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Confluence of obligations: Ministry of Health found guilty in case of illegal drug administration
The Ministry of Health of the Russian Federation was found guilty of attempting to introduce a drug to the Russian market using forged documents. This decision was handed down by the Arbitration Court of Appeal in Moscow. It considered a case concerning an attempt to register and start selling in Russia an Indian antibiotic whose active substance had already been produced and patented by another company from India. The firm-right holder did not authorize the use of its substance, but the company "Jodas Expoim" provided the Ministry of Health with a forged letter of consent, as follows from the case materials. According to the court ruling, it was the specialists of the ministry who should have checked all the proper documents. At the same time, the Ministry has no competence to determine the authenticity of the submitted papers, experts say.
Why the Ministry of Health turned out to be guilty
In November, the Ninth Arbitration Court of Appeal of Moscow found the Ministry of Health guilty of attempting to introduce an Indian antibiotic to the Russian market using false documents. Izvestia has familiarized itself with its decision.
In February 2024, the Indian company Copran Research Laboratories Limited, which produces pharmaceutical ingredients and finished dosage forms, filed a lawsuit against the Russian Ministry of Health in the Moscow Arbitration Court. In it, it claimed that the drug was illegally registered in the Ministry of Health's register and that its patent rights to use its substance for the drug Biapenem were infringed. In the lawsuit, the company demanded that the registration of the drug in Russia be canceled.
The holder of the registration certificate turned out to be JODAS Expoim, a Russian legal entity of the Indian pharmaceutical company JODAS Expoim Pvt. Ltd. Ltd. "In the lawsuit, Copran Research claimed that JODAS representatives had forged their written consent to the use of their active ingredient, which should have been contained in Biapenem (the document is available to the editorial board).
"Copran appealed to the Ministry of Health (Izvestia also has the letter), assuring that it had not provided any substances or documents for the production of Biapenem. In its reply, the ministry said that it had received documents from Jodas confirming the company's consent to use the substance - they met all the requirements.
After that, the registration dossier of Biapenem was amended. The active substance, according to the documents, is now produced by the Chinese companies Shenzhen Haibin Pharmaceutical Co. Ltd.", "Shandong Losin Pharmaceutical Group Hengxin Pharmaceutical Co. Ltd." As of February 2024, Copran was listed on the docket.
In June 2024, the arbitral tribunal concluded that the claimed claims were not eligible. But Copran did not agree with the decision and appealed against it.
As a result, the Moscow Arbitration Court of Appeal overturned the decision of the court of first instance. And also recognized the inaction of the Ministry of Health as illegal. As stated in the case materials, the agency did not take action to suspend and cancel the state registration of the drug "Biapenem", despite the fact that "Jodas Expoim" provided unreliable documents and information about the active pharmaceutical substance and its manufacturer.
"To oblige the Ministry of Health to cancel the state registration of the drug Biapenem and exclude it from the state register of medicines," the court ruling reads. - To recover from the Ministry of Health in favor of "Copran Research Laboratories Limited" the costs of state duty in the amount of 3 thousand rubles on the application and 1.5 thousand rubles on the appeal".
The ruling enters into legal force from the date of its adoption - November 7. "Izvestia" sent a request to the Ministry of Health with a request to clarify the position of the department on this case and answer whether the Ministry plans to appeal the decision.
What else has been recalled from Jodas Expoim?
Jodas Expoim supplies drugs to state hospitals as well. Some of the latest customers, according to the state procurement website, were medical institutions of St. Petersburg, Krasnoyarsk, Belgorod, Simferopol, Voronezh region.
In May 2024, Roszdravnadzor revealed in the circulation of a batch of the drug "Fulvestrant" (a drug used for breast cancer), the quality of which did not meet the established requirements. This was reported to Izvestia by the agency. The violation was found on the criterion "Quantitative determination. Ethanol".
