An infringement action should be brought before the court (specialised IP division of the Regional Court in Warsaw) 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.

Patent invalidation proceedings are conducted by the Polish Patent Office (PPO). Any entity, including the alleged infringer, can bring a motion for patent invalidation. 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 PPO.

The PPO does not issue infringement or validity opinions.

The decision to sue a particular 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 healthcare regulatory authorities (HRAs) can theoretically be sued, such cases do not occur in practice.

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 patent invalidation is filed with this body.

In matters of patent infringement, a preliminary injunction (PI) is available. Claims for patent infringement may be pursued after a patent is granted. 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.

An 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 only exists if the motion for a PI was filed six months before the date on which the applicant became aware of the patent infringement. Although there are legislative plans to remove this requirement, it currently remains in force and may significantly restrict the possibility of obtaining an injunction.

In course of PI proceedings, the applicant is required to notify the court of any invalidation proceedings. When assessing the merits of the PI motion, the court is required to take into account the likelihood of the patent being invalidated.

Obtaining a marketing authorisation is insufficient for the court to issue a PI, 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) or any other entity undertake actions that constitute patent infringement.

It is possible to request a PI even before an infringement occurs. Polish law allows claims to cease actions that threaten to infringe a patent right (eg, preparing to manufacture goods covered by the patent without authorisation). Such a claim may be secured. To prove this claim, one must show that future patent infringement is inevitable. As in the case of securing a claim for patent infringement, one must demonstrate a legal interest.

The court usually grants a PI after hearing the alleged infringer. 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 inter partes proceedings, as outlined below.

• The court may grant a PI without hearing the obliged party if an immediate decision on the application is necessary.
• Moreover, the court decides without the participation of the obliged party in the case of those methods of injunction that are entirely subject to execution by the court bailiff. One such method of injunction is the seizure of goods infringing the patent. Please note that, in the authors’ experience, courts now frequently grant the alleged infringer an opportunity to be heard even in such cases, relying on the general principles of civil procedure.

In cases where the court rules on an PI without the participation of the obliged party (ex parte), they may learn about the pending proceedings by monitoring court dockets. There may be a delay in court records being updated, although it usually does not exceed a few days.

In anticipation of the possible submission of a PI and ex parte proceedings, the presumed infringer may file a protective letter with the court. Protective letters are not regulated under Polish law, and it is within the discretionary power of the judge to consider this letter. In practice, judges often take protective letters into account, which means that the position and evidence submitted by the obliged party can persuade the judge not to grant a PI. There is currently a fairly intense debate in Poland about whether protective letters should be introduced into the legal system.

A significant drawback of the Polish legal system in patent infringement cases is the excessive length of proceedings concerning motions for PIs. Although the courts are required to examine such motions without delay, preferably within seven days, applications for PIs are often adjudicated over several months.

If the PI is granted ex parte, it is usually not served on the obliged party until enforcement begins, and in such cases, it is delivered by a bailiff during execution. In inter partes proceedings, however, the order is served on both parties.

In both scenarios, the obliged party may appeal the PI. 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. If the PI is not granted, the applicant may also lodge an appeal against such an adverse decision with the second instance court.

The infringement proceedings are independent of the invalidity proceedings. In civil cases, the Regional Court in Warsaw, which handles intellectual property matters, is responsible for recognising patent infringement. Meanwhile, the PPO has the authority to invalidate a national or European patent.

The court is not required to suspend the patent infringement proceedings when there are ongoing 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, which begins when the entitled entity becomes aware of both the infringement and the infringer՚s identity. This three-year period applies to each separate infringement. However, claims are barred after five years from the date 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. The deadline cannot be shorter than two weeks. As a rule, the court requires that a party present all allegations and evidence in response to the complaint. Failure to do so may result in losing the right to invoke them later, unless it can be demonstrated that the party could not raise those points due to new facts or circumstances, or that the need to raise them arose at a later stage.

A request for invalidation is served on the patent holder by the PPO. If the patent holder resides or is based in Poland, the PPO sets a response deadline of no less than one month. If the patent holder is based outside of Poland, the deadline is extended to two months. This deadline can be extended further if the patent holder notifies the PPO in writing, explaining the reasons for the delay before the original deadline expires.

In the case of patent infringement, the first court hearing is usually scheduled within eight to ten months from the date of filing the response to the claim, and the first-instance proceedings generally last about two to three years. Usually, before the first hearing, the court orders the exchange of further preparatory pleadings.

