By Jacob Moore
On Jan. 23, 2018, the Federal Circuit in In re Janssen held that a patent issuing from a continuation-in-part (CIP) application is not eligible for 35 USC § 121 safe harbor protection, even if the patent is re-categorized as a divisional application during reexamination. Thus, the court determined that the patent at issue—US 6,284,471 (the ’471 Patent)—was invalid over reference patents US 5,656,272 (the ’272 Patent) and 5,698,195 (the ’195 Patent) under the doctrine of obviousness-type double patenting.
In re Janssen is the newest case in a line of recent decisions interpreting the scope of the safe harbor provision, which shields a patent or application from an obviousness-type double patenting rejection under certain conditions. That provision provides:
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.
By way of background, the Federal Circuit has previously determined that “aside from the original application and the original patent, the protection afforded by § 121 is limited to divisional applications and patents issued on divisional applications.” In re Janssen, at 9 (emphasis added). Thus, the safe harbor does not protect CIP applications.
Factual and Procedural Background
Parent US Application No. 08/013,413 (the ’413 application) was filed in 1993, after which the PTO issued a 5-way restriction requirement between the following subject matter groups (emphasis added to groups relevant to In re Janssen):
I: Antibodies / compositions / assay methods
II: TNF polypeptides
III: polynucleotides encoding antibodies
IV: Methods for treating
V: methods for removing TNFα from a sample
The ’471 Patent was filed as a CIP of the parent, with (i) claims encompassing Groups I and IV of the parent and (ii) claims setting forth subject matter not included in the parent (i.e., containing subject matter added in the CIP). However, the patent ultimately issued with claims fully supported by the parent (i.e., not containing the added subject matter) and that were directed to Group I, but not Group IV, of the parent.
Unlike the ’471 Patent, the cited reference patents—the ’272 Patent and the ’195 Patent —contained claims directed to subject matter characterized as Group IV in the parent restriction requirement. The relationship between the respective patents/applications is illustrated below, as a modified version of the figure appearing on page 3 of the In re Janssen decision:
Several years after issuance of the ’471 Patent, the PTO instituted reexamination of the patent and determined that the claims were not patentable under the doctrine of obviousness-type double patenting over the reference patents mentioned above. In an effort to shield the
’471 Patent via the safe harbor, Janssen amended the specification to conform with the parent (i.e., to remove subject matter not present in the parent) and requested that the ’471 Patent be designated as a divisional application (instead of a CIP).
Despite Janssen’s efforts, the PTO determined that the safe harbor cannot protect the ’471 Patent because they “f[ou]nd no reason to permit [Janssen] now, by amendment, to acquire the benefit of the safe harbor when [Janssen] voluntary[il]y and deliberately filed a [CIP] application with claims directed to subject matter absent from the [parent application] . . . .” Id. at 7-8.
The Federal Circuit Decision
In a prior Federal Circuit decision — Searle v. Lupin, 790 F.3d 1349 (Fed. Cir. 2015) — the court held that reformulating a CIP as a divisional via a reissue proceeding is insufficient to establish protection under the safe harbor. In Searle, the patent at issue was filed as a CIP, and the issued claims contained subject matter not disclosed in the parent application. The patent owner used the reissue proceeding as a vehicle for (i) amending the specification and claims of the patent to remove added subject matter and (ii) re-designating the CIP as a divisional application. The court nevertheless refused to apply the safe harbor because “for years [after the patent issued] the public was not free to practice that new matter . . . . Fairness to the public does not permit [the patent owner from taking] advantage of the safe harbor provision, simply by designating it as a divisional application years after the fact.” Searle at 1355.
The instant case is different from Searle, however: the issued ‘471 Patent claims never contained new matter, i.e., they were fully supported by the parent application. Even so, the court highlighted that Janssen still received a benefit from designating the application as a CIP. For instance, the added—but unclaimed—subject matter provided priority-related benefits for subsequent applications. In particular, “Janssen had benefitted because more than thirty patents issued to Janssen claiming priority to the ’471 Patent . . . . Determining whether any of those patents rely on the deleted subject matter for support cannot be accomplished without reopening examination of each patent.” In re Janssen at 13.
Even without receiving such a benefit though, the ’471 Patent still would not be protected under the safe harbor. In this regard, the court pointed to the “issued on” requirement of the safe harbor provision, and emphasized that the ’471 Patent “cannot retroactively become, for purposes of § 121 a ‘patent issued on’ a divisional application after it already issued on a CIP application; not even if that CIP application is effectively redesignated as a divisional application during reexamination.” (emphasis added). Id. at 12. Thus, “[f]or a challenged patent to receive safe-harbor protections, the application must be properly designated as a divisional application, at the very latest, by the time the challenged patent issues on that application.” Id. at 12-13.
In other words: The Federal Circuit seems to rely on a patent’s issue date as a bar for post hoc pursuit of safe harbor protection by designating an application as a divisional.
The In re Janssen court held that patents filed as CIP applications, and later reclassified as divisional application during reexamination, are not eligible for safe harbor protection under 35 USC § 121. This is the case even if the application could have been properly designated as a divisional application prior to issuance.
That being said, the decision raises additional questions regarding instances where it may be acceptable to reclassify an application as a divisional for safe harbor purposes. For instance, does designating an application as a divisional the day before issuance confer safe harbor protection? The In re Janssen court expressly states that such a situation was not at issue in the instant case: “we do not decide whether such filing practices or amendments made prior to issuance — wherein an application is designated as a divisional application by the time the challenged patent issues on that application — would be sufficient to bring the challenged patent within the scope of the safe-harbor protections.”
Given the uncertainty associated with application of the safe harbor “redesignated divisionals,” applicants may want to classify continuing applications as divisionals at filing when appropriate and desired.