Re-energizing
In the global pharmaceutical industry, the terms of patents for popular medicines of famous brands have been massively expiring. New opportunities for Ukrainian manufacturers and previously inaccessible medicines for patients are being offered
Alexander Mamunya,
patent attorney, lawyer, partner of the law company AEQUO
patent attorney, lawyer, partner of the law company AEQUO
The medicines based on the active ingredient Rituximab are used to treat blood cancer. The patent owner for this substance obtained in a certain way is the American corporation Genentech, and the license for its sale in Ukraine belongs to the company Hoffmann-La-Roche. No one else can produce and sell a medicine that is protected by a patent. Therefore, the company owner can dictate the price of its medicine. Now, a course of therapy with this medicine costs more than UAH 300 000 for a patient.
If there were no patent, companies from other countries could launch their products with the same active substance in the Ukrainian market at a greatly reduced price.
A course of treatment with such a medicine, for example, of Indian production would cost about three times cheaper. You must admit that this difference is more than significant for most patients. Now these patients have a chance. One by one, the terms of patents for popular medicines have been expiring. This phenomenon is called the patent cliff in world practice.
The epoch of mass patenting took place at the end of the 1980s ‑ the beginning of the 1990s. Usually a patent is valid for 20 years. Then the company has the opportunity to renew it for another five years. If we count from the early 1990s, 25 years are expiring right now. In return, a much smaller number of new pharmaceutical patents appear. In modern practice, companies are moving to secondary patents, trying to gain as much money as possible from this. After all, patenting and its protection in the courts is also a large investment of time and money.
So, we can say that the patent boom has fallen down. It is followed by a new stage – the production of generic medicines and bioequivalents. In fact, these are legal analogues of medicines, the patents for which have already expired. Their main advantage is a relatively low price, which means greater accessibility for consumers.
Manufacturers of generics and bioequivalents, as a rule, keep track of which patents expire. This includes Ukrainian manufacturers as well. Domestic pharmaceutical production is predominantly generic. Therefore, the current patent cliff provides our companies with new opportunities for development.
If the company is serious, everything is ready by the time the patent expires: all the necessary preparations have been made; the production line has been adjusted. As soon as the term of patent ends, the machine starts.
If there were no patent, companies from other countries could launch their products with the same active substance in the Ukrainian market at a greatly reduced price.
A course of treatment with such a medicine, for example, of Indian production would cost about three times cheaper. You must admit that this difference is more than significant for most patients. Now these patients have a chance. One by one, the terms of patents for popular medicines have been expiring. This phenomenon is called the patent cliff in world practice.
The epoch of mass patenting took place at the end of the 1980s ‑ the beginning of the 1990s. Usually a patent is valid for 20 years. Then the company has the opportunity to renew it for another five years. If we count from the early 1990s, 25 years are expiring right now. In return, a much smaller number of new pharmaceutical patents appear. In modern practice, companies are moving to secondary patents, trying to gain as much money as possible from this. After all, patenting and its protection in the courts is also a large investment of time and money.
So, we can say that the patent boom has fallen down. It is followed by a new stage – the production of generic medicines and bioequivalents. In fact, these are legal analogues of medicines, the patents for which have already expired. Their main advantage is a relatively low price, which means greater accessibility for consumers.
Manufacturers of generics and bioequivalents, as a rule, keep track of which patents expire. This includes Ukrainian manufacturers as well. Domestic pharmaceutical production is predominantly generic. Therefore, the current patent cliff provides our companies with new opportunities for development.
If the company is serious, everything is ready by the time the patent expires: all the necessary preparations have been made; the production line has been adjusted. As soon as the term of patent ends, the machine starts.
Due to the production of generics, the cost of treatment will decrease
However, this is in theory. In practice, generics have to wait. To produce a new medicine, you still need to register it with the Ministry of Health. This procedure lasts an average of 6-12 months. During this time, the effectiveness and safety of the medicine is checked. When the state is convinced that the medicine works and does not harm, a certificate of state registration is issued.
The specificity is that the state registration in Ukraine can be terminated by the patent owner while this patent is valid. In other words, while no one produces anything, there is already an injunction. If you apply for the state registration at the end of the term of the patent, then 6-12 months of waiting actually work for the rightholder, prolonging its monopoly for this time.
Therefore, generics are not always waiting for these months to pass. There are cases when pharmaceutical manufacturers filed an application for registration, then fought off the rightholder in the courts, and when the patent expired, they began to release the medicine without any obstacles. They understand that an extra month of sales can recoup their money spent on trial lawyers.
But the patent cliff means not only new opportunities for Ukrainian manufacturers. And pharmaceutics is not only business but also social responsibility. And if, due to the production of generics, the cost of treating certain diseases decreases, it will give hope to tens of thousands of Ukrainians.
With quality therapy, a person with blood cancer can receive precious time ‑ months and years during which much can be done. This is the main result which is worth making an effort.
The specificity is that the state registration in Ukraine can be terminated by the patent owner while this patent is valid. In other words, while no one produces anything, there is already an injunction. If you apply for the state registration at the end of the term of the patent, then 6-12 months of waiting actually work for the rightholder, prolonging its monopoly for this time.
Therefore, generics are not always waiting for these months to pass. There are cases when pharmaceutical manufacturers filed an application for registration, then fought off the rightholder in the courts, and when the patent expired, they began to release the medicine without any obstacles. They understand that an extra month of sales can recoup their money spent on trial lawyers.
But the patent cliff means not only new opportunities for Ukrainian manufacturers. And pharmaceutics is not only business but also social responsibility. And if, due to the production of generics, the cost of treating certain diseases decreases, it will give hope to tens of thousands of Ukrainians.
With quality therapy, a person with blood cancer can receive precious time ‑ months and years during which much can be done. This is the main result which is worth making an effort.