What’s in a Claim? The Federal Circuit Rules on Orange Book Patent Listings

Whether a patent can be listed in the Orange Book is a critical issue for both brand and generic manufacturers, and, of particular interest in the last few years is whether patents claiming just the device constituent of a combination product is eligible for listing.  While mums the word from FDA, the FTC has some strong opinions on the issue.  And both the First Circuit and the District Court for New Jersey have weighed in.  Now, the arbiter of all things patent, the Federal Circuit, has made the most definitive statement yet, holding that:

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.

The background of this case is pretty simple.  Teva is the sponsor of ProAir® HFA, indicated for the “treatment or prevention of bronchospasm with reversible obstructive airway disease in adults and children 12 years of age or older.”  Nine patents are listed in the Orange Book with ProAir HFA.   Amneal filed an ANDA seeking approval to market a generic and filed Paragraph IV certifications for those 9 patents; Teva sued Amneal for infringement of 6 of those patents—later amended to 5—and triggered a 30 month stay.  But because the patents at issue relate to the dose counter of the device constituent, Amneal filed antitrust counterclaims, counterclaims for declaratory judgment of noninfringement and invalidity, and counterclaims seeking an order requiring Teva to delist the five patents that it asserted against Amneal.  Amneal alleged that but for those device patents, only Paragraph I certifications would have been filed and no 30-month stay would have been imposed.   Teva moved to dismiss and Amneal moved for a judgment on the pleadings.  The District Court granted Amneal’s motion and ordered Teva to delist the 5 patents because the patents “are directed to components of a metered inhaler device, but do not claim or even mention albuterol sulfate or the ProAir® HFA.”  Teva appealed to the Federal Circuit, and the Federal Circuit stayed the District Court’s delisting order pending resolution of the case.

On appeal, Teva argued that a patent must be listed in the Orange Book if the claimed invention is found in its product.  Because ProAir HFA contains features claimed by the patent—the dose counter and canister—Teva argued that its patents were properly listed in the Orange Book.  Teva asserted that a patent “claims the drug” as long as the NDA drug product infringes that claim; in other words, “claims” means “infringes”.  Teva also argued that the Federal Food, Drug, and Cosmetic Act’s definition of “drug” includes the device component.  The Court rejected both these arguments “as allowing for the listing of far more patents than Congress has indicated.”

In short, the Court held that a patent does not claim the drug just because it reads on the approved drug product.  Instead, “a patent claims the drug when it particularly points out and distinctly claims the drug as the invention.”  Therefore “to qualify for listing, a patent must claim at least what made the product approvable as a drug in the first place—its active ingredient.”  The fact that a product could infringe a patent does not mean that the patent “claims” the drug.

The Court then moved to Teva’s second argument: that a patent is listable if it claims any part of the combination product.  The Court rejected this argument because, essentially, the device component is not part of the drug.  The Court explained, citing to Genus, that the fact that FDA approved the combination product as a drug does not make the device constituent a drug; that is, a combination product is not a drug, as the drug and device constituents retain their identities as drugs or devices.  “[I]ncluding a drug in a combination product does not transform each and every component of that combination product into a drug.”

In short, “to qualify for listing, a patent must claim at least the active ingredient in the application and the approved drug product.”  Nevertheless, it’s unclear whether this decision, despite its definitiveness, will have the effect of pressuring combination product sponsors to delist their device patents.

Ultimately, this case brings us to the question “what’s in a claim?”  In the context of listing patents in the Orange Book, the Federal Circuit has decided that the answer must be the active ingredient.  We’ll see what FDA and industry does with that.