Patent Litigation 2023

Last Updated January 04, 2023

Portugal

Law and Practice

Authors



Morais Leitão, Galvão Teles, Soares da Silva & Associados (Morais Leitão) is a leading full-service law firm in Portugal, with decades of litigation experience. Broadly recognised, Morais Leitão’s reputation amongst both peers and clients stems from the excellence of the legal services provided in a variety of sectors. The firm’s work is characterised by a technical expertise, combined with a distinctive approach and cutting-edge solutions that often challenge conventional practice. With over 250 lawyers at a client’s disposal, Morais Leitão is headquartered in Lisbon with additional offices in Porto and Funchal. Due to its network of associations and alliances with local firms and the creation of the Morais Leitão Legal Circle in 2010, the firm can also offer support through offices in Angola (ALC Advogados), Mozambique (MDR Advogados) and Cabo Verde (VPQ Advogados).

The Portuguese legal system foresees the protection of inventions through patents and utility models. Naturally, in certain circumstances, an invention may also be protected by trade secrets and there is a new regime, in force since the start of 2019, for this type of protection. This article will focus, however, on the first two intellectual property rights. 

Various types of patents can be protected in Portugal. It is possible to protect an invention through a national patent, a European patent (as granted by the European Patent Office (EPO)) and also an international (Patent Cooperation Treaty, or PCT) patent application designating Portugal. The prohibition against double protection was eliminated in 2018 and, therefore, it is even possible to have a Portuguese patent and European patent covering the same invention and co-existing in the Portuguese territory.

Provisional patent applications are also foreseen under Portuguese law and were created so as to assist with urgent filings or situations where the applicant wishes to have more time to assess the advantages of filing a definitive patent application.

The unitary patent and a unified patent court system was approved in the Portuguese parliament by Resolution No 108/2015 of 10 April 2015 and ratified by the Portuguese President of the Republic through Presidential Decree No 90/2015, published on 6 August 2015. Consequently, when the unitary patent and the unified patent court become realities, they will be applicable in Portugal.

Patents and utility models in force in Portugal may be searched in both national and international patent databases. However, in Portugal, there is no equivalent to an Orange Book that lists applicable patents in relation to certain products or processes (eg, in the pharmaceutical sector).

The entire system in Portugal is based on statutory law. Case law can assist in interpreting the statutory law. European Union directives may also be invoked for purposes of interpretation, when the national legislation does not seem to conform with mandatory EU directive provisions.

This chapter seeks to describe what is foreseen in Portuguese law, and the latter is focused, by and large, on Portuguese patents. It will therefore abstain from describing provisions that are foreseen in international treaties such as the European Patent Convention (EPC) or the PCT.

Process

The process for the grant of a Portuguese patent is similar to that of a Portuguese utility model. 

The process begins with the filing of an application. To receive a filing date, the application must contain at least the identification of the applicant and a document that describes the invention and the scope of the application in such a way as to be executed by an expert in the field. As in other jurisdictions, for the application to be considered complete, it should contain a description, claims, drawings and an abstract. If invoking a priority, the previous application should also be identified.

Once the application is complete, there is an examination regarding the formal requirements. Unless early publication is requested, the application will be published 18 months from the application date or priority date. This opens up a two-month opposition period. After this opposition stage is closed, the application enters the phase of examination on patentability requirements. If there are objections to the grant, the applicant will be invited to adjust the text of the application. This may happen more than once. At the end of the process, the Instituto Nacional da Propriedade Industrial (Portuguese Patent and Trademark Office, or PTO) will issue a decision to grant or will refuse the application.

Representation

The applicant does not necessarily need to be represented by a lawyer or patent attorney. However, if the applicant is a non-resident of Portugal, it must indicate an address in this country, as well as a fax number or an email address.

Costs

The Portuguese government seeks to promote the filing of Portuguese patent applications by applying low official fees. The cost of filing a Portuguese patent application, including examination, is currently EUR109.07.

If the applicant files a provisional patent application, the cost is currently EUR10.91 for filing, EUR54.54 for the search report and EUR76.36 to convert the application into a regular Portuguese patent application.

The time to process a Portuguese patent application and examine the invention depends heavily on the size of the description and number of claims, the complexity of the invention, the technical field and the quality of the documentation submitted.

On average, the time taken between the filing and the decision to grant is around three to four years, although one should bear in mind that the application is normally only published 18 months after filing and only begins to be examined in full at around 20 months after filing.

The maximum durations assume annual renewals to keep the IP right in force.

A granted patent will be valid for a term of 20 years, counting from the date of application. A supplementary protection certificate (SPC) can extend the life of a patent in the pharmaceutical field for a maximum of five years (an additional six-month extension is possible for paediatric medicines).

With respect to utility models, they are valid for an initial period of six years, but can be renewed a maximum of two times, for periods of two years. Consequently, a utility model can remain in force for a maximum of ten years counting from the application date.

Pre-grant

After the publication of the patent application, the patentee acquires some provisional protection (Article 5 of the Portuguese Industrial Property Code, or PIPC), namely for purposes of calculation of damages if infringement is confirmed in the future.

As regards obligations at the pre-grant stage, the payment of annual renewal fees is an obligation that does not depend on the grant of the patent.

Indeed, if the annual renewal fees are not paid, the patent application or the granted patent will lapse.

Post-grant

The grant of the patent is the moment when the patentee obtains the full breadth of the rights foreseen in the law. Pursuant to Article 102 of the PIPC, the patent owner has the exclusive right to exploit the invention in any part of the territory of Portugal and also to prohibit third parties from manufacturing, offering for sale, storing, placing on the market, importing, possessing or using a product or process covered by a patent.

Naturally, if these exclusive rights are infringed, the patent owner is entitled to redress; namely, to obtain a court decision ordering that the infringement cease and the payment of an indemnification. Supplementary measures may also be decreed, such as the seizing of equipment, materials and closing of the premises used for carrying out the infringing activities.

In addition to rights, the patent owner also has some obligations. Aside from the need to renew the patent annually, as mentioned above, the patent owner has the obligation to put the patented invention to use in the territory.

Article 107 of the PIPC states that the patent owner must exploit the patented invention directly or indirectly and commercialise the results so as to satisfy the needs of the national market. This must be done within four years of filing the patent application or three years after the grant of the patent, whichever occurs later. The consequence for not putting the invention to use is the possible compulsory licensing of the technology to satisfy national needs. These provisions regarding compulsory licensing are rarely put into practice.

SPCs that serve as an extension to a patent right are governed by EU regulation and can be obtained in Portugal. They apply to specific pharmaceutical and plant protection products that have been authorised by regulatory authorities.

For an SPC to be granted, it is necessary to comply with a variety of administrative requirements and the pharmaceutical product or plant protection product must be foreseen in the base patent.

An SPC can extend a patent right for a maximum of five years. A six-month additional extension is available in accordance with Regulation (EC) No 1901/2006 if the SPC relates to a medicinal product for children for which data has been submitted according to a paediatric investigation plan (PIP). PIPs are required to support the authorisation of medicines for children.

In Portuguese patent grant proceedings, third-party oppositions can be filed within two months from the publication date. These oppositions are filed with the PTO either in paper format or through the PTO’s electronic platform. There are no third-party observations in Portuguese patent grant proceedings as there are in other jurisdictions.

