The Court Determined the Burden of Proof in Cases for a Compulsory License to a Pharmaceutical Patent (Article 1362(1) of the Russian Civil Code)

In case No. A40-185112/2022, the Moscow Commercial Court determined the evidence to be presented by the claimant when considering a claim for a compulsory license under Article 1362(1) of the Russian Civil Code. The case is currently being considered by the appellate court.

It should be noted that this case is the first one where the court determined the burden of proof in cases for a compulsory license.

According to Article 1362(1) of the Russian Civil Code, in case of non-use or insufficient use of the invention within 4 years from the date of grant of the patent and if the patentee refused to conclude a license agreement, one willing and ready to use such invention has the right to file a lawsuit against the patentee for granting a compulsory simple (non-exclusive) license to use the patent on the Russian territory.

Dismissing the claim, the court indicated evidence that have to be submitted by the claimant to obtain such a compulsory license.


The Court’s Comment

Non-use or insufficient use of the invention

Such evidence which allows to conclude that the invention is not used or used insufficiently shall be provided. Failure to prove this circumstance is an independent ground to dismiss the claim

Willingness and readiness of the claimant to use the invention

The claimant shall provide information on the drug to be imported to Russia, the country of its registration, information about its manufacturers and the volumes of the intended import

Conclusion of the relevance of the patents listed in the claim both to the drug which the claimant intends to import into Russia and to the defendant's original drug

Otherwise, Article 65 of the Russian Commercial Procedure Code is breached

Additionally, the court noted that the claimant shall specify independent claims of the patent with respect to which a compulsory license is required. This issue is especially actual if patents protect not only the product but also its manufacturing or a method of treatment. Also, it is not sufficient to provide only a patent attorney’s opinion describing the original patents.

We believe that similar provisions can be applied when issuing a compulsory license under Article 1360 of the Russian Civil Code.