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The Indian company Lok-Beta Pharmaceuticals wants to deprive Pharmasynthesis of the rights to the popular drug

12 Apr 2024

In March 2024, the pharmaceutical company from India Lok-Beta Pharmaceuticals filed a lawsuit with the IP Court demanding to reverse the decision of Rospatent, which retained the patent rights for lopinavir+ritonavir for the Russian Pharmasynthesis. This drug is used to treat and prevent HIV infection.

Rospatent refused to revoke the patent from Pharmasynthesis to the Indian manufacturer on November 30, 2023. Sergey Zuykov, patent attorney, managing partner of Zuykov and partners, told Vedomosti that the agency did not agree with Lok-Beta Pharmaceuticals' arguments about the inconsistency of this formula with the novelty criterion. This means that other pharmaceutical compositions of a similar composition were known before the patent registration date.

Pharmasynthesis produces lopinavir + ritonavir under the brand "kalidavir" – this is a generic drug of the American company Abbvie kaletra. The domestic medicine appeared on the market in 2018, bypassing the Abbvie patent, valid until 2024. Pharmasynthesis registered water-insoluble polymers in its formula, while the American manufacturer had water-soluble ones, said Sofia Volkova, a lawyer at Asterisk Law Firm. But the drug of Lok-Beta Pharmaceuticals probably falls under the patent of Pharmacynthesis, says Zuykov. For this reason, the lawyer suggests, the Indian manufacturer cannot produce the drug without revoking the rights of the Russian company.

After the outbreak of the COVID-19 pandemic, lopinavir + ritonavir began to be used for the treatment of coronavirus infection, the drug was included in the recommendations of the Russian Ministry of Health. Abbvie relinquished its patent rights to this drug worldwide in March 2020. According to RNC Pharma, in 2020, sales of drugs with the active ingredient lopinavir + ritonavir in Russia amounted to 8.6 billion rubles. (4.5 billion rubles accounted for the generic "Pharmasynthesis" and 4 billion rubles for the original Abbvie product). In the following years, sales declined.

Experts interviewed by Vedomosti believe that Lok-Beta Pharmaceuticals has little chance of winning the lawsuit. This is not the first attempt by an Indian company to revoke the patent of Pharmasynthesis, the past ones ended unsuccessfully, recalls Volkova. In addition, in recent years, Russia has embarked on import substitution in the pharmaceutical industry and its independence. Pharmasynthesis largely covers the population's need for drugs with the active ingredient lopinavir+ritonavir.

Source: Vedomosti