Under Portuguese law, the applicant of a patent or utility model may appeal a decision that refuses to grant said industrial property right to the Intellectual Property Court or, alternatively, to the Intellectual Property Arbitration Centre (ARBITRARE).

There is also an administrative proceeding to react to a refusal decision, whereby the applicant requests the reassessment of the decision to someone hierarchically superior to the director of Patents and Trademarks Department at the PTO. In practice, this is almost always the Directive Board of the PTO. Furthermore, it is understood that this mechanism should only be used when there are new facts or arguments not considered by the initial decision-maker.

If a patent or utility model is not renewed within the normal deadline, the renewal fee can still be paid within an additional six months, subject to the payment of a surcharge. Failure to renew within this supplementary period leads to the lapse of the right and the publication of a notice in the IP Bulletin. The patent or utility model may still be revalidated within a period of one year following the publication, subject to the payment of triple the normal renewal fees.

Pursuant to Article 102(8) of the PIPC, the owner of a patent may limit its scope by modifying the claims. A submission with the new set of claims must be filed with the PTO and a fee is due for this proceeding. The patent examiner will assess the amendments and, if in conformity with the law, approve the new claims.

It is also possible to request the limitation of patent claims in response to a judicial action seeking the invalidation of the patent (Article 115(2), PIPC). This provision is also applicable to utility models.

In short, the general rule is that the patent owner may limit the scope of the granted right, but it is forbidden to broaden the scope.

When confronted with the infringement of a patent or utility model in Portugal, the owner of the right is presented with a series of possible responses.

First and foremost, patent infringement is a crime under Portuguese law (Article 318, PIPC) and, consequently, it is possible to file a criminal complaint against the infringer so that the situation is investigated by the Public Prosecutor’s Office to determine if a criminal accusation can be brought against the infringer.

The patent owner may also file a civil action against the infringer, notably at the Intellectual Property Court, requesting the resolution of the dispute.

If the owner requires urgent relief, the grant of a preliminary injunction may also be requested from the Intellectual Property Court.

Finally, under Portuguese law, the patent owner may propose to the suspected infringer that the dispute be submitted to voluntary arbitration. This is expressly foreseen in Law No 62/2011 (as amended) for pharmaceutical patent disputes.

The voluntary arbitration may be “ad hoc” or institutional arbitration governed by the rules of an institutional arbitration centre. In Portugal, there is an arbitration centre specialising in intellectual property disputes called “ARBITRARE”.

It is also possible for patent owners to request customs border actions so as to detect and prevent the importation of patent infringing products into Portuguese territory. Customs border actions are governed by Regulation (EU) No 608/2013 of the European Parliament and of the Council of 12 June 2013 concerning customs enforcement of intellectual property rights and repealing Council Regulation (EC) No 1383/2003, and also Law-Decree No 360/2007, of 2 November 2007.

A third party wishing to use commercially a patented invention in Portugal without the consent of the patent owner has a range of options depending on whether it believes the intellectual property right to be valid or not.

Actions Seeking the Invalidity of the Patent

As mentioned in 1.7 Third-Party Rights to Participate in Grant Proceedings, under Portuguese law, opposition proceedings can be initiated during the administrative phase, before the patent application undergoes the examination on patentability requirements. In this way, third parties have the opportunity to try and prevent the granting of the patent right in the first place.

If the opposition is unsuccessful or if no opposition is filed, a third party may always respond to the decision to grant by filing an appeal within two months (see 1.8 Remedies against Refusal to Grant an Intellectual Property Right, mutatis mutandis).

A third party may also file a judicial action to invalidate, totally or partially, a granted patent. Invalidation may take the form of a nullity action or an annullability action.

A nullity action may be filed at any time and is reserved for cases where (i) the object of the protection cannot be patented under the law, (ii) there were significant failings in the administrative process, or (iii) public order provisions were infringed. The overwhelming majority of patent nullity actions in Portugal are based on the lack of novelty of the invention or the lack of inventive step.

An annullability action is reserved for situations where the right has been attributed incorrectly to the wrong person or entity.

Actions That do Not Seek the Invalidity of the Patent

Although extremely rare, it is possible for a third party to file a judicial action aimed at obtaining a judgment declaring that a product or process does not infringe a patent (declaration of non-infringement).

Equally rare are compulsory licences. These are based on statutory law and are foreseen for the following situations: (i) public interest reasons, (ii) lack of use of the invention in the Portuguese territory, or (iii) in situations of dependency between patents.

Patents may also be expropriated by the state in situations where this is essential for the public interest, subject to the payment of just compensation. There are no known cases of patent expropriation in the last decades.

Irrespective of the action, the third party must, as a general rule, show legitimate interest and standing. These requirements are met by showing that the third party has genuine and lawful grounds for seeking and obtaining the legal remedy.

In Portugal, there is a specialised first instance court for patent litigation: the Intellectual Property Court. This judicial court is competent for most intellectual property civil disputes (ie, criminal disputes fall under the jurisdiction of other courts).

Appeals of decisions of the Intellectual Property Court are assigned to a specialised section of the Second Instance Court of Lisbon, which deals with intellectual property cases.

There is no specialised section at the Supreme Court for intellectual property matters, but this highest court can rule on cases related to points of intellectual property law.

Likewise, the Constitutional Court is sometimes called upon to assess the constitutionality of some legal provisions in Portuguese intellectual property law.

It should be noted that Portugal also has a separate structure for administrative courts. Although it is now rare for these administrative courts to deal with patent matters, there was a time (approximately 2006–11) in which they were heavily involved in patent-linkage cases in the pharmaceutical sector.

As mentioned in 2.3 Courts with Jurisdiction, Portugal has a specialised first instance judicial court for civil disputes related to intellectual property matters. The Intellectual Property Court was created by Law No 46/2011, of 24 June 2011, and installed pursuant to Ordinance No 84/2012, of 29 March 2012. This Court’s scope is currently defined in Article 111 of Law No 62/2013, of 26 August 2013 (in its current version).

As also mentioned at 2.3 Courts with Jurisdiction, the Second Instance Court of Lisbon also has a section specialised in intellectual property, as foreseen in Law No 55/2019, of 5 August 2019.

In addition to these judicial bodies, Portugal also has, since 2008, a fixed arbitration centre specialising in intellectual property matters called ARBITRARE (Dispatch No 28519/2008, of 22 October 2008). The PTO and the Institute for Registries and Notaries are bound to this arbitration centre, which means that interested parties can refer cases to it and the aforementioned public entities must accept the competence of ARBITRARE (Ordinance No 1046/2009, of 15 September 2009).

Finally, it is worth noting that Lisbon (the capital of Portugal) has been proposed as a host city for one of the patent mediation and arbitration centres under the Unified Patent Court system. This has not yet become definitive.

There is no requirement to issue a formal demand letter or a warning letter in Portugal prior to filing a lawsuit. However, given the time and costs associated with litigation, it is always logical to explore the possibility of reaching an extra-judicial resolution before initiating judicial or arbitration proceedings.

In pharmaceutical patent disputes under Law No 62/2011 (as amended), the patent owner must react to a marketing authorisation (MA) application or registration by initiating proceedings against the applicant within 30 days. This does not always give much time to the patent owner to contact the MA applicant and seek an amicable resolution to the dispute.

