The case centers on several Teva patents related to its ProAir HFA inhaler device and dose counter, which Amneal seeks to delist from the FDA's Orange Book.
A key question on appeal is whether device patents must explicitly claim the active drug ingredient to qualify for listing under the Hatch-Waxman Act.
If the court rules in Teva's favor, it could enhance patent protection strategies for pharmaceutical companies, providing them additional leverage against generic competition.
The key benefit to patentees is an automatic 30-month stay of FDA approval that blocks generic entry during litigation without showing likelihood of success.
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