The Federal Circuit today affirmed the D.N.J. decision that Teva's inhaler patents cannot be listed in the Orange Book, because they do not claim the drug for which the application was listed.
As I wrote in my last post below, I thought Teva would have a hard time prevailing given that the patents at issue did not even claim an active ingredient, let alone any specific active ingredient. The Federal Circuit panel agreed, focusing on this absence.
For example, in its discussion of the patents, it noted "None of the claims in the five asserted patents explicitly require the presence of an active drug, let alone any specific active drug." Interestingly, the panel ruled entirely based on the first clause, requiring that the patent to "claims the drug" and not the more specific requirement that the patent “is a drug substance (active ingredient) patent or a drug product (formulation or composition) patent.” 21 U.S.C. § 355(b)(1)(A)(viii). Specifically, the panel held that "claims a drug" means "when it particularly points out and distinctly claims the drug—not simply when the claim could somehow be interpreted to read on the drug." It then rejected Teva's argument that the definition of drug controlled, focusing instead on the entirety of the FDA regulatory scheme. The panel noted that while Teva's product may be a drug, the inhaler alone (without an active ingredient) would be a device, not a drug, and it is only the active ingredient that makes the product a drug. Thus, "to claim that drug, the patent must claim at least the active ingredient."
The Court then addressed a question I raised in my previous post—how specific must one claim the active ingredient to "claim a drug." Teva argued that the claims, though not explicitly reciting an active ingredient, should be construed to require one. The panel found this argument "dubious" but held even 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." The panel left open the question of what would be sufficient (e.g. claiming albuterol generally? A class that includes albuterol?).
The clear message to patent drafters is that to be listable, a claim must be as specific as possible in claiming the active ingredient approved.