Liability for patent rights infringement in Ukraine involves a combination of customs, civil, and commercial sanctions: ranging from the suspension of customs clearance for up to 20 working days and judicial seizure of a product batch to the complete withdrawal of products from commercial circulation, their forced destruction at the infringer’s expense, and the recovery of documented losses, including the rightholder’s lost profits.
- Customs Barrier: Recording a patent for an invention in the customs register of intellectual property objects blocks the release of generics into free circulation under Articles 399–401-1 of the Customs Code of Ukraine without the need for prior court proceedings.
- Interim Relief: The commercial court may seize a batch of pharmaceutical products or prohibit the State Service of Ukraine on Medicines and Drugs Control from carrying out registration actions if the plaintiff proves the proportionality of the measures and provides counter-security under Article 141 of the Commercial Procedure Code of Ukraine.
- Expert Standard: The fact of unlawful use of an invention is proven through forensic examination under specialty 13.1.1, examining each element of the independent claim or applying the doctrine of equivalents (triple identity test).
- Material Sanctions: In addition to the disposal of counterfeit medicines, the importer or distributor bears financial liability for lost profits and legal costs, the volume of which is calculated based on license analogy or lost sales of the originator.
Protecting patent rights in Ukraine is always a high-intensity clash of commercial interests where every day of delay translates into million-dollar losses for the rightholder or irreversible losses for the distributor. This balance becomes especially acute in the pharmaceutical sector (Pharma & Life Sciences), where original drugs protected by invention patents (compounds, crystalline forms, compositions, or treatment methods) collide with generic equivalents striving for the fastest possible market entry after the monopoly expires.
This material provides a detailed analysis of practical response tools: from customs interaction algorithms and cargo seizure mechanisms to the appointment of expert examinations and the recovery of compensation for exclusive rights violations.
Customs Blocking of Generics: Algorithm of Legal Actions
The customs border is the first line of defense for a patent monopolist. When an economic entity attempts to import a batch of goods into Ukraine whose characteristics fall under the scope of a registered invention or utility model, the key legal barrier is the Customs Register of Intellectual Property Rights Objects (CRIPRO). Registering an object in this register allows the State Customs Service to initiate the suspension of customs clearance of goods automatically based on the risk management system (RMS).
However, in practice, this tool often becomes a battlefield between bona fide patent owners and importers, or conversely, turns into a weapon when bad-faith patent trolling is recorded. To secure supply chains, businesses need timely preventive protection against counterfeit products, which includes customs monitoring and risk profile tracking.
Customs Suspension Procedure and Response Timelines
According to the provisions of Articles 399 and 400 of the Customs Code of Ukraine (CCU), if the customs authority, based on CRIPRO data, suspects that the declared goods violate protected patent rights, customs clearance is suspended for 10 working days. This period can be extended for an additional 10 working days upon a reasoned motion by the rightholder. The total border blocking limit is up to 20 working days (almost a calendar month including weekends).
During this period, the importer suffers tangible losses: vehicle downtime fees, demurrage, and the cost of storing products at a customs-licensed warehouse (CLW). For pharmaceutical products, a critical factor is compliance with the cold chain and Good Distribution Practice (GDP), the violation of which can lead to the complete loss of the medicinal product’s consumer properties.
If you are acting on behalf of a distributor, the first 48 hours determine the success of your entire subsequent legal position. A detailed algorithm of actions in case of blocking a generic at customs requires immediate execution of formalized steps.
- Audit of Customs Notice: Within the first 12 hours, record the exact date and time of receipt of the notice in the form prescribed by the CCU, and identify the patent entered into CRIPRO.
- Verification of Patent Legal Status: Check the validity of the patent, payment of annual maintenance fees, and the absence of judicial challenges via official Ukrpatent registers or public services on the Diia portal under intellectual property services.
- Fixation of Cargo Storage Conditions: Submit an official application to the customs post and the CLW warehouse administration to ensure the temperature regime in accordance with the requirements of the registration dossier for the medicinal product.
- Participation in Sampling: Ensure the presence of an attorney or patent attorney during the collection of samples by the rightholder’s representatives pursuant to Article 401 of the CCU to prevent evidence falsification.
- Preparation of Written Objections: Draft and submit a reasoned position to the customs authority regarding the absence of rights infringement (e.g., references to non-use of all features of the independent claim or application of the Bolar exemption).
Bolar Provisions and Boundaries of Lawful Import
A fundamental tool for protecting importers of generic drugs is the Bolar exemption in Ukraine, enshrined in Part 4 of Article 31 of the Law of Ukraine “On Protection of Rights to Inventions and Utility Models.” Under this norm, the use of an invention in studies conducted for the purpose of preparing and submitting information for the registration of a medicinal product is not recognized as an infringement of patent-derived rights.
The boundary between lawful research and commercial infringement is extremely thin:
- Lawful Import under Bolar: Import of limited batches of Active Pharmaceutical Ingredients (APIs) or finished dosage forms purely for bioequivalence studies, stability tests, and the formation of a registration dossier for submission to the State Expert Center of the Ministry of Health of Ukraine (SEC).
