The new Spanish Patent Act

The new Spanish Patent Act The author Luis Fernández-Novoa Valladares is the Managing Partner of the HOYNG ROKH MONEGIER office in Madrid. He is specialized in IP litigation, and mainly in patent litigation, before the Spanish commercial, criminal and administrative courts. This article The new Spanish Patent Act, Act 24/2015, was adopted on 24 July 2015 and published in the Spanish Official Bulletin on 25 July 2015. It entered into force on 1 April 2017. This new Spanish Patent Act strengthens Spanish national patents, aligns Spanish legislation with the most recent amendments to the European Patent Convention, introduces relevant changes to patent civil court proceedings and strengthens utility models. Another important change is that the new Law reduces the number of Commercial Courts entitled to hear patent cases. This article is not intended to be comprehensive but aims to illustrate some of the most important novelties introduced by the new Spanish Patent Act. The Patent Act 24/2015 entered into force on 1 April 2017. The new Spanish Patent Act replaces the previous one from 1986, which had caused a sea change in a patent system dating back to 1929, requiring complete reform by virtue of Spain’s entry into the then European Economic Community and accession to the European Patent Convention (EPC). The new Patent Act’s Preamble sets out the need to modernize and update Spanish Patent Law, since a mere partial reform of the 1986 Act was not enough. The Preamble notes that, since 1986, there have been numerous legislative developments at the international and European Union level that required a general updating of the national legislation to more closely align the Spanish patent system to the international context. However, the need to adopt a new Act was not shared unanimously. Some believe that a partial modification of the 1986 Act would have been more than enough, since there do not seem to be enough changes and novelties in the new Act to justify its adoption in lieu of amendments to the existing legislation. In a way, the fact that the new Act was approved at a time when the Spanish government faced strong pressure to change its position rejecting the Unitary Patent system might have been an influencing factor. The adoption of a new Act could be interpreted as an attempt to show the Spanish government’s commitment to the promotion and defense of innovation, taking a chance at modifying the legal framework as a counterweight to its position of keeping Spain out of the Unitary Patent system and the Unitary Patent Court (UPC). In this regard, it is interesting to emphasize the legislator’s silence, in the new Act, on the Unitary Patent, which is a clear indication of the persistent reluctance of the Spanish government to get involved. The fact that certain articles of the new Act differ from their 1986 counterparts only in purely formal aspects or wording could be seen as an indication that the lawmaker was forced to introduce purely cosmetic changes to give the impression that greater differences exist between the new Act and the old 1986 Act than they really do. Nevertheless, the new Act’s very positive aspects cannot be denied: for instance, it introduces compulsory substantive examination of patent applications; the term to respond to complaints or counterclaims in invalidity or infringement judicial proceedings has been extended to 2 months, beyond the common term of 20 days for all civil proceedings; and the recognition of protective letters for the first time in Spanish law. The improved regulation of utility models is also worth mentioning. The purpose of this article is to offer a brief and concise analysis of the new Act’s most relevant changes. Novelty Concerning the novelty requirement and when defining the relevant prior art, the new Act [Article 6(3)] now explicitly refers—as encompassed within the prior art—to applications for European Patents where Spain is designated and also to international applications (PCT) which have entered the national phase in our country, applied for before the patent’s application date and published in the Spanish language on that date or afterwards. The fact that the new Act specifically mentions these documents as forming part of the prior art for the purpose of determining the novelty of Spanish patents does not mean that they were not considered to be part of the prior art under the old Act. On the contrary, the Spanish Patent Office’s own Guidelines for Examination granted the same consideration for that purpose. The patentability of the second and subsequent [Article 6(4) and (5)] indications for therapeutic use is also included for the first time in the wording of the new Act. It includes provisions identical to those found in sections 4 and 5 of Article 54 EPC. Employee inventions The scheme governing employee inventions has been partially modified. There are no changes concerning the employer’s right, without any limitation, to inventions created by an employee within the framework of an employment or service contract, when the invention is the outcome of a research activity explicitly or implicitly resulting from that contract. Otherwise, the invention shall belong to the employee, unless the latter used means or knowledge acquired at the company, in which case the employer will have the option of assuming ownership of the invention in exchange for financial compensation. Nevertheless, the system of conflict resolution has been modified compared to that of the former Act, which obliged employee and employer to submit to a conciliation before the Patent Office as a pre-requisite to accessing the courts. The new Act (Article 133) no longer requires the step of conciliation; the new system allows an employer and employee to turn to the courts at any time to settle disputes concerning work-related inventions. Non-mandatory conciliation is also handled differently, since the conciliation commission will be comprised