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TITLE IX OBLIGATION TO WORK AND COMPULSORY LICENSES
Chapter I Obligation to Work
The owner of a patent shall be obliged to work the patented invention either himself or through a person authorized by him, 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 national 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.
(1) The owner of the patent shall prove its working before the Registry of Industrial Property by means of an official certificate issued by the relevant body and corresponding to the prescribed criteria and general regulations.
(2) The certificate of working shall be based on inspection of the manufacturing process in the industrial establishment where the invention is being worked and on proof that the object of the invention is effectively being marketed.
(3) The said certificate shall be issued within three months following the date on which it was requested and shall state specifically that the patented invention is being worked, setting out the information substantiating that statement.
(4) The certificate of working shall be recorded at the Registry of Industrial Property.
When working has been proved before the Registry of Industrial Property by means of the relevant certificate, unless there is proof to the contrary, it shall be presumed that the patented invention is being worked in the form required by Article 84 of the present Law.
Chapter II Requirements for the Granting of Compulsory Licenses
Where a particular patent is not the subject of the offer of ex-officio licenses and where one of the following situations exists, a compulsory license may be granted:
(a) failure or insufficiency of working of the patented invention;
(b) export necessities;
(c) dependency of patents;
(d) existence of reasons of public interest.
(1) Following expiration of the period laid down in Article 83 for working the invention protected by the patent, any person may request the granting of a compulsory license for the patent provided that, at the time of the request, unless there are legitimate excuses, working of the patent has not commenced or effective and concrete preparations have not been made to work the invention that is the subject matter of the patent, or working has been suspended for more than three years.
(2) Legitimate excuses shall be deemed to be objective difficulties of a legal technical nature, independent of the will and circumstances of the owner of the patent, which make working of the patent impossible or prevent its working from being more extensive that it is.
Where the export market cannot be satisfactorily supplied due to insufficient production of the subject matter of the patent, thus creating serious prejudice for Spain's economic and technological progress, the Government may, by Royal Decree, make the said patent subject to a regime of compulsory licenses the objective of which shall cover exclusively the unsatisfied needs of the export market.
(1) Where it is not possible to work the invention protected by a patent without harming the rights conferred by an earlier patent, the owner of the subsequent patent may at any time require the granting of a compulsory license for the earlier patent provided that his invention has distinctive industrial objectives or represents considerable technical progress in comparison with the earlier patent.
(2) Where inventions used for the same industrial purpose are protected by patents that are dependent one upon another and a compulsory license has been granted to the owner of the dependent patent, the owner of the earlier patent may also apply for the grant of a license for the later patent.
(3) Where the subject matter of a patent is a process to obtain a chemical or pharmaceutical substance protected by a patent in force and provided that the patent for the process represents considerable technical progress in comparison with the earlier patent, both the owner of the patent for the process and the owner of the patent for the product shall have the right to obtain a compulsory license for the patent of the other party.
(4) The content of a compulsory license granted for reasons of dependency of patents shall only be sufficient to allow working of the invention protected by the patent concerned and it shall no longer have effect after invalidation or forfeiture of any of the patents on which it is dependent.
(1) For reasons of public interest, the Government may at any time make a patent application or a patent already granted subject to the grant of compulsory licenses, acting in that respect by Royal Decree.
(2) Reasons of public interest shall be deemed to exist when 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.
Reasons of public interest shall also be deemed to exist when failure to work or the insufficient quality or quantity of working leads to serious prejudice for Spain's economic or technological development.
(3) A Royal Decree on the granting of compulsory licenses shall be drawn up at the proposal of the Ministry of Industry and Energy. In cases where the importance of working the invention concerns public health or national defense, the proposal shall be formulated jointly with the competent Minister for health or defense, respectively.
(4) A Royal Decree making a patent subject to the granting of compulsory licenses because of its importance for national defense may reserve the possibility of soliciting one or several specific enterprises for such licenses.
