{"id":38707,"date":"2026-06-09T09:55:00","date_gmt":"2026-06-09T13:55:00","guid":{"rendered":"https:\/\/www.drugpatentwatch.com\/blog\/?p=38707"},"modified":"2026-05-04T10:05:49","modified_gmt":"2026-05-04T14:05:49","slug":"russia-patent-term-extensions-what-every-pharma-ip-team-needs-to-know-right-now","status":"publish","type":"post","link":"https:\/\/www.drugpatentwatch.com\/blog\/russia-patent-term-extensions-what-every-pharma-ip-team-needs-to-know-right-now\/","title":{"rendered":"Russia Patent-Term Extensions: What Every Pharma IP Team Needs to Know Right Now"},"content":{"rendered":"\n
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Russia is a $9.2 billion pharmaceutical market where the rulebook on intellectual property is being rewritten in real time. [1] Patent-term extensions (PTEs) \u2014 the mechanism that compensates innovators for years lost to regulatory review \u2014 still exist in Russia. They still work. And for companies that understand how to use them correctly, they remain a legitimate competitive tool. But the ground under them has shifted substantially since 2022, and a naive application of pre-war IP strategy to the current Russian market is a reliable way to lose both time and money.<\/p>\n\n\n\n

This article walks through the full picture: the legal mechanics of Russian PTEs under Article 1363 of the Civil Code, how Rospatent’s practice has evolved since the 2015 reform, the compulsory licensing threat that now sits alongside every supplementary patent, the strategic calculus that multinational pharmaceutical companies face in deciding whether to file, and the specific case studies \u2014 Gilead’s Sovaldi, Novo Nordisk’s Ozempic, and Vertex’s Trikafta \u2014 that show how the system behaves under pressure. It also covers the Eurasian route, the Pharma 2030 policy framework that shapes the entire environment, and the practical steps companies can take to preserve value.<\/p>\n\n\n\n

Professionals tracking these developments can use DrugPatentWatch to monitor supplementary patent filings, expiration timelines, and competitive intelligence on the Russian pharmaceutical patent landscape \u2014 data that is increasingly critical as the market bifurcates between domestic generics and imported innovation.<\/p>\n\n\n\n

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The Architecture of Russian Patent Law: Where PTEs Fit<\/strong><\/h2>\n\n\n\n

The 20-Year Baseline and Why It Erodes<\/strong><\/h3>\n\n\n\n

The standard patent term for a pharmaceutical invention in Russia is 20 years from the filing date. That baseline is unremarkable \u2014 it mirrors the global norm established by the TRIPS Agreement \u2014 but it conceals an enormous practical problem for drug developers. A pharmaceutical patent is typically filed years before the drug reaches patients. Between filing and first regulatory approval, a company runs preclinical studies, Phase I, II, and III clinical trials, and then navigates the marketing authorization process with the Russian Ministry of Health (Minzdrav). By the time the product is actually on shelves and generating revenue, a substantial portion of that 20-year clock has already expired.<\/p>\n\n\n\n

The period from patent application to first marketing authorization in pharmaceuticals typically runs between five and 10 years. [2] In practice, this can reduce effective market exclusivity \u2014 the period during which the originator faces no generic competition \u2014 to anywhere from 10 to 15 years, or sometimes less for particularly complex regulatory reviews. That is the core commercial problem that PTEs are designed to solve.<\/p>\n\n\n\n

Russia recognized this problem formally in 2003, making it one of the earlier non-EU jurisdictions to introduce a pharmaceutical PTE mechanism. The current framework is codified in Article 1363(2) of the Civil Code of the Russian Federation. The provisions entered into effect on January 1, 2008, under Part IV of the Civil Code, with the most consequential amendments arriving on January 1, 2015. [3] Understanding those 2015 changes is essential \u2014 they fundamentally restructured how extensions are granted and how broad the resulting protection can be.<\/p>\n\n\n\n

The Pre-2015 Regime and the 2015 Structural Break<\/strong><\/h3>\n\n\n\n

Before 2015, Russian PTE practice was more permissive. A patent holder could request an extension of its existing patent, and in the early years of implementation, Rospatent allowed the extended protection to cover not just the specific approved product but also certain embodiments of the invention. This gave brand companies meaningful latitude to draft their supplementary protection broadly enough to make design-arounds difficult.<\/p>\n\n\n\n

The 2015 reform changed that architecture entirely. Under the current rules, Rospatent does not simply extend the term of the existing patent. Instead, it issues a separate supplementary patent \u2014 a new patent instrument with its own claims \u2014 and those claims are subject to significant restrictions. [4] The supplementary patent cannot contain alternative features. Its claims must be limited to the exact features of the product for which marketing authorization was granted. A Markush claim in the original patent, which might cover hundreds of related compounds, is effectively collapsed to a single compound \u2014 the specific stereoisomer, salt form, or formulation that corresponds to the authorized product. [5]<\/p>\n\n\n\n

This shift had immediate and lasting consequences. Companies whose original claims were broad by design \u2014 intended to cover a genus of related molecules \u2014 found that their supplementary patents were narrow by operation of law. The claims that are most commonly eligible for extension are compound claims corresponding to the active pharmaceutical ingredient (API), certain pharmaceutical composition claims, EPC 2000-style claims, and Swiss-type or German-type use claims. Process claims, expression vector claims, and cell-line claims are generally not eligible. [6]<\/p>\n\n\n\n

There is no statutory cap on the number of patents for which a PTE can be sought, provided each patent contains at least one independent claim that covers all features of the approved product. A company with a complex biologics portfolio might therefore file multiple PTE requests for the same authorized product, layering protection across compound patents, composition patents, and use patents. In practice, this approach requires careful coordination with Rospatent examiners, who have become increasingly skeptical of broad claim sets since 2015. [7]<\/p>\n\n\n\n

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Calculating the Extension: The Formula and Its Limits<\/strong><\/h2>\n\n\n\n

How the Math Works<\/strong><\/h3>\n\n\n\n

The formula for calculating a Russian PTE is straightforward in principle. The extension period equals the time elapsed from the patent application date to the date of the first marketing authorization, minus five years. [8] So if a company filed its patent application in January 2005 and received its first Russian marketing authorization in July 2015, the calculation would be approximately 10.5 years minus 5 years, yielding a PTE of about 5.5 years. But Russia caps the extension at five years, so the maximum supplementary patent term in Russia is five years beyond the original 20-year patent term.<\/p>\n\n\n\n

Two clarifications are critical here. First, the reference date for the marketing authorization is the date of actual receipt by the applicant \u2014 not the date of the Ministry of Health’s internal decision. The IP Court established this in Abbott v. Russian Patent Office (Case IPC-81\/2014, October 9, 2013), a ruling that matters practically because the two dates can differ by weeks or months. [9] Second, the calculation uses the first marketing authorization globally \u2014 or the first Russian marketing authorization, depending on how the applicable rules are read and how the specific patent was drafted. In practice, most applications use the Russian marketing authorization date as the reference, since that is the event that triggers the right to file.<\/p>\n\n\n\n

The Six-Month Filing Deadline and Why It Bites Companies<\/strong><\/h3>\n\n\n\n

Russia imposes a hard deadline for filing PTE applications. The applicant must submit the request to Rospatent within the validity period of the patent and no later than six months from whichever is later: the date of first marketing authorization receipt or the date of patent grant. [10] Miss this window, and the right to a supplementary patent is gone permanently. There is no equitable tolling, no grace period for late-filed requests, and no administrative appeal that can cure a missed deadline.<\/p>\n\n\n\n

For global pharmaceutical companies managing dozens of patent families across multiple jurisdictions simultaneously, six months is a tight window. Marketing authorizations often arrive in bunches \u2014 a major company might receive Russian approval for three or four products within a few months of each other \u2014 and the internal process of identifying which patents cover which approved products, confirming the precise marketing authorization date, preparing claim sets narrow enough to satisfy Rospatent’s requirements, and assembling the required documentation can easily consume most of that six months if the work does not begin promptly.<\/p>\n\n\n\n

