An infringement action should be brought by the patent holder. If several entities own the patent, each co-holder can bring an action independently. An exclusive licensee who is registered in the patent register can also bring an action. The patent holder does not have to participate in the proceedings if the action is brought by an exclusive licensee.
A motion for patent invalidation can be brought by any entity, including the alleged infringer. A motion for invalidation in the public interest can also be brought by the Attorney General of the Republic of Poland or the President of the Polish Patent Office (the PPO).
The decision to sue a certain entity for patent infringement depends on many factors, which may vary depending on the type of patent (product patent, process patent or use patent), as well as the mode of distributing the medicinal product. The most sued entities are those that offer medicinal products for sale.
Although pharmacists, doctors and HRAs can theoretically be sued, in practice such cases do not occur.
In the case of patent infringement, there is no obligation to notify HRAs or the PPO. In the case of invalidation, the PPO knows about the ongoing proceedings ex officio because the application for the patent invalidation is filed with this body.
In matters of patent infringement, as a rule, the court grants a PI after hearing the obliged party. The proceedings are therefore inter partes. The hearing should take place within one month from the date of receipt of the motion for a PI. The obliged party may respond to the motion for a PI and present relevant evidence within the time limit set by the court.
In matters of patent infringement, the court usually grants a preliminary injunction (PI) after hearing the party that is obliged to cease the infringing activities. The proceedings are therefore inter partes, meaning that both parties are involved. The court should hold the hearing within one month from the date of receiving the motion for a PI. The obliged party may respond to the motion and present relevant evidence within the time limit set by the court.
There are two exceptions to this rule.
In cases where the court rules on an injunction without the participation of the obliged party, they may learn about the pending proceedings by monitoring court dockets. It is within the discretionary power of the judge to take into account the position of the party in a situation where the injunction is ex parte. In the case of an injunction executed by a bailiff, the bailiff, when proceeding to the seizure, delivers the decision on the injunction, which the obliged party may appeal against.
An appeal against an injunction must be filed within one week from the date of delivery of the decision granting a PI with a justification.
The entitled party who requests an injunction to prevent patent infringement must prove the existence of a patent infringement claim and demonstrate a legal interest in granting the PI. However, a legal interest exists only if the motion for a PI was filed before the expiry of six months from the date on which the applicant became aware of the patent infringement. The applicant is also required to notify the court of any invalidation proceedings. When assessing the validity of a patent infringement claim, the court is bound to take into account the likelihood of the invalidation of the patent.
Claims for patent infringement may be pursued after the grant of a patent. In the case of European patents, this is possible after their validation in Poland, ie, after the publication of the translation of the European patent into Polish. Claims for patent infringement cannot be pursued based on a patent application.
Polish law also allows a claim to cease actions that threaten to infringe the patent right. Such a claim may also be secured. To prove such a claim, one must show that patent infringement in the future is inevitable. Likewise, as in the case of securing a claim for patent infringement, one must demonstrate a legal interest.
Obtaining a marketing authorisation is not sufficient to obtain an injunction, as the decision to authorise a medicinal product for marketing does not constitute patent infringement. It is necessary to show that the marketing authorisation holder (MAH) will undertake actions that constitute patent infringement.
The infringement proceedings are independent of the invalidity proceedings. The Regional Court in Warsaw – the Court for Intellectual Property Matters – recognises patent infringement in civil proceedings. The PPO recognises the invalidation of a national or European patent.
The court is not obliged to stay the proceedings in case of patent invalidity proceedings. However, suspending the infringement proceedings cannot be completely ruled out due to the large margin of discretion of the court in this matter.
The patent invalidation proceedings can be initiated independently of the ongoing opposition proceedings.
Claims for patent infringement are subject to a three-year limitation period, starting from the date when the entitled entity became aware of the infringement and the identity of the infringer, for each separate infringement. However, the claims are barred after five years from the date when the patent infringement occurred.
A lawsuit for infringement is served on the defendant by the court. The court sets a deadline for responding when serving the complaint and the defendant may request an extension of this deadline. As a rule, the court requires the party to state all the allegations and evidence in the response to the complaint, or risk losing the right to invoke them at a later stage, unless it is justified that they could not invoke them due to new facts or circumstances or the need to invoke them arose later. The deadline cannot be shorter than two weeks.
A request for invalidation is served on the patent holder by the PPO. The PPO sets a deadline for the response, not shorter than one month, if the patent holder is resident or based in Poland, or two months if the patent holder is resident or based abroad. This deadline may be extended if the patent holder notifies the PPO in writing of the reasons for not meeting it before the deadline expires.
In the case of patent infringement, the first hearing is usually scheduled within eight to ten months from the date of filing the response to the claim. The proceedings in the first instance last about two to three years. Usually, before the first hearing, the court orders the exchange of further preparatory pleadings.
In the case of a request for invalidation, the first hearing is usually scheduled within six months from the date of filing the request for invalidation. The invalidation proceedings before the PPO usually last about one to two years.
Claims for patent infringement can be pursued after obtaining the patent. Claims can be pursued for the period starting from the day when the PPO announced the invention application, if the infringer acted in good faith. However, if the patentee notified the infringing person about the filed application earlier, then the claims can be pursued for the period from the date of notification.
In the case of European patents, the patentee must submit a Polish translation of the European patent to the PPO within three months from the date of publication by the European Patent Office (the EPO) of the information about the European patent being granted.
Claims for infringement of the European patent can be pursued from the date of publication in the Bulletin of the PPO of the information on the translation into Polish of the claims of the European patent application, filed by the applicant in the PPO.
In the case of patents for a process, the burden of proof is shifted. With respect to new products or when the patentee proves that they could not determine, despite making due efforts, the actual method of producing the product used by another person, the patentee may rely on the presumption that the product was produced using the patented method of production.
The Polish procedure in patent infringement cases provides for two types of discovery/disclosure proceedings:
Request for Information
A request for information can be filed both before and during the infringement proceedings.
