If No Generic Claim Is Finally Held Allowable, Election Of A Species Creates A Restriction Under 35 U.S.C. § 121

In St. Jude Medical, Inc. v. Access Closure, Inc., No. 12-1452 (Fed. Cir. Sept. 11, 2013), the Federal Circuit reversed the district court's safe harbor ruling regarding U.S. Patent No. 7,008,439 ("the Janzen patent"), determined that the district court's rulings on claim constructions in the Janzen patent were moot, and affirmed the district court's ruling that U.S. Patent Nos. 5,275,616 and 5,716,375 (collectively "the Fowler patents") are nonobvious and not shown to be invalid.

St. Jude Medical, Inc. and St. Jude Medical Puerto Rico, LLC (collectively "St. Jude") own the Janzen patent and the Fowler patents, which relate to methods and devices for sealing a vascular puncture. During prosecution of the Janzen patent's grandparent application, the examiner required restriction of the application under 35 U.S.C. § 121 to Group I (device) or Group II (method) and an election of Species A, B, or C. The applicant elected Group I, Species B. Subsequently, the applicant filed U.S. Patent Application No. 08/318,380 ("the parent application") as a divisional of the grandparent application. Before the parent application issued, the applicant filed U.S. Patent Application No. 08/399,535 ("the Janzen application") as a continuation of the parent application. The Janzen patent ultimately issued with both device and method claims. The applicant also filed another continuation based on the parent application, which issued as U.S. Patent No. 5,725,498 ("the sibling patent").

St. Jude sued Access Closure, Inc. ("ACI"), alleging that ACI infringed several patents, including the Janzen patent and the Fowler patents. The jury found that ACI had infringed the Janzen patent, but that the Janzen patent was invalid for double patenting in light of the sibling patent. Subsequently, the district court determined that the safe harbor provision of 35 U.S.C. § 121 prevented the claims of the Janzen patent from being invalidated, and overturned the jury's finding of invalidity. The jury also found that ACI infringed the Fowler patents, and that those claims were valid. After the verdict, ACI filed a renewed JMOL motion on various claims in the Fowler patents, but the district court denied the motion. ACI appealed three of the district court's rulings: (1) that the safe harbor provision of § 121 protects the Janzen patent from invalidity for double patenting; (2) the construction of key terms in the Janzen patent; and (3) that ACI was not entitled to JMOL that the...