An invalidating public use need not be the intended use of the invention disclosed or claimed in the patent. If the invention is fully disclosed to the public without restriction, a public use will be deemed to have occurred.
Background / Facts: The patents-in-suit are directed to a fish-oil derived prescription drug used to reduce triglyceride levels in adult patients with severe hypertriglyceridemia, i.e., high levels of triglycerides. Prior to the § 102(b) critical date before filing, the applicant for the patents distributed samples of a product embodying the claimed invention to several prominent university professors. It is undisputed that the distributions were (1) unrestricted, (2) non-experimental, and (3) for purposes of generating interest in the product. The professors did not use the products they received per se, in the sense of ingesting them or attempting to personally take advantage of their purported benefits, but did perform a variety of analytical tests on the chemical compounds in the ordinary course of study.
Issue(s): Whether an invalidating use of a pharmaceutical compound must be for the purposes identified in the patents themselves – in this instance, to treat hypertriglyceridemia.
Holding(s): No. “The inquiry is not whether the third person to whom an invention is disclosed makes an open and obvious use of it, but whether the inventor himself has made a use of his invention which is ‘public’ because it was given to a member of the public without restriction. … We are not persuaded by [the] argument that ‘use’ of a pharmaceutical formulation cannot occur until it is used to treat the condition it is intended to counteract, or at least physically ingested. Certainly, where only a partial demonstration of a system’s (or formulation’s) capabilities occurs … or where unsophisticated users are provided a compound with no detail regarding its formulation … there will be no public use. Where, as here, however, a compound is provided without restriction to one highly skilled in the art, that compound’s formulation is disclosed in detail, and the formulation is subject to confirmatory testing, no other activity is needed to render that use an invalidating one. Once the formulation was disclosed in full to [the university professors], without any restriction on its use, it had been released into the ‘public domain’ for purposes of § 102(b).”