The scope of information and the manner of the proceedings in the case of a request for information do not differ depending on whether the request is filed before or during the infringement proceedings. The entitled party is obliged to credibly demonstrate the circumstances indicating the infringement. Within these proceedings, only information on the origin and distribution networks of goods or services can be demanded, if it is necessary for pursuing the claim.
If the request for information was filed before the commencement of the proceedings, and the court ordered the entity to provide information, then the party requesting information shall commence the infringement proceedings within the time limit set by the court, not longer than one month from the date of the decision on providing information. If such proceedings have not been initiated, the required party has a claim for damages. This claim also applies in cases where the lawsuit was dismissed, withdrawn or discontinued.
Request for Disclosure or Delivery of Evidence
A request for disclosure or delivery of evidence is possible only during ongoing infringement proceedings.
A request for disclosure or delivery of evidence can be made during ongoing proceedings if the plaintiff has substantiated their claim. The requesting party must specify the evidence that they seek to disclose or deliver and provide reasons for such a request. In particular, they must show that the defendant holds the evidence in question.
Polish civil procedure does not address the use of evidence or information obtained in proceedings conducted abroad. Therefore, there is no formal prohibition on using such information. However, when using such information, one should avoid disclosing the trade secrets of the defendant in another jurisdiction. This means that the disclosure of information obtained abroad would be possible in practice only if the proceedings in both Poland and abroad involved the same parties.
Evidence can be secured before the proceedings start or at any point until the trial ends in the first instance. The application for securing evidence should be examined within one week from the date of its submission. Both before the initiation of the proceedings for infringement and during their course, the entitled party must demonstrate the claims and show the existence of a legal interest in securing evidence. A legal interest exists when:
The court decides on the application without the parties’ participation. If it rules before the initiation of the proceedings, it sets a deadline for filing an infringement lawsuit within a period of not less than two weeks and not more than one month from the date when the decision becomes final.
The court sends its decision on securing evidence to the entitled party only. The other party gets this decision from the bailiff, who executes it. The execution of this decision, at the request of the obliged party or the defendant, may take place with the participation of a court expert. A complaint against the decision on securing evidence is admissible.
Polish civil procedure is silent on the use of evidence or information obtained in proceedings conducted abroad. Therefore, there is no formal barrier to using such information. However, when using such information, one should avoid disclosing the trade secrets of the defendant in another jurisdiction. This means that the disclosure of information obtained abroad would be possible in practice only if the same parties were involved in the proceedings in both Poland and abroad.
Polish law provides for an action to establish that the actions taken or intended do not infringe a patent. Such an action can be brought by an entity that has a legal interest. According to Polish law, legal interest occurs in two cases:
The law also provides that, to be duly set, the deadline for the patent holder to respond must:
Polish law does not expressly provide for the doctrine of equivalents. However, Polish courts sometimes refer to the doctrine of equivalents. In particular, the Supreme Court confirmed in its judgment (V CSK 149/15) that the court cannot rely on a literal interpretation of the claims. According to the methodology proposed by the Supreme Court, the answer whether there has been an infringement is based on the following stages of examination:
Polish law does not provide for an obligation to “clear the way” ahead of a new product launch.
In patent infringement cases, the court uses written expert opinions as evidence. The court appoints experts at the request of the parties. The parties must make such a request in the claim or the reply to the claim.
The party requesting the admission of an expert opinion may suggest persons or institutions that have the appropriate knowledge, but the final decision on who will become an expert in the case belongs to the court. The parties may ask questions to the experts at the hearing if they make such a request after familiarising themselves with the expert opinion. If the party disagrees with the content of the opinion, it may file a motion for the appointment of another expert. The admission of another opinion from a different expert depends on the discretion of the court.
The parties may also attach expert opinions prepared at their own request. Such opinions are, however, treated as statements of the parties themselves. Such opinions are often used by the parties in patent infringement proceedings. They allow them to better explain to the court the complex issues of a technical nature.
In patent invalidation proceedings, evidence from an expert opinion is usually not admitted, unless the PPO deems it necessary. Such evidence is seldom admitted by the PPO. The parties – as in infringement proceedings – often submit private expert opinions to corroborate their claims.
Experiments are allowed in patent infringement proceedings. An experiment can also be part of expert opinion evidence, if conducting it or assessing its results requires expert knowledge. The court determines the manner of conducting the experiment.
The results of the experiments carried out outside the court proceedings can also be attached as so-called private documents. In such cases, they are subject to evaluation according to the rules applicable to other evidence.
Theoretically, there are no obstacles to admitting evidence in the form of an experiment also in the invalidation proceedings before the PPO. However, in practice, this would have to involve admitting an expert, which the PPO is generally reluctant to do. On the other hand, it is not uncommon for the parties to submit documents describing the conduct and results of experiments, which of course the PPO can take into account when deciding the case.
The party claiming infringement is obliged to provide evidence that the patent has been infringed. It must therefore prove that the defendant committed acts constituting patent infringement, eg, by providing samples of the goods introduced to the market and documents confirming their purchase, or evidence confirming the offering of such products, eg, in the form of relevant information on the availability of medicinal products. To demonstrate infringement, it is necessary to show that these goods have the features protected by the patent, such as documents containing relevant analyses or private opinions.
The defendant must show that the products introduced to the market do not have the features protected by the patent, by presenting descriptions of products, processes, or documents in the form of private opinions or analyses.
Polish law does not contain a closed list of defences that can be raised in patent infringement proceedings. Patent infringement is precluded by the consent of the right holder (eg, in the form of a licence agreement) or by a statutory right to use the patent.
Polish law allows the use of the patent in the following cases:
The accused infringer may invoke exhaustion as a defence. The defence cannot be based on the so-called free state-of-the-art.
Due to the principle of bifurcation, the court cannot examine the invalidity of the patent on its own initiative, but of course raising the invalidity defence may – if the court deems it appropriate – lead to the suspension of the infringement proceedings until a decision on the invalidity claim is issued.
The court that adjudicates on the infringement is bound by the decision to grant the patent. In theory, a parallel proceeding for the invalidation of the patent does not affect the examination of the infringement case. However, the court may sometimes suspend the infringement proceeding in such a situation. This is a matter of the court’s discretion.
