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BIODELIVERY SCIENCES INTL., INC. v. AQUESTIVE THERAPEUTICS, INC.

| Aaron S. JohnsonAndrea Cheek

Federal Circuit Summary

Before Newman, Lourie, and Reyna. Appeals from the Patent Trial and Appeal Board.

Summary: A party did not waive SAS-based relief in an IPR appeal when it requested remand for consideration of non-instituted claims shortly after issuance of SAS and requested remand for consideration of non-instituted grounds shortly after issuance of the Federal Circuit’s first orders recognizing that SAS also required consideration of all grounds raised in an IPR petition.

BioDelivery filed three petitions for inter partes review of a patent owned by Aquestive. In the first petition, the PTAB instituted review on less than all asserted claims and less than all asserted grounds. In the second and third petitions, the PTAB instituted on all challenged claims but on less than all asserted grounds. The PTAB issued separate final written decisions for each petition and upheld the patentability of all instituted claims on all instituted grounds. BioDelivery appealed all three decisions to the Federal Circuit. Oral argument was held in the three appeals, more than two months prior to the Supreme Court’s decision in SAS Institute, Inc. v. Iancu, 138 S. Ct. 1348 (2018). Nine days after the SAS decision, BioDelivery submitted a motion to remand the final decision in the first of its IPR petitions, requesting consideration of the patentability of the non-instituted claims. Shortly after the Federal Circuit began issuing remands when the PTAB considered less than all asserted grounds, BioDelivery moved to remand the final decision in the second and third IPRs.

Both Aquestive and the PTO Director argued that BioDelivery waived any such SAS-based relief for not raising the issue: (1) upon the Supreme Court agreeing to hear SAS; (2) during the pendency of the IPRs; or (3) during the briefing period in the Federal Circuit appeal. The Federal Circuit rejected these arguments. Citing Polaris Indus. Inc. v. Arctic Cat, Inc., 724 F. App’x 948 (Fed. Cir. 2018), the Federal Circuit held that waiver did not apply in this case because SAS represented a significant change in law that occurred during the pendency of BioDelivery’s appeals.

Aquestive and the PTO Director also argued that BioDelivery’s request for remand for consideration of non-instituted grounds was untimely. The Federal Circuit disagreed, pointing that BioDelivery requested such SAS-based relief soon after the Federal Circuit began issuing remands in cases in which the PTAB considered less than all asserted grounds. Aquestive argued that BioDelivery should have nonetheless requested this type of relief sooner because the PTAB recognized SAS to require institution on all challenged claims and all challenged grounds in guidance issued earlier than the Federal Circuit’s first remand orders. However, the Federal Circuit disagreed, holding that the “second request for SAS-based relief was not untimely simply because BioDelivery did not predict that this court would authorize requests for remand when the PTAB instituted on less than all grounds as well as on all claims.” Thus, the Federal Circuit granted BioDelivery’s requests for remand and vacated the PTAB’s decisions in all three IPRs.

This case is: BIODELIVERY SCIENCES INTL., INC. v. AQUESTIVE THERAPEUTICS, INC.

Editor: Paul Stewart