By its Ruling of 25.09.2023 in case No. A40-185112/2022, the Ninth Commercial Court of Appeal ordered the pharmaceutical company Vertex, the right holder of a series of patents for the drug Trikafta (INN: Ivacaftor+Tezacaftor+Elexacaftor, Ivacaftor), to grant a simple (non-exclusive) license to the Russian pharmaceutical company MIK under Article 1362(1) of the Russian Civil Code (insufficient use of patents).
In the reasoning part of the decision, the appellate court explained what circumstances shall be established in order to issue a compulsory license:
- Lack of use or non-use of the invention, resulting in an insufficient provision of patent-protected goods on the market
This circumstance can be confirmed, in particular, by providing information on the number of patients who are insufficiently supplied with the original drug and failed state procurements. Analytical publications of Russian and foreign mass media may be presented as evidence of insufficiency.
At the same time, registration of an original drug alone cannot serve as proof of sufficient supply on the market.
The court also pointed out that the burden of proof primarily falls on the patent holder, while the claimant’s failure to provide evidence of insufficient use of the invention is not a ground for dismissal of the claim under Article 1362(1) of the Russian Civil Code.
- Claimant's willingness and ability to use the invention
This circumstance may be confirmed by information on the implementation of preparatory actions for the production and sales of the drug, in particular, a license for the importation of the drug into Russia, a copy of a contract with a foreign generic manufacturer, and information on the expected import volumes.
- Requesting an offer to conclude a license agreement, compliance of such license agreement with established practice
In this case, it is sufficient to provide confirmation of sending the request to the right holder’s legal address, as well as to indicate the absence of a substantive response or attach a corresponding written refusal to conclude a license agreement.
It is worth noting that this case is not only the first case in which a compulsory license was issued under Article 1362(1) of the Russian Civil Code, but also an important legal precedent describing the burden of proof in this category of disputes.
Given the complexity of the dispute, we expect further clarification to be obtained at the level of the Intellectual Property Court and the Supreme Court.