There are no legal grounds to suspend the proceeding because of a parallel proceeding in another jurisdiction. The judgments of courts from other jurisdictions may only have a psychological impact. The court does not refer to the reasoning contained in the rulings issued in other jurisdictions in its justification.
The PPO can limit a patent upon the patentee’s request. A patentee can file such a request even if there is an ongoing infringement proceeding, but this is not a common practice. The court that hears the infringement case has to respect the patent as granted unless the PPO changes it. Alternatively, a patentee can request the limitation of a patent during an invalidity proceeding, but only before the first hearing. The PPO will not accept any requests for limitation after the first hearing.
The Regional Court in Warsaw – the Court for Intellectual Property Matters – has exclusive jurisdiction in matters concerning inventions, in both PI and infringement proceedings. The judges deciding in this court are specialised in intellectual property matters. They do not have technical background or expertise. The cases are decided by a single judge. Appeals are heard by a single judge in the same court.
A lawsuit for infringement may be filed if actions that constitute an infringement of the patent right are taken, ie, making, offering, using, putting on the market, importing, exporting, or storing or keeping for those purposes.
Obtaining a marketing authorisation alone does not constitute an infringement of the patent right, as it does not yet amount to offering. However, the Polish courts considered entering a medicinal product on the reimbursement list as an offering. An offering also includes submitting a bid in a tender procedure.
In the case of patents for use, the trigger point that allows for filing a lawsuit for infringement is offering the product for the protected use, even if that use has been removed from the SmPC. In practice, such a case may occur when a product is reimbursed outside the protected use or when a bid is submitted in a tender concerning the protected use despite skinny labelling.
The data exclusivity period is eight years from the date of granting the first marketing authorisation in Poland, the EU or a state party to the agreement on the European Economic Area (the EEA). However, the market exclusivity is ten years. This period is calculated in the same way as for the data exclusivity period.
The market exclusivity period may be extended for up to 12 months, if within the eight-year data exclusivity period an approval or authorisation is issued to add a new indication or indications. The extension of the market exclusivity is conditional on a positive assessment by the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (the Polish Drug Authority), that the new indications constitute significant clinical benefits.
An application for registration of a product containing a substance with well-established medical use in the territory of an EU state or a state party to the EEA agreement may be submitted after at least ten years have elapsed since the first systematic and documented use of this substance in a medicinal product and its proven efficacy and acceptable level of safety. If the application includes new therapeutic indications based on significant non-clinical or clinical studies for such a substance, an additional one-year exclusivity period is granted from the date of the decision on this matter.
The data exclusivity periods described above, resulting from Polish law, apply to reference medicinal products for which a marketing authorisation has been obtained in the national procedure or the mutual recognition procedure. In the case of authorisations obtained in the centralised procedure, Regulation 726/2004, laying down community procedures for the granting of authorisations, applies directly. This Regulation provides for a similar eight-year period of data exclusivity and a ten-year period of market exclusivity, which may be extended to eleven years if, during the first eight years of exclusivity, the holder obtained an authorisation for one or more therapeutic indications that bring significant clinical benefits compared to existing therapies.
With regard to orphan medicinal products, Regulation 141/2000 applies directly. This Regulation provides for a ten-year period of market exclusivity, which is obtained by the first marketing authorisation. This means that, in the case where the authorisation has been granted in the centralised procedure or the mutual recognition procedure, no other application for a marketing authorisation, no authorisation and no application for an extension of an existing authorisation for the same therapeutic indication will be accepted in the EU and the member states for a period of ten years for a similar medicinal product. This period may be reduced to six years, if at the end of the fifth year it is shown that the product does not meet the criteria for designation as an orphan.
Polish law provides for the so-called Bolar exemption. The Bolar exemption is defined very broadly in Polish law and allows for the use of an invention consisting of making, using, storing, keeping, offering, putting on the market, exporting or importing. These activities can be undertaken for the purpose of performing the acts that are required by law for obtaining a marketing authorisation. According to the law, the Bolar exemption can be invoked not only by the person who applies for the registration of a medicinal product, but also by a third party, eg, a manufacturer of an active substance. The Bolar exemption can be invoked if the application was filed in the countries constituting the territory of the EEA, as well as in other countries.
The Polish Drug Authority maintains the Register of Medicinal Products Authorised for Marketing on the territory of Poland. The following are entered into the Register:
The Polish Drug Authority announces once a month a list of medicinal products that have obtained a marketing authorisation. In principle, information on the registration of a medicinal product is available after the granting of the marketing authorisation. As part of the access to public information, the Polish Drug Authority usually refuses to provide detailed information, only stating the fact that there are ongoing proceedings for marketing authorisation and indicating the number of ongoing proceedings.
The MAH for the reference product registration is not notified about the ongoing procedure concerning marketing authorisations for generic products or biosimilars. However, they can request access to the files of the ongoing procedure. Although the Polish Drug Authority refuses access to the files, invoking the necessity of demonstrating a legal interest, according to the latest jurisprudence of administrative courts, the MAH of the reference product should receive access to the files of the ongoing proceedings.
As a rule, the procedure for granting a marketing authorisation does not take into account the existence of patent protection. Similarly, in the case of reimbursement, patent protection is irrelevant. An exception is the situation when the responsible entity, applying for the registration of a generic medicinal product, submits a request to remove from the SmPC data relating to therapeutic indications or pharmaceutical forms covered by patent protection. Such an entity submits, in the procedure for granting the authorisation, a statement about the existence of patent protection for the specified indications or forms, from which it wants to withdraw. The authority issuing the authorisation is not obliged to examine whether the patent protection of these indications or forms exists.
Therefore, theoretically, a generic drug can be entered on the list of reimbursed drugs despite the existence of patent protection. However, in practice, drugs whose reference equivalents are protected by patents are rarely entered on the list of reimbursed drugs due to the possibility of the patent holder initiating a patent infringement proceeding and the possibility of obtaining a prohibition of introducing the generic product to the market in the PI proceeding.