In cases of requests for invalidation, the first hearing is typically scheduled within six months from the filing date. The invalidation proceedings before the PPO usually last one to two years, but they may take much longer in particularly complex cases.

Claims for patent infringement can be initiated once the patent has been granted. If the infringer acted in good faith, claims can be pursued starting from the day the PPO announced the invention application. However, if the patentee had previously notified the infringing party about the filed application, claims can be pursued from the date of that 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 of the information about the European patent being granted.

Claims for infringement of a European patent can be pursued starting from the date when the translation of the claims of the European patent application is published in the bulletin of the PPO. This translation must be filed by the applicant with the PPO.

In cases involving patents for a process, the burden of proof is shifted. When it comes to new products, if the patent holder can demonstrate that they were unable to determine the actual method used by another person to produce the product, despite making due efforts, they may rely on the assumption that the product was made using the patented production method.

The Polish procedure in patent infringement cases provides for two types of discovery/disclosure proceedings:

• request for information; and
• request for disclosure or delivery of evidence.

Request for Information

A request for information can be filed both before and during the infringement proceedings.

The scope of information requested and the manner of the proceedings do not differ depending on whether the request is filed before or during the infringement proceedings. The entitled party is obliged to demonstrate the circumstances indicating the infringement credibly. Within these proceedings, only information on the origin and distribution networks of goods or services can be demanded if it is necessary to pursue the claim.

If the request for information was filed before the commencement of the proceedings, and the court ordered the entity to provide information, the party requesting information must commence the infringement proceedings within the time limit set by the court, which may not exceed one month from the date of the decision ordering the provision of 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 and can be made if the plaintiff has substantiated their claim. The requesting party must specify the evidence they seek to disclose or submit 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 defendant՚s trade secrets 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:

• not securing evidence would make it impossible or severely hamper the presentation or proof of facts relevant for reaching the decision;
• there is a risk of evidence being destroyed;
• a delay in obtaining evidence could hinder the achievement of the goal of the evidentiary proceedings; or
• there is a need to ascertain the existing state of affairs for other reasons.

The court decides on the application without the parties’ participation. If it issues a ruling 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 on which the decision becomes final.

The court only sends its decision on securing evidence to the entitled party. The other party gets this decision from the court 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 defendant’s trade secrets in another jurisdiction. This means that the disclosure of information obtained abroad would be possible only if the same parties were involved in the proceedings in both Poland and abroad.

Polish law provides for an action to establish that certain acts, whether performed or intended, do not infringe a patent. Such an action can be brought by an entity with a legal interest.

Under Polish law, legal interest occurs in the following two cases.

• The patent holder has asserted that the acts covered by the action constitute an infringement of the patent. This assertion is usually made by sending a cease-and-desist letter to the entity.
• The legal interest arises when the entity asks the patent holder to confirm that the acts covered by the lawsuit do not infringe their patent, but the patent holder fails to confirm this within a reasonable timeframe.

The law also provides that, to be duly set, the deadline for the patent holder to respond must:

• be in writing;
• not be shorter than two months from the date of delivery of the request;
• clearly indicate the actions that may infringe the patent and the extent of possible infringement; and
• ask the patent holder to expressly confirm that these actions do not infringe the patent.

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 they cannot rely on a literal interpretation of the claims. According to the methodology proposed by the Supreme Court, the answer to whether there has been an infringement is based on the following stages of examination:

• determining the subject matter of the patent on the basis of its claims, description and drawings, taking into account the technical problem underlying the invention and the essence of its solution, as well as the type of the protected solution;
• determining the technical features of the disputed solution, including the technical problem underlying it and the essence of the disputed solution;
• determining which of the technical features of the disputed solution correspond functionally to the solutions already existing in the prior art (determining the closest prior art for the disputed solution);
• comparing the determined subject matter of the patent with the technical features of the disputed solution to verify which features of the protected solution have been reflected in the disputed solution, including their obvious equivalents; and
• determining, in the event the technical features (obvious equivalents) reproduced in the disputed solution are essential to the technical solution protected by the patent, whether these features could have been developed by a person skilled in the art without knowledge of the patent.

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 response 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 be appointed as 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 is subject to the court’s discretion.

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 (seldom) deems it necessary. As in infringement proceedings, the parties often submit private expert opinions to corroborate their claims.

