An International Guide to
Patent Case Management for Judges

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.