The reimbursement list is publicly announced by the Minister of Health every two months. The list is announced in the month preceding the next two-month period in which it will be valid. Monitoring the Minister of Health’s announcements is the only way to find out if a given medicinal product will be reimbursed, because the MAH of the reference drug is not notified of the inclusion of the generic/biosimilar drug on the reimbursement list. The reimbursement list indicates for each drug the range of indications covered by the reimbursement, distinguishing situations for individual preparations, whether they are all registered indications, or just some of them.
For biosimilars, the situation is much like that of generic drugs.
For biosimilars, the data exclusivity periods are the same as for generic drugs. To use the data of the reference product, the biological product must meet the same criteria as the generic products for equivalence to the reference medicinal products. If these criteria are not met, especially because of differences in the starting materials or manufacturing processes of these products, the responsible entity must present the results of clinical or non-clinical studies.
For biosimilars, the situation is much like that of generic drugs.
For biosimilars, the situation is much like that of generic drugs.
For biosimilars, the situation is much like that of generic drugs.
SPCs are available in Poland on the basis of EU Regulation 469/2009. This protection is therefore identical in all EU member states.
Granting an SPC is possible if:
An SPC is granted to the entity entitled to the basic patent. The subject matter of SPC protection is any medicinal product protected by a basic patent in Poland (national or European).
The basic patent can be a patent for a product, a process or an application of the product. However, the theoretical possibility of obtaining an SPC for a product protected by a patent for a use was significantly limited by the CJEU’s interpretation of the concept of the first marketing authorisation in the Santen case (C-673/18). According to this judgment, a marketing authorisation for a new use of an active ingredient or a combination of active ingredients, which had already been the subject of a marketing authorisation for another therapeutic use, cannot be considered as the first marketing authorisation. In practice, this means that only in the case of a patent for the first medical use can an SPC be granted.
A medicinal product is a product consisting of a substance or a mixture of substances, used for treatment, prevention, therapy or diagnosis. A product is protected by the basic patent as long as the product in its chemical form mentioned in the marketing authorisation remains protected by the basic patent.
An application for an SPC must be filed in the country in which protection is sought within six months from the date of the marketing authorisation for the medicinal product. If the marketing authorisation was issued before the patent was granted, then the application for the certificate must be filed within six months from the date of granting the patent.
As explained by the CJEU, if the same patent protects several products, then several supplementary protection certificates can be obtained, provided that each of these products is protected by the basic patent and is contained in the medicinal product for which marketing authorisations have been issued.
If the patent protects a mixture of products, as well as each product separately, then on the basis of the same patent and the same marketing authorisation, a certificate can be issued both for the mixture of active ingredients and for the active ingredient, considered individually. An SPC can only be granted for those active ingredients that have been mentioned in the claims of the basic patent. If the patent only protects a mixture of active substances, and does not protect the individual substances separately, then it is not possible to issue an SPC that protects one of the substances in the mixture.
An SPC applies after the expiry of the basic patent. The duration of the SPC cannot exceed five years from the date on which the SPC takes effect. The term of the SPC in a specific case is determined by calculating the period that elapsed between the date of filing of the basic patent and the date of the first marketing authorisation granted for the product in the EU, and subtracting five years from it.
Regulation 469/2009 allows for the extension of the SPC by six months. The granting of the so-called paediatric extension depends on whether the application for a marketing authorisation of the medicinal product in the EU included the results of all the studies conducted and the details of all the information collected in accordance with the approved paediatric investigation plan, pursuant to Article 36 of Regulation 1901/2006 on medicinal products for paediatric use.
Under the provisions of the code of civil procedure, a party subject to a wrongful injunction is entitled to claim damages from the patentee. Third parties cannot claim such compensation.
Generally, a PI is immediately enforceable. If the PI entails seizure of goods, it is served by a bailiff. Otherwise, it is the court who serves the injunction. Although it is not a standard requirement, the court can condition the enforcement of the issued PI on the entitled party paying a bond, either on its own initiative or at the request of the obliged party.
While granting a PI, the court sets out a deadline (no longer than two weeks) for the claimant to bring the main action. Failure to do so results in the revocation of the PI.
It is at the court’s discretion to stay a PI pending appeal, on the request of a party subject to the PI.
Final injunctions are enforceable after the court’s ruling becomes final, which means that it is not subject to further appeal or cassation.
However, the court may order the immediate enforceability of the injunction, even if it is still appealable, if it finds that the delay will impede or seriously obstruct the enforcement of the judgment or put the claimant at risk of harm. In such cases, the court may also require the claimant to provide a bond to cover the potential damages of the defendant if the injunction is reversed or modified on appeal.
The enforcement of the injunction is based on the enforceable ruling and an enforcement clause issued by the court. The enforcement is carried out by a bailiff, who acts upon the request of the claimant.
The court may award damages in lieu of a final injunction:
In practice, the applicability of this measure is fairly limited, and Polish courts rarely use this discretion. While deciding on a PI, the court is always under a general obligation not to place an undue burden on the party subject to injunction.
There are two main pecuniary claims that can be raised against a patent infringer.
First, there is a classic claim for damages where the claimant is required to demonstrate that:
Both the actual damage (damnum emergens) and hypothetical but highly probable lost profits (lucrum cessans) are subject to compensation. It is the claimant who should demonstrate the value of the damages, which is especially troublesome with respect to lost profits.
The claimant may also choose to have the compensation calculated as an amount of a hypothetical licence fee or other remuneration that would have been due for authorising the infringer to exploit the invention (reasonable royalty).
Second, there is a claim to hand over any benefits unlawfully obtained by the infringer (corresponding to the “recovery of profits” as described in Article 13(2) of Directive 2004/48). Therefore, this is not exactly a claim for hypothetical profits lost by the patent holder (or by the licensee) but for actual profits of the infringer resulting from unlawful exploitation of the invention. It is not clear, however, to what extent the infringer is allowed to deduct their expenses, ie, whether the claim is limited to the infringer’s net profit or whether they have to hand over literally any benefits, ie, all the income resulting from exploiting the inventions. The claim to hand over unlawfully obtained benefits does not require the claimant to demonstrate damage on their side and does not depend on whether the infringement is attributable to the infringer.
