Lawyers of «A.Zalesov and Partners» Patent and Law firm successfully represented Russian pharmaceutical company JSC «Generium» in a dispute over the protection of exclusive rights to an invention under Russian patent No. 2793459. The plaintiffs demanded not only that the introduction of the drug «Lantesens» (INN «Nusinersen») into civil circulation be recognized as a violation of the exclusive right, but also that the Russian Ministry of Health be obliged to revoke the registration certificate, exclude the drug from the State Register of Medicines and from the Unified Register of the EAEU, and also exclude the maximum selling price from the register of vital and essential drugs and prohibit introduction of the drug into civil circulation before June 17, 2030.
The drug «Lantesens» is a generic version of the reference drug «Spinraza" (INN «Nusinersen») and is used for the treatment of spinal muscular atrophy (SMA), a severe orphan disease. SMA leads to progressive muscle atrophy and is one of the most common hereditary diseases causing child mortality. Access to effective therapy is a matter of life and death for patients with SMA: this severe chronic disease requires lifelong therapy.
The associates of «A.Zalesov and Partners» developed and consistently implemented a comprehensive strategy for the litigation.
One of the important steps of the strategy was to work with the materials of the court case to obtain evidence and substantiate the position that there was no violation, and respond to new evidence.
Following a thorough revision of the conclusion of the judicial patent examination, it became clear that it was unfounded and contained errors and contradictions, in connection with which a request was filed to summon the expert to the court hearing to provide explanations.
Our interrogation of the expert was based on pre-prepared questions and allowed to demonstrate to the court that the expert used incorrect methods during examination, and that the conclusions he reached were unreliable.
In the interests of the client, a request was filed for a re-examination, since the court had doubts about the validity of the first conclusion based on the results of the expert’s questioning. The findings of the re-examination refuted the fact of the use of the invention in the medicinal product, after which the plaintiffs declared a waiver of the claims in full.
This result is of particular importance both for the client and for patients with orphan diseases for whom Lantesens is vital. The continued availability of the drug for consumers was ensured by the lawyers' well-developed and implemented strategy.
The client's interests in the case were represented by the Head of Intellectual Property Practice, Aleksey Zalesov, and senior associate Darya Kushnarenko.