of an expert from the Patent Office and two other members freely chosen by each of the parties (instead of an expert appointed by the employees of the company to which the inventor belongs, and an expert designated by the employer, as envisaged in the former Act). Patent-granting procedures Although the number of Spanish patent applications is no greater than 28001 per year, the new Act reforms the granting system with the aim of increasing the quality of Spanish patents. One of the main amendments in the new Act is the elimination of the previous dual system in which the applicant could choose whether the patent would be granted with or without a prior examination of the substantive patentability requirements. This option no longer exists under the new Act (Articles 22–42); the prior examination of the substantive patentability requirements is now mandatory. Under the previous system, avoiding substantive examination was the preferred option for patent applicants and, in practice, it gave rise to weak patents with a high litigation rate, unable to compete in the international market. The new procedure aims to cease this widespread practice by supporting high-quality patents and, in general, to enhance legal certainty, although it could result in a further decrease of the total number of patents granted in Spain. The new Act’s patent-granting system is a replica of the European system. The application procedure shall be subject to the following steps: Establishment of filing date and admission. Ex officio examination of the formal requirements and determination on the patentability of the subject matter. Issuance of a prior art report that seeks a non-binding opinion as to the application’s compliance with patentability requirements so that the applicant may have time to decide whether or not to continue with the prosecution of the patent application. Publication of the application 18 months after its filing date and after having passed the ex officio examination. Possibility for third parties to make observations. Substantive examination upon the applicant’s request. Decision on the granting of the patent. Pre-granting oppositions by third parties have been replaced with a post-granting opposition system, which will allow third parties to express their objections within 6 months following the publication of the grant in the IP Official Gazette. Both the decision to deny and to grant a patent can be appealed before the Contentious-Administrative courts. The legitimacy to appeal the concession is reserved exclusively to those who have opposed the same. The patent owner may modify the patent (Article 48) during the opposition or appeal procedure. Exhaustion of patent rights and Bolar exemption The new Act [Article 61(2)] contemplates for the first time the possibility that legitimate reasons may justify the right-holder’s opposition to the commercialization of the product initially put on the market by him or by a third party with his consent or in a Member State of the European Economic Area. Therefore, the exhaustion of the patent right shall not occur in all the cases set forth in the Act of 1986. One of the most relevant modifications of the new Act is the drafting of the so-called Bolar Clause [Article 61(1)(b)], which limits the patent holder’s rights so that they do not extend to the carrying out of studies and trials needed to ‘obtain the marketing authorization for drugs within Spain or outside of Spain’. Differently from the former Act, which included in its Article 52 the Bolar Clause as a subclass of experimental acts and limited it to studies and trials carried out ‘for the authorization of generic drugs within Spain and outside of Spain’, the new Article 61 separates the Bolar Clause from the experimental acts, hence echoing their different origin and purpose, in accordance with the case law of the Spanish Supreme Court, and creates a separate category of acts which fall outside the scope of the rights conferred by the patent and extended to any authorization procedure for drugs, whether generic or not. Actions for infringement The regime of the defense actions of the patent right maintains significant similarities with the regime of the 1986 Act, though some noteworthy changes are introduced. One of the most important changes concerns compensation for damages. It is no longer limited in time, unlike in the former Act, according to which only the damages and losses suffered during the 5 years prior to the complaint’s filing date could be claimed. In the absence of judicial interpretation of this rule, it is difficult to believe that there will be no time limit to claim past damages, because the Act itself (Article 78) states that the actions derived from the infringement of the patent, including the compensation of damages, expire 5 years after the moment they could be exercised. Nonetheless, we must not forget that, according to our Supreme Court’s consolidated case law on continued crime, in the case of infringing acts that continue or are repeated over time, the 5-year expiration period shall begin to run on the day the infringement ceases. With regard to the liability of those who perform any kind of exploitation activity other than manufacturing or importing the patented product or using the patented process, such as acts performed by intermediaries, the Act eliminates the prior notification requirement. Under the Act of 1986, intermediaries could be deemed liable for damages only if they were previously notified of the infringement by the patent owner, or if their actions were culpable or negligent. Under the new Act (Article 72), however, it will be enough to show that they acted with purpose. The prior notification will be a means of evidence, but not the only one. Unlike the former Act, which allowed the patent holder’s compensation for damages to be calculated according to the hypothetical royalty criterion, the new Act [Article 74(2)(b)] introduces the possibility of