In a AIPPI article, Nath, Goldberg & Meyer ‘s Joshua Goldberg and Leia Dingott dissect the recent U.S. District Court of New Jersey Court ruling in a patent infringement dispute under the Hatch-Waxman Act, between Teva Branded Pharmaceutical Products R&D, Inc., et al. v. Amneal Pharmaceuticals LLC, et al.
A ruling from the U.S. District Court in New Jersey has ordered Teva (including Teva Branded Pharmaceutical Products R&D, Inc., Norton (Waterford) Ltd., and Teva Pharmacueticals USA, Inc.) to delist U.S. Patent Nos. 8,132,712, 9,463,289, 9,808,587, 10,561,808, and 11,395,889. The court held that these patents have been improperly listed in the Orange Book as related to the drug product, albuterol sulfate, which is the subject of New Drug Application 021457, even though the patents all relate to medical devices. Teva is appealing the decision to the U.S. Court of Appeals for the Federal Circuit (CAFC). Teva has also asked for a stay to the delisting requirement during the appeal. The Stay has been granted as of July 10, 2024, until further notice by the court.
A ruling from the U.S. District Court in New Jersey has ordered Teva (including Teva Branded Pharmaceutical Products R&D, Inc., Norton (Waterford) Ltd., and Teva Pharmacueticals USA, Inc.) to delist U.S. Patent Nos. 8,132,712, 9,463,289, 9,808,587, 10,561,808, and 11,395,889 (collectively “the Teva patents”). The court held that these patents have been improperly listed in the Orange Book as related to the drug product, albuterol sulfate, which is the subject of New Drug Application 021457, even though the patents all relate to medical devices. Teva is appealing the decision to the U.S. Court of Appeals for the Federal Circuit (CAFC). Teva has also asked for a stay to the delisting requirement during the appeal. The Stay has been granted as of July 10, 2024, until further notice by the court.
Specifically, Teva sells the ProfAir® HFA (a metered dosage inhaler providing an albuterol sulfate HFA Inhalation aerosol) for which it submitted a New Drug Application (NDA) to be included in the Orange Book. The Orange Book Transparency Act of 2020 (OBTA) requires that a New Drug Application (NDA) Brand list non-method of use patents only if (1) it is a “drug” substance patent or a drug patent, and (2) it “claims the drug” for which the brand patents including a drug. A competitor can file an Abbreviated New Drug Application (ANDA) seeking to market a generic before the expiration of the listed patents, but the Brand is entitled to a 30-month stay before the competitor markets the generic.
Amneal (including Ireland Limited, Amneal Pharmaceuticals LLC and Amneal Pharmaceuticals, Inc.) filed ANDA No. 211600, seeking to make and sell a generic version of ProAir® HFA. Amneal’s ANDA submission included a paragraph IV certification indicating Anneal’s ANDA proposed product will not infringe any valid claim of the Teva Patents at issue. After Amneal sent Teva required notice, Teva filed suit alleging patent infringement for the Teva Patents at issue. Amneal filed an Amended Answer to the Amended Complaint asserting 12 counterclaims. Counterclaims 1-5 seek to have Teva delist the Patent at issue from the Orange Book as being improperly listed due to their coverage for a medical device only.
Read the full article in AIPPI.
Orange Book listings should not include medical devices (aippi.org)