The claim for damages and the claim for unlawfully obtained benefits are independent and can be raised together. However, the court is likely to limit the damages by the amount awarded as unlawfully obtained benefits.
Claiming lost profits is usually the least preferred patent infringement claim, as it is exceptionally troublesome from an evidentiary perspective. Claimants would rather claim unlawfully obtained benefits since once the infringer’s business records are secured, it is relatively easy to track how the infringer profited from the infringement.
The royalty on revenues for units sold is determined on a case-by-case basis. In legal literature, values in the range between 1% and 10% are usually indicated. Polish law provides no basis for the court to aggravate the damages awarded depending on whether the infringement was intentional or negligent. It has been a subject of controversy whether the statutory interest for default in payment can only accrue from the moment the damages are awarded by the court or from the moment the infringed party issues a call for payment.
Damages are generally considered together with liability, although it is possible for the court to issue a partial award on liability and only then continue the proceedings to determine the exact compensation.
Damages for Wrongful Injunction
An alleged infringer can claim damages for a wrongful injunction. See 5.1 Preliminary Injunctive Relief for more details.
The rule is that the party who loses the dispute has to pay the legal costs, including court fees, attorney fees and certain other expenses (eg, the remuneration of a court-appointed expert).
Costs before filing actions are usually not recoverable. And so are many expenses incurred during the proceedings (eg, commissioning a private expert opinion).
Generally, the legal costs awarded by the court are usually but a fraction of a party’s actual expenses. This is especially true with respect to attorney fees.
The claimant’s conduct may lead to a reduction of the legal costs awarded but will generally not affect the scope of the final relief.
Trade mark disputes in the life sciences and pharma sector are not very common in Poland.
However, in 2022 the Supreme Administrative Court issued two judgments concerning a long standing dispute between Swiss Pharma International AG (Polpharma Group) and Hasco TM (Hasco Group) over the “ANACARD PRO” trade mark (Hasco’s trade mark) and its similarity to the “ACARD” trade mark (Swiss Pharma). Both companies produce drugs containing acetylsalicylic acid, used in the prevention of heart diseases. Swiss Pharma filed an invalidation application for the “ANACARD PRO” trade mark, claiming that it was similar to the “ACARD” trade mark, which is a reputable trade mark, and therefore Hasco’s trade mark was detrimental to its reputation. Hasco, on the other hand, argued that the “ACARD” trade mark had not been used for five years and filed a motion to invalidate it on that basis. The PPO issued a decision on invalidation of the “ACARD” trade mark and dismissed the invalidation motion for “ANACARD PRO”, stating that the trade marks were not similar. Both these cases were appealed to the administrative courts. The decision on the invalidation of the “ACARD” trade mark was set aside and the decision dismissing the invalidation application for the “ANACARD PRO” trade mark was upheld. Both judgments were appealed to the Supreme Administrative Court, which set them aside and referred them back for re-examination. The authors anticipate that the final judgments of both cases will be issued within the next few years.
The applicable laws are mainly the Act on Industrial Property Law of 2000, the Act on Pharmaceutical Law of 2001, the Act on Medical Devices of 2022 and the Act on Combating Unfair Competition of 1993.
Copyright disputes in the life sciences and pharma sector in Polish jurisdiction are not very common and so far, no significant dispute has reached its final decision in court. The most prominent case of GSK against Celon ended with a settlement. In this case, GSK claimed that the shape of its inhaler for treating asthma had a sufficient level of originality to be a work within the meaning of copyright law. Celon argued that the shape of the inhaler was necessary to obtain a technical result and was described in such a way in an earlier expired patent and therefore it cannot by protected by copyright law. However, because of the settlement, the dispute was not decided by the court on the merits.
Some typical copyright issues which may arise in the life sciences and pharma sector are:
The relevant sources of Polish law that regulate copyright are the Act on Copyright and Related Rights of 1994.
Trade secret disputes are relatively rare in the Polish life sciences and pharma sector. They happen occasionally, especially when former employees, competitors, or third parties unlawfully access confidential information through hacking, espionage, or contract breach. In Poland, a trade secret is valuable information that is not widely known or easy to obtain by others in the same field, and that must be protected by the owner with reasonable measures.
The main legal source for trade secret disputes in the Polish life sciences and pharma sector is the Act on Combating Unfair Competition of 1993, which stipulates that the breach of a trade secret as defined in this act is an act of unfair competition. On a separate note, Polish law does not separately define “know-how” and it is basically treated as a trade secret within the meaning of the aforementioned act.
In the Polish legal system, due to the principle of bifurcation, there are two different appellate proceedings:
Patent Infringement Cases
In patent infringement cases, the appeal is filed to the court of second instance (through the court that issued the challenged judgment) within a two-week period from the delivery of the judgment with the reasoning to the appealing party (the deadline may be extended to three weeks). Filing an appeal prevents the challenged judgment from becoming final and transfers the examination of the case to the higher instance court.
In the appeal, the party may raise objections relating to the factual findings made by the first instance court, violations of substantive or procedural law. The appellant has full freedom in presenting the grounds of appeal.
The appellate proceedings consist of a re-examination of the case by the court of second instance on the basis of the material collected both before the court of first instance and the court of second instance. The court of second instance may admit new evidence and facts invoked by the party if the possibility of invoking them only arose in the course of the appellate proceedings. The examination of the case takes place within the scope of the grounds specified in the appeal. However, if the proceedings of the court of first instance are invalid, the court will take it into account ex officio. The court may examine the case at a non-public session, if holding a hearing is not necessary. However, a court hearing must take place if the party has filed a motion for it.
Second-instance decisions can be appealed to the Supreme Court within two months of the delivery of a reasoned judgment. An appeal on a point of law to the Supreme Court can only be based on points of law or procedural violations that could have affected the outcome of the case. The Supreme Court accepts an appeal on a point of law for examination only in exceptional cases, such as if there is a significant legal issue or there is a need for interpretation of legal rules that raise serious doubts in the jurisprudence of the courts. The Supreme Court can uphold, quash, or amend the second-instance decisions, or remand the case to the lower courts for reconsideration.
