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New opportunities for registration and patenting of medicines

23 October 2020

Maria Shuvalova

The emergence and rapid spread of a new coronavirus infection has necessitated the most rapid development and introduction of medicines aimed at treating and preventing COVID-19. To this end, in the spring of this year, Russia introduced an accelerated procedure for registration of medicinal products intended for use in emergency situations, which provides for registration within 20 days from the date of application submission, and a simplified procedure with the possibility of submitting an incomplete package of documents. for the treatment of diseases that pose a danger to surrounding diseases (Resolution of the Government of the Russian Federation of April 3, 2020 No. 441; hereinafter - Resolution No. 441, valid until January 1, 2021). Its main difference from the standard procedure is the admissibility of the registration of a medicinal product before the completion of clinical trials - provided that a sufficient volume of preclinical trials is carried out, confirming the receipt of a positive effect from the use of a medicinal product when testing it on several species of animals and allowing the selection of an effective dose of the corresponding active substance for humans (Clause 4-5 of the Peculiarities of Circulation of Medicinal Products for Medical Use, approved by Resolution No. 441; hereinafter - Peculiarities of Circulation of Medicinal Products). In this case, the section of clinical documentation may provide a brief summary report on the results of studying its efficacy and safety in clinical trials at the time of filing an application for state registration of the drug, which should contain all available information on the properties of the drug.

However, it should be borne in mind that when registering a drug before the completion of clinical trials, the Ministry of Health of Russia establishes specific conditions for its use (one or more), among which is the mandatory post-registration clinical trials, based on the results of which the ratio of the expected benefit to the possible risk of using the drug is assessed. , conducting serial random quality control of this drug in circulation, requirements for its labeling, notifying Roszdravnadzor about each fact of using the drug, submitting information to the department about side effects, adverse reactions in connection with the use of the drug, about the peculiarities of its interaction with other drugs, individual intolerance and other circumstances affecting the change in the ratio of the expected benefit to the possible risk of use, identified at any stage of drug circulation (clause 7 of the Peculiarities of drug circulation tov).

In addition, it was established that it was necessary to subsequently carry out the procedure for confirming the registration of a drug registered under these conditions - the applicant must send a corresponding application to the Ministry of Health of Russia by December 1 of the current year (clauses 17.2-17.4 of the Peculiarities of the circulation of medicinal products). The reason for refusing to confirm registration is the decision of the Ministry of Health of Russia, made based on the results of an examination of the relationship between the expected benefit and the possible risk of using the drug, that the risk of harm to health due to taking this drug exceeds the effectiveness of its use. If the ministry makes a positive decision to confirm the registration of a drug, information about it is entered into the state register of medicines, and the applicant receives a registration certificate, which is valid for five years (but expires no later than December 31, 2025). The circulation of a medicinal product may be carried out before its expiration date, provided that it was produced within 180 calendar days from the date of the decision to confirm the registration, in accordance with the information contained in the registration dossier for this drug prior to the date of such a decision (p. 17.12-17.15 Peculiarities of drug circulation).

The indicated accelerated and simplified procedure was applied when registering in Russia both the first and second vaccines against COVID-19:

• the first, developed by the National Research Center for Epidemiology and Microbiology named after N.F. Gamalei, - Gam-COVID-Vac (combined vector vaccine for the prevention of coronavirus infection caused by the SARS-CoV-2 virus), which, we recall, became the first registered vaccine against COVID-19 in the world, was registered on August 11 (registration certificate number: LP-006395);

• the second, developed by the State Scientific Center of Virology and Biotechnology "Vector" of Rospotrebnadzor, - EpiVacCorona (a vaccine based on peptide antigens for the prevention of COVID-19) - registered on October 13 (registration certificate number: LP-006504).

In both cases, the developers in the published information on the registration of the vaccine indicated plans for conducting post-marketing clinical trials (gamaleya.org/research/vaktsina-protiv-covid-19/, Information from the Federal Service for Surveillance on Consumer Rights Protection and Human Welfare dated October 14, 2020 G.).

The emergence of a new infection and the need to combat it spurred the patenting activity of drug developers. So, according to Igor Pomytkin, Deputy Director of the Scientific Center for Biomedical Technologies of the FMBA of Russia, reported during the thematic section within the framework of the XXIV international conference of Rospatent, in the period from February 11 - the day WHO gave the official name of the new coronavirus infection - to October 19 of this year in the international PubMed database there was more than 63 thousand materials on COVID-19-related research have been published, which, in fact, constitute a technical level that can be opposed by the novelty of patented developments in the field of diagnosis, treatment and prevention of COVID-19. ClinicalTrials.gov has a record of 3,695 ongoing and completed studies related to COVID-19 to date (October 23). In such conditions, of course, it is extremely important to quickly register patents for relevant inventions: drugs, vaccines, diagnostic test systems, etc.

Accelerated patenting procedure

In April of this year, Rospatent launched a procedure for priority consideration of applications for the grant of patents for developments in the field of combating viruses and related diseases. All applications for patents for antiviral drugs, technologies for diagnosing viral diseases (in particular, diagnostic test systems), medical devices (including ventilators and inhalers), protective equipment (medical masks, respirators, protective suits, etc. etc.), sterilizing and disinfecting agents are considered by the department in an accelerated mode - the first correspondence on the application is sent to the applicant within two months from the date of the commencement of the substantive examination (while the average period for consideration of applications for a patent for an invention is 3-4 months). In practice, this period is much less than the declared two months and now, according to Deputy Director of the Federal Institute of Industrial Property (FIPS) Tatyana Erivantseva, an average of 22 days. "22 days after the start of the substantive examination, the applicant receives either a request for additional materials, or, if the development is described qualitatively and fully, a decision to grant a patent, or a notice of refusal to grant it. In any case, the developer promptly receives information about the results. conducted information search, which allows him, if necessary, to continue working in the chosen direction, or, if he received confirmation that the solution is a breakthrough, to begin its commercialization as soon as possible, "the expert notes. It is important that no additional action in the form of a request for the application of such an accelerated procedure for consideration and payment of the fee for the grant of a patent in an increased amount (for speed) is required from the applicant.

