Patent dispute between Medical Research Company and American Vertex
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A medical research company (MRC), which tried to force the American Vertex to license the expensive cystic fibrosis drug Trikafta, managed to achieve this in the appeal court. Courts make such decisions extremely rarely, lawyers say. However, in the case of MIC, the list of approved patents did not include two patents protecting one of the active ingredients of Trikafta. And without this, the company still cannot supply its generic to the Russian market. The pharmaceutical manufacturer will try to change the situation in the Chamber of Patent Disputes.
As Kommersant discovered in the file of arbitration cases, the Ninth Court of Appeal on September 20 ordered the American Vertex to enter into a licensing agreement with MIC for ten patents protecting the expensive drug Trikafta, used for cystic fibrosis. The Russian company is allowed to use the patents for two years, in exchange it must pay Vertex 3% of the total cost of the generic product sold. Thus, the appeal overturned the decision of the first instance, which sided with the American manufacturer (see Kommersant of August 18).
The MIC told Kommersant that they were satisfied with the result of the consideration of the complaint and “after complying with a number of necessary formalities,” the Trikafta analogue will go into circulation in the Russian Federation. However, Sanofi (representing Vertex in Russia) says that the appeal decision does not apply to all patents for Trikafta, which remains under patent protection in Russia. They promise to appeal the decision to a higher authority.
The Ministry of Health registered the original Trikafta in June 2023: before that it was supplied as unregistered. The drug is purchased, among other things, for the beneficiaries of the Circle of Good Foundation, as well as by the regions. According to Headway Company, in January-August the regions purchased this product for 1.34 billion rubles.
MIC is going to import an analogue of Trilexa from Argentine Laboratorio Tuteur into Russia and register it in the country. The company, insisting on issuing a compulsory license for Trikafta, motivated this by the inaccessibility of the drug to the majority of Russians with cystic fibrosis. In the initial lawsuit, the MIC demanded a license to use 12 patents for Trikafta, guided by Art. 1362 of the Civil Code of the Russian Federation. This section of the code allows an applicant to claim patents if the owner does not make sufficient use of them within four years of issue.
But two patents protecting one of Trikafta’s active ingredients (elexacaftor) were issued less than four years ago. Even at the first instance, the MEC agreed to exclude them from consideration for this reason. The fact that Trikafta would still not be able to be legally imported without permission to use these two patents was one of the reasons for the trial court’s refusal to satisfy the claims. It is possible that in the appeal the plaintiff presented new evidence justifying the inadequacy of Vertex’s use of his patents, believes Anastasia Dudko, head of the Intellectual Property and Technologies practice at BGP Litigation. The reasoning for the appeal ruling has not yet been published.
The patent, which was not included in the list, is now being disputed in the Chamber of Patent Disputes, the MEC reported. If the company manages to end the legal protection of patents for elexacaftor, obstacles to supplies will be eliminated, says Semenov & Pevzner partner Yulia Yarnykh. But the very question of using the invention under the patent for elexacaftor “is not obvious,” the MIC notes. “If we can discuss the Eurasian patent, then everything is clear with the Russian one: all forms of elexacaftor fall under the invention formula,” says Alexey Mikhailov, head of patent practice at the Patentus bureau.
Courts extremely rarely agree to issue compulsory licenses to pharmaceutical companies, mainly due to the complexity of the subject of proof, notes Anastasia Dudko. So far, two such cases are known: in both cases, Spectr (formerly Nativa) received such licenses.
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