In re Janssen Biotech, Inc., No. 2017-1257, 2018 U.S. App. LEXIS 1640 (Fed. Cir. Jan. 23, 2018) (Before Prost, C.J., Reyna, and Wallach, J.) (Opinion for the court, Prost, C.J.).
Janssen filed and later abandoned patent application ‘413, for antibodies specific to human tumor necrosis factor (“TNF”) alpha. Janssen also filed and then abandoned patent application ‘406, for immunoreceptor molecules specific for TNF alpha or beta. Janssen also field applications ‘093 and ‘102 as continuations-in-part (“CIP”) of the 413 and ‘406 applications. The ‘471 patent issued from Janssen’s ‘093 application, which included subject matter disclosed and claimed in the ‘413 and ‘406 applications. Janssen’s ‘272 patent issued from Janssen’s ‘102 application, and its ‘195 patent issued from a CIP of the ‘102 application.
In response to a third-party request, the Patent Office instituted reexamination of the ‘471 patent, to consider obviousness double-patenting over three patents, including the ‘272 and ‘195 patents. Janssen cancelled claims 8 and 9 and requested that the ’471 patent be amended: (1) to delete benefit of the ’406 application; (2) conform the specification, abstract, and drawings to the ’413 application; and (3) designate the ’093 application as a divisional of the ‘413 application.
Ultimately, the PTO rejected claims 1-7 of the ’471 for obviousness-type double patenting over Janssen’s ‘272 and ‘195 patents. The Patent Trial and Appeal Board (“Board”) affirmed. Janssen appealed. The Federal Circuit affirmed again. First, the safe-harbor provision of 35 U.S.C § 121 did not protect the ’471 patent from confronting the ’272 and ’195 patents as prior art. Second, Janssen was not entitled to the two-way test for obviousness-type double patenting.
The safe-harbor provision of 35 U.S.C § 121 is a defense against a double patenting rejection. If it applied, the ‘272 and ‘195 patents could not be used as prior art against the ’471 patent. “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.” G.D. Searle LLC v. Lupin Pharm., Inc., 790 F.3d 1349, 1351 (Fed. Cir. 2015) (citing Eli Lilly & Co. v. Teva Parenteral Meds., Inc., 689 F.3d 1368, 1376 (Fed. Cir. 2012)). Under § 121, “[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 Court reiterated that the protection afforded by § 121 is limited to divisional applications and their progeny. Patents issued on CIP or continuation applications did not fall within the scope of § 121.
The issue before the Court was whether Janssen could retroactively bring its ‘471 patent within the scope of § 121 several years after the patent issued from a CIP application. Could Janssen amend the CIP during reexamination, to redesignate it as a divisional application? Relying on Searle and a strict reading of § 121, the Court said no.
Searle held that the patent owner could not take advantage of the safe-harbor provision simply by designating a CIP as a divisional application in a reissue application, years later. Deleting matter from the reissue patent could not turn a CIP into a divisional application for purposes of invoking the safe harbor. Id. at 1354–55. The language of § 121 supported this holding. After it issued on a CIP application, the ’471 patent could not retroactively become a “patent issued on” a divisional application.
The Court rejected Janssen’s argument that it never enjoyed any benefits from having filed the ‘093 application as a CIP of the ’406 and ’413 applications, rather than as a divisional of the ’413 application. (No issued claims in the ‘471 patent relied upon any “new matter” in the ‘093 application.) First, Janssen did reap benefits from the CIP because more than thirty issued patents iclaim priority to the ’471 patent and/or the ’093 application as a CIP of both the ’406 and ’413 applications. Second, even if Janssen had received no benefit, it would not be entitled to the safe harbor. Janssen properly designated the application as a CIP and did so voluntarily; it did not seek to delete the subject matter disclosed in the ’406 application from its ’093 application until reexamination, and it did not try to change the designation until after issuance of the ‘471 patent.
The Court further rejected Janssen’s argument that its holding creates a rigid “divisional as filed” test that ignores existing PTO rules and practices, in part, because Jenssen did not follow any of those practices. The Court declined to decide whether practices not present in this case would be sufficient to bring the challenged patent within the scope of the safe harbor protections. These practices include designating an application as both a CIP and divisional, or filing a copy of the original application with the same claims as those subjected to a restriction and then filing a preliminary amendment to limit the claims.
Next, the Court affirmed that Janssen was not entitled to the two-way test for obviousness-type double patenting. Usually, the examiner considers whether the application claims (here the reexamined claims) are obvious over the claims of the reference patent. In the two-way test, the examiner also considers whether the patent claims are obvious over the application claims. This second test applies only where (1) a second-filed application issues prior to a first-filed application, and (2) the PTO is solely responsible for the delay in the issuing the first-filed application.
This timing was not present in Janssen’s cases, and the two-way test for double patenting did not apply. First, the ’471 and ‘272 patents were both filed on the same day. Second, the PTO was not “solely responsible” for any delay associated with the ’471 claims. Instead, several of Janssen’s actions, including filing a preliminary amendment, filing a Notice of Appeal and waiting one year to file a submission under 37 C.F.R. § 1.129(a), and adding claims from another application after a final rejection, caused the ’471 patent to issue after the ’272 and ’195 reference patents.
To fall within the safe-harbor protection against obviousness-type double patenting, a patent application must be properly designated as a divisional application before the patent issues. Attempts to retroactively re-designation a CIP application as a divisional does not bring the patent granted from that application within the protection of the safe-harbor, whether or not any benefit was gained from the initial CIP designation.