claiming a lump-sum amount which, at least, should include the amount the infringer would have had to pay if he had obtained a license, thus giving the patent holder the possibility of claiming an amount greater than the cost of a patent license. Finally, the possibility of publishing the ruling is restricted because the Act states [Article 71(1)(f)] that such a measure may be ordered by the judge on an exceptional basis. It is difficult to understand the restriction to the publication of the ruling when Directive 2004/48/EC itself describes it as an ordinary remedy, having the important function of dissuading infringement.2 Infringement and invalidity proceedings, patent limitation and protective letters One of the most novel aspects of the new Act, and perhaps one of the wisest changes, is the regulation of patent-related civil lawsuits. First, fewer courts are now competent to hear patent cases, as opposed to the former Act which granted jurisdiction to the Commercial Courts (Juzgados de lo Mercantil) located in the city housing the High Court of Justice (Tribunal Superior de Justicia) of the corresponding Autonomous Community, which is why there was at least one court per Autonomous Community competent to hear such matters. The new Act decrees that only the Commercial Courts located in the host city of the High Court of Justice of the Autonomous Community corresponding to whichever one the General Council of the Judiciary has exclusively attributed patent matters, shall have jurisdiction; pursuant to this rule, some Commercial Courts of Madrid (nos 6, 7, 8, 9, 10 and 11), Barcelona (nos 1, 4 and 5) and Valencia (no 2) are now the only courts with the authority to hear patent cases and solve these conflicts. More reasonable terms have been established in order to reply to an infringement or invalidity complaint, compared to a period of 20 days common to all civil proceedings. The new Act grants a period of 2 months, a unique feature based on the technical-legal nature of these proceedings. A period of 20 days was insufficient to research prior art in order to evaluate the possibility of challenging a patent and raising an invalidity attack, as well as to obtain expert opinions, paramount in this type of litigation. Concerning the scope of the protection conferred to the patents, the new Act includes the need to take into account any elements equivalent to those used in the patent claims to establish the claims’ scope, thus echoing for the first time the doctrine of equivalents developed and applied by the courts. Another noteworthy change is that the determination of damages is now postponed to the enforcement phase of the judgment based on the guidelines established therein [Article 74(5)]. This measure is especially important because, under the former Act, damages were often determined needlessly during the main proceedings phase: for instance, a ruling finding a patent’s non-infringement would result in a waste of time and money for all parties, since in many cases economists or auditors would be appointed to carry out the corresponding calculations. The new Act [Article 103(1)] eliminates requirements for bringing an action for patent invalidity, declaring for the first time that such an action takes on a public scope. Anyone has legitimacy to exercise an action for patent invalidity, thus eliminating the restrictions imposed by the former Act that limited the possibility of exercising an invalidity claim to ‘whoever considers himself to be harmed’. Consequently, the plaintiff in a patent invalidity action is no longer required to submit evidence proving the harm caused by the challenged patent. The new Act sets forth [Article 102(2)] that if the causes for invalidity affect only a single part of the patent, the patent in question shall be declared only partially null and, even more significantly, the patent shall be limited by the modification of the affected claims. In addition, in proceedings where the validity of a patent is challenged, the Act introduces the possibility for the judge to request from the Spanish Patent Office or from a third-party institution, chosen at the judge’s discretion, the issuance of a report addressing the various controversial matters contained in the parties’ expert reports. It is difficult to understand the reinstatement of the possibility of requesting the Spanish Patent Office’s opinion when the validity of the patent is at stake, since Article 128 of the 1986 Act, which contemplated this possibility, was revoked in 2006, due inter alia to the Spanish Patent Office’s examiners’ lack of enthusiasm to be involved in court proceedings. Another main aspect of the new Act is the possibility of modifying patent claims. For the first time, the new Act also introduces the possibility that the patent owner could voluntarily limit the patent’s scope of protection by modifying the claims at any time during the patent’s lifetime, including the enforceability period of supplementary protection certificates, if any. This limitation was banned under the former Act, except for the correction of ‘manifest’ errors. Although the possibility of limiting a European patent with effects in Spain already existed starting with the EPC Revision Act of 29 November 2000, the new Act extends this possibility also to national patents. This includes the possibility of amending the patent claims prior to engaging in litigation, before the Spanish Patent Office, and in the course and context of court proceedings. The limitation can be requested by the patent holder in different situations: Subsequent to its granting in the framework of an opposition proceeding. At any time during its legal life, including the validity period of the supplementary protection certificates, unless there are pending court proceedings concerning the patent’s validity, in which case prior authorization by the presiding judge or court is needed in order to file the limitation request with the Patent Office. When