European drug patents expire, paving the way for generics

The Spanish Patent and Trademark Office (OEPM) has published in the Official Gazette of Industrial Property (BOPI) the expiration of several European patents with effects in Spain, which enter the public domain due to the expiration of their legal life. Among them are the insulin precursor cleavage patent from Sanofi-Aventis and F. Hoffmann-La Roche, and the atomizer with a counter from Boehringer Ingelheim. The announcement is included in volume II of inventions of the BOPI, number 7229, dated September 2, 2026.

The BOPI, edited by the OEPM, a body attached to the Ministry of Industry and Tourism, publishes the expiration resolutions in its “European applications and patents with effects in Spain” section. Expiration due to the end of legal life means that the protection conferred by the patent is exhausted upon reaching the maximum term of validity, such that the invention becomes free for use by any third party.

Expiration due to end of legal life

The published resolutions are not final in the administrative route: an administrative appeal (recurso de alzada) may be filed against them within one month before the director of the OEPM. The incorporation into the public domain occurs on different dates depending on each file, and in all cases, the stated reason is the expiration of the patent’s legal life.

Drugs entering the public domain

Among the expiring European patents, two in the pharmaceutical field stand out:

• ES 2370657 T3 (application E 06791678), “Cleavage of insulin precursors using a trypsin variant,” jointly owned by Sanofi-Aventis Deutschland GmbH and F. Hoffmann-La Roche AG, incorporated into the public domain on 08/27/2026.
• ES 2449107 T3 (application E 11009899), “Atomizer comprising a counter and an end of an actuation lock,” by Boehringer Ingelheim International GmbH, incorporated into the public domain on 08/15/2026.

Other expired European patents

Alongside the drugs, the same section lists the expiration of other European patents with effects in Spain, such as the surgical stapling device from Covidien LP, the truck door handle from Pastore & Lombardi, the parachute slider from Airborne Systems, and the communication method from Koninklijke Philips. All of these enter the public domain for the same reason: expiration of legal life.

Regorafenib and supplementary certificates

In the same issue, the OEPM announces the granting of the extension of the supplementary protection certificate (SPC) for regorafenib, by Bayer Healthcare LLC, with a validity deadline of 03/01/2029. The SPC, regulated by Regulation (EC) 469/2009, extends the protection of medicines beyond the basic patent.

The entry into the public domain of these patents opens the door to the commercialization of generics and biosimilars in Spain, which may promote competition and access to treatments at lower prices. Expiration due to the end of legal life is a common milestone in the life cycle of medicines, and its publication in the BOPI constitutes the official guarantee that the invention is free for exploitation by third parties.

Source: Official Gazette of Industrial Property (BOPI), volume II: Inventions, year CXL, no. 7229, September 2, 2026, section 5 “European applications and patents with effects in Spain”, pág. 15-16 (official reference: CVE-BOPI-T2-20260902-00000015).