Moscow court sides with Indian company in dispute with Health Ministry

The Ninth Arbitration COURT of Appeal of Moscow found the Russian Ministry of HEALTH guilty of attempting to introduce an Indian antibiotic to the Russian market using forged documents, Izvestia reports, citing the court's decision. The press service of the Ministry of Health told RBC that the ministry does not agree with the court's ruling and will appeal it in the cassation instance.

In February of this year, the Indian company Kopran Research Laboratories Ltd filed a lawsuit against the Ministry of Health. The company claimed that patent rights for the use of its substance for the drug Biapenem had been violated and demanded that the registration of the drug in RUSSIA be cancelled.

The holder of the registration certificate was Jodas Expoim, a Russian legal entity of another Indian pharmaceutical company, JODAS Expoim Pvt Ltd. In its lawsuit, Kopran Research stated that representatives of this company forged their written consent to use the active substance they produced, Izvestia writes, citing the document. It should have been contained in Biapenem.

Kopran contacted the Ministry of Health and stated that it had not provided any substances or documents for the production of Biapenem. The department responded by stating that it had received documents from Jodas confirming the company's consent to use the substance, and these documents met all the requirements. However, Izvestia writes that changes were subsequently made to the registration dossier of Biapenem: the active substance, according to the documents, is produced by the Chinese companies Shenzhen Haibin Pharmaceutical Co. Ltd., Shandong Luoxin Pharmaceutical Group Hengxin Pharmaceutical Co. Ltd.

In June, the Arbitration Court rejected the Indian company's claims , but Kopran did not agree with the decision and appealed it. As a result, the decision of the court of first instance was overturned and the inaction of the Ministry of Health was declared illegal. The appellate court decided that the Russian agency did not try to suspend or cancel the state registration of the drug Biapenem, despite the fact that Jodas Expoim provided false documents and information. The Ministry of Health was ordered to pay Kopran the state fee in the amount of 3 thousand rubles for the application and 1.5 thousand rubles for the appeal.

Earlier in October, the FAS found that AkselPharm and Akrikhin had violated antitrust laws and ordered them to pay more than 1.5 billion rubles in illegally obtained income. The FAS noted that the pharmaceutical companies introduced generic versions of the drugs Ruxolitinib (AksilPharm) and Fordiglyph (Akrikhin), the originals of which are protected by patents until 2028. AkselPharm was ordered to return about 960 million rubles to the budget, and Akrikhin was ordered to return about 577 million rubles.

Prior to this, in August, Germany's Bayer filed a lawsuit against Russian drugmaker Promomed for releasing an analogue of the best-selling drug in Russian pharmacies, Xarelto. The patent for it is valid until December 2024. Promomed then stated that it complies with current legislation, including intellectual property, and does not admit to violating "any valid patent rights" by Bayer when introducing its analogue of Xarelto to the market.