If the patent owner is the claimant, the patent registry should be checked to ensure the patent is correctly recorded with the name of the patent owner. This is important for purposes of legitimacy and standing. Likewise, the recordal of a patent licence is important if the claimant seeks to claim damages suffered by the licensee.

If the lawsuit is to be filed by the licensee, it is also required that the licence be recorded at the PTO.

As a general rule, the majority of lawsuits related to patent matters will require each party to retain legal counsel.

A few theoretical cases may fall outside this general rule if the value of the case is very low and no possibility of appeal would apply. In any case, given the complex and technical nature of the proceedings, even in these exceptional cases, professional legal representation is advised.

Portuguese judicial courts are able to grant interim injunctions on an inter partes or ex parte basis. It should be noted that such an injunction needs to be linked to a main action. The interim injunctions can be requested prior to the filing of the main action or during its pendency. 

The general criteria for an ex parte interim injunction are fumus boni iuris (prima facie evidence of the existence and validity of the right) and periculum in mora (irreparable harm or at least harm that could only be repaired with great difficulty unless urgent relief was given). The applicant must also convince the court that notification of the alleged infringer before the measures are enforced would run a serious risk of rendering them useless.

Inter partes interim injunctions are also possible and far more common. The criteria of fumus boni iuris and periculum in mora mentioned above are applicable for situations where the infringement is imminent, but not yet occurring. In cases where infringement is ongoing, the applicant need only show the existence of fumus boni iuris.

Protective briefs are not foreseen under Portuguese law. However, a bond can indeed be required to be posted by the patent owner/applicant of the interim injunction as a condition for the granting of the interim measure.

Often, the best course of action for the defendant to preventively protect itself against the risk of an interim injunction being granted against it is to file a pre-emptive invalidity action so as to weaken the fumus boni iuris criterion, assuming there are grounds for this.

An action to obtain a declaration of non-infringement could have the same purpose, but it is a strategy that is rarely adopted and carries with it several risks.

A judicial action that seeks to stop an imminent or ongoing infringement of a patent may be filed at any time while the industrial property right is in force. Likewise, injunctive relief may also be requested at any time. Under Portuguese law, it would be required to show periculum in mora in situations where the patent infringement is imminent, which would impose the filing of the interim injunction on an urgent basis, although not within a defined period of time. This requirement of periculum in mora does not need to be shown in cases where the infringement is ongoing.

If a judicial action seeks indemnification for damages suffered as a result of the infringement of a right, the limitation period is three years counting from the date when the injured party became aware of the right to indemnification.

If the infringement may also qualify as a crime – which would be the case in patent infringement – the limitation period will be defined under criminal law. Article 118 of the Portuguese Criminal Code sets the limitation period at five years for crimes that may imply prison sentences of over one year but less than five years.

Evidence gathering procedures have been foreseen in Portuguese intellectual property law since the transposition of the Enforcement Directive (Directive 2004/48/EC of the European Parliament and of the Council of 29 April 2004 on the enforcement of intellectual property rights) in 2008. These measures aim at obtaining evidence in the possession of the counterparty or from another party not connected to the case and can be requested prior to the filing of the court action or while it is ongoing (during the appropriate phase of the proceedings).

For patent infringement cases, these measures are foreseen in Articles 339 and 344 of the PIPC. 

In general terms, the procedure is commenced with an application to the competent court. In said application, the court must be provided with an indication of the specific evidence that the applicant wishes to obtain and the likelihood that it exists and is in the possession of the counterparty. It is also necessary to show the existence or threat of infringement of the patent right. In order to obtain financial and accounting documentation, the applicant must also show that the alleged infringement is occurring on a commercial level. In other words, the infringing acts have a direct or indirect commercial or economic goal.

The Portuguese civil procedure system is front-loaded, which means that the plaintiff will need to provide in detail all the facts that substantiate its claim and also attach all the documentary evidence with the initial pleadings. Article 552 of the Civil Procedure Code sets out a series of formal requirements in order for the initial pleadings to be considered correctly drafted and accepted by the secretariat of the court.

There are no special provisions for patent cases, with the exception of the indication of the competent court which, in cases of patent infringement or invalidation, will be the Intellectual Property Court. In relation to the rest, the plaintiff must follow the general rules of the Civil Procedure Code.

Although the proceedings are front-loaded, there are some (limited) opportunities for the parties to file additional submissions and documents at other stages of the proceedings, although with the risk of these being disregarded or being admitted subject to the payment of a fine.

If the defendant files a counterclaim, the plaintiff will be entitled to submitting a reply (“replica”).

Representative or collective actions (such as class actions) exist under Portuguese law and have been initiated in situations involving public health, quality of life, consumer protection, etc. Nothing is expressly foreseen in the class action law for intellectual property matters and there is no precedent of this type of action being used for patent cases.

The PIPC foresees a plethora of situations that limit or restrict the enforcement of a patent right, for example, private acts with no commercial purposes (Article 103, PIPC). Portuguese law also foresees the exhaustion of patent rights after the first authorised sale on the market (Article 104, PIPC).

A patent is also not considered to be enforceable against a third party that, in good faith, had reached the invention independently before the priority date of the patent and was using the invention or making serious preparations to do so (Article 105, PIPC).

Other legal defences, such as abuse of a right, are also generally foreseen under the law and may be invoked by a defendant in order to try and prevent a conviction for infringement.

Finally, the enforceability of patent rights must also co-exist with Portuguese and EU competition law. It is beyond the scope of this chapter to detail the aspects in which patent right enforcement may be incompatible with competition law, however, the same issues faced in other European jurisdictions would also be relevant in Portugal (eg, “pay for delay”).

Likewise, the matter of standard-essential patents (SEPs) and their licensing on fair, reasonable and non-discriminatory (FRAND) terms is also relevant in a discussion related to the enforcement restrictions faced by a patent owner in Portugal.

In a civil patent infringement action, there must be at least a plaintiff and a defendant. These are the necessary parties to file the infringement action. In criminal proceedings related to patent infringement, it is possible to file a complaint against unknown parties and it will be the Public Prosecution Office’s role to investigate and determine the suspected infringers.

Pursuant to Article 338 of the PIPC, a licensee is entitled to file an action for infringement, as well as to request interim measures and evidence gathering measures in patent infringement cases, unless the licence agreement stipulates otherwise. The licence agreement should, however, be recorded with the PTO.

The reform of the PIPC in 2018 clarified the issue of direct and indirect patent infringement, a topic which had raised curiosity amongst some patent law scholars.

Direct infringement is a situation in which the alleged infringer, without authorisation from the patent owner, carries out one of the infringing acts foreseen in the law (eg, manufacturing, offering for sale, storage, placement on the market or importation of a product or process that infringes a patent).

Indirect infringement covers cases in which a third party offers or makes available to another person the means for the latter to execute the invention. Article 102(3) makes it clear that this contributory infringer must know or should know that the means made available are suitable and aimed at the execution of the invention. A theoretical scenario would be if an entity prepared assembly kits with all the individual parts necessary to assemble an infringing product and sold them to a distributor. The kit itself does not fall in the scope of the patent claims, but the actions clearly contribute to the infringement by another party.

The remedies for direct and indirect infringement are those described in 1.5 Rights and Obligations of Owners of Intellectual Property Rights.

In accordance with Article 99 of the PIPC, if the patent covers a process for producing a new product, there is a reversal of the burden of proof, and the same product produced by third parties will be presumed to have been made through the patented process. This is a particularity of patent infringement proceedings.

