Results achieved in the intellectual property protection as part of an accelerated review of applications related to COVID-19 by Rospatent

To combat the spread of the new coronavirus infection (COVID-19), at the beginning of 2020, Rospatent introduced a mechanism for expedited review of applications for inventions and utility models on the relevant topic, according to which the average duration of the first substantive examination action is 27 days. The average application review duration as a whole takes about 3.8 months.

As a result of this mechanism, about 1000 applications have been submitted for technical solutions (vaccines, pharmaceuticals, methods of treating and preventing both the disease itself and its consequences, testing methods, test systems, protective equipment, and medical equipment) related to coronavirus. Since the pandemic's beginning, more than 400 patents have already been issued in the Russian Federation.

In addition, the world's first patent for a vaccine against COVID-19 was issued in the Russian Federation.

The Federal State Budgetary Institution "National Research Center of Epidemiology and Microbiology named after Honorary Academician N. F. Gamaleya" of the Ministry of Health of the Russian Federation used a comprehensive approach to patenting and protected variants of immunobiological agents with many related patents:

• RU 2723008 "Method for obtaining a strain of Chinese hamster ovary cells, producer of recombinant protein RBD of SARS-CoV-2 virus, a strain of Chinese hamster ovary cells, producer of recombinant protein RBD of SARS-CoV-2 virus. CoV-2, a method for obtaining recombinant protein RBD of the SARS-CoV-2 virus, a test system for enzyme-linked immunosorbent assay of human serum or plasma and its application",
• RU 2720614 "Immunobiological agent and method for its use for induction of specific immunity against the SARS-CoV-2 severe acute respiratory syndrome virus (variants)", an updated description of which was published on 09.02.2021.

In addition, further inventions were developed, more patents were obtained:

• RU 2743962 "Means for induction of specific immunity against the severe acute respiratory syndrome virus acute respiratory syndrome SARS-CoV-2 in a freeze-dried laboratory", RU 2743963" Means for inducing specific immunity against the SARS-CoV-2 severe acute respiratory syndrome virus in liquid form (variants)", published on 01.03.2021
• RU 2744442" application of a means for inducing specific immunity against the SARS-CoV-2 severe acute respiratory syndrome virus in persons over 60 years of age and/or with chronic diseases (variants)", RU 2744444" application of a means for inducing specific immunity against the SARS-CoV-2 severe acute respiratory syndrome virus acute respiratory syndrome SARS-CoV-2 for revaccination of the population (options), published on 09.03.2021.

On 05.10.2021, patent RU 2731356 was obtained for an expression vector for creating an immunobiological agent for inducing specific immunity against the SARS-CoV-2 severe acute respiratory syndrome virus (variants).

The research center comprehensively patented and registered the vaccine for the coronavirus infection prevention "Sputnik V "and the one-component vaccine" Sputnik Light." It started with the isolated strain of Chinese hamster ovary cells, ending with the current immunobiological means of diagnosis, prevention, and treatment of this disease and methods of their application.

The Russian biotech company BIOCAD, which received the patent RU 2760301 for a vaccine against coronavirus in November 2021, is also keeping up with the Gamaleya Research Center. A vaccine was developed to prevent coronavirus infection using codon-optimized nucleic acid. It is also vector-based and is based on the AAV5 adenovirus to induce specific immunity.

The State Scientific Center of Virology and Biotechnology "Vector" of the Federal Service for Supervision of Consumer Rights Protection and Human Welfare has developed vaccines containing artificially synthesized fragments of viral proteins. Specialists can get acquainted with the details, for example, from the description of one of the four received patents RU 2743595 "Vaccine composition against coronavirus infection COVID-19", which was published on 20.02.2021, and discloses the preparation of a vaccine composition, known to us as "EpiVacCorona," using peptide immunogens and a carrier protein that carry the minimum necessary antigenic determinants for the formation of a specific immune response and induce protective immunity.

Patent RU 2747762 "Vaccine for the prevention or treatment of coronavirus infection based on a genetic construct", published on 13.05.2021, the patent holder of which is the ATG Service Gen founder Ilya Dukhovlinov protects another vector vaccine, which is a polynucleotide for expression in cells of the target organism that encodes a hybrid protein that includes fragments of coronavirus M, S, N, and E proteins connected by flexible bridges.

In addition to vector and peptide vaccines "FSBSI IEM" under the leadership of Alexander Suvorov developed a live vaccine protected by patent RU 2745626 "Method for creating a live vaccine against coronavirus infection COVID-19 based on the probiotic strain Enterococcus faecium L3 and live vaccine Enterococcus faecium L3-pentF-covid-19", published on 29.03.2021. The patent presents a live vaccine Enterococcus faecium L3-pentF-covid-19 containing a clone of enterococci COVID 19+ with a DNA region inserted into its genome. Oral administration of the Enterococcus faecium pentF-covid-19 vaccine stimulates the development of a specific systemic and local immune response, which is manifested by the production of specific immunoglobulins of classes G and A, as well as increased production of interferon gamma in vaccinated patients.

Another vaccine patent is patent RU 2759227, published on 11.11.2021, as its patent holders are residents of the UK – the company "Geneticist Diagnostics and Therapy 21 Ltd." and Russia-LLC "RECOMBITECH", who jointly developed a DNA vaccine against the virus SARS-CoV-2 based on the gene therapy DNA vector GDTT1. 8NAS12, consisting of a composition of the gene therapy DNA vectors GDTT1. 8NAS12-S, GDTT1. 8NAS12-M and GDTT1. 8NAS12-N encoding immunogenic epitopes of the S, M, N proteins of the virus SARS-CoV-2.

In addition, special attention should be paid in the shortest possible time to patented inventions related to pharmaceutical drugs that are currently actively used in methods of treatment for COVID-19 approved by the Ministry of Health.

