Addressing whether patent holders can use the 35 USC § 121 safe harbor on a self-help basis to avoid obviousness-type double patenting, the US Court of Appeals for the Federal Circuit upheld a Patent Trial and Appeal Board (PTAB) rejection based on such double patenting. In re: Janssen Biotech, Inc., Case No. 17-1257 (Fed. Cir., Jan. 23, 2018) (Prost, CJ). The panel concluded that once a patent issues on a continuation-in-part (CIP), rather than as a divisional, with claims to subject matter outside the scope of a restriction requirement, there is no safe harbor refuge from double patenting.

Janssen filed a CIP claiming priority to an application that ultimately matured into a patent. Both the CIP and the issued patent disclosed and claimed priority through a series of applications directed to antibodies specific to human tumor necrosis factor alpha and a later application directed to immunoreceptor molecules specific for tumor necrosis factor alpha or beta. All told, more than 30 patents reached through the original priority application for the benefit of an earlier filing date.

In 2013, in response to a third-party request, the US Patent and Trademark Office re-examined the issued patent on double patenting grounds over three patents. During the re-examination, Janssen cancelled two claims and requested that the issued patent be amended to delete the benefit claims to the earlier application directed only to tumor necrosis factor alpha. Janssen also amended the specification, abstract and drawings to conform to the later application, thereby deleting the portions relating only to the alpha factor. Lastly, Janssen requested that the application for the issued patent be designated as a divisional of the later application (directed to tumor necrosis factor alpha or beta), rather than as a CIP. The examiner and the PTAB maintained the double patenting rejections on the basis that the § 121 safe harbor did not apply. Janssen appealed.

On appeal, the Federal Circuit considered “whether, several years after a challenged patent issues on a CIP application, a patent owner can retroactively bring the challenged patent within the scope of the § 121 safe harbor by amending the CIP application during a reexamination proceeding to predesignate it as a divisional application.”

The Federal Circuit applied a strict application of § 121, noting that in accordance with its literal terms, the safe harbor protects only divisional applications (or the original application) and patents “issu[ed] on” such applications. Therefore, patents issued on CIP applications are not within the scope of the safe harbor. The Court cited in support G.D. Searle v. Lupin Pharma. (IP Update, Vol. 18, No. 7), which held that “the patent owner should not take advantage of the safe-harbor provision simply by designating the CIP as a divisional application in a reissue application years after the fact.” The Court reasoned that the application on which the challenged patent had issued was not a divisional because it contained new matter that was not in the original application, nor could the application be retroactively altered by simply deleting new matter, and the patent owner could not for purposes of § 121 retroactively relinquish the new matter in the CIP after enjoying years of patent protection.

Applying the reasoning in Searle, the Court concluded that “a patent owner cannot retroactively bring its challenged patent within the scope of the safe-harbor provision by amendment in a reexamination proceeding.”