AIPM statistics: IP disputes

According to the AIPM analytics, from 2017 to 2026, 170+ disputes related to intellectual property in the pharmaceutical industry were submitted to the courts for consideration (Table No. 1 - According to estimates as of May 15, 2026)
During this period, the number of patent disputes has increased, and new trends have been observed, in particular a shift in focus -from challenging patents to disputes related to the early entry of generics onto the market and obtaining compulsory licenses (Table No. 2).

Trends in judicial practice for the period 2017 – 2026:

• The number of cases involving the introduction of generic drugs into civil circulation during the validity of patents protecting original drugs without the patent holder’s consent has increased.
• Court proceedings last for several years, during which the right holder is unable to effectively prevent the infringement of their rights.
• The number of companies launching generic drugs before the permitted timeframe is growing, as is the number of disputes between Russian pharmaceutical companies.
• The period for the launch of a generic drug before the expiry of the patent has increased (from 3 to 6–7 years), and the number of amicable settlement agreements in legal cases between the right holders and companies launching generic drugs has drastically declined as a result.
• Disputes involve drugs with varying localization levels (including 5 INNs for which a Special Investment Contract has been executed). The number of localized drugs subject to disputes has increased by 2026.
• In the majority of cases courts refuse to take interim measures in patent disputes.

Despite the initiated legal proceedings, analogues introduced into civil circulation with the violation of patent rights continue to be the subject of state procurement and circulate on the market, since patent holders actually have no opportunity to use the mechanism of interim measures.
The systematic non-application of the institution of interim measures continues even after the FAS Commission issued decisions recognizing the introduction of generics into civil circulation before the expiration of the patent for the original drug as an act of unfair competition.

• The practice of issuing compulsory licenses for the reasons of “extreme necessity” and under-utilization has developed (in case of “extreme necessity”, a compulsory license is issued by a subcommission at the Russian Government in accordance with Article 1360 of the Russian Civil Code, and in case of under-utilization of the invention, by court in accordance with Article 1362 of the Russian Civil Code). Until 2022, compulsory licenses were only requested in court for the reason of a subordinate patent and as part of a counterclaim.
• In cases on the use of information on the results of preclinical and clinical studies, there is no legal certainty and a unified approach at the EAEU level when providing legal protection for information on the results of preclinical and clinical studies.
• Registration of a generic and its price more than 5.5 years (А40-293087/2024) before the expiration of the patent for the original drug does not confirm the threat of infringement of rights. In this regard, the criteria for the threat of infringement of intellectual rights, established in judicial practice, make the application of this institution in practice impossible.

Key trends in judicial practice for the period from late 2024 to 2026:

Compulsory licensing

• In 2024 - 2026, no less 37 cases related to the issuance of compulsory licenses were submitted to the courts. At the same time, some of the original drugs for which a compulsory is requested are supplied in the volumes requested by the Russian healthcare system, and patients continue to be provided with the necessary therapy.
• Despite the development of the practice of issuing compulsory licenses, there are currently no criteria and conditions under which authorized bodies can decide to use an intellectual property object without the consent of the right holder. There is no legislative definition of the term 'insufficient use' (under paragraph 1 of Article 1362 of the Civil Code of the Russian Federation), and judicial practice has not developed criteria for determining such insufficient use, nor are there criteria for an important technical achievement or significant economic advantages (under paragraph 2 of Article 1362 of the Civil Code of the Russian Federation).
• Approximately 70% of claims have been filed under paragraph 1 of Article 1362 of the Civil Code of the Russian Federation.
• Most of the cases are considered in a close mode, which makes it impossible for the expert community to conduct a full and comprehensive analysis of the grounds for granting license. Courts do not always involve local distributors and partners as third parties to substantiate the fact of using the invention in the Russian Federation.
• The issue of the sufficiency of the degree of use is currently an evaluative one. At the same time, the arbitration court introduced a new criterion for assessing the degree of use of an invention – the criterion of “market saturation”:

(i) market saturation with goods in which part of the inventions are used does not confirm the fact of sufficient use of all inventions (А40-164493/2024) ,
(ii) the situation of market saturation must not only be instantaneous, at a certain point in time, but must also persist in the future.

• A complaint regarding the violation of constitutional rights by the provisions of paragraph 1 of Article 1362 of the Civil Code was examined by the Constitutional Court of the Russian Federation.
• On December 18, 2025, the Constitutional Court of the Russian Federation, in an open hearing, examined the case reviewing the constitutionality of the provisions of paragraph 1 of Article 1362 of the Civil Code of the Russian Federation based on complaints from joint-stock company Sanofi Russia and Vertex Pharmaceuticals Incorporated. Position of the applicants: i) The norm allows for the possibility of incorrectly determining the scope of circumstances to be proven and the judicial assessment of circumstances. ii) The norm does not define the powers and obligations of courts regarding the correct determination of the scope of opportunities granted to the licensee.

