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The FDA received a citizen petition from the International Center for Technology Assessment (ICTA) raising health and safety concerns relating to sunscreen products that contain nano-sized materials. In response, the FDA in August 2007 requested comments and data from the public about the safety and effectiveness of sunscreens with nanoparticles and how they should be regulated.
Faced with a new technology that creates challenges for business as usual, the USPTO seems to be granting rights to the same nanotechnology to several different entities—a sure recipe for disastrous litigation down the road.
According to the U.S. Department of Energy, nanotechnologies “reach into electronics, biotechnology, medicine, transportation, agriculture, environment, national security, and other fields.” It is likely that a particular nanotechnology—such as a carbon nanotube or a quantum dot—will have uses in multiple fields, but the USPTO is not organized for analyzing multidisciplinary patents. Instead, it is divided into eight specific technology centers: biotechnology and organic chemistry; chemical and materials engineering; computer architecture, software, and information security; communications; semiconductors, electrical and optical systems and components; designs; transportation, construction, electronic commerce, agriculture, national security, and license and review; and mechanical engineering, manufacturing, and products.
When an inventor submits a patent application, the USPTO routes it to the technology center with expertise in the particular discipline covered by the patent application. Because nanotechnology has such a broad scope, the USPTO does not have a single, specific technology center devoted to it.
Without specialization within the patent office, it is more difficult for examiners to gain experience with nanotechnology patents, more difficult for examiners to communicate with other examiners experienced with nanotechnology, and more difficult for the USPTO to educate personnel. As a result, nanotechnology patents may be issued that are overbroad, of poor quality, or invalid.
The ETC Group, a nonprofit environmental group, criticizes patents that claim one basic nanotechnology application but cover large portions of the periodic table. One applicant claimed proprietary rights to a metal-oxide nanorod made with any one of 33 different chemical elements. A quantum dot patent claimed semiconducting nanocrystals made from any of the elements contained within Groups III-V of the periodic table.
Columbia University economist Bhaven Sampat found that, between 2001 and 2003, 794 different primary patent examiners analyzed the 3,748 nanotechnology patents he identified in his study. This represented nearly one-fourth of the primary patent examiners employed by the USPTO during that time period. Similarly, in 2004, patent attorneys Donald Featherstone and Michael Specht reported that 142 examiners analyzed 206 nanotube patents. Less than one-quarter of these examiners examined more than one nanotube patent.
