Posted: November 12th, 2013
The Metropolitan Tribunal (Budapest) has granted at first instance a preliminary injunction in a pharmaceutical patent infringement case based on a supplementary protection certificate.
The case involved two plaintiffs, one of them being the exclusive licensee of the subject SPC, while the other is a pharmaceutical company who acquired from the first plaintiff the marketing authorization of the product protected by the SPC in Hungary. The holder of the SPC was not party to the case, it empowered the first plaintiff to proceed in its own name. The defendant was a Hungarian company importing and marketing a pharmaceutical preparation that infringed the SPC in the view of the plaintiffs.
The main claim of the basic patent covered the synergetic combination of two compounds as active agents in a pharmaceutical preparation , while one of the subclaims defined the ratio of the agents. The basic patent expired in 2012.
The SPC covers a pharmaceutical preparation containing the combination of two specific active ingredients. The protected product is a painkiller.
At the time of the filing of the request for the institution of a preliminary injunction both the patent and the SPC were subject of a first instance revocation proceeding in front of the Hungarian Intellectual Property Office (HIPO).
In its decision the court mostly agreed with the request and granted preliminary injunction, however, only in favor of the first plaintiff, that is the registered licensee of the SPC holder. Namely, the court rejected the request of the second plaintiff, the marketing authorization holder of the protected product arguing that the company was not a registered licensee and mere the fact that the first plaintiff had earlier transferred the marketing authorization to the second plaintiff did not establish the latter’s legal standing in the preliminary injunction proceeding.
After such preliminary remarks the court established that the product of the defendant infringed the subject SPC as it contained the combination of specific active agents described in the certificate and their ratio also fell within the range given in the cited sub-claim of the basic patent. As in many earlier decisions, the court emphasized that the arguments used in the ongoing revocation proceedings against the patent and the SPC as well as the references to foreign validity decisions were irrelevant in the proceeding related to infringement (bifurcation principle).
The court had stated that in line with the Patents Act it should be presumed that the preliminary injunction was necessary for the protection of the plaintiffs' rights as the preliminary injunction proceeding was initiated in due time, i.e. within 60 days from the date the plaintiffs had become aware of the infringement and at the same time within 6 months from the start of the infringing activity.
In connection with this the court did not share the objections of the defendant who argued against the evidence used by the plaintiffs to establish the respective dates. Namely, the defendant complained that the plaintiffs submitted English language business e-mails to prove the date when they had learnt about the infringement, about which the defendant argued that they should not have been accepted as evidence in the absence of sufficient authenticity. The court rejected this argument stating that this way of communication is generally reasonable and natural in the business area, so the e-mails could be accepted as proof in the absence of any specific objection to their content.
On the other hand, the court stated that the plaintiffs failed to prove the necessity of the preliminary injunction with respect to the need to prevent imminent damages.
The court argued that the defendant’s product had been on the market for a few months and it was too early to draw any consequence as to the potential decrease of the plaintiffs' sales from the IMS data of this period.
Regarding the proportionality of the injunction the court established that the benefits would outweigh the disadvantages on the defendant’s side who had already voluntarily suspended orders of the infringing product. Furthermore, the court contended that interest of patients would also not be harmed as there remained other products available on the market with the same therapeutic indication and the fact that the products in suit are not reimbursed by the National Health Insurance Fund suggested that the state does not regard these type of products to be of distinguished importance for the patients.
The court made the injunction subject to the deposition of a security bond of HUF 21 million, approx. EUR 70 000 by the first plaintiff. This amount was less then half of what the defendant had asked for, however, the court emphasized that the defendant failed to provide specific calculation supporting its claim. On the other hand, the first plaintiff offered the amount that was eventually ordered supported with detailed calculations on the potential and expected profit loss of the defendant based on IMS data, which was agreed by the court. Importantly, the court emphasized that it was not possible to determine more punctually the amount of the expected profit loss of the defendant at this point, however, that was not even required. Namely, should the preliminary injunction turn out to be unfounded eventually, the defendant will have the possibility to claim additional compensation should its actual damages exceed the amount of the deposited bond.
The first plaintiff has paid the bond in due time, therefore the preliminary injunction entered into force, however, the defendant is allowed to file an appeal to the Metropolitan Appeal Court for the reversal of the decision.
Date of the decision: 2nd October, 2013
Docket number 3.Pk.24.148/2013/7.
Reported by Eszter Szakács