News 2026

A New Chapter in Pharma Patent Disputes: Insights from the AIPM and ALUMNI Partners Conference

2026-04-17 10:51
The March positions of the Supreme and Constitutional Courts have given the pharmaceutical market not only new guidelines, but also a wider range of questions: how to implement the decisions of the Federal Antimonopoly Service and the courts, whether it is possible to make interim measures a working tool, and where the line is drawn in disputes over compulsory licensing. Against this backdrop, companies are having to reevaluate their defense strategies, the evidence in antitrust cases, and the risks of bringing drugs to the market. At the AIPM and ALUMNI Partners conference, participants discussed the approaches that are already emerging in practice and what else is hindering the development of predictable legal enforcement.

Current issues of unfair competition

On April 15, the Association of International Pharmaceutical Manufacturers (AIPM) and ALUMNI Partners held a joint patent conference titled "Preventing and Quickly Countering Patent Infringements in the Pharmaceutical Industry." The main topic was the protection of rights in the pharmaceutical market in the face of increasing disputes, the growing role of antitrust tools, and increasing competition between original and generic manufacturers.

The first session began with the March ruling of the Supreme Court on the dispute between the Federal Antimonopoly Service and Axelpharm (case No. A40-264483/2024). At the beginning of the session, the participants were asked to answer whether this decision had any impact on the companies' defense strategies. For 44.4% of the participants, the decision did not change anything, while about 30% considered the administrative procedure in the Federal Antimonopoly Service to be acceptable, and some of the participants advocated for the parallel use of administrative and judicial mechanisms.

After that, the participants moved on to analyzing the Supreme Court's position. Elena Trusova, partner of the dispute resolution and intellectual property practice at ALUMNI Partners, recalled that prior to this, the practice in cases of unfair competition in the pharmaceutical industry was mainly not in favor of the FAS. The Service found a violation under Article 14.5 of the Law "On Protection of Competition" and collected revenue from the budget, but the courts then overturned such decisions. In fact, the speakers said, there was a situation in which the FAS established unfair competition, and judicial review almost always turned against the copyright holders. Against this background, the position of the Supreme Court became crucial primarily because it refused to evaluate the evidence in isolation and pointed out the need to look at their totality, the behavior of the defendant and the logic of the entire construction of the dispute.

Among the key conclusions, two were singled out. First, the registration of a drug as reproduced in itself has evidentiary value, because the applicant thereby indicates the connection of his product with the original drug. Secondly, an extract from the Eurasian Pharmaceutical Register should not be discounted in advance as just a reference source. The Supreme Court also took into account the inconsistency of Axelpharma's position: the company denied using the patent in the dispute under Article 14.5, but at the same time sought a compulsory license for the same patent. The court linked this argument to the principle of estoppel.
"The state is currently seeking a balance between generic interests and those of drug manufacturers. It's amazing that, even in this difficult situation for foreign companies, the Supreme Court can follow high, fundamental principles of public order - legality and effectiveness - and not be influenced by manipulative political speech. This gives all of us hope that, although the process is controversial and unstable, it's still moving in a positive direction.", - Elena Trusova, partner of the dispute resolution and intellectual property practice at ALUMNI Partners.
Nikolay Voznesensky, the managing partner of ALUMNI Partners, emphasized the importance of expertise in the case. He pointed out that the lack of expertise had been a significant psychological and procedural obstacle. During the CIP hearing, the court directly questioned the FAS about why an expert examination had not been conducted, given that the law allows it. However, Voznesensky stressed that the Supreme Court's position did not imply that such examinations were unnecessary in all cases under Article 14.5. The court had merely refused to consider them as the sole form of evidence, thereby lowering the standard of proof. Otherwise, the antitrust mechanism would remain ineffective: an examination would prolong the dispute, provide parties with additional means to delay it, and effectively discourage the FAS from taking such cases.

Voznesensky noted that appealing to the FAS is not a straightforward or quick process for copyright holders. Unlike some other services, the FAS does not handle everything; the applicant must gather evidence, develop a position, and actively engage in the dispute, much like in court. He also recalled another crucial conclusion from the Supreme Court: direct competition between the copyright holder and the infringer is not always necessary for such cases. The copyright holder's economic interest can be fulfilled through distributors, which is particularly relevant in the pharmaceutical industry, where supply is often distributed. Another significant point was the sanction: the dispute involved over 513 million rubles, and the Supreme Court confirmed that if the regular fine is disproportionate, the FAS can seek revenue recovery for the budget.
"In its March ruling, the Constitutional Court declared that the copyright holder bears the responsibility for ensuring the product's availability on the market, even if it's through distributors. Essentially, the court broadened the copyright holder's obligations to encompass distributors. Simultaneously, the Supreme Court issued a parallel statement, recognizing that the copyright holder's economic interests are realized through these distributors, provided they operate in the market. Even without a copyright holder's direct presence, their economic interests are still protected, and direct competition between the copyright holder and the infringer isn't always necessary.", - Nikolay Voznesensky, Managing Partner at ALUMNI Partners.
Following this, the discussion turned to what the extract from the Eurasian pharmaceutical register actually confirms. Aurelia Cheban, Deputy Head of the Expertise Department and Chief of the Chemistry and Medicine Department at the Eurasian Patent Office, reminded attendees that the register was established in 2021, with national patents integrated from 2022. By December 2023, it had been officially recognized as the EAPO's official register. The register details patent validity in participating states, as well as extensions and licenses, including compulsory ones. Anyone can request an extract, often done by third parties in practice.

