Background

Pursuant to Article 41(3) of the Patent Law, applications for interim measures (ie, provisional protection measures) are regulated by the law and the Code of Civil Procedure. Article 41(3)(2) of the law provides that if there are sufficient grounds to suspect a violation of the rights established by the law, the court may, in accordance with the procedure in the code, apply such interim measures as are necessary to prevent imminent unlawful activities, promptly terminate such activities or enforce a final court decision. The court may:

• prohibit persons from committing an imminent infringement of rights established by the law;
• order persons temporarily to terminate an infringement of such rights;
• prohibit an intermediary from providing services to a third party that uses such services by infringing such rights;
• order the seizure of copies of material that is subject to such rights, and either prevent the entry of goods into the channels of commerce or remove goods from such channels if the goods are suspected of infringing such rights;
• in the case of an infringement committed on a commercial scale, order the seizure of the property of persons suspected of infringing such rights, whether it is in the possession of such persons or a third party (including assets held in the accounts of banks or other credit institutions), and either order the communication of bank, financial or commercial documents or require appropriate access to such documents; and
• apply other measures for which the code provides.

Facts

On February 24 2011 Bayer filed a preventive civil action against UAB Ladee Pharma Baltics for alleged infringement of its extended European patents 1214076 and 1380301 for the pharmaceutical combination of ethinyl estradiol and drospirenone for use as a contraceptive. Bayer sought interim measures, asking the court to order Ladee Pharma Baltics:

• immediately to cease selling and advertising medicinal products containing the pharmaceutical composition of ethinyl estradiol and drospirenone - the main ingredient in the medicinal product Etindros - in Lithuania;
• to withdraw Etindros already supplied to the Lithuanian market; and
• to refrain from violating Bayer’s Patent rights in future, thus prohibiting Ladee Pharma Baltics from selling, advertising, importing and exporting Etindros (containing the pharmaceutical composition of ethinyl estradiol and drospirenone, in a micronised or other rapidly soluble form, as the active substance) in Lithuania until the enforcement of a final decision in the case.

At the time of Bayer’s filing of a civil action, Ladee Pharma Baltics had already brought a civil action against Bayer in Lithuania, challenging the validity of the extended European Patent 1380301 (among others). Meanwhile, the European Patent Office has been handling a dispute based on an appeal by pharmaceutical company Hexal Pharmaforschung GmbH over the challenged European Patent 1214076 B1.

In the circumstances the first instance court refused to impose interim measures on Ladee Pharma Baltics. It found that Bayer’s civil action had not met a level of proof that would justify the application of interim measures that would have almost exactly the same consequences as the satisfaction of the claim.

Bayer appealed. Its main argument was that the disputed court decision was inconsistent with longstanding court practice, whereby the courts have generally satisfied requests for interim measures in preventive civil actions and have not sought to determine whether the claims made are legally valid and well founded when deciding on the application of interim measures.

Decision

On May 19 2011 the Court of Appeal confirmed the first instance court’s decision and reasoning.

The Court of Appeal explained that under Article 41(3)(2) of the law, when deciding on the need for interim measures in a dispute about violation of a Patent owner’s rights, the prima facie validity of the claim must be assessed. It considered that:

“the court must, prima facie, assess the demands stated in the claim and supporting evidence. If, upon carrying out such an assessment, the court believes that a decision favourable to the plaintiff could not be adopted, it also becomes clear that the execution of such a decision could not be impeded or become impossible either. Thus, pursuant to Article 41(3)(2) of the Patent Law, where the level of provability of claims is obviously questionable, the application of interim measures becomes purposeless. The purpose of this mandatory provision is primarily attributable to the fact that the nature of claims and interim measures in disputes over a violation of the rights of Patent holders is virtually the same, and therefore the legal consequences created for the defendant during application of interim measures are basically the same as in the case of satisfaction of the claim.”

The fact that the validity of both extended European patents was being challenged, either in national court proceedings or in the European Patent Office, and that equivalent patents had been invalidated in other national jurisdictions, was significant. Combined with the specialists’ conclusions that the patents in question did not meet the relevant patentability requirements, these factors were sufficient for the court to conclude that:

“the adoption of a decision favourable to the plaintiff in this case raises reasonable doubts because there are reasonable doubts about the validity of recognition of the plaintiff as the owner of the patents. Therefore, it cannot be stated that there are sufficient grounds to suspect that the defendant has committed a violation of the rights of a Patent holder protected by the Patent Law.”

Comment

The decision clarifies that if a Patent holder seeks interim measures in Patent infringement cases in Lithuania, where the effect of such measures would virtually coincide with the consequences of a successful claim, it must have a strong Patent with no reasonable doubts surrounding its validity.

Lideika Petrauskas
 LAWIN