898 F.3d 1205
Fed. Cir.2018Background
- BioDelivery filed three IPR petitions challenging multiple claims of U.S. Patent No. 8,765,167; the PTAB instituted review on all challenged claims in two petitions but on only some grounds/claims in IPR2015-00165.
- The PTAB issued three separate final written decisions sustaining the patentability of the instituted claims on the instituted grounds. BioDelivery appealed to the Federal Circuit.
- After oral argument, the Supreme Court decided SAS Institute, Inc. v. Iancu, holding that the PTAB must institute on all claims and grounds included in a petition (all-or-nothing institution).
- BioDelivery moved for remand to the PTAB to consider non‑instituted claims and grounds under SAS; Aquestive and the Director opposed, arguing waiver, untimeliness, and prejudice.
- The Federal Circuit declined to find waiver given SAS was a change in law during the appeal, found BioDelivery’s remand requests timely in context, rejected prejudice and piecemeal‑litigation concerns, and ordered the three PTAB decisions vacated and remanded for full consideration under SAS.
Issues
| Issue | Plaintiff's Argument (BioDelivery) | Defendant's Argument (Aquestive/Director) | Held |
|---|---|---|---|
| Whether SAS requires remand so PTAB considers non‑instituted claims and grounds | SAS requires institution consistent with the petition; remand needed for omitted claims/grounds | No substantive dispute about SAS’s rule, but argue relief should be denied for other reasons | Remand required; PTAB decisions vacated and proceedings remanded to consider non‑instituted claims/grounds under SAS |
| Waiver: Did BioDelivery waive SAS‑based relief by not raising it earlier? | No; SAS was a significant change in law during the appeal, so raising it post‑decision is permitted | Argue BioDelivery should have raised the issue earlier (when SAS was granted certiorari or during PTAB proceedings) | No waiver — change in law during appeal excuses earlier failure to raise the argument |
| Timeliness of BioDelivery’s remand requests | Requests were filed promptly after SAS and after Federal Circuit started granting remands; thus timely | Requests are untimely because filed after briefing, argument, and months after SAS | Requests were timely in context; not barred by delay given evolving precedent and PTO guidance timing |
| Prejudice and piecemeal litigation: Should appeals be decided first or remanded? | Remand prevents piecemeal disposition and implements SAS uniformly; district courts can manage stays if needed | Remand prejudices patent owner’s enforcement in district courts and multiple litigations | Remand favored; courts disfavor piecemeal appeals and alleged prejudice does not outweigh need to correct PTAB’s incomplete institution |
Key Cases Cited
- SAS Institute, Inc. v. Iancu, 138 S. Ct. 1348 (2018) (PTAB must institute on all claims and grounds in the petition)
- PGS Geophysical AS v. Iancu, 891 F.3d 1354 (Fed. Cir. 2018) (SAS requires an all‑or‑nothing institution choice)
- Medtronic, Inc. v. Barry, 891 F.3d 1368 (Fed. Cir. 2018) (statute does not permit partial institution leading to a partial final written decision)
- Polaris Indus. Inc. v. Arctic Cat, Inc., [citation="724 F. App'x 948"] (Fed. Cir. 2018) (party need not have waived SAS‑based relief that arose during appeal)
- In re Micron Tech., Inc., 875 F.3d 1091 (Fed. Cir. 2017) (change in law can justify allowing arguments not made earlier)
- W.L. Gore & Assocs., Inc. v. Int'l Med. Prosthetics Research Assocs., Inc., 975 F.2d 858 (Fed. Cir. 1992) (appellate courts disfavour piecemeal litigation)