Teva secures suspension of patent cancellation for inhalers in the Orange Book

New Jersey court grants 30-day stay after ordering removal of five asthma inhaler patents from FDA’s Orange Book | Decision follows ruling in favor of Amneal Pharmaceuticals, which argued the patents were improperly listed.

Teva Pharma has convinced a New Jersey judge to grant a 30-day stay on an order requiring the removal of its patents from the U.S. Food and Drug Administration (FDA). Orange Book.

Teva filed an appeal on June 11 and requested a stay of the hearing after Judge Stanley Chesler decided in favour of Amneal Pharma and ordered Teva to remove five patents for its ProAir HFA asthma inhaler from the list of approved medicines.

On June 13, the court granted Teva’s request for a 30-day grace period.

The judgment of the United States District Court for the District of New Jersey on 10 June found that Teva’s patents only covered parts of an inhaler technology, but not ProAir HFA (albuterol sulfate) inhalation aerosolthus paving the way for the generic proposed by Amneal.

This was followed by the The FTC’s fight against “illegal tactics” by pharmaceutical manufacturers by challenging “improper or inaccurate” entries in the Orange Book.

In April, the FTC sent warning letters to ten pharmaceutical companies because they had filed so-called “junk” patent applications. More than 300 patents for 20 different branded products were affected.

Background of the case

Teva, owner of the approved drug ProAir HFA, claimed last year that the generic version of Amneal infringed several of its patents (US patent numbers 8,132,712, 9,463,289, 9,808,587, 10,561,808 and 11,395,889).

Amneal filed an ANDA claiming that its generic drug did not infringe any valid claims of these patents.

Teva filed suit for patent infringement and Amneal responded with twelve countersuits, including demands for removal of the patents from the Orange Book and allegations of violations of the Sherman Act and the New Jersey Antitrust Act.

In its opinion of June 10, the Court addressed Teva’s motion to dismiss Amneal’s antitrust counterclaims as well as Amneal’s motion for partial judgment on the complaints.

Teva is represented by Daryl Wiesen and Natasha Daughtrey of Goodwin Procter.

Amneal is represented by Rebekah Conroy of Stone Conroy; Steven Maddox and Jeremy Edwards of Procopius.

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