Argument Recap

In February, the Federal Circuit heard oral argument in Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals LLC, a patent case that attracted an amicus brief. In this case, the Federal Circuit is reviewing 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. The panel hearing the oral argument included Judges Lourie, Reyna, and Taranto. This is our argument recap.

Steven Horowitz argued for Jazz. He began by arguing that the relevant regulations state that innovators need to list terms and conditions of use on which drug approval is sought. Moreover, he asserted, the FDA has interpreted method of use to encompass a condition of use for which approval is sought. One judge asked whether patent law should be applied here. Horowitz responded that other law controls the regulations and conditions of use. Another judge asked how Jazz makes the connection between a method of using a drug and a condition of use. Horowitz responded that a method constitutes a condition of use in the relevant statute.

In response to the question whether this case comes down to what the claim encompasses, Horowitz argued that the plain meaning of the system claim indicates it is part of a method. Horowitz further argued that there are other patents in the relevant family that explicitly use the word method.

Gabriel Bell argued on behalf of Avadel. He began by asserting that Jazz is overcomplicating the whole case when in reality it is really simple. He argued that these are computer process claims, which are classic patent law claims. Moreover, he said, the relevant statute directs the court to apply certain principles to the question of delisting a patent from the Orange Book. One judge then asked about Jazz’s argument regarding a condition of use claim. Bell responded by arguing that Jazz never contended that patent law should not apply. Moreover, he argued, the delisting statute’s language does not include other things that do not include methods of use. He further asserted that a method of use has a common sense meaning, that conditions of use is not broader than methods of use, and the court does not need to dig deeper to find a different meaning.

Another judge asked why the context or method of use does not change if the drug is dangerous. Bell responded that patents that are just about distribution do not fall within the terms of the statute and that is the end of the inquiry.

In rebuttal, Horowitz argued that conditions of use pertain to dosage. He concluded his rebuttal by arguing that the key question in this case is whether there is a condition of use, not whether there is a method.

We will report on the Federal Circuit’s disposition of this case.