An antiviral agent containing favipiravir, made in the form of film-coated tablets, is protected by Kromis LLC with patent RU 2731932 "Anti-COVID-19 (SARS-CoV-2) viral pharmaceutical composition", patent published on 09.09.2020. The proposed composition includes: 43-44 % micronized favipiravir with a particle size of 40-50 microns, 5.5-6.0 % croscarmellose sodium, 4.8-5.0 % povidone, 0.6-0.8 % magnesium stearate, 0.5-0.7 % colloidal silicon dioxide, 2.5-2.7 % film shell and the rest-microcrystalline cellulose. The above formulation provides rapid release of favipiravir from tablets.

By the patent holder of the patent RU 2746362, published on 12.04.2021, State Scientific Center "SSC Institute of Immunology" of the FMBA of Russia, presented a combined drug that has an antiviral effect against coronavirus has been presented SARS-CoV-2 and related viruses, provided that the genetic target against which the specific component of this drug is directed is identical, containing: the effective number of siRNA molecules produced against the virus genome SARS-CoV-2 two complementary chains, where the modified nucleotides in the sense and antisense chains are represented by a modification of LNA, a dendrimeric cationic peptide with transfection activity, and a pharmaceutically acceptable auxiliary solvent.

Representatives of a Russian company LLC "Aviron" and the American company "ASAVI LLS" with Alexander Ivashchenko, Andrey Ivashchenko, Nikolay Savchuk, Alena Ivashchenko, Vladimir Loginov, and Mikhail Topr received several patents of the Russian Federation at once:

• RU 2738885 "Anti-SARS-CoV-2 viral agent Antiprovir", published on 18.12.2020, from which a pharmaceutical composition is known for the treatment and prevention of COVID-19, providing high antiviral activity, which is a pharmaceutical composition containing aprotinin as an active component and excipients, as an antiviral agent;
• RU 2745986 "Anti-coronavirus agent for combination therapy of COVID - 19 (SARS - CoV-2) and method of treatment", published on 05.04.2021, which discloses a combined method of treatment of COVID - 19, including sequential or simultaneous administration to a patient in therapeutically effective amounts and ratios of two drugs, one of which includes aprotinin, and the other-the SARS-CoV-2 replication inhibitor favipiravir;
• RU 2744429 "Anti - RNA viral, including anti-coronavirus agent-substituted quinoxalin, pharmaceutical composition and applications", published on 09.03.2021, from which a pharmaceutical composition is known that has the property of an inhibitor of RNA-dependent RNA polymerase (RdRp) Viral RNA.

Patents RU 2740657 and RU 2740660 "Antiviral composition", published on 19.01.2021, the patent holder of PROMOMED RUS LLC protected a pharmaceutical composition and a method for treating a disease caused by exposure to a virus whose genome is encoded by a single-stranded RNA strand and which uses viral RNA-dependent RNA polymerase for its replication. The proposed composition according to patent RU 2740657 contains favipiravir and darunavir at a mass ratio of favipiravir: darunavir, a component of 1:1. The combined use of darunavir and favipiravir in the indicated ratio leads to a significant increase in the mutual effect against viruses in the absence of additional side effects. The pharmaceutical composition, according to patent RU 2740660, is designed to alleviate the clinical symptoms, course, and/or cure of a disease caused by exposure to a virus whose genome is encoded by a single-stranded RNA strand and which uses viral RNA-dependent RNA polymerase for its replication contains an effective amount of favipiravir and an effective amount of a zinc compound selected from zinc sulfate, zinc acetate, zinc lactate, zinc-diethyl-bis (N-4-methylthiosemicarbazone), zinc dithiocarbamate, in the mass ratio of favipiravir to zinc salt 1: 1-10:1, where the effective amount of favipiravir is 50-800 mg, the effective amount of zinc salt is 15-250 mg.

A group of authors from the Republic of Belarus, who are also the patent holders of patent RU 2745774 "Method for treating patients with a new coronavirus infection (COVID-19)", published on 31.03.2021, Alexey Marochkov, Artur Lipnitsky, Dmitry Tsopov, Olga Dozortseva proposed a method that includes the diagnosis of infection by obtaining a positive test for the presence of RNA or IgM to SARS-CoV-2 or a typical x-ray picture on computed tomography of the chest organs. The patient is additionally assigned acetylsalicylic acid 300 mg on the first day and 150 mg on days 2-21 of the disease, clopidogrel 300 mg on the first day and 75 mg on days 2-21, and rivaroxaban 20 mg on days 1-21. The invention provides effective treatment of COVID-19 infection in patients of different age groups with minimal side effects.

The author and patent holder of patent RU 2751488 "Method for the treatment of coronavirus infection", published on 14.07.2021, Vsevolod Kiselev, presents a method for the treatment of mild and moderate coronavirus infection using a drug containing 3,3' - diindolylmethane, fish oil type A and polysorbate 80 at a mass ratio of 15:2:58 components. The drug is administered in doses of 3,3' - diindolylmethane from 1200 to 2400 mg/day. In the first 2-3 days, then 600-900 mg/day for 4-10 days. The drug is administered as monotherapy or in combination with an antiviral drug based on favipirovir. The use of the invention makes it possible to achieve faster positive dynamics in the clinical picture and laboratory parameters, to prevent the development of acute respiratory distress syndrome by stabilizing the concentration of interleukin-6 with the introduction of 3,3' - diindolylmethane.

Summing up the review of patent documents presented above, we would like to hope that the developed vaccines and pharmaceuticals patented in a short time in the Russian Federation, thanks to the accelerated review mechanism, will prevent the further spread of COVID-19 not only in the Russian Federation, but also in many other countries of the world.

Originally published in Patent Lawyer