Company: SNY
Filing Date: 2025-02-13
Form Type: 20-F
Source: 0001121404-25-000010
Chunk: 455

Company: Sanofi
Filing Date: 2025-02-13
Form: 20-F
Chunk 455
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 the criminal complaint, the court ruled in September 2024 that the action was time-barred. Claimants have appealed. In Ireland, there are two cases in Pre-Action stage and two civil claims ongoing. In the United Kingdom, there is one case in the Pre-Action stage in Great Britain and one civil claim ongoing in Northern Ireland. It is not possible, at this stage, to assess reliably the outcome of these cases. Dengvaxia (Philippines) From early 2018 up to present date, several claims have been filed in the Philippines by parents of deceased children whose deaths were allegedly due to vaccination with Dengvaxia. In early March 2019 and in 2020 and 2022, the Philippine Department of Justice (DOJ) prosecution panel announced it had found probable cause to indict several Sanofi employees/former employees and former Government officials for “reckless imprudence” resulting in homicides. Since then, several criminal actions have been filed in court as a result of this finding and are pending at various stages of the legal procedure. Petitions for Review to the DOJ Secretary have been filed and the said petitions remain pending. Meanwhile, the majority of the respondents have challenged the jurisdiction of the lower court where the first eight cases had been assigned and this issue was filed with the Supreme Court. There are several claims that have not yet been filed in any court despite resolutions by the DOJ that there is probable cause. In July 2024, the Court dismissed the first eight criminal cases, ruling the prosecution failed to establish the elements of “reckless imprudence” resulting in homicide. Remaining cases are still pending at various stages.

| F-86 | SANOFIFORM 20-F2024 |

| NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS |

b) Patents Ramipril Canada Patent Litigation Sanofi was involved in a number of legal proceedings involving companies which market generic Altace (ramipril) in Canada. In 2004, Sanofi unsuccessfully brought Notice of Compliance proceedings (NOC proceedings) at the end of which eight manufacturers obtained marketing authorizations from the Canadian Minister of Health for generic versions of ramipril in Canada. Sanofi filed unsuccessful patent infringement actions against all those companies and ultimately Sanofi was liable for damages under Section 8. Sanofi made payment in complete satisfaction of those awards. In June 2011, Apotex commenced an action in the Ontario Superior Court of Justice asserting damages under the Ontario Statute of Monopolies, the UK Stat