the patent’s validity is challenged, in a nullity action, counterclaim or defensive plea, the patent as limited would underlie the procedure thereafter. The main change in terms of precautionary measures is the elimination of the requirement of the patent’s exploitation, necessary for obtaining precautionary measures under the 1986 Act. It is also very important to highlight the fact that, for the first time, the new Act gives a voice in Spain to Protective Letters, a tool unknown under Spanish law to date. The legislator has inserted as a new procedural instrument a certain type of protective letter, an instrument that the Commercial Courts of Barcelona had already accepted. It allows a potential defendant facing infringement claims to defend himself against any future ex parte preliminary injunctions, affording him a chance to appear in court and justify his position in advance. Unlike other countries, in Spain the protective letter will be notified to the opposing party. Also, its validity has been restricted to three months. In any case, it will not be binding, so the filing of a protective letter will not necessarily prevent the judge from issuing a decision granting ex parte preliminary injunctions. Utility models Utility models are a controversial topic (the number of utility model applications is around 20003 per year in Spain). They were discussed extensively during the drafting and processing of the new Act and the feasibility of their elimination was also debated. Ultimately, however, they were maintained because the general understanding was that they favoured the innovation of small and medium companies. The most important modification of the utility model’s protection lies in the expansion of inventions that may be protected by this title. If under the old Act, utility models were reserved to inventions in the field of mechanics, the new Act (Article 137) extends protection to any object or product whose configuration, structure or composition is advantageous to its use or manufacturing. In this way, chemical products, substances or compositions can be protected as utility models, except for ‘procedural inventions, those that fall within biological material and pharmaceutical substances and compositions’. Utility models will continue to be granted without prior examination, though a fundamental change, long claimed, is that the prior art relevant for determining the novelty and inventive step of utility models (Article 139) will be exactly the same as that considered for patents. Under the 1986 Act, only written or oral disclosures that had taken place within the Spanish territory were considered prior art for utility models. Lastly, another change is that, in order to exercise actions for the infringement of a utility model, it will be necessary (Article 148) to first obtain the so-called prior art report (‘IET’) that must be filed with the complaint. Otherwise, the defendant may request the suspension of the deadline to reply to the complaint until the submission of same. The IET is similar to a search report carried out by the Patent Office aimed at informing the model’s owner of its strength. This requirement, subject to the exercising of legal action based on a utility model, is a replica of the system set forth in the 1986 Act for the exercise of infringement actions based on Spanish patents granted without an examination of the substantive patentability requirements. Obligation to exploit and compulsory licenses A disappointing change in the new Act is the regulation of the obligation to exploit patents and compulsory licenses and the maintenance of ex officio licenses, which lack any practical value and are granted as a result of the patent holder’s public offer to grant non-exclusive licenses to any interested party, with the ‘benefit’ of paying only half the amount of the annual fees in exchange for the offer. The new Act maintains the obligation that either the owner himself or an authorized person must exploit the patent (Article 90) within 4 years from its filing date or 3 years from its granting, through its implementation in Spain or a WTO member country, so that such exploitation shall be sufficient to supply the demand of the Spanish market. The reasons for which compulsory licenses can be granted undergo significant alterations. Once exploitation has begun, the period during which terminating the same may be cause for granting a compulsory license [Article 92(1)] is limited to 1 year. The new Act also eliminates the possibility (Article 91) of granting a compulsory license for exporting as a reason for the license and extends the reasons for concession to put an end to practices declared anti-competitive by the antitrust bodies and courts, and also for the manufacturing of drugs for exportation to countries with public health concerns as per Regulation (EC) No 816/2006. Footnotes 1 See <http://consultas2.oepm.es/ipstat/faces/IpsBusqueda.xhtml> accessed 23 May 2018. 2 para 27 of the Preamble to the Directive: ‘To act as a supplementary deterrent to future infringers and to contribute to the awareness of the public at large, it is useful to publicize decisions in intellectual property infringement cases.’ 3 See <http://consultas2.oepm.es/ipstat/faces/IpsBusqueda.xhtml;jsessionid=Ej5GdollfVsKmNmlGdL8bL4l.nodo2EAPConsultasPRO> accessed 18 April 2018. © The Author(s) 2018. Published by Oxford University Press. All rights reserved. This article is published and distributed under the terms of the Oxford University Press, Standard Journals Publication Model (https://academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model) http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Journal of Intellectual Property Law & Practice Oxford University Press

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Oxford University Press
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© The Author(s) 2018. Published by Oxford University Press. All rights reserved.
