Duration of patents for medicines

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:

1. 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, 1994
2. Civil Code of the Russian Federation. Part four (with amendments and additions), Federal Law of December 18, 2006 No. 230-FZ
3. The 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 809
4. Patent instructions to the Eurasian Patent Convention, approved. By the Administrative Council of the Eurasian Patent Organization on December 1, 1995 (as amended and supplemented)
5. REGULATION (EC) No 469/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 6 May 2009 concerning the supplementary protection certificate for medicinal products
6. US Code , Title 35 (as amended 2012)
7. 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