Novartis Ag v. Focarino
740 F.3d 593
Fed. Cir.2014Background
- Novartis challenged PTO patent term adjustment determinations under 35 U.S.C. § 154(b) (2011).
- District court dismissed 15 of 18 claims as untimely; three claims survived on merits.
- Novartis asserted two § 154(b)(1)(B) interpretations and sought Wyeth v. Kappos recalculation.
- District court held PTO interpretation correct for timeliness but partly incorrect for § 154(b)(1)(B) interpretations.
- Court affirmed timeliness ruling for 15 patents and remanded 3 for redetermination of adjustments; Fifth Amendment claim was not resolved on timeliness.
- No costs; judgment: affirmed in part, reversed in part, remanded.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Timeliness under § 154(b)(4) for final determinations | Novartis argues 180-day clock applies only to provisional determinations. | PTO contends 180-day period covers final determinations as reviewed under § 154(b)(4). | 180-day period applies to final determinations. |
| Continued examination and the three-year pendency | Continued examination time should count against the three-year limit if initiated after three years. | Time spent in continued examination, regardless of initiation, does not count toward the three-year pendency. | PTO interpretation correct: continued examination does not deplete three-year pendency. |
| Allowance-to-issuance time and continued examination | Time after allowance should be excluded only if continued examination resumes. | Time after allowance, until issuance, is excluded if caused by continued examination. | Time after allowance to issuance is not automatically excluded; no continued examination in these cases. |
| Wyeth recalculation and Takings arguments | Novartis seeks Wyeth-based recalculation and claims taking under Fifth Amendment. | Wyeth recalculation applies only where appropriate; no takings here due to self-help timing rule. | Recalculation limited to appropriate cases; Fifth Amendment takings rejected on these facts. |
Key Cases Cited
- Wyeth v. Kappos, 591 F.3d 1364 (Fed. Cir. 2010) (addressed overlap of delay periods in § 154(b)(2) and Wyeth standard applied)
- United States v. Locke, 471 U.S. 84 (Supreme Court, 1985) (takings not compensating for consequences of own neglect)
- Hosl West Virginia Univ. Hosp., Inc. v. Casey, 499 U.S. 83 (Supreme Court, 1991) (statutory interpretation principles; avoid nonsense results)
- Holland v. Florida, 560 U.S. 631 (Supreme Court, 2010) (equitable tolling standards; diligence and extraordinary circumstances)
- Venture Coal Sales Co. v. United States, 370 F.3d 1102 (Fed. Cir. 2004) (equitable tolling not available where theory was known earlier)
- Commc’ns Vending Corp. of Arizona Inc. v. FCC, 365 F.3d 1064 (D.C. Cir. 2004) (timely filing and statutory interpretation principles)
- BlackLight Power, Inc. v. Rogan, 295 F.3d 1269 (Fed. Cir. 2002) (exceptional action to withdraw from issue; resumption of examination)