A medical research company was not allowed to import Trikafta, a generic drug for cystic fibrosis.

Despite the fact that the Medical Research Company (MRC) managed in court to obtain from the American Vertex a compulsory license to use patents protecting the expensive drug against cystic fibrosis, Trikafta, it is too early to put an end to the dispute. Rospatent refused to cancel, at the request of the MIC, two patents for medicines that were not included in the agreement between the parties. This decision prevents the start of the import of the Argentine generic into the Russian Federation, which the MIC plans to do, lawyers say. However, according to them, at the end of 2024 the four-year period from the date of issue of patents expires, after which a compulsory license can be obtained for them.

On November 17, the panel of the chamber for patent disputes refused to satisfy the MIC’s objections to two patents protecting the drug against cystic fibrosis “Trikafta”, produced by the American Vertex, follows from the Rospatent database. The MEC says that it is studying the decisions made by Rospatent. Vertex told Kommersant that they were satisfied with the department’s decision, adding that they continue to work “to ensure the availability of Trikafta to everyone who needs it.”

In the summer of 2022, MIC filed a lawsuit demanding that Vertex enter into a licensing agreement with it for the use of patents protecting Trikafta. The American pharmaceutical manufacturer registered its product in the Russian Federation in June 2023. In January-October of this year, government purchases of drugs with the active ingredients of Trikafta, according to Headway Company, amounted to 1.4 billion rubles.

MIC began legal proceedings with Vertex, as it intends to register its drug in the country – the generic Trilexa of the Argentine Laboratorio Tuteur – which is hampered by the presence of patents on the American side. The first instance refused the MEC, citing, among other things, a violation of the principle of enforceability of a judicial act.

The fact is that the MIC initially indicated 12 patents in the claims, but then excluded two of them. They cannot be included in the license agreement, since the four-year period from the date of their issuance has not expired, the court indicated. Without these two patents, which MIC challenged in Rospatent, the company would still not be able to legally import Trilexa, the arbitration court concluded.

But already in September of this year, in the appeal court, the MIC managed to obtain a compulsory license for two years with an obligation to pay Vertex 3% of the cost of the imported Argentine generic. However, the appeal decision did not include two patents challenged by the MIC. They defend Trikafta, Vertex explains. The MIC, in turn, claims that “the use by third parties” of the inventions protected by these patents “is not currently established.”

The obvious way for the MIC is to challenge the conclusions of Rospatent in the intellectual rights court (IPR), the company has three months to file a claim, points out independent patent attorney Anatoly Sherstin. But other persons may try to challenge patents at Rospatent on new grounds, the expert points out. The MIC has little chance of challenging refusals in the SIP, says Alexey Mikhailov, head of the patent practice at Patentus.

But even if the outcome of the case is unsuccessful for MIC, already in 2024 the company will be able to file a new claim for compulsory licensing, points out lawyer at IP Versus.legal practice Yuri Petrushevsky. At the end of next year, the four-year period from the date of issue of two patents that were not included in the licensing agreement between MIC and Vertex expires, he explains.

Vertex, in turn, filed a cassation appeal against the decision of the appeal to issue a compulsory license; it was accepted for proceedings on November 14. The cassation may return the case for reconsideration in the first instance, points out Alexey Mikhailov. According to him, if this is done only on the basis of the unenforceability of the decision due to two disputed patents, then it will be easier for the MEC to begin restarting the procedure for obtaining a compulsory license from the end of 2024.

Polina Gritsenko