Features of the Russian Patenting Strategy in the Pharmaceutical Industry

The pharmaceutical industry is traditionally one of the most science-intensive and capital-intensive sectors of the economy. The development of a new drug takes years and requires significant investment in research, preclinical and clinical trials, as well as subsequent registration. In these conditions, a patent becomes not just a legal tool for protection, but a key element of the economic model of the pharmaceutical business, which allows you to ensure a return on investment and a return on innovation.

The Russian pharmaceutical market is undergoing tectonic shifts. The departure of a number of Western companies, the policy of import substitution and the tightening of regulatory control over intellectual property create a unique landscape in which typical global patent strategies often fail.

The Russian patenting system in the pharmaceutical industry is formed at the intersection of national legislation and international obligations. The basis of regulation is Part IV of the Civil Code of the Russian Federation, which defines the criteria for patentability of inventions, including medicines and related technologies. At the same time, the Federal Service for Intellectual Property (Rospatent) plays a central role in the registration process, which examines the applications on the merits and evaluates them for compliance with the criteria of novelty, inventive step, and industrial applicability.

In addition to the national system, international patent architecture has a significant impact. Russia participates in the TRIPS Agreement within the framework of the World Trade Organization, as well as in the Paris Convention and the Patent Cooperation Treaty (PCT), which allows applicants to build global strategies for the protection of inventions. In addition, the Eurasian Patent Organization system operates in the Eurasian region, which provides an opportunity to obtain a single patent valid in several countries at once.

Moving on to the specifics of pharmaceutical inventions, it should be noted that they have a number of features that significantly affect the structure of patent protection.

In Russia, not only new chemical compounds are subject to protection, but also pharmaceutical compositions, methods for obtaining active substances, polymorphic forms, as well as dosage forms and certain medical applications. However, it is important to take into account that human treatment methods are recognized as patentable, which distinguishes Russian practice from some foreign jurisdictions.

One of the most controversial aspects of pharmaceutical patenting remains the strategy of so-called "patent life extension" through secondary applications. We are talking about patenting new forms of delivery, combinations of known substances, dosage modifications, or isomeric forms. Although such approaches are formally permissible, their sustainability is increasingly being critically assessed by both Rospatent and the courts, especially in cases where it is an attempt to artificially extend the monopoly position in the market.

In practice, large international pharmaceutical companies are building complex multi-level patent protection strategies adapted to the Russian market. Among them, players such as Pfizer, Roche, Novartis and AstraZeneca are building global patent portfolios covering not only active substances, but also various forms of their use, production methods and combinations. Typically, such companies use a combination of the PCT international system, regional Eurasian applications and national patents to maximize the geography of protection.

When forming a patenting strategy, the choice of the application route is of particular importance. Depending on the business goals, the applicant can use the national procedure through Rospatent, the PCT international system with subsequent entry into the national phase, or the Eurasian patent mechanism. Each of these approaches has its own advantages and limitations, both in terms of cost and time to market.

An equally important element of the strategy is the competent formation of the claims. It determines the scope of legal protection and, in fact, the boundaries of the monopoly of the right holder. A formula that is too narrow makes a patent vulnerable to being circumvented by competitors, while a formula that is too broad can lead to a refusal to grant a patent or its subsequent challenge. In the pharmaceutical field, special attention is paid to the inclusion of dependent items covering dosages, dosage forms, and technological features of production.

However, obtaining such a patent is only half the battle. The second half unfolds in the field of price registration and entry into civil circulation.

The claims must be drafted in such a way as to withstand not only the inspection of Rospatent, but also a potential challenge in the Chamber for Patent Disputes (PPC) from a local generic manufacturer. Russian opponents have perfectly learned how to "rock" patents, using data on properties that have become obvious from the previous state of the art. Therefore, when submitting an application, an array of experimental data confirming the technical result in the territory of the Russian Federation is critically important.

Before filing an application, as a rule, an international patent search is carried out and an in-depth analysis of the identified patent documents is carried out, which allows you to assess existing patents, their validity periods and possible risks of overlapping rights. Such analysis is becoming an important risk management tool, especially in a highly competitive pharmaceutical market.

Modern challenges and patent protection strategy in Russia

The issue of the term of patent protection deserves special attention. In Russia, it is 20 years from the date of filing the application, but for pharmaceutical inventions, it is possible to extend legal protection under certain conditions. This is due to the long process of registration of medicines, which can significantly reduce the actual period of commercial use of the patent.

In addition to patent protection, the regulatory environment plays an important role. In particular, the clinical trial data protection system restricts the use of the registration data of the original drug by competitors for a set period of time. This creates an additional layer of protection along with the patent monopoly.

In recent years, the import substitution policy has had a significant impact on the market, which stimulates the development of local production and the accelerated introduction of generics. This, in turn, strengthens the importance of a competent patent strategy, since it determines the stability of the position of the original drug in the market.

Against the backdrop of these processes, patent disputes related to challenging secondary patents and bringing generics to the market are increasingly arising. Judicial practice shows a tendency towards a stricter assessment of inventive step, especially in cases where it comes to minor modifications of known solutions.

Do not forget about compulsory licensing. This is the most painful and dynamically changing block. Article 1360 of the Civil Code of the Russian Federation allows the Government of the Russian Federation to issue compulsory licenses in the interests of defense and security, and Article 1362 of the Civil Code of the Russian Federation – in case of non-use or insufficient use of the patent.

In 2022–2025, we are witnessing the transformation of this institution:

• Accelerated access to generics. Amendments have been made to simplify the issuance of permits for the use of inventions without the consent of the patent holder (from foreign states committing unfriendly acts), with the payment of commensurate compensation. This is a new reality in which the exclusive right ceases to be absolute.
• Dependent inventions. Local pharmaceutical companies are actively patenting improved methods for obtaining substances or more stable formulations, blocking the originator (who may own a patent for the molecule) without obtaining a compulsory license. This is an instrument of counter pressure.

In the current conditions, a patent attorney must develop a strategy in which it is impossible to "put all eggs in one basket" of a patent for an active substance. It is necessary to have a valid patent for the method of obtaining (if the technology is transferred or adapted to the Russian site); have a patent for a method of treatment/use (second medical use), which is more difficult to circumvent through compulsory licensing for the substance; maintain the registration dossier and clinical data in the regime of trade secret (know-how), since production without access to the complete dossier, even with a compulsory license, is often technologically impossible.

Thus, the formation of an effective patent strategy in the pharmaceutical industry requires an integrated approach that combines legal analysis, understanding of the regulatory environment and long-term planning of the life cycle of the drug. In modern conditions, intellectual property is becoming not just a tool of protection, but one of the key assets of a pharmaceutical company, directly affecting its competitiveness and stability in the market.