Pfizer’s Billions: A Russian Patent Showdown

In a significant legal development within the pharmaceutical landscape, Pfizer, the American pharmaceutical giant, has initiated a legal battle in Russia to claim over 12.5 billion rubles from Nativa, a company currently undergoing bankruptcy proceedings. This substantial claim is believed to encompass the financial losses that Pfizer asserts it incurred due to the sale of a generic version of its anti-tumor medication, sunitinib, by Nativa.
The indicated legal dispute between Pfizer and Nativa is rooted in the alleged patent infringement related to Sunitinib-Native, a generic version of Pfizer’s oncological drug, Sutent. Notably, Nativa began marketing this generic in 2017, while Pfizer’s patent for sunitinib, the active component within Sutent, was still in effect until August 31, 2022. Pfizer had previously engaged in legal disputes with Nativa over patent infringements, aiming to terminate the production and distribution of Sunitinib-Native. The court initially ruled in favor of Nativa, granting them a compulsory license for sunitinib in exchange for annual payments to Pfizer, amounting to 10% of the product’s sales revenue. It was only in October 2022 that Pfizer successfully challenged this decision on appeal.
In the most recent development, the court granted Pfizer Innovations’ request for information from Nativa about the quantity and pricing of Sunitinib-Native, which has been available in the market since March 2017. Sunitinib-Native has remarkably overtaken the original Sutent in sales since 2019 – 8.12 billion rubles vs 4.88 billion rubles through state procurement between 2018 and 2022.
Current complex patent dispute extends to Nativa’s prior legal conflicts with prominent pharmaceutical entities, including BMS, Celgene, and AstraZeneca. By the time bankruptcy proceedings were initiated, Nativa no longer held valid certificates for its pharmaceutical products. As a result, some of these certificates, including sunitinib, were transferred to Pharmmental Group in 2021.
In the legal battle with Pfizer, Nativa’s insolvency adds complexity to the case, raising questions about the practicality of recovering substantial damages.