Cheban explained the verification process in detail. Experts compare the INN, chemical name, and structural formula of a substance with the patented invention, using multiple international databases. For biotech products, they also check amino acid sequences and other intricate characteristics. This is a resource-intensive and highly specialized process. Any discrepancies between the protected item and the claimed substance result in the patent not being included in the register. In response, Trusova noted that these clarifications make the argument that the EAPO extract is merely a reference material "less persuasive."
Pfizer's Senior Corporate Lawyer, Zhanna Shubina, described the Supreme Court's decision as a positive signal not only for pharmaceutical companies but also for the entire market. It is particularly important that the Supreme Court has effectively confirmed the FAS's competence to consider such cases in the presence of signs of unfair competition. This includes not only the protection of foreign innovative companies but also the protection of bona fide market participants in general, including generic manufacturers who are waiting for the expiration of patent protection and entering the market within the legal framework.

Shubina emphasized that the problem of generic drugs entering the market has been around for several years. Companies that violate patent protection gain a competitive advantage and take market share away from those who follow the rules.
"In the medium term, this decision aims to curtail the number of market entries prior to patent expiration, enhance the predictability of innovation and investment protection, and foster a more conducive investment climate. We hope this approach will guide companies that invest in research and development, adhere to legal requirements, and utilize existing patents and protection tools as they navigate future practices.", - Zhanna Shubina, Senior Corporate Counsel at Pfizer.
Konstantin Sdobnov, head of regulatory policy and support measures at R-Pharm, emphasized that predictability in the regulatory environment is vital for companies with diverse portfolios. He noted that the Supreme Court's new approach provides a tool to address "false starts" where one player enters the market before others. However, Sdobnov also highlighted the risks: if the issue isn't about a patent for the active ingredient but related or dependent patents, there's a danger the new mechanism could become a tool for extending patents unnecessarily. He suggested determining who should initiate protection if the copyright holder doesn't take action, and ensuring the interests of other market participants and patients aren't compromised.

Even winning a case doesn't guarantee practical implementation. Irina Sheykkha, Legal and IP Director at the AIPM, pointed out that the market lacks a clear mechanism for executing such decisions. By the time rulings are made, tenders may already be awarded, drugs may be on the market, and contractual obligations may have been triggered. Therefore, the challenge is not to find quick fixes but to adjust the system to ensure decisions are properly implemented and completed swiftly.

Sheykkha identified key areas for improvement. First, a unified source of information on decisions should be accessible through government systems, eliminating the need to search for letters and acts on websites. Second, procedures for introducing drugs into circulation should align with restrictions imposed by the Federal Antimonopoly Service (FAS) or courts; currently, drugs can face restrictions in one system while moving forward in another. Third, regulatory frameworks should consolidate the legal consequences of FAS and court decisions across different stages of public procurement, including application review, winner determination, contract conclusion, and execution.

Sheykkha also noted that current procedures for setting initial contract prices and revoking registrations don't adequately account for such decisions. The AIPM aims to address these gaps with regulators.

The market is still adapting to the Supreme Court's new approach. This is partly due to the fact that in disputes over fair competition, the effectiveness of defense often depends on timing.
"The market may have theoretically strong legal tools, but if their implementation takes years (companies are forced to collect a large amount of evidence and overcome an extremely high standard of proof), then even a positive decision may ultimately be useless. The Supreme Court's ruling provides hope for a faster and more effective mechanism for protecting patent rights in cases of infringement. This approach may also have implications for related issues, including the practice of interim measures.", - Irina Sheykkha, Legal and IP Director at AIPM.

Patent Infringement Disputes and Injunctions

The second session focused on interim measures in pharmaceutical patent disputes. In Russia, courts almost never grant such requests, and if they do, higher courts usually overturn them. This sets Russian practice apart from international standards. Lyudmila Novoselova, a professor and head of the Department of Intellectual Property at the Moscow State Law Academy, noted that, according to comparative studies, up to 60% of such claims are granted in Germany, while in the United States, the figure ranges from 20% to 50%, depending on the period and category of cases. Unlike in Russia, decisions are not made on a formal basis on the same day, but rather after a discussion between the parties.