The issue of parts of an allegedly infringing process being practised outside Portugal is an interesting one, since, as is well known, infringement will only occur when all the integers of the independent claims are present. Therefore, only when the various parts of the patented process are put together in Portugal will there be an infringement situation.

Similar to what occurs in other European jurisdictions, the scope of a patent under Portuguese law is defined by the patent claims, which should be interpreted, in the event of a lack of clarity, based on the content of the patent description and drawings.

Portuguese courts and other dispute resolution bodies (ie, arbitration tribunals) tend to follow the teachings of the Protocol on the Interpretation of Article 69 of the EPC, and, therefore, the doctrine of equivalence is accepted in Portuguese case law.

The role of the prosecution history may also be relevant in many cases, notably in terms of verification of added matter and the search for contradictory statements made by the applicant. However, it does not have the same weight as in some other jurisdictions, such as in US case law.

The most common defences in a patent infringement case are (i) arguments of non-infringement (ie, that the product or process does not fall in the scope of the patent), and (ii) the invalidity of the patent itself.

In some cases, there are other formal procedural defences also, such as lack of standing, statute of limitations, and incomprehensible pleadings.

Other patent specific defences – such as exhaustion of rights, compulsory licensing, FRAND licensing – are possible in certain cases but there is not much case law regarding these defences.

In complex patent cases, experts are frequently called upon to explain the scope of the invention and the technical aspects behind it. Expert reports are often prepared and filed regarding infringement, but also regarding issues such as novelty and inventive step.

The perspective of these experts is often important to provide the court with the opinion of a person skilled in the art.

It is more common for the parties to appoint experts to provide testimony as (expert) witnesses. However, the courts frequently appoint experts as well, when requested by the parties or when the court feels that it is essential to have a clear understanding of the technical matters being discussed.

Some judges also appoint a technical assistant to advise them directly.

There is no separate procedure for construing the terms of the patent’s claims. The claims are interpreted in the context of the judicial proceedings and in accordance with the normal reasoning described in 3.4 Scope of Protection for an Intellectual Property Right.

In Portuguese patent cases, the court may request an expert opinion or seek specific information from private or public entities (such as the PTO). However, this information and evidence is assessed freely by the court and the court will not seek a third-party opinion of what the judgment should be. Indeed, it is the court’s function to administer justice and this cannot be delegated to third parties.

A patent revocation action may be initiated as a reaction to a concrete infringement claim or it may be motivated by a wish to reduce the risk of such an infringement in the future (ie, to clear the path). In the first scenario, it is common for the revocation of the patent to be requested as a counterclaim in the infringement proceedings.

In order to request the revocation of a patent right, the requestor must demonstrate some legitimate interest in order to have standing. However, this legitimate interest need not be personal. Indeed, it would be possible, for example, for a software association to request the revocation of a software patent if it was believed that it was meritless and stifled competition in the sector as a whole.

Partial revocation of a patent or utility model is possible in situations where some claims are invalid and others remain patentable. Article 115(1) and (3) of the PIPC confirms this possibility.

Another scenario where it would be possible to obtain a partial revocation or cancellation would be if the invention is the result of the work of more than one person or entity and there is a dispute as to the ownership of the content included in the patent. The court may cancel some claims in these cases.

The amendment of a patent’s claims is possible in revocation proceedings, in accordance with Article 115(2) of the PIPC, provided the scope of protection is limited and not broadened.

The amendment request can be submitted directly to the court handling the case or, alternatively, pursuant to Article 102(8) of the PIPC, the patent owner may request the amendment to the PTO and then communicate said limitation to the court.

Unlike the German system, the Portuguese system concentrates patent revocation and infringement issues in the same proceedings and the same trial (assuming, however, that the revocation is raised as a counterclaim).

If the revocation of the patent is raised in separate proceedings before or at roughly the same time as the infringement action, the revocation action is generally seen as a preliminary matter that must be resolved before infringement can be assessed. Consequently, the infringement proceedings will typically be stayed until such time as the revocation action is definitively resolved.

Cases involving patent rights in civil, criminal and administrative proceedings follow the same general procedural rules that are applicable to other matters. By way of example, in civil proceedings, there will be an initial stage where the parties exchange briefs. This is followed by a preliminary hearing to deal with exception defence arguments and organise the trial.

There will be a single trial hearing (typically lasting for more than one day) where all the evidence will be produced and discussed. All parties will have the opportunity to produce witnesses to prove facts alleged by them and the witnesses will be subject to cross-examination. The witnesses may be technical experts or other witnesses that are relevant for providing evidence on other issues (eg, regarding damages).

The trial is concluded with final statements from the attorneys and the court will then typically adjourn and issue a written decision.

Similar to what occurs in civil proceedings involving other matters, if the damages cannot be determined at the same time as the decision on merits, there is the possibility of determining the precise amount of damages in a subsequent phase, known as the “liquidação” phase.

Notwithstanding the above, there are a few particularities that are specific to intellectual property cases, detailed below.

Evidence Gathering

One of the areas where there are specific procedural provisions in intellectual property cases is evidence gathering. These specific measures are a result of the transposition of the Enforcement Directive and take into consideration the specificities of intellectual property rights and the difficulties in obtaining and preserving evidence of infringement.

Preservation of Trade Secrets

Portuguese intellectual property law also contains specific procedural provisions aimed at preserving trade secrets in court proceedings and during trial. These consist, for example, in limiting the access to documents containing trade secrets, restricting the attendance of trials by third parties or access to transcripts and the redaction of judgments.

Preliminary Injunctions

Unlike the general civil procedure rules for the granting of a preliminary injunction, namely showing fumus boni iuris and periculum in mora, intellectual property infringement cases are special since there are specific provisions and there is no need to demonstrate periculum in mora when the infringement is ongoing. This facilitates the granting of interim measures to stop a patent infringement that is occurring at the time.

Patent related cases are decided by legal judges, although these may sometimes request to be assisted by a technical expert/assistant. A case heard at a first instance court (eg, the Intellectual Property Court) will be managed and directed by a single judge. If an appeal is filed to a second instance court, the judgment will be typically taken by three legal judges and that will also be the norm at the Supreme Court. In certain cases, it is possible to involve additional judges in the decision-making process.

Trial by jury only exists in very limited situations in criminal cases and is not applicable to patent infringement cases.

It should also be noted that the judges are selected randomly in accordance with the court system’s procedures. Consequently, it is not possible to influence who the decision-maker will be.

Forum-shopping is also not a possibility in Portugal since the Intellectual Property Court has jurisdiction over the entire territory.

Civil proceedings, including patent infringement civil proceedings, may always terminate as a result of a settlement amongst the parties.

At the preliminary hearing, the court will ask the parties if any settlement is possible as part of normal procedure. There are often situations where the court is informed that settlement is very likely and, consequently, at the request of the parties, suspends the proceedings until such time as the parties conclude their settlement.

There are mediation services in Portugal that litigating parties can resort to, albeit they are infrequently used.

The vast majority of patents that are in force in Portugal are European patents. Consequently, when litigation arises, it is not unusual for the disputes to be pan-European.

