BioDelivery Sciences Int’l, Inc. v. Aquestive Therapeutics, Inc., Appeal Nos. 2019-1643, -1644, -1645 (Fed. Cir. Aug. 29, 2019)

Our case of the week this week focuses on Section 314(d)—the “no appeal” provision of the America Invents Act statute concerning inter partes reviews. In short, the panel reinforced the import and effect of that provision, even in light of the decision by the PTAB to vacate and terminate proceedings following a remand decision by the Federal Circuit after a first appeal.

BioDelivery filed three petitions for inter partes review. The PTAB instituted review on a single ground in each petition, declining to institute review on the remaining fourteen asserted grounds. The Board sustained the patentability of all claims based on the instituted grounds and BioDelivery appealed. After oral argument in the appeals, the Supreme Court issued its decision in SAS Institute, Inc. v. Iancu, 138 S. Ct. 1348 (2018), holding that the PTAB could not institute only on selected grounds. The Federal Circuit remanded the case, ordering that “BioDelivery’s request for remand to implement the Court’s decision in SAS is granted in [the three appeals]” and “[t]he PTAB’s decisions in PTAB Nos. IPR2015-00165, IPR2015-00168, and IPR2015-00169, are vacated.”

On remand, rather than consider the other fourteen grounds, the PTAB decided to vacate its prior institution decisions and terminate the proceedings, finding that pursuing such IPRs would not be an efficient administration of the Office, since the petitioner was unlikely to prevail on the vast majority of grounds asserted. BioDelivery appealed again.

A motions panel of the Federal Circuit affirmed, relying on Section 314(d). The Court reiterated that “Section 314(d) plainly states that the Patent Office’s decision whether to institute IPR is not appealable,” and noted its prior decision that “[t]he Board’s vacatur of its institution decisions and termination of the proceedings constitute decisions whether to institute inter partes review and are therefore ‘final and nonappealable.’”  The Court noted that the AIA expressly contemplates the termination of IPRs before a final written decision.

The Court also rejected an argument that there is a “strong presumption in favor of judicial review,” finding that the IPR statute expressly provided for no appeals from such decisions. Thus, the Court dismissed the appeal. Judge Reyna drafted the opinion, joined by Judge Lourie.

Judge Newman dissented. She believed that the PTAB did not comply with the remand order from the first appeal by failing to consider the additional grounds asserted in the petitions.

The opinion can be found here.


Allergan Sales, LLC v. Sandoz, Inc., Appeal No. 2018-2207 (Fed. Cir. Aug. 29, 2019)

The Federal Circuit affirmed the grant of a preliminary injunction in an Abbreviated New Drug Application case, where the validity of the asserted claims turned on the effect of detailed “wherein” clauses relating to the safety and efficacy of the claimed formulation. The Court agreed with the district court’s construction of such clauses as constituting claim limitations. For example, where the claims recited a topical treatment “wherein the method is as effective as the administration of” a specified alternative treatment, the Court rejected defendants-appellants’ argument that the clauses were not material to patentability and “merely state the intended results.” Instead, relying on portions of the specification and prosecution history emphasizing the importance of improved safety and efficacy, including to distinguish the claimed formulation over the prior art, the Court found that the “wherein” clauses were material to patentability and therefore limiting. Chief Judge Prost entered a concurring opinion, agreeing with the majority’s conclusion but arguing that the plain meaning of the claim terms dictated the same result from the outset.

The opinion can be found here.

Guangdong Alison Hi-Tech Co. v. International Trade Commission, Appeal No. 2018-2042 (Fed. Cir. Aug. 27, 2019)

In this appeal from a U.S. International Trade Commission investigation, the Federal Circuit addresses issues relating to indefiniteness and anticipation. Specifically, the Court affirmed the Commission’s decision that the patent-at-issue was not invalid on those grounds. As to indefiniteness, the Court found that while the term “lofty … batting” is a term of degree, the specification provides objective boundaries—in the form of distinguishing features, examples, and metrics—that inform the meaning of the term and as such, it is not indefinite. As to anticipation, the Court affirmed the Commission’s decision that the patent was not anticipated by a reference that was also considered by the examiner during prosecution and by the PTAB during an IPR because that reference did not expressly or inherently disclose the “lofty … batting” limitation.

The opinion can be found here.

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