The required documentation package for a Rospatent PTE filing includes a notarized copy of the first marketing authorization, a list of claims from each patent being extended that cover the approved product, and documentary evidence proving that the chemical formulation of the authorized product and the patented compound are identical. [11] The last requirement is more demanding than it might appear. Rospatent examiners require specific evidence of chemical identity \u2014 not just a generic assertion \u2014 and acceptable documents include pharmacopoeia monographs, extracts from the registration dossier, package inserts, and entries from authoritative references such as the Merck Index.<\/p>\n\n\n\n

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Rospatent’s Tightening Practice: What Examiners Reject and Why<\/strong><\/h2>\n\n\n\n

The Overclaiming Problem<\/strong><\/h3>\n\n\n\n

Since 2015, Rospatent has adopted a progressively more demanding approach to the scope of supplementary patent claims. The dominant practice issue is overclaiming \u2014 the submission of amended claims that Rospatent examiners believe are still too broad to cover only the specific authorized product. This is not a trivial compliance problem. It is the most common reason PTE applications receive Office Actions, and in a significant number of cases, it is the reason they are rejected outright. [12]<\/p>\n\n\n\n

The Gilead Pharmasset case involving Sovaldi (sofosbuvir) is the most widely cited illustration of this dynamic. Rospatent initially rejected Gilead’s PTE application on the basis that sofosbuvir \u2014 the active pharmaceutical ingredient in Sovaldi \u2014 is a specific stereoisomer, but the original patent broadly claimed ‘stereoisomers’ as a class. Rospatent’s position was that the amended claims submitted for the supplementary patent still encompassed the broader class and could not be narrowed to the single stereoisomer through the mechanism of the PTE proceeding. Gilead challenged this decision at the IP Court of the Russian Federation, which ultimately overturned Rospatent’s rejection. [13] But the case consumed years of litigation, and the uncertainty it created shaped how practitioners advise clients to draft their original patent applications.<\/p>\n\n\n\n

A second category of rejections involves antibodies and biological molecules, where the complexity of the structural description creates particular friction with Rospatent’s claim-narrowing requirements. In one case, Rospatent rejected a PTE where independent claim 1 covered an antibody described only in its variable regions, while the dependent claims described the constant regions. The IP Court upheld the rejection, noting that the applicant could have included the constant region features in the independent claim during the PTE proceeding and chose not to. [14] The lesson is unambiguous: every feature of the actual authorized product that appears in the marketing authorization should be represented in the supplementary patent’s independent claim.<\/p>\n\n\n\n

The Current Trend of Hyper-Narrowing<\/strong><\/h3>\n\n\n\n

A pattern of ‘hyper-narrowing’ has emerged from recent Rospatent practice. Examiners have pushed applicants to restrict claims beyond what the statutory text strictly requires \u2014 demanding, for example, that specific salt forms, crystalline polymorphs, or particle size distributions be included in the claims even when these characteristics are not the defining novel features of the invention. Some practitioners argue that this approach goes beyond the mandate of Article 1363(2), which requires only that the supplementary patent claims ‘characterize the product’ for which authorization was granted.<\/p>\n\n\n\n

The paradox is that a narrowly drafted supplementary patent is simultaneously easier to obtain and easier to design around. A generic manufacturer facing a compound patent covering a single specific stereoisomer, described down to its crystalline form and specific salt, has a narrow but defined target. Modify the polymorph, use a different salt, and the supplementary patent may no longer reach the generic product. This is the central strategic tension in Russian PTE practice: the more you narrow to satisfy Rospatent, the more you create space for competitors to engineer around your protection.<\/p>\n\n\n\n

DrugPatentWatch’s tracking of Russian supplementary patents shows this trend quantitatively. The average claim count in supplementary patents issued after 2018 is substantially lower than in those issued in the 2008-2015 period, and the specificity of claim language \u2014 down to IUPAC names, specific salt forms, and defined dosage ranges \u2014 has increased markedly.<\/p>\n\n\n\n

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The Eurasian Patent Route: An Alternative Architecture<\/strong><\/h2>\n\n\n\n

How the Eurasian System Works<\/strong><\/h3>\n\n\n\n

Russia is a member of the Eurasian Patent Convention, administered by the Eurasian Patent Office (EAPO) in Moscow. A Eurasian patent, filed in Russian under a single procedure, provides protection in up to nine member states: Russia, Armenia, Azerbaijan, Belarus, Kazakhstan, Kyrgyzstan, Tajikistan, Turkmenistan, and Uzbekistan. This makes the Eurasian route an efficient option for companies seeking broad regional coverage from a single filing.<\/p>\n\n\n\n

The relationship between Eurasian patents and Russian PTEs is an area that requires careful strategic thought. A Eurasian patent for a pharmaceutical product does not automatically receive PTE treatment from Rospatent simply because the Russian national patent route would qualify. The PTE mechanism under Article 1363 of the Russian Civil Code applies to Russian national patents. Eurasian patents enjoy protection in Russia by virtue of the Eurasian Patent Convention, but the PTE application procedure interacts with both systems in ways that practitioners must navigate specifically.<\/p>\n\n\n\n

The Gilead remdesivir compulsory licenses covered Eurasian patents \u2014 specifically patents EA025252, EA025311, EA029712, EA020659, EA032239, and EA028742 \u2014 demonstrating that government use orders under Article 1360 apply to Eurasian patents in exactly the same way they apply to Russian national patents. [15] This equivalence has strategic implications: a company that relies exclusively on Eurasian patent protection, without maintaining Russian national patents, is equally exposed to the compulsory licensing mechanisms discussed below.<\/p>\n\n\n\n

Filing Trends and the China Shift<\/strong><\/h3>\n\n\n\n

One of the most telling structural shifts in the Russian patent landscape is visible in filing statistics. China surpassed the United States as the top foreign filer in Russia in 2024, a reversal that reflects both the chilling effect of geopolitical tensions on Western companies’ willingness to invest in Russian IP and the growing appetite of Chinese pharmaceutical manufacturers to establish patent positions in a market where they increasingly supply APIs and finished dosage forms. [16] Domestic Russian filings also increased in 2024, driven by state support for domestic R&D and the Pharma 2030 strategy’s emphasis on home-grown innovation.<\/p>\n\n\n\n

For Western pharmaceutical companies, the filing data presents a stark question: if you are reducing your Russian patent filings, you are simultaneously reducing the number of patents eligible for PTE protection and reducing your ability to enforce against generic competition \u2014 even the competition that a PTE would have given you grounds to contest. The decision to file or not file is therefore not simply an IP budgeting decision. It is a market access decision with a five-to-ten-year horizon.<\/p>\n\n\n\n

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The Geopolitical Disruption: How 2022 Changed Everything<\/strong><\/h2>\n\n\n\n

Federal Law No. 46-FZ: The Opening Salvo<\/strong><\/h3>\n\n\n\n

On March 8, 2022 \u2014 two weeks after Russia’s invasion of Ukraine \u2014 Federal Law No. 46-FZ entered into force. Its implications for pharmaceutical intellectual property were immediate and substantial. The law expanded the Russian government’s authority to override normal IP protections in several ways. [17]<\/p>\n\n\n\n

First, it authorized an expedited registration procedure for drug master file amendments in cases of shortage or risk of shortage attributable to foreign sanctions. This opened the door for Russian manufacturers to register analog drugs more quickly when the market lost access to originator products. Second, and more significantly, it granted the government powers \u2014 initially for 2022 but subsequently extended \u2014 to define categories of goods that fall outside the scope of certain Civil Code IP protections. In plain language: the government could designate product categories where Russian manufacturers could copy patented products without the normal legal constraints.<\/p>\n\n\n\n

