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Seem farfetched? Not really. Given the current application of law to biotechnology, enforcement might be even more stringent, as in the case in which a farmer was found liable because he had saved and planted seed from patented genetically modified (GM) plants that had blown onto his land. The court suggested that a truly innocent bystander who did not intend to use patented GM seed could avoid liability by acting to arrange for the seed’s removal. This leaves open the possibility that a person who unintentionally is contaminated with a nanorobot would have to take action to have it removed, even if she never wanted it—or needed it—in the first place.
The patent office and regulators in general had better dust off their green eyeshades because, with the boundaries between living things and manufactured things beginning to blur, the old rules and procedures will not suffice.
The National Cancer Institute alone has implemented a five-year, $144.3-million program to fund nanotechnology development to improve options for the prevention, diagnosis, and treatment of cancer. Federal funds are augmented by individual state investment in nanotechnology, about 40 cents for every federal dollar of investment. For 2008, President George W. Bush allocated $1.44 billion for nanotechnology, an increase from $1.35 billion in 2007.
Private investment in the field is also substantial. More than 1,200 American startups base their existence solely on the promise of technology at the nano scale. The National Science Foundation has predicted that the global market for nanotechnology-related goods and services will reach $1 trillion by 2015, exceeding the combined economic impact of the telecommunications and information technology industries during the technology boom of the 1990s.
Government agencies and intellectual property policies will, for better or worse, constrain or encourage these developments. To get a patent, an applicant must prove that the invention is novel, non-obvious, and useful. Once a patent is granted, the patent holder can prevent anyone else from making, using, selling, or importing the invention. According to the principle of strict liability, a person or company doesn’t have to intend to infringe to be liable. While these patent rules seem straightforward, applying them to the field of nanotechnology might lead to preposterous results, potentially creating a patent thicket or absurdly ensnaring innocent infringers.
Take the requirement that an invention must be novel. Nanotechnologies take advantage of the fact that smaller size alone gives substances novel properties. However, the FDA considers the nano version of a chemical or product equivalent to the original larger version under the FDA approval process, so these smaller products would require no new pre-market approval testing. Yet, if the USPTO follows the FDA’s lead and maintains that these nanotechnology products are equivalent to their larger counterparts, they would not be patentable.
Various nanotechnology products have been found non-novel by the FDA and novel by the USPTO. NanOss is a bone implant that uses nanocrystals of calcium phosphate created from a patented precipitation process. The manufacturer, Ångstrom Medica, a privately held company located in the Boston area, claims that the nanocrystals, which will be reabsorbed by living bone, are very strong and resist cracking as compared to larger particles. It advertises the nanocrystals as duplicating “the microstructure, composition, and performance of human bone.”
