Argument Preview / Panel Activity

Three cases being argued in February at the Federal Circuit attracted amicus briefs. One of those cases is Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals LLC, a patent case. In it, the Federal Circuit will review a determination by a district court that Jazz must request the Food and Drug Administration remove (or “delist”) one of its patents from the FDA’s so-called Orange Book because that patent was improperly listed. This is our argument preview.

In its opening brief, Jazz argues that, “[e]ven if the district court were right that the [relevant] patent is a system patent for patent-law purposes, a patent containing system claims can nonetheless recite ‘an approved method of using the drug’ within the meaning of the key [Federal Food, Drug, and Cosmetic Act] provision.” Moreover, it asserts, the Risk Evaluation and Mitigation Strategy-based distribution plan of the patent “falls comfortably within the ordinary meaning of ‘method of using [a] drug’ because the distribution plan specifies how physicians can prescribe, how pharmacists can dispense, and how patients can use, the drug.” Jazz goes on to argue that, “[i]ndependently, the district court erred in concluding that whether the [relevant patent] was properly listed in the first place is irrelevant to the question of whether it should be delisted.” Finally, in the alternative, it asserts that, “[e]ven if patent law provided the correct framework for determining whether a patent should be listed under the FDCA, the evidence before the district court on claim construction demonstrated that the claimed system of the . . . patent is a method of use.”

Avadel in its response brief first argues that the district court correctly found the patent “does not claim any ‘methods’ at all, but rather claims ‘systems'” and “[t]hat claim-construction analysis ‘disposes of the [delisting] inquiry.’” It further argues the district court properly rejected the argument that its “delisting counterclaim depends on showing that the . . . patent was not properly listed in the first place.” Lastly, it asserts, “the district court correctly construed the . . . patent claims as systems rather than methods.” This, says Avadel, is because “every single claim of the . . . patent recites a ‘computer-implemented system’ with computer components.”

Jazz, in its reply brief, reasserts the arguments it made in its opening brief. For example, it argues that FDCA law referring to an approved method of using a drug “encompasses conditions of use, such as those claimed in the . . . patent.” Moreover, it contends, “the interpretation of ‘an approved method of using the drug’ is an FDCA question, not a patent-law question.” Thus, says Jazz, “its answer is informed by the broader statutory FDCA context and FDA’s authoritative regulations.”

The Public Interest Patent Law Institute, Professor Robin Feldman, Eliana Bookbinder, Brian Mahn, and the Niskanen Center filed an amicus brief in favor of Avadel. Their brief argues that “patent holders like Jazz . . . have not created the kinds of inventions [the relevant legislation] was designed to encourage.” Moreover, they assert holding for Jazz would harms patients “by blocking a useful improvement to their treatment.”

This case will be argued on Tuesday, February 14. We will report on any developments.