These powers were exercised almost immediately. Government Resolution No. 299, issued March 6, 2022, amended the methodology for calculating compensation payable to patent holders when the government issues a compulsory license under Article 1360. For patent holders from the 48 designated ‘unfriendly countries’ \u2014 which includes the United States, the United Kingdom, all 27 EU member states, Canada, Australia, Japan, South Korea, Norway, Iceland, and Switzerland \u2014 the compensation rate was set to 0% of the revenues generated by the generic manufacturer. [18]<\/p>\n\n\n\n

The practical meaning of this decree requires one sentence: Western pharmaceutical companies whose patents are compulsorily licensed in Russia receive nothing. Their supplementary patents, which they may have spent years and significant legal fees obtaining, provide protection that can be nullified by a government order, with zero financial compensation.<\/p>\n\n\n\n

Article 1360 as a Weapon<\/strong><\/h3>\n\n\n\n

Article 1360 of the Russian Civil Code is the government’s ’emergency use’ compulsory licensing provision. It permits the government to authorize any Russian entity to use a patented invention without the patent holder’s consent, in cases of ‘extreme necessity’ related to national defense, national security, or the protection of citizens’ lives and health. [19] Compensation must be paid \u2014 or theoretically must be paid \u2014 but the amount and the practical enforceability of that obligation depend entirely on the government’s determination of the applicable rate.<\/p>\n\n\n\n

Before 2020, Article 1360 was dormant. No compulsory license had ever been issued under it in the history of Russian patent law. The COVID-19 pandemic changed that: on December 31, 2020, the government issued its first-ever Article 1360 compulsory license, granting Pharmasintez JSC the right to produce remdesivir (Gilead’s Veklury) for one year. [20] A second license for the same drug was issued to another company in March 2022. Gilead filed a lawsuit challenging the original decree in Russia’s Supreme Court. The Supreme Court dismissed the case in May 2021, ruling that the pandemic emergency conditions justified the license. [21]<\/p>\n\n\n\n

The Gilead litigation established a critical precedent: Russian courts will not second-guess the government’s determination that ‘extreme necessity’ exists. With that precedent in place, Article 1360 became a routinely available tool \u2014 not an emergency measure in the traditional sense, but a policy instrument deployable against any foreign pharmaceutical company whose product becomes a target.<\/p>\n\n\n\n

Resolution 380 of March 2024: The Institutionalization<\/strong><\/h3>\n\n\n\n

Russian Government Resolution 380 of March 27, 2024 established a formal procedure and institutional subcommittee for reviewing compulsory license requests under Article 1360. [22] Russian legal entities that meet defined prerequisites can now submit requests to the Ministry of Economic Development through a structured process. This resolution transformed what had been an ad hoc emergency mechanism into a standard administrative pathway. It also established that annual renewals for Russian patents, utility models, and designs now require five-year advance payments \u2014 a change the patent office presented as helpful to foreign applicants who might otherwise lose rights due to future payment difficulties, but which also represents a significant cash commitment for companies uncertain about their future position in Russia.<\/p>\n\n\n\n

The institutionalization of the compulsory licensing pathway has direct implications for PTE strategy. A supplementary patent obtained through the rigorous Rospatent process can now be effectively overridden through an administrative procedure that takes weeks, not years. The two instruments \u2014 the PTE that creates the right, and the compulsory license that can override it \u2014 exist in the same legal ecosystem, and any serious analysis of Russian pharmaceutical IP must address both simultaneously.<\/p>\n\n\n\n

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Three Case Studies That Define the Current Environment<\/strong><\/h2>\n\n\n\n

Case Study 1: Gilead and Remdesivir \u2014 The Benchmark for Government Overreach<\/strong><\/h3>\n\n\n\n

Gilead Sciences was the first Western pharmaceutical company to have its Russian and Eurasian patents compulsorily licensed under Article 1360. The drug was remdesivir, known in Russia under Gilead’s brand Veklury. The compulsory license was issued to Pharmasintez JSC on December 31, 2020, with Pharmasintez producing its generic version under the brand name Remdeform at a registered maximum price of 7,400 rubles \u2014 versus Gilead’s offered rate of 28,000 rubles for the same course of treatment. [23]<\/p>\n\n\n\n

Gilead’s legal position was not frivolous. The company argued that it had repeatedly expressed its ability to supply remdesivir to Russia and had not refused to negotiate a voluntary license or supply agreement. The government’s counter-argument was that Gilead had not registered the drug under Russia’s maximum-price regime for essential medicines at the time the decree was issued, making the licensing order a necessary public health measure rather than an act of patent appropriation. The Supreme Court found for the government.<\/p>\n\n\n\n

Separately, Gilead’s PTE application for Sovaldi (sofosbuvir) \u2014 Russian Patent No. 2651892, filed with Rospatent on August 20, 2018 \u2014 ran into the claim-scope problems described above. Rospatent’s initial rejection was based on the position that sofosbuvir is a specific stereoisomer while the original patent claimed the broader genus. The IP Court ultimately overturned this rejection, but the case consumed years and established the legal framework that now governs how examiners approach stereoisomer claims in PTE applications. [24]<\/p>\n\n\n\n

The compound lesson from the Gilead experience is that even when a PTE is eventually granted through litigation, the enforcement value of that supplementary patent can be negated by a compulsory license \u2014 and the compensation for that compulsory license, for a U.S. company, is now zero under the post-2022 regime.<\/p>\n\n\n\n

Case Study 2: Novo Nordisk and Semaglutide \u2014 The Ozempic Template<\/strong><\/h3>\n\n\n\n

In late 2023, Novo Nordisk informed Russian authorities that it would stop supplying Ozempic (semaglutide) to Russia. The drug, which treats type 2 diabetes and is also used for weight management, was protected by a patent running to 2035. With no voluntary license available and the originator withdrawing, Russian manufacturer Geropharm attempted to negotiate a license agreement with Novo Nordisk, offering compensation from net proceeds of semaglutide sales. Novo Nordisk did not respond to those offers. [25]<\/p>\n\n\n\n

In December 2023, the Russian government issued compulsory licenses under Article 1360 to two domestic companies: Geropharm, which would produce semaglutide under the brand Semavic, and Promomed, which would produce it under the brand Quincenta. [26] Geropharm completed a bioequivalence study against Ozempic and received marketing authorization on October 6, 2023 \u2014 before the formal compulsory license was issued. The price agreed by the Ministry of Health for Semavic was 4,279.5 rubles per pack, approximately 26% below the approved price of the originator product. [27]<\/p>\n\n\n\n

By early 2024, first batches of both Semavic and Quincenta had entered Russian pharmacies. Two additional companies \u2014 PSK Pharma and Pharmasyntez-Nord \u2014 subsequently also received permissions to manufacture semaglutide. [28] Government purchases of semaglutide-based drugs in Russia increased 28% year-on-year by 2025, measured in rubles.<\/p>\n\n\n\n

The compensation picture remains a case study in contradiction. Under Resolution 380 of March 2024, royalties to holders from ‘unfriendly countries’ are set at 0.5% of revenue, to be paid into a special ‘O’ bank account \u2014 an account to which Western companies currently have no access due to sanctions-related banking restrictions. By March 2025, Promomed had made a payment to Novo Nordisk, reportedly less than 15 million rubles. Geropharm had not paid anything, citing the restrictions on payment to unfriendly-state patent holders. Novo Nordisk stated publicly that it had not received any licensing remuneration. [29]<\/p>\n\n\n\n

The Ozempic case has become the operational template for how Russia now handles patent-protected drugs whose originators have withdrawn. The sequence \u2014 voluntary license request, rejection or no response, Article 1360 petition, government decree, domestic production, minimal or zero compensation \u2014 is now a documented and institutionalized pathway. Any company holding Russian patents on a drug that could be characterized as essential should treat this template as a baseline scenario rather than an unlikely outcome.<\/p>\n\n\n\n