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1747-1532
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1747-1540
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Abstract

The author Luis Fernández-Novoa Valladares is the Managing Partner of the HOYNG ROKH MONEGIER office in Madrid. He is specialized in IP litigation, and mainly in patent litigation, before the Spanish commercial, criminal and administrative courts. This article The new Spanish Patent Act, Act 24/2015, was adopted on 24 July 2015 and published in the Spanish Official Bulletin on 25 July 2015. It entered into force on 1 April 2017. This new Spanish Patent Act strengthens Spanish national patents, aligns Spanish legislation with the most recent amendments to the European Patent Convention, introduces relevant changes to patent civil court proceedings and strengthens utility models. Another important change is that the new Law reduces the number of Commercial Courts entitled to hear patent cases. This article is not intended to be comprehensive but aims to illustrate some of the most important novelties introduced by the new Spanish Patent Act. The Patent Act 24/2015 entered into force on 1 April 2017. The new Spanish Patent Act replaces the previous one from 1986, which had caused a sea change in a patent system dating back to 1929, requiring complete reform by virtue of Spain’s entry into the then European Economic Community and accession to the European Patent Convention (EPC). The new Patent Act’s Preamble sets out the need to modernize and update Spanish Patent Law, since a mere partial reform of the 1986 Act was not enough. The Preamble notes that, since 1986, there have been numerous legislative developments at the international and European Union level that required a general updating of the national legislation to more closely align the Spanish patent system to the international context. However, the need to adopt a new Act was not shared unanimously. Some believe that a partial modification of the 1986 Act would have been more than enough, since there do not seem to be enough changes and novelties in the new Act to justify its adoption in lieu of amendments to the existing legislation. In a way, the fact that the new Act was approved at a time when the Spanish government faced strong pressure to change its position rejecting the Unitary Patent system might have been an influencing factor. The adoption of a new Act could be interpreted as an attempt to show the Spanish government’s commitment to the promotion and defense of innovation, taking a chance at modifying the legal framework as a counterweight to its position of keeping Spain out of the Unitary Patent system and the Unitary Patent Court (UPC). In this regard, it is interesting to emphasize the legislator’s silence, in the new Act, on the Unitary Patent, which is a clear indication of the persistent reluctance of the Spanish government to get involved. The fact that certain articles of the new Act differ from their 1986 counterparts only in purely formal aspects or wording could be seen as an indication that the lawmaker was forced to introduce purely cosmetic changes to give the impression that greater differences exist between the new Act and the old 1986 Act than they really do. Nevertheless, the new Act’s very positive aspects cannot be denied: for instance, it introduces compulsory substantive examination of patent applications; the term to respond to complaints or counterclaims in invalidity or infringement judicial proceedings has been extended to 2 months, beyond the common term of 20 days for all civil proceedings; and the recognition of protective letters for the first time in Spanish law. The improved regulation of utility models is also worth mentioning. The purpose of this article is to offer a brief and concise analysis of the new Act’s most relevant changes. Novelty Concerning the novelty requirement and when defining the relevant prior art, the new Act [Article 6(3)] now explicitly refers—as encompassed within the prior art—to applications for European Patents where Spain is designated and also to international applications (PCT) which have entered the national phase in our country, applied for before the patent’s application date and published in the Spanish language on that date or afterwards. The fact that the new Act specifically mentions these documents as forming part of the prior art for the purpose of determining the novelty of Spanish patents does not mean that they were not considered to be part of the prior art under the old Act. On the contrary, the Spanish Patent Office’s own Guidelines for Examination granted the same consideration for that purpose. The patentability of the second and subsequent [Article 6(4) and (5)] indications for therapeutic use is also included for the first time in the wording of the new Act. It includes provisions identical to those found in sections 4 and 5 of Article 54 EPC. Employee inventions The scheme governing employee inventions has been partially modified. There are no changes concerning the employer’s right, without any limitation, to inventions created by an employee within the framework of an employment or service contract, when the invention is the outcome of a research activity explicitly or implicitly resulting from that contract. Otherwise, the invention shall belong to the employee, unless the latter used means or knowledge acquired at the company, in which case the employer will have the option of assuming ownership of the invention in exchange for financial compensation. Nevertheless, the system of conflict resolution has been modified compared to that of the former Act, which obliged employee and employer to submit to a conciliation before the Patent Office as a pre-requisite to accessing the courts. The new Act (Article 133) no longer requires the step of conciliation; the new system allows an employer and employee to turn to the courts at any time to settle