180-Day Statute of Limitations Under 35 U.S.C. 154(b)(3) & (4) Applies to Final Patent Term Adjustment Determinations, Although Time Between Allowance and Issuance Should Not Be Excluded

The Fed Cir affirms dismissal of challenges to the PTO's patent term adjustment determinations on 15 patents as untimely under 35 U.S.C. 154(b)(3) & (4), but reverses patent term adjustment determination on 3 patents under 35 U.S.C. 154(b)(1)(B).--more-->

Novartis AG v. Lee., ___ F.3d ___ (Fed. Cir. Jan. 15, 2014) (TARANTO, Newman, Dyk) (D.D.C.; Huvelle) (2 of 5 stars)

The Fed Cir rejected the patentee's argument that the 180-day statute of limitations for challenging patent term adjustment determinations only applied to provisional adjustment determinations and not to final adjustment determinations under 35 U.S.C. 154(b)(3) & (4) because "the statutory language on which [patentee] relies is a flaw in drafting that cannot reasonably support the construction [patentee] advances." Slip op. at 11 (noting that Congress recognized and corrected the drafting flaw). In addition, the 180-day rule of paragraph (b)(4) did not need to be equitably tolled, because a failure to advance a legal theory is not a sufficient basis for securing equitable tolling. And the dismissal was not a violation of the Fifth Amendment, because the dismissal resulted from the patentee's own neglect.

Regarding the patent term adjustment of the patentee's three remaining patents under 35 U.S.C. 154(b)(1)(B), the Fed Cir ruled that no adjustment time is available for any time in continued examination, even if the continued examination initiated more than three calendar years after the application's filing. The Fed Cir, however, determined that time between allowance and issuance should be part of patent term adjustments as "time consumed by continued examination," because allowance-to-issuance time is time attributable to the PTO.