I. INTRODUCTION
During the last decades in Portugal, the judgment on Imminent Infringement of pharmaceutical or biotech patents involves several analysis and interpretations and outcomes from the Courts. In fact, long and complex discussions have occurred in National Courts and the Unified Patent Court (UPC).
The basic question is whether some authorizations from the competent health administrative bodies such as generic or other medicines Marketing Authorizations (MA´s), price approvals and reimbursements may fall within the concept of imminent infringement of pharmaceutical patents.
The holders of those patents corresponding to reference medicines quite often try to avoid the launch onto the market of generic medicines related to reference medicines which infringe the same patents. The available routes to that goal are (i) an extra-judicial or judicial agreement to achieve it, (ii) a judicial action before the courts, (iii) an arbitral action or (iv) a criminal proceeding.
From the 80’s decade until 2012, few cases have been filed before the courts notably because of the lack of an administrative process for the marketing of medicines and the quite low number of judicial cases regarding pharmaceutical patents enforcement.
In the 90´s and 20´s some cases have been decided in preliminary injunctions of enforcement of pharmaceutical patents, but the tendency was to reject them based on the inexistence of imminent infringement within the legal criteria of periculum in mora.
For the first time, a single decision rendered by the Court of Commerce of Lisbon in 2010 has granted injunctions to inhibit the commercialization of generic medicines considering the administrative acts of INFARMED – the Portuguese body regarding the medicine marketing authorizations – as facts conducting to an imminent patent infringement.
The present article aims to better understand the Imminent Infringement in Pharmaceutical Patent Litigation considering the regulatory and judicial (or arbitral) perspective.
II. THE REGULATORY PERSPECTIVE
The regulatory pathway to the market for a medicinal product comprises several steps and procedures that must be followed prior to its effective commercialisation to patients and healthcare services.
These steps are clearly defined within EU and national legal frameworks, which contain an exhaustive description of the requirements, procedures, and formalities upon which the regulatory authority’s grant of an MA for a given medicinal product depends. Naturally, given the nature of medicinal products, this process is highly demanding, complex, and time-consuming.
Notwithstanding that the law provides for certain exceptions – justified, inter alia, by the different types of medicines and their respective regulatory status – it is fair to say that the procedures are fundamentally similar for all medicinal products.
These procedures are, as expected, of a legal-administrative nature. Throughout them, the regulatory authority assesses the quality, safety, and efficacy of the medicinal product, thereby ensuring its suitability for entry into the EU market.
All formalities associated with obtaining a marketing authorisation culminate, once all substantive and procedural requirements have been successfully met, in the granting of an MA to the applicant. From a territorial perspective, these procedures may cover all Member States of the European Union, only some of them, or a single Member State.
Procedures aimed at placing a medicinal product on the market may also pursue different objectives, depending on the intention of the MA holder: whether the product is to be marketed exclusively for outpatient use, also for hospital use, or whether the holder intends to obtain State reimbursement for its price. Depending on these choices, the administrative procedures to be followed by the applicant will vary.
The common denominator of all these authorisations is that they must be obtained prior to the effective marketing or availability of the medicinal product. It is therefore not legally permissible to place a medicinal product on the market before obtaining one of the authorisations provided for by law, whether a standard MA or any other authorisation provided under the applicable legal framework, such as the authorisation for exceptional use.
In addition to market access authorisations strictu sensu, State financing authorisations are also relevant. Although these do not constitute marketing authorisations, since medicinal products may be placed on the market without State reimbursement or without being procured by the hospitals of the National Health Service (SNS), they are closely linked to them. These authorisations concern economic and financial conditions, depending on whether the MA holder intends to obtain State reimbursement for an outpatient product or, in the case of hospital-only medicines, the conditions under which such products may be purchased by entities under the supervision of the Ministry of Health, in particular hospitals integrated into the SNS.
These authorisations arise from the need, on the one hand, to ensure patient access to safe, effective, and high-quality medicines and, on the other hand, to safeguard the financial sustainability of the SNS through the rationalisation of expenditure.
For this reason, the legislature has established, in addition to market access authorisations, specific procedures primarily focused on the economic and financial aspects of medicinal products, namely the conditions under which they may be reimbursed in community pharmacies or procured by SNS hospitals.
The pricing regime applicable to medicinal products in Portugal is set out in Decree-Law No. 97/2015 of 1 June, which establishes the National System for the Assessment of Health Technologies (SiNATS). Together with its implementing Ministerial Orders, it lays down the rules governing the pricing of medicinal products and other health technologies (e.g. medical devices) and their funding by the State.
As said, the law establishes mechanisms to ensure that public expenditure on medicines remains within reasonable limits. Among these mechanisms, in the outpatient market, particular relevance is given to the maximum price regime applicable to reimbursed prescription medicines, to medicines for which reimbursement has been requested, and to reimbursed over-the-counter medicines. This regime sets a price ceiling that cannot be exceeded by the MA holder, without prejudice to the possibility of setting a lower price.
