At the end of August, an amendment to the Polish Code of Civil Procedure (KPC) was announced, with key provisions addressing patent litigation, injunctions, and intellectual property rights protection, which will come into effect on 1 March 2026.
The planned 2025 amendment will abolish the rigid six-month deadline for filing injunction requests, legal measures that temporarily prevent the market launch of allegedly infringing products. This change has drawn responses from both generic and innovative pharmaceutical sectors.
“Intellectual property protection forms the foundation for investing in the lengthy, complex, risky, and costly process of bringing innovative medicines to patients, which improves healthcare efficiency and contributes to economic growth by enhancing public health,” Michal Byliniak, Director General of INFARMA, told Euractiv.
Protecting patients
Prior to the 2023 legal changes, courts could ban sales of competitor medicines based solely on patent holder claims, without hearing the accused party. This led to situations where sales were blocked based on patents under invalidation rules or already invalidated elsewhere.
The 2023 provisions introduced a strict six-month limit for filing injunction requests, starting from when the patent owner learnt of an alleged infringement. The patent holder also had to inform courts of ongoing invalidation proceedings.
Crucially, courts were required to hear both parties before granting injunctions, which temporarily banned cheaper generic medicines, making automatic blockades less common. These measures aimed to curb patent abuse, enhance patient access to generics, and save the National Health Fund (NFZ) money.
The 2025 amendment will remove the fixed six-month limit, leaving courts’ discretion to assess timeliness based on each case’s circumstances. Likewise, patent holders will no longer be obliged to automatically disclose ongoing invalidation actions, although courts may still consider such information.
Industry debate
The amendment has stirred debate. Generic drug producers warn that it may hinder competition, increase therapy costs and limit access to reimbursed medicines.
Cheaper generics can reduce therapy costs by 85–99%, generating multimillion-euro savings annually and broadening patient access.
Grzegorz Rychwalski, Vice-President of Poland’s Association of National Drug Manufacturers, argues: “The project harms Polish patients and exposes the NFZ to unjustified expenses. It blocks fair market competition for domestic producers and damages the economy.” Even a three-month delay in launching one generic could cost the NFZ about €2.34 million, the association argues.
The innovative medicines sector offers a different perspective. “The amendment preserves the importance of a timely reaction to alleged rights infringements. The timeliness assessment remains, but within a broader legal interest analysis, not a fixed deadline,” Byliniak told Euractiv.
He notes the previous six-month limit sometimes obstructed legitimate delays due to prolonged negotiations, temporary product launch halts, or complex evidence gathering.
Procedural delays
Polish courts have historically considered response delays, often interpreting lengthy delays as tacit acceptance of infringement, thereby negating the need for court injunctions.
Removing the compulsory duty to inform courts of ongoing patent invalidation does not mean ignoring such factors. Courts may still consider high invalidation likelihood when evaluating claims.
Specialised Polish courts deal with patent disputes flexibly, using consistent criteria without rigid statutory limits. Past regulations restricted judicial discretion, drawing criticism. The amendment restores courts’ ability to weigh multiple factors, aiming for fair, context-sensitive rulings.
Byliniak rejects fears that changes will restrict access to generics or remove currently available medicines. “The amendment will not lead to withdrawal of legally marketed generics introduced after patent expiry,” he stated.
Judicial injunctions do not equate to lost access to treatment, as reimbursed innovative medicines remain available, ensuring continuous care.
He added that intellectual property protection balances stimulating innovative drug development with transferring technology to generics. While recognising payers’ valid desire for more affordable generics, this must not undermine fundamental intellectual property rights or judicial powers.
[VA, BM]