Antares Pharma. v. Medac Pharma. Inc.,: Specification Must Clearly and Unequivocally Disclose New Claims on Reissue

Category: Post-Grant Proceedings 
By: John Kirkpatrick, Contributor 
TitleAntares Pharma. v. Medac Pharma. Inc., No. 2014-1648 (Fed. Cir. Nov. 17, 2014).
Issue[Are] the asserted reissue claims of [RE44,846 ("the '846 patent)] invalid for [...] failing the original patent requirement of [35 U.S.C. § 251, requiring] that the original specification expressly disclose the particular invention claimed on reissue[?]
Antares Pharma, at *4 (text added).
HoldingU.S. Industrial Chemicals, Inc. v. Carbide & Carbon Chemicals Corp., 315 U.S. 668 (1942) made clear that, for § 251, “it is not enough that an invention might have been claimed in the original patent because it was suggested or indicated in the specification.” [...] Rather, the specification must clearly and unequivocally disclose the newly claimed invention as a separate invention.
Id. at *15 (text added, internal citation removed).
Procedural HistoryAntares filed suit against Medac in the District of Delaware [...] alleging infringement. [...]  Antares [then] filed a motion for preliminary injunction. [...] [T]he district court denied the motion for preliminary injunction, finding that Antares failed to carry its burden of showing a likelihood of success on the merits with respect to the ’846 patent because [the claims] are likely invalid for violating the recapture rule.
Antares Pharma, at *4-5 (text added).
Legal Reasoning (DYK, Reyna, Taranto)
Facts[Antares] is the assignee of U.S. Patent No. 7,776,015 (“the ’015 patent”).  That patent [...] discloses a system for injecting medicant in which a needle punctures the skin before forcefully expelling the medicant, thereby minimizing some of the downsides of typical jet injectors [...], while still maintaining some of the advantages of typical jet injectors.  During prosecution, the applicants repeatedly distinguished their invention from the prior art by focusing on the “jet injector” limitation present in their claims but not the prior art.  The originally issued claims all contained the “jet injection” limitation. [...] Antares sought a reissue for the patent pursuant to 35 U.S.C. § 251, stating that there was an error in the original ’015 patent insofar as the patentee claimed “more or less than he had a right to claim in the patent.” [...] The reissue claims (claims 23–37) cover embodiments of injection devices (not restricted to jet-injection devices) with particular combinations of safety features.
Antares Pharma, at *2-3 (text added).
Standard of ReviewWe have jurisdiction pursuant to 28 U.S.C. §§ 1292 & 1295. We review the district court’s denial of the preliminary injunction for abuse of discretion, but we review errors of law relating to that denial de novo. [...] We review the applicability of the recapture rule and the original patent requirement of 35 U.S.C. § 251 de novo.
Id. at *5 (text added, internal citations removed).
Relevant Legal StandardWhenever any patent is, through error . . . , deemed wholly or partly inoperative or invalid . . . by reason of the patentee claiming more or less than he had a right to claim in the patent, the Director shall . . . reissue the patent for the invention disclosed in the original patent . . . . 35 U.S.C. § 251(a). Id. at *8 (emphasis removed). [A] reissue claim is for the “same invention” if the original patent specification fully describes the claimed inventions, but not if the broader claims “are [] merely suggested or indicated in the original specification.” Id. at *9-10 (text added, internal citation removed).
The Original Specification Discussed Only One InventionApplying the Industrial Chemicals standard, asserted reissue claims [...] are invalid. The original claims [contain] the “jet injection” limitation. The asserted claims are focused on particular safety features and do not contain the jet injection limitation. [...] [T]he original patent requirement focuses on the original specification rather than the original claims. [...] The original specification [...] discussed only one invention: a particular class of jet injectors. This is clear from the title of the patent (“Needle Assisted Jet Injector”), the abstract (“A jet injection device. . .”), the summary of the invention (“The present invention relates to a needle assisted jet injector.”), the repetitive descriptions of the “present invention” as being for a jet injector (e.g., “[t]he present invention relates to a needle assisted jet injector,” [...] and repetitions of “the needle assisted jet injector according to the present invention,” [...] and the entirety of the specification.
Antares Pharma, at *15-16 (text added, internal citations removed).
The Claimed Safety Features Were Never Described Separately from the Jet InjectorAlthough safety features were mentioned in the specification, they were never described separately from the jet injector, nor were the particular combinations of safety features claimed on reissue ever disclosed in the specification. Rather, the safety features were serially mentioned as part of the broader conversation: how to build the patented jet injection device. [...] Nowhere does the specification disclose, in an explicit and unequivocal manner, the particular combinations of safety features claimed on reissue, separate from the jet injection invention.
Id. at *16-17 (text added, internal citations removed).
Amos: Exact Embodiment Claimed on Reissue Was Expressly Disclosed[W]e held [in In re Amos, 953 F.2d 613 (Fed. Cir. 1991)] that the original patent requirement was satisfied. In Amos, the patentee sought to broaden his claims on an invention relating to the use of rollers to hold down workpieces on a moving table. The specification expressly disclosed that rollers, as they approached the end of the table, could be “raised either mechanically by the roller cams or electronically by the computer controlling the router.” [...] The original claims only covered the manual embodiment. On reissue, the applicant sought to add the computer-controlled embodiment. [...] [T]he exact embodiment claimed on reissue was expressly disclosed in the specification.
Id. at *17-18 (text added, internal citations removed).
"The claims on appeal are invalid for failure to satisfy the original patent requirement [...].  Because Antares cannot show likelihood of success on the merits with respect to these claims, the district court properly denied Antares’ motion for preliminary injunction."  Antares Pharma, at *18 (text added). Because we hold that the asserted claims of the ’846 patent fail the original patent requirement of 35 U.S.C. § 251, we do not reach the question of whether the recapture rule applies and, if it does, whether it was violated here.
Id. at *6.
 Image Attribution Statement: CDC, “Influenza Vaccination 1976,” available as a public domain image prepared by office of US Government, http://commons.wikimedia.org/wiki/File:Influenza_Vaccination_1976.jpg (image edited) (last visited Feb. 19, 2014).
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