What Impact Will the New Unitary Patent System Have in Europe

Pharmaceutical Technology, Pharmaceutical Technology, September 2022, Volume 46, Issue 9

A new unitary patent system is due to come into effect in Europe later on this year.

The unitary patent (UP) will build on European Union (EU) patents granted by the European Patent Office (EPO) under the rules of the European Patent Convention (EPC) (1). This system could be very advantageous to owners of EU patent applications and EU patents when it comes into effect, potentially in October 2022. At this point, it will be possible for inventors to gain patent protection in up to 25 EU member states through the submission of a single request to the EPO. The same standards and timelines will apply to patent submissions; however, once a EU patent has been granted, the patent proprietor will be able to request unitary effect, receiving uniform patent protection in up to 25 EU Member States (Figure 1) (2).

The United Kingdom has not been involved the development of the UP policy despite the fact that EU constitutional experts have called for the United Kingdom to be involved, as a non-EU member state, in the Unified Patent Court (UPC) framework (3). It is hoped that the UK, Switzerland, and other EU countries will be incorporated into the UP patent system later. The UP covers 25 member states, whereas the classical European patent system presently covers 38 member states (Table I).

Current EU patent process is complex and costly

Currently, an inventor can protect an invention in Europe through an EU or national patent. The EU patent is reviewed centrally by the EPO, and if granted, the EU patent must be validated and maintained individually in each country. This is a complex and costly process resulting in high direct (e.g., translational fees, validation fees, national renewal fess) and indirect (e.g., attorney fees) costs. The UP system aims to reduce the complexity and costs associated with the patent process (Figure 2).

What does this mean for the pharma industry?

The UP and the new UPC has implications for the pharma industry. On the upside, the UP system provides a simpler, more cost-effective process, and if an EU patent is granted for a pharmaceutical product through the UP system, it would provide patent protection across all 25 member states and enable them to obtain a pan-EU interim injunction should an infringement occur. Challenging or enforcing EU patents on a national scale currently requires separate actions in each individual country of interest. On the flip side, if the UPC system rejects a patent application or a patent is revoked, it may prevent patent protection across all the EU member states.

In the future, the UP is likely to incorporate unitary supplementary protection (SPC) (5). SPCs are an intellectual property (IP) that extends a patent right which apply to specific pharmaceutical and plant protection products that have been authorised by regulatory authorities. SPCs help to offset the loss of patent protection for pharmaceutical (and plant protection products) that can occur due to prolonged clinical trials and compulsory testing, which are required prior to obtaining regulatory marketing approval. An SPC can extend a patent right for a maximum of five years; a six-month extension is for a medicinal product for children for which data has been submitted according to a Paediatric Investigation Plan (PIP) (6).

Opting in or out of UPC?

The first seven years after the UPC comes into effect it will be possible for pharma companies to opt out of from the UPC jurisdiction and this will also extend to SPC based on an EU patent. A sunrise period of up to three months has been proposed to enable companies to consider their options before the system begins (7). Therefore, pharma companies will need to carefully weigh up the merits of opting in or out of this new patent system, and they will need to do this soon as it may come in effect as early as October 2022.

References

1. EPO, The European Patent Convention, 17th Edition, November 2020.
2. M. Best, “European Patent System Overhaul—the Unified Patent Court and Unitary Patent,” Client Alert, 5 May 2022.
3. A. Henry, “Unitary Patent System Tipped as Next Biggest IP Development in Europe,” Out-Law News, Pinsent Masons, 11 Feb. 2021.
4. EPO, Unitary Patent available from epo.org [Accessed 13 Aug. 2022].
5. C. Drew, “EU Pharma Strategy has Patients and Collaboration at its Heart,” Out-Law News, Pinsent Masons, 25 Nov. 2020.
6. EC, Supplementary Protection Certificates for Pharmaceutical and Plant Protection Products available from ec.europa.eu [Accessed 13 Aug. 2022].
7. V.O., “Be prepared for the Unitary Patent (UP) and the Unified Patent Court (UPC) Sunrise,” News, 2 Feb. 2022.

About the author

Cheryl Barton is director of PharmaVision, info@pharmavision.co.uk

Article details

Pharmaceutical Technology Europe
Vol. 34, No. 9
September 2022
Pages: 7–8

Citation

When referring to this article, please cite it as C. Barton, “What Impact Will the New Unitary Patent System Have in Europe,” Pharmaceutical Technology Europe 34 (9) 2022.