Case Study 3: Vertex and Trikafta \u2014 Compulsory Licensing Beyond Obvious Targets<\/strong><\/h3>\n\n\n\n

The compulsory licensing of Trikafta (elexacaftor\/tezacaftor\/ivacaftor), Vertex Pharmaceuticals’ cystic fibrosis triple combination, by Russia \u2014 confirmed as an active case by multiple sources \u2014 illustrates that Article 1360 is not reserved for blockbuster diabetes drugs or pandemic antivirals. [30] Trikafta carries a U.S. list price exceeding $300,000 per patient per year. Russia’s relatively small cystic fibrosis patient population and the product’s extreme cost create a combination that makes it politically attractive to compulsorily license and practically difficult for Vertex to contest.<\/p>\n\n\n\n

The Trikafta case is also significant from a patent complexity standpoint. Trikafta is protected by 36 active U.S. patents, with an estimated U.S. generic launch date of July 2038 based on patent and exclusivity analysis. [31] The Russian and Eurasian patent positions are comparably dense. A domestic Russian manufacturer seeking to produce a generic Trikafta equivalent must navigate not just the compound patents on elexacaftor, tezacaftor, and ivacaftor individually, but also combination formulation patents and method-of-use patents. The compulsory license mechanism cuts through all of this \u2014 it does not require the domestic producer to invalidate any patent. It simply authorizes use without consent.<\/p>\n\n\n\n

The broader principle illustrated by the Trikafta case is that Article 1360 reaches any product that can be characterized as essential to citizen health. Cystic fibrosis is a life-shortening genetic disease. A drug that dramatically improves lung function in CF patients meets that threshold as easily as a COVID-19 antiviral. The limiting principle is not medical necessity \u2014 it is political will.<\/p>\n\n\n\n

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‘About 300 innovative drugs for advanced therapy are expected to fail to reach the Russian market over the next 10 years’ due to multinational companies discontinuing clinical trials and reducing commercial activities in the country.’ \u2014 Yakov and Partners, Russian Pharma 2030 Analysis [32]<\/p>\n<\/blockquote>\n\n\n\n

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The Pharma 2030 Framework: The Policy Environment That Defines the Risk<\/strong><\/h2>\n\n\n\n

From Pharma 2020 to Pharma 2030: An Escalation in Ambition<\/strong><\/h3>\n\n\n\n

To understand the IP risk facing foreign pharmaceutical companies in Russia, you need to understand Pharma 2030 \u2014 the government’s industrial strategy for the pharmaceutical sector through the end of this decade. Published on January 11, 2022, just weeks before the Ukraine invasion, Pharma 2030 is not a policy paper that gets overtaken by events. It is a structural blueprint for achieving ‘technological sovereignty’ in medicines. [33]<\/p>\n\n\n\n

Its predecessor, Pharma 2020, was launched in 2009 with an ambitious goal: increase the share of domestically produced medicines to 75% of all drugs sold in Russia by 2020. The target was not fully met, but the program catalyzed real change. Thirty pharmaceutical plants were commissioned between 2010 and 2020, approximately half built in cooperation with members of the Association of International Pharmaceutical Manufacturers (AIPM), which estimates that foreign companies invested close to one trillion rubles in Russian localization projects during this period. [34] By 2024, domestic drugs exceeded 64% of market volume in Russia \u2014 a dramatic increase from 28.5% before Pharma 2020 began. [35]<\/p>\n\n\n\n

Pharma 2030 escalates the ambition. Where Pharma 2020 focused primarily on localizing manufacturing of finished dosage forms, Pharma 2030 targets the entire value chain \u2014 including synthesis of active pharmaceutical ingredients, which Russia currently imports at 80-95% dependency levels, primarily from China and India. [36] The strategy sets an explicit target: by 2030, 90% of drugs on the ‘Strategically Significant Medicines’ (SSM) list must be produced through a full domestic production cycle within Russia or the Eurasian Economic Union.<\/p>\n\n\n\n

The Import Paradox and What It Means for IP<\/strong><\/h3>\n\n\n\n

The Russian pharmaceutical market in 2024 had a total value of 2.85 trillion rubles, representing a 10% increase over 2023 in local currency terms. [37] In U.S. dollar terms, the market remained flat at approximately $30.9 billion. Domestically produced drugs made up approximately 64% of market volume but only about 36.8% of market value \u2014 meaning that higher-priced imported innovative products continue to dominate the revenue side of the market even as domestic generics dominate the volume side. [38]<\/p>\n\n\n\n

This ‘import paradox’ \u2014 high volume but low value for domestic products, low volume but high value for imports \u2014 is exactly the dynamic that Pharma 2030 aims to resolve by pushing domestic companies up the value chain toward innovative products. State support measures, including the ‘second extra’ mechanism that favors full-cycle domestically produced drugs in government procurement, actively accelerate this shift. The share of generics in Russian sales increased from 62% in 2024 to 63.2% in 2025 in value terms, with forecasts showing continued growth.<\/p>\n\n\n\n

For IP purposes, the policy environment means that patents covering drugs in the VED (Vital and Essential Drugs) list or the SSM list are particularly exposed to compulsory licensing pressure. These lists define exactly the products the government most wants to see produced domestically. A foreign patent on a VED-listed drug is a target, not a shield, in the current political context.<\/p>\n\n\n\n

The Clinical Trial Collapse and the Innovation Gap<\/strong><\/h3>\n\n\n\n

One direct consequence of the post-2022 environment that shapes the long-term IP landscape is the near-collapse of Western-sponsored clinical trials in Russia. By March 2023, foreign-sponsored clinical trials in Russia had fallen to just seven active studies, down from 32 in the period September-February 2023 and 102 in the March-August 2022 period. [39] This is not a temporary disruption. It represents a structural break in how new drugs reach Russian patients.<\/p>\n\n\n\n

Without clinical trials, new drugs cannot be registered in Russia. Without registration, there is no marketing authorization date \u2014 and without a marketing authorization date, there is nothing to base a PTE application on. This creates what practitioners call a ‘launch gap’: drugs approved by the FDA and EMA in 2024 and 2025 will not be registered in Russia for years, if ever, unless Russian companies conduct their own local trials independently of the originator. [40]<\/p>\n\n\n\n

For companies that withdrew from the Russian market in 2022, this means their Russian patents are sitting in a state of partial limbo \u2014 valid (for now), generating annual maintenance fees, but not generating any royalty income and not supporting any PTE application because no marketing authorization has been sought. For those same companies, the annual fee increase of 20-25% that took effect in 2024 adds a concrete cost to the decision to maintain a patent portfolio in Russia without generating revenue from it. [41]<\/p>\n\n\n\n

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The Pediatric Extension Gap: A Structural Absence<\/strong><\/h2>\n\n\n\n

One area where Russian law is notably less generous than the EU is in pediatric patent extensions. The European system provides for a six-month extension of the supplementary protection certificate (SPC) when a drug has been studied and approved for pediatric use \u2014 an explicit incentive for companies to run the expensive trials needed to establish pediatric safety and efficacy data. Russia has no equivalent provision. [42]<\/p>\n\n\n\n

This absence matters for two reasons. First, it represents a lost incentive for investing in pediatric drug development for the Russian market \u2014 a market with a large and medically significant pediatric population. Second, it means that companies planning global pediatric programs cannot count on Russia contributing to the financial return that makes those programs viable. In a market where clinical trial activity has collapsed, the absence of a pediatric extension incentive is one more structural factor discouraging future investment.<\/p>\n\n\n\n

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Practical PTE Strategy in the Current Environment<\/strong><\/h2>\n\n\n\n