Novoselova emphasized that in patent disputes, the denial of interim measures often results in irreparable damage for the copyright holder. A patent has a limited duration, and the proceedings can take years. During this time, the generic drug can enter the market, win procurement due to its lower price, and displace the original drug. It is extremely difficult to remove the generic drug from circulation, especially if it is a life-saving medication. The situation is further complicated by the fact that the procurement is often carried out not by the manufacturer itself, but by an intermediary with no significant assets. Therefore, even if the dispute is successful, the chances of recovering losses remain minimal. In such a structure, the expert noted, the balance of interests actually disappears: the one who violates is in a better position than the one who defends their rights.
"After the bidding has already taken place and the product has started to enter the market, it is very difficult for the court to withdraw the drug from circulation, especially if it is a vital drug. Even from a psychological point of view, it's easier not to make such a decision than to accept it.", - Lyudmila Novoselova, Doctor of Law, Professor, Head of the Department of Intellectual Rights at MSAL.
As possible solutions, Novoselova suggested several directions. First, to return to the idea of a soft form of patent binding — not necessarily through blocking registration, but through a more predictable account of patent status. Second, to discuss the transfer to the Intellectual Property Court not only of disputes over compulsory licenses, but also of a broader range of patent disputes. Finally, she suggested introducing special procedural rules for interim measures in patent disputes: to set more realistic deadlines for consideration, to define the range of circumstances that the court should take into account, and to describe the types of measures that are permissible. According to her assessment, this would reduce the courts' concerns and at least partially change the current practice. She also advocated for a faster connection between the courts and the registration authorities, so that the decision would not lose its meaning due to delays in implementation.

Dmitry Galkin, Director of the Department for the Development of the Pharmaceutical and Medical Industry at the Ministry of Industry and Trade of the Russian Federation, reminded us that the topic of interim measures has already been included in the Pharma-2030 strategy's action plan. The main problem, according to him, remains the same: the courts are not ready to remove a drug from the healthcare system if it has already been registered and is intended for patients. Therefore, the discussion has shifted to another issue: how to deprive the offender of the economic rationale for the dispute without stopping the flow of goods.

Federal authorities have already attempted to propose a more effective solution: instead of blocking the circulation of the drug, they propose to impose security measures on the money that the defendant receives under existing and future contracts. In this case, the drug continues to be supplied to patients, but the defendant is not allowed to freely dispose of the revenue from the disputed supplies until the dispute is resolved. According to Galkin, the discussion of this issue with the Supreme Court has already provided an important guideline for practice: such measures are generally permissible under the current regulations, provided that they are related to the subject of the dispute and are properly justified. Therefore, the market should not wait for new general clarifications; instead, this tool should be tested in specific cases to provide the courts with a body of practice. In the meantime, the parties are mostly asking for stricter measures, such as a ban on circulation, cancellation, or suspension of registration. On the other hand, the financial aspect of the dispute has barely been developed, although Galkin considers it to be one of the most promising areas.
Dmitry Travnikov, Deputy Director of the Department of Strategic Development and Innovation at the Ministry of Economic Development of the Russian Federation, spoke about compulsory licenses and the future jurisdiction of such cases. According to him, the increase in the number of such disputes and the lack of uniform practice have shown that they need a more specialized format of consideration. He reminded us about the draft law on transferring cases involving compulsory licenses to the Court for Intellectual Rights. The draft law has already been supported by the Supreme Court and federal executive authorities, and it was submitted to the government on April 1. It is currently being reviewed by the government, and it is planned to be submitted to the State Duma. It is possible that it will be adopted before the end of the spring session.
"The Intellectual Property Court's strength has always been in developing solutions to complex law enforcement issues and then applying the law quickly and uniformly by the entire court. What the IP Court will likely face difficulties with is establishing the circumstances of the case: whether there is a need; whether there is a sufficient supply of the medicine on the market to meet that need; whether the person seeking a license has the ability to use the invention; and the scope of rights required to carry out the activity for which the license is sought.", - Dmitry Travnikov, Deputy Director of the Department of Strategic Development and Innovation at the Ministry of Economic Development of the Russian Federation.
According to Travnikov, the executive authorities could help the courts in this regard. He linked this to the idea that the Constitutional Court has already outlined: to use the conclusions that the state receives as part of the work of the governmental subcommittee.

Speaking about the future of compulsory licenses, the speaker suggested separating paragraphs 1 and 2 of Article 1362 of the Civil Code. Regarding the first paragraph, which deals with the shortage and market demand, the Ministry of Economic Development proposes discussing a mechanism where the court can take into account the government's or the subcommittee's conclusions. In the second case, which involves an important technical achievement and significant economic benefits, he suggested that the development of criteria through judicial practice would be more effective than a new law amendment. However, he was more cautious about the idea of transferring all patent disputes to the Federal Circuit Court, as he believed that while there were advantages to this solution, it could potentially create issues with access to justice.
For more information, see the source: Pravo.ru