Pharm registry of patents as a tool to protect developers of original drugs

Patents are an important tool for promoting new ideas and technologies, and the patenting of developments in the pharmaceutical industry is no exception.

The invention of new pharmaceuticals is made possible by patents that encourage pharmaceutical corporations to innovate. Patents allow large pharmaceutical companies not only to monopolize the market, but also to recover the costs associated with long-term scientific research, while the success of new drug development is highly dependent on the manufacturer's ability to obtain a patent for their product.

A pharmaceutical preparation can be patented as a new chemical substance, composition, dosage form, method for obtaining (synthesis) of a substance, preparation of a composition, use of a substance or composition for a specific purpose, for example, for the treatment of previously unknown nosologies. At the same time, the same medicinal product can be protected by several patents at once.

When protecting medicines, the practice of “umbrella patenting” is common, when, as new research appears, an increasingly narrow solution is patented: from the Markush formula to a specific crystalline form of an enantiomer of a certain salt, which leads to the emergence of so-called “evergreen patents” and an “infinite” period the original manufacturer's monopoly on a particular drug. This prevents smaller companies that do not have their own resources for conducting global research to bring to the market after the expiration of the patent cheaper analogues of the original drugs available to consumers (generics).

According to the patent law, inventions are subject to three conditions of patentability - these are global "novelty", "inventive step" and "industrial applicability".

In order for the examination to determine whether a solution meets the conditions of patentability and, as part of an international patent information search, to determine whether a pharmaceutical preparation can be patented, the developers need, in addition to a detailed description of the compound, composition, composition and method of its preparation, to present the distinctive features of the proposed patenting of developments with the results of experiments and clinical studies confirming the achievement of a positive effect, therefore, preference is given to large international companies that spend huge amounts of money on research.

Some time ago, the active implementation of another protective mechanism for originating companies began , which prevents competitors from obtaining "bypass" patents for medicines - this is the pharmaceutical registry of the Eurasian Patent Office (EAPO).

Since March 2021, anyone on the EAPO website can access a search resource that includes information on Eurasian patents related to pharmacologically active substances that have been assigned international non-proprietary names (INN).

In essence, this is a database that includes information about INNs or combinations of INNs, brand names of the manufacturer of these drugs in the member states of the Eurasian Association, Eurasian patents for compounds, formulations, including pharmaceutical compositions and combinations of active ingredients, for medical use, as well as patents for manufacturing processes related to these INNs, legal status and expected expiration dates of patents in the territory of each of the eight states of the Eurasian Convention, certificates of additional protection and extension of patent validity issued based on national registration, oppositions filed against Eurasian patents and registered license agreements. It is possible to search in the volume of the presented database by the name of the substance, by the patent number or, for example, by the name of the patent holder.

The replenishment of this database depends, among other things, on the patent holders themselves, who have the opportunity to file an application with the EAPO for the entry of the corresponding patent in the Pharm Register , if this patent covers any INN or combination of INNs. The application can be submitted on paper or through the EAPO online system, after verifying the information provided, information on the relevant patent is included in the register.

Now, when conducting an examination of an application for a medicinal product on the merits, experts first of all turn to this Pharmregistry in order to obtain all the necessary information about the availability of already patented similar drugs and thereby check whether the claimed solution meets the “novelty” patentability condition, and for companies exploring the possibility production of generics , this registry allows you to evaluate patent purity.

It should be noted that Rospatent is also working on a similar database of Russian patents for inventions relating to INNs, group names, chemical names and biosimilars . In the future, Eurasian patents will also be included in the database.

To date, the only significant difference between the Rospatent Pharm Register and the EAPO Pharm Register is that it includes only active substances, but not their combinations or manufacturing technologies. However , in the future, Rospatent does not exclude improvements and additions by analogy with the Eurasian version.

It is assumed that the creation of the above pharmaceutical registries and providing access to them for all interested parties will improve the drug registration system and solve problems with violation of intellectual property rights in the pharmaceutical industry.