Whether to File: The Calculation Has Changed<\/strong><\/h3>\n\n\n\n

Before 2022, the calculus on whether to file a PTE application in Russia was primarily a cost-benefit analysis: does the value of the extended exclusivity period justify the filing fees, attorney time, and potential litigation costs? For most blockbuster drugs with significant Russian market exposure, the answer was straightforwardly yes.<\/p>\n\n\n\n

Post-2022, that calculation includes several additional variables. First, what is the probability that the drug will be targeted by a compulsory license if the company reduces its Russian commercial presence? The more essential the drug and the more visible the company’s withdrawal from the market, the higher that probability. Second, if a compulsory license is issued, what compensation will the company receive? Under the current regime, for companies from ‘unfriendly countries,’ the statutory rate is 0% \u2014 meaning the supplementary patent, even if perfectly drafted and obtained, has zero commercial value against a government-ordered override. Third, does maintaining an active Russian patent portfolio \u2014 including filing for PTEs \u2014 create any legal or regulatory complications for the company in its home jurisdiction or with sanctions authorities?<\/p>\n\n\n\n

The answer to that last question is generally no: maintaining existing patent portfolios and filing for PTE extensions of those portfolios does not typically violate sanctions, since patents are intellectual property instruments rather than financial transfers. But the optics and business logic of investing in Russian IP protection when the protection is likely to be overridden have caused many companies to reduce rather than expand their Russian patent activities.<\/p>\n\n\n\n

The Case for Continuing to File<\/strong><\/h3>\n\n\n\n

Despite the risks, there are serious arguments for maintaining Russian patent positions, including PTE filings, rather than abandoning them.<\/p>\n\n\n\n

First, abandoning Russian patents does not reduce the compulsory licensing risk. A Russian generic manufacturer can produce a patented drug under a government compulsory license regardless of whether the patent holder is actively maintaining its rights. The patent’s existence is what triggers the legal framework \u2014 but an abandoned patent is actually worse, because a generic company can then register and sell without even the fig leaf of licensing formalities. An active patent at least requires the compulsory license process, which creates a documented record of what was taken and theoretically establishes a basis for future compensation claims.<\/p>\n\n\n\n

Second, geopolitical situations change. A patent or supplementary patent granted today with a five-year extension could still be in force in 2030 or 2032 \u2014 a time horizon during which the political relationship between Russia and Western countries could plausibly shift. Abandoning a patent because it has no value today forfeits any optionality on that future state.<\/p>\n\n\n\n

Third, maintaining Russian patent positions preserves standing in any future TRIPS dispute or bilateral negotiation over IP treatment. Countries that have abandoned their Russian patent portfolios are in a weaker position to argue that Russia has violated its WTO IP obligations \u2014 because they have voluntarily removed the specific IP right that was allegedly violated.<\/p>\n\n\n\n

How to Draft Original Claims with PTE in Mind<\/strong><\/h3>\n\n\n\n

One of the clearest lessons from the post-2015 Rospatent PTE practice is that the most effective time to plan for a Russian PTE is at the original patent application stage \u2014 not after marketing authorization has been received. Several practices have emerged from the case law and practitioner experience.<\/p>\n\n\n\n

Include sufficient disclosure of the specific compound or formulation that is most likely to become the authorized product. When the original application is filed, the most advanced clinical candidate may not be fully characterized, but drafting the specification to include detailed structural and functional description of that candidate \u2014 its stereochemistry, specific salt forms, crystalline polymorphs, and preferred dosage ranges \u2014 creates a disclosure record that supports the narrow claim set Rospatent will demand in the supplementary patent proceeding.<\/p>\n\n\n\n

In the dependent claims of the original application, capture the specific features of the product as it will likely be authorized. If the clinical program is heading toward a specific salt of the API in a specific dosage strength, include those features as dependent claims. When the PTE proceeding arrives, those dependent claims provide a ready claim set that Rospatent is more likely to accept as the basis for the supplementary patent.<\/p>\n\n\n\n

Avoid relying exclusively on Markush claims for the active compound. While Markush claims are essential for broad genus protection, a PTE application built solely on a broad Markush claim without a specific subordinate claim to the individual authorized compound gives Rospatent examiner’s grounds for rejecting or requiring extensive narrowing \u2014 as the Gilead sofosbuvir case demonstrated. [43]<\/p>\n\n\n\n

Consider filing multiple Russian national patents or Eurasian applications covering different aspects of the authorized product \u2014 the compound itself, the pharmaceutical composition, the method of use. Each separately patented aspect is eligible for its own PTE request, and the layering of supplementary patents across multiple aspects creates a more robust position than relying on a single patent.<\/p>\n\n\n\n

Managing the Rospatent Prosecution<\/strong><\/h3>\n\n\n\n

PTE applications are reviewed by the same examiner branch that handled the original patent prosecution. This creates continuity \u2014 the examiner is already familiar with the invention \u2014 but also means that positions taken adversely during original examination can resurface in PTE review. If an examiner was skeptical of a particular claim feature during original prosecution, the same skepticism will likely apply when that feature needs to be preserved in the supplementary patent.<\/p>\n\n\n\n

Office Actions during PTE prosecution typically raise three categories of issues: claims that are still too broad (not limited to the authorized product), discrepancies between the patent claims and the marketing authorization documents, and questions about whether the claim type (composition, compound, use) is eligible for extension. Responding to these Office Actions requires both technical expertise in pharmaceutical chemistry and familiarity with Rospatent’s current administrative guidelines, which are periodically updated and are not always publicly announced in advance.<\/p>\n\n\n\n

The IP Court of the Russian Federation serves as the primary appellate body for Rospatent decisions. The court has developed a body of case law on PTE questions that is navigable \u2014 unlike the Russian political environment for compulsory licensing, the IP Court’s PTE decisions follow legal logic and can be predicted with reasonable accuracy by practitioners familiar with the precedents. When Rospatent rejects a PTE application improperly \u2014 as it did in the Gilead sofosbuvir case \u2014 the IP Court has been willing to correct it.<\/p>\n\n\n\n

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The Parallel Import Question: Why It Is Not a PTE Substitute<\/strong><\/h2>\n\n\n\n

In March 2022, Russia also legalized parallel imports of goods, including pharmaceuticals, from countries that had sanctioned Russia. In theory, this allows Russian distributors to import a patented drug from a third-country market without the patent holder’s permission, bypassing the normal right of the patent holder to control imports. In practice, parallel imports of prescription drugs have remained limited, primarily because of the difficulty of guaranteeing cold chain integrity and product authenticity for grey-market pharmaceutical imports.<\/p>\n\n\n\n

The Russian Ministry of Health restricts parallel importation for prescription medicines more severely than for consumer goods, and the government’s stated preference is for compulsory licensing of domestic production rather than parallel importation from third-country markets. [44] For branded pharmaceutical companies, this means that parallel imports are not the primary competitive threat they face in Russia \u2014 domestic generic production under compulsory license is the more significant concern, and it is the one that interacts directly with PTE strategy.<\/p>\n\n\n\n

\n\n\n\n

The TRIPS Tension: What International Law Says and What It Does<\/strong><\/h2>\n\n\n\n

Russia’s WTO Membership and the TRIPS Obligations<\/strong><\/h3>\n\n\n\n

Russia joined the World Trade Organization in 2012, making it a party to the TRIPS Agreement. TRIPS Article 31 establishes the rules for compulsory licensing \u2014 specifically, it requires that the rights holder be paid ‘adequate remuneration in the circumstances of each case, taking into account the economic value of the authorization.’ A compensation rate of 0% for companies from ‘unfriendly countries’ self-evidently fails the Article 31 standard. [45]<\/p>\n\n\n\n

