To Add Claims to a Separate Invention on Reissue, the Specification Must Clearly and Unequivocally Disclose the Newly Claimed Invention as a Separate Invention

Antares Pharma Inc. v. Medac Pharma Inc., ___ F.3d ___ (November 17, 2014) (DYK, Reyna, Taranto) (D. Del.: Robinson) (3 of 5 stars)
Federal Circuit affirms denial of preliminary injunction in a patent case involving injection devices used to self-administer pharmaceuticals, holding new claims added during reissue invalid based on the "original patent" requirement of 35 U.S.C. § 251.

Original Patent: The Federal Circuit held that the Supreme Court's decision in U.S. Industrial Chemicals, Inc. v. Carbide & Carbon Chemicals Corp., 315 U.S. 668 (1942) provided the definitive test for the original patent requirement of § 251 despite changes to the language of the reissue statue in the 1952 Patent Act, noting that "[t]here is nothing in the statutory language or legislative history suggesting that Congress intended to overturn the long line of Supreme Court cases culminating in Industrial Chemicals by [the] change in language," slip op. at 11, and that both the regional circuits and CCPA continued to apply Industrial Chemicals after 1952. The Federal Circuit further held that the original patent requirement was "analogous to the written description requirement," but that the two standards are not coextensive; in order to add claims to a separate invention during reissue "the specification must clearly and unequivocally disclose the newly claimed invention as a separate invention." Id. at 15. The court held that the asserted reissue claims, which focused on combinations of safety features for injection devices, did not satisfy that standard because (1) the specification described the safety features only in combination with the jet injection invention claimed in the original claims, but the reissue claims were not limited to jet injectors, and (2) the specification merely described the safety features serially rather than in the "particular combinations" claimed during reissue.

Preliminary Injunction: The Federal Circuit affirmed denial of Antares' motion for a preliminary injunction, holding that because the asserted claims were invalid under § 251, Antares could not show a likelihood of success on the merits.

Authors: Chris W. Dryer, Michael C. Tyler