Generic Drug Registration in Russia — What’s Allowed Before a Patent Expires
In November 2024, the Federal Antimonopoly Service (FAS) ordered Akrikhin to return 577.7 million rubles to the state budget for bringing the generic drug «Fordiglif» (dapagliflozin) to market prior to the expiration of AstraZeneca’s patent for «Forxiga.» In May 2025, a court overturned this decision, although it agreed that a patent infringement had occurred. In December 2025, the Intellectual Property Court recognized AstraZeneca’s own actions to block the generic as an act of unfair competition.
Three different conclusions on the same active substance within two years show what happens when the law does not directly specify which steps a generic company is entitled to take before a patent expires, and which steps already create a threat of infringement. In May 2026, a third bill in several years was introduced in the State Duma in an attempt to close this gap. While it undergoes its first reading, regulatory and patent departments at pharmaceutical companies should examine current practice and assess what will change if the amendment is adopted.
How Courts and FAS Diverge in Assessing the Actions of Generic Companies
Paragraph 2 of Article 1359 of the Civil Code of the Russian Federation (CC RF) allows the use of another party’s invention for scientific research or experimentation without the consent of the patent holder. The text makes no direct mention of drug registration procedures. The meaning of this provision was shaped over years of judicial practice without direct clarification from the legislature, and approaches in different cases developed inconsistently.
Established practice draws the boundary roughly as follows. Bioequivalence studies, filing documents for generic registration, and the subsequent registration of the maximum wholesale price for a drug on the Vital and Essential Drugs List (ZhNVLP) are generally not treated as patent infringement. Importing or synthesizing raw materials for commercial batches, manufacturing and storing finished lots, registering the supply price, and signing distribution contracts, however, are permissible only after the patent expires.
The dispute over dapagliflozin shows that even this boundary does not guarantee predictability. Akrikhin brought «Fordiglif» into circulation in spring 2024, before the expiration of AstraZeneca’s patent, which remains valid until 2028. AstraZeneca chose a different path to protect its rights: it filed a complaint with FAS alleging unfair competition under Article 14.5 of Federal Law No. 135-FZ dated 26 July 2006 «On Protection of Competition» (hereinafter, Federal Law No. 135-FZ). In November 2024, FAS found a violation and ordered Akrikhin to remit 577.7 million rubles in illegal proceeds to the state budget.
From there, the ruling began to unravel. In May 2025, the Moscow Arbitrazh Court set aside specifically the order to recover that sum, while still agreeing that Akrikhin had infringed AstraZeneca’s rights. In December 2025, the Intellectual Property Court, reviewing Akrikhin’s counterclaim, found that AstraZeneca’s own attempts to interrupt the generic’s circulation constituted an act of unfair competition. In April 2026, AstraZeneca filed a new suit, this time against the Slovenian company KRKA, which had launched another generic of the same substance.
A similar lack of clarity appears in the dispute over osimertinib («Tagrisso»), used to treat lung cancer. AstraZeneca’s base Eurasian patent on the substance runs until 2032. In mid-2023, AxelPharm registered a generic, and in July 2024 began selling it without waiting for a ruling on the compulsory license it had itself applied for.
In August 2024, Rospatent invalidated AxelPharm’s dependent patent on the crystalline form of the substance. In November 2025, the Presidium of the Intellectual Property Court overturned that decision and reinstated AxelPharm’s patent. The case shows that patent linkage is not just about the base patent on a substance: dependent patents on a specific crystalline form or manufacturing process create a separate, less predictable layer of disputes.
Similar disputes arose earlier too. Back in 2019, the Supreme Court ordered Jodas Expoim to withdraw the marketing authorization for its generic «Gefitinib,» registered before the expiration of AstraZeneca’s patent. Courts at the time found that the registration itself amounted to preparation for bringing the drug into circulation. More than five years have passed since then without a direct statutory rule settling this question.
The number of such disputes is growing. According to research by the Higher School of Economics (HSE) and PBN, the number of patent disputes in the Russian pharmaceutical sector nearly doubled in 2022-2025 compared with 2017-2021, rising from 30 to more than 60 cases. Market participants note that courts rarely grant preliminary injunctions in patent disputes, and that FAS rulings on unfair competition are often later overturned in court, as the «Fordiglif» case showed. Neither a civil suit nor a complaint to FAS currently gives a patent holder a fast, reliable outcome, and market participants describe the procedure for applying compulsory licensing under Article 1360 of the CC RF as unclear.
