In Teva v. Amneal the Federal Circuit joined the 1st and 2nd Circuits in holding that medical device patents could not be properly listed in the Orange Book unless the patents contained at lease one claim which claimed both the drug being administered and the medical device used to administer the drug. Teva asserted that Amneal's proposed generic equivalent for its ProAir® HFA albuterol sulfate metered inhaler infringed 5 Teva inhaler patents listed in the Orange Book. Teva had previously received a warning letter from the FTC asserting it was engaging in unfair competition by listing the patents in the Orange Book because the listings triggered a 30 month stay of FDA approval of the ProAir® HFA generic.
Due to these and similar improper listings, aggrieved generic companies can bring antitrust actions for treble damages under the Sherman and Clayton Acts which may result in substantial treble damages. Brand name drug manufacturers can avoid this antitrust liability by updating their patent drafting practices to ensure at least one claim in combination medical device patents are directed towards both the active pharmaceutical ingredient and the device.
This webinar discussed the history of how listing medical devices in the Orange Book occurred, best practices for drafting medical device patents, how medical devises can be properly listed if they are part of a combination drug, and how to possibly repair any improper listings.
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