Rospatent proposes special register of pharmaceuticals to protect intellectual property rights for innovative drugs
The expert discussion Pharmaceutical Intellectual Property as a Factor of Achieving Major Social Indicators and an Instrument of Access to the International Market was held on Thursday, January 17, as part of the 10th Gaidar Forum.
The participants focused on the specifics of regulating intellectual property in Russia and the world. They included Grigory Ivliev, Director General of the Federal Service for Intellectual Property (Rospatent); Yelena Maksimkina, Director of the Department of Drug Supply and Regulation of Medical Devices at the Healthcare Ministry; Filipp Romanov, Head of the Department of State Regulation of the Circulation of Medicines at the Healthcare Ministry; Timofei Nizhegorodtsev, Head of the Public Services and Retail Oversight at the Federal Anti-Monopoly Service (FAS); Yury Krestinsky, Director of Institute of Public Healthcare Development; AIPM Executive Director Vladimir Shipkov; Head of InPharma Association Vadim Kukava; Bayer CEO Niels Hessman, General Representative in Russia and the CIS; and Vladimir Dergousov, Head of Legal Advisory Practice, Alliance Consulting as part of ACIG Group of Companies.
The speakers noted that patent law in the field of pharmaceuticals plays an important role in achieving the goals set by the president for the government – to extend the healthy lifespan while developing an innovative, competitive and investment-attractive pharmaceutical industry.
“In the worldwide picture, we can see that countries that have relied on creating an attractive environment for the protection of intellectual property have achieved significant success, both in improving their socio-demographic indicators and in attracting foreign direct investment. Today, Russia ranks 29th out of 50 by the level of intellectual property protection. Given its ambitious goals for demographics and healthcare along with increasing the innovative component of the Russian pharmaceutical industry, including the priorities listed in the Pharma-2030 pharmaceutical industry development strategy project, improving the intellectual property protection mechanisms for innovative drugs is as relevant as ever,” Krestinsky said.
In Russia, 2018 saw high-profile trials between originator companies and Russian manufacturers that make biosimilars of innovative foreign drugs. The originators claimed these companies have introduced their drugs into the market illegally before the expiration of patents on the originator brands.
“In regard to protecting intellectual property rights, 2018 was particularly difficult for Bayer in Russia. We encountered violations of our intellectual property rights. The Bayer generic cancer drug was included in government procurement long before the expiration of the patent for the Bayer reference drug. The company was forced to defend its rights in court. The decision of the intellectual property court to review the Bayer patent infringement case served as a positive signal for the entire industry. Effective intellectual property protection is the most important engine of innovation. We want innovations to be available to Russian patients as much as to patients in other countries. Therefore, it is critically important to ensure that the intellectual rights of innovative companies are not violated. Not only foreign manufacturers are interested in this, but also Russian ones, and certainly patients,” Niels Hessman said.
The head of Rospatent, Grigory Ivliev, spoke about the regulator’s initiative to create a unified drug register. Rospatent is now working with the Healthcare Ministry to develop a relevant mechanism for the proposed register, the Unified Register of patent-protected active pharmaceutical ingredients.
“It is necessary to codify in the legislation that procurement of such drugs can become available only after the expiration of the patent period of originator drugs. Furthermore, it is necessary to create a register of patented drugs prone to such problems [arising from the prior introduction of generics to the market]. It should contain data on patented inventions used in reference medicinal products related to the active ingredient, the numbers of the relevant patents and their validity periods, as well as information about the patent holders. These data should be entered into the register at the initiative of the right holders on the basis of the submitted supporting documents after verification by Rospatent. The Healthcare Ministry will add to the register information on the state registration of reproduced drugs, information about the holders of registration certificates and comments on their entry into circulation [such as entry into circulation with a deferral],” Ivliev said.
Yelena Maksimkina urged patent holders to defend their rights while keeping in mind the needs of patients. “Pharmaceutical companies should not claim additional financial benefits from their intellectual rights. When patent rights allow a monopoly price to be established, even state regulation cannot make this drug economically affordable for patients,” she explained.
She was seconded by Timofei Nizhegorodtsev who urged manufacturers to feel more comfortable going to court, adding that Russian laws provide an opportunity to protect their intellectual property rights. “Going to court should not be seen as something extraordinary. All over the world, protecting intellectual property is a competitive process. To resolve the problem [of challenging the patents of originator companies in Russia], we need to hold consultations with Rospatent and the Supreme Court to agree on injunctive measures in such cases. And immediately the situation will improve, because once injunctive measures are imposed on the money received from the sale of the drug, and then the money is confiscated with a fine, the problem will dissolve like smoke,” he said.
Vladimir Shipkov said investment is best attracted to countries where proper protection of intellectual property rights is provided. “There will be no investment if intellectual property rights are violated. There will be no modern breakthrough treatment technologies or modern generics, because originator products will not be introduced into the Russian market,” he explained. In conclusion, he cited the example of China, since Russian regulators often refer to that country’s experience. “Let's see what our Chinese neighbors are doing in the trade war with their overseas partners. They zeroed the duties on imported drugs, increased the term of patent protection by five years, and tightened injunctive measures, such as banning registration and putting a drug on the market before the expiration of patent protection. Furthermore, they removed all administrative barriers to introducing new drugs, and other measures,” he said.
Patent rights should be properly protected, regardless of whether they contribute to innovation and the inflow of investment or not, Vladimir Dergousov concluded. “It is much easier and more correct to prevent an offense than to deal with the consequences of such violations. In practice, it often happens that the right holder protecting their rights in court has zero commercial efficiency; it is the company that abuses rights by violating the patents that gains commercial advantage. In this regard, the Healthcare Ministry’s initiative seems reasonable: the amendments to Federal Law No. 61-FZ on the Circulation of Medicines introducing a legal mechanism would prevent the registration of a generic drug before the expiration of the patent for the originator drug and allow the right holders to effectively defend their rights in court. Of course, these amendments still require need to be finalized,” he concluded.
10th Gaidar Forum Organizers:
The Russian Presidential Academy of National Economy and Public Administration (RANEPA);
The Gaidar Institute for Economic Policy (Gaidar Institute);
The Association of Innovative Regions of Russia (AIRR).
The general partners of the Gaidar Forum are Gazprom and Gazprombank; strategic partners include Prosveshcheniye publishing house, Coca-Cola, Pharmstandard group, ACIG Group of Companies, the Russian Textbook Corporation, SANOFI, Novartis, Johnson & Johnson, Russian Railways, MSD, and Mastercard; EY, Cisco and Russian Direct Investment Fund are partners. This discussion’s partners are Philips, Cherkizovo and RVC.
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