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781 F.3d 1349
Fed. Cir.
2015
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Background

  • SCR Pharmatop filed a PCT application claiming priority from a June 6, 2000 French filing and failed to meet the 30‑month U.S. national‑stage filing requirements, so the U.S. application was deemed abandoned.
  • SCR filed a PTO petition to revive the application on January 2, 2003, stating the delay was "unintentional." The PTO granted revival on April 25, 2003; U.S. Patent No. 6,992,218 issued in 2006.
  • In 2011 Pharmatop sued Exela for infringement under the Hatch‑Waxman statute after Exela filed an ANDA with a Paragraph IV certification.
  • Exela filed a petition with the PTO and then an APA suit in district court seeking to vacate the PTO’s revival decision, arguing § 371(d) (as then written) allowed revival only for "unavoidable" delay and the PTO misapplied its regulation permitting "unintentional" revival.
  • The PTO refused to accept Exela’s third‑party petition, asserting no authority exists for non‑parties to challenge revival, and moved to dismiss Exela’s APA complaint.
  • The district court dismissed (on reconsideration) as time‑barred under 28 U.S.C. § 2401(a); the Federal Circuit affirmed on the independent ground that third parties cannot obtain APA review of PTO revival rulings.

Issues

Issue Plaintiff's Argument Defendant's Argument Held
Whether a third party may challenge a PTO revival decision under the APA Exela: APA § 702 and the presumption of judicial review allow a third party to seek review of ultra vires PTO revival decisions PTO: The Patent Act’s scheme and PTO practice preclude third‑party collateral APA challenges to revival rulings Held: No; third parties may not obtain APA review of PTO revival rulings (affirmed)
Whether the PTO erred by applying 37 C.F.R. § 1.137 ("unintentional") instead of § 371(d) ("unavoidable") Exela: PTO misapplied statute and regulation—regulation cannot override statute; revival was ultra vires PTO: Even if error alleged, Exela lacks a cognizable APA cause of action as a non‑party Held: Court did not reach merits; barred from judicial review by third‑party APA challenge framework
Whether Exela’s APA claim was time‑barred Exela: timely (or merits should be reached regardless) PTO: Statute of limitations bars action; district court applied 6‑year limit Held: Affirmance rests on non‑reviewability; district court had dismissed as time‑barred on reconsideration but appellate decision affirms on non‑reviewability ground
Whether precedent allows improper‑revival defenses in infringement suits Exela: APA is needed because Aristocrat bars such defenses, leaving no judicial route PTO: Patent Act channels challenges to specified procedures; third‑party APA suits are inconsistent with statutory scheme Held: Patent Act’s structure bars third‑party APA review; Aristocrat and related precedent support limiting collateral revival challenges

Key Cases Cited

  • Bowen v. Michigan Academy of Family Physicians, 476 U.S. 667 (1986) (presumption in favor of judicial review of agency action)
  • Block v. Community Nutrition Institute, 467 U.S. 340 (1984) (statutory scheme and omission can show Congress intended to preclude review)
  • Morganroth v. Quigg, 885 F.2d 843 (Fed. Cir. 1989) (applicant may seek APA review of PTO refusal to revive an application)
  • Aristocrat Techs. Australia Pty Ltd. v. Int’l Game Tech., 543 F.3d 657 (Fed. Cir. 2008) (improper revival is not a defense in infringement suits)
  • Pregis Corp. v. Kappos, 700 F.3d 1348 (Fed. Cir. 2012) (third party cannot sue PTO under APA to challenge issuance of a patent)
  • Magnivision, Inc. v. Bonneau Co., 115 F.3d 956 (Fed. Cir. 1997) (procedural lapses in prosecution generally do not support invalidity defenses)
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Case Details

Case Name: Exela Pharma Sciences, LLC v. Lee
Court Name: Court of Appeals for the Federal Circuit
Date Published: Mar 26, 2015
Citations: 781 F.3d 1349; 2015 WL 1344662; 114 U.S.P.Q. 2d (BNA) 1328; 2015 U.S. App. LEXIS 4895; 2013-1206
Docket Number: 2013-1206
Court Abbreviation: Fed. Cir.
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    Exela Pharma Sciences, LLC v. Lee, 781 F.3d 1349