In Re: Janssen Biotech, Inc., New York Univ.


Docket No. 2017-1257

PROST, REYNA, WALLACH
January 23, 2018

Brief summary: The FC panel affirmed the Board obviousness-type double patenting decision since “a patent owner can[not] retroactively bring the challenged patent within the scope of the § 121 safe harbor by amending the CIP application during a reexamination proceeding to redesignate it as a divisional application”, and that its application of the “one-way” test was appropriate.

Summary: Janseen appealed from Board ex parte reexamination decision finding US 6,284,471 unpatentable for obviousness-type double patenting. The FC panel explained that the doctrine “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, FC 2015). “[A]s in Searle, the double-patenting issue in this case turns on whether Janssen is entitled to invoke § 121 as a defense against a double patenting rejection” (§ 121 is a “safe-harbor provision” dictating that a patent that was subject to a restriction requirement cannot be used as a reference against a divisional application if that divisional application was filed before the patent issued). Further, § 121 “by its literal terms, protects only divisional applications (or the original application) and patents issued on such applications” and not CIP applications (Pfizer, FC 2008; Amgen, FC 2009). It also noted however (FN3), that intervening divisionals and continuations may also be protected under § 121 as long as those “descend from a divisional application filed as a result of a restriction requirement” (Boehringer, FC 2010; Amgen). The question here, the FC panel explained, is “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 redesignate it as a divisional application”, noting it held this cannot be done in reissues (Searle). In Searle, the court held “[t]he application on which the challenged patent had issued was not a divisional because it contained new matter that was not present in the original application”, “the nature of that application” could not be “retroactively altered by simply deleting that new matter”, and “the patent owner could not (for purposes of § 121) retroactively relinquish the new matter in the CIP application after having enjoyed years of patent protection for it.” It explained that Janssen’s reexamination amendments similarly “deleted portions of the challenged patent’s specification that were not present in the original application and changed the designation…from a CIP to a divisional application.” “Thus, here too, even assuming Janssen’s amendments made during reexamination were to become effective by way of a reexamination certificate,” the FC panel “conclude[d] that the ‘471 patent is not entitled to safe-harbor protection” (it “cannot retroactively become, for the purposes of § 121, a ‘patent issued on’ a divisional application after it already issued on a CIP application”). Janssen argued “that Searle is distinguishable because…no issued claims…relied upon any of the new matter” but the FC panel disagreed with this reasoning because, e.g., “the examiner found that Janssen had benefited” from the more than thirty related patents that issued, and “[d]etermining whether any of those patents rely on the deleted subject matter for support cannot be accomplished without reopening examination of each patent.” And it found Janssen’s statements during prosecution “cannot undo Janssen’s filing…as a CIP and properly designating it as such.” The FC also found the Board correctly applied the “one-way” double patenting test and not the “two-way test” (“a narrow exception to the general rule of the one-way test”). The two-way test is applied only in the “unusual circumstances” in which “applicants filed first for a basic invention and later for an improvement, but, through no fault of the applicants, the PTO decided the applications in reverse order of filing…a narrow exception to the general rule of the one-way test”. As these circumstances did not apply here, the FC panel found the Board correctly applied the one-way test.

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