disputes concerning work-related inventions. Non-mandatory conciliation is also handled differently, since the conciliation commission will be comprised of an expert from the Patent Office and two other members freely chosen by each of the parties (instead of an expert appointed by the employees of the company to which the inventor belongs, and an expert designated by the employer, as envisaged in the former Act). Patent-granting procedures Although the number of Spanish patent applications is no greater than 28001 per year, the new Act reforms the granting system with the aim of increasing the quality of Spanish patents. One of the main amendments in the new Act is the elimination of the previous dual system in which the applicant could choose whether the patent would be granted with or without a prior examination of the substantive patentability requirements. This option no longer exists under the new Act (Articles 22–42); the prior examination of the substantive patentability requirements is now mandatory. Under the previous system, avoiding substantive examination was the preferred option for patent applicants and, in practice, it gave rise to weak patents with a high litigation rate, unable to compete in the international market. The new procedure aims to cease this widespread practice by supporting high-quality patents and, in general, to enhance legal certainty, although it could result in a further decrease of the total number of patents granted in Spain. The new Act’s patent-granting system is a replica of the European system. The application procedure shall be subject to the following steps: Establishment of filing date and admission. Ex officio examination of the formal requirements and determination on the patentability of the subject matter. Issuance of a prior art report that seeks a non-binding opinion as to the application’s compliance with patentability requirements so that the applicant may have time to decide whether or not to continue with the prosecution of the patent application. Publication of the application 18 months after its filing date and after having passed the ex officio examination. Possibility for third parties to make observations. Substantive examination upon the applicant’s request. Decision on the granting of the patent. Pre-granting oppositions by third parties have been replaced with a post-granting opposition system, which will allow third parties to express their objections within 6 months following the publication of the grant in the IP Official Gazette. Both the decision to deny and to grant a patent can be appealed before the Contentious-Administrative courts. The legitimacy to appeal the concession is reserved exclusively to those who have opposed the same. The patent owner may modify the patent (Article 48) during the opposition or appeal procedure. Exhaustion of patent rights and Bolar exemption The new Act [Article 61(2)] contemplates for the first time the possibility that legitimate reasons may justify the right-holder’s opposition to the commercialization of the product initially put on the market by him or by a third party with his consent or in a Member State of the European Economic Area. Therefore, the exhaustion of the patent right shall not occur in all the cases set forth in the Act of 1986. One of the most relevant modifications of the new Act is the drafting of the so-called Bolar Clause [Article 61(1)(b)], which limits the patent holder’s rights so that they do not extend to the carrying out of studies and trials needed to ‘obtain the marketing authorization for drugs within Spain or outside of Spain’. Differently from the former Act, which included in its Article 52 the Bolar Clause as a subclass of experimental acts and limited it to studies and trials carried out ‘for the authorization of generic drugs within Spain and outside of Spain’, the new Article 61 separates the Bolar Clause from the experimental acts, hence echoing their different origin and purpose, in accordance with the case law of the Spanish Supreme Court, and creates a separate category of acts which fall outside the scope of the rights conferred by the patent and extended to any authorization procedure for drugs, whether generic or not. Actions for infringement The regime of the defense actions of the patent right maintains significant similarities with the regime of the 1986 Act, though some noteworthy changes are introduced. One of the most important changes concerns compensation for damages. It is no longer limited in time, unlike in the former Act, according to which only the damages and losses suffered during the 5 years prior to the complaint’s filing date could be claimed. In the absence of judicial interpretation of this rule, it is difficult to believe that there will be no time limit to claim past damages, because the Act itself (Article 78) states that the actions derived from the infringement of the patent, including the compensation of damages, expire 5 years after the moment they could be exercised. Nonetheless, we must not forget that, according to our Supreme Court’s consolidated case law on continued crime, in the case of infringing acts that continue or are repeated over time, the 5-year expiration period shall begin to run on the day the infringement ceases. With regard to the liability of those who perform any kind of exploitation activity other than manufacturing or importing the patented product or using the patented process, such as acts performed by intermediaries, the Act eliminates the prior notification requirement. Under the Act of 1986, intermediaries could be deemed liable for damages only if they were previously notified of the infringement by the patent owner, or if their actions were culpable or negligent. Under the new Act (Article 72), however, it will be enough to show that they acted with purpose. The prior notification will be a means of evidence, but not the only one. Unlike the former Act, which allowed the patent