Spotlight on Upcoming Oral Arguments – February 2023

The following telephone 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: http://www.cafc.uscourts.gov/public-access-arguments.

Friday, February 10, 2023

SNIPR Technologies Ltd. v. Rockefeller University, No. 22-1260, Courtroom 402

This appeal explores whether, after the AIA eliminated interference proceedings for patent applications filed after March 16, 2013, the USPTO can subject a post-AIA application to an interference proceeding over a pre-AIA application. Rockefeller requested that the USPTO declare an interference proceeding for five SNIPR-owned patents related to methods of killing bacteria, all of which were filed after the enactment of the AIA. Rockefeller filed a provisional application in February 2013, before the AIA, and later filed a PCT application and a U.S. national-stage application that both claimed priority to the provisional application. SNIPR filed a U.S. patent application in May 2016 that claimed priority to an application with a post-AIA filing date. SNIPR then filed multiple divisional applications, which resulted in five patents. In its interference request, Rockefeller alleged that SNIPR’s applications were directed to the same invention as Rockefeller’s applications and the Board instituted Interference No. 106,123. In its decision, the Board invalidated all five of SNIPR’s patents by awarding priority to Rockefeller. SNIPR appealed.

On appeal, SNIPR argues that the AIA’s plain text prevents the USPTO from subjecting applications with a post-AIA priority date to interference proceedings. SNIPR asserts that, without exception, Congress eliminated interference proceedings for applications filed after the effective date and replaced them with derivation proceedings. SNIPR further argues that the case should at least be remanded because the Board failed to determine whether Rockefeller’s post-AIA national-stage application could claim priority to its pre-AIA provisional application. SNIPR alleges that the provisional application disclosed examples of killing only a single species of bacteria, while the claims cover killing mixed populations of bacteria. According to SNIPR, a skilled artisan reading the provisional application would not have understood that Rockefeller possessed the claimed invention.

In response, Rockefeller argues that the AIA’s plain text instead supports the Board’s decision to institute an interference proceeding. Rockefeller focuses on the pre-AIA priority date of its patent application and argues that the AIA makes clear that pre-AIA patents can be subjected to interference proceedings and that the filing date of the interfering patents is irrelevant. Rockefeller also argues that SNIPR failed to apply the correct analysis to determine whether Rockefeller’s national-stage application could claim priority to the provisional application and is attempting to improperly raise new arguments on appeal.

Tuesday, February 14, 2023

Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC, No. 23-1186, Courtroom 201

In December 2020, Avadel sought approval from the FDA for its proposed sodium oxybate product. Avadel filed a § 505(b)(2) application relying on Jazz’s Xyrem as the “listing drug” for that application. Xyrem is a sodium oxybate oral solution used to treat symptoms associated with narcolepsy. To avoid misuse of the compound, Jazz invented a computer-implemented system treatment known as Xyrem REMS, which is covered by the Orange-Book listed U.S. Patent No. 8,731,963 (the ’963 patent). After Avadel filed the 505(b)(2) application, the FDA determined that Avadel was seeking approval of a condition of use claimed by the ’963 patent and requested appropriate patent certification. Jazz sued for patent infringement in the District of Delaware and Avadel brought a counterclaim seeking to delist the ’963 patent. The district court issued an injunction requiring Jazz to delist the ’963 patent. Jazz appealed.

On appeal, Jazz argues that the district court misinterpreted the Federal Food, Drug, and Cosmetic Act (FDCA). Under the FDCA, Jazz asserts that Avadel had the burden to prove that the ’963 patent “does not claim” an “approved method of using the drug.” Jazz asserts that the FDCA does not define the phrase “an approved method of using the drug” and, in interpreting that phrase, the district court treated it as a patent-law question by construing the patent to include “system” claims (which cannot be listed in the Orange Book) rather than “method” claims (which can be listed in the Orange Book). Jazz argues that this interpretation of the FDCA is a question of FDCA law, not patent law and that the FDA’s decision that Avadel’s application covers a method of use claimed by the ’963 patent should be awarded deference. Furthermore, Jazz argues that even if the ’963 patent does not claim a “method,” as defined by the FDCA, it was properly listed in the Orange Book in the first instance because the district court failed to address whether Jazz was permitted to list the patent at the time of listing. Jazz argues this is a reversible error because the delisting statute offers no basis to delist patents that were appropriately included in the Orange Book at the time they were listed.

In response, Avadel argues that the district court correctly applied patent law in evaluating whether the ’963 patent claims a “method of using the drug.” Avadel asserts that, as a matter of statutory construction, when a term is clearly transplanted from another legal source, courts must use that source to interpret the term’s meaning. Accordingly, because the delisting statute uses terms such as “patent,” “method,” and “claims,” Avadel argues that patent-law principles apply when interpreting the statute. Avadel further argues that the FDA improperly listed the ’963 patent to begin with and that the statute requires delisting improperly listed patents. For support, Avadel relies on the language of the delisting statute, arguing that it requires the delisting of patents that do not claim either a drug or a method of using a drug.