Experiments are allowed in patent infringement proceedings. An experiment can also form part of expert opinion evidence if conducting it or assessing its results requires expert knowledge. The court determines the manner in which the experiment is to be carried out.

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 in the invalidation proceedings before the PPO. However, in practice, this would 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 required to provide evidence that the patent has been violated, which entails proving that the defendant engaged in acts that constitute patent infringement. For instance, this could involve presenting samples of the goods made available in the market, along with documents confirming their purchase, or providing evidence of such products being offered, such as relevant information regarding the availability of medicinal products. To establish infringement, it is essential to demonstrate that these goods possess the features protected by the patent, which may include documents containing relevant analyses or expert opinions.

The defendant must show that the products placed on 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:

• transit privilege (transit);
• use of the invention for state purposes (subject to a decision by the relevant public authority);
• use of the invention for research and experimental purposes, including assessment, analysis, or teaching;
• Bolar exception; or
• preparation of the medicine in a pharmacy based on an individual medical prescription.

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. However, 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 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, at its discretion, suspend the infringement proceeding in such circumstances.

There are no legal grounds to suspend the proceeding due to a parallel proceeding in another jurisdiction. The judgments of courts from other jurisdictions may only have a psychological effect. The court, generally, does not rely on the reasoning contained in the rulings issued in other jurisdictions in its decision.

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 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 – 22nd Intellectual Property Division – 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 a technical background or expertise. The cases and appeals (appeals are decided by the Court of Appeal in Warsaw, 7th Commercial and Intellectual Property Division) are decided by a single judge.

A lawsuit for infringement may be filed if actions that constitute an infringement of the patent right are taken, ie, making, offering, using, placing 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 amount to an offer of the product. However, the Polish courts consider that entering a medicinal product on the reimbursement list qualifies as an offer. An offer also includes submitting a bid in a tender procedure.

In the case of patents for use, the trigger for filing a lawsuit for infringement is the offering of the product for protected use, even if that use has been removed from the Summary of Product Characteristics (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 EEA. However, market exclusivity is ten years and this period is calculated in the same way as the data exclusivity period.

The market exclusivity period may be extended for up to 12 months if an approval or authorisation is issued to add a new indication or indications within the eight-year data exclusivity period. 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), which shows 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 or mutual recognition procedures. In the case of authorisations obtained in the centralised procedure, Regulation (EC) No 726/2004, laying down community procedures for granting 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 11 years if, during the first eight years of exclusivity, the holder obtained authorisation for one or more therapeutic indications that bring significant clinical benefits compared to existing therapies.

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, placing on the market, exporting or importing it. These activities can be undertaken to perform the acts that are required by law to obtain 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 within the territory of the EEA, as well as in other countries.

The Polish Drug Authority maintains the Register of Medicinal Products Authorised for Marketing in Poland. The following are entered into the Register:

• medicinal products with a marketing authorisation issued by the President of the Polish Drug Authority in national (NAR), mutual recognition (MRP) and decentralised (DCP) procedures;
• medicinal products with a marketing authorisation issued by the European Commission in the centralised (CEN) procedure; and
• medicinal products with a parallel import authorisation (IR).

Once a month, the Polish Drug Authority announces a list of medicinal products that have obtained marketing authorisation. In principle, information on the registration of a medicinal product is available after the marketing authorisation is granted. 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 of the reference product is not automatically notified about ongoing procedures concerning marketing authorisations for generic products or biosimilars. However, they can request access to the files of such procedures. While the Polish Drug Authority has previously refused 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 is entitled to access 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 arises 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. In the procedure for granting authorisation, such an entity must submit 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, a generic drug can be added to 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 obtaining a prohibition on introducing the generic product to the market.

The Minister of Health publicly announces the reimbursement list every three months. The list is announced in the month preceding the three-month period in which it will be valid. Monitoring the Minister of Health՚s announcements is the only way to determine 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 the range of indications covered by the reimbursement for each drug, distinguishing, for individual preparations, whether it applies to all registered indications or only to some of them.

For biosimilars, the situation is much like that of generic drugs.

The data exclusivity periods for biosimilars are the same as for generic drugs. To use the data of the reference product, the biological product must meet the same equivalence criteria applied to generic products. If these criteria are not met, particularly due to 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.

Supplementary Protection Certificates (SPCs) are available in Poland under Regulation (EC) No 469/2009. This protection is, therefore, identical in all EU member states.

