscale materials that the agency intends to pursue enforcement actions against companies that fail to heed EPA's new focus on regulating nanomaterials under TSCA. In light of these developments, companies with an interest in nanotechnology may want to reexamine the agency's recent regulatory initiatives, in order to gain a better understanding of how those actions might affect them.
A recent report gives an overview of how five jurisdictions (US, UK, EU, Australia and Canada) reacted to the recent emergence of nanotechnology-based products in the marketplace and it describes how this triggered activities in three domains: (a) public and stakeholder debate, (b) development of initial policy options, and (c) the management of regulatory development in a situation of scarce data. The bulk of the report describes the current situation (up to March 2009) in the five jurisdictions and this part doesn't contain information that hasn't already been covered elsewhere. In analyzing this data, however, the authors make some interesting observations and attempt to develop a set of six key regulatory governance principles that they propose for consideration by regulators.
Companies manufacturing, using, or selling nanoproducts in the Unites States would be well-served, at this early stage, to think proactively about minimizing future litigation risks. Candidly, the legal world has thus far lagged behind the growth in nano-related products and enterprises. But if the encyclopedic history of toxic tort, product liability, and environmental litigation in this country is any guide whatsoever, there is no reason enterprising plaintiffs' attorneys are less likely to tackle nanotechnology than other lucrative products and technological advances. Indeed, references to a potential link between carbon nanotubes and lung cancer have already sprouted on plaintiff-oriented websites across the country.
Complex technical and scientific issues means complex intellectual property issues. This especially is the case with nanotechnologies, which are not easy to classify. Patents are of critical importance for start-ups and smaller companies because they may help in negotiations over infringement of their patents during competitive posturing with larger corporations. There is also ample evidence that companies, start-ups, and universities are ascribing ever-greater value and importance to patents. Increasingly, they are willing to risk a larger part of their budgets to acquire and defend patents. A new book on bionanotechnology lists nine key considerations and strategies that bionanotechnology inventors must follow in order to adequately protect an invention even before a patent application is drafted or filed.
In 2005, the Project on Emerging Nanotechnologies released a report by Dr. J. Clarence Davies (Managing the effects of nanotechnology) that found that U.S. legislation was inadequate. Davies concluded that nanotechnology is difficult to address using existing regulations and a new regulatory framework was needed in order to take the unique properties and risks of nanomaterials into account. This was in somewhat contradiction to what the EU Commission had found after its preliminary risk assessment workshop in 2004. The European Commission concluded that the European Union could protect health and environment by using an incremental approach and adapt existing legislation. Although there are cultural and legal differences between the EU and U.S., some people had a hard time understanding how the conclusions of the two reports could be so different. Among them, a group of scientists in Denmark and Italy decided to take a very product-specific approach and analyze the existing legislation along the life-cycle of three different commercially available products containing nanomaterials. They conclude that the 'incremental approach' could work effectively, provided due explanations and amendments are taken where necessary.
The Oklahoma land rush of 1889 and similar land runs were events in which previously restricted land of the United States was opened for homesteading on a first come, first claim basis. A number of the individuals who participated in the run entered early and hid out until the legal time of entry to lay quick claim to some of the most choice homesteads. These people came to be identified as "sooners" and their actions led to hundreds of legal contests. Nowadays, universities and companies, from start-ups to multinational conglomerates, are rushing to aggressively stake out their turf in the nanotechnology patent area. The "sooners" in this nanotechnology patent land rush may be the ones who were issued what some say are "unduly broad" patents early on, in the hope of getting a windfall of nanotechnology intellectual property (IP) rights. While not violating the rules intentionally, upon re-examination some broad patents might not hold up to the United States Patent Act's requirement for full and complete disclosure. This uncertainty provides fertile grounds for possible litigation over nanotechnology patent claims based on broad and unprecise definitions and descriptions. Efforts are underway to address some of these problems.
Carbon nanotubes (CNTs) belong to the most exciting nanomaterials discovered so far and the buzz associated with them has to do with their amazing properties. Depending on their structure, they can be metals or semiconductors. They exhibit extraordinary mechanical properties, which make them extremely strong materials with good thermal conductivity. Their tensile strength is several times that of steel. These characteristics have generated strong interest in their possible use in reinforced composites, nanoelectronics, nanomechanical devices, circuits and computers. Single-wall nanotubes (SWNTs) are an intriguing variant of carbon nanotubes because they exhibit important electrical properties that are not shared by the multi-walled carbon nanotubes (MWNT). SWNTs are the most likely candidate for miniaturizing electronics toward the nanoscale. Because of their enormous commercial potential, universities, start-ups, and corporations have aggressively sought patent protection on nanotube-based products. A recent legal paper identifies key patents claiming compositions of matter, methods of production, and products incorporating nanotubes. The authors summarize potential patent invalidity arguments that may be raised against certain patents in the field and explain how the patent landscape impacts the commercialization of nanotube-based products. A proposed "Nanotube Patent Forum" could be a means for industry to facilitate cost-effective licensing transactions between patent holders and manufacturers.