Bayer retains rights to sorafenib in Russia
[ad_1]
German pharmaceutical manufacturer Bayer refused compensation of more than 400 million rubles. from Nativa (renamed Spectrum) for the use of patents on the anticancer drug sorafenib. Under the terms of the settlement agreement concluded by the parties, Nativa undertakes not to introduce a generic version of the drug around which the dispute flared up, and not to register its new analogues until 2026. But experts call these agreements an actual loss for Bayer: the Russian company transferred the rights to sorafenib to another company two years ago, and that company did not enter into any agreements with the German pharmaceutical manufacturer.
On October 25, Bayer entered into a settlement agreement with Nativa (renamed Spectrum in 2022; now at the bankruptcy stage) for the oncology drug sorafenib, Kommersant discovered in the file of arbitration cases. Now Nativa will not have to pay more than 400 million rubles, which the German pharmaceutical manufacturer demanded from it for the use of its patents on the drug. At the same time, Nativa undertakes not to introduce its generic into circulation and not to register new drugs with sorafenib until 2026. In February of the same year, Bayer’s second patent for sorafenib expired; the first expired in June 2022. If the agreement is violated, Nativa will have to pay fines to Bayer.
On October 25, another dispute between Bayer and Nativa over a ban on the sale of sorafenib, which lasted almost six years, ended with a similar settlement agreement in the Moscow Region Arbitration Court on October 25. It began immediately after the Russian company launched its generic on the market in 2018.
Bayer told Kommersant that until the patent expires it will continue to protect the rights to its original drug Nexavar based on sorafenib. Temporary manager of Nativa Mikhail Cherny did not respond to Kommersant’s request.
The generic “Nativa” sorafenib-native was one of the leaders at government auctions. According to Headway Company, in 2022 the drug’s share in government procurement of sorafenib was 30% – more than that of the original Nexavar (13%). In total, in 2022, the regions purchased this product for 1.2 billion rubles.
But at the end of 2021, Nativa re-registered the rights to its generic to Pharmaceutical Group. For this reason, the concluded settlement agreement for Bayer does not solve the problem: this, according to lawyer Anzhelika Reshetnikova, means a loss for the German manufacturer. Since Farmmental Group was not a party to the dispute, it is not covered by the settlement agreement approved in court, she explains.
At the same time, the agreement does not say that the Nativy drug, transferred to Farmmental Group, violates the Bayer patent, says Maria Pershonkova, senior lawyer at the Kosenkov and Suvorov law firm. She believes that Pharmaceutical Group’s production and sale of sorafenib may be the subject of separate proceedings with Bayer. Farmmental Group did not respond to Kommersant’s request.
Bayer’s lawsuit, filed in June 2022, was one of the rare cases seeking damages for patent infringement. More often, originators demand to stop the illegal use of patents, since it is extremely difficult to justify the amount of damage and losses and to collect real compensation, Ms. Reshetnikova points out.
In addition, in June 2022, Bayer also filed a lawsuit demanding compensation of 19.7 million rubles. to Pharmasintez, which also sold sorafenib, and its supplier Remedium. A decision on this lawsuit has not yet been made. Pharmasyntez, which in turn is challenging one of Bayer’s patents on the drug, declined to comment.
Despite the fact that Bayer’s second patent expires only in February 2026, since the second half of 2022, four more companies have launched their generics on the market and are selling them at government auctions, according to Headway Company data. This happened because the formula of the second patent can be circumvented, believes Mikhail Pasynok, head of the Chemistry and Pharmaceuticals department of the Online Patent company. According to him, this path was taken, for example, by the Amedart company, which registered a generic with a lower content of active substance to the weight of the composition than established in the patent. The expert does not rule out that Bayer may file lawsuits against generic drug manufacturers who did not change the quantitative composition of their compositions.
Priority is given to Russian medical products
In government procurement of medical devices for diabetics, priority with equivalent technical characteristics will be given to Russian products. The preference is contained in the rules approved by the Russian government on October 24 for allocating funds to regions for equipping hospitals and endocrinology centers under the federal project to combat diabetes, Pharmvestnik reported. In 2023, at least 89 rural hospitals and 36 medical institutions must be equipped with the necessary equipment, for which the Russian government has allocated 3.6 billion rubles.
It is expected that in 2023 a total of 10 billion rubles will be allocated to the federal project, and in 2024–2026 – 9 billion rubles each. annually. The source of financing is funds from excise taxes on sugar-sweetened beverages introduced on July 1, 2023.
This year, difficulties arose in Russia with the supply of sensors for continuous glucose monitoring, which were included in the US restrictive list as dual-use products. No Russian systems have been registered yet. Such systems are used to control glucose levels mainly in children with type 1 diabetes.
[ad_2]
Source link