Regarding the SNS hospital market, the law has established a prior evaluation procedure, the completion of which constitutes, save for a few very specific circumstances, a sine qua non condition for the supply of medicines to SNS hospitals.
Given the subject of the present analysis, we will focus on this specific instrument.
A. THE PRIOR EVALUATION OF MEDICINAL PRODUCTS
The prior evaluation of medicinal products is governed by SiNATS and by Ministerial Order No. 195-A/2015 of 30 June, which establishes the procedural framework for applications for reimbursement and prior evaluation of medicinal products.
Under the applicable rules, prescription-only medicines intended to be purchased by SNS hospitals are subject to prior evaluation. Likewise, non-prescription medicines may also be subject to prior evaluation where they have a significant volume of sales to SNS hospitals.
The prior evaluation procedure is structured around two fundamental criteria. On the one hand, a technoscientific criterion, under which the therapeutic innovation or therapeutic equivalence of the medicinal product is assessed for the claimed indications. On the other hand, an economic criterion, intended to demonstrate its economic advantage compared to existing alternatives on the market. Among these, the technoscientific criterion is predominant, as the economic evaluation is only carried out where the technoscientific assessment is favourable.
As side note, the prior evaluation of medicinal products follows the framework established by Council Directive 89/105/EEC of 21 December 1988, which lays down rules to ensure transparency in systems for pricing and reimbursement of medicinal products in the Member States of the European Union, ensuring that decisions in this regard are transparent, objective, and verifiable. Reference should also be made to Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on health technology assessment, which complements Directive 89/105/EEC and focuses particularly on the scientific and clinical evaluation of medicinal products.
B. PRIOR EVALUATION CONTRACTS
SiNATS provides that the evaluation of health technologies constitutes the basis for, inter alia, decisions – through prior evaluation – on the acquisition of medicinal products by SNS hospitals. It further establishes that such acquisitions are to be carried out through the conclusion of a contract or by means of an administrative act.
Accordingly, the acquisition of medicinal products by SNS hospitals must be formalised between Infarmed – National Authority of Medicines and Health Products, I.P. (Infarmed), and the MA holder. These contracts must be authorised by the member of the Government responsible for health, who may delegate this power to the Board of Directors of Infarmed.
These instruments, referred to as prior evaluation contracts, must define the terms under which the medicinal products concerned are to be acquired by SNS hospitals. The legislature has set out, in considerable detail, the elements and conditions that such contracts must include.
Under the applicable law, prior evaluation contracts must contain several mandatory elements, without prejudice to the possibility of the parties adding further clauses, provided that these do not substantially alter the nature of the contract. Naturally, the MA holder’s discretion in negotiating contractual terms is limited and, in most cases, confined to accepting the conditions proposed by Infarmed.
Once the prior evaluation phase has been successfully completed, the prior evaluation contract is concluded between the MA holder and Infarmed, establishing the terms and conditions under which the medicinal product will be purchased by SNS hospitals. Additionally, Infarmed must notify the pharmacy and therapeutics committees of SNS hospitals of the conclusion of the contract, informing them that the medicinal product is available for procurement.
Following these steps, the MA holder is only required to notify Infarmed of the commencement of commercialisation of the medicinal product subject to prior evaluation, which must take place on the first day of a given month. This notification must be submitted between the 1st and the 15th day of the month immediately preceding the start of commercialisation.
As noted, once a favourable decision has been issued in the prior evaluation procedure and the corresponding contract has been concluded, the mandatory administrative steps enabling the MA holder to supply medicinal products to SNS hospitals are completed. Indeed, following such a decision and its communication to SNS hospitals, no further regulatory barriers prevent the commencement of marketing.
Although the MA holder is required to notify Infarmed of the start of commercialisation, this requirement should be understood as a mere communication obligation rather than a regulatory approval step. In response to such notification, Infarmed cannot oppose the commencement of commercialisation, having already adopted a favourable decision in the prior evaluation procedure.
Accordingly, the process is deemed complete, and the commencement of commercialisation depends solely on a discretionary decision of the MA holder.
III. THE JUDICIAL (and ARBITRAL) PERSPECTIVE – NATIONAL EXPERIENCE
The explained regulatory regime should be now linked to the patent enforcement before the courts.
The basic question is whether the administrative authorizations aiming the commercialization of generic products can be understood as situations of imminent infringement of patents.
A historical review can be helpful to have a full picture of the matters at stake.
During the 80´s in Portugal the patent litigation cases before the courts were relatively rare.
In the 90´s and 2000´s the Court of Commerce of Lisbon dealt with some judicial actions of enforcement of pharma patents and the jurisprudence began to be interesting from the patent law view.