(5) Where public interest can be met without the need to generalize working of the invention or entrusting its working to a person other than the owner of the patent, the Royal Decree may conditionally make the patent subject to the granting of compulsory licenses, authorizing the Minister of Industry and Energy to allow the owner a period not exceeding one year to initiate, increase or improve working of the invention to the extent necessary to meet the public interest. In such cases, the Minister of Industry and Energy, having heard the owner of the patent, may allow the period he deems appropriate or may immediately make the patent subject to the granting of licenses. Following expiration of the period which has been fixed, where appropriate, the Minister of Industry and Energy shall decide whether the public interest has been met and, if such is not the case, shall make the patent subject to the granting of compulsory licenses.
Chapter III Procedure for Granting Compulsory Licenses
(1) Before applying for a compulsory license, the interested party may request the mediation of the Registry of Industrial Property in order to obtain a contractual license for the same patent.
(2) The request for mediation shall be subject to payment of a fee and shall contain the following:
(a) full indications concerning the applicant;
(b) the patent to which the request refers, together with an indication of its owner,
(c) the relevant circumstances that may justify the granting of compulsory licenses;
(d) the scope of the license sought and the reasons substantiating that claim;
(e) information permitting a decision on whether or not the applicant can effect real and effective working of the patented invention and can offer the securities reasonably required by the owner of the patent for granting a license.
(3) The request for mediation shall be accompanied by:
(a) documents supporting the claims made therein;
(b) a document attesting to constitution of a security, the amount of which shall be prescribed in the Regulations, to be used to meet the costs of the procedure to be paid by the applicant;
(c) a complete copy of the application and the accompanying documents.
(1) Following submission of the request for mediation, within the non-extendable period of one month, the Registry of Industrial Property shall decide whether to agree to mediate.
(2) The Registry shall agree to mediate when the interested party's request and the accompanying documents, as well as the investigations carried out by the Registry itself, reasonably show that there are circumstances that could lead to the granting of compulsory licenses for the patent, that the applicant is solvent and that he has at his disposal the necessary means to achieve serious working of the patented invention.
(3) The Registry shall notify its decision to the interested party and to the owner of the patent, and at the same time shall transmit a copy of the request for mediation to the latter.
(4) No appeal may be made against the Registry's decision.
(1) Where the Registry of Industrial Property agrees to mediate, it shall immediately notify the interested parties accordingly and shall invite them to commence negotiations on the granting of a contractual license, with the Registry participating as mediator. The negotiations shall last a maximum of two months.
(2) In its role as mediator, the Registry shall take an active part in bringing together the positions of the interested parties and facilitating the granting of a contractual license.
(3) When it has agreed to mediate and during the period provided for negotiations, the Registry shall carry out the necessary inquiries to acquaint itself with the specificities of the case and evaluate satisfactorily the positions of the interested parties, in particular, by ascertaining whether circumstances justify the granting of a compulsory license. This investigative work shall be carried out whatever the progress of the negotiations and whether or not they have broken down or not yet begun.
(4) At the expiration of a period of two months after notification to the interested parties of its agreement to mediate, if no agreement has been reached on the granting of a contractual license, the Registry shall declare its mediation and investigation terminated and shall inform the interested parties accordingly.
This period of two months may be extended for a specified period at the joint request of the two parties, provided that the Registry deems that such an extension will effectively serve to achieve the granting of the license. Where the Registry considers that no possibility of reaching agreement exists, it may terminate its mediation even though the specified period of extension has not expired.
(5) Both before and after the final decision, the documentation on mediation may only be consulted by the parties, who may have copies made of all the documents at their own expense. The parties and the Registry staff who have access to the documentation shall respect the secrecy of the contents.
(1) Where, as a result of the negotiations carried out with the mediation of the Registry of Industrial Property, the parties agree to a license for the patent, they may request that no applications for compulsory licenses for the patent be permitted during the period necessary for the licensee to start working the invention. This period may under no circumstances exceed one year.
