The patent owner may make unlimited use of the technical solution protected by the patent from the date of filing the application, and may place the product according to the invention on the market. When the subject of the application is a medicinal product or a plant protection product, the duration of 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 of time 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. In order to compensate for inequalities between those sectors, the European Union has 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 in these sectors of particular importance. 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.
By Regulation (EU) 2019/933 of the European Parliament and of the Council of 20 May 2019, which enters into force on 1 July 2019, amending Regulation (EU) 469/2009 on the supplementary protection certificate for medicinal products, an exception to the protection granted by the SPC for medicinal products is introduced. 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 operation, with a view to making it ready for sale in the EU after the SPC expires.
The exemption initially applies only to SPCs applied for on or after 1 July 2019. From 2 July 2022, the exemption will also apply to SPCs applied for before 1 July 2019, but only if 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 give the Patent Office of 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.
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