Several governments and industry groups have raised this concern in WTO fora. Russia’s response has been to invoke TRIPS Article 73, the national security exception, which allows WTO members to take ‘any action which it considers necessary for the protection of its essential security interests.’ The argument is that the sanctions imposed against Russia constitute an emergency in international relations sufficient to trigger the Article 73 exception.<\/p>\n\n\n\n

This is legally contested. The scope of the WTO national security exception has been litigated, and while the DS512 panel decision in Ukraine v. Russia (2019) gave Article 73 a broad interpretation, the panel also noted that the exception is not self-judging in a way that completely removes WTO oversight. Whether Russia’s compulsory licensing and zero-compensation policies ultimately survive WTO dispute settlement proceedings is uncertain \u2014 but the practical reality is that WTO dispute proceedings take years, the Russian market continues operating in the meantime, and the enforcement mechanism for WTO decisions against a country that has withdrawn from international engagement is limited.<\/p>\n\n\n\n

TRIPS Article 31bis and the Export Waiver<\/strong><\/h3>\n\n\n\n

In May 2022, Russia issued Government Order No. 947, which added explicit language invoking TRIPS Article 31bis as the legal basis for a compulsory export license for pharmaceutical products. [46] Article 31bis is the 2005 amendment to TRIPS that created a mechanism for countries to issue compulsory licenses for the production of generic drugs specifically for export to countries without adequate manufacturing capacity \u2014 the so-called ‘Paragraph 6 system.’ Russia’s use of this provision was widely regarded by legal commentators as an expansive reading of its scope, but it signals that Russia is not simply flouting international IP norms \u2014 it is actively constructing a legal rationale, however contested, for its actions.<\/p>\n\n\n\n

\n\n\n\n

What Friendly-Country Companies Can Still Expect<\/strong><\/h2>\n\n\n\n

The differential treatment of companies from ‘unfriendly’ versus ‘friendly’ states is built into the compensation structure for compulsory licenses. Companies from countries that have not imposed sanctions on Russia \u2014 which includes India, China, Brazil, and a wide range of emerging markets \u2014 face a different risk profile than U.S. or EU companies.<\/p>\n\n\n\n

For Indian pharmaceutical companies, Russia is one of the largest export markets in the world. India has emerged as Russia’s top pharmaceutical supplier since 2022, with exports increasing by 3% in 2023 to nearly 294 million boxes of medicines. [47] Indian companies are not subject to the 0% compensation rule for compulsory licensing \u2014 though the practical enforceability of even the 0.5% rate that applies to neutral-country patent holders remains questionable given banking and sanctions complications.<\/p>\n\n\n\n

Chinese companies have similarly expanded their Russian market presence, and China’s overtaking of the United States as the top foreign patent filer in Russia in 2024 reflects a strategic positioning for the post-Western market environment. Chinese companies filing for PTEs in Russia are not subject to the same political risk as Western companies \u2014 their supplementary patents, if challenged, would not face the 0% compensation override.<\/p>\n\n\n\n

This creates a genuinely asymmetric competitive environment. A Chinese pharmaceutical company that develops an innovative drug, patents it in Russia, obtains a PTE, and is later subjected to a compulsory license theoretically has access to the standard 0.5% royalty pathway and can receive payment into a functioning banking channel. A U.S. company in the identical situation receives nothing. This asymmetry has direct implications for which companies will be willing to introduce innovative products into the Russian market going forward.<\/p>\n\n\n\n

\n\n\n\n

Enforcement: What a Supplementary Patent Actually Gives You<\/strong><\/h2>\n\n\n\n

Civil Enforcement Mechanisms<\/strong><\/h3>\n\n\n\n

A Russian supplementary patent confers the same exclusive rights as the original patent for the duration of the extension. The patent holder can pursue infringement claims in the Russian Arbitrazh (commercial) courts, seek injunctions against infringing manufacturers and distributors, and claim damages based on the profits of the infringer or the royalties the patent holder would have received under a license.<\/p>\n\n\n\n

The Russian IP Court, established in 2013, has become the specialized first-instance court for patent disputes. Its decisions are generally technically competent and follow the relevant provisions of the Civil Code and the case law that has developed since 2008. In cases that do not involve a government compulsory license \u2014 straightforward generic competition where a Russian company launches a product without any authorization during the supplementary patent term \u2014 enforcement is available and has been used by major pharmaceutical companies.<\/p>\n\n\n\n

The Bayer\/Nativa dispute over sorafenib (Nexavar) illustrates how these enforcement mechanisms work in practice. Bayer filed a lawsuit against Russian generic company Nativa in January 2018, seeking to ban sales of Nativa’s generic sorafenib product during the patent protection period. Over the course of two court proceedings, Nativa successfully argued that its own manufacturing process used a proprietary formula distinct from Bayer’s protected process. During the litigation, Nativa had already signed 301 state contracts for its generic drug, with pricing approximately 20% below the originator product. [48] The case highlights a tension that runs through Russian pharmaceutical patent enforcement: even when the litigation process runs correctly, the commercial damage occurs in real time as state procurement channels favor lower-priced generics.<\/p>\n\n\n\n

The Limits of Enforcement Against Government-Authorized Use<\/strong><\/h3>\n\n\n\n

A supplementary patent cannot be enforced against a use authorized by a government compulsory license under Article 1360. That is the definitional characteristic of a compulsory license: it overrides the patent holder’s exclusive right. The only recourse is through the compensation mechanism \u2014 and as established above, for companies from unfriendly states, that compensation is zero under current policy.<\/p>\n\n\n\n

Civil enforcement remains available against unauthorized generic manufacturers who are not operating under a government license. A generic company that launches a semaglutide product in Russia without either a compulsory license or a valid patent position is still an infringer who can be enjoined. But in the current environment, major generic companies are not launching patent-infringing products without formal government authorization \u2014 they are obtaining that authorization through the Article 1360 process before going to market.<\/p>\n\n\n\n

\n\n\n\n

Using DrugPatentWatch to Monitor the Russian PTE Landscape<\/strong><\/h2>\n\n\n\n

Navigating the Russian supplementary patent landscape without systematic data is effectively flying blind. DrugPatentWatch provides tracking of patent term extensions, supplementary patent filings, and expiration dates across jurisdictions including Russia. For IP teams managing pharmaceutical portfolios with Russian exposure, this data serves several practical functions.<\/p>\n\n\n\n

First, it enables proactive identification of supplementary patent opportunities. DrugPatentWatch’s tracking of marketing authorization dates and patent filing dates can flag situations where a company may be approaching the six-month deadline for a PTE filing without having initiated the process \u2014 a risk that is particularly acute for companies that reduced their IP staff or outsourced their Russian patent management after 2022.<\/p>\n\n\n\n

Second, it supports competitive intelligence. Monitoring which drugs held by domestic Russian manufacturers or Chinese companies have obtained or applied for supplementary patents helps map the competitive landscape for any given therapeutic area. If a Russian domestic manufacturer has a supplementary patent on a compound, that information changes the risk calculation for a foreign originator considering whether to (re)enter that market.<\/p>\n\n\n\n

Third, it provides context for licensing negotiations. When a company is considering a voluntary license agreement with a Russian partner \u2014 an approach that several major multinationals have used to maintain market presence while reducing direct exposure \u2014 understanding the remaining term of the relevant supplementary patents quantifies the value of what is being licensed and the leverage each party brings to the negotiation.<\/p>\n\n\n\n

\n\n\n\n

The Decision Framework: Four Categories of Company and What Each Should Do<\/strong><\/h2>\n\n\n\n

Category One: Companies That Have Maintained Russian Market Presence<\/strong><\/h3>\n\n\n\n

Pfizer, Sanofi, Bayer, and Novartis are among the foreign pharmaceutical companies that have retained localized production in Russia despite the post-2022 environment, halting R&D activities and new investments but continuing to manufacture existing products. [49] For these companies, Russian PTE filings are a straightforward continuation of normal IP practice. The supplementary patents provide enforceable rights against unauthorized generics \u2014 and for companies operating in Russia under local manufacturing agreements, the risk of being targeted by a government compulsory license is lower because they are already contributing to the domestic production goals of Pharma 2030.<\/p>\n\n\n\n