(2) For the Registry of Industrial Property to respond favorably to the request, the following conditions shall be met:
(a) the license agreed upon is exclusive and its exclusivity is not contrary to the objective that could be pursued by making the patent subject to the granting of compulsory licenses;
(b) the interested parties provide documentary proof that the licensee has at his disposal the means necessary to work the invention and the period requested is indispensable for commencement of working;
(c) the interested parties provide what the Registry of Industrial Property considers to be a sufficient security to meet any liabilities incurred if working of the invention does not commence within the prescribed period;
(d) the legally prescribed fee has been paid.
(3) Having examined the documentation submitted by the interested parties and having carried out the investigations and consultations it deems necessary, the Registry of Industrial Property may suspend the submission of applications for compulsory licenses for the patent in question for a specified period, provided that the conditions laid down in the preceding paragraph have been met and that, under the circumstances, it is considered that the parties seriously wish to commence working the patented invention without delay. This suspension shall be entered in the Patent Register.
(4) The interested parties shall each month provide proof of the efforts being made to commence working and the Registry of Industrial Property shall order the inspections that it deems necessary.
(5) The Registry of Industrial Property may annul the suspension of submission of applications for compulsory licenses if it is proved that a serious error was committed when evaluating the circumstances justifying its decision or that the interested parties are not undertaking serious and continuous activity to commence working within the prescribed period.
(6) Where the licensee does not commence working within the prescribed period, the Registry of Industrial Property shall impose a fine on the interested parties the amount of which shall be calculated on the basis of the average sum to be paid by the licensee to the owner of the patent as royalties during the period of the contract's validity equivalent to the period of suspension.
(1) Following a period of three months from the expiration of the period referred to in Article 83, or from the refusal of the Registry to accept the proposed mediation, or from the expiration of the period established by mediation, without any agreement being reached between the parties, the interested party may apply to the Registry for the granting of a compulsory license for the patent.
(2) In the application for a compulsory license, which shall be subject to payment of the legally prescribed fee, the interested party shall, on the basis of the contents of the mediation documentation, where appropriate, and the documents he provides, explain his application and set out the circumstances justifying it, the interest on which it is based, the means by which he intends to achieve real and effective working of the patented invention and the securities he can offer if the license is granted.
(3) The application shall be accompanied by the following:
(a) documents proving the claims made therein and which do not appear in the mediation documentation, where appropriate;
(b) a document attesting to the constitution of a security, the amount of which shall be fixed in general in the Regulations, to be used to meet the procedural costs payable by the applicant;
(c) a complete copy of the application and the documents submitted.
(1) Following application for a compulsory license and provided that the conditions mentioned in the preceding Article have been met, the Registry shall commence the relevant procedure, including therein the mediation documentation, where appropriate, and shall transmit a copy of the application and the accompanying documents to the owner of the patent so that he may contest it within a period not exceeding one month.
(2) Where an application for a compulsory license is accompanied by proof that the Registry refused to mediate, the period during which the owner of the patent may contest it shall be two months.
(3) Contestation shall take into account the contents of the mediation documentation, where appropriate, and shall be accompanied by evidence substantiating the claims made therein and which do not appear in the said documentation. It shall be accompanied by a complete copy for transmission to the applicant.
(4) Where satisfactory working of the patented invention is invoked, the owner of the patent shall include in his contestation information concerning the said working, together with evidence proving its exactitude.
(1) Following receipt of the patent owner's contestation, the Registry shall transmit it to the other party and, within a non-extendable period of one month, shall take a decision to grant or refuse a compulsory license.
(2) Where the owner of the patent does not contest the application within this period, the Registry shall immediately grant the license.
(3) The decision granting the license shall specify its contents. In particular, it shall determine the scope of the license, the royalties, the term, the securities to be provided by the licensee, the time at which working shall commence and any other clauses to ensure serious and effective working of the patented invention.
