Pharmaceutical manufacturers propose to reduce the number of “evergreen patents” for medicines issued in Russia

“Evergreen patents” that pharmaceutical companies receive from Rospatent after the expiration of the main registration, making minor changes to the composition or dosage of the drug, make it difficult or impossible to promptly bring analogues to the Russian market. This is stated in an analytical study of the Association of Pharmaceutical Manufacturers of the Eurasian Economic Union (AFPEAES), which includes Active Component, Biocad, Welfarm, Generium, Geropharm, Nanolek, Medisorb, Polisan , “Pharmstandard”, Scientific Research Institute “Khimrar”. In a number of foreign countries, the requirements for obtaining an “evergreen patent” are much stricter, so pharmaceutical companies can produce generics without the risk of litigation, follows from the document. For example, in Argentina and India, it is issued if the manufacturer can prove a previously unknown property of the drug, while in Russia there is no such requirement.

In addition, the release of analogues in Russia often leads to lengthy litigation. For example, the Russian drug manufacturer Geropharm is still defending the rights to insulin glargine in courts. The patent for it at a concentration of 100 units / ml belonged to the French pharmaceutical company Sanofi. But in 2012, it expired, so some domestic manufacturers, including Geropharm, began to develop their own analogues. In 2016, Sanofi registered the same insulin glargine at a higher concentration (300 units/ml) in Russia and protected it with a patent. Geropharm, in turn, appealed to the courts with a demand to recognize it as invalid. Among the arguments of the Russian pharmaceutical company was the decision of the Chinese patent office, which denied Sanofi a patent for insulin glargine because it did not meet the criteria for “novelty” and “inventive step”. The trial on this matter is still ongoing.