The existence of other court or patent office proceedings may, naturally, have an impact on current proceedings. The classic example in patent cases is the suspension of a patent infringement case while the revocation of the patent is being discussed in another proceeding. In Portugal, the staying of the infringement case may occur if the invalidation of the patent is being discussed in another Portuguese court or, in the case of European patents, if there are ongoing opposition proceedings at the EPO. As Portuguese courts are not bound to the decisions of other foreign courts, invalidation proceedings in other countries will not have the same impact, but the decisions may have some influence on the judge, particularly from experienced and well-respected courts in Germany, Netherlands and the UK.

Anti-suit injunctions in patent litigation, that have been popular in recent times in other jurisdictions, have not yet been tried and tested in Portugal and, therefore, it is unclear how a Portuguese court would react to such a request.

The Enforcement Directive was transposed into Portuguese law in 2008 and, therefore, the remedies that exist for the patentee in a patent infringement case are largely harmonised with those that exist in other EU jurisdictions.

In addition to the right to obtain a decision to cease the infringement, the patentee will typically be entitled to be indemnified for damages suffered. In civil procedures, these damages are determined in a main action and not in a preliminary injunction.

The general rule under Portuguese patent law is that the injured party is entitled to damages equivalent to the losses suffered and the patentee has the burden of proof in relation to those losses. The court should take into consideration the profit obtained by the infringer, the damages that resulted from the infringement, the lost profits suffered by the right-holder, as well as the expenses borne by the right-holder related to the protection of the IP right and the investigation and termination of the infringing activity. The court should also consider the moral damages to the injured party.

In the event that it is not possible to determine the value of the damages suffered by the injured party, the court may – provided the right-holder does not oppose such an approach – establish an equitable amount that takes into consideration, at least, (i) the income that the IP holder would have gained had the infringer requested a licence to use the intellectual property right, and (ii) the expenses incurred by the IP holder related to the protection of the IP right and the investigation and termination of the infringing activity.

Enhanced damages for wilful or repeated infringement are also foreseen in Article 347(6) of the PIPC. In this situation, the court may sum up all the different types of damages foreseen in the previous paragraphs of Article 347.

Although the provisions mentioned above do give the judge more flexibility than that which exists in many other types of civil proceedings, the fact remains that the judge does not have discretion in ordering remedies. Indeed, these must be requested by the plaintiff and the latter still has the burden of proof. Even in a regime of compensation through reasonable licence royalties, the plaintiff must consent to the judge applying such a methodology.

In addition to damages, the injured party may request auxiliary remedies/sanctions such as the seizure of equipment or the closure of premises.

A prevailing defendant in Portugal does not have many rights in comparison to other European jurisdictions. The prevailing defendant will be entitled to the reimbursement of court fees and expenses and a small compensation to cover attorneys’ fees.

If the issue of bad-faith litigation is raised by the defendant, it is possible that the plaintiff will be ordered to indemnify the former for some additional expenses. 

In the specific context of preliminary injunctions, the plaintiff may be ordered to pay compensation for the damages caused to the prevailing defendant in the event that the injunction is ultimately found to be unjustified or ceases to have effect as a result of the plaintiff’s conduct, or when it transpires that no infringement has occurred or if the risk of suffering irreparable or hardly reparable damage is considered unfounded, in all cases when the plaintiff acted with fault or abusively.

The types of remedies that are available in Portuguese patent law are the same as those that exist for other intellectual property rights, irrespective of whether they are technical IP rights.

A preliminary injunction may be requested at any time, including before the initiation of a main action. If a patent is found valid and infringed at first instance, the appeal of that decision will not normally have suspensive effect unless the losing party requests such a suspension and offers up a bond. It will be up to the court to assess the viability of staying the enforcement of the decision, pending appeal.

It is not common to request a preliminary injunction after the first instance decision confirming the validity of the patent and its infringement. When no suspensive effect is granted to the appeal and the defendant does not voluntarily comply with the first instance orders, it is more frequent for the patent owner to initiate proceedings aimed at enforcing those orders (“processo executivo”).

There are no special provisions concerning the appellate procedure for patent infringement and validity proceedings. It should be noted, however, that Article 45(3) of the PIPC stipulates that in appeals related to decisions of the PTO, it is not possible to appeal against second instance court judgments (save in exceptional cases where such appeals are always possible).

An appeal to the second instance court will generally imply a full review of the facts of the case (although the scope of the appeal is defined by the parties) and, on occasion, this court will order the first instance court to repeat part of the trial in order to produce additional evidence.

The Supreme Court of Justice is reserved for legal reviews and the Constitutional Court will only assess the constitutionality of legal provisions.

As described in 2.5 Prerequisites to Filing a Lawsuit, there are no requirements in Portugal regarding warning letters, protective briefs and other such measures. However, it is fairly common to send one or more cease and desist letters through lawyers and this will, evidently, have some costs.

Furthermore, the investigation and preparation of the lawsuit also represents costs for the plaintiff. Often, this is one of the most expensive stages of the proceedings, since it is necessary to collect, analyse and organise a great deal of evidence. Portuguese proceedings are front-loaded and, therefore, a considerable amount of time and effort is dedicated to the phase prior to filing a lawsuit.

The court fees that must be paid for commencing proceedings are based on the value of the case (eg, on the amount of damages being claimed).

Portuguese procedural law stipulates that the value of intangible rights, for civil law cases, is fixed at EUR30,000.01 when no other criteria is applicable. This value allows the case to be appealable to the higher courts.

In a patent revocation case and other proceedings not related to the indemnification of damages, it will be customary to use this amount as the value of the case.

The court fees that must be paid to file the lawsuit are determined in accordance with the provisions of the Regulation on Procedural Costs (Regulamento de Custas Processuais).

In a judicial court scenario, the winning party is entitled to recoup the court costs and other expenses, as well as a contribution towards its legal fees (ie, attorneys’ fees).

This contribution is calculated based on the outcome of the litigation (if it was a full victory or a partial one) and the amount of court costs that were paid by the parties. In practice, the contribution tends to be a fairly symbolic amount compared to the actual legal costs that each party has to bear with the litigation.

The use of alternative dispute resolution proceedings to settle patent disputes (particularly, arbitration proceedings) is no longer common in Portugal, after a period (2012–18) in which it was mandatory for pharmaceutical patent infringement cases, pursuant to Law No 62/2011 of 12 December 2011.

Currently, arbitration is only mandatory for disputes between employee-inventors and the employer, in order to determine the remuneration due for the invention assigned automatically to the employer.

As mentioned in 1.8 Remedies against Refusal to Grant an Intellectual Property Right, Portugal has a fixed arbitration centre specialised in intellectual property matters called ARBITRARE which was established in 2008. The PTO is bound to this arbitration centre.

In terms of patents, ARBITRARE is used more frequently by parties wishing to appeal decisions of the PTO, including the refusal of patent applications. The applicant must file the appeal against the decision within two months of the publication of said decision in the IP Bulletin. Following this, typically a single arbitrator is appointed to conduct the proceedings in accordance with a pre-established arbitration centre regulation. The decision of the arbitrator has the same value as that of a first instance court.

With the exception of the disputes above, solely between the PTO and a private entity, all other disputes that involve other opposing parties require the consent of all for the arbitration to be valid and to proceed.

Under Portuguese law, the assignment of a patent must be subject to a written agreement that identifies the parties (assignor and assignee), the patent, whether the assignment is total or partial and whether it is for a consideration or not.

