Spotlight on Upcoming Oral Arguments – November 2024

The following arguments will be available to the public live, both in-person and through online audio streaming. Access information will be available by 9 AM ET each day of argument at: https://cafc.uscourts.gov/home/oral-argument/listen-to-oral-arguments/.

Thursday, November 7, 2024, 10:00 A.M.

BearBox LLC v. Lancium LLC, No. 23-1922, Courtroom 203, Panel H

BearBox LLC (“BearBox”) sued Lancium LLC (“Lancium”) to amend the named inventors of U.S. Patent No. 10,608,433 (“the ’433 patent”) to include Austin Storms. The ’433 patent, issued on March 31, 2020, names Michael McNamara and Raymond Cline, Jr. from Lancium as inventors on the face of the patent. This patent pertains to computing systems for performing computational operations, such as Bitcoin mining. Both BearBox and Lancium are technology companies focused on, inter alia, cryptocurrency.

Two issues on appeal are: (1) whether federal patent law preemption applies to BearBox’s conversion claims; and (2) whether striking an expert report was an abuse of discretion.

Conversion Claims

BearBox will argue that the district court erred because conflict preemption only preempts a state-law cause of action based on conduct protected by federal patent law. Specifically, BearBox asserts that its inventorship claim is based only on the contention that that Storms was an inventor of the claimed invention; not that Lancium wrongfully took Storms’ property and misused it. BearBox thus argues that its conversion claim is not “patent-like” and does not seek to enforce patent rights.

Lancium argues that the district court was correct in finding that federal patent law preempted Lancium’s conversion claim. Lancium argues that BearBox made the data file publicly available, preventing BearBox from claiming “patent-like” protection. In addition, Lancium proffers both statute of limitations and Louisiana state law grounds as independent bases for barring BearBox’s preemption claim. Finally, Lancium asserts that BearBox cannot claim inventorship as a separate and distinct issue from a claim for conversion.

Expert Report

As a secondary issue, BearBox argues that Lancium failed to properly raise claim construction as an issue, thereby waiving its right to do so. Consequently, BearBox claims that the district court’s decision conflicts with both Federal Circuit and Third Circuit law. In addition, BearBox argues that the district court’s decision to strike the expert report left it unable to adequately support the construed terms for the claim elements. Specifically, BearBox asserts that the district court erred in failing to credit BearBox’s supplemental expert report as a response to Lancium’s motion for summary judgment, which purportedly included terms the parties disputed that were not addressed in the district court’s earlier claim construction. BearBox contends that less severe remedies should have been considered, such as rebuttal supplements or cross-examination.

Meanwhile, Lancium argues that the supplemental expert report was indeed untimely. Specifically, Lancium argues that the district court rejected BearBox’s argument because BearBox and its expert were aware of Lancium’s proposed construction six months prior to the supplemental report. Rather than address Lancium and its expert’s construction in reply briefing, Lancium asserts BearBox’s decision to wait until the eve of trial to raise the issue was a “problem[] of their own making.”

Friday, November 8, 2024, 10:00 A.M.

Teva Branded Pharma. Prods. R&D, Inc. v. Amneal Pharmas. of New York, LLC, No. 24‑1936, Courtroom 402, Panel K

Teva Branded Pharmaceutical Products R&D, Inc. (“Teva”) holds the approved new drug application (“NDA”) for ProAirHFA, an inhaler with albuterol sulfate as its active ingredient. Amneal Pharmaceuticals of New York, LLC (“Amneal”) submitted an abbreviated NDA for a generic version of ProAirHFA. Teva sued Amneal in the District of New Jersey for patent infringement, asserting six patents—all listed in the Orange Book—covering a metered-dose inhaler used in ProAirHFA. Amneal counterclaimed for an injunction compelling Teva to delist these patents from the Orange Book because the patents allegedly did not claim the drug for which the NDA was submitted. Amneal moved for judgment on the pleadings. Before Teva answered, the district court granted Amneal’s motion and ordered Teva to delist the asserted patents.

On appeal, the Federal Circuit will decide whether, to be listed in the Orange Book, the “Listing Statute” of the Food, Drug & Cosmetic Act requires that a patent claim the active ingredient for which an NDA was approved and whether the district court erred in assessing the language of the asserted patents without conducting any claim construction.

Both parties argue for different statutory interpretations of the Listing Statute. Teva argues the statutory language requires the asserted patents to be listed. Teva interprets the meaning of the term “claim” in patent law and the statutory definitions of “drug” and “drug product” to support the position that a patent need not directly claim the active ingredient of a drug to be listed in the Orange Book. Specifically, Teva argues “drug” includes not just the active ingredient, but also the entire drug product. Teva also argues the definition of “drug product” is a finished dosage form, and the FDA has categorized metered aerosols as a finished dosage form. And in conjunction with the meaning of “claim” in patent law, Teva contends that the asserted patents claim a “drug” because ProAirHFA would infringe the claimed subject matter of the asserted patents. Taken together, Teva concludes that the asserted patents claim the drug for which the NDA was submitted and must be listed in the Orange Book. Even if a patent must directly claim an active ingredient of a drug, Teva maintains that the district court should have conducted claim construction to make this finding before granting judgment on the pleadings.

Meanwhile, Amneal agrees with the district court’s finding that the asserted patents do not claim the drug for which Teva submitted its NDA. Amneal contends that the language of the Listing Statute and other statutory definitions are not as broad as Teva contends. Instead, Amneal argues that to “claim” requires particularly pointing out and distinctly claiming subject matter. So, Amneal argues that drug product patents, like the asserted patents, must specifically claim the active ingredient of the NDA. Because the asserted patents do not require the presence of the active ingredient of the NDA, Amneal argues that the asserted patents do not qualify as a listable drug product patent. Amneal also argues that, even if the district court construed the claims, Teva’s constructions do not specifically require the active ingredient of its NDA.