For these companies, the practical PTE strategy is: continue filing for every eligible drug, use the drafting approach described above to maximize the defensibility of supplementary patent claims, monitor Rospatent practice carefully, and be prepared to litigate at the IP Court when examiners apply unreasonably narrow interpretations of claim eligibility.<\/p>\n\n\n\n

Category Two: Companies That Have Scaled Back but Not Exited<\/strong><\/h3>\n\n\n\n

The majority of large Western pharmaceutical companies have adopted a posture of reduced commercial activity \u2014 stopping new clinical trials, halting new capital investment, cutting marketing expenditures, but continuing to supply existing registered drugs through existing distribution channels. [50] For these companies, the PTE question is more nuanced.<\/p>\n\n\n\n

The core analysis is: which products in the Russian market have PTE-eligible patents with sufficient remaining term to justify the filing effort? For products where the original patent expires within two or three years regardless, a PTE of only one or two years may not be worth the cost and management attention given the geopolitical environment. For products with longer supplementary patent terms available \u2014 up to the five-year maximum \u2014 the analysis tips differently, because the potential value of exclusivity even in a challenging enforcement environment is greater.<\/p>\n\n\n\n

Category Three: Companies That Have Exited the Russian Market<\/strong><\/h3>\n\n\n\n

Some pharmaceutical companies \u2014 particularly those with significant U.S. government contracts or strong political pressure from home-country governments \u2014 have effectively exited Russia. For these companies, the conventional argument for Russian PTE filings disappears: there is no revenue to protect, no market position to defend, and no commercial rationale for extending a period of exclusivity in a market you are not operating in.<\/p>\n\n\n\n

The counter-argument is the optionality argument: if the political situation changes and the company eventually re-enters Russia, having maintained its patent portfolio \u2014 including any available PTEs \u2014 preserves the commercial position that would otherwise have to be rebuilt from scratch. How much weight to give this argument depends on each company’s view of the probability and timeline of Russia’s geopolitical rehabilitation, which is a judgment call well outside the scope of patent law.<\/p>\n\n\n\n

Category Four: Companies Entering Russia for the First Time<\/strong><\/h3>\n\n\n\n

For Chinese, Indian, Korean, or other non-Western pharmaceutical companies without existing Russian market exposure, Russia presents a different calculus. The 0% compensation rule does not apply to them. The Pharma 2030 strategy’s emphasis on non-Western sourcing creates genuine opportunities. And the regulatory landscape, while challenging, has not been weaponized against companies from non-‘unfriendly’ states in the way it has been used against Western companies.<\/p>\n\n\n\n

For these companies, PTE filings in Russia are straightforwardly valuable \u2014 they extend exclusivity in a growing market without the political risk overlay that characterizes Western companies’ positions. The strategic recommendation for these companies is to file PTE applications as a standard element of Russian market entry, use the same claim-drafting discipline required by Rospatent’s post-2015 practice, and build relationships with Rospatent through responsive prosecution rather than adversarial litigation.<\/p>\n\n\n\n

\n\n\n\n

The CIS Dimension: Extending the Russian PTE Framework<\/strong><\/h2>\n\n\n\n

Russia does not exist in IP isolation. The CIS countries \u2014 Armenia, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Turkmenistan, and Uzbekistan \u2014 all have pharmaceutical PTE mechanisms, introduced at different times and governed by different national patent laws. For a company with a significant post-Soviet market strategy, coordinating PTE applications across these jurisdictions with the Russian filing creates a more complete regional exclusivity picture.<\/p>\n\n\n\n

Belarus introduced its PTE of up to five years in December 2002, before Russia. Armenia, Kyrgyzstan, and Moldova followed. The conditions and procedures vary \u2014 some jurisdictions require applications within six months of marketing authorization, others allow up to one year. Some issue supplementary certificates analogous to the EU SPC system; others (like Russia post-2015) issue separate supplementary patents. [51]<\/p>\n\n\n\n

The Eurasian Patent Office’s jurisdiction covers Russia, Armenia, Azerbaijan, Belarus, Kazakhstan, Kyrgyzstan, Tajikistan, Turkmenistan, and Uzbekistan. A single Eurasian patent, obtained through the EAPO, can serve as the foundation for PTE applications in multiple member states \u2014 reducing the filing and prosecution burden compared to separate national applications in each country.<\/p>\n\n\n\n

\n\n\n\n

What Comes Next: Structural Trends Through 2030<\/strong><\/h2>\n\n\n\n

The Domestic Innovation Push<\/strong><\/h3>\n\n\n\n

Russia’s government is not content to remain a generics-producing market indefinitely. Pharma 2030 explicitly calls for the development of domestic innovative drugs, and state funding for pharmaceutical R&D has increased meaningfully since 2022. Russian patent applications from domestic companies increased in 2024, including in the pharmaceutical and biotechnology sectors. The development of Russian-origin innovative drugs \u2014 starting with the Sputnik V vaccine platform and extending to other areas \u2014 means that Russian domestic companies will eventually need the PTE mechanism themselves to protect their own innovations.<\/p>\n\n\n\n

This creates a political dynamic that could gradually improve the PTE environment for all filers: as Russian domestic innovators build patent portfolios that need protection and extension, the political incentive to weaken the patent system shifts. A government that undermines PTEs for foreign companies also undermines them for domestic innovators \u2014 and Russia’s stated ambition to build a globally competitive domestic pharmaceutical industry requires that the IP system work in both directions.<\/p>\n\n\n\n

The Biosimilars Surge<\/strong><\/h3>\n\n\n\n

The biosimilars segment is expanding rapidly in Russia, driven by the need to replace imported biologics for which clinical trial and registration activity has stopped. The share of bioequivalence study permits issued by the Ministry of Health reached 71% of all drug approvals in 2024, up from 41% in 2021. [52] Biosimilars for oncology, autoimmune disease, and diabetes drugs are the primary targets, and many of these products are covered by Russian and Eurasian patents with active or recently expired PTEs.<\/p>\n\n\n\n

The biosimilar approvals create a patent enforcement environment that is both active and legally complex. Unlike small-molecule generics, where bioequivalence can be demonstrated through straightforward pharmacokinetic studies, biosimilars require more extensive comparability data \u2014 but the Russian biosimilar approval process has become significantly faster in the current environment. Companies with supplementary patents on originator biologics should monitor Russian biosimilar registrations closely, since a biosimilar approval does not automatically resolve any patent dispute \u2014 it simply authorizes the product for sale pending any applicable patent bar.<\/p>\n\n\n\n

The Five-Year Advance Payment Requirement<\/strong><\/h3>\n\n\n\n

The October 2024 change requiring five-year advance payment of Russian patent renewal fees is a two-edged development. Rospatent framed it explicitly as a measure to help foreign applicants maintain patent rights even if future sanctions or restrictions complicate ongoing fee payments. [53] In practice, it forces companies to commit cash upfront for protection they may not be able to enforce commercially \u2014 a significant financial decision for companies that have already reduced or eliminated Russian revenue.<\/p>\n\n\n\n

For companies that decide to maintain Russian patent portfolios, the five-year advance payment is simply a cash flow consideration. For companies that are on the fence about whether to continue Russian patent maintenance, the advance payment requirement forces an earlier and more definitive decision than the annual renewal structure previously required. This crystallization of the strategic choice is itself a notable development in Russian patent administration.<\/p>\n\n\n\n

