Company: SNY
Filing Date: 2025-02-13
Form Type: 20-F
Source: 0001121404-25-000010
Chunk: 460

Company: Sanofi
Filing Date: 2025-02-13
Form: 20-F
Chunk 460
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 or refund obligations against Sanofi for any “overcharges”. The court also rejected Sanofi’s challenge to the ADR Rule and dismissed its challenge to the AO as moot. Sanofi appealed the court’s decision to the Third Circuit Court of Appeals (Third Circuit) and the government filed a cross-appeal. In January 2023, the Third Circuit held that Sanofi’s restrictions on delivery to contract pharmacies do not violate Section 340B. It also enjoined HHS from enforcing against Sanofi its reading of Section 340B in the AO and the May 2021 violation letter. As to Sanofi’s challenge to the 340B ADR rule, the Third Circuit held that HHS did not violate the Administrative Procedure Act in promulgating the ADR Rule (HHS revised and finalized a new ADR rule in April 2024). The Third Circuit remanded the case back to the US District Court for the District of New Jersey (District Court) and on May 24, 2023, the District Court issued an injunction and declaratory judgment consistent with the Third Circuit’s opinion. This ruling concluded the case as to Sanofi. On May 21, 2024, the District Court Circuit, in cases brought by Novartis and United Therapeutics, issued an opinion holding that Section 340B does not categorically prohibit manufacturers from imposing conditions on the distribution of covered drugs to covered entities. The Court further held that the conditions at issue in the case did not violate section 340B on their face and that the lower court had correctly set aside enforcement letters to Novartis and United Therapeutics. On September 17, 2024, based on the District Court Circuit’s decision, the United States District Court for the District of Columbia entered stipulated final judgments upholding contract pharmacy restrictions that Amgen, Boehringer Ingelheim, Merck and UCB each placed in 2021. The rulings vacated letters that HRSA sent each drugmaker in 2021 or 2022 that declared their contract pharmacy restrictions illegal. A similar case, brought by Eli Lilly, remains pending in the Seventh Circuit. On May 31, 2024, Sanofi filed a lawsuit in the United States District Court for the District of Columbia against HHS and HRSA under the Freedom of Information Act (FOIA) seeking an order declaring that Sanofi is entitled to covered entities’ pharmacy contracts, requiring HRSA to produce the contracts and enjoining HRSA from withholding pharmacy contracts from San