A C-I-P Application is not Entitled to the Section 121 Safe Harbor from Double Patenting; and Cannot Retroactively be Turned into a Divisional Application

In In re: Janssen Biotech, Inc., [2017-1257] (January 23, 2018), the Federal Circuit affirmed the rejection during reexamination of claims 1-7 of U.S. Patent No. 6,284,471 for obviousness-type double patenting.

The doctrine of obviousness-type double patenting is intended to prevent the extension of the term of a patent by prohibiting the issuance of the claims of a second patent that are not patentably distinct from the claims of the first patent.  Janssen argued that obviousness-type double patenting is not applicable because the safe-harbor provision of 35 U.S.C. § 121 protects the ’471 patent claims, so double-patenting turned on whether §121 applied, which in turn depended upon an interpretation of the prosecution history of the ’471 patent and that patent’s relationship to application to its parent application.

In that prosecution history, Janssen filed an application and received a 5-way restriction requirement with Group I drawn to antibodies, pharmaceutical compositions, and assay methods, and Group IV drawn to methods for treating an animal.  Rather responding to the restriction, Janssen expressly abandoned that application and filed two continuation-in-part application, one of which resulted in the patent under reexamination.

During reexamination, the Board found no reason to permit Janssen by amendment, to acquire the benefit of the safe harbor when Janssen  voluntarily and deliberately filed a continuation-in-part application with claims directed to subject matter absent from the parent application and outside the scope of its restriction.  Applying the one-way test for double patenting because it found that there were at least four instances where Janssen’s actions constituted deliberate and unnecessary actions that lengthened the prosecution time of the application.

The Federal Circuit agreed that the §121 safe harbor, by its literal terms, protects only divisional applications (or the original application) and patents issued on such applications.  Accordingly, the Federal Circuit said that patents issued on CIP applications or continuation applications are not within the scope of §121. The Federal Circuit said that its precedent was clear: 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.

Further, the Federal Circuit said that a patent owner cannot retroactively bring its challenged patent within the scope of the safe-harbor provision by amendment in a reexamination proceeding.