Pharm-Sintez failed to sue Primafarm for 553 million rubles due to changes in the terms of the contract for the supply of lenalidomide.

According to the case materials, the contractor signed a contract with the Federal Center for Prevention and Prevention of Obstetrics and Gynecology (FCPiLO) for the supply of one of the most expensive oncohematological drugs, worth 3.1 billion rubles, on June 2, 2022. Primapharm won the tender, indicating it could supply over 671,000 capsules of the 25 mg lenalidomide drug under the trade name Myelanix (manufactured by Pharm-Sintez). The drug itself was submitted to the tender in defiance of the patent for the original Revlimid from Bristol-Myers Squibb (BMS), which expired later, in the summer of 2022.

Then, on June 6, 2022, Primafarm, with the consent of the Federal Center for Prevention and Control of the Population, added another product to the contract for potential supply: Lenalidomide from Pharmasintez. The plaintiff emphasized in court that the distributor had twice provided the federal center with "deliberately false information about the risks of Myelanix being unavailable on the market," which, according to Pharm-Sintez, led to the amendments to the contract. The defendant had not contacted the manufacturer of the claimed product to inquire about the possibility of producing the required volume of the drug, and the plaintiff had "no obstacles" to producing the required quantity of Myelanix.

Pharm-Sintez deemed Primafarm's actions illegal and unfair. Myelanix, manufactured by the applicant specifically for delivery under the state contract, was never delivered, resulting in losses for the pharmaceutical company amounting to 152.7 million rubles in damages and 400 million rubles in lost profits.

In its ruling, the Moscow Arbitration Court stated that the plaintiff had failed to prove grounds for recovering damages from the defendant, as Pharm-Sintez had not bid in the auction for the drug, and the defendant "had no obligations whatsoever" to the manufacturer. The court found that the adverse consequences arose as a result of Pharm-Sintez's own actions, which "failed to meet the requirements of reasonableness and prudence," and that the company had failed to prove that it was unable to sell the manufactured drug under other government contracts. As noted in the ruling, the drugs, which were entirely Russian-made, were not commercially available at the time the contract and its supplemental agreement were concluded due to patent restrictions.

"Other medicinal products were manufactured from pharmaceutical substances originating from foreign countries, including those on the list of countries committing unfriendly acts against the Russian Federation, which could have led to potential supply restrictions and logistical difficulties," the court ruling stated. These conditions support the justification for adding Primapharm as an additional trade name to the contract. Furthermore, the court cited examples of failed procurements of lenalidomide-containing products, which, in particular, were intended to include Myelaniks.

Last year, Pharm-Sintez also failed to force the Federal Center for the Prevention and Control of the Population's Development and Primafarm to fulfill the state contract under the original terms, that is, to supply the declared Myelanix. At the time, the plaintiff emphasized that "the drug under the trade name Myelanix was never sold in either 2022 or 2023." The court of first instance upheld the claim in full at the end of March 2024, but by that time, the contractor had already delivered the entire volume of medication to the Ministry of Health.

The Ninth Arbitration Court of Appeal, where Primapharm attempted to appeal the first-instance decision, also ruled that the contract amendments made by the parties were unlawful. However, in September 2024, the Moscow District Arbitration Court, in response to Primapharm's petition, overturned the decisions of the previous courts and denied Pharm-Sintez's claims. The court held that the customer had the right to accept interchangeable medications, since the active ingredient was the subject of the procurement. The Supreme Court of the Russian Federation refused to refer the pharmaceutical manufacturer's appeal to the judicial panel for consideration.