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2133.03(e) Permitted Activity; Experimental Use [R-2] - 2100 Patentability
2133.03(e) Permitted Activity; Experimental Use [R-2]
The question posed by the experimental use doctrine is "whether the primary purpose of the inventor at the time of the sale, as determined from an objective evaluation of the facts surrounding the transaction, was to conduct experimentation." Allen Eng'g Corp. v. Bartell Indus., Inc., 299 F.3d 1336, 1354, 63 USPQ2d 1769, 1780 (Fed. Cir. 2002), quoting EZ Dock v. Schafer Sys., Inc., 276 F.3d 1347, 1356-57, 61 USPQ2d 1289, 1295-96 (Fed. Cir. 2002) (Linn, J., concurring). Experimentation must be the primary purpose and any commercial exploitation must be incidental. >Moreover, the experimental activity must have a nexus with the claimed invention. In other words, testing must be performed to "perfect claimed features, or . features inherent to the claimed invention." SmithKline Beecham Corp. v. Apotex Corp., ___ F.3d ___, 2004 WL 868425 (Fed. Cir. April 24, 2004) (holding that clinical trials to gain FDA approval were not "experimental use" because the claimed invention was a chemical compound that was reduced to practice when synthesized; the FDA trials had no relationship to the claimed invention because the testing was directed to the compound's unclaimed intended use).<
If the use or sale was experimental, there is no bar under 35 U.S.C. 102(b). "A use or sale is experimental for purposes of section 102(b) if it represents a bona fide effort to perfect the invention or to ascertain whether it will answer its intended purpose..If any commercial exploitation does occur, it must be merely incidental to the primary purpose of the experimentation to perfect the invention." LaBounty Mfg. v. United States Int'l Trade Comm'n, 958 F.2d 1066, 1071, 22 USPQ2d 1025, 1028 (Fed. Cir. 1992) (quoting Pennwalt Corp. v. Akzona Inc., 740 F.2d 1573, 1581, 222 USPQ 833, 838 (Fed. Cir. 1984)). "The experimental use exception.does not include market testing where the inventor is attempting to gauge consumer demand for his claimed invention. The purpose of such activities is commercial exploitation and not experimentation." In re Smith, 714 F.2d 1127, 1134, 218 USPQ 976, 983 (Fed. Cir. 1983).
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