Pfizer has given itself a prescription.
The American Pfizer is trying to recover more than 12.5 billion rubles from the bankrupt Nativa. Most likely, the pharmaceutical manufacturer estimated the losses caused by Nativa during the sale of a generic version of the antitumor drug sunitinib at this amount. For the Russian pharmaceutical industry, this is an unprecedented amount of claims within the framework of patent infringement. But it will be difficult to compensate for the damage, lawyers warn.
Pfizer structures – Pfizer Innovation LLC, Sugen and Pharmacia & Upjohn – filed an application to be included in the register of claims of creditors of the bankrupt pharmaceutical manufacturer Nativa (renamed Spectrum in 2022), Kommersant discovered in the file of arbitration cases. The amount of claims is 12.56 billion rubles. The court materials do not contain any other details. Pfizer and the interim manager of Nativa, Mikhail Cherny, did not respond to Kommersant’s request.
The claims of Pfizer entities are designated as damages.
Considering the history of mutual claims between the companies, the head of the Vegas Lex directorate, Kirill Nikitin, suggests that we may be talking about damage due to a violation of Pfizer’s patent rights.
In August 2023, the court granted Pfizer Innovation’s request to request from Spectrum information on the quantity and cost of the drug Sunitinib-native, sold since March 2017.
Sunitinib-native is a generic version of Pfizer’s oncology drug Sutent. Nativa began marketing it in 2017, while Pfizer’s patent on sunitinib, the active ingredient in Sutent, expired only on August 31, 2022. The American company sued Nativa over patent infringement, demanding to stop the production and sale of Sunitinib-Nativa. But in 2019, the court rejected Pfizer, satisfying Nativa’s counterclaim for a compulsory license for sunitinib in exchange for annual payments to Pfizer of 10% of the proceeds from the sale of the product. Pfizer was able to finally challenge this decision on appeal only in October 2022.
According to Headway Company, since 2019, Sunitinib-native has become the sales leader among drugs containing sunitinib and has supplanted the original Sutent.
In 2018–2022, Sunitinib-Nativa was purchased at state auctions for 8.12 billion rubles, while Sutenta was purchased for 4.88 billion rubles.
Nativa received a compulsory license based on its patent for a form of sunitinib. Pfizer managed to cancel it in 2021; the exclusive right is considered terminated from the date of filing the patent application with Rospatent (in the case of Sunitinib-native – since 2014), explains Stanislav Sobolev, senior lawyer at the Regionservice Bar Association. This may mean that Nativa was illegally using the patented drug the entire time it was selling sunitinib, he believes. Having proven this in court, Mr. Sobolev notes, Pfizer can demand recovery of damages or double the cost of the lawful use of the patent. The net profit received by Nativa from the sale of patented drugs can be considered as losses.
It will not be easy to justify the amount of losses incurred, says Lidings senior lawyer Vladislav Ryabov. The copyright holder, according to him, must prove not only the fact of violation of his rights, the amount of losses, but also the cause-and-effect relationship between the losses incurred and the actions of Nativa. Stanislav Sobolev admits that other pharmaceutical companies whose patent rights were violated by Nativa will also be involved in the process. Kirill Nikitin notes that the German Bayer may apply for inclusion in the register of creditors of Nativa, demanding compensation from the company through the court in 2022 in the amount of 400 million rubles. for violation of exclusive rights to sorafenib.
At various times, Nativa also sued BMS, Celgene and AstraZeneca. These companies, like Bayer, declined to comment. By the time the bankruptcy procedure began, Nativa itself had no regulatory certificates left for the drugs. Some of them, including sunitinib, were transferred to Pharmaceutical Group in 2021. Now Nativa is owned by general director Vitaly Voronkov.