On April 27, 2023, the European Commission (EU Commission) published its proposals for regulations on supplementary protection certificates (SPCs), including a unitary SPC for medicinal products and plant protection products (see here). This could be an incentive for the pharmaceutical industry to make use of the European patent with unitary effect (Unitary Patent), as it avoids the current split approach for product protection conferred by a Unitary Patent on one hand and various national SPCs on the other.

Europe provides national SPCs only, resulting in a plurality of rights

SPCs provide a patent term extension of up to five years for national parts of European patents protecting either medicinal products or plant protection products. The extension is provided to compensate the loss of effective patent protection caused by the lengthy testing required under European regulatory law to obtain marketing authorizations for such products.

SPCs are currently available on a national basis only, i.e. an innovator company that wants to extend its term of patent protection can apply for it on a country-by-country basis only. This is burdensome and costly since applications need to be filed e.g. in the various languages of the respective countries. Furthermore, the protection status may differ in the various jurisdictions, as each national authority makes its own decision. Ultimately this leads to a plurality of separate and independent rights.

Similar landscape under the new UPC regimen

There won’t be much change when the Unified Patent Court (UPC) opens for business on June 1, 2023. Although innovators may obtain European patents with unitary effect, they still have to apply for SPCs on a country-by-country basis to extend the protection conferred. As noted, this is not only burdensome and costly, but may also lead to a hotchpotch protection status if the national authorities decide differently. In addition, uniform protection will cease to exist when the protection conferred by the Unitary Patent expires.

Legislation proposal by the EU Commission

Accordingly, the EU Commission has detected a clear need to

  • establish a Unitary SPC to complement the Unitary Patent,
  • simplify the SPC system in Europe by significantly decreasing the administrative tasks and costs,
  • increase the legal certainty and transparency, so that also small and medium-sized undertakings can clearly identify the protection status in Europe.

To achieve this the EU Commission proposes amendments of the already existing two regulations for SPCs related to (i) medicinal products for human and veterinary use (Regulation (EC) No 469/2009) and (ii) plant protection products (Regulation (EC) No 1610/96). The amendments include a new centralized procedure for the granting of national SPCs.

In addition, the EU Commission wants to establish two new EU regulations to provide also a Unitary SPC for both (i) medicinal products and (ii) plant protection products to complement the Unitary Patent, including also a centralized examination procedure.

But there is more. Also, a “Combined Application” is envisaged, where an applicant may request the grant of (i) a Unitary SPC if the product is protected by a Unitary Patent and (ii) of nationals SPCs for states not participating in the UPC.

Apart from that the currently known SPC regimen will remain unaffected, meaning that national SPCs are still available based on grants by national authorities.