Patent litigation in Practice Series: How the Finnish principle of openness in governmental activities affects patent enforcement measures

Every month our international team provides practical insights into patent litigation across jurisdictions. Our Helsinki IP partner Henri Kaikkonen explains how Finland's principle of openness in governmental activities affects patent enforcement, particularly in relation to medicines.

Principle of openness

Finland strongly upholds the principle of openness in governmental activities, granting everyone the right to obtain information from both official documents prepared by authorities or courts, and private documents held by them. By default, all documents submitted to or held by authorities are public, with non-disclosure being the exception.

The Finnish Act on Openness in Governmental Activities (621/1999) outlines key non-disclosure provisions, including protection of trade secrets. Businesses may request that certain parts containing trade secrets should not be disclosed. If authorities agree, only redacted versions are publicly available. However, parties directly affected by the matter may access unredacted versions under certain circumstances.

Publicly available information on medicines

Under this openness principle, the Finnish Medicines Agency (Fimea) maintains a list of all marketing authorisations (MA) applications being processed, which is updated biweekly. The list contains information on applicants, the nature of the application, process start times and application numbers, grouped by ATC classification and active substance.
As this level of transparency for pending MA applications is rare among EU countries, many originators leverage Fimea's information to send warning letters to generic companies when their products appear on lists of pending or granted MAs.

Additionally, MA holders seeking reimbursement status must apply to the Finnish Pharmaceutical Pricing Board (Hila), which publishes information on pending and granted applications. Since approximately 90% of prescription-only medicines in Finland are reimbursable, this is a common procedure for market entry.

When a generic medicine becomes reimbursable, it enters Finland's mandatory generic substitution and reference price system. MA holders must submit quarterly reports about their medicines' availability and prices to the Social Insurance Institution (Kela). Kela then determines price bands and reference prices, which are published shortly before the start of each quarter. While the price notifications aren't public, the list of medicines that require mandatory notification is public. MA holders don't know with certainty if competitors’ substitutable medicines will be available in the upcoming quarter until about a week before. 

Finally, when a medicine is released for sale and becomes generally available, the MA holder must notify Fimea at least 8 days in advance. Fimea will then update its publicly available medicine database to show if the medicine is actually on sale or not.

Paper measures or acts of infringement?

While applying for an MA doesn't constitute patent infringement under Section 3(3) of the Finnish Patents Act (550/1967) due to the Bolar exemption, the situation is less clear regarding other regulatory measures. Since these steps may be completed well before launch, a common question is what measures can a MA holder take without risking infringement litigation or preliminary injunctions (PIs).

Section 3 of the Patents Act specifies infringing acts for product patents and manufacturing method patents, including manufacturing, offering, marketing, use, importing, and possessing products for these purposes. According to Section 70d, the same applies to supplementary protection certificates (SPCs).

Finnish legal literature (citing Swedish Supreme Court Ruling HD20081223 – T 4705-07) indicates that MA applications and reimbursement requests don't constitute ‘offering' under section 3. However, the travaux préparatoires of the Patents Act define 'putting on the markets’ broadly to include activities intended to place products on the market, raising questions about whether regulatory measures qualify.

Reimbursement status equals risk of infringement

These questions were partially addressed by the Helsinki Court of Appeal in its ruling no. 3867 (November 28, 2007), where a patent holder sought both a PI and permanent injunction because the defendant had obtained an MA and reimbursement status.

While the District Court dismissed the action as premature, the Court of Appeal disagreed, stating that PI applications and permanent injunctions were permissible where an imminent threat of infringement existed. The Court noted that TRIPS requires effective remedies for threatening infringements, not just those that have already occurred.

In a more recent case (MAO:186/2024, March 28, 2024), the Market Court granted a PI where the patent owner argued that obtaining an MA and reimbursement status indicated the defendant’s readiness to enter the Finnish market, noting that the infringement risk wasn't 'highly unlikely'. Similar reasoning appeared in Market Court cases MAO:421/2023 and MAO:423/2022, where PIs were granted based on defendants obtaining MAs and reimbursement status for allegedly infringing products.

Price notification as an act of infringement

In case MAO:420/2022, an SPC owner went a bit further and applied for an ex parte PI against a defendant whose medicine had received MA and reimbursement status in Finland.

The ex parte PI against 'offering’ and ‘putting on the markets’ was granted. Notably, the SPC was about to expire. The owner also sought to prevent the defendant from making a price notification to Kela indicating availability before the SPC expired, to prevent Kela from considering the medicine in reference pricing for the subsequent quarter. 

Though the Market Court rejected the PI in relation to the price notification, the parties debated whether such notifications should constitute patent infringement. The SPC holder argued that Finnish law requires medicines to be available when notifications are made, while the defendant maintained that price notifications were statutory, non-public processes made only to authorities. The Court ultimately dismissed the PI application without taking a clear stand as the SPC expired during the proceedings. 

Conclusions

The transparency of Finnish medicine authorities (Fimea, Hila, Kela) creates opportunities for international originators to enhance patent monitoring and enforcement. Recent Supreme Court case law (discussed here) has also strengthened the presumption of patent validity in PI proceedings, making them more effective.

Generic companies wishing to avoid launching at risk should also take into account Finland’s high level of public information and prepare defence strategies early. After certain regulatory steps, a warning letter pertaining to Finland may be the first indication of interest from the patent owner, even within the broader European context.