Structural Transformation: Analysis of Patent Dispute Dynamics in the Pharma Industry (2022–2026)

In recent years, the Russian pharmaceutical market has shown significant changes in the field of intellectual property protection. According to the latest analytics by the Association of International Pharmaceutical Manufacturers (AIPM), published by the Pravo.ru portal, the number of litigations in this area over the past three years has almost tripled compared to the previous five-year period.

Experts note not only quantitative growth but also the qualitative evolution of disputes: strategies for bringing drugs to market, the composition of conflict participants, and the courts’ approaches to interpreting patent law are all changing.

Statistics and Changing Strategies

An analysis of data from 2017 to January 2026 shows a steady upward trend in litigation activity. While courts considered just over 30 cases between 2017 and 2021, the number exceeded 90 in the last three years (2022–2026). The list of drugs involved in legal conflicts has also expanded.

A key trend is the shifting timeline for the market entry of generic drugs. Previously, companies began preparing for a generic launch on average three years before the originator’s patent expired. Currently, this process is initiated 6–7 years before the end of patent protection.

This has led to a change in the nature of litigations:

• The focus has shifted from direct patent challenges to conflicts over the early introduction of drugs into civil circulation.
• The number of settlement agreements between patent holders and generic manufacturers has significantly decreased.

The Localization Factor and Domestic Competition

The composition of dispute participants has undergone significant changes. While the typical conflict model used to be a confrontation between a foreign rightsholder and a Russian manufacturer, recent years have seen a rise in disputes between local players (at least five cases during the reporting period).

The localization of production is becoming increasingly important in the legal field:

• The share of disputes concerning drugs localized in the Russian Federation has grown from ~20% to over 55%.
• About 40% of proceedings involve drugs with varying degrees of localization, including five INNs for which special investment contracts (SPICs) have been concluded.

Compulsory Licensing: The Issue of Legal Certainty

Lawsuits for compulsory licensing have become one of the most complex categories of cases. Over the 2022–2026 period, courts received about 30 such applications, with 70% filed under clause 1 of Article 1362 of the Civil Code of the Russian Federation due to “insufficient use of the invention.”

AIPM experts point out the lack of clear legislative criteria for the concept of “insufficient use.” In recent judicial practice, an approach has formed that assesses the degree of use through the criterion of “market saturation.” According to the courts’ position, even if the market is saturated with a product, it does not always indicate sufficient use of all inventions protected by the patent. At the same time, the patent holder is required to provide evidence of the ability to supply the market in the future in volumes comparable to the time the license is issued.

The lack of unified criteria led to the constitutionality of the provisions of Article 1362 of the Civil Code being reviewed by the Constitutional Court (complaints by Sanofi Russia and Vertex Pharmaceuticals). Applicants point to the uncertainty of court powers and the scope of circumstances subject to proof.

Law Enforcement Conflicts: FAS and Interim Measures

There is a divergence in the approaches of the antimonopoly authority and the courts regarding interim measures. The Federal Antimonopoly Service (FAS) has formed a position according to which the introduction of a generic to the market before the patent expires constitutes an act of unfair competition.

However, courts systematically refuse rightsholders in adopting interim measures (banning the circulation of the disputed drug until a court decision). Examples of complex judicial practice include cases involving the drugs Dapagliflozin (Case No. A40-95140/2025) and Bosutinib (Case No. SIP-298/2025), where the decisions of different instances contradicted each other.

In several cases, courts refused to protect rights, citing unproven competitive relations or the non-acceptance of patent attorneys’ conclusions and extracts from EAEU registers. Currently, key disputes over the drugs Axitinib and Osimertinib are pending before the Supreme Court and the Intellectual Property Court, respectively.

Regulatory Data Protection (RDP)

A separate set of issues is related to the protection of information on the results of preclinical and clinical trials (Regulatory Data Protection). The number of disputes in this area has increased, including conflicts between Russian manufacturers. Currently, a unified approach to the protection of such data is lacking both at the national level and within the EAEU.

The current period is characterized by the formation of new law enforcement practice amidst high activity by market participants and the search for a balance between the protection of intellectual property rights and the development of local production.