Granting an SPC is possible if:

• the product constituting the active ingredient or a mixture of active ingredients of the medicinal product is protected by a basic patent that is still in force;
• a marketing authorisation has been issued for the product as a medicinal product in accordance with the relevant EU regulations (ie, Directive 2001/83/EC for medicinal products for human use and Directive 2001/82/EC for veterinary products);
• the product has not been previously the subject of a certificate; and
• the marketing authorisation is the first authorisation to market the given product as a medicinal product.

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 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, 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 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 specified 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 SPCs 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 combination of products and each product separately, then on the basis of the same patent and marketing authorisation, a certificate can be issued both for the combination of active ingredients and for the individual active ingredient. An SPC can only be granted for those active ingredients that have been mentioned in the claims of the basic patent. However, if the patent only protects a combination 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 on its own.

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 then subtracting five years from that period.

Regulation (EC) No 469/2009 allows for a six-month extension of the SPC. The granting of the so-called paediatric extension depends on whether the application for marketing authorisation of the medicinal product in the EU includes 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 (EC) No 1901/2006 on medicinal products for paediatric use.

Paediatric use marketing authorisation (PUMA) is available in Poland on the basis of Regulation (EC) No 1901/2006; therefore, the procedure to obtain it is identical in all EU member states. PUMA is granted through existing marketing authorisation procedures and only applies to medicinal products developed exclusively for paediatric medicines no longer covered by intellectual property rights. However, the application must include a paediatric investigation plan on the quality, safety and efficacy of the medicine among children. PUMA benefits from eight years of data exclusivity, plus an additional two years of marketing exclusivity.

According to the provisions of Regulation (EC) No 141/2000, medicinal products designated as orphan medicines benefit from a ten-year market exclusivity period, which is granted for a specific clinical indication, meaning that each indication with an orphan designation confers an independent ten-year exclusivity period. Once the period of market exclusivity for all the orphan designations has expired, the product ceases to be classified as an orphan medicine.

Regulation (EC) No 1901/2006 allows for an extension of this period. Two additional years can be granted if the requirements for use in the paediatric population are fully met. Extensions are granted following a positive compliance assessment conducted by the Paediatric Committee and Committee for Medicinal Products for Human Use.

Under the Polish civil procedure, a party subject to a wrongful injunction is entitled to claim damages from the patentee. Third parties have no standing to seek such compensation.

A preliminary injunction is generally immediately enforceable. Where it provides for the seizure of goods, service is effected by a bailiff; otherwise, the court serves the injunction. Although this is not standard, the court may condition enforcement on the applicant providing security, either of its own motion or at the obliged party’s request.

When granting a PI, the court sets a deadline (no longer than two weeks) for the claimant to commence the main action; failure to meet this deadline causes the injunction to lapse.

It is possible to obtain an order suspending the enforceability of a granted PI pending appeal; however, this is entirely at the court’s discretion.

Final injunctions are enforceable after the court’s ruling becomes final, which means it is not subject to further appeal or cassation.

However, the court may order the immediate enforceability of the final 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 defendant’s potential damages if the final injunction is reversed or modified on appeal.

The enforcement of the final injunction is based on the enforceable ruling and an enforcement clause issued by the court. Enforcement of final injunctive relief, for example a prohibition on placing patent infringing products on the market, is carried out by the court acting in an enforcement capacity, which may impose a penalty on the infringer for breaching that prohibition.

The court may award damages in lieu of a final injunction:

• at the infringer’s request;
• if the infringement was not culpable (ie, neither intentional nor negligent);
• where awarding the injunction would place an undue burden on the party subject to it; and
• only if pecuniary compensation is sufficient to satisfy the infringed party’s interest.

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 the injunction.

General Considerations

Two main pecuniary claims can be raised against a patent infringer.

The first is a classic claim for damages where the claimant is required to demonstrate that:

• the infringement is attributable to the infringer (it was either intentional or caused by the infringer’s negligence); and
• damage was inflicted on the claimant, and that damage is a result of the infringement (there is a so-called ordinary/adequate causal relationship between the two).

Both the actual damage (damnum emergens) and hypothetical but highly probable lost profits (lucrum cessans) are subject to compensation. The claimant 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).

