Patent expiry dates for biologicals eu pertuzumab?

Which EU patents cover Pertuzumab?
The key European patents for the anti‑HER2 antibody Pertuzumab are held by Genentech/Roche and are listed under the EP 1,567,000 family. The core invention covers the antibody’s structure, production methods, and therapeutic uses for HER2‑positive breast cancer and other solid tumours.
The most recent patents in the family are WO 2008/060469 and WO 2010/021015, which protect the antibody’s sequence, affinity‑enhancing mutations, and combination therapy with trastuzumab.

When will those patents expire in the EU?
European patent protection lasts 20 years from the filing date, subject to annual maintenance fees.
- The WO 2008/060469 family (filing 2008) expires 2028.
- The WO 2010/021015 family (filing 2010) expires 2030.
- Earlier patents such as WO 2005/030210 (filing 2005) expire 2025.

These dates are rounded to the year of expiration; the exact expiry day depends on the maintenance payment schedule.

What does “data exclusivity” mean for Pertuzumab?
Even after patents lapse, the European Union imposes 8 years of data exclusivity for biologics, meaning that no generics or biosimilars can rely on the originator’s clinical data until that period ends. For Pertuzumab, the data exclusivity window will close around the same time as the last patent expires—circa 2030—if no extensions are granted.

Can biosimilars enter the EU market before the patents expire?
In principle, a biosimilar can be approved only after the last patent and data exclusivity periods expire, unless the originator’s patents are invalidated or a court grants an injunction. No biosimilar for Pertuzumab is currently approved in the EU, and the first approval is expected only after 2030 unless the originator relinquishes exclusivity.

Why do the expiry dates differ across patents?
Patents in the EP 1,567,000 family cover distinct aspects: the antibody’s core structure, affinity‑enhancement modifications, and combination‑therapy methods. Each was filed at a different time, so their 20‑year life cycles end at different years. Some later patents also cover specific manufacturing processes or formulation tweaks, extending protection for those specific claims.

When might the first Pertuzumab biosimilar be available?
Given the patent and data exclusivity schedule, the earliest realistic entry point for a biosimilar in the EU is 2030. Any earlier entry would require legal challenges against the validity of the existing patents.

Sources
[1] https://drugpatentwatch.com/patent/pertuzumab
[2] https://patents.google.com/patent/WO2008060469
[3] https://patents.google.com/patent/WO2010021015
[4] https://ec.europa.eu/health/biologics/medicallicenses/overviewen.htm