CAFC addresses patent term adjustment in Novartis v. Lee

Novartis v. Michelle Lee.

While we thus disagree with Novartis on its first § 154(b)(1)(B) issue, we agree with Novartis on its second §154(b)(1)(B) issue. Novartis argues that the “time consumed by continued examination” should be limited to the time before allowance, as long as no later examination actually occurs. In contrast, the PTO contends that any time up until the patent issues, even after allowance, should be excluded from the adjustment awarded to the patentee. We reject the PTO’s view that the time after allowance, until issuance, is “time consumed by continued examination” and so is excluded from adjustments given to the patentee. Such time from allowance to issuance undisputedly would count toward the PTO’s three-year allotment in a case not involving a continued examina- tion. There is no basis for distinguishing a continued- examination case.

The CAFC cites Blacklight Power v. Rogan, 295 F.3d 1269, 1273-74 (Fed. Cir. 2002) (even after payment of the issue fee, but before issuance, PTO officials can take “extraordinary action to withdraw a patent from issue” and “return the . . . application to examination”); 37 C.F.R. § 1.313(a) (applicant may request resumption of examination).