- Infringement of Patent Owner Rights: Import of industrial commercial batches of a drug to a distributor’s warehouse before the expiration date of the basic patent for the purpose of their immediate sale on the day the monopoly expires. Judicial practice unambiguously qualifies stockpiling as introduction into civil circulation or preparation for it, which is not covered by the Bolar exemption.
Interim Relief in Pharma Disputes: Judicial Practice
If customs suspension measures expire and mutual understanding between the parties is not reached, the rightholder is obliged to apply to court. The patent owner’s key task on the very first day of filing is to block the movement of goods through the institution of interim relief.
Batch Seizure and Prohibition of Actions
According to Articles 136–137 of the Commercial Procedure Code of Ukraine (CPC of Ukraine), interim relief is permitted if the failure to take such measures could substantially complicate or make impossible the execution of a court decision or the effective protection of violated rights. In pharmaceutical disputes, specific seizure of a batch of medicinal products as an interim relief measure or a prohibition on customs authorities to perform customs clearance of a specific customs declaration is applied.
Originator plaintiffs typically demand combined measures:
- Seizure of a batch of goods located on the territory of a CLW or a distributor’s pharmacy warehouses;
- Prohibition on the State Customs Service and its structural units to release goods into free circulation (import customs regime);
- Prohibition on the Ministry of Health of Ukraine and the SEC of the Ministry of Health from making changes to the State Register of Medicinal Products or adopting decisions on the state registration of the generic.
However, higher-instance courts take a very balanced approach to such prohibitions because they can violate public order and citizens’ constitutional right to access medical care.
Standards of Proportionality Proof and Counter-Security
Counter-security of a claim (Article 141 of the CPC of Ukraine) is the most effective tool to protect a distributor from unjustified blocking of lawful business. The court is obliged to apply counter-security if there is a risk of causing significant material damage to the defendant in the event of claim dismissal.
The form of counter-security is depositing funds into the court’s deposit account or providing an irrevocable bank guarantee in an amount equal to the value of the batch of medicines or the distributor’s projected storage and demurrage costs. Courts refuse relief if the originator provides declarative evidence without proper financial coverage of the defendant’s risks.
| Evaluation Criterion | Admissible Evidence of Relief Necessity | Inadmissible / Insufficient Evidence (High Risk of Refusal) |
|---|---|---|
| Proportionality of Measures | Seizure applied exclusively to a specific declared batch of goods with a clearly defined serial number. | A demand to ban the import of any products of the defendant or suspend the distributor’s license entirely. |
| Proof of Infringement Fact | Conclusion of a forensic patent examination or specialist report regarding the presence of all claim features in the product. | Only a copy of the plaintiff’s patent and assertions of external similarity or identical INN (International Nonproprietary Name). |
| Counter-Security | Deposit of funds into the court account in the amount of the customs value of the goods batch + 6 months of storage costs. | Refusal or evasion of making a deposit with references to the high business reputation of the foreign company. |
| Impact on Public Interest | Evidence of the presence of a sufficient quantity of alternative drugs at affordable prices on the market. | Creation of a monopoly shortage of a critically important drug during a state of emergency or martial law. |
Forensic Examination and Doctrine of Equivalents in Disputes
After addressing the procedural issues of interim relief, the commercial court proceeds to hear the case on the merits. The central figure in the process becomes a certified forensic expert, and the main evidence is a forensic examination in the field of intellectual property. Judges lack special knowledge in bioorganic chemistry, molecular pharmacology, or the synthesis of polymorphic forms, so the court decision is 90% based on expert conclusions.
Below is the procedural structure of proof during the resolution of such conflicts in court.
Key Action: Sampling of imported products at the CLW and requesting customs documentation.
Goal / Requirement: Obtaining a Certificate of Analysis (CoA) and technological regulations for the API.
Result: Fixation of physical material samples of the substance for comparative analysis.
Key Action: Motion to the commercial court for appointing an examination under specialty 13.1.1.
Requirement: Approval of the certified expert’s candidacy and formulation of precise questions.
Result: Court ruling on staying proceedings and sending materials to the expert institution.
Action: Comparison of each feature of the independent claim with the chemical composition of the sample.
Requirement: Use of chromatography-mass spectrometry, NMR, or X-ray diffraction analysis.
Result: Establishment of literal use of the claim or replacement of individual components.
Body / Action: Application of the doctrine of equivalents by the expert in case of detecting modified elements.
Basis: Analysis via the “function — way — result” test (triple identity test).
Result: Conclusion on the identity of the impact of the replaced feature on the technical result.
Decision: Court evaluation of the expert conclusion in aggregate with other evidence and application of infringement consequences.
Result: Claim satisfaction, seizure and destruction of goods, or claim dismissal and lifting of restrictions.
