St. Jude: Double Patenting at the Federal Circuit


hosp-sj-campus-2013-03In the recent Federal Circuit case of St. Jude Medical v. Access Closure, the defendant Access Closure, Inc. (ACI) appealed several rulings made by the United States District Court for the Western District of Arkansas in favor of St. Jude Medical, the patentee-plaintiff. The rulings relate to three patents that St. Jude asserted against ACI, namely U.S. Patent No. 7,008,439 to Janzen et al., U.S. Patent No. 5,275,616 to Fowler, and U.S. Patent No. 5,716,375, also to Fowler.

St. Jude filed its complaint in the United States District Court for the Western District of Arkansas on October 22, 2008, alleging that ACI infringed various claims of the aforementioned patents. During the litigation, the district court issued a Markman order in which it construed various claim terms found in the Janzen patent, including “means for ejecting” and “ejecting mechanism.” Unable to resolve the dispute, the parties proceeded to trial before a jury.

The jury rendered a verdict that ACI had infringed claims 7 and 8 of the Janzen patent, but that claims 7, 8, and 9 of the Janzen patent were invalid for double patenting in light of the sibling ’498 patent. Implicit in the jury’s double patenting finding was the jury’s conclusion that claims 7, 8, and 9 of the Janzen patent were not patentably distinct from claim 7 of the sibling patent.

The district court termed the jury’s double patenting finding an “advisory opinion” since the court had withheld from the jury the question of whether the safe harbor provision in 35 U.S.C. § 121 prevented the claims from being invalidated. § 121 of Title 35 states, in relevant part:

A patent issuing on an application with respect to which a requirement for restriction under this section has been made, or on an application filed as a result of such a requirement, shall not be used as a reference either in the Patent and Trademark Office or in the courts against a divisional application or against the original application or any patent issued on either of them, if the divisional application is filed before the issuance of the patent on the other application.

The district court then held a bench trial to determine whether the safe harbor provision applied to the Janzen claims. The court concluded that the safe harbor did apply, thus overturning the jury’s invalidity finding, and upholding the validity of the claims.

With regard to the Fowler patents, the jury found that ACI had infringed claim 14 of the Fowler ’616 patent, and claim 21 of the Fowler ’375 patent. The jury also found that ACI willfully infringed the Fowler claims. Regarding validity, the jury found that the Fowler claims were not obvious and thus valid.

After the jury rendered its verdict, ACI filed a renewed JMOL motion on various issues. The district court denied ACI’s motion. ACI appealed the district court’s application of the safe harbor provision to the Janzen patent, the court’s construction of the claim terms “means for ejecting” and “ejecting mechanism” from the Janzen patent, and the court’s denial of ACI’s renewed motion for JMOL that the Fowler claims are invalid for obviousness.

With respect to double-patenting, ACI argued that the Janzen patent violates “consonance.” The judicially created consonance concept derives from the safe harbor provisions of § 121 and specifies that the line of demarcation between the independent and distinct inventions that prompted the restriction requirement be maintained. The requirement for consonance applies to both the patent challenged for double patenting (i.e., the challenged patent) and the patent being used as a reference against the challenged patent (i.e., the reference patent).

The Federal Circuit determined that the restriction resulting from the election of species affected the line of demarcation. In particular, the first restriction separated Group I from Group II, and the second restriction operated on top of the first restriction to separate the Species.

With the line of demarcation settled, the Court turned to whether that line was honored. The Court determined that consonance was not maintained. The sibling patent’s independent claim 1 is drawn to a method of sealing a puncture in a wall of a blood vessel involving neither a guidewire nor a dilator. Thus the sibling application was not filed “as a result” of the restriction since it pursued a claim generic to all of the Species in Group II, and therefore overlapped Group II, Species C found in the Janzen patent. Therefore, the Court concluded that, consonance not maintained, the safe harbor provision could not apply. Thus, claims 7, 8, and 9 of the Janzen patent were declared invalid.

The Federal Circuit would go on to explain that the claim construction issue was mooted because the underlying claims were invalid. The Court also affirmed the district court ruling that the Fowler patents were not invalid. Thus, St. Jude still prevailed in its claims associated with the Fowler patents.

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