On solid ground: double patenting safe harbour applies to election of species

In a decision rendered on September 11, 2013, the US Court of Appeals for the Federal Circuit reversed the district court’s ruling that claims in a first sibling patent (Janzen patent) were protected under the safe-harbour provision of 35 USC §121 from invalidity due to double patenting over claims in a related second sibling patent.

This case is particularly important in areas such as biotechnology, wherein patent examiners often issue a restriction requirement in combination with an election of species requirement.

The safe-harbour provision can be invoked when a line of demarcation between independent and distinct inventions that prompted a restriction requirement in a parent application has been maintained as between the parent application and the offspring application(s). When this line of demarcation has been maintained, the relevant patents are said to meet the requirement for consonance.

"Judge Lourie inidcated that the comingling of restriction practice with election of species practice was improper and 'overcomplictaes the analysis'"

There are four related patents owned by St Jude Medical Inc and St Jude Medical Puerto Rico, LLC discussed in the opinion: i) US Patent No. 5,391,183 (grandparent patent); ii) US Patent No. 5,830,130 (parent patent); iii) US Patent No. 7,008,439 (Janzen patent); and iv) US Patent No. 5,725,498 (sibling patent). The application which issued as the parent patent was designated as a divisional application of the grandparent patent. Both the Janzen patent and the sibling patent are direct offspring of the parent patent.

At the district court, a jury made a finding that the claims of the Janzen patent were invalid for double patenting in light of the sibling patent. Nevertheless, the district court held a bench trial wherein it was determined that the safe-harbour provisions applied, thereby overturning the jury’s invalidity finding.

The defendants at trial, Access Closure, Inc (ACI) filed an appeal with the Federal Circuit asking for review of the district court’s application of the safe-harbour provision to the Janzen patent.

Turning to the facts of this case, in the application (grandparent application) which issued as the grandparent patent, the examiner gave both a restriction requirement and an election of species requirement. The examiner separated the device claims (Group I) from the method of use claims (Group II) in the restriction requirement. Also, the examiner identified three patentably distinct species (A, B and C) in the election of species requirement.

With respect to the determination of the line of demarcation between independent and distinctinventions, ACI argued that the determination should be based solely on the restriction requirement (and not the election of species requirement). As such, ACI argued that the line of demarcation created just two inventions by separating the device claims (Group I) from the method of use claims (Group II).

However, St Jude argued that the election of species requirement in the grandparent application should also affect the line of demarcation, thereby creating six different inventions: Group I, species A; Group I, species B; Group I, species C; Group II, species A; Group II, species B; and Group II, species C.

The Federal Circuit agreed with St Jude’s argument that the line of demarcation between independent and distinct inventions should be based on both the restriction requirement and the election of species requirement. The Federal Circuit took the position that the election of species in the grandparent application imposed a second restriction on the applicant.

In support of this position, the Federal Circuit asserted that 37 CFR §1.146 “states that if no generic claim is found allowable, then the election of species will create a restriction under 35 USC §121.” Writing for the majority, Judge Plager indicated that a “critical point” in this case was that the grandparent application lacked a generic claim.

“Since no generic claim was applied for, and no such claim was finally held allowable, that is what occurred: the election of species in the grandparent created a restriction.” To hold otherwise would give a result that would be “unfair” to the applicant, since it was the examiner who created the further division of the application with the election of species, not the applicant, and the examiner had already indicated that species A, B and C were patentably distinct. “The unfairness of the result would violate the purpose of the safe harbor.”

The requirement of consonance

Based on this determination of the line of demarcation, the Federal Circuit looked to see if the requirement of consonance was met. According to the Federal Circuit, for the requirement of consonance to be met in this case, all three patents (the grandparent patent, the Janzen patent and the sibling patent) had to claim different inventions identified by the examiner in the restriction requirement and the election of species requirement made in the grandparent application.

With respect to the grandparent patent and the Janzen patent, the line of demarcation was maintained. The grandparent patent was drawn to Group I, species B and the Janzen patent was drawn to Group I, species C and Group II, species C.

However, the line of demarcation was not maintained between the Janzen patent and the sibling patent. The sibling patent was drawn to Group II, but the claims were not limited to any particular species. This meant that both the Janzen patent and the sibling patent contained claims encompassing Group II, species C. As such, the requirement of consonance was not met, and the safe-harbour provision did not apply.

With the safe-harbour provision removed, the jury’s finding that claims of the Janzen patent were not patentably distinct from claims of the sibling patent controlled, and the Federal Circuit held that the claims of the Janzen patent were invalid.

Agreeing with the conclusion of invalidity in the majority opinion, but not the legal analysis, Judge Lourie wrote a concurring opinion. Believing this to “perhaps be an issue of first impression”, Judge Lourie indicated that the comingling of restriction practice with election of species practice was improper and “overcomplicates the analysis”. His determination of the line of demarcation would have been based solely on restriction practice.

The question now arises as to how the results of this case will affect prosecution practice. The biggest concern is maintaining the line of demarcation so that the related applications issue as patents, each claiming independent and distinct inventions as defined by the examiner’s restriction requirement and election of species requirement.

This concern can be alleviated by not filing divisional applications prematurely. Examiners have the ability to rejoin non-elected subject matter even after a first office action has been mailed.

If the examiner does rejoin non-elected subject matter in a parent application after a divisional application has been filed, then it is possible for the divisional application to claim subject matter which was considered by the examiner in the parent application and (once the examiner in the divisional application has considered the overlapping subject matter) the consonance requirement would not be met.

As such, it is best to file divisional application(s) on or after the date the non-elected subject matter has been cancelled from the parent application, and before the date that the parent application issues as a patent.

The case is St Jude Medical, Inc v ACI, case number 2012-1452, in the US Court of Appeals for the Federal Circuit.

Garth Dahlen is a partner at Birch, Stewart, Kolasch & Birch. He can be contacted at: GMD@bskb.com