An appeal against a PI decision must be filed by a party to the court of second instance (the appellate court). In cases of patent infringement, the competent court will always be the Court of Appeal in Warsaw. However, if a PI decision is issued by the court of second instance, it must be filed with and reviewed by another panel of judges of the same court.
The obliged party must file an appeal against the decision within seven days of receiving it, along with a justification (the only exception to this is when the court dispenses with the need for a justification of the decision). The appeal is not examined by the court that issued the challenged decision, but that court can review its own decision and amend it before sending the case files to the court of second instance.
During the appeal proceedings, the obliged party has the right to present its arguments. The court of second instance examines the motion for PI by considering all the circumstances. The appeal against a PI decision should be examined by the court of second instance without delay, but no later than one month from the date of its receipt. In practice, however, the courts often exceed the one-month deadline and the review of the appeal may take several months.
In the event of a final dismissal of the motion for a PI, the injunction ceases to be effective.
Patent Invalidation Proceedings
A complaint against decisions on patent invalidity can be filed with the Voivodeship Administrative Court within 30 days from the date of delivery of the decision to the complainant together with a written justification. The complaint to the administrative court is filed through the PPO. The PPO may exercise self-control over the issued decision, ie, accept the complaint in full within 30 days from the date of its receipt and revoke the contested decision.
In the proceedings, the administrative court does not establish the factual circumstances of the case (it does not conduct evidentiary proceedings) and does not assess the evidence collected, leading to the recognition of certain facts as proven. The court only examines the correctness of the performance of these activities by the administrative authorities. It checks whether the authorities, in determining the factual situation, did not violate the relevant provisions of the administrative procedure and substantive law, including whether the authorities thoroughly examined and assessed the evidence.
The administrative court issuing a judgment is not bound by the scope of the complaint or the legal basis invoked by a party.
A cassation appeal against the judgment of the Voivodeship Administrative Court may be filed with the Supreme Administrative Court within 30 days from the date of service of the judgment. A cassation appeal can be based on a violation of substantive law or a violation of the provisions of the proceedings if the infringement could have a significant impact on the outcome of the case.
Patent Infringement Cases
An appeal against a court judgment or a PI decision is examined by one judge specialising in intellectual property matters.
Patent Invalidation Proceedings
The panel of the Voivodeship Administrative Court that reviews the PPO’s decision usually consists of three judges, who may or may not specialise in patent law, depending on the availability and allocation of judges.
A separate procedure for IP cases was introduced in 2020 with the aim of ensuring high quality of judgments and facilitating the evidence gathering for claimants to pursue claims for infringement of intellectual property rights.
The IP cases are examined by intellectual property divisions within the Regional Courts, where judges specialising in intellectual property adjudicate. Particularly complex cases, such as those concerning computer programs, inventions and utility models, are adjudicated exclusively by the Regional Court in Warsaw.
In IP cases, in principle, it is mandatory for the parties to be represented by a professional attorney (an advocate, an attorney-at-law or a patent attorney).
The IP procedure introduced a wide range of possibilities, such as securing evidence, requesting disclosure of evidence and requesting information from the other party (see 1.7 Pre-action Discovery/Disclosure and 1.8 Search and Seizure Orders for more details).
There are no other relevant forums or procedures with respect to life sciences & pharma IP litigation in Poland.
In Poland, patent litigation continues to be the norm. ADR forms in life sciences disputes in Poland are rare and face several obstacles. These are particularly attributable to the following factors: the lack of awareness of ADR options, the preference for court litigation (specialised courts), the bifurcated patent litigation system that prevents the arbitrability of patent disputes concerning patent validity, and the invalidity of settlements concerning patent validity.
Regardless of the above, the following ADR forms are available in Poland.
In court proceedings, mediation is regulated by the Civil Procedure Code, which provides for both court-annexed and out-of-court mediation. Court-annexed mediation may be initiated by the parties or suggested by the court at any stage of the proceedings, and the parties may choose their own mediator or accept one appointed by the court. Out-of-court mediation may be initiated by the parties before or after the commencement of litigation, and the parties may select their own mediator and rules.
The PPO offered a way to resolve amicable disputes arising from oppositions to trade mark applications by voluntary mediation proceedings, conducted jointly with the WIPO and following the WIPO’s mediation rules.
There are some specific settlement/antitrust considerations in Poland that may affect pharma/biopharma settlements.
Poland is a member of the EU and therefore subject to EU competition rules, including Article 101 of the Treaty on the Functioning of the European Union, which prohibits agreements that restrict or distort competition within the internal market. This means that pharma/biopharma settlements that involve potential or actual competitors and that have an effect on trade between EU member states may be subject to EU antitrust enforcement, as well as national enforcement by the Office of Competition and Consumer Protection.
In addition to EU competition rules, Poland has its own national competition law, which is largely aligned with EU law, but may have some differences in interpretation or application. The main national competition law provisions of the Act on Competition and Consumer Protection prohibit agreements that restrict or distort competition within the Polish market (Article 6) and the abuse of a dominant position (Article 9).
The European Commission has shown an increasing interest and activity in the pharma/biopharma sector in recent years, especially in relation to potential anticompetitive practices, such as patent settlements, pay-for-delay agreements and the abuse of patent rights. For example, in Lundbeck v Commission (2021), the European Court of Justice held that the pay-for-delay agreements at issue constituted restrictions of competition and affirmed/vindicated the EC’s decision to fine Lundbeck and the other parties EUR146 million.
The Latest in Polish Life Sciences & Pharmaceutical IP Litigation
The year 2023 was mainly a year of changes in regulatory provisions. The issues related to parallel import of medicinal products have attracted a lot of attention.