In order for the assignment to be applicable vis-à-vis third parties, it must be recorded at the PTO. If the agreement is not in Portuguese, a translation must also be submitted.

If the recordal of the assignment is requested by the assignor, there must be documentary proof of the acceptance of the assignment by the assignee.

The PTO will assess if all the requirements are met and, if so, will approve and publish the recordal.

The procedure for assigning a patent or utility model in Portugal is fairly straightforward. Please see 10.1 Requirements or Restrictions for Assignment of Intellectual Property Rights regarding the requirements of the assignment agreement.

Once the assignment agreement has been executed, and, if applicable, a translation has been prepared, the interested party must file a recordal application with the PTO and pay the respective fees.

Upon approval, the PTO will publish a notice of the assignment and send the applicant a confirmation letter.

Under Portuguese law, the licensing of a patent or utility model must also be subject to a written agreement (under pain of being considered invalid) and should identify if the rights granted are total or partial, if the licence is for consideration or not, what geographic territories are covered and if it is for the duration of the IP right or another time frame.

The licence should also deal with the issue of exclusivity. Under Portuguese law, if the agreement is silent regarding exclusivity, it will be assumed that the licence is non-exclusive. If the parties agree to absolute full exclusivity, in the sense that even the patent owner is excluded from using the patented rights, then that circumstance should be expressly foreseen. Finally, if sublicensing is permitted, then this should also be expressly contemplated in the agreement.

A licence agreement may not be assigned to a third party without the written consent of the patent owner.

The licensing of a patent application is possible under Portuguese law, with the caveat that, in the event that the application is refused, the licence will automatically lapse.

The procedure for recording a patent or utility model licence in Portugal is similar to that described in 10.2 Procedure for Assigning an Intellectual Property Right.

Once the licence agreement has been executed, and, if applicable, a translation has been prepared, the interested party must file a recordal application with the Portuguese PTO and pay the respective fees.

Upon approval, the Portuguese PTO will publish a notice of the licence in the IP Bulletin and send the applicant a confirmation letter.

Morais Leitão, Galvão Teles, Soares da Silva & Associados

Rua Castilho, 165
1070-050 Lisboa
Portugal

+351 21 381 74 00

+351 21 381 74 99

mlgtslisboa@mlgts.pt www.mlgts.pt
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Trends and Developments


Authors



Abreu Advogados is an independent law firm with over 28 years of experience in the Portuguese market, and is present in ten locations. As a full-service law firm, Abreu is one of the largest law firms in Portugal, working with the most prestigious law firms in the world in cross-border projects. Universally recognised as market leaders in IP (notably in patent and trade mark litigation), Abreu’s team has a comprehensive approach to the clients’ commercial requirements, including industrial property rights, copyright protection, enforcement (ie, administrative and court litigation), arbitration, as well as drafting and revision of IP licensing and contracts. Abreu has represented world-renowned pharmaceutical companies on lawsuits related to patent and SPC infringement and invalidity, as well as judicial appeals before the IP Court and Court of Appeals against the refusal of SPCs. The team is also experienced in trade mark and designs litigation, notably for famous and well-known brands.

Introduction

The year 2022 was a challenging one regarding patent litigation, despite the fact that, as in 2021, the number of judicial and arbitration cases was not that high. In fact, contrary to 2012-2017 – where hundreds of arbitral actions were filed and judged – and since Law 62/2011 of 12 December was amended by the current Industrial Property Code (2018), the number of patent cases has significantly decreased.

The reason is quite simple: there was a mandatory arbitration system in place, which established that in disputes between pharmaceutical patents and generic drugs, the publication of a marketing authorisation application for a generic medicine triggered a legal term of 30 days for the patent holder to file an arbitration proceeding. Of course this caused a massive surge in patent litigation in Portugal until the end of 2017.

The amendment of Law 62/2011 saw the establishment of voluntary arbitration instead of mandatory arbitration. Since January 2018, the triggering of the 30-day legal term to file a voluntary arbitration proceeding implies the agreement of the parties to submit the dispute before an arbitral tribunal – or in a case where there is no agreement on that question, the patent holder must file a legal action before the Intellectual Property (IP) Court. Considering that usually there is no agreement between the parties to follow the arbitration route, patent litigation cases are filed in the Estate Court and this means a decrease in patent litigation cases in Portugal in pharma and biotech patents and generic medicines.

It is also noted that the law change has meant a considerable number of agreements between pharma originator companies (patent holders) and generic companies, with a view to avoiding the costs and slowness of legal proceedings.

In relation to other patents – eg, mechanical patents or utility models – the number of cases in Portugal during 2022 was also not significant.

What follows is an analysis of (i) patent litigation cases, (ii) Supplementary Protection Certificates (SPCs) and (iii) the trends in Information Technology (IT) and trade secrets litigation.

Patent Cases

Although, as mentioned previously, the number of patent litigation cases was not high in 2022, there were a couple of interesting proceedings regarding the enforcement of pharma and biotech patents, as well as cases related to patented medical devices.

Specifically, Abreu Advogados represented pharma companies in legal proceedings where the discussion of classical matters like literal infringement, infringement by equivalence, novelty, inventiveness and sufficiency took place.

There is a tendency of the IP Court to assess sufficiency in a much more in-depth way than it did in previous years.

The judgments on infringement by equivalence are also increasingly addressed with a much better technical approach.

In addition, the IP Court is increasing the assessment of infringement and validity within expert evidence, which is normally requested by the parties or ordered by the court on an ex officio basis.

Abreu Advogados has also been involved in very interesting cases dealing with patented medical devices, one of which is still pending.

In these cases, the discussions on the inventiveness of the enforced patents are concentrated on the problem/solution approach following the European Patent Office’s (EPO’s) Boards of Appeal case law.

Appeals before the Court of Appeal of Lisbon regarding decisions of the IP Court are also being argued, and some of them are still pending.

In two different rulings, the courts declared that if the second active principle is directly identified or is identified under a functional formula in the claims of the basic patent, then Article 3(c) of the EU Regulation No 469/2009 should be interpreted in the sense that the combined product is eligible for a second SPC. This is because the new combined product defined under Articles 1(b) and (c), resulting from the association of two active principles, is protected in the basic patent and has not yet per se benefitted from an SPC.

As for the rest, the IP Court still usually dismisses legal actions based on the view that a marketing authorisation application, and even the grant of a marketing authorisation to a generic company for a product whose origin is patent-protected, does not represent patent infringement.

In preliminary injunctions, if there is no actual launch onto the market of a generic product that infringes a patent, the patent holder must evidence irreparable harm within the legal concept of periculum in mora.

On the contrary, if the generic is launched onto the market, the patent holder should only evidence the existence of the patent right and the infringement, which is what the Enforcement Directive expressly states.

As for the mandatory legal action before the IP Court under Law 62/2011 – if no voluntary arbitration is agreed by the parties – the jurisprudence of the Court of Appeal of Lisbon remains stable regarding the legal standing and procedural interest of a patent holder in filing such action. In other words, there is an explicit procedural interest of the patent holder in filing this specific legal action to legitimately enforce its patent rights.

