Landmark Ruling Reshapes Pharmaceutical Patent Litigation

In recent pharmaceutical patent litigation, the Court of Appeals for the Federal Circuit has ruled that patents must specifically claim an active ingredient to be properly listed in the FDA’s Orange Book. The case was Teva v. Amneal.

The Haynes Boone firm writes that this decision significantly impacts pharmaceutical patent litigation for device-related patents and reinforces the role of antitrust considerations in Hatch-Waxman disputes.

Teva, the party affected by this ruling, is expected to seek Supreme Court review, as the decision will shape future strategies for both brand-name and generic drug companies regarding Orange Book listings and related legal challenges.

The Hatch-Waxman Act established the Orange Book to list patents covering approved drugs, helping to manage disputes between brand-name and generic manufacturers.

When a generic drug maker files an Abbreviated New Drug Application, it must certify its position regarding the listed patents. If the generic company challenges a listed patent under a Paragraph IV certification, the brand-name company may sue, triggering a 30-month stay on FDA approval of the generic.

The Federal Trade Commission has scrutinized improper Orange Book listings as potential antitrust violations that hinder market competition and increase drug costs.

In this case, Teva listed patents covering the inhaler device for its ProAir® HFA product, despite ceasing production of the inhaler. Amneal, a generic manufacturer, challenged these listings, arguing they did not claim the active ingredient, albuterol sulfate.

The Federal Circuit agreed, ordering Teva to delist the patents. Additionally, Amneal has filed antitrust claims against Teva, which remain pending.

Attorneys for pharmaceutical companies should be aware of potential antitrust risks. Patent strategies must account for new regulatory requirements, and counsel should prepare for heightened scrutiny in pharmaceutical patent litigation.