The legislator finally decided to change those provisions of the Pharmaceutical Law of 2001 which, according to the CJEU judgments, violated Articles 34 and 36 of the Treaty on the Functioning of the European Union (the TFEU). However, parallel import and the rules for labelling medicinal products imported into the territory of Poland and access to public information have again aroused a lot of interest, due to a controversial judgment of the Supreme Court. Last year was another year of the fight of the holders of the registration of reference products against the registration procedures of generic drugs. This year also brought numerous changes in regulations concerning the advertising of medicinal products and medical devices, which is of course also related to a greater supervision over the advertising market. Finally, it seems that another year will result in increased activity of the Office of Competition and Consumer Protection (the UOKiK).
New rules for parallel import
Less arbitrariness of regulatory authorities
Last year brought significant changes in the rules for obtaining permits and performing activities related to parallel import, from the point of view of parallel importers. As of 1 November 2023, the provisions on parallel import were amended in connection with two CJEU judgments, issued in cases C-387/18 and C-488/20. In both cases, the proceedings were initiated by the same entity – Delfarma sp. z o.o. against the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. Both cases concerned the provisions introduced in the Pharmaceutical Law, allowing the regulatory authority to make a decision, without the need to examine the possible risk to human health and life, based solely on the occurrence of certain factual events. The changes made as a result of the Pharmaceutical Law amendment certainly facilitated the conduct of business by parallel importers, freeing them from the arbitrariness of the actions taken by the regulatory authority, while imposing on the regulatory authority the need to examine whether there was really a risk of endangering human health and life in these factual situations.
Delfarma sp. z o.o. is a well-known parallel importer of medicinal products on the Polish market. The company did not obtain a parallel import permit for a medicinal product, because in the country of export the product had the status of a generic product, while in Poland the product had the status of a reference product. The President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, refusing to grant consent for parallel import, relied on Article 2 point 7b lit b) of the Pharmaceutical Law according to which the imported medicinal products and the medicinal products authorised for marketing in the territory of Poland are respectively in the state from which the product is imported and, in the territory of Poland, are simultaneously reference medicinal products or equivalents of reference medicinal products.
In the justification of his decision, the President of the Office stated, inter alia, that the prohibition of quantitative restrictions on imports and measures having the equivalent effect resulting from Article 34 of the TFEU does not preclude the application of prohibitions and restrictions justified by reasons of protection of health and life. In the opinion of the President of the Office, the admission to the market of a medicinal product for which the registration authority in the country of export does not have documentation allowing for the verification of data, constitutes a threat to life and health.
Delfarma sp. z o.o. appealed against this decision, raising, inter alia, the argument that the President of the Office had erroneously assumed that Article 2 point 7b of the Pharmaceutical Law was justified by security reasons. The company claimed that such an interpretation of this provision prevented the examination of the therapeutic identity of the products under consideration and resulted in a decision that constituted a restriction on the free movement of goods, unjustified on the basis of Article 36 of the TFEU.
Finally, the case was referred to the CJEU, which ruled that Articles 34 and 36 of the TFEU preclude provisions of a member state that require, for the issuance of a parallel import permit for a medicinal product, that the medicinal product and the medicinal product subject to the marketing authorisation in that member state are both reference medicinal products or both generic medicinal products, and which consequently prohibit the issuance of any parallel import permit for a medicinal product if it is a generic medicinal product, when the medicinal product already authorised for marketing in that member state is a reference product.
As emphasised in the CJEU judgment, such a decision can only be the result of a lack of available information, allowing for a reliable comparison of products, and cannot be the result of preventing any examination of a similar nature of the medicinal products under discussion, only for the reason that the product in the country of export is registered as a generic product, and in the country of import as a reference product. A provision that is based on a presumed systematic insufficiency of documentation for the purposes of carrying out the necessary verification or, on the risk of such insufficiency, goes beyond what is necessary to achieve the objective of protecting the health and life of any person, cannot be considered to be in accordance with Article 36 of the TFEU.
As a consequence, as of 1 November 2023, the provisions of the Pharmaceutical Law were amended, removing the requirement that the imported medicinal product and the medicinal product authorised for marketing in the territory of Poland are respectively in the state from which the product is imported and, in the territory of Poland, are simultaneously reference medicinal products or equivalents of reference medicinal products.
On the other hand, the second of the cases, which became the reason for the amendment of the Pharmaceutical Law, led to the removal from Polish law of the provision, according to which the parallel import permit expired after one year from the date of expiry of the marketing authorisation for the reference medicinal product in the country of export. Considering the case, the CJEU pointed out that the parallel import permit for medicinal products may be, for reasons of a general nature or, in specific cases, for reasons related to the protection of public health, necessarily linked to the reference marketing authorisation in such a way that the withdrawal of that marketing authorisation may justify the withdrawal of the parallel import permit. However, it ultimately ruled that the automatic expiry of such a permit, provided for in Polish law, without examining the possible risk to the health and life of people, violates Articles 34 and 36 of the TFEU, as it goes beyond what is necessary for the protection of health and life of people.
The CJEU pointed out that the national regulatory authority responsible for the supervision of pharmacovigilance in the member state of import has access to the updated information necessary to perform its function, regardless of the circumstance that parallel importers are not obliged to submit periodic safety reports. This means that it can examine and assess the risk of a possible threat to the health and life of people in the situation when the authorisation to market the medicinal product has expired in the country of export. Moreover, the CJEU noted that Article 36 of the TFEU cannot justify such provisions, which are motivated essentially by the concern to reduce the administrative burden or public expenditure, as long as such provisions would entail efforts or expenditure exceeding the limits of what can reasonably be required.
The CJEU also emphasised that the availability of information on products that have obtained authorisation in the EU means that the administrative burden and the resulting expenditure do not exceed – even when many medicinal products are subject to parallel import – the limits of what can reasonably be required from those authorities, which – as follows in particular from Article 101 of Directive 2001/83 – are responsible for the supervision of pharmacovigilance and medicinal products.
Trade mark in parallel import
The year 2023 also brought a breakthrough judgment on the admissibility of using trade marks of the entity entitled to register repackaged products imported into Poland as part of a parallel import. This judgment forces parallel importers to change their current practice of marking products imported into Poland as part of the parallel import with a trade mark used by the entity entitled to the right of protection in Poland.
