Orange Book listings should not include medical devices
20 Sep 2024 | Newsletter
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.
In Amneal’s motion for judgment on the pleadings, Amneal and amicus, the FTC, argued that the listing of the Inhaler Patents is improper and not authorized by the Listing Statute. Teva argued the delisting claims were premised on erroneous interpretations of the Listing Statute. The two sides are arguing over interpretations of the Listing Statute in the OBTA.
Teva argued that their Inhaler Patents are drug product patents, and that they are properly listed pursuant to § 355(b)(1)(A)(viii)(I). Subsection § 355(b)(1)(A)(viii) authorizes the listing of certain patents of three kinds: drug substance patents, drug product patents, and method of use patents.
Amneal and the FTC argued that the Inhaler Patents do not qualify as non-method of use patents that may be listed in the Orange Book because the patents do not claim a drug or drug product. They further argued that a drug or drug product would include the chemical compound, formulations, or composition of the drug. In their Amicus Brief filed in the appeal, the FTC takes the position that no device patents that do not directly claim a drug substance or drug product should be listed in the Orange Book. The FTC also points out that Teva’s patent 5,695,743, directed to an aerosol formulation containing salbutamol, expired in 2014. The FTC asserted that the improper listing of device patents in the Orange Book unjustly extends the patent protection of life saving drugs.
Neither side disputed whether the Inhaler Patents contain claims for the active ingredient in the inhalers, albuterol sulfate. Rather, Teva argued about the definition of “drug” and cited the FDA definition which includes that a drug may include an “article intended for use in the diagnosis, cure, mitigation, treatment of prevention of disease.” See 21 U.S.C. § 321(g)(1)(B). Teva argued, because the inhalers were used to treat breathing issues, the inhalers fell under the definition of a drug.
While the court agreed that Inhalers fall under the definition of drug in 21 U.S.C. § 321(g)(1)(B), that definition does not establish that the Inhaler Patents at issue claim the drug included in Teva’s NDA Application “albuterol sulfate.”
The District Court found that the listing issue turns on interpretation of the first element of the listing statute:
Subsection § 355(b)(1)(A)(viii)(I) states two requirements: 1) the patent must “claim[] the drug for which the applicant submitted the application;” and 2) the patent must be directed to a drug substance or a drug product.
The court held that, because the NDA that Teva submitted and provided to the court cited “albuterol sulfate” and the inhaler patents did not,the patents were not properly listed.
Teva has appealed this decision and several amicus briefs have been submitted. This is an ongoing issue and it will be interesting to see how the CAFC decides the case.