In face of administrative acts from the regulatory administrative body (INFARMED) authorizing Marketing Authorizations for generic medicines, patent holders filed several actions before the Administrative Courts and globally the results were positive to them in the sense of preventing and ceasing the commercialization of those generics which infringed patents.
But several constitutional legal issues were raised, and the “famous” EU Sector Inquiry has paid attention to the alleged blocking of generic medicines in the Portuguese market.
In 2011, Decree-Law 62/2011, marked the initiation of a new era in pharma litigation with the establishment of a mandatory arbitral system.
Basically, the new regime was based on the publication of MA’s applications of generic medicines and the legal trigger to start an arbitral action in a scarce period of 30 days upon such publication on INFARMED’s website.
With this mandatory arbitration system hundreds of arbitral actions were filed and judged by ad hoc arbitral tribunals. Many procedural questions were raised – legal standing, coalition of defendants, competence to deal with patent validity issues, etc. – as well as infringement arguments.
This massive litigation trend was modified in 2023 – with a revision of Law 62/2011 and the Industrial Property Code – changing the mandatory arbitration to a voluntary one.
Since this amendment arbitrations were no longer used – due to a lack of agreement between generic and originator companies – and the legal actions were submitted before the Intellectual Property Court (IP Court), based in Lisbon, where pharma and biotech litigation stands in the present.
The mentioned 30 days period of Law 62/2011 was redefined by Constitutional and Supreme Court of Justice decisions, which means that a patent holder can start an action in 30 days upon the publication of a generic MA application or enforce the patent at a later stage, for instance where price and reimbursement are approved.
There are advantages to file an action at an early stage – for example to legally obtain information on the generic medicines to analyze infringement – but the disadvantage is the limited conditions to a front-loaded action without a minimum set of evidence.
Anyhow, the IP Court is practically – together with the UPC – the unique national forum to enforce infringement and validity actions.
The IP Court case law sometimes is not consistent and largely depends on expert evidence and depositions from patent experts.
The basic grounds of the IP Court decisions follow the EPC and Boards of Appeal, notably the notion of skilled person in the art, problem-solution approach and doctrine of equivalence.
The typical court proceeding can start with a preliminary injunction to prevent or cease the infringement normally accompanied by main actions where final decisions are rendered. The sentences are subject to appeal to the Court of Appeal of Lisbon (IP Section) and there is very limited access to appeal before the Supreme Court of Justice and Constitutional Court, to discuss only matters of law and constitutionally, respectively.
IV. THE JUDICIAL PERSPECTIVE – UPC EXPERIENCE
It should be noted that the UPC was not an entire success considering the large percentage of opting-outs regarding pharma and biotech patents. Yet the transitional period will end and all the EU Member States that ratified the UPC Agreement will have a unique forum for patent litigation.
The judicial experience of the Unified Patent Court (UPC), although still recent, already reveals a clear and increasingly structured approach to the concept of imminent infringement in pharmaceutical patent litigation. This experience is particularly relevant in cases involving generic medicines and the interaction between patent law and pharmaceutical regulatory frameworks, an area traditionally marked by divergent national approaches and legal uncertainty.
The local divisions of the UPC are achieving fair relevance in the global context of the UPC – mostly happening in German UPC Courts – and some decisions have been rendered so far.
The local division of Lisbon has already dealt with a couple of cases and one of them has been appealed to the Court of Appeal of the UPC where a landmark decision was issued.
In fact, one of the most illustrative examples of this emerging jurisprudence is the decision of the Court of Appeal of the UPC of 13 August 2025 – rendered in the dispute between Boehringer Ingelheim and Zentiva, concerning a patent relating to Nintedanib. In this decision, the UPC was called upon to assess whether a set of regulatory and administrative steps taken by a generic company – prior to the actual placing of the product on the market – could amount to an imminent infringement within the meaning of Article 62(1) UPCA.
The Court of Appeal expressly confirmed that imminent infringement under the UPCA is an autonomous concept of Union patent law, although it may require an assessment of national regulatory frameworks as a matter of fact.
The UPC clarified that an imminent infringement may exist where the alleged infringer has “set the stage” for the infringement, so that the infringing act is no longer speculative but merely a matter of initiating conduct for which all material preparations have already been completed.
Importantly, the Court rejected a purely formal or abstract assessment based solely on the absence of actual marketing. Instead, it adopted a substantive and realistic evaluation of the commercial and regulatory context, focusing on whether the remaining steps required to enter the market are minor, easily reversible, or entirely within the control of the alleged infringer.
In line with this approach, the UPC confirmed that the mere application for, or grant of, a marketing authorization for a generic medicine does not, in itself, constitute imminent infringement. This position aligns with both long-standing national case law and the logic of the Bolar exemption.