The legal basis for marking repackaged medicinal products introduced to the market in Poland was Article 21a paragraph 9 of the Pharmaceutical Law, according to which the parallel importer may introduce the imported product in parallel to the market in Poland under the name:
Until the resolution described below, it was assumed that the entity importing medicinal products into Poland could freely choose how to mark this product – in case of repackaging. The Supreme Court completely changed this perspective, indicating that in fact the parallel importer does not benefit from such a far-reaching freedom of marking repackaged goods.
In the factual state of this case, an entity holding a permit to import medicinal products from Lithuania to Poland as part of the parallel import, notified the trade mark owner of its intention to market in Poland the parallelly imported product under the name constituting a registered trade mark in new outer packaging.
In response, the trade mark owner objected to the repackaging and questioning of, inter alia, the existence of such a necessity to obtain real access to the Polish market of medicines. The parallel importer did not take into account the above reservation of the plaintiff and started to introduce the product to the market.
During the proceedings, the court dismissed the lawsuit of the trade mark owner, stating, inter alia, that in Poland there is a consolidated and accepted practice by the entities entitled to trade marks, of using trade names for medicinal products originating from a parallel import, which are used for the same products in Poland by producers. It was also accepted that the import of goods from Lithuania under the trade mark used in the country of export would result in a factual limitation of the parallel importer’s access to the Polish market of medicines. Justifying the position allowing for the change of the trade mark to the designation used in Poland, it was emphasised that the applicable Pharmaceutical Law grants the parallel importer the right to use the name used in the territory of Poland for the imported medicinal product. This provision constitutes, as it were, the basis for the “statutory consent to use a specific name”. This, in consequence, means that acting within the limits of the statutory authorisation is not unlawful and cannot constitute an infringement of the right of protection for a trade mark. It was also raised that the use of the trade mark used in Poland by the parallel importer was necessary to obtain effective access to the market by the defendant. On the other hand, the actions of the entity entitled to the right of protection, consisting of using different trade marks in the EU member states for the same product, were aimed at dividing the market.
The Supreme Court pointed out, however, that the provision of the Pharmaceutical Law cited above does not constitute the basis for the use by the parallel importer of the trade mark of the entitled entity. The fact that this provision indicates what designations the parallel importer can use does not mean that this provision constitutes a sufficient basis for interfering with the sphere of rights of private entities. This provision only defines the sphere of freedom, which exists within the framework of the parallel import procedure in marking medicines introduced to the market in the territory of Poland. From this provision, it follows only the administrative obligation to apply a name falling within one of the categories and not the right of the importer to use trade marks, for which the rights of protection belong to other entities.
The Supreme Court emphasised that in the light of the criteria of the CJEU judgment in the BMS case, “access to the market” does not mean “access to the market position”. Thus, the single market of the member states of the EU does not preclude the granting of protection to the trade mark used by the producer in the target country of parallel import, in a situation where the entity infringing the rights to that trade mark is guided by the desire to achieve a higher profit. The protection of trade marks cannot lead to an artificial division of the EU market into the markets of individual member states, which, however, does not mean that the entity entitled to the trade mark has an obligation to allow other entrepreneurs to use this mark free of charge, just because the lack of such permission would put another entrepreneur in a worse market position.
More public information
In 2023, innovative drug manufacturers still struggled with refusals by the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products to provide access to the registration documentation to entities whose data is used in the process of registering generic products.
The President of the Office, generally contrary to the interpretation made by the Supreme Administrative Court, maintains the position that the Pharmaceutical Law requires the entity requesting access to the content of the registration documentation to demonstrate a legal interest.
In this respect, the President of the Office refers to Article 34 of the Pharmaceutical Law, which provides that the register and documents submitted in the proceedings for marketing authorisation are available to persons having a legal interest in this, subject to the provisions on the protection of classified information and industrial property protection.
However, the Supreme Administrative Court has twice stated that the wording of this provision does not imply the obligation to demonstrate a legal interest by entities requesting access to the registers and documents referred to in this provision. The wording of the provision only implies the conditioning of access to these documents on the existence of a legal interest of persons requesting this access. There is no basis for demanding the demonstration of a legal interest also from the systemic interpretation of Article 34 of the Pharmaceutical Law. Access to registers and documents is of the nature of access to public information. The Act on Access to Public Information prohibits the authorities from demanding the demonstration of this interest, and Article 34 of the Pharmaceutical Law does not provide for such a requirement. According to the position of the Supreme Administrative Court, every entity has the right to request access to public information, and such is the information contained in the content of registration documents.
The authors are therefore looking forward to the resolution of the next complaints, awaiting consideration.
New advertising rules in the life science market
Last year brought many changes in the field of advertising in the life science market.
The advertising of medicinal products underwent relatively minor corrections compared to the previously applicable provisions. The novelty is the introduction of three new (instead of one) warning formulas, one of which must be included in drug advertisements. It was considered that the previous formula had lost its significance in the perception of the average consumer during the 15 years of the application of the provisions. Additionally, a rotational system of modifying the messages with warnings was introduced, ie, each new version of the advertisement must be broadcast using a different form of warning, taking into account the use of all three types of warnings.
This regulation is supposed to prevent the consumer from ignoring the content of the warning, which he/she had previously heard only in one version. The obligation to indicate in the advertisement the contraindications to the use of the medicinal product was removed.
A complete novelty, however, are the regulations concerning the rules of advertising medical devices. The most important rules concerning advertising are as follows.
Announcements of the UOKiK on increasing supervision over the pharmaceutical industry in Poland
The President of the UOKiK announced an increase in the number of proceedings concerning the pharmaceutical market conducted by this office. He pointed out that the actions taken in recent years on this market (eg, initiated proceedings on the wholesale market concerning the allegation of data exchange, market research and interventions in the case of COVID-19 tests and decisions on consumer protection for medical and quasi-medical products) are part of the plans to strengthen supervision over this industry. In particular, as he emphasised, the UOKiK is preparing to conduct cases in the area of intellectual property law, including cases related to patent protection of medicinal products.