How to find out if a drug is patented in Russia

Patent purity is a legal property of an IP object, which means that it can be freely used in a given country without the danger of violating patents owned by third parties in force in its territory. The purpose of the patent search is to identify the features of a patented technical solution of intellectual property used in the object, despite the differences in other features.

An invention under a patent can be recognized as used only if every feature of the invention included in an independent claim of the invention or equivalent to it, including a generic concept reflecting its purpose, is used.

Accordingly, when checking for patent purity, the object as a whole is checked, all or most of the solutions implemented in it are evaluated, the possible replacement of features is assessed using the so-called “doctrine of equivalents”, namely: the invention is recognized as used even in cases where the replacement is allowed one or more features of the invention with other interchangeable elements (equivalents).

The search is carried out for each country separately. Checking for patent purity is carried out in a certain territory, as a rule, in the countries of the intended production and export of products, and within the life cycle of a medicinal product, which should be understood as the duration of a patent for inventions (20 years), taking into account the possibility of its extension - for a maximum of 5 years.

As a rule, in the Russian Federation, the vast majority of patents for new chemical or biotechnological active substances are issued to foreign right holders. They are called "originators". Russian applicants more often patent improving solutions related to already known means. Such solutions include new ready-made forms; combinations with other adjuvants that have a synergistic effect; the use of known drugs for a new purpose; new treatment regimens using non-standard dosages, etc. Such patents are considered "secondary". The current situation in the Russian Federation is primarily due to the lack of state funding for the development of domestic drugs, organizational support for scientists in carrying out complex and expensive stages of studying new chemical compounds, their preclinical and clinical trials.

If the developer still needs to conduct such a search without the participation of a patent attorney, then a pharmaceutical company needs:

• Check data on pharmacologically active substances protected by a patent for an invention valid in the territory of the Russian Federation, in particular, the international non-proprietary name (INN) of the substance, the numbers of the corresponding patents and their validity periods. Such information about patent holders is included in the Unified Pharmaceutical Register (EAPO) at the request of the right holders on the basis of the submitted supporting documents. The information obtained will make it possible to identify the patent owner - the "originator", since in the first place one should expect "cascade protected" valid patents from him.
• See if similar drugs are registered in the State Register of Medicines of the Russian Federation, by whom it is registered (a hypothetical applicant) and in what forms (indicative search objects are new finished dosage forms of known drugs).
• Analyze the information published in Pat-INFORMED by the International Federation of Pharmaceutical Manufacturers and Associations, representing knowledge-intensive companies in the pharmaceutical industry. This resource is implemented as an open access database, where patent holders post information about patents for registered medicines; purchasing organizations send direct requests to companies-patent holders and receive information about the right holder of medicines in the territory of a particular country for further interaction. In this way, stakeholders can easily establish a direct link between granted patents and existing drugs, and speed up patent analysis.
• Taking into account the information received about hypothetical applicants, conduct an extended search using information retrieval resources of databases of Rospatent patent documents, including through the new Rospatent Search Platform, the Espacenet patent database and the World Intellectual Property Organization (Patentscope), databases EAPATIS, KIPRIS, Internet search engines: Yandex patent, Google patent.

At the same time, in order to minimize the risks of possible infringement, attention should be paid, in addition to published valid patents for inventions, including published claims to applications for inventions that are at the stage of substantive examination; for descriptions and claims to Eurasian patents for inventions maintained annually on the territory of the Russian Federation; and international PCT applications with a priority date set 2.5 years prior to the day of the examination, since the deadline for transferring a PCT application to the national phase in Russia is 31 months from the date of priority claimed in the international application.

Based on the results of the search, it is necessary to analyze in detail the revealed information: compare the features of the independent claims of each identified similar invention with the features of the developed drug, evaluate the possibility of recognizing an alternative replacement of the features. And only in case of complete confidence in the purity of this product, enter the pharmacological market with it.