United States: Safe Harbor Provision Of 35 U.S.C. § 121 Does Not Apply When Consonance Is Not Maintained

St. Jude Medical, Inc. v. Access Closure, Inc.

Addressing whether the safe harbor provision of 35 U.S.C. § 121 protects a patent from invalidity due to double patenting, the U.S. Court of Appeals for the Federal Circuit reversed a lower court's application of the safe harbor, finding that consonance was not maintained between the challenged patent, the reference patent and the patent in which the restriction requirement was made. St. Jude Medical, Inc. v. Access Closure, Inc., Case No. 12-1452 (Fed. Cir., Sept. 11, 2013) (Plager, J.) (Lourie, J., concurring).

St. Jude Medical sued Access Closure (ACI) in the district court for alleging that ACI infringed its patents, including U.S. Patent No. 7,008,439 (the Janzen patent) and U.S. Patent Nos. 5,275,616 and 5,716,375 (the Fowler patents).

The Janzen patent is a continuation of a parent patent that is a divisional of a grandparent patent. During prosecution of both the grandparent and parent patents, the U.S. Patent and Trademark Office examiner required restriction of the application under 35 U.S.C. § 121 to one of the device or method inventions and further to one of the identified species. The applicant elected a device and a species. Later, the Janzen application was filed as a continuation of the parent application, but the Janzen application issued with both device and method claims out of an interference proceeding. While the Janzen application was pending, another sibling application issued prior to issuance of the Janzen patent. The Janzen patent included claims similar to those of the sibling patent.

At trial, the jury found that ACI had infringed the Janzen patent, but that the Janzen patent was invalid for double patenting in view of its sibling patent. However, at a bench trial, the district court determined the safe harbor provision of 35 U.S.C. § 121 applied to the Janzen patent and thus overturned the jury's invalidity finding. ACI appealed.

On appeal, the Federal Circuit reversed the district court's ruling, finding that the Janzen patent is invalid because the safe harbor provision does not apply to the Janzen patent since the Janzen patent and the sibling patent did not maintain consonance. Consonance requires "that the challenged patent, the reference patent, and the patent in which the restriction requirement was imposed (the restricted patent) do not claim any of the same inventions identified by the examiner." In the case of the Janzen patent, the Court determined that the sibling application was not filed "as a result" of the restriction and it overlapped with the Janzen claims, that is, both of the sibling patent and the Janzen patent included device and method claims and included inventions that are not distinct, and thus consonance was not maintained between the Janzen patent and the sibling patent.

Concurring with the majority opinion, Judge Lourie commented that "the majority opinion overcomplicates the analysis of this appeal and improperly commingles restriction practice with election of species practice" and also suggested "[i]f there was no generic claim . . . then the applicant could have argued that the species were not independent and distinct inventions. Alternatively, a separate application could have been filed on non-elected species."

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