Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals LLC


Issue(s) Presented

1. “Whether the FDCA’s references to patents that claim a ‘method of using [a]’ drug should be interpreted to encompass those claiming ‘conditions of use,’ as FDA has interpreted that phrase under the FDCA, or instead only to encompass claims construed to cover ‘methods’ as a matter of patent law.” 2. “Whether 21 U.S.C. § 355(c)(3)(D)(ii)(I) creates a delisting remedy for patents that were properly listed at the time of their original listing.” 3. “Whether—even assuming that patent law provides the correct interpretive framework—the ’963 patent claims a method.”


1. “The scope of ‘conditions of use’ in [the FDCA’s] provisions… does not expand the meaning of ‘method of using the drug’ in the statutory provision at issue here, which must take its meaning from the patent laws.”

2. “[T]he delisting statute does not require us to consider whether the patent holder violated the law by listing the patent in the first instance. It simply provides that those accused of infringing a listed patent may request an order requiring the patent holder to correct or delete listings for patents that do not claim the drug or a method of using the drug.”

3. ‘We therefore find that the claims of the ’963 patent were properly construed by the district court as system claims, not method claims.”