The second claim is for the handover of any benefits unlawfully obtained by the infringer (corresponding to the “recovery of profits” as described in Article 13(2) of Directive 2004/48/EC). Therefore, this is not exactly a claim for hypothetical profits lost by the patent holder (or by the licensee) but for the infringer’s actual profits resulting from the 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 it extends to all the income generated from exploiting the invention. 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 will likely 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, determining how the infringer profited from the infringement is relatively easy. 

Awards

The royalty on revenues for units sold is determined on a case-by-case basis, however legal literature usually indicates values between 1% and 10%. Polish law provides no basis for the court to increase the damages awarded based on whether the infringement was intentional or negligent. It has been a subject of debate whether 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 demand for payment.

Procedural Issues

Damages are generally considered together with liability, although it is possible for the court to issue a partial award on liability and 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.

As a rule, 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 incurred before filing actions are usually not recoverable, nor are many expenses incurred during the proceedings (eg, commissioning a private expert opinion).

In practice, the legal costs awarded by the court are often only a fraction of a party’s actual expenditure, particularly in relation to lawyers’ fees.       

The maximum filing fee for a statement of claim in cases involving monetary claims (eg, damages claims) in Poland is currently PLN100,000 (approximately EUR24,000).

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 uncommon 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’s trade mark). Both companies produce drugs containing acetylsalicylic acid, which is used in the prevention of heart disease. Swiss Pharma sought invalidation of “ANACARD PRO”, alleging harm to the reputation of “ACARD”, while Hasco argued non-use of “ACARD” and filed for its invalidation. The PPO issued a decision on the invalidation of the “ACARD” trade mark and dismissed the invalidation motion for “ANACARD PRO”, stating that the trade marks were not similar. Both decisions were appealed to the administrative courts and later to the Supreme Administrative Court, which decided to refer the cases back for re-examination, with final rulings expected in the coming years.

Swiss Pharma and Hasco were also engaged in another trade mark dispute. In 2016, Hasco sought invalidation of the “Ibuvit K+D” trademark owned by Swiss Pharma, claiming that the trade mark infringes the rights to Hasco’s earlier trade marks, ie, “ibum”, “IBUM POKONAJ BÓL SZYBKO”, “Ibum forte - najsilniejszy Ibum na rynku” and “JUVIT” trade marks, all of which were registered for pharmaceutical preparations. The dispute ended in the dismissal of Hasco’s invalidation application. The case advanced all the way to the Supreme Administrative Court.

The applicable laws for trade mark disputes in the life sciences and pharma sector are mainly found in 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 a final decision in court.

The most prominent case of GSK v Celon ended with a settlement. In this case, GSK claimed that the shape of its inhaler for treating asthma had sufficient 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 be protected by copyright law. However, as the dispute was settled, the court did not decide on the merits of the dispute.

Some typical copyright issues which may arise in the life sciences and pharma sector are:

• the protection and enforcement of copyrights in the originality, expression, and form of life sciences and pharma products;
• the transfer of copyrights to works such as the packaging of a drug, its shape, or its trade mark; or
• claims related to advertising activities when a drug manufacturer infringes on someone else’s copyrights.

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 breaches. 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 define “know-how” separately, 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:

• from a judgment of the court of first instance in a patent infringement case, the party may file an appeal to the court of second instance; and
• from a decision of the PPO in patent invalidation proceedings, the party may file a complaint to the Voivodeship Administrative Court.

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, such as violations of substantive or procedural law. The appellant has full freedom to present 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 arose only 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 in the court of first instance are invalid, the court will consider it ex officio. The court may examine the case at a non-public session if holding a hearing is unnecessary. 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 the 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 courts’ jurisprudence. The Supreme Court can uphold, quash, or amend the second-instance decisions or remand the case to the lower courts for reconsideration.

PI Proceedings

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, 7th Commercial and Intellectual Property Division.

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 court of second instance should examine the appeal against a PI decision 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 appeal may take several months to be reviewed.

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, nor does it conduct evidentiary proceedings or assess the evidence collected to determine which facts can be considered proven. Instead, the court focuses on reviewing the actions of the administrative authorities to ensure they were performed correctly. It checks whether the authorities adhered to the relevant provisions of administrative procedure and substantive law, including whether they thoroughly examined and assessed the evidence presented.

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 significantly impact 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

Typically, the panel of the Voivodeship Administrative Court that reviews the PPO’s decision consists of three judges who may (but do not have to) specialise in patent law, depending on their availability and allocation.

