Antares Pharma, Inc. v. Medac Pharma Inc.

Addressing the original-patent requirement, tracing vintage Supreme Court cases and interpreting the statutory purpose of 35 U.S.C. § 251, the U.S. Court of Appeals for the Federal Circuit affirmed a denial of preliminary injunction and a determination of patent invalidity, finding that reissue claims must be tied to a “clear and unequivocal” disclosure in the specification of the original patent.  Antares Pharma, Inc. v. Medac Pharma Inc., Case. No. 14-1648 (Fed. Cir., Nov. 17, 2014) (Dyk, J.).

After Antares Pharma (Antares) filed suit accusing Medac Pharma (Medac) of infringing a reissue patent, Antares moved for a preliminary injunction.  The asserted claims, which related to automatic injection devices used to self-administer pharmaceuticals, were drawn to safety features on injection devices.  The reissue claims were broader than the claims of the original patent, which were limited to “jet injection devices.”  In opposing the request for a preliminary injunction, Medica argued, inter alia, that the reissue claims were invalid under § 251, because the reissue claims violated the original-patent requirement and the recapture rule.  The district court agreed with Medica that the claims violated the recapture rule because the broadened the scope of the reissue claims impermissibly covered subject matter that was surrendered during the original prosecution.  Because the recapture analysis was sufficient to deny the motion for a preliminary injunction, the district court did not address the original-patent requirement.  Antares appealed.

On appeal, Antares challenged the recapture analysis, while Medica contended that the district court was correct, but even so, maintained that failure to satisfy the original-patent requirement provided an alternative ground for affirmance.  The Federal Circuit opinion focused on the original-patent requirement, declining to address the district court’s recapture ruling.

The Federal Circuit opinion provides several significant clarifications regarding the invalidity inquiry for reissue patents.  First, the Court expressly stated that the recapture rule and the original-patent requirement, both falling under 35 U.S.C. § 251, are separate requirements for patentability.  Second, citing to the 1942 Supreme Court decision in U.S. Industrial Chemicals v. Carbide & Carbon Chemicals, the Federal Circuit articulated the standard to satisfy the original-patent requirement, finding that the original specification must clearly disclose the newly claimed invention—hints, suggestions or indications in the specification are not sufficient.

The Federal Circuit began its discussion by distinguishing between the grant of a reissue patent under § 251 and securing a patent that is a continuation or divisional of an earlier application under § 120.  Reissue claims are necessary only when an applicant has delayed seeking amendment until after the original patent application has issued.  The Federal Circuit therefore reasoned that additional requirements will attach to reissue claims to ensure consistency between the original specification and the reissued claims.  The analysis traced Supreme Court cases dating back to 1854 to support the proposition that a reissue claim must be drawn to the “the same invention as the original patent.”  The holding in U.S. Industrial Chemicals was touted as the “definitive explanation” of the requirement, setting forth a test wherein reissue claims would be invalid if the original patent specification did not “fully describe” the broader reissue claims.

After reconciling that § 251, as enacted in 1952, was analogous to the statute being addressed in the earlier U.S. Industrial Chemicalscase, the Court proceeded to address the elements of the asserted claims.  Importantly, the specification of the original patent only envisioned “jet”-type automatic injection devices, but the asserted reissue claims covered non-jet-type injectors.  According to the Federal Circuit, the asserted reissue claims “focused on particular safety features” not contained in the “jet injection limitation,” thus compelling the finding that the original claims were significantly different in scope.  Indeed, as Antares argued in its opening brief, the reissue claims are a “different invention than that originally claimed.”  After concluding that the “present invention” language in the original patent specification was limited to jet-type automatic injection devices, the Federal Circuit explained that the absence of express written description disclosure for the reissue claims compelled the conclusion that there was a failure to satisfy the original-patent requirement.  Because the question presented on appeal was a pure issue of law, the appellate court affirmed the denial of the preliminary injunction, confirmed the invalidity of the asserted claims, and noted that a remand was not required.

Practice Note:  This decision appears to be the first time the Federal Circuit has indicated that the original-patent requirement is distinct from recapture.  Attorneys prosecuting reissue applications before the PTO will need to pay particular attention to the scope of the original specification in drafting broadened reissue claims to ensure that the subject matter of the reissue claims is adequately (i.e.,expressly) disclosed.