holder’s compensation for damages to be calculated according to the hypothetical royalty criterion, the new Act [Article 74(2)(b)] introduces the possibility of claiming a lump-sum amount which, at least, should include the amount the infringer would have had to pay if he had obtained a license, thus giving the patent holder the possibility of claiming an amount greater than the cost of a patent license. Finally, the possibility of publishing the ruling is restricted because the Act states [Article 71(1)(f)] that such a measure may be ordered by the judge on an exceptional basis. It is difficult to understand the restriction to the publication of the ruling when Directive 2004/48/EC itself describes it as an ordinary remedy, having the important function of dissuading infringement.2 Infringement and invalidity proceedings, patent limitation and protective letters One of the most novel aspects of the new Act, and perhaps one of the wisest changes, is the regulation of patent-related civil lawsuits. First, fewer courts are now competent to hear patent cases, as opposed to the former Act which granted jurisdiction to the Commercial Courts (Juzgados de lo Mercantil) located in the city housing the High Court of Justice (Tribunal Superior de Justicia) of the corresponding Autonomous Community, which is why there was at least one court per Autonomous Community competent to hear such matters. The new Act decrees that only the Commercial Courts located in the host city of the High Court of Justice of the Autonomous Community corresponding to whichever one the General Council of the Judiciary has exclusively attributed patent matters, shall have jurisdiction; pursuant to this rule, some Commercial Courts of Madrid (nos 6, 7, 8, 9, 10 and 11), Barcelona (nos 1, 4 and 5) and Valencia (no 2) are now the only courts with the authority to hear patent cases and solve these conflicts. More reasonable terms have been established in order to reply to an infringement or invalidity complaint, compared to a period of 20 days common to all civil proceedings. The new Act grants a period of 2 months, a unique feature based on the technical-legal nature of these proceedings. A period of 20 days was insufficient to research prior art in order to evaluate the possibility of challenging a patent and raising an invalidity attack, as well as to obtain expert opinions, paramount in this type of litigation. Concerning the scope of the protection conferred to the patents, the new Act includes the need to take into account any elements equivalent to those used in the patent claims to establish the claims’ scope, thus echoing for the first time the doctrine of equivalents developed and applied by the courts. Another noteworthy change is that the determination of damages is now postponed to the enforcement phase of the judgment based on the guidelines established therein [Article 74(5)]. This measure is especially important because, under the former Act, damages were often determined needlessly during the main proceedings phase: for instance, a ruling finding a patent’s non-infringement would result in a waste of time and money for all parties, since in many cases economists or auditors would be appointed to carry out the corresponding calculations. The new Act [Article 103(1)] eliminates requirements for bringing an action for patent invalidity, declaring for the first time that such an action takes on a public scope. Anyone has legitimacy to exercise an action for patent invalidity, thus eliminating the restrictions imposed by the former Act that limited the possibility of exercising an invalidity claim to ‘whoever considers himself to be harmed’. Consequently, the plaintiff in a patent invalidity action is no longer required to submit evidence proving the harm caused by the challenged patent. The new Act sets forth [Article 102(2)] that if the causes for invalidity affect only a single part of the patent, the patent in question shall be declared only partially null and, even more significantly, the patent shall be limited by the modification of the affected claims. In addition, in proceedings where the validity of a patent is challenged, the Act introduces the possibility for the judge to request from the Spanish Patent Office or from a third-party institution, chosen at the judge’s discretion, the issuance of a report addressing the various controversial matters contained in the parties’ expert reports. It is difficult to understand the reinstatement of the possibility of requesting the Spanish Patent Office’s opinion when the validity of the patent is at stake, since Article 128 of the 1986 Act, which contemplated this possibility, was revoked in 2006, due inter alia to the Spanish Patent Office’s examiners’ lack of enthusiasm to be involved in court proceedings. Another main aspect of the new Act is the possibility of modifying patent claims. For the first time, the new Act also introduces the possibility that the patent owner could voluntarily limit the patent’s scope of protection by modifying the claims at any time during the patent’s lifetime, including the enforceability period of supplementary protection certificates, if any. This limitation was banned under the former Act, except for the correction of ‘manifest’ errors. Although the possibility of limiting a European patent with effects in Spain already existed starting with the EPC Revision Act of 29 November 2000, the new Act extends this possibility also to national patents. This includes the possibility of amending the patent claims prior to engaging in litigation, before the Spanish Patent Office, and in the course and context of court proceedings. The limitation can be requested by the patent holder in different situations: Subsequent to its granting in the framework of an opposition proceeding. At any time during its legal life, including the validity period of the supplementary protection certificates, unless there are pending court proceedings