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In re Janssen Biotech, Inc.

In EPRx, Patentee May Not Gain Access to Safe Harbor Against Obviousness-Type Double Patenting Via Retroactive Redesignation as Divisional

In re Janssen Biotech, Inc., 2018 WL 503335 (Fed. Cir. Jan. 23, 2018) (PROST, Reyna, Wallach) (PTAB) (3 of 5 stars)

Fed Cir affirms EPRx determination of unpatentability due to obviousness-type double patenting. The PTAB did not err in determining that two Janssen patents could be used as references because they did not qualify for the § 121 “safe-harbor.” The opinion describes how § 121 protects later-filed divisional applications from rejection based on parent applications. During reexamination, Janssen had asked for its patent under reexamination to have its claim, drawings, and description amended, and to be designated as a “divisional” of that prior application, replacing its previous designation of “continuation-in-part.” Citing G.D. Searle LLC, 790 F.3d 1349 (Fed. Cir. 2015), the opinion reasons that “a patent owner cannot retroactively bring its challenged patent within the scope of the safe-harbor provision by amendment in a reexamination proceeding.” Op. at 11. The opinion rejects Janssen’s criticism that a rigid “divisional as filed” test would be inconsistent with “widely followed practice” before the PTO, in which applicants respond to restriction requirements by filing copies of the originally-filed application, then amending the claims via preliminary amendment. The opinion describes how Janssen took a more circuitous path to its attempt to create a retroactive divisional. “Because the practices Janssen points to are not presented in this 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.” Id. at 16.

The PTAB also did not err in concluding that Janssen was not entitled to the “two-way test” for obviousness-type double patenting. In the “two-way test,” the PTO’s obviousness review would not only analyze whether the application claims are obvious over the [reference] patent claims,” but also “whether the [reference] patent claims are obvious over the application claims.” Id. At 16–17 (quoting In re Basell Poliolefine Italia, 547 F.3d 1371 (Fed. Cir. 2008)). This was not a circumstance where a patentee’s patent for a basic invention issued, through no fault of the patentee, after the patent for an improvement.

KEYWORDS: SECTION 121; EX PARTE REEXAMINATION; DIVISIONAL; RETROACTIVE; OBVIOUSNESS-TYPE DOUBLE PATENTING