Nanotechnology is Starting to Produce Big Legal Issues

In the view of some, nanotechnology is expected to become the transformational technology of the 21st century.

This technology focuses on controlling matter at the scale of one billionth of a meter (approximately 100,000th the width of a human hair) in order to “create new materials with novel properties and functions.”

The National Science Foundation predicts that nanotechnology “eventually could impact the production of virtually every human-made object” and “lead to the invention of products yet to be imagined.”

Yes, the technology of the very small could become very big.

Not surprisingly, the promise of nanotechnology also carries with it unique risks and technical issues. Studies have already shown that certain nanoparticles may pass through cell membranes and distribute to sensitive sites throughout the body, including bone marrow, spleen, heart and brain.

Other nanomaterials have been found to potentially interfere with the body’s antioxidant defenses. The assessment of nanotechnology hazards, which is only in its preliminary stages, is complicated by the difficulty of detecting nanoparticles at low concentrations and the difficulty of applying studies of macro materials to their nanocounterparts.

Environmental Hazard?

Since it is far more efficient than the macro-technologies of today, nanotechnology can drastically reduce consumption of natural resources, as well as the generation of waste. There is already a market for remediation technologies using nanoparticles that can inexpensively clean the environment by breaking down contaminants into less harmful materials. Nanotechnology also has the potential to make an impact on the detection of pollutants, such as toxic substances in drinking water.

Unfortunately, nanomaterials may also present risks to the environment. Waterborne nanoengineered Carbon-60 was found to lead to “oxidative stress” in the brains of largemouth bass.

Some scientists are concerned that runaway nanoparticles could self-replicate into destructive masses, either accidentally or through acts of terrorism. Based on the perception that the current, very limited regulatory frameworks in the United States and in other parts of the world do not adequately address the use of nanomaterials, a task force of the Section of Environment, Energy and Resources of the American Bar Association is currently preparing briefing papers for the Environmental Protection Agency to assist the Agency with the creation and implementation of new laws to regulate the development and use of nanotechnology. (One of the authors of this article, Jane Warren, is a member of this task force.)

Occupational Safety and Health Danger

Studies of ultra-fine aerosol particles in the workplace have shown that inhalation of nanosized fibers and particles can lead to increased rates of cancer, lung disease and respiratory problems.

Given the emerging indications that the toxicity of nanomaterials depends on their shape, solubility, surface chemistry and surface area, scientists have already concluded that typical toxicity screening studies cannot be effectively used to evaluate nanomaterials. Therefore, little is really known about how such materials could affect exposed workers. Not surprisingly, OSHA does not have any specific standard that addresses permissible exposure limits for nanomaterials, and, given the potential for a wide variety of nanomaterials being introduced into the workplace, developing standards on a substance-by-substance basis may be impossible.

In fall 2005, the National Institute for Occupational Safety and Health released its plans for pursuing strategic nanotechnology research. If research identifies a clear, quantifiable hazard involved with the production or use of nanomaterials, OSHA can be expected to use the general duty clause or even its authority to issue emergency temporary standards to regulate these materials, at least on a limited basis.

Intellectual Property Questions

Patenting nanotechnology inventions raises several issues that have not yet been addressed. For example, nanotechnology inventions in which a size range is claimed that overlaps with the size range of a product described in a prior patent or publication are usually rejected by the Patent & Trademark Office (PTO) as obvious.

In some cases, the prior patent or publication may not express a lower size limit on the particular product described, although nanoscale products were not contemplated. The courts have not yet addressed the propriety of rejecting a nanotechnology patent as obvious in these circumstances.

The PTO has begun to address some of the new issues that are created by patent applications for nanotechnology. The PTO has created a new classification within the PTO for nanotechnology applications.

In the new classification, Class 977, nanotechnology is generally defined as inventions having “the length of scale of approximately 1-100 nanometer range in at least one direction,” and where novel properties or functions are attributed to the nanoscale of the invention.

The PTO has not yet created a specialized group of patent examiners to review nanotechnology patents, although as more patents on nanotechnology are filed, it would seem that a specialized examination would be appropriate.

Products Liability

It has been estimated that by 2004, there were already $13 billion worth of products incorporating nanotechnology in the global marketplace. It is estimated that the number will rise to $1 trillion by 2015. The Project on Emerging Nanotechnologies reports that there are already approximately 1,200 nanotech startups worldwide, with more than 60 percent of these located in the U. S.

This activity suggests the possibility that nanoproducts will be pushed to market before their risks, particularly long-term risks, are fully understood. Since nanoparticles can enter the body through a variety of routes, including the possibility of penetrating the skin, and since – as noted earlier – nanoparticles may travel within the body in unconventional ways, the risk assessment which is typically done before a product is introduced in commerce may be very difficult for nanomaterials. One observer commented that “we are at the bottom of a very steep learning curve.”

The evolving situation indicates that there is a critical need for research findings to be shared widely so that product risk assessment can be done as quickly and as thoroughly as possible.

The Project on Emerging Nanotechnologies is compiling an inventory of worldwide risk-related research in order to facilitate this process. Although we know little about the risks associated with nanoproducts, we know enough to be aware that the premature introduction of such materials into the marketplace could produce significant product liability litigation.

The authors are attorneys with the Hartford, Conn. firm of McCarter English.
Eric E. Grondahl’s practice focuses on patent prosecution, licensing and patent infringement litigation, concentrating on chemicals, pharmaceuticals and medical devices. He can be reached at [email protected] and (860) 275-6704.

Richard Voigt represents employers in a wide variety of employment-related matters, including wrongful discharge cases, employment discrimination cases, trade secret/proprietary information cases, NLRB unfair labor practice proceedings, arbitration matters, OSHA citation cases, and wage-hour claims. He can be reached at [email protected] and (860) 275-6776.