Patent linkage is often confused with two adjacent mechanisms, though they work differently. Parallel import concerns the import of already-manufactured original drugs without the right holder’s consent and does not affect the patent on the substance itself; it only deprives the right holder of control over the supply channel. Compulsory licensing under Article 1360 of the CC RF allows the state to authorize use of an invention without the patent holder’s consent in the interest of national security or public health. The osimertinib dispute showed that simply applying for such a license does not grant the right to begin sales before a ruling on the application.
Before filing registration documents, it is worth checking the patent status of the active substance in the Eurasian Pharmaceutical Register of the Eurasian Patent Office (EAPO Pharma Register). The register links the International Nonproprietary Name (INN) to patents in force across the eight member states of the Eurasian Patent Convention and shows the right holder, the subject matter protected, and the patent’s status, including dependent patents on specific forms of the substance. It is also worth checking the Register of Eurasian Invention Patents and Rospatent’s national database, since the term and scope of protection can differ across EAEU countries.
Similar rules on permissible generic preparation are already in force in several jurisdictions. An equivalent of the Bolar exemption applies in the US, the EU, Canada, Switzerland, Australia, Brazil, and India. In the US, the rule is set out in the 1984 Hatch-Waxman Act and works together with the «Orange Book» patent register: an applicant for generic registration must certify that it does not infringe the patents listed in the register, and the patent holder may challenge the registration within a limited period. Since June 2021, China has introduced a similar system linking patents to drug registration, modeled on the US, South Korea, and Japan. Russian law currently has neither a dedicated patent register tied to drug registration nor a comparable suspension mechanism, so disputes over a generic’s patent clearance are resolved after the fact, through the courts or FAS.
What the Bolar Exemption Bill and Rising Patent Fees and Damages Change
In late May 2026, Deputy Irina Filatova, a member of the State Duma Committee on Competition Protection, introduced a bill clarifying paragraph 2 of Article 1359 of the CC RF. The amendment adds the following wording: scientific research or experimentation may be carried out for the purpose of obtaining authorization to use a medicinal product and may proceed under the administrative procedures established by law. According to the author, the first reading could take place in mid-July or in the autumn, once the new State Duma convenes.
This is the third attempt to write a Russian equivalent of the «Bolar exemption» into law (a rule that first appeared in the US Hatch-Waxman Act of 1984, after the Roche Products v. Bolar Pharmaceutical dispute over the tranquilizer flurazepam). An earlier 2023-2024 draft from deputies Fedot Tumusov and Sergey Kabyshev proposed allowing generic companies to take almost any action short of an outright sale, including manufacturing and offering the product for sale before patent expiration. The Government of the Russian Federation gave it a negative review: in officials’ view, expanding generic manufacturers’ rights in that form could harm Russian developers of original drugs. The bill was rejected.
Filatova’s wording is milder than the earlier drafts and applies only to the pharmaceutical sector, not to patent law generally. Lawyers are split on it. Some experts believe the current wording of Article 1359 of the CC RF is already interpreted by courts as an exception equivalent to the Bolar rule, and that the new wording changes nothing in substance.
Others point out that the line between preparing to launch a drug and infringing a patent is still drawn differently from case to case, and that a direct statutory rule would cut the number of such disputes. Russian companies that earn mainly from generics support the amendment. International pharmaceutical companies, which more often hold the patents, worry that the new wording will add uncertainty to processes already settled by court practice.
According to one Russian pharmaceutical company cited in the press, flaws in the law governing generic market entry cost the state budget more than 10 billion rubles a year, through delayed access to cheaper therapy and litigation costs.
For a foreign manufacturer entering the EAEU market with an original drug, the dispute over the Bolar rule has a direct bearing on the horizon of commercial exclusivity. A regulator is not required to take a patent into account when reviewing a generic’s dossier if that patent is not entered in the EAPO Pharma Register. The same applies to a patent whose fees have not been paid on time under Decree No. 1278. Maintaining the patent register and monitoring the EAEU Unified Register of Medicines by INN deserves the same routine attention as tracking the renewal deadlines of the marketing authorization itself.
| Parameter | 2023-2024 draft (Tumusov, Kabyshev) | 2026 draft (Filatova) |
|---|---|---|
| Permitted actions | Development, preclinical and clinical trials, regulatory review, registration, price registration, manufacturing, offering for sale | Scientific research and experimentation to obtain authorization to use a medicinal product |
| Scope of application | Any patentable subject matter | Pharmaceutical products only |
| Status of the bill | Rejected after a negative government opinion | Under consideration; first reading expected in July or autumn 2026 |
While the bill is going through its first reading, the financial rules around patents have already changed. As of 5 October 2024, under Decree of the Government of the Russian Federation No. 1278 dated 18 September 2024 (hereinafter, Decree No. 1278), the 30% discount on fees for electronic filings with Rospatent was abolished. Patent maintenance fees are now paid as a single lump sum for a five-year period, instead of annually. For holders of large patent portfolios, this raises the cost of keeping low-value patents in force and encourages voluntary abandonment of such patents. Over time, this cleans up the register and reduces the risk of disputes over patents with expired commercial value that are still formally listed as active.
