One Ingredient, One Term
March 24, 2004
Last Month at the Federal Circuit - April 2004
Judges: Rader (author), Bryson, and Dyk
In Arnold Partnership v. Godici, No. 03-1339 (Fed. Cir. Mar. 24, 2004), the Federal Circuit affirmed the district court’s denial of term extension for U.S. Patent No. 4,587,252 (“the ‘252 patent”), which claims, inter alia, compositions comprising hydrocodone and ibuprofen. Term extension for the ‘252 patent would be proper under 35 U.S.C. § 156 “if . . . the permission for the commercial marketing or use of the product . . . is the first permitted commercial marketing or use of the product . . . .” 35 U.S.C. § 156(a)(5)(A). More specifically, term extension would have been proper if the statutory term “product” referred to the claimed combination of hydrocodone and ibuprofen, rather than these individual active ingredients, because both of these ingredients had been previously marketed individually, whereas the combination had not.
The Federal Circuit held that “product” under the statute referred to “the active ingredient,” not to the “active ingredient[s],” because that was precisely how the statute defined the term “product”: as singularly referring to “the active ingredient.” See 35 U.S.C. § 156(f)(1)(A) and (f)(2)(A). The Court found no statutory history that contradicted this “straightforward reading of the statute.” The Court also rejected the implication that a provision for calculating the period of the extension, 35 U.S.C. § 156(c), which referred to the “review period for the approved product,” somehow required “a definition in harmony with the product approved by [the] FDA,” contrary to the plain language of the statute. Accordingly, the Federal Circuit affirmed the district court’s denial of term extension under 35 U.S.C. § 156.