An International Guide to
Patent Case Management for Judges

12.13.1 Pharmaceutical patents and supplementary protection certificates

The granting of a patent for a pharmaceutical product does not permit its owner to start selling the patented product immediately. “Marketing approval” must first be granted by health authorities following a verification and control procedure. This requirement significantly shortens the useful life of the patent, making it difficult to amortize the investments made in developing the patented invention. The same situation applies in the case of plant protection products.

In the late 1980s, what was then called the European Economic Community began work on a legal instrument to address this lag between the patent application date for medicines and plant protection products and the date when marketing of the patented products could commence. The result of this effort was the creation of two specific industrial property titles: the “supplementary protection certificate for medicinal products” and the “supplementary protection certificate for plant protection products”, regulated by two uniform texts for all member countries in what were then called the European Economic Community (EEC) and the European Communities (EC). Those texts were Council Regulation (EEC) No. 1768/92¹³³ and Regulation (EC) No. 1610/96 of the European Parliament and of the Council.¹³⁴

Regulation No. 1768/92 was repealed in 2009 by Regulation (EC) No. 469/2009, the regulation now in force with respect to supplementary protection certificates for medicinal products.

A supplementary protection certificate (SPC) is an industrial property title that under certain conditions extends patent protection for up to five years for the active ingredient or combination of active ingredients of a medicinal or plant protection product.

SPCs are accessory titles in the sense that they are granted to provide protection in conjunction with an existing patent. But an SPC is also a substantive title in its own right, since:

• SPC protection becomes effective after the underlying patent has expired; and

• that protection extends only to a “product” for which marketing approval has been obtained for use as medicine or for plant protection (which may be only a part of the product protected by the basic patent).¹³⁵

The SPC regime, as indicated earlier, is uniform for the entire European Union. But SPC titles themselves are not uniform (as European patents and trademarks are). They are national titles that must be obtained from national patent offices in EU member states, each of which processes the applications and grants the titles following procedures established in national legislation, without prejudice to EU regulations governing fundamental aspects of that process. Once granted, SPCs are entered into national registries, which produce effects only in the country where granted. They enter into force the day after expiration of the underlying patent.

The conditions for obtaining an SPC are as follows:

• the product is protected by a basic patent in force;

• a valid authorization to place the product on the market as a medicinal or plant protection product has been granted;

• the authorization to place the product on the market is the first referring to the product as a medicinal or plant protection product; and

• the product has not already been the subject of a certificate.

An SPC confers the same rights as the basic patent and is subject to the same limitations and obligations. It must be noted, however, that Regulation 2019/933,¹³⁶ in amending Regulation 469/2009, introduced an exception to the protection provided by an SPC to permit companies located in the European Union to manufacture generic pharmaceutical products similar to medicinal products protected by a valid SPC, exclusively for the purpose of:

• export to third countries; or

• storage during the last six months of the SPC’s effective life and prior to the product’s entry into the European market (upon expiration of the SPC).

Lastly, the overall duration of protection that the basic patent and the SPC can provide may not exceed 15 years from the date of the product’s first marketing approval as a medicinal or plant protection product.