Appointment and Questions of Forensic IP Examination
Forensic examination is appointed under specialty 13.1.1 “Research related to inventions and utility models.” The main rule of Ukrainian patent law enshrined in Part 2 of Article 28 of the Law of Ukraine “On Protection of Rights to Inventions and Utility Models”: a patent is recognized as infringed when every element (feature) included in the independent claim of the invention, or an equivalent element, has been used.
If at least one essential feature of the independent claim is not used in the studied sample of goods or API, patent infringement is absent. The loss of patent disputes in most cases is caused by the incorrect formulation of questions to the forensic expert.
Doctrine of Equivalents: Practice of Ukrainian Courts
The doctrine of equivalents is applied in court when a bad-faith manufacturer intentionally introduces minor, non-essential changes to a product or technological process (e.g., replaces one inactive stabilizer with another or uses a solvate instead of an anhydrous form), trying to bypass the literal text of the patent claim.
The practice of the Commercial Cassation Court within the Supreme Court (CCC SC) has established an approach whereby a feature is recognized as equivalent if it performs the same function in the same way and achieves the same result (the so-called “triple identity test”), and this must be obvious to a person skilled in the relevant art at the priority date of the invention application. It is important to consider that the doctrine of equivalents applies only to inventions where a high inventive step is presumed, and does not apply to simple utility models.
Sanctions and Compensation: Consequences of Patent Infringement
When the commercial court establishes the fact of infringement of the exclusive property rights of the patent owner, the stage of determining the legal liability of the defendant begins. The law provides for a wide range of civil law sanctions: from prohibitions on use and product withdrawal to the complete destruction of counterfeit batches and recovery of compensation for caused losses.
Seizure and Disposal of Counterfeit Goods
According to Article 432 of the Civil Code of Ukraine (CC of Ukraine), the court has the right to decide on the withdrawal from commercial circulation of goods manufactured or introduced into civil circulation in violation of intellectual property rights, and the destruction of such goods at the expense of the person who committed the violation.
The destruction of counterfeit medicines by a court decision entails colossal risks for a distributor:
- Direct Material Losses: Irreversible loss of the value of the goods batch (customs value along with paid duty, excise, and VAT is not subject to refund from the state budget);
- Special Disposal Costs: Pharmaceutical products belong to hazardous waste, so their destruction is carried out exclusively by specialized licensed enterprises through high-temperature incineration, the costs of which are fully recovered from the infringer through the State Enforcement Service bodies (SES);
- Impossibility of Re-export: If the court orders the goods to be destroyed, customs will not issue a permit for their re-export to the manufacturer in the country of origin, even if the contract provided for buyback.
To prevent total financial collapse and effectively manage claims, companies need comprehensive protection against counterfeit products in judicial and out-of-court procedures, allowing them to reach settlement agreements with the possibility of lawful processing or re-export of packaging or components if the basic substance is not affected.
In addition to protecting invention rights, rightholders often employ combined strategies, invoking the norms of the Law of Ukraine “On Protection of Rights to Trademarks for Goods and Services” when patent infringement is accompanied by imitating the design of blisters, packaging, or using similar trademarks.
Methods for Calculating Losses and Compensation
Civil liability for patent rights infringement provides for compensation for material damages, specifically actual losses and lost profits. Lost profits in pharma disputes are the most difficult to prove, as the plaintiff must provide irrefutable evidence of a causal link between the generic importer’s actions and the reduction of their own income.
Ukrainian judicial practice applies three main approaches to calculating recoveries:
- Lost Sales Concept: The plaintiff calculates the number of generic packages sold by the defendant on the Ukrainian market and multiplies this volume by their own marginality per unit of the original drug. Courts satisfy such claims only when the originator proves that they possessed the production capacities to fully satisfy market demand in the absence of the generic.
- Disgorgement of Profits: Recovery of net profit obtained by the infringer from the sale of the illegally imported batch based on tax and accounting reporting data seized under a court request.
- Reasonable Royalty Method: Calculation of the monetary amount that the defendant would have had to pay to the patent owner under a concluded license agreement for the right to import and sell the relevant volume of products. The calculation base is average market royalty rates in pharmaceuticals (usually 5% to 15% of the batch value) or the plaintiff’s active license contracts in other jurisdictions.
Comprehensive Patent Protection: Rightholder Strategy
Patent protection in Ukraine can no longer exist as a reactive procedure when a company remembers its rights only after analogues appear on pharmacy shelves. An effective barrier against infringements is built on the integration of preventive customs mechanisms, a high-quality patent portfolio, and readiness for fierce judicial defense.
Entering patents into the customs register is a critically important, but insufficient step. Without systematic monitoring of registrations at the SEC of the Ministry of Health, prior audit of the patent clearance of generic drugs, and preparation of a forensically flawless invention formula, winning a lawsuit is impossible. If your business faces illegal import or, conversely, unlawful blocking of legal products through manipulative patents, contact legal assistance to implement a comprehensive service of protection against counterfeit products, judicial support, and intellectual property audit.
