Tatiana Babakova

At first glance, it may seem that patent legislation appeared in our country only in recent history. However, it has quite ancient origins.Before the introduction of the 1812 Manifesto “On Privileges for Various Inventions and Discoveries in Crafts and Arts” [1], the objects of patent law were indeed in no way regulated. In those days, only individual requests were granted by the sovereign and only some inventors could receive certain grants - privileges, and such privileges could be expressed in completely different concessions for the copyright holder, for example, in the possibility of non-payment of certain duties. However, over time, a kind of rudiments of the concept of exclusive right began to appear in privileges more and more often.The most indicative here are the letters of grant from the time of Peter I. One of these privileges was received in 1701 by Johann Gregory, whom the sovereign instructed to build a pharmacy in Novonemetskaya Sloboda. The wording of the privilege was as follows: “so that, besides him, in this settlement no one else should open a pharmacie again or secretly sell medicine from their houses.” This is how the monopoly was secured.Probably the most famous of the privileges is the one issued in 1752 to Mikhail Lomonosov for “making multi-colored glass, beads, bugles and other haberdashery items ” with a very significant phrase: “ So that he, Lomonosov, as the first in Russia to find out those secrets, for the damage incurred they could have enjoyed their work: for the sake of this, from now on, for thirty years, no one else in the establishment of those factories will be given permission.” Why not an exclusive right?!In a later privilege, issued to Lehmann in 1758, a different wording was used: “so that for twenty years no one will be allowed to oppose the invention of his work, which he himself will invent, wallpaper, carriages and other things to make and start factories” (approx. lat. inventio - invention), although essentially the meaning is the same - prohibition of use by third parties.The issuance of privileges in those days was determined only by the mercy of the sovereign.The situation changed with the introduction in 1812 of the above-mentioned Manifesto “On Privileges for Various Inventions and Discoveries in Crafts and Arts.”According to A.A. Pilenko, the publication of the Manifesto was caused by the following circumstances. In 1810, foreigners Geren and Jelglund petitioned Alexander I to grant them the privilege of a distillation device invented by foreigners Adam and Berard. The request was granted, and Geren and Jelglund were granted exclusive rights until May 1, 1820. At the same time, the Emperor instructed the Committee of Ministers to establish the conditions for using this privilege. In response to this, Count Mikhail Speransky, a famous Russian reformer, prepared a draft general law, which was considered by the State Council on May 8, 1812. This is how the first patent law in Russia appeared.The manifesto established state registration of inventions. Relevant petitions were considered by the Ministry of Internal Affairs, and the decision was made by the State Council.The Manifesto defined the first requirements for inventions to be registered. Firstly, according to § 6 of the Manifesto, “privileges are not granted for inventions of which the Government will not be presented... with a detailed and accurate description,” i.e., the requirement of sufficiency of disclosure of the invention was established (note that in modern Russia this condition was introduced as a basis for refusing to issue a patent only in 2014). Further, according to § 7, “privileges are not granted to items that do not bring any benefit not only to the State, but also to private people, or can also cause harm,” i.e., a kind of analogue of the patentability condition “industrial applicability” has been established.In addition to those indicated, another criterion was enshrined in the Manifesto. According to § 17, the privilege may be terminated if “it is proved by the court that the same invention or discovery, at the time when the privilege was applied for, was already described in public Gazettes or writings, published within or outside the Empire” “that the same device and action could have been made and performed without a new description.” Thus, the condition of patentability “novelty” was established, non-compliance with which was considered as a basis for challenging the validity of the privilege.Privileges were issued for a period of 3, 5 or 10 years and could be transferred to other persons.After the adoption of the Manifesto, Mikhail Speransky continued his legislative work. So, in 1833, the “Regulations on Privileges” was published [2], which developed the norms laid down in the Manifesto. In particular, a new object of protection was introduced - an improvement, which was considered on a par with inventions. According to § 1 of the Regulations, “every discovery, invention or improvement of any generally useful object, or method of production in the arts, manufactures and crafts, is the property of the person by whom it was made, and this person, in order to ensure his rights to his property, may request receive an exclusive privilege from the Government.”Another reason for refusal has appeared: “for minor discoveries, inventions