1. “Whether the statutory requirement to list in the Orange Book any patent that ‘claims the drug for which the applicant submitted [an NDA] and is a drug product (formulation or composition) patent’ excludes drug product patents unless they recite, by name, the active ingredient in the drug product.”
2. “Whether the district court properly assessed that the five patents at issue do not claim the drug for which the applicant submitted the application without conducting any claim construction.”
1. “To summarize, our analysis of the numerous relevant statutory provisions and the relevant case law leads us to only one conclusion: To list a patent in the Orange Book, that patent must, among other things, claim the drug for which the applicant submitted the application and for which the application was approved. And to claim that drug, the patent must claim at least the active ingredient. Thus, patents claiming just the device components of the product approved in an NDA do not meet the listing requirement of claiming the drug for which the applicant submitted the application.”
2. “Even accepting Teva’s (somewhat dubious) construction, we conclude that the district court properly ordered Teva to delist the five asserted patents. . . . A claim requiring the presence of ‘an active drug’ is far too broad to particularly point out and distinctly claim the drug approved in Teva’s NDA. Teva’s construction permits the presence of any active ingredient in any form. As a matter of law, Teva’s construction does not particularly point out and distinctly claim what was approved—the ProAir® HFA with albuterol sulfate as the active ingredient. We do not and need not decide more.”