In a decision rendered by the Court of Appeal of Lisbon on 18 May 2022, the court was very clear:

In the light of the ratio legis of Law No 62/2011, that provision must be interpreted in the sense that it does not prevent the filing of a lawsuit against a generics manufacturer based on an imminent or current violation of an industrial property right after the period set therein has elapsed, provided that the patent is in force. Otherwise, a new patent expiry date would have been created in the Portuguese legal order, which neither the Industrial Property Code nor the international conventions to which Portugal is bound in this matter to provide or consent; and which would, moreover, be of strongly questionable compatibility with the provisions of Articles 42 and 62 of the Constitution, which protect, respectively, intellectual rights and private property.

[...]

The submission of an application for authorisation to market a generic medicinal product is, therefore, sufficient for holders of intellectual property rights (eg, patents) on the active substance of the medicinal product to have an interest in acting, requesting that the applicant for authorisation is ordered to refrain from manufacturing, marketing, storing or exporting medicinal products.

And so, it is concluded that the general criterion for assessing the procedural interest the violation of a right or the existence of a dispute is derogated by Article 3 of Law No 62/2011, of 12 December namely, in the wording of Decree-Law No 110/2018, of 10 September in derogation from the general rules, the holders of [intellectual property] rights do not need to justify resorting to action based on an infringement, current or imminent, or to demonstrate an interest in acting.

It is, therefore, sufficient the publication, on the Infarmed website, of a request for [marketing authorisation] (or registration) for a generic medicine so that the holders of the patents of the reference medicines can propose the action.

In addition, a recent decision from the Supreme Court of Justice on 15 September 2022, should be highlighted, which is a very comprehensive decision regarding all the issues that have been discussed in relation to the matters at stake.

“Regarding the question that matters to be considered, we have that this Supreme Court of Justice (SCJ) has taken a consistent orientation in the sense of recognising the interest in acting to the plaintiffs with recognised industrial property rights, resulting from a patent, in the face of a request for a marketing authorisation, however publicised, from which we will closely follow a recent statement that, in a clear and well-structured way, highlights the jurisprudential orientation adopted.

Thus, in the judgment of this SCJ, handed down on 21 April 2022, within the scope of Process No 40/20.3YHLSB.L1.S1, it was understood, and this Collective Court supports, that the holders of IP may propose the special action provided for in Article 3 of Law No 62/2011, of 12 December, in the wording of Decree-Law No 110/2018, of 10 September, in view of the publication of a simple request for a marketing authorisation, gleaning from this paragraph: As for the matter of the defendants appeal involving the assumption of procedural interest, even if this is not included in the Code of Civil Procedure, it is admitted and recognised by case law.

[...]

This requirement of interest in acting being fulfilled when, in relation to the plaintiff, the situation of need, in which he finds himself, requires the intervention of the courts […] hand of the process or to make the action proceed but no more than that’– Antunes Varela/José Miguel Bezerra/Sampaio e Nora, op. cit. p.180 and 181 – it follows from this that the claimant of a conviction action will only have a procedural interest as long as he alleges the violation of his right – cfr Manuel de Andrade, Elementary notions of civil procedure, p.80 or by Antunes Varela/José Miguel Bezerra/Sampaio e Nora, op. cit. p.182.

[...]

Law No 62/2011, of 12-12, when introducing amendments to the Medicines Statute, also added an Article 23-A, in which it is expressly stated that the request that aims to obtain inclusion of the medicine in the co-payment cannot be rejected based on the existence of any industrial property rights, and that the decision to be taken on the inclusion or exclusion of medication in the reimbursement is not intended to assess the existence of any industrial property rights.

[...]

In tune with this understanding also the decision of the SCJ of 5-17-2018, in proc. 889/17.4YRLSB.S1 repeats that [the] grant of [a marketing authorisation] for a generic does not constitute, in itself, a violation of the industrial property right arising from the patent of the reference medicine, not being included, for therefore, in none of the actions prohibited by the provisions of Article 101.º, No 2, of the Industrial Property Code (text of Article 102 of the new Industrial Property Code, approved by Decree-Law No 110/2018).

[...]

As already stated in the decision of SCJ of 8-4-2021 in proc. 219/19.0YHLSB.L1.S1 of which the here rapporteur was a subscriber and whose understanding was replicated in ac. STJ of 9 December 2021, in proc. 225/20.2YHLSB-A.S1, of which the rapporteur here was rapporteur there being a condemnation action at stake, such as the one proposed by the plaintiffs against the defendants, the question that arises as an alternative is to know whether ’the presentation of a marketing authorisation application for a generic medicine is sufficient for the holders of intellectual property rights (eg, patents) on the active substance of the medicine to have an interest in acting, requesting that the authorisation applicant is condemned to abstain from the manufacture, marketing, storage or export of medicinal products or if the presentation of an application for authorisation to market a generic medicinal product is not sufficient for holders of intellectual property rights to on the active substance of the medicine are interested in acting, making it necessary that the applicant has started or is about to start manufacturing, marketing, storage to, or the export of medicines.

In this context, the important thing is to find out whether the general criterion for assessing the procedural interest mentioned above is derogated by Article 3 of Law No 62/2011, of 12 December, in the wording of Decree-Law No 110/2018, of 10 September.

[...]

In this regard, it is enunciated in decision of the SCJ of 8-4-2021 that we follow [The] text of Article 3 of Law No 62/2011, of 12 December, in the wording of Decree-Law No 110/2018, of 10 September, is compatible with two interpretations: the first in the sense that it prevents holders to invoke their IP rights after the expiry of a period of 30 days counting from the publication on the Infarmed website of the application for authorisation to market a generic medicine; the second in the sense that it does not prevent or, in any case, does not absolutely prevent holders from invoking their rights after the 30-day period has elapsed.

The preference for the first interpretation would determine one of two things – either that the procedural interest would be waived or, even if the procedural interest was not waived, that the application for a marketing authorisation would have as an automatic, immediate and necessary effect the need reasonable, justified, well-founded, to resort to the process.

In any case, the first interpretation, in the absolute, rigid terms in which it is stated, would cause insurmountable or almost insurmountable difficulties as they concluded; eg, the judgment of the Constitutional Court No 123/2015, of 7 July 2015[11], the judgment of the SCJ of 7 December 2016, handed down in case No 554/15.7YRLSB.L1.S1 or the judgments of the Constitutional Court No 187/2018, of 10 April 2018, and No 496/2018, of 10 October 2018.

Concretising: the decision of Constitutional Court No 123/2015 deemed unconstitutional the normative dimension resulting from Article 3, paragraph 1, in conjunction with Article 2 of Law No 62/2011, of 12 December, according to which the holder of an industrial property right may not sue the holder of the marketing authorisation or the applicant for a marketing authorisation beyond the period of 30 days, counting from the publication by Infarmed referred to in Article 9, paragraph 3, of the same Law, for violation of Article 20, paragraphs 1 and 5, of the Constitution of the Portuguese Republic.

[...]

On the other hand, the preference for the second interpretation, which does not prevent or does not at all prevent holders from invoking their rights after the 30-day period has elapsed is compatible with two solutions: the first in the sense that the special action provided for in Article 3 of Law No 62/2011 may be proposed as long as an application for authorisation to market a generic drug is published on the Infarmed website – advocated Evaristo Mendes, Patents for medicines. Arbitration required. Jurisprudence commentary. Precedent of Law No 62/2011, in: Intellectual Properties, No 4-2015.