and improvements that show only the sharpness or ingenuity of the mind and which, however, do not promise any significant benefit, as well as for those that can be detrimental to society or State revenues, privileges are not granted” are issued." Thus, in essence, the patentability condition of “inventive step” was established.A rule was introduced regarding dependent inventions, albeit in a form that is unusual for the modern average person: “if in an invention for which a privilege has been issued to one person, some improvement is made by another person, then a special privilege cannot be issued to this latter for this improvement” , unless he first proves that he has made an agreement with the owner of the first privilege regarding his use of the remaining parts of the object; but on the expiration of the first privilege a special privilege may be granted on the improved part.”In addition, the Regulations provided that the privilege could terminate due to non-use of the protected object within a quarter of the period of validity of the privilege.In accordance with the Regulations, applications for privileges were submitted to the Department of Manufactures and Internal Trade and considered by the Manufacture Council.Further development of legal science led to a limitation of the categories of objects that may be the subject of a privilege. Thus, according to Article 1984 of the Charter on Industry [3], privileges cannot be issued for inventions and improvements on “scientific discoveries and abstract theories”, “contrary to public order, morality and decency”, “privileged already in Russia or received application without a privilege, or described in the literature in sufficient detail to reproduce them, prior to the date of filing the application for the grant of privilege.” In addition, privileges were not granted to chemical, food and flavoring substances and to compound medicines, as well as to methods and apparatus used for their production. This restriction was introduced probably due to the difficulty of proving a violation in those years.According to articles 19816 and 19826 of the Charter, privileges were issued for a period not exceeding fifteen years and could be challenged by any person within two years from the date of their promulgation.Later, the unstable domestic and foreign political situation required the introduction of new measures. Thus, in 1912, the Rules on the compulsory alienation of privileges for inventions and improvements were adopted [4], according to which privileges can be forcibly alienated “if there is a state necessity, in favor of the state,” while providing for the payment of remuneration to the owner of the alienated privilege.Thus, in the Russian Empire the system of protection of inventions gradually developed and improved.However, the change in the political system led to fundamental changes in legal science. The entire clearly structured system of privileges was abolished by the Decree of the Council of People's Commissars of June 30, 1919: “Any invention recognized as useful by the Committee for Inventions, perhaps, by resolution of the Presidium of the Supreme Council of the National Economy, is declared the property of the RSFSR,” “All laws and regulations on privileges for inventions published before the publication of this decree are cancelled.” Thus began a new era - the time of copyright certificates, assigning only the right of authorship to inventors.Although it should be recognized that the legislator has made attempts to return to the previous concept of protection. Thus, on September 12, 1924, the Patent Regulation was adopted [5], created according to the German model and providing for the possibility of granting the patent holder exclusive rights, similar to those that existed in the Russian Empire. However, this system was not popular among domestic inventors. Indeed, if the inventor received a copyright certificate, thereby alienating his exclusive right in favor of the state, he could count on payment of remuneration. The patent system, for obvious reasons, did not provide for any rewards. In this regard, the further development of the invention protection system in the USSR leaned more and more towards copyright certificates, and patents were issued for the most part only to foreigners.The next change of the political system in 1991 again nullified the concept of copyright certificates created in the Soviet years. In many ways, the patent legislation of our country in the 90s was borrowed from Western sources. In addition, norms from numerous international acts signed by the Russian Federation were implemented, including the TRIPS Agreement [6], which is valid for the Russian Federation as a member of the World Trade Organization (WTO). Although not all foreign norms have taken root in the legislation of our country, and Russian identity is still gradually making its own adjustments, including to patent law.The further development of Russia will certainly require various changes to legislation. However, as history has shown, our country is capable of responding to any challenges of the time.  Bibliography:Pilenko A.A. Inventor's right (privileges for inventions and their protection in Russian and international law). Historical and dogmatic research. In 2 parts. St. Petersburg, 1902-1903;Revinsky D.O. Patenting inventions in Russia, 1812-1870. // Economic history: Yearbook, 2001. M. 2002. pp. 339-376.Sources: Manifesto on privileges for various inventions and discoveries in the arts and crafts of June 17, 1812 - Complete collection of laws of the Russian Empire. Collection 1st. T. 32. No. 25143Regulations on privileges November 22, 1833 - Complete collection of laws of the Russian Empire. Collection 2nd. T.8. Dept. 1. No. 6588St. Zak. vol. XI part 2, ed. 1893Collection Uzak. 1300, 1912Resolution of the Central Executive Committee and Council of People's Commissars of the RSFSR on patents for inventions dated September 12, 1924Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), WTO, Marrakech, April 15, 1994

