EPISODE · Mar 19, 2025 · 23 MIN
Teva Branded Pharmaceutical Products R&D, Inc. v. Amneal Pharmaceuticals Of New York, LLC, decided 20 Dec 24
from CAFC News Brief · host Sentinel
This case decision concerns a dispute between Teva and Amneal over Teva's listing of patents in the FDA's Orange Book, which impacts generic drug approvals. Amneal argued that Teva improperly listed patents relating to the inhaler device, not the active ingredient, delaying generic competition. The district court agreed, ordering Teva to delist the patents. The appeals court affirmed this decision, clarifying that to be listable, a patent must claim at least the active ingredient of the approved drug, not just any component. The court rejected Teva's arguments that "claims" equates to "infringes" and that any component of a drug product qualifies for listing.
What this episode covers
This case decision concerns a dispute between Teva and Amneal over Teva's listing of patents in the FDA's Orange Book, which impacts generic drug approvals. Amneal argued that Teva improperly listed patents relating to the inhaler device, not the active ingredient, delaying generic competition. The district court agreed, ordering Teva to delist the patents. The appeals court affirmed this decision, clarifying that to be listable, a patent must claim at least the active ingredient of the approved drug, not just any component. The court rejected Teva's arguments that "claims" equates to "infringes" and that any component of a drug product qualifies for listing.
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Teva Branded Pharmaceutical Products R&D, Inc. v. Amneal Pharmaceuticals Of New York, LLC, decided 20 Dec 24
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