An International Guide to
Patent Case Management for Judges

12.13 Selected topics

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Regulation No. 1768/92 was repealed in 2009 by Regulation (EC) No. 469/2009, the regulation now in force with respect to supplementary protection certificates for medicinal products.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

12.13.2 Compulsory licenses

According to applicable Spanish provisions, compulsory licenses¹³⁷ may be granted in the following situations:

• Failure or insufficiency of working the patented invention. The law provides in this regard that the owner of a patent shall be obliged to work the patented invention either themself or through a person authorized by them, by implementing it in Spain or on the territory of a Member of the World Trade Organization in such a manner that the working is sufficient to satisfy demand on the Spanish market. Working must take place within a period of four years from the date of filing the patent application or three years from the date on which grant of the patent was published in the Official Bulletin of Industrial Property, the period which expires latest being automatically applied. Following expiration of this period, any person may request the grant of a compulsory license for the patent, provided that, at the time of the request, working of the patent has not commenced or has been suspended for more than one year. The applicant must show that they have attempted to obtain a contractual license from the patent owner but have been unable to do so on commercially reasonable terms and conditions within a reasonable period of time. A compulsory license may not be granted for this reason if objective difficulties of a legal or technical nature, independent of the will and circumstances of the owner of the patent, have made working of the patent impossible or prevented its working from being more extensive than it has been.

• Dependency between patents, or between patents and plant variety rights. Where such dependency exists, the owner of the later patent or plant variety right may apply for a compulsory license but must demonstrate that: (i) the subject matter of the later patent or plant variety right represents significant technical progress of considerable economic importance relative to the prior patent or plant variety right; and (ii) they have attempted, without success in a reasonably timely manner, to obtain a contractual license from the owner of the prior patent or plant variety right. If such a license has been granted, the owner of the prior patent or plant variety right may in turn request a license for the later patent or plant variety right on reasonable terms. This type of compulsory license is granted only where necessary to permit the working of the later patent or plant variety right.

• Need to put an end to practices that a firm administrative or judicial decision has declared contrary to legislation for the protection of fair competition. In this case, it is not necessary for the applicant for a compulsory license to demonstrate that prior negotiations have taken place with the patent owner to obtain a contractual license.

• Matters of public interest. The government may directly declare a patent or patent application subject to the compulsory license regime when: (i) the initiation, increase or generalization of working of the invention, or improvement of the conditions in which it is being worked, are of paramount importance for public health or national defense; (ii) failure to work or the insufficient quality or quantity of working leads to serious prejudice for the country’s economic or technological development.; and (iii) supply of the domestic market so requires.

• The manufacture of pharmaceutical products for export to countries with public health problems. These licenses are processed and regulated in accordance with Regulation No. 816/2006, of May 17, 2006.¹³⁸

Compulsory licenses are not exclusive and entail adequate compensation for the patent owner based on the circumstances in each case and economic importance of the invention. They also include supplementary certificates, upon issuance or later, applicable to the subject matter of the patent that falls within the scope of the compulsory license.