Although argument week isn't until next week, the Federal Circuit heard oral argument today in two cases. One was rescheduled from earlier this month for medical reasons. But the other, GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., No. 18-1976, caught our eye because of how it came about procedurally. (It's also super interesting substantively, but because we're procedure nerds, we're focusing on procedure today.) The case appears to represent the rare situation (first we've seen) where a Federal Circuit panel withdraws its own precedential opinion and asks for re-argument without public action by the en banc Court. And it provides a nice case study of how the rehearing process works at the Federal Circuit, so we thought we'd walk through it.

So how did we get here? If the case name sounds familiar, that's because the Federal Circuit already heard oral argument in the case almost a year and a half ago, in September 2019 (back in the good ol' days of in-person arguments). Then in October 2020, the Court issued a widely discussed opinion—authored by Judge Newman and joined by Judge Moore—holding that Teva was liable for infringing a GSK method of treatment patent based at least in part on Teva's drug label. Chief Judge Prost dissented, concluding that the majority opinion wrongly found inducement based on Teva's marketing for unpatented uses through a so-called “skinny label.” See 21 U.S.C. § 355(j)(2)(A)(viii).

Teva filed a petition for en banc rehearing only. That is, Teva's petition did not ask for panel rehearing. But the Practice Notes to the Federal Circuit's rules explain that “[a] petition for rehearing en banc is presumed to request relief that can be granted by the panel that heard the appeal, and action on the petition for rehearing en banc will be deferred until the panel has an opportunity to grant the relief requested.” That note matches the Court's internal operating procedures (IOPs), which specify that the clerk sends en banc rehearing petitions first to the original panel. IOP #14, ¶ 2(a). The original panel then has ten working days to act on the petition. IOP #12, ¶ 1(b). If the panel takes no action or votes to deny the petition within that time, the clerk will circulate the petition to the full en banc Court.

Teva filed its petition on December 2, 2020. Ten working days later, on December 16, the Court invited a response to the petition, which a single judge can request. Because that request came within ten working days of the petition's filing, the IOPs suggest the request likely came from one of the original panel members. (The clerk doesn't have to wait the full ten working days if all original panel members indicate before then that they are voting to deny the petition, so it's possible the petition had already been circulated to the en banc Court.)

GSK filed its response on January 29, 2021 (with lots of amici filing briefs in the interim supporting further review). Under the IOPs, the clerk would have then circulated the petition and response back to the original panel members with a new ten-working-day deadline to decide whether to take any action. IOP #12, ¶ 4. Seven working days later, on February 9, the Court issued an order “On Petition For Rehearing” that listed only Chief Judge Prost and Judges Newman and Moore. The order vacated the October 2020 judgment and withdrew the accompanying opinion. And it scheduled a new oral argument for 10 a.m. today.

What does it all mean? The timeline and wording of the Court's order suggest that even though Teva filed an en banc rehearing petition, the petition never made it beyond the original panel. That distinguishes this case from others we've seen (such as American Axle) where an original panel withdrew its prior opinion and issued a revised one at the same time the full Court issued an order denying en banc review. When that happens, judges beyond the original panel participated in the action on the petition, and likely at least had a chance to comment on the revisions to the panel decision. After all, once the clerk circulates a petition to the full court, any judge can weigh in about whether certain revisions would lead him or her to agree with the panel decision or at least to vote to deny en banc review. From the public information here, nothing indicates other judges had a chance to weigh in. Of course, it's possible that still happened privately—this is a fairly high-profile case and petition, and because the original panel decision was precedential, it would have circulated to the full Court before issuing. IOP #10, ¶ 5. But all public indications are that the action here came only from the original panel. (If the panel drafts a new opinion for publication, however, that draft likely would again circulate to the full Court before issuance, and the full Court may issue an order acting in some way on the en banc petition simultaneously with the issuance of any new panel opinion. See IOP #14, ¶ 2.)

Time will tell what all this means for the case outcome. Today's oral argument was lively and well worth a listen (available here). For now, we'll have to be satisfied with understanding a bit about how the sausage is made.

Originally Published by Morrson Foerster, February 2021

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