G.D. Searle LLC, et al. v. Lupin Pharmaceuticals, Inc. et al.

Docket No. 2014-1476

June 23, 2015

Brief Summary: DC decision of invalidity for obviousness-type double patenting affirmed; no § 121 safe harbor for divisional application because it was filed as a continuation-in-part (CIP) and could not retroactively be designated a divisional.

Summary: G.D. Searle and Pfizer appealed DC final judgment that RE44,048 (originally US 5,760,068) is invalid for obviousness-type double patenting. The ‘068 patent was previously invalidated for obviousness-type double patenting in view of Pfizer’s US 5,563,165 (Pfizer, FC 2008). The FC held the ‘068 patent was not shielded by the “safe harbor” provision of 35 U.S.C. § 121 for divisional application because it was filed as a continuation-in-part (CIP). Pfizer then filed the ‘319 application seeking reissue of the ‘068 patent under 35 U.S.C. § 251, declaring it had erred in prosecuting the ‘068 patent as a CIP rather than a divisional and filed a preliminary amendment to conform the ‘068 patent to a divisional of the ‘594 application, the original application in its lineage (e.g., deleting portions of the specification not present in the ‘594 application). The examiner rejected the amendment and found the “error” not correctable under § 251. Pfizer then filed an RCE and an additional reissue declaration, claiming errors in the chemical structures that rendered the claims indefinite. The examiner found this to be a proper basis and allowed both the amendments and the claims; this application issued as the ‘048 patent. The DC found the ‘048 patent was not to be a valid reissue because the application was a CIP, the safe harbor provision did not apply, and the claims invalid in view of the ‘165 patent. The FC opinion explained that a “strict test” is applied to safe harbor (§ 121) questions “given the potential windfall [a] patent term extension could provide to a patentee” (Geneva Pharm., FC 2003; Amgen, FC 2009). The panel agreed with the DC because “[s]imply deleting…new matter from [a] reissue application does not retroactively alter the nature of the…application” (“The ‘048 patent issued from the ‘319 application, a reissue of the ‘068 patent, which in turn issued from the ‘113 application. The ‘113 application cannot be a divisional of the ‘594 application, despite being designated as such in the reissue patent, because it contains new matter not present in the ‘594 application.”) In addition, “when the ‘113 application issued as the ‘068 patent in June 1998, Pfizer obtained patent protection for the new matter that was not present in the ‘594 application”, thereby excluding the public from practicing that new matter….“Pfizer cannot…retroactively relinquish the new matter…after having enjoyed years of patent protection for it” (In re Harita, FC 1988; In re Serenkin, FC 2007). The panel also concluded safe harbor did not application since the ‘048 patent and the ‘165 patent “are not ‘derived from the same restriction requirement’” (Pfizer, FC 2008; Boehringer, FC 2010; Bristol-Myers, FC 2004) (record must show restriction requirements carried forward between applications). It explains that under Boehringer, a divisional of a divisional of a grandparent application can fall under safe harbor as long as: 1) the claims prosecuted in two or more applications share common lineage in the divisional chain; and, 2) the lines of demarcation drawn by the examiner are preserved. The DC decision was therefore affirmed.

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