New Jersey Federal Court Weighs in on Orange Book Patent Listings

By: Erica R. Sutter , Robert Counihan

What You Need To Know

  • The court for the District of New Jersey becomes the latest federal court to weigh in on the issue of “device” patents listed in the Orange Book.
  • The court held that patents related to the device component of a drug product—but that did not “claim” the active ingredient—are not eligible for Orange Book listing.

In recent months, the issue of whether certain patents are appropriately listed in the Food and Drug Administration (FDA) Orange Book, associated with the Hatch-Waxman Act, has garnered the attention of the Federal Trade Commission and courts. Most recently, on June 10, 2024, Judge Stanley Chesler in the District of New Jersey issued an opinion requiring a New Drug Application (NDA) holder to “de-list” or correct information for so-called “device” patents in the Orange Book. In the same opinion, the court also denied the NDA holder’s motion to dismiss antitrust counterclaims relating to the Orange Book listed patents.

That case, Teva v. Amneal (Case No. 23-cv-20964-JXN-MAH), involves Teva’s “ProAir® HFA,” an albuterol sulfate aerosol that is sold in an inhaler. Prior to the litigation, Teva had identified patents relating to aspects of the inhaler for Orange Book listing.

Last year, Teva sued Amneal after Amneal filed an Abbreviated New Drug Application (ANDA) seeking to market and sell a generic version of ProAir® HFA. Pertinent to the recent decision, Teva alleged that Amneal infringed ProAir® HFA Orange Book listed patents under the Hatch-Waxman regulatory scheme. In response, Amneal brought counterclaims seeking declaratory judgment requiring that Teva de-list from the Orange Book patents related to the inhaler device and alleging violations of federal and New Jersey antitrust laws.

The present decision stems from Teva’s motion to dismiss these claims and Amneal’s cross-motion for partial judgment on the pleadings as to the de-listing counterclaims. As part of this dispute, the FTC filed an amicus brief, offering its views on the listing of “device” patents. The FTC’s arguments in Teva v. Amneal are consistent with its prior actions and statements related to its interest in Orange Book patent listing.1

In the June 10 decision, the court granted Amneal’s motion for judgment on the pleadings and required Teva to de-list or correct the information pertaining to the “device” patents currently listed in the Orange Book. It also denied Teva’s motion to dismiss Amneal’s antitrust claims, thus allowing those claims to proceed.

The court’s decision focuses on the statutory language “the drug for which the applicant submitted the application,” and appears to require that a patent claim encompass the active ingredient (for example, by claiming the active ingredient itself or a drug formulation that includes the active ingredient) for the patent to be listed in the Orange Book.

Specific to Teva’s ProAir® HFA, the court noted that “[a]ccording to the FDA, the drug for which the applicant submitted the NDA is ‘albuterol sulfate HFA Inhalation Aerosol.’” The court then concluded:

“[T]he Inhaler Patents do not meet a key requirement of the Listing Statute: they do not claim ‘the drug for which the applicant submitted the application,’ NDA No. 021457, ProAir® HFA (albuterol sulfate) Inhalation Aerosol. Nor do the Inhaler Patents claim the ‘finished dosage form’ that is the subject of that NDA application.”

In doing so, the court rejected Teva’s arguments, including Teva’s reliance on the statute’s definition of “drug,” which includes articles intended for use in the “treatment” of disease. The court’s decision is also consistent with the position the FTC set forth in its amicus: “In short, the Hatch-Waxman Act does not authorize the listing of the asserted patents because they do not mention any drug in their claims and are therefore not ‘drug product (formulation or composition) patent[s]’ under the listing provisions.”

On June 11, Teva filed a notice of appeal and a motion to stay the court’s order pending resolution of that appeal. On June 13, the court granted Teva’s motion for a period of 30 days.

1 Fenwick previously discussed some of the FTC’s recent actions pertaining to Orange Book patent listings.