However, the Court introduced a significant and innovative clarification by holding that the completion of national procedures for health technology assessment, pricing, and reimbursement may, depending on the circumstances, amount to imminent infringement. In the Portuguese context, the approval of the Prior Evaluation Procedure (PEP) by INFARMED was considered a decisive factor, as it enabled the generic company to offer the product to public hospitals without the need for further substantive administrative approvals.
The Court emphasized that the assessment must be conducted with due regard to the specific national regulatory framework, including public procurement rules and hospital acquisition mechanisms which were addressed in this article (II. Regulatory Experience).
Nevertheless, it made clear that participation in procurement procedures or offering products within such procedures may constitute an infringing “offer” under Article 25 UPCA, regardless of whether such acts are characterized as pre-contractual under national law.
A particularly noteworthy aspect of the UPC’s judicial experience is its rejection of arguments based on the alleged infringer’s self-restraint. In the Boehringer Ingelheim v. Zentiva case, it follows that the Court considered that the absence of infringement cannot be presumed merely because the generic company claims it will voluntarily refrain from commercializing the product until patent expiry. Where the legal and regulatory framework does not objectively prevent market entry, the risk of imminent infringement remains.
As a matter of fact, this argument brought by generic companies in arbitrations and judicial actions – the intention of not to launch the generic drugs prior to patent expiry – is a mere intention not secured by a judicial decision which may be executed immediately, as an executive title, in case of breach of such intention.
For this reason, several judicial and arbitral agreements were concluded and homologated by arbitral and judicial courts precisely to guarantee an executive title to enforce kin case of breach of the agreement undertakings.
The mentioned UPC reasoning marks a departure from more conservative national approaches, which often relied on assumptions of regulatory compliance or voluntary abstention. The UPC instead requires objective legal or factual barriers capable of effectively preventing infringement.
The UPC’s case law also demonstrates a heightened sensitivity to the economic and market effects of premature generic entry. The Court acknowledged that the expectation of imminent generic availability – particularly where pricing and reimbursement have already been approved – can itself lead to irreversible market consequences, such as price erosion, suspension of purchases of the originator product, and spill-over effects in countries applying international reference pricing.
These considerations played a central role in the Court’s assessment of the necessity of provisional measures and confirm that the UPC adopts a pragmatic, market-oriented approach when weighing the interests of the parties.
The Boehringer Ingelheim v. Zentiva decision represents the culmination of pre-Pharma Package jurisprudence on imminent infringement in the pharmaceutical sector. Far from being incompatible with the newly proposed Bolar clause set out in Article 85 of the EU Pharma Package, the judgment precisely delineates the normative space that the European legislator now seeks to occupy: namely, the explicit exclusion of pricing, reimbursement and health technology assessment procedures from the scope of patent infringement. The relevance of the decision will therefore persist, not as a restrictive precedent, but as a structural point of reference for defining, in the future, the boundary between regulatory acts protected by a statutory safe harbor and commercial acts capable of triggering patent enforcement before the Unified Patent Court.
This is a crucial question to respect the protection of patents according to the international framework of TRIPS and the Enforcement Directive.
The possibility to judicially prevent acts that are clearly an imminent infringement must be safeguarded irrespectively of a broader notion of the Bolar exemption.
We should mention that all the discussions around those matters involve fundamental rights normally at the constitutional level. In fact, the classic debate on the right to health namely the access to (cheaper) medicines v. right to property (like Intellectual Property) as also a fundamental right, is the “back of mind” of some judges.
Which fundamental right should prevail in the end? A provocative question to still consider and eventually answer.
Finally, there is also room to set out the emerging trends in UPC Jurisprudence. Overall, the judicial experience of the UPC in pharmaceutical cases suggests a trend towards:
• a broader and more flexible understanding of imminent infringement.
• a fact-intensive, case-by-case assessment grounded in regulatory and commercial realities.
• a willingness to intervene at an earlier stage than many national courts traditionally did.
• and a growing convergence between patent enforcement and pharmaceutical regulatory law.
This evolving jurisprudence positions the UPC as a central forum for resolving complex cross-border pharmaceutical patent disputes and is likely to significantly influence litigation strategies for both originator and generic companies in Europe.
We can fairly conclude that the price approval or maxime prior evaluation of generic medicines can been seen as an imminent infringement of patents.
However, the specific analysis should be construed on a case-by-case basis, notably considering the timelines of those administrative approvals and the expiry of the patents related to reference medicines.
Far from being totally pacific – and particularly regarding the ongoing discussions on the pharma package – the courts should, on one hand, taking into consideration the Bolar exemption and, on the other hand, assure the protection of patent rights and its enforcement according to TRIPS and the Enforcement Directive.
Time for the debate in the Lisbon Patents & Standards Conference on 19 June 2026!
Lisbon, 2 April 2026
António Andrade and Ricardo Rocha
