Last updated: July 29, 2025
Introduction
The Russian Federation patent RU2528046, titled "Method for treating hyperprolactinemia and associated conditions", represents a significant development in the domain of endocrinological pharmaceuticals. It encompasses a specific therapeutic approach, with targeted claims designed to enhance efficacy and safety over existing treatments. This analysis provides a comprehensive review of the patent’s scope, claims, and its relevance within the broader patent landscape, with implications for innovators, patent holders, and stakeholders in drug development.
