Federal Circuit Clarifies Double Patenting Safe Harbor Provision

Earlier this month, in St. Jude Medical, Inc. v. Access Closure, Inc., No. 2012-1452 (Sept. 11, 2013) the Federal Circuit clarified the double patenting safe harbor provision in 35 U.S.C. § 121. The safe harbor provision is designed to prevent the inherent unfairness that would occur if claims found to be patentably distinct by the examiner and required to be restricted and filed in a separate application could then be found invalid for double patenting if a court concluded the claims were not patentably distinct. The Court clarified the requirement that the patent must maintain consonance in order for the safe harbor provision to be applicable. This ruling is especially important to those prosecuting patents who may be making decisions about which claims to elect under a restriction requirement.

St. Jude Medical, Inc. ("St. Jude") sued Access Closure, Inc. ("ACI") in the United States District Court for the District of Arkansas for infringement of several patents, including U.S. Patent No. 7,008,439 ("the Janzen patent"). The Janzen patent is a descendant from U.S. Patent Application No. 07/746,339 ("the grandparent application"). During prosecution of the grandparent application, the examiner stated that the claims included two patentably distinct inventions: Group I (device claims) and Group II (method claims) and required restriction of the application under 35 U.S.C. § 121. In addition, the examiner identified three patentably distinct species of claims and required the applicant to elect one of Species A, B and C. The Applicant elected Group I Species B.

The applicant then filed U.S. Patent Application No. 08/318,380 ("the parent application") as a divisional of the grandparent application. The examiner imposed a similar restriction requirement and the applicant again elected Group I Species B. The applicant filed the application that became the Janzen patent as a continuation of the parent application. The applicant cancelled the original claims and added new claims including both device and method claims. The applicant also pursued another continuation of the parent application, which became the sibling patent to the Janzen patent and issued before it.

In the district court, the jury returned a verdict of infringement of the Janzen patent but also found that the patent was invalid for double patenting in light of the sibling patent. The judge had withheld from the jury the question of whether the safe harbor provision applied, and...