The court sent the case on the ban on the sale of an analogue of Enterosgel for a new trial

The Intellectual Property Court (IPC) canceled the decisions of the previous instances and sent for a new consideration the claim of the distributor “Farmasil” to the pharmaceutical company “Alvils” on the prohibition of the sale of an analogue of “Enterosgel” used for intoxication.

The international non-proprietary name (INN, active substance) of the drug, which is sold under the Enterosgel brand, is polymethylsiloxane polyhydrate. Its distributor – Pharmasil (connected through the CEO Emil Kadchinsky with the manufacturer – TNK Silma) protected it with a patent (gives the right to prohibit the implementation of identical inventions by others) from Rospatent, which is valid until December 22, 2025.

This did not prevent Alvils (distributor) from registering a medicine with the same active ingredient, but in the State Register of Medicines (GRLS, confirms the safety of the substance, without this the drug cannot be put into civil circulation), after which it began to sell the drug under the Enterodesgel brand .

In February 2022, Pharmsil filed a lawsuit against Alvils with the Moscow Arbitration Court demanding to prohibit the sale of a medicine with the active ingredient polymethylsiloxane polyhydrate, but under a different trademark. The co-defendants in the case were the manufacturer of the active substance, the Ukrainian Ecological Company Kreoma-Pharm, and the company that produces enterodesgel itself, the Kirov Pharmaceutical Factory, as well as a number of pharmacy chains that sold the drug.

In August last year, the first instance satisfied the claim, and in November the decision was confirmed by the 9th Arbitration Court of Appeal. The courts of first instance relied on the expertise provided by Pharmasil, according to the case file. On May 15, 2023, the Intellectual Property Court sent the case for a new trial, as it considered that a new independent forensic examination was needed to prove or disprove the identity of the drug formula.

A Pharmasil representative told Vedomosti that with the help of a lawsuit, the company is defending its patent rights to the drug Enterosgel and the trademark. In Alvils, Vedomosti was told that in the development of their drug they used the same active ingredient – polymethylsiloxane polyhydrate, but with a different formula from 1994, the patent for which had long expired. “In this regard, it cannot repeat the enterosgel formula,” said Vitaly Aleinikov, CEO of the company. In case of victory in court, Alvils plans to continue producing and selling an analogue of enterosgel, but now the company does not produce products due to a court ban.

In addition to Alvils, Solopharm (LLC Grotesk), Usolie-Sibirsky Chemical Pharmaceutical Plant, and Tula Pharmaceutical Factory have a valid certificate for a medicine with the same active ingredient as enterosgel.

There are no direct analogues of enterosgel with the same pharmaceutical substance on the Russian market today, and the Farmasil lawsuit is an attempt to block competitors, says RNC Pharma Development Director Nikolay Bespalov. In the group of enterosorbents, enterosgel is not the only drug, but it is the undisputed leader in terms of recognition and sales volumes, said Sergey Shulyak, CEO of DSM Group. Farmasil does not want to lose its market share, so it fears the emergence of generics.

According to DSM Group, over the past three years, the volume of pharmacy sales of this product in terms of money has been steadily growing. In 2020, this indicator amounted to 2.9 billion rubles, in 2021 – 3.3 billion rubles, in 2022 – 3.4 billion rubles.

Roszdravnadzor did not respond to Vedomosti’s request. The Ministry of Health reported that control over compliance with legislation in the field of intellectual property is not within the powers of the ministry.

The prospect of this claim will depend on the appointed examination, lawyers noted. If the results of the audit show that the defendant used the same formula to create his drug, then legally he will not be able to bring the same medicine to the market before the expiration of the plaintiff’s patent, said Sergey Zuykov, managing partner of Zuykov and Partners. To win the case, the defendants need to prove that their drug differs in at least one of the features of the invention formula protected by the Pharmasil patent, Dmitry Borodin, senior lawyer at the Technologies and Investments group at the Vegas Lex law firm, explained.