The Constitutional Court of the Russian Federation stated that:

1. The process of issuing a compulsory license does not contradict the Constitution of the Russian Federation, as it serves the public interest – the protection of health. The issuance of a compulsory license must be preceded by the absence of an intention to ensure the supply of the product to the market, which is expressed, in particular, in the abuse of rights and actions aimed at maintaining a dominant market position.
2. The purpose of issuing compulsory licenses is to compensate for and ultimately eliminate the existing shortage in the market, as well as to adjust, for the future, the manner in which the right holder exercises its intellectual property rights that led to the shortage.
3. When determining the grounds for encumbering intellectual property rights for each of the interrelated patents in a complex group, it is necessary to proceed from the priority of achieving the goal of granting a compulsory license in the form of saturating the market with a certain product and, accordingly, from the necessity and sufficiency of each of the patents to achieve that goal. Consideration of the validity periods of interrelated patents, if they are not identical, must be resolved based on the actual circumstances of specific cases, but with priority given to ensuring that the licensee is able to achieve the required consumer effect to saturate the market with the product by using the entire complex of inventions necessary for that purpose.
4. The court deciding on the granting of compulsory licenses must have the ability to authorize competent and appropriately qualified bodies to monitor the consumer effect of using such products and to apply immediate response measures upon detection of low levels of such effect or, even more so, a harmful nature.
5. In order to improve the quality and competence of judicial consideration of claims for the grant of compulsory licenses, the Constitutional Court indicated that the practice of administrative prejudgment of judicial consideration of such claims — in the form of a preliminary analysis and assessment of specific cases by the FAS of Russia, a governmental subcommittee, or another body authorized by the Government of the Russian Federation — 4 А40-164493/2024 4 may appear advisable.
6. As the Russian market becomes saturated with goods, works, or services, the production and/or sales of which were permitted to the licensee on the basis of a compulsory license, in the absence of prerequisites for the immediate emergence of new states of extreme necessity, threats to defense and security interests, the life and health of citizens (in particular, with a significant reduction in market prices for such products, the emergence of guaranteed alternative supply channels, the existence of guaranteed supply on the market), and provided that the patent holder is ready to use the patented intellectual property object in a sufficient volume at a reasonable price, the previously granted compulsory license shall be subject to revocation.

Decisions of the FAS of Russia on the recognition of unfair competition for introduction of a generic before the expiration of the patent:

• In 2024, the FAS of Russia formed a position that the entry of a generic onto the market before the expiration of the patent for the original drug is unfair competition.
• The court of first instance confirmed the legality of two FAS decisions (INN Bosutinib, INN Dapagliflozin (А40-31162/2025, А40-305697/2024)). For INN Dapagliflozin, the appellate court upheld the FAS decision; the case is currently being examined in cassation (Intellectual Property Court). For INN Bosutinib, the court of first instance refused to declare the FAS decision invalid; the appellate court overturned the decision of the court of first instance, finding the FAS decision unlawful; however, the Intellectual Property Court overturned the appeal decision, upholding the legality of the decision of the FAS Russia.
• In two other cases (INN Osimertinib, INN Axitinib) - (А40-315385/2024, А40-264483/2024), the court of first instance annulled the FAS decision: (1) failing to establish the existence of competitive relations with the copyright holder of the result of intellectual activity; (2) refusing to accept an extract from the Pharmaceutical Register of the Eurasian Patent Office, citing its informational nature; (3) refusing to accept the opinion of a patent attorney, citing its preparation in the interests of third parties. For INN Axitinib, the appellate court and the cassation court (Intellectual Property Court) left the decision of the court of first instance unchanged; the decision was appealed to the Supreme Court.
• For INN Osimertinib, the appellate court upheld the decision of the court of first instance; but the Intellectual Property Court overturned the decisions of the lower courts and refused to grant the claims filed by Axelpharm.
• The Supreme Court of Russia in the Axitinib case agreed with the position of the FAS of Russia that launching a generic before the expiration of the patent without the consent of the patent holder constitutes unfair competition. The FAS of Russia decision issued to Axelpharm was found lawful by the Supreme Court. The Supreme Court stated that the FAS reasonably concluded that there was unlawful use of the invention under a Eurasian patent when putting the generic Axitinib into circulation based on the opinion of a patent attorney. The ruling also noted that the actions of a pharmaceutical company which simultaneously confirmed the production of the generic to obtain a compulsory license and denied infringement of the patent protecting the active ingredient of the generic are inconsistent and constitute grounds for refusing legal protection based on the principle of estoppel.
• Furthermore, the court found the requirement to order a patent and technical examination erroneous when the evidence provided by the patent attorney's opinion had not been rebutted. The court also stated that unfair competition also extends to cases where competition arises between the generic manufacturer and the distributor.
• In the case involving INN Ruxolitinib (А40-301763/2024) , the court of first instance declared the decision of the FAS of Russia unlawful and annulled it; the case is currently pending before the appellate court.

Interim measures:

• The violation of intellectual property rights recognized by the decision of the FAS Russia does not confirm the need for the court to take interim measures.
• Courts (including regional courts handling disputes regarding the adoption of interim measures by medical institutions to suspend the operation of concluded contracts for the supply of generics, the introduction of which into circulation has been recognized as unfair competition) still do not confirm that the applicants have justified the need to impose interim measures.

Inaccurate information in the registration files (dossier):

• Submission of inaccurate documents about the medicinal product in the registration dossier materials may become the basis for suspension of the registration certificate (А40-28914/2024).