A significant ruling for Russian pharmaceutical distributors: The Arbitration Court of the Bryansk Region has sided with a supplier in a dispute with the antitrust authority. The court ruled that public customers do not have the right to reject a tender bid based solely on an entry in the Eurasian Pharmaceutical Register, ignoring national legislation and the actual status of the patent.
The Core of the Dispute
The conflict arose around the procurement of the vital anti-tumor drug Axitinib for the state enterprise “Bryanskpharmatsia”. The bid from the supplier “AlkorPharm” LLC was rejected by the customer’s tender commission.
Arguments of the parties:
- The Customer: Rejected the bid citing infringement of exclusive rights held by Pfizer Inc. (holder of patent No. 004460). Data from the Pharmaceutical Register of the Eurasian Patent Organization (EAPO) was used as the sole evidence.
- The Supplier (“AlkorPharm”): Argued that the drug holds a valid Registration Certificate (RC) in Russia, and its maximum selling price is registered in state registries, making the restriction of competition unlawful.
Regulatory and Judicial Position
Initially, the supplier appealed to the Bryansk office of the Federal Antimonopoly Service (OFAS). The antitrust authority deemed the complaint unfounded, effectively supporting the blocking of the generic based on the international register entry. However, the Arbitration Court overturned this decision, formulating key conclusions for the entire public procurement sector.
Key Court Findings:
- Object of Procurement. The customer has the right to demand exclusive rights only if the contract specifically involves their transfer. In this case, the procurement was for physical goods (tablets).
- Status of the EAPO Register. The EAPO Pharmaceutical Register performs a strictly informational function. Its entries cannot automatically serve as grounds for restricting access to tenders, especially when contradicting national registration documents.
- Legitimacy of the Drug. The presence of a valid Registration Certificate and a registered price is sufficient confirmation of the drug’s legality for circulation in the market.
“The subject of the procurement was goods, not the acquisition of exclusive rights to intellectual property results. The commission had no legal grounds to reject the application,” the court’s press service noted.
Market Implications
The court’s decision sets an important precedent in the fight against artificial barriers for generic drugs in public procurement. It confirms the priority of the national Registration Certificate over reference data from patent databases and deprives customers of the ability to use the Eurasian Register as a tool for unjustified screening of suppliers.
Sources: Guberniya.TV, EAPO Pharmaceutical Register