In favour of the second term of the alternative, it is argued that holders of intellectual property rights need continue to need to justify recourse to action based on an infringement, current or imminent, and to demonstrate an interest in taking action. The presumption of interest in bringing an action could not be fulfilled by the allegation by the plaintiff that there is, on the part of the defendant, the intention to market the drugs for which he requested marketing authorisations, above all, when the court is faced with the peremptory assertion of the defendant, who has not challenged the claimants right nor has he been accused of having violated it, that he does not intend to commercialise the generic in question before the expiry or invalidation of the patent.

Violation, or the threat of violation, of the applicants IP rights would always be necessary because the non-existence of the legal obligation to initiate an arbitration action whenever the application for marketing authorisation for a generic drug is publicised and because the mere formulation of such a request does not, in itself, generate any infringement or threat of infringement of the patent relating to a pharmaceutical compound used in the production of medicines it would determine that there is no interest in acting by the holder of that patent in an action in which the abstention of infringement is petitioned of the rights arising from the same and the prohibition of alienation of the marketing authorisation to third parties, to the exclusion of other circumstances that point to the likelihood of the prediction of the violation of a right.

[...]

Having exposed the issue in its argumentative terms and consequences, we accept, as we have already done in the transcribed judgment and in the one of 9 December 2021 in proc. 225/20.2YHLSB-A.S1 of which the rapporteur here was rapporteur there that Article 3 of Law No 62/2011, of 12 December, is essentially in favour of holders of IP rights not needing to justify recourse to action based on an infringement, current or imminent, or to demonstrate an interest to act, being sufficient to publish, on the Infarmed website, a request for marketing authorisation (or registration) for a generic drug. It is not required that the interested party who intends to invoke his industrial property right under the terms of the previous article must do so before the IP Court, being able to do so there (at the IP Court) but also before an institutionalised arbitral tribunal or before a non-institutionalised arbitral tribunal.

[...]

In short, the process provided for in Article 3 of Law No 62/2011, of 12 December, sets up a special process for settling rights that is likely to be triggered by the publication of a simple application for marketing authorisation (at which time there will be no in principle, any infringement or imminent threat of infringement of industrial property rights), allows the holders of rights to establish it or not, depending on their interest in it. And can such a procedure be initiated within a period of one month from this publication, because this fits the logic of a quick process, intended to end, ideally, before there is an Infarmed decision on the application for marketing authorisation.

[...]

It was decided and an attempt was made to explain that the general criterion for assessing the procedural interest, dependent on the concrete allegation of violation of the invoked right, is derogated by Article 3 of Law No 62/2011 (in the wording of Decree-Law No 110/2018, of 10 September) which accepts the exceptional possibility that holders of IP rights do not need to justify the recourse to action based on an infringement, current or imminent, it being sufficient to publish, on the Infarmed website, an application for marketing authorisation (or registration) for a generic drug. However, this understanding, in deviation from the aforementioned general rule, is admitted because, in the absence of any concrete violation of the authors rights, the existence/publication of the marketing authorisation application comprises, in the interpretative economy of the observed precepts, relevant objective reasons for, even in this case, grant protection of interest to the claim of the plaintiffs. Even if there is no violation of the invoked right, there is an marketing authorisation publication request and it is this existence and what it means that determines the configuration of the interest in acting.”

SPC Cases

In what concerns SPC litigation, the pending cases are still focused on the fulfilment of the legal requirements established by Article 3(a) and (c) of EU Regulation No 469/2009.

In this regard, the tendency of the IP Court and Court of Appeal of Lisbon remains to follow the European Court of Justice (ECJ).

The IP Court has decided that a product protected by an SPC is protected in the basic patent (i) where the active principle is claimed in the basic patent and (ii) where the active principle is not directly claimed in the basic patent, but the functional definition formulae of the claims, interpreted in light of the description of the basic patent, implicitly contain and necessarily identify the active principle in a specific form.

In addition, a very important decision from the Court of Appeal of Lisbon granted an SPC based on the following assumptions:

“If it is demonstrated that a non-active principle (excipient) – combined with an active principle – produces a pharmacologic, immunologic or metabolic effect per se covered by the therapeutic indications contained in the marketing authorisation.

An excipient can be included in the definition of the product established by Articles 1(b) and 3(a) of EU Regulation 469/2009 in the case that the excipient of a pharmaceutical product per se has therapeutic efficacy on its own covered in the marketing authorisation.”

This is a landmark judgment not only because it overturned the refusal to grant an SPC decision from the Patent Office and the IP Court decision rendered in an appeal, but also because it is believed that it was the first grant of an SPC in the EU in the particular circumstances.

The Trend of IT and Trade Secrets Litigation

In Portugal, there has been an increase in litigation regarding patents in the field of telecommunications and IT.

Furthermore, so-called computer-implemented inventions are also subject to a large number of litigation cases, also involving copyright issues.

Software in general is not patentable in Portugal, however if the software has a technical contribution which is novel, inventive and has industrial applicability, it can be protected by a patent. The computer-implemented inventions are thus software patents and this area is being quite well developed in Portugal, notably through a large number of start-ups.

Following this notable development, it is inevitable that disputes over software patents are increasing. 

Trade secrets is also an area where there are some legal disputes and it is believed that these will increase.

Outlook for 2023

It is expected that the trend of more judicial litigation regarding (i) patented medical devices, (ii) IT, TMT patents and computer-implemented inventions and (iii) trade secrets, will continue in 2023.

Legal questions related to the scope and extension of protection through SPCs shall also be ongoing.

Substantial changes to the technical and legal approach are not expected from the IP Court and Court of Appeal of Lisbon.     

The impact of the Unified Patent Court is crucial to be assessed.

Abreu Advogados

Av. Infante D. Henrique, 26
1149-096 Lisboa
Portugal

+351 21 723 18 00

+351 21 723 18 99

lisboa@abreuadvogados.com www.abreuadvogados.com
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Law and Practice

Authors



Morais Leitão, Galvão Teles, Soares da Silva & Associados (Morais Leitão) is a leading full-service law firm in Portugal, with decades of litigation experience. Broadly recognised, Morais Leitão’s reputation amongst both peers and clients stems from the excellence of the legal services provided in a variety of sectors. The firm’s work is characterised by a technical expertise, combined with a distinctive approach and cutting-edge solutions that often challenge conventional practice. With over 250 lawyers at a client’s disposal, Morais Leitão is headquartered in Lisbon with additional offices in Porto and Funchal. Due to its network of associations and alliances with local firms and the creation of the Morais Leitão Legal Circle in 2010, the firm can also offer support through offices in Angola (ALC Advogados), Mozambique (MDR Advogados) and Cabo Verde (VPQ Advogados).

Trends and Developments

Authors



Abreu Advogados is an independent law firm with over 28 years of experience in the Portuguese market, and is present in ten locations. As a full-service law firm, Abreu is one of the largest law firms in Portugal, working with the most prestigious law firms in the world in cross-border projects. Universally recognised as market leaders in IP (notably in patent and trade mark litigation), Abreu’s team has a comprehensive approach to the clients’ commercial requirements, including industrial property rights, copyright protection, enforcement (ie, administrative and court litigation), arbitration, as well as drafting and revision of IP licensing and contracts. Abreu has represented world-renowned pharmaceutical companies on lawsuits related to patent and SPC infringement and invalidity, as well as judicial appeals before the IP Court and Court of Appeals against the refusal of SPCs. The team is also experienced in trade mark and designs litigation, notably for famous and well-known brands.

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