During the period from April to early October, Rospatent received 340 applications for the grant of patents for inventions and utility models in the field of technologies for combating viruses and associated diseases, on the basis of which 6 patents for vaccines have already been registered (for vaccines Gam-COVID-Vac, EpiVacCorona and related decisions), 7 - for drugs for the treatment and prevention of COVID-19 and related complications, 11 - for diagnostic test systems, 26 - for disinfection technology, 6 - for personal protective equipment.


The deadlines for payment of patent and other fees required for the implementation of registration actions by Rospatent, which expire from March 30 to November 30 of the current year, are extended until the end of the year at the appropriate request of the applicant or copyright holder (Resolution of the Government of the Russian Federation of June 20, 2020 No. 893) ...

It should be noted that applicants, when applying for a patent, can save not only time, but also money if they choose the electronic format of interaction with Rospatent. Recall that when submitting documents in electronic form through the services of Rospatent or the portal of public services, the amount of the fee for registering an application and registration actions related to its consideration is reduced by 30% (clause 7 of the Regulation on patent and other fees for legally significant actions, approved by the Decree of the Government of the Russian Federation dated December 10, 2008 No. 941; hereinafter - the Regulation on Patent Fees). But you need to understand that we are talking about electronic documents signed with a strengthened qualified electronic signature1 (applicants who do not have such can use the services of patent attorneys), and not electronic copies of documents that can be sent to fips@rupto.ru during a pandemic. International applications for patent protection in the PCT system can also be filed electronically, and when filing an application through the ePCT service (which is part of the WIPO portal: ipportal.wipo.int), the applicant receives a privilege to pay a fee, the amount of which depends on the format of the filed documents (detailed information on filing applications in electronic form can be found on the official FIPS website: new.fips.ru/news/pravila-priema-zayavok-v-usloviyakh-pandemii/).

Also, keep in mind that certain categories of applicants are entitled to certain reduced fees. These include, in particular, scientific organizations (clause 16 of the Regulation on Patent Fees), which, as you can see, are currently the main developers of drugs for the treatment and prevention of COVID-19. By the way, when such preferential categories of applicants submit applications for obtaining a patent in electronic form, the corresponding benefits are summed up with a discount on the payment of the 30% fee provided for electronic applications.

What should you pay attention to when obtaining patents for medicines and test systems?

In the context of the active development of the pharmaceutical and biotechnological industries, it is extremely important to take into account the need to ensure comprehensive legal protection of the results of intellectual activity. So, in the development of, for example, antiviral vaccines, not only the drug itself is important as a result of the development, but also the strains of viral and bacterial vectors used, which are the primary link in the creation of fundamentally new pharmaceutical products with certain properties, as well as methods for their preparation and use. , emphasizes the head of the laboratory of molecular biotechnology of the National Research Center for Epidemiology and Microbiology named after N.F. Gamalei Maxim Shmarov. Therefore, the center did not limit itself to obtaining a patent only for a vaccine (for an invention in the form of an immunobiological agent and a method for its use to induce specific immunity against the severe acute respiratory syndrome virus SARS-CoV-2), three variants of expression vectors for creating such an immunobiological agent were also patented, pharmaceutical compositions with an indication of the dosage forms of the pharmaceutical agent and methods of their use for the induction of specific immunity, as well as a test system for an enzyme-linked immunosorbent assay of human blood and its use for assessing the immune response to a vaccine. Thus, a comprehensive legal protection of the results of each stage of vaccine development has been implemented: from the idea of ​​constructing adenoviral vectors and their use to the creation of direct pharmaceutical compositions of an immunobiological agent, and this approach provides full protection of the developer's rights when introducing a drug into circulation, Maxim Shmarov is sure.

And yet, the provision of legal protection to registered results of intellectual activity does not always allow avoiding violation of the rights of patent holders - the practice of bypassing patented solutions still exists, notes Olga Bashkina, Rector of the Astrakhan State Medical University of the Ministry of Health of Russia. For example, in relation to test systems that use molecular genetic methods for specific diagnostics of COVID-19 (including PCR), such a bypass is possible, for example, by changing the nucleotide sequences of microorganisms through insertions, substitutions or deletions of nucleotides in non-coding and non-functional plots. How to protect your developments from such use in a slightly modified format is still, unfortunately, not clear.

As practice has shown, in the face of the urgent need for the development of diagnostic systems and drugs for the detection, treatment and prevention of diseases caused by a new virus, organizations conducting ongoing research, which, among other things, involve the analysis of known patented solutions in the relevant direction, and having sufficient experience in obtaining patents for their developments, have a significant priority over other developers. But those who created and patented their products should not stop research, since viruses mutate, and SARS-CoV-2 is no exception: the variability of the virus is also recorded in general - in connection with adaptation to the human population, and when observing the course diseases caused by COVID-19 in each individual patient, which means that continuous improvement of methods of their detection and treatment is required.

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