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Key Takeaways<\/strong><\/h2>\n\n\n\n
    \n
  • Russia’s PTE mechanism under Article 1363 of the Civil Code provides up to five years of extended exclusivity through a supplementary patent with claims narrowed strictly to the authorized product. The six-month filing deadline is absolute.<\/li>\n\n\n\n
  • Rospatent’s practice has tightened substantially since 2015. Claims must be narrow, specific, and aligned character-by-character with the marketing authorization documents. Broad Markush claims must be collapsed to the single authorized compound. The Gilead sofosbuvir case defined the outer limits of what Rospatent will accept.<\/li>\n\n\n\n
  • Government compulsory licenses under Article 1360 of the Civil Code can override any supplementary patent. For companies from the 48 designated ‘unfriendly countries,’ the compensation for such a license is currently set to 0% of the generic manufacturer’s revenue. This is a direct confiscation mechanism with no meaningful judicial remedy.<\/li>\n\n\n\n
  • The Novo Nordisk semaglutide and Gilead remdesivir cases are the operational templates for how Russia applies compulsory licensing: voluntary license request, no response from patent holder, government decree, domestic production, minimal or zero compensation. Any drug on Russia’s essential medicines list should be evaluated against this template.<\/li>\n\n\n\n
  • Maintaining Russian patent positions \u2014 including PTE filings \u2014 preserves optionality for future market re-entry, establishes standing for potential future TRIPS-based claims, and prevents generic manufacturers from operating outside any licensing framework at all. Abandonment does not eliminate the risk of generic competition; it eliminates the legal mechanisms for addressing it.<\/li>\n\n\n\n
  • The Pharma 2030 strategy targets full domestic production of 90% of essential medicines by 2030. Any product on Russia’s SSM or VED lists is a compulsory licensing target; the PTE protecting it is a speed bump, not a barrier.<\/li>\n\n\n\n
  • Non-Western companies \u2014 Chinese, Indian, Korean \u2014 face a materially different risk environment in Russia. The 0% compensation rule does not apply to them, creating asymmetric competitive conditions that will shape which companies introduce innovative products into the Russian market going forward.<\/li>\n\n\n\n
  • Tools such as DrugPatentWatch provide patent term and supplementary patent tracking for Russia that is essential for IP teams managing portfolios with Russian exposure, particularly for identifying upcoming PTE filing deadlines or competitive biosimilar threats.<\/li>\n<\/ul>\n\n\n\n
    \n\n\n\n

    FAQ<\/strong><\/h2>\n\n\n\n

    Q1: Can a company from an ‘unfriendly country’ actually receive any compensation if a Russian compulsory license is issued on its supplementary patent?<\/strong><\/h3>\n\n\n\n

    Technically, the current regulatory framework (as of 2024’s Resolution 380) sets compensation for ‘unfriendly country’ patent holders at 0.5% of the generic manufacturer’s revenue, to be paid into a special ‘O’-type bank account. In practice, Western companies cannot access these accounts due to sanctions-related banking restrictions. The Geropharm\/semaglutide case showed that even the notional 0.5% rate is inconsistently applied \u2014 Promomed made a small payment to Novo Nordisk, while Geropharm made none, citing restrictions on paying patent holders from unfriendly states. Novo Nordisk publicly stated it had received no remuneration. For practical purposes, Western companies should plan around receiving zero compensation from a Russian compulsory license.<\/p>\n\n\n\n

    Q2: If a company files a PTE application in Russia and Rospatent rejects it, what are the realistic options?<\/strong><\/h3>\n\n\n\n

    The primary avenue for challenging a Rospatent PTE rejection is an appeal to the IP Court of the Russian Federation, which functions as the specialized patent court for these matters. The IP Court has reversed Rospatent rejections \u2014 the Gilead sofosbuvir (Sovaldi) case being the most prominent example \u2014 and generally applies legal standards derived from the Civil Code and its own case law. An IP Court appeal is a viable option when Rospatent’s rejection is based on a legally incorrect application of Article 1363(2) rather than a factual dispute about the identity of the patented compound and the authorized product. Litigation timelines typically run 12 to 24 months. Pre-litigation administrative reconsideration within Rospatent is also available but less frequently successful when the examiner’s position reflects current agency policy rather than individual error.<\/p>\n\n\n\n

    Q3: How does the Russian PTE system compare to the EU Supplementary Protection Certificate (SPC) system in terms of the scope of protection it provides?<\/strong><\/h3>\n\n\n\n

    Both systems cap the extension at five years (with the EU system providing an additional six-month pediatric extension that Russia does not offer). Both systems restrict the extended protection to the specific authorized product. The key practical difference is in the mechanism: the EU SPC is a separate IP right tied to the marketing authorization, while the Russian supplementary patent is a patent \u2014 with patent-style prosecution at Rospatent, patent-style claims, and patent-style enforcement. Russia’s claims-narrowing requirements are arguably more stringent in practice than SPC scope interpretation under EU case law. The EU system also benefits from decades of CJEU case law providing predictable guidance on SPC scope; Russia’s supplementary patent case law is thinner and less settled, creating more practitioner uncertainty about how specific edge cases will be resolved.<\/p>\n\n\n\n

    Q4: Is there a strategic value in filing Russian PTEs purely for defensive purposes \u2014 not expecting to enforce them, but using them as leverage in future license negotiations or geopolitical settlements?<\/strong><\/h3>\n\n\n\n

    Yes, and this argument has gained traction among IP strategists since 2022. A documented record of valid supplementary patents in Russia \u2014 including patents that have been compulsorily licensed with zero compensation \u2014 creates a quantifiable claim in any future bilateral negotiation between Russia and Western governments over IP treatment. It also establishes that the company made good-faith efforts to protect its intellectual property through the available legal mechanisms, which supports any future TRIPS dispute filing by the company’s home government. The monetary value of these defensive benefits is difficult to quantify, but the cost of maintaining a Russian patent portfolio is relatively modest compared to the potential negotiating leverage it provides if Russia eventually seeks to restore normal IP relations with Western trading partners.<\/p>\n\n\n\n

    Q5: How should a company approach the situation where its original patent expires before a PTE application is resolved by Rospatent?<\/strong><\/h3>\n\n\n\n

    The PTE application must be filed before the original patent expires \u2014 that is one of the core statutory requirements. If the original patent expires while the PTE application is still under examination by Rospatent (which can happen when there are Office Actions requiring responses, or when an appeal to the IP Court is pending), the applicant is in a procedurally difficult position. Russian Civil Code Article 1363(2) requires that the application be filed within the patent’s validity period. If the original patent lapses due to non-payment of maintenance fees while a PTE application is pending, the application typically fails \u2014 another reason why the five-year advance payment requirement introduced in October 2024 is actually protective for patent holders who are uncertain about their ability to make future annual payments. Strategic advance payment of maintenance fees for patents where a PTE application is pending or anticipated is a basic but essential element of Russian pharmaceutical IP management.<\/p>\n\n\n\n

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    References<\/strong><\/h2>\n\n\n\n
      \n
    1. IMARC Group. (2024). Russia pharmaceutical market size, industry, forecast 2033<\/em>. https:\/\/www.imarcgroup.com\/russia-pharmaceutical-market<\/li>\n\n\n\n
    2. Gorodissky & Partners. (2015). Extending patent terms in Russia and CIS countries<\/em>. Gorodissky.com. https:\/\/www.gorodissky.com\/publications\/articles\/extending-patent-terms-in-russia-and-cis-countries\/<\/li>\n\n\n\n
    3. IAM Media. (2015, June 17). Extending patent terms in Russia and CIS countries<\/em>. https:\/\/www.iam-media.com\/extending-patent-terms-russia-and-cis-countries<\/li>\n\n\n\n
    4. IAM Media. (2020, September 9). Getting the most out of pharmaceutical patent-term extensions in Russia<\/em>. https:\/\/www.iam-media.com\/article\/getting-the-most-out-of-pharmaceutical-patent-term-extensions-in-russia<\/li>\n\n\n\n
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