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“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.”
At the everyday level of human experience, gold is a shiny inert metal and a medium of exchange. At the level of a nanoparticle, however, gold becomes a semiconductor, its color changes, and its melting point decreases dramatically as the particle size gets smaller. And small is the essence of nanotechnology—the manipulation and control of matter at the scale of 1 to 100 nanometers (a nanometer is 1 billionth of a meter), which capitalizes on the unique properties at this scale.
Nanogold is already used in home pregnancy testing kits in which the pregnancy hormone causes the gold nanoparticles to aggregate and appear red. It is also used to detect lead in water, to locate minute amounts of a protein linked to the early diagnosis of Alzheimer’s in cerebrospinal fluid, and to target and destroy cancerous tissue.
But as the “gold rush” of nanotechnology converges with biotech to form a “biomolecular economy,” the very shape-shifting, boundary-crossing nature of this field that holds such promise also makes it a regulator’s nightmare. Already, the U.S. Food and Drug Administration (FDA) and the U.S. Patent and Trademark Office (USPTO) are being criticized for their approaches as they attempt both to encourage and to impose order on the field.
Consider, for example, the nano implications of the standard patent holder’s right to demand royalties from anyone who “uses” his or her invention. Researchers at Carnegie Mellon University are currently working on nano-sized machines that could be inserted into the bloodstream to clear cholesterol from clogged arteries. Nanotechnology eventually may be used to help fight a person’s cold or flu by introducing nano-sized devices or particles into a person’s bloodstream or airway that could hunt and destroy viruses. Depending on the nature of these devices, a person may need only to share saliva or blood to pass on his or her nanotechnology device to another.
Here’s one hypothetical challenge for regulatory authorities: Let’s say that a woman goes to visit her brother, who is a recent recipient of an injection of artery-cleaning nanobots. While talking, the brother sneezes, exhaling nanobots that are immediately and unwittingly inhaled by his sister. Now the nanobots begin coursing through her arteries, clearing them of plaque. For purposes of the Patent Act, the sister is “using” the nanobots, even though she did not intend to use them and, apart from breathing, did not take any action to start doing so. Under the patent statute, the sister is liable for infringement and could be required to pay a royalty.
