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:
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.