"Roszdravnadzor took all necessary measures taking into account the requirements of the legislation in the sphere of circulation of medicines, - reported in the federal service. - After that, the company "Jodas Expoim Pvt. Ltd. submitted an application for amendments to the registration dossier, which were approved by the Ministry of Health".
Then, as Roszdravnadzor noted, the updated drug was tested - it met the requirements.
In June 2024, a batch of prescription antibiotic cefepime + sulbactam for the treatment of bacterial infections produced by Jodas Expoim was blocked at the Russian border. Neurotoxicity was detected in most of the drugs.
In 2022, Roszdravnadzor identified a series of several drugs produced by the Indian company Jodas Expoim, the quality of which did not meet the requirements of regulatory documentation. Then it was about the drugs "Clarithromycin-J", they were found to contain "mechanical particles", "Ceftriaxone" turned out to be toxic, and "Polymyxin B" - pyrogenic (causing an increase in temperature).
This is not the first time that an Indian company has been involved in litigation over patent infringement of drugs and active ingredients. In May 2024, the American pharmaceutical giant Pfizer filed an arbitration claim against the company. The manufacturer feared that "Jodas Expoim" would put into circulation a generic with the active substance avibactam + ceftazidime before the expiration of the patent for the original drug, which is valid until July 26, 2026.
In May 2018, a lawsuit against Jodas Expoim demanding protection of patent rights to the anti-tumor drug Iressa was filed with the Moscow Arbitration Court by the British-Swedish pharmaceutical company AstraZeneca. "Jodas" then registered in the state register the maximum selling price for the analog of this drug. The Court of Appeal obliged the company to cancel its registration.
What has the Ministry of Health got to do with it?
The appeal proceedings between Jodas and Copran lasted longer than in normal court practice, said Vladislav Usachev, a lawyer and expert on economic disputes.
- "Four months for an appeal is considered even longer than average," he told Izvestia. - The ministry dragged its feet on drafting a withdrawal until October, although the appeal was accepted for consideration in July. One of the judges was even replaced in November.
According to practicing lawyer Zara Gorbushina, there is no fault of the Ministry of Health in the dispute between the two Indian pharmaceutical companies. As the expert emphasized, the ministry issues approvals and registers drugs based on the documents provided by the company and samples of drugs that undergo laboratory tests.
- Only after that the authorization to sell drugs on the territory of Russia is issued," she said. - It is mandatory to involve as a co-defendant the person who pretended to be a person authorized to use the product in question. The co-defendant must be fully responsible for his actions and be punished.
Due to the fact that all trademarks and patent certificates, including information on the certificate of state registration, are publicly available, and many manufacturers are located outside Russia, it is quite easy to prepare a fake letter - consent to the right to use, the expert believes.
Maxim Vaskin, senior lawyer for foreign economic activity at Magenta Legal, emphasized two problems in these proceedings.
- The first one is the absence of a mechanism in the Russian drug registration rules allowing interested third parties to raise objections during the registration process," he explained. - In one form or another, such mechanisms exist, for example, when registering companies, real estate or trademarks. Something similar could well have existed with regard to the registration of medicines, but this was not envisaged. It was this gap that the court of first instance noted in rejecting Copran Research's claim.
The court of appeal, in his opinion, considered it possible for the Ministry of Health to cooperate with Copran Research even if the company did not have the status of a registration certificate holder.
- The second problem concerns the actions of the state body in case of suspicion of using forged documents," the lawyer noted. - If a document looks formally correct, the Ministry of Health, as a rule, has no opportunity to check the authenticity of signatures and seals, as such checks are beyond its competence. At the same time, Copran Research did not have significant additional tools to protect its rights.
The fact that it was the Ministry of Health that acted as a defendant, while Jodas Expoim was involved as a third party, is a fairly standard situation, Maxim Vaskin emphasized. For example, when trademark registration is challenged, Rospatent acts as a defendant, he reminded.
Переведено сервисом «Яндекс Переводчик»
