Pharmaceutical manufacturers are waiting for the settlement of problems that have arisen after the adoption of the law on the protection of intellectual property rights during martial law in connection with the armed aggression of the Russian Federation at the beginning of the war.
This was reported to Interfax-Ukraine by representatives of pharmaceutical companies producing generic drugs.
According to the director of corporate, legal relations and compliance of pharmaceutical company “Darnitsa” Serguey Bobylev, in practice, the adoption of the law, which sought to prevent the loss of intellectual property rights by their owners during martial law, due to the fact that the first months of war, many rights holders, patent attorneys, lawyers and specialists for various reasons were not able to make in time to comply with the legislation of Ukraine to maintain these rights, “created a number of problems Ukrainian pharma
“The inaccurate wording of the law allowed certain companies to argue that intellectual property rights that expired during martial law continued in force. This has created the basis for litigation, in which the owners of such patents are trying to artificially extend their validity, thus creating a monopoly of certain medicines and therefore preventing the market entry of analogues that are of the same quality and effectiveness, but cost much less,” he said.
Bobylev noted that it takes an average of three years for a generic drug to enter the market, but “with the current wording of the law, it is impossible to invest in the development and entry into the market, because it is impossible to determine the end date of such artificially extended patents.
“As far as I know, about half a dozen of relevant disputes against competitors of patent owners are in Ukrainian courts. These lawsuits have actually stopped the release of several drugs. In addition, the very fact of going to court to protect patents that have finally expired and the uncertainty created by this stops many domestic and foreign pharmaceutical manufacturers from entering the Ukrainian market,” he said.
Bobylev noted that the biggest loser in this situation is the consumer, who is forced to use more expensive medicines without access to alternatives in the form of high-quality and cheaper generics in conditions of war and lower incomes.
“We need immediate clarification of one wording of the law in order for it to implement its real purpose, as reflected by the authors in the explanatory note to the bill, but without creating artificial grounds for the extension of patents. According to the Ukrainian National Office of Intellectual Property and Innovation, the appropriate changes have already been worked out and submitted to the parliament. We are waiting for the registration of the bill and its speedy adoption,” he said.
In turn, the director of government relations “Teva Ukraine” Marina Buchma, said that the extension of the patent during martial law is a non-standard situation: patent law provides protection for an invention for 20 years. Patents for medicines can be additionally extended for up to five years, i.e., the maximum duration of a patent cannot exceed 25 years.
“The situation seems to be exceptional and contrary to the interests of patients. After all, during martial law we need more stable access to drugs than ever before,” she said.
According to Buchma, after the law went into effect, it turned out that patents on some drugs were to expire in 2022 and that would have made it possible for generic drugs to appear on the market, these two drugs are caspofungin and etoricoxib.
“That said, it remains debatable whether extensions apply to patents that have expired the maximum term defined by patent law. Generic drugs were applied for registration in 2021 with the expectation that they could be marketed in 2022. Thus, some generic drugs are still not available to patients and the healthcare system,” she said.
Buchma noted that along with legislative mechanisms to resolve the problem that has arisen, “the pharmaceutical companies whose patents are extended by this law may take a voluntary decision to allow generic drugs to enter the market of Ukraine”.
As the agency was told by the company, at the moment Teva-Ukraine cannot bring to market the drugs caspofungin and etoricoxib due to the unjustified prolongation of patents during the martial law.
For his part, Pharmak’s legal support director Dmytro Taranchuk believes that the extension until the end of martial law of intellectual property rights has “no justification of procedural or procedural expediency, and is therefore discriminatory against market participants in Ukraine, both local and foreign.
“Adoption of the norm in the law on the extension of property rights for the period of martial law has led to an unprecedented monopoly, including in the market of medicines of Ukraine. There are cases when both basic and additional protection of rights to an invention has expired, but patent protection continues to be in force and gives the right to prohibit the use of his invention to the right holder. This is a dangerous precedent, including for the international system of protection of intellectual property rights,” he said.
Taranchuk noted that currently “monopolists retain the possibility of maintaining unreasonably high prices in the absence of competition.
“The norm of the law has a negative impact on the entire generic market of medicines in Ukraine and prevents the timely entry of generics into the market after the completion of patent protection. There are already precedents in Ukraine, when rightholders, using the norm of this law, through judicial institutions prohibit the sale of generic drugs, for example, containing molecules etoricoxib and caspofungin” – he said.
Taranchuk believes that “the authors of the bill were guided by motives to protect the interests of certain entities in the field of IP, rather than motives to protect the rights of entities in the field of IP.”
“The only effective way to solve this problem is to immediately repeal the provision of the law on the extension of property rights to protect fair competition in the markets, including medicines, and to protect the rights of consumers and patients to quality and affordable medicines in fair competition in the markets,” said the lawyer.
