Claimed inventions of a reissue patent must be clearly and unequivocally disclosed in the original specification
Kumiko Ide | December 17, 2014
Antares Pharma, Inc. v. Medac Pharma Inc., et al.
November 17, 2014
Panel: Dyk, Reyna, and Taranto. Opinion by Dyk.
The Federal Circuit found the asserted reissue claims invalid for failure to comply with the “original patent” requirement of 35 U.S.C. § 251. Under § 251, the original patent specification must adequately disclose the later-claimed features. Here, the Federal Circuit found that the original specification failed to clearly and unequivocally disclose the inventions of the asserted claims of the reissue patent.
Plaintiff-Appellant Antares Pharma, Inc. develops automatic injection devices used to self-administer pharmaceuticals, and is an assignee of U.S. Patent No. 7,776,015 (“the ‘015 patent”) entitled “NEEDLE ASSISTED JET INJECTOR.” During prosecution, the applicants repeatedly distinguished their invention from the prior art by focusing on the “jet injector” limitation. The claims of the ‘015 patent all contained the “jet injector” limitation.
After the issuance of the ‘015 patent, plaintiff sought a reissue for the patent pursuant to 35 U.S.C. § 251, stating that there was an error in the patent insofar as the patentee claimed “more or less than he had a right to claim in the patent.”
The reissue patent, RE44,846 (“the ‘846 reissue patent”), was granted. The specification and claims 1-22 were left unaltered. Claims 23-37 were added. While the originally allowed claims recite various embodiments of a jet injection device, the reissue claims are not restricted to jet-injection devices, and cover embodiments of injection devices with particular combinations of safety features. Plaintiff admits that the reissue claims recite a different invention from what was originally claimed.
Defendants, Medac Pharma, Inc. and Medac GmbH filed a 505(b)(2) new drug application with the FDA for their syringes. Plaintiff filed suit against the defendants alleging infringement. Defendants counter-claimed for invalidity and non-infringement. In response to Plaintiff’s motion for preliminary injunction, Defendants argued that the asserted ‘846 reissue claims were invalid for violating the recapture rule and failing to meet the original patent requirement of § 251.
The district court denied the motion for preliminary injunction, finding that Plaintiff failed to carry its burden of showing a likelihood of success on the merits with respect to the claims of the ‘846 reissue patent because the claims added during reissue are likely invalid for violating the recapture rule. The district court did not consider whether the original patent requirement was satisfied, because the court held that the recapture rule was violated. Plaintiff appealed.
On appeal, the Federal Circuit found that because the ‘846 reissue patent claims fail the original patent requirement of 35 U.S.C. § 251, the question of whether the recapture rule applies and whether it was violated need not be reached. Here, the Federal Circuit applied the Industrial Chemicals standard, and found the asserted reissue claims of the ‘846 patent are invalid. Under the Industrial Chemicals standard, to satisfy the requirement of § 251, “the specification must clearly and unequivocally disclose the newly claimed invention as a separate invention.”
The Federal Circuit found the original claims to be significantly different in scope and coverage from the asserted claims, and found the original specification did not adequately disclose the later-claimed features. The original specification discusses only a particular class of jet injectors. While the safety features claimed in the reissue patent are mentioned in the specification, these features are never described separately from the jet injector. Because the original specification failed to disclose, in an explicit and unequivocal manner, the particular combinations of safety features claimed on reissue separate from the jet injection invention, the original patent requirement under § 251 was not met.
The Federal Circuit therefore found the claims on appeal invalid for failure to satisfy the original patent requirement of 35 U.S.C. § 251, and affirmed the district court’s denial of Plaintiff’s motion for preliminary injunction.
In order to meet the patent requirement of 35 U.S.C. § 251, it is not enough that the original specification simply mentions features covered by the reissue claims, but the original specification must clearly and unequivocally disclose the newly claimed invention as a separate invention.