Regulation (EU) 2019/933, which amends Regulation (EC) n. 469/2009 on the supplementary protection certificate (SPC) for medicinal products, came into force on 1 July 2019.

As clarified in the related preamble, the new text starts from the consideration that, pursuant to Regulation (EC) n. 469/2009, makers of generic and biosimilars established in the EU are prevented from manufacturing them in order to export them to third countries where the protection does not exist or has expired, or for storage purposes in order to enter the EU market immediately after the deadline of the SPC. These circumstances put those makers at a competitive disadvantage compared to those operating in third countries that offer less or no protection. On the other hand, the timely entry of generic and biosimilar medicines into the EU market is important to increase competition, reduce prices and ensure that national healthcare systems are sustainable and that patients have better access to affordable medicines. Hence the recognised need to amend Regulation (EC) n. 469/2009.

The new legislative text therefore establishes that the rights conferred by the SPC, which is to say the same rights attributed by the basic patent, do not allow the following activities to be prohibited:

  1. the making of a product for the purpose of export to third countries;
  2. the making of a product, no earlier than six months before the expiry of the SPC, in order to place that product on the market of Member States after the expiry of the corresponding SPC;
  3. any related act that is strictly necessary to the above purposes.

However, in order for the exception to apply, the maker must notify both the industrial property office of the Member State in which the manufacturing is to take place and the holder of the SPC. This must take place no later than three months before the date of manufacture or the first related act prior to manufacture. In addition, in the case of products manufactured for export outside the EU, the manufacturer must affix the logo reproduced above both on the outer packaging of the product and, where feasible, on its immediate packaging.

The exception shall not apply to any act or activity carried out for the import of products into the Union merely for the purpose of repackaging, re-exporting or storing.

The Regulation applies immediately to any SPCs applied for starting from 1 July 2019. For SPCs applied for before 1 July 2019, but which take effect from that date onwards, the application is instead postponed to 2 July 2022. Finally, SPCs taking effect before 1 July 2019 shall not be affected by the application of the new rules.