"In the memorandum opinion, Judge Sparkle L. Sooknanan found that Teva's claims either failed on the merits or were unripe. The case is one of several challenges to the validity of the 2022 Inflation Reduction Act's (IRA) Drug Price Negotiation Program, which establishes a methodology for determining the price at which Medicare will reimburse drug costs incurred by Medicare beneficiaries."
"Teva Pharmaceuticals USA brought the lawsuit against various officers and employees of the U.S. Department of Health and Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS) who implement the Drug Price Negotiation Program. Teva alleged that CMS's guidance governing program selections is contrary to law and that the program itself violates the Fifth Amendment's Due Process Clause."
The District Court for the District of Columbia rejected Teva Pharmaceuticals' challenge to the Medicare Drug Price Negotiation Program. Judge Sparkle L. Sooknanan found that Teva's claims either failed on the merits or were unripe. Teva sued HHS and CMS officials, alleging CMS guidance governing program selections is contrary to law and that the program violates the Fifth Amendment Due Process Clause. Teva's products AUSTEDO and AUSTEDO XR are included in the program's second negotiation round. The decision aligns with a Third Circuit ruling that found the program does not constitute a physical taking or violate First Amendment rights. The IRA establishes the methodology for Medicare reimbursement pricing.
Read at IPWatchdog.com | Patents & Intellectual Property Law
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