The SPTO grants Roche the supplementary protection certificate for inavolisib

The Spanish Patent and Trademark Office, O.A. (OEPM) has granted F. Hoffmann-La Roche AG the supplementary protection certificate (SPC) for the oncology drug inavolisib, according to the resolution published in the Official Gazette of Industrial Property (BOPI), Volume II: Inventions, number 7230, dated September 3, 2026. The grant, dated August 28, 2026, extends the drug’s exclusivity until July 22, 2040.

The announcement is included under the heading for the resolution on the granting of supplementary protection certificates provided for in Article 57 of the Implementing Regulation of Law 24/2015, of July 24, on Patents. In accordance with the provisions of said regulation, the published resolutions are not final in the administrative process, and an administrative appeal may be filed within one month before the management of the OEPM.

Data of the granted certificate

The SPC corresponds to application C 202530047, filed on September 26, 2025, and is based on European patent ES2764497T3 (application E16733600), titled “Benzoxazepine oxazolidinone compounds and methods of use.” The protected product is inavolisib, and the first marketing authorization in Spain and the European Union corresponds to number EU/1/25/1942, dated July 18, 2025.

• Application number: C 202530047
• Filing date: 09/26/2025
• Basic patent: ES2764497T3 (E16733600)
• Protected product: Inavolisib
• First marketing authorization (EU/Spain): EU/1/25/1942, 07/18/2025
• SPC expiration date: 07/22/2040
• Grant date: 08/28/2026

Holder and representation

The holder of the certificate is F. Hoffmann-La Roche AG, of Swiss nationality and domiciled at Grenzacherstrasse 124, 4070 Basel (Switzerland), with 100% ownership. Representation before the OEPM corresponds to the agent Ponti & Partners, S.L.P.

Relevance for the pharmaceutical sector

The supplementary protection certificate is an instrument that compensates laboratories for the time spent on the marketing authorization of a drug, extending exclusivity beyond the basic patent. In the case of inavolisib, a targeted inhibitor for the treatment of certain tumors, the grant ensures the protection of the product in the Spanish market until 2040, a relevant horizon for both Roche’s commercial strategy and the planning of access to generics and biosimilars.

The publication in the BOPI provides official notice of the grant and opens the period for interested third parties to challenge the resolution through administrative channels, within the framework of Law 24/2015 and Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products.

Source: Official Gazette of Industrial Property, Volume II: Inventions, no. 7230, September 3, 2026, section of Supplementary Protection Certificates (official reference: CVE-BOPI-T2-20260903-00000006; application C 202530047).