(4) The decision shall specify the costs to be paid by each party, which shall be those occasioned by the request. Common costs shall be divided in half.
Payment of all the costs may be imposed on one of the parties where he is declared to have acted imprudently or in bad faith.
(5) Contentious administrative appeals may be lodged against the Registry's decision. Lodging of an appeal shall not suspend execution of the act imposed; however, the Registry may authorize the licensee, following a substantiated request by him, to postpone commencement of working until the decision on the license becomes final.
(1) Following the filing of an application for a compulsory license, the Registry may automatically take the necessary steps in order to reach a decision on granting the license.
(2) At the duly substantiated joint request of the applicant for a license and the owner of the patent, the Registry may, at any time, on one occasion only, suspend the procedure at the stage reached for a specified period not exceeding three months. Following expiration of the period of suspension, the Registry shall notify the parties and the procedure shall be resumed.
(1) License contracts agreed with the mediation of the Registry that directly or indirectly involve payment in foreign currency shall be subject to the authorization provided for in the regulations governing transfer of foreign technology.
(2) Any decision by the Registry of Industrial Property on granting a compulsory license that directly or indirectly involves payment in foreign currency shall require the issuance of a prior favorable report by the body competent to authorize contractual licenses involving such forms of payment.
(3) The necessary coordination between the Registry of Industrial Property and the body authorizing licenses involving payment in foreign currency shall be established so as to harmonize criteria and simplify procedure for the purposes laid down in the present Article.
Where the owner of a patent does not have his legal domicile or usual residence in Spain, the communications provided for under the present Title shall be sent to the representative, an industrial property attorney, who has previously been designated for this purpose.
Chapter IV Compulsory License System
(1) Compulsory licenses shall not be exclusive.
(2) The license shall provide for adequate remuneration according to the particular circumstances of each case, due regard being had to the economic importance of the invention.
(1) Relations between the owner of the patent and the licensee who has been granted a compulsory license shall be governed by the principle of good faith.
(2) Where a legal decision declares that the owner of the patent has violated that principle, the licensee may request the Registry to reduce the royalties fixed for the license in proportion to the importance of the unfulfilled obligation for working the invention.
(1) Compulsory licenses shall include additions to the relevant patent at the time of granting the license.
(2) Following the grant of a compulsory license, where new additions are made to the patent and their subject matter has the same industrial application as the patented invention that is the subject of the license, the licensee may request the Registry to include the new additions in the license. Where the interested parties do not reach agreement with the mediation of the Registry, the latter shall fix the royalties and the other conditions under which the scope of the license may be extended.
(1) The transfer of a compulsory license shall only be valid where the license is transferred together with the enterprise or the part of the enterprise that works the patented invention and the transfer shall be noted specifically by the Registry of Industrial Property. In the case of licenses for dependent patents, the license shall be transferred with the dependent patent.
(2) Any sublicenses granted by the owner of a compulsory license shall be null and void.
(1) Both the licensee and the owner of the patent may request the Registry to modify the royalties or other conditions of the compulsory license when new facts occur that justify such changes, in particular, where, after granting of the compulsory license, the owner of the patent grants contractual licenses under conditions that are unjustifiably more favorable.
(2) Where the licensee fails seriously or repeatedly to fulfill any of his obligations under the compulsory license, the Registry of Industrial Property may automatically or at the request of the interested party annul the license.
To the extent that they are not specifically contrary to the provisions of the present Title, the provisions governing contractual licenses in Chapter II of Title VIII of the present Law shall apply to compulsory licenses.
Chapter V Promotion of Applications for Compulsory Licenses
(1) The Registry of Industrial Property shall make systematic efforts to promote effectively license applications for patents subject to the granting of compulsory licenses. The Registry of Industrial Property shall also publish periodically details of such patents.
(2) Where the importance of working patented inventions in Spain so warrants, the Government may institute financial and other incentives to encourage enterprises to apply for licenses for specific patents subject to the granting of compulsory licenses for reasons of public interest.
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