As a general rule, a patent for an invention can be valid for no more than 20 years. This period is established by Article 33 of the Agreement on Trade Aspects of Intellectual Property Rights [1] and is reflected in paragraph 1 of Article 1363 of the Civil Code of the Russian Federation [2]. It is assumed that during this period the patent holder uses his invention in any way that does not contradict the law.However, in certain areas, copyright holders do not have the opportunity to timely introduce their invention into civil circulation and, accordingly, fully exercise their exclusive rights. First of all, this applies to medicines. In addition to obtaining a patent, pharmaceutical manufacturers must undergo quite a few tests, sometimes spending several years on clinical trials and state registration of their drug, before being able to use their development on the market.In order to compensate for the wasted time of not using one’s patent, the legislator has provided the possibility of extending the twenty-year validity period of a patent for medicines. Thus, according to paragraph 2 of Article 1363 of the Civil Code of the Russian Federation, if from the date of filing an application for a patent for an invention relating to a product such as a medicine, pesticide or agrochemical, the use of which requires obtaining permission in accordance with the procedure established by law, until the day of receipt of the first permission to use has passed more than five years, the validity period of the exclusive right to the corresponding invention and the patent certifying this right is extended by the time elapsed from the date of filing the application for a patent for the invention to the day of receipt of the first permission to use the product, minus five years, but not for more than five years.Thus, copyright holders of pharmaceutical patents have the opportunity to increase the period of protection of their invention from 20 to 25 years.To extend the twenty-year validity period of a patent for a medicinal product, the patent holder must provide the department with a copy of the first registration certificate received from the Ministry of Health of the Russian Federation, and, if necessary, other information proving the identity of the medicinal product for which permission has been obtained and the patented product. It should be borne in mind that the validity of a patent can be extended only on the basis of the first registration certificate issued with a validity period of five years.We would like to inform the interested reader that paragraph 2 of Article 1363 of the Civil Code of the Russian Federation and the Procedure for the issuance and validity of an additional patent for an invention [3] establishes comprehensive conditions for the renewal of a patent, including the terms and requirement that the characteristics of the product for the use of which permission has been obtained be identical and the patented product.From practice, the main difficulties for copyright holders arise precisely in proving that the invention formula characterizes a product that belongs to a medicinal product and the use of which has been approved. However, as a rule, this issue is resolved by providing an extract from the World Health Organization dossier - Lists of Recommended and Proposed INNs.Let us note that the above provision of Article 1363 of the Civil Code of the Russian Federation is equally valid for Eurasian patents valid in the territory of the Russian Federation. According to Rule 16(5) of the Patent Regulations to the Eurasian Patent Convention [4], the validity period of a Eurasian patent may be extended in relation to that Contracting State whose legislation provides for the extension of the validity period of a national patent for an invention, while the extension of the validity period of a Eurasian patent is carried out in accordance with the conditions provided for by the legislation of this states to extend the validity period of a national patent for an invention. Thus, the conditions for renewing a Eurasian patent are exactly the same as for Russian patents.At the same time, there are differences in the procedure for renewing patents of the Russian Federation and Eurasian patents. Paragraph 2 of Article 1363 of the Civil Code of the Russian Federation establishes that if the application for patent renewal is satisfied, an additional patent is issued - a kind of analogue of the Additional Protection Certificate used in the countries of the European Union, Canada and a number of other countries. Such an additional patent is usually granted directly