Diabetes in Russia: insulin, patents, and patient access
Experts estimate that about 10 million people in Russia live with diabetes. The condition arises when the body cannot use insulin effectively, a hormone that keeps blood sugar in check. Diabetes is a serious, ongoing health challenge and, in many cases, a leading cause of death. Yet medicine has advanced to counteract its impact.
Drugs for patients in this category are part of a list of vital medicines approved by the government. In 2022, amid tense sanctions rhetoric, some drugs briefly faced shortages in the market. Insulin, however, remained available. In particular, insulin glargine at 300 U/ml, used by about 200,000 patients, was produced without interruption at a plant in the Oryol region. In recent years, this drug has become a focal point in patent discussions, as Geropharm has pursued a challenge to a Sanofi patent to produce a generic version.
patent right
Developing a diabetes drug does not take a year. For a long time, insulin glargine appeared in a single concentration of 100 units per milliliter under the trade name Lantus. During further research, Sanofi researchers discovered that raising the finished concentration to 300 U/ml could improve pharmacological properties at the same dose. This longer, gentler action lowers the risk of hypoglycemia — a dangerous drop in blood sugar soon after insulin administration — which is especially important for diabetics, according to Vladislav Ugryumov, a partner at the law firm Ivanov Makarov.
The patent for this 300 U/ml formulation is valid through 2030. It covers a pharmaceutical composition containing 300 U/ml insulin glargine for treating both type I and type II diabetes, meeting standard patentability criteria. Ugryumov notes that the 300 U/ml concentration is a novel approach not previously used, and that the inventive step was clear to a clinician. Similar patents are current in more than 60 countries.
The story to continue
Earlier this year, the Rospatent Patent Disputes Chamber issued a fourth ruling saying that Tujeo, the original 300 U/ml insulin glargine, met all patentability criteria. However, the decision was not signed by the head of Rospatent, sending the matter back for reconsideration. A new session was scheduled for April 21. For lawyers, the process is complex; for patients and doctors, it raises concern.
Ugryumov points out that the head of Rospatent has the authority to withhold signing a decision, but doing so in this case is troubling. The Patent Disputes Chamber previously refused to retract the patent in January 2023, supporting the patent’s continued validity. In that view, there appears to be little reason to reopen the same objection.
The patent dispute continues to draw attention and could affect the availability of original, innovative drugs for patients. Investors and companies view intellectual property protections as essential to sustaining research and development. The issue spans both foreign and Russian firms, and it highlights the mixed landscape where some players copy others while some create new formulations locally.
Patient Priority
Federal data show that more than 180,000 Russians use the original 300 U/ml insulin glargine produced at the Oryol plant, a sizable share of those on insulin therapy. If the drug’s patent status becomes restrictive, doctors and patients may face a difficult transition to generics. Such a switch would require careful treatment reviews that have proven effective over time.
To prevent disruptive changes, the All-Russian Patients’ Association has proposed adjustments to public procurement, aiming for longer-term arrangements and the possibility of assigning a drug to a patient for a full year. Yuri Zhulev, co-chair of the association, notes that even well-intentioned changes can create anxiety among patients if treatment regimens are altered. He emphasizes that decisions should consider the practical realities of biologics, where abrupt changes can undermine therapy outcomes.
Elvira Gustova, president of the Moscow Diabetes Association, echoes the call to prioritize patient interests. She argues that patients deserve access to high-potency, non-interchangeable biologic drugs prescribed by clinicians and tailored to individual needs.
As the patent dispute unfolds, the patient community watches closely, hoping for stability and clear signals about future drug availability. Foreign manufacturers may be wary of entering the Russian market if patent risks persist. Meanwhile, the original drug Tujeo has continued to be produced on a full cycle under a special investment contract, with experts predicting the dispute may resolve by 2030. Patents in dozens of countries, including Russia, point to broad recognition of the drug’s novelty and therapeutic value.