Original Specification Must Expressly Disclose the Invention Covered by Reissue Claims: Federal Circuit | Practical Law

Original Specification Must Expressly Disclose the Invention Covered by Reissue Claims: Federal Circuit | Practical Law

In Antares Pharma Inc. v. Medac Pharma Inc., the US Court of Appeals for the Federal Circuit affirmed the US District Court for the District of Delaware, holding that the asserted reissue claims were invalid for failure to comply with the original patent requirement of Section 251 of the Patent Act.

Original Specification Must Expressly Disclose the Invention Covered by Reissue Claims: Federal Circuit

by Practical Law Intellectual Property & Technology
Published on 18 Nov 2014 • USA (National/Federal)
In Antares Pharma Inc. v. Medac Pharma Inc., the US Court of Appeals for the Federal Circuit affirmed the US District Court for the District of Delaware, holding that the asserted reissue claims were invalid for failure to comply with the original patent requirement of Section 251 of the Patent Act.
On November 17, 2014, the US Court of Appeals for the Federal Circuit issued an opinion in Antares Pharma Inc. v. Medac Pharma Inc., affirming the US District Court for the District of Delaware and holding the asserted reissue claims invalid for failure to comply with the original patent requirement of Section 251 of the Patent Act (No. 2014-1648, (Fed. Cir. Nov. 17, 2014)) (35 U.S.C. § 251).
The invention concerned automatic injection devices used to self-administer pharmaceuticals. The originally issued claims covered various needle assisted jet-injection devices. The original patent specification disclosed only a particular class of jet injectors, which the Federal Circuit noted was evidenced by:
  • The patent's jet injector title.
  • The abstract describing a jet injection device.
  • The summary of the invention, which related to a needle assisted jet injector.
  • The repetitive description in the specification that the present invention is a jet injector.
In contrast, the claims of the reissue patent, US RE44,846, covered embodiments of injection devices, not restricted to jet-injection devices, with particular safety feature combinations.
The Federal Circuit applied the standard articulated in the US Supreme Court’s decision in U.S. Industrial Chemicals, Inc. v. Carbide & Carbon Chemicals Corp., which held that:
  • The original specification must clearly and unequivocally disclose a later-claimed invention as a separate invention.
  • It is not enough that the later-claimed invention was suggested or indicated in the specification.
(315 U.S. 668 (1942).)
Based on this standard, the Federal Circuit held that the reissue claims did not comply with the original patent requirement of Section 251 of the Patent Act because:
  • The original specification discussed only one particular class of jet injectors.
  • The safety features, while mentioned in the original specification, were never described separately from the jet injector.
  • The particular claimed combinations of safety features were never disclosed in the original specification but were only mentioned as part of the broader description of building the patented jet injection device.
The original specification's suggestions or indications of the alternative safety inventions were not sufficient to satisfy the original patent requirement because those alternatives were not disclosed in an explicit and unequivocal manner separate from the jet injection invention.