to the active ingredient in the drug and pharmaceutical compositions containing it. The supplementary protection certificate used in the European Union contains information directly about the active ingredient and/or finished dosage form, the use of which has been authorized and for which a particular patent continues to apply.In the case of renewal of a Eurasian patent, the office simply enters data into the patent register that an extension has been carried out for a certain period in relation to certain claims. In this way, the entire claim is extended, whether it is a Markush formula covering thousands of different individual compounds, or a pharmaceutical composition expressed in general terms. It should be recognized that the legislator made an attempt to limit legal protection to the pharmaceutically active substance or drug containing it for the use of which a registration certificate was issued. Thus, Rule 16(5) of the Patent Instructions to the Eurasian Patent Convention explains that when extending the validity period of a Eurasian patent, its validity extends to an invention related to a product protected by a Eurasian patent, for the use of which permission has been obtained from the authorized body of the relevant Contracting State, and to the specified in permission to use this product. It would seem that with this clause the Eurasian Patent Organization normatively consolidated the principle laid down in the Supplementary Protection Certificates of the European Union. However, it should be recognized that there is no law enforcement practice of this provision. Currently, there is not a single administrative or judicial decision that reflects the application of this provision. Moreover, often, on the basis of one registration certificate, the entire pool of patents relating to both the Markush formula and individual chemical compounds, including stereoisomers and crystalline forms, and finished dosage forms is renewed, which is clearly seen from the information of the Eurasian PharmRegister.If it is necessary to renew patents in other jurisdictions, copyright holders may face another problem. The legislation of the Russian Federation, like the Eurasian legislation, does not limit the right holder to the possibility of renewing only one patent for a medicinal product. However, in many countries there is such a restriction. In the countries of the European Union, a Supplementary Protection Certificate can only be issued in respect of one patent, as established by Article 3 of EU Regulation No 469/2009 [5]. In other words, the principle “one registered drug = renewal of one patent” applies.Similarly, in the United States, only one patent can also be renewed based on one marketing authorization (35 US Code § 156 [6]). Although there are some peculiarities here too. Unlike the Russian Federation, the Eurasian Patent Organization and the European Union, in the United States the subject of renewal can be not only products (a substance and/or a composition containing it), but also methods, including methods for obtaining or using a medicinal product.In conclusion, we note the procedure for challenging the extension of patents, since, unlike basic patents, this also has its own specifics. An additional patent in the Russian Federation can be challenged on the basis of non-compliance with the renewal requirements, i.e. the conditions of paragraph 2 of Article 1363 of the Civil Code of the Russian Federation and the above-mentioned Procedure for the issuance and validity of an additional patent for an invention, in particular paragraphs 7 and 8, according to which the claims of the invention must characterize the product for the use of which permission has been obtained. Amendments to paragraph 5 of Article 1363 of the Civil Code of the Russian Federation at the end of 2022 determined the possibility of challenging an additional patent administratively.It should be noted that the Eurasian Patent Office has also approved administrative rules for appealing decisions to extend a patent, established by the Procedure for filing and considering objections to the extension of the validity period of a Eurasian patent for an invention [7].Sources:Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) (as amended), Annex 1C to the Marrakesh Agreement Establishing the World Trade Organization of April 15, 1994Civil Code of the Russian Federation. Part four (with amendments and additions), Federal Law of December 18, 2006 No. 230-FZThe procedure for the issuance and validity of an additional patent for an invention, extension of the validity period of a patent for an invention, approved. by order of the Ministry of Economic Development of Russia dated November 3, 2015 N 809Patent instructions to the Eurasian Patent Convention, approved. By the Administrative Council of the Eurasian Patent Organization on December 1, 1995 (as amended and supplemented)REGULATION (EC) No 469/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 6 May 2009 concerning the supplementary protection certificate for medicinal productsUS Code , Title 35 (as amended 2012)The procedure for filing and considering objections to the extension of the validity period of a Eurasian patent for an invention, approved. by order of the Eurasian Patent Office of July 27, 2021 No. 34, as amended and supplemented