A separate procedure for IP cases was introduced in 2020 to ensure high-quality judgments and facilitate evidence gathering for claimants to pursue claims for infringement of intellectual property rights.

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, 22nd Intellectual Property Division.

The vast majority of IP cases in Poland that have been handled under a separate IP procedure concern copyright protection, with a significant number also involving trade mark protection. As for patent disputes, only a small number of new cases are registered each year.

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 and pharma IP litigation in Poland.

In Poland, patent litigation continues to be the standard method of resolving disputes. ADR in life sciences disputes in Poland is rare and faces 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 options are available in Poland.

Arbitration

Life sciences disputes are rarely resolved in arbitration proceedings. This results largely from the necessity of concluding an arbitration clause by the parties to the dispute (and some disputes concern infringement of rights by entities with whom no contract was concluded) and the lack of the arbitrability of disputes concerning patent validity. A decision by an arbitral tribunal on the validity of a patent would be invalid – this is a competence reserved exclusively for the PPO. Nevertheless, it is possible to conclude an arbitration agreement between the parties for the remaining scope and resolve the dispute, for example, on patent infringement.

Mediation

Depending on the type of proceedings, whether in court or before the PPO, there are instruments designed to encourage the parties to reach a settlement on their dispute. Nevertheless, mediation is not a common option for life sciences disputes in Poland.

In court proceedings, mediation is regulated by the Polish 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. The parties may initiate out-of-court mediation before or after the commencement of litigation, and they may select their own mediator and rules.

The Polish legislator continuously updates the regulations to further encourage parties to engage in mediation and to streamline the resolution of disputes through this method. A significant step was taken in August 2025 with an amendment to the civil procedure provisions, which introduced measures to simplify mediation procedures, including the electronic signing of settlement agreements and expanded powers for court clerks to direct cases to mediation. It is expected that mediation will become a more popular method of ADR in Poland in the coming years.

In trade mark opposition proceedings, the PPO imposes a mandatory two-month cooling-off period to allow the parties to seek an amicable settlement. This period may be extended up to six months on the joint request of the parties. During the cooling-off period, the PPO offers a way to resolve the dispute through voluntary mediation proceedings conducted jointly with the WIPO and following the WIPO’s mediation rules.

Some specific settlement/antitrust considerations in Poland 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 affect trade between EU member states may be subject to EU antitrust enforcement and 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 differ 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 anti-competitive practices, such as patent settlements, pay-for-delay agreements and the abuse of patent rights. For example, in Lundbeck v Commission (2021), the CJEU held that the pay-for-delay agreements at issue constituted restrictions of competition and upheld the EC’s decision to fine Lundbeck and the other parties EUR146 million.

The Enforcement of Claims in Group Proceedings Act and the Code of Civil Procedure provide for a statutory collective redress procedure. Collective proceedings can be initiated by a group of at least ten individuals or legal entities whose claims are based on the same factual basis and can be pursued within a collective redress regime. Class actions are brought to the court by the group’s representative, who acts in their own name but on behalf of the whole group and must be represented by a professional attorney. Claims that can be examined include:

• liability claims for damages caused by hazardous products;
• claims for damages;
• liability claims for non-performance or improper performance of contractual liability;
• claims for unjust enrichment;
• claims regarding customer protection; and
• claims regarding bodily injury or health disorders.

Claims for the protection of personal rights are not allowed in group proceedings, except for those arising from bodily injury or health disorders. However, pecuniary claims related to bodily injury or health disorders, including claims of the immediate family of an injured person who died, can only be pursued to establish the defendant’s liability. Each member of the group must have damages and causation clearly established. Any monetary claims should be standardised within the group as equal lump-sum compensation payments, though smaller subgroups can be created if needed. During the preliminary stage of group proceedings, the court determines the group claim’s admissibility and decides to pursue the case as a class action or reject the lawsuit. A decision to examine the case is followed by an announcement to commence group proceedings. Individuals who were not original claim holders can join the group, but the defendant can also file an objection to the inclusion of certain members. The merits of the claims are examined during the main stage of the group proceedings, which ends with the court issuing a judgment. Group proceedings in the life sciences and pharma sector are uncommon in Poland.

However, there have been cases in which the claim holders used a mechanism of collective redress. In November 2024, a class action lawsuit was filed by a group of Polish entrepreneurs regarding the establishment of liability of the State Treasury for losses arising from regulations that have created significant barriers for pharmacies to enter and exit the pharmaceutical market.