In general, from the date of filing a patent application, the patent holder may use the decision protected by the patent indefinitely. He can place the product of the invention on the market. In the case of medicinal products and plant protection products, patent protection is reduced, as the use of the product is delayed until the marketing authorization is obtained from the health and agricultural authorities. This period significantly reduces the period of protection provided by the patent, and the period of effective protection is insufficient to cover the investment made in research and development and other investments. To compensate for these inequalities for these sectors, the European Union adopted Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products and Regulation (EC) No 1610/96 of the European Parliament and of the Council of 23 July 1996 concerning the creation of a supplementary protection certificate for plant protection products in order to compensate patent holders for the lack of effective protection and to stimulate research and development activities in those critical sectors.
The Supplementary Protection Certificate (SPC) is a form of sui generis legal protection that extends the protection granted by a patent (called a "basic patent") to a medicinal product or plant protection product.
Regulation (EU) 2019/933 of the European Parliament and of the Council of 20 May 2019 amending Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products introduces an exception to the protection provided by the SPC for medicinal products. Regulation (EU) 2019/933 allows third country manufacturers to manufacture SPC-protected medicinal products for export outside the EU. Regulation (EU) 2019/933 also allows the manufacture and storage of medicinal products during the last six months of the SPC's effect in order to be ready for sale in the EU after the SPC expires.
The exemption initially only applies to SPC, applications for which are submitted on or after 1 July 2019. From 2 July 2022, the exception will also apply to SPCs for which applications were submitted before 1 July 2019, but only if they did not enter into force before 1 July 2019.
Manufacturers must meet certain requirements to use the exemption under Regulation (EU) 2019/933. These include notifying the SPC holder of the information required by law. Manufacturers must also provide the Patent Office with the same information. Notifications must be made at least three months before the relevant activity is carried out. Manufacturers must use a standard form when notifying the Patent Office.