Additional information about the product cannot be considered as re-packaging

Author: Inga Lukauskiene, Associated Partner, Attorney-at-Law, Patent Attorney at METIDA

8588247323_647a19a26d_zOn 20 March 2015 the Supreme Court of Lithuania rejected a cassation by Roche Diagnostics GmbH (a plaintiff) concerning a judgement of the Panel of Judges of the Civil Division of the Court of Appeal of Lithuania of 22 April 2014 which dismissed their claim to Optifarma Ltd (a defendant) on the protection of trademark proprietor’s rights and the discontinuation of distribution of medical devices that do not meet the requirements of legal acts.

According to the plaintiff, an informational sheet in Lithuanian  (user manual) for defendant’s distributed medical device is added to it its paper package separately, i.e. it is attached to the exterior part of the package by a rubber band, but not stored inside, thus it can easily fall off. What is more important, neither the Lithuanian user manual, nor the package of the device includes the name of the distributor, and the instruction added to the defendant’s distributed medical device does not match original producer’s instructions. Finally, defendant’s distributed devices produced by the plaintiff do not meet the requirements of other legal acts and infringe producer’s rights.

The plaintiff further claims that a medical device Accu-Check Performa distributed by a defendant had a misleading manual written for another device (the number in the Lithuanian manual attached to the device did not match the number of the medical device itself and the number displayed on the package). Under plaintiff’s opinion, defendant’s actions have infringed the rights of the producer, a proprietor of the national trademark Accu-Check. To specify, the illegally changed package of the device marked by the trademark and the illegally attached instructions have worsened the quality of the medical device where the instruction is one of its component parts. Thus, if consumers followed the instructions, they could inappropriately use the device and injure themselves.

Both the court of first instance and the Lithuanian Court of Appeal ruled that plaintiff’s rights had not been infringed. The Supreme Court of Lithuania upheld this decision after having determined that there was no re-packaging in this case, as under the legislation on regulations concerning the distribution of in vitro diagnostic medical devices, paper labels on the package and the instructions written in Lithuanian (in the form the information was given) cannot be considered as way of re-packaging.

Furthermore, the defendant included the additional information to the package’s exterior only to comply with the requirements of the regulatory legal acts of the Republic of Lithuania, stating that the information about the device dedicated to the final consumer must be written in a national language. Therefore, the attached translation of the text on the original package as well as the instructions translated in the national language presented in the manner described above cannot be considered as the re-packaging of plaintiff’s produced goods. In addition, the defendant neither opened the packages, nor caused any damage inside and outside the package, and only attached the translation with the manual to the original package. Thereby, these defendant’s actions could not have had any impact on the quality of plaintiff’s produced devices.

The plaintiff in this case also complained about the copyright infringement, as the manual was translated into Lithuanian without their consent. The Supreme Court of Lithuania did not agree with lower courts’ opinion that under article 5 of the Law on Copyright and Related Rights of the Republic of Lithuania the user manual of the in vitro diagnostic medical devices should not be considered as the subject of copyright per se. However, according to part 1 of article 4 of this law, the instructions of the in vitro diagnostic medical devices do not meet the originality requirement, which is an important condition for the protection to be granted. According to the courts, plaintiff’s manual only gives information on the composition of the device and its impact on human body as well instructs step-by-step how to use the device, as law regulations require to do this. Thereby, the manual cannot be considered a result of the creative process.

To conclude, companies that distribute medical devices have the right to translate the user manual into Lithuanian as well as attach it to product’s package unless the package or the quality of the product is damaged (under the marking requirements, they are obliged to do so).

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