As of 4 January 2026, under Federal Law No. 214-FZ dated 7 July 2025 (hereinafter, Federal Law No. 214-FZ), damages for patent infringement increased under the new Article 1252.1 of the CC RF. The minimum award for patent infringement rose from 10,000 to 50,000 rubles, and the maximum fixed award rose from 5 million to 10 million rubles. Courts also gained the power to change the method of calculating damages on their own if the method chosen by the claimant does not fit the circumstances of the case. For a generic company, this means a higher cost of getting a contested registration wrong. For a patent holder, it is a stronger card in negotiations and in court, though the «Fordiglif» case shows that even a successful FAS complaint does not guarantee the money is ultimately recovered.
| Parameter | Before (until 04.01.2026) | Now (from 04.01.2026) |
|---|---|---|
| Minimum patent infringement damages | 10,000 ₽ | 50,000 ₽ |
| Maximum fixed damages | 5,000,000 ₽ | 10,000,000 ₽ |
| Court’s power to change the calculation method | Not available | Available |
What to Do
Check the patent status of the INN before filing registration documents. Request an extract from the EAPO Pharma Register and the Register of Eurasian Invention Patents for the generic’s active substance. Record the expiration date of the base patent, any dependent patents on a specific form or manufacturing process, and the right holder.
Keep preparatory work and commercialization documentarily separate.
Maintain separate records for two groups of actions:
Permissible before patent expiration: bioequivalence studies, filing registration documents, registering the maximum wholesale price for the Vital and Essential Drugs List.
Requires patent expiration: importing or synthesizing raw materials for commercial batches, manufacturing and storing commercial lots, signing supply contracts, and taking part in tenders. Support every action with dated primary documents.
Do not count on fast preliminary injunctions. In practice, courts rarely grant them in patent disputes. Patent holders should prepare two parallel lines of defense in advance: a civil suit and a complaint to FAS under Article 14.5 of Federal Law No. 135-FZ, bearing in mind that an FAS ruling can also be overturned in court, as happened with «Fordiglif.»
Track the progress of the Filatova bill through the State Duma. The first reading is expected in July or September 2026. Industry associations can be used to submit comments on the text while it is being prepared for a second reading.
Recalculate financial risk under the new damages rules. When preparing a claim or defending against one, factor in the range of 50,000 to 10,000,000 rubles under Article 1252.1 of the CC RF, and the chance that a court will change the calculation method the other side proposes.
Patent holders: set up monitoring of the EAEU Unified Register of Medicines by INN. It is better to catch a competitor’s generic registration application at the dossier review stage, before the drug reaches the market and before public procurement begins.
The «Fordiglif» case shows that even a full cycle (an FAS complaint, a fine, a court overturning the fine, a countersuit over unfair competition) does not settle who is right. The bill has not been adopted yet, preliminary injunctions remain rare, and FAS rulings remain open to challenge in court. The outcome of any specific dispute will depend above all on the quality of the documentation gathered at the earliest stage.
Companies that check patent status through the EAPO Pharma Register in advance and keep preparation documentarily separate from commercialization lower their own risk regardless of who wins the next dispute. For the industry as a whole, a clear rule in Article 1359 of the CC RF matters as much as the outcome of any single case: it will decide how many more years pharmaceutical companies spend on litigation instead of on developing and launching drugs.
Regulatory Basis:
1. Draft law amending Article 1359 of the Civil Code of the Russian Federation (Deputy I.V. Filatova, introduced in the State Duma in May 2026; not yet adopted as of the publication date)
2. Civil Code of the Russian Federation, Part Four, Articles 1359, 1360, 1252.1 (as amended 23 July 2025)
3. Federal Law No. 135-FZ dated 26 July 2006, «On Protection of Competition,» Article 14.5
4. Federal Law No. 214-FZ dated 7 July 2025, «On Amendments to Part Four of the Civil Code of the Russian Federation»
5. Decree of the Government of the Russian Federation No. 1278 dated 18 September 2024, «On Amendments to Decree of the Government of the Russian Federation No. 941 of 10 December 2008»