concerning the patent’s validity, in which case prior authorization by the presiding judge or court is needed in order to file the limitation request with the Patent Office. When the patent’s validity is challenged, in a nullity action, counterclaim or defensive plea, the patent as limited would underlie the procedure thereafter. The main change in terms of precautionary measures is the elimination of the requirement of the patent’s exploitation, necessary for obtaining precautionary measures under the 1986 Act. It is also very important to highlight the fact that, for the first time, the new Act gives a voice in Spain to Protective Letters, a tool unknown under Spanish law to date. The legislator has inserted as a new procedural instrument a certain type of protective letter, an instrument that the Commercial Courts of Barcelona had already accepted. It allows a potential defendant facing infringement claims to defend himself against any future ex parte preliminary injunctions, affording him a chance to appear in court and justify his position in advance. Unlike other countries, in Spain the protective letter will be notified to the opposing party. Also, its validity has been restricted to three months. In any case, it will not be binding, so the filing of a protective letter will not necessarily prevent the judge from issuing a decision granting ex parte preliminary injunctions. Utility models Utility models are a controversial topic (the number of utility model applications is around 20003 per year in Spain). They were discussed extensively during the drafting and processing of the new Act and the feasibility of their elimination was also debated. Ultimately, however, they were maintained because the general understanding was that they favoured the innovation of small and medium companies. The most important modification of the utility model’s protection lies in the expansion of inventions that may be protected by this title. If under the old Act, utility models were reserved to inventions in the field of mechanics, the new Act (Article 137) extends protection to any object or product whose configuration, structure or composition is advantageous to its use or manufacturing. In this way, chemical products, substances or compositions can be protected as utility models, except for ‘procedural inventions, those that fall within biological material and pharmaceutical substances and compositions’. Utility models will continue to be granted without prior examination, though a fundamental change, long claimed, is that the prior art relevant for determining the novelty and inventive step of utility models (Article 139) will be exactly the same as that considered for patents. Under the 1986 Act, only written or oral disclosures that had taken place within the Spanish territory were considered prior art for utility models. Lastly, another change is that, in order to exercise actions for the infringement of a utility model, it will be necessary (Article 148) to first obtain the so-called prior art report (‘IET’) that must be filed with the complaint. Otherwise, the defendant may request the suspension of the deadline to reply to the complaint until the submission of same. The IET is similar to a search report carried out by the Patent Office aimed at informing the model’s owner of its strength. This requirement, subject to the exercising of legal action based on a utility model, is a replica of the system set forth in the 1986 Act for the exercise of infringement actions based on Spanish patents granted without an examination of the substantive patentability requirements. Obligation to exploit and compulsory licenses A disappointing change in the new Act is the regulation of the obligation to exploit patents and compulsory licenses and the maintenance of ex officio licenses, which lack any practical value and are granted as a result of the patent holder’s public offer to grant non-exclusive licenses to any interested party, with the ‘benefit’ of paying only half the amount of the annual fees in exchange for the offer. The new Act maintains the obligation that either the owner himself or an authorized person must exploit the patent (Article 90) within 4 years from its filing date or 3 years from its granting, through its implementation in Spain or a WTO member country, so that such exploitation shall be sufficient to supply the demand of the Spanish market. The reasons for which compulsory licenses can be granted undergo significant alterations. Once exploitation has begun, the period during which terminating the same may be cause for granting a compulsory license [Article 92(1)] is limited to 1 year. The new Act also eliminates the possibility (Article 91) of granting a compulsory license for exporting as a reason for the license and extends the reasons for concession to put an end to practices declared anti-competitive by the antitrust bodies and courts, and also for the manufacturing of drugs for exportation to countries with public health concerns as per Regulation (EC) No 816/2006. Footnotes 1 See <http://consultas2.oepm.es/ipstat/faces/IpsBusqueda.xhtml> accessed 23 May 2018. 2 para 27 of the Preamble to the Directive: ‘To act as a supplementary deterrent to future infringers and to contribute to the awareness of the public at large, it is useful to publicize decisions in intellectual property infringement cases.’ 3 See <http://consultas2.oepm.es/ipstat/faces/IpsBusqueda.xhtml;jsessionid=Ej5GdollfVsKmNmlGdL8bL4l.nodo2EAPConsultasPRO> accessed 18 April 2018. © The Author(s) 2018. Published by Oxford University Press. All rights reserved. This article is published and distributed under the terms of the Oxford University Press, Standard Journals Publication Model (https://academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model)

Journal

Journal of Intellectual Property Law & PracticeOxford University Press

Published: Dec 1, 2018

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