According to expert estimates, about 10 million people in Russia suffer from diabetes. This chronic disease develops when the body lacks insulin, a hormone that regulates blood sugar. The disease is insidious: diabetes is the fourth leading cause of death. But medicine has learned to resist it.
Medicines required for patients in this category are included in the list of vital and essential medicines approved by the Council of Ministers. In 2022, when the sanctions rhetoric was at its strongest, there was a shortage of some drugs in the market. But as practice shows, there was no lack of insulin. And insulin glargine 300 U/ml, needed by nearly 200,000 patients, was launched in full: the production plant in the Oryol region did not stop for a day. But in recent years, the patent wars have been raging around this very drug: Geropharm is trying to challenge a Sanofi patent in order to make a copy of itself.
patent right
It doesn’t take a pharmaceutical company a year to create a drug for people with diabetes mellitus. For a long time, insulin glargine was used in a single concentration – 100 units per 1 milliliter – in finished dosage form under the trade name Lantus.
“During further research, Sanofi experts unexpectedly found that increasing its concentration in the finished form, which has never been used before, by a factor of three to 300 U / ml, significantly improves the pharmacological properties at the same dose administered. “By providing a longer and gentler effect, it reduces the risk of hypoglycemia (i.e. an undesirable drop in blood sugar shortly after insulin administration), which is critical for diabetics,” says Vladislav Ugryumov, Partner and associates of the Ivanov Makarov law firm.
The patent of this invention is valid until 2030, the development protects a pharmaceutical composition containing 300 U/ml insulin glargine for the treatment of type I and type II diabetes, as it fulfills all the conditions for patentability. “Insulin glargine at a concentration of 300 U/ml has not been used until recently (patentability condition “novelty”). It could not be clear to a person skilled in the treatment of diabetes mellitus that increasing the concentration of insulin in finished form from 100 U / ml to 300 U / ml will lead to an improvement in the pharmacological properties of the drug. same applied dose (“inventive step” patentability condition)”, – draws attention to V.Ugryumov. Also, similar patents are valid in more than 60 countries.
The story to continue
At the beginning of the year, the Rospatent Chamber of Patent Disputes board made its fourth decision that Tujeo, the original insulin glargine 300 U/ml, meets all the criteria for patentability (industrial applicability, innovation and inventive step). But it was not signed by the Rospatent leadership, which means it was sent for reconsideration. It is expected to take place on April 21. For lawyers, the new round of a long dispute is confusing and alarming for patients and representatives of the medical community.
“Despite the fact that the law provides the head of Rospatent with the right not to approve the decision of the Patent Disputes Chamber without explaining the reasons, the refusal of the head of Rospatent to approve the decision of the Patent Disputes Chamber is of serious concern in this case,” says Ugryumov.
In his opinion, the Board of Patent Disputes Board made the only correct decision at the meetings of January 23, 2023 – to refuse to meet the objection and leave the patent in effect. According to the lawyer, under these circumstances, there is no reason for the Patent Disputes Office to re-examine the same objection.
Meanwhile, the patent dispute remains in the limelight and could negatively impact the availability of original innovative drugs for patients. Business reacts painfully to possible risks. The protection of intellectual property is of decisive importance for many companies developing new original drugs and is the foundation of their existence. And it does not matter whether it is a foreign company or a Russian. After all, there are those in our country who not only copy Western drugs, but also create their own.
Patient Priority
According to information from the Federal Registry of Diabetes of the Russian Federation, more than 180,000 people in Russia use the original insulin glargine 300 U/ml produced at the Oryol factory, which is almost a quarter of the number of diabetic patients on insulin therapy. If this drug is patented, doctors and patients alike will find themselves in a difficult situation: switching from an original drug to a generic drug, the so-called “non-medical switch,” will require a review of all treatments. has been effective for years.
For example, in order to prevent such a change, the All-Russian Patients’ Association has repeatedly proposed to change the mechanism of public procurement to be longer-term, and it is possible to assign at least one drug to a patient. year.
“Switching from one drug to another when we talk about diabetes raises big questions because we’re talking about biologics. Patients ask a legitimate question: If everything is fine, why change their treatment regimen? Yuri Zhulev, co-chairman of the All-Russian Patients’ Association (VSP), medically unconditional decisions are devastating. It creates an atmosphere and negatively affects patients’ compliance with treatment.
This perspective is shared by Elvira Gustova, President of the Moscow Diabetes Association. According to him, the interests of patients should be considered above all. Patients with diabetes should take drugs of high potency, which are not interchangeable, prescribed by a doctor and selected individually.
Therefore, assessing the possible risks, the patient community carefully and anxiously follows the patent dispute, which among other things gives negative signals to foreign manufacturers. “Any patent dispute must be resolved very carefully. They create anxiety and misunderstanding about how stable business in Russia can be and whether a similar scenario will be repeated with other companies. Manufacturers are starting to think about whether it’s worth it to enter Russia with new drugs because of patent risks,” says Yuri Zhulev.
As for the original drug Tujeo, it has been produced in Russia for many years continuously in a full cycle and is placed on the market under a special investment contract. Experts expect disputes over the drug’s patent to end soon and patients will be given the drug by at least 2030, the expiration date. Recall that the patents for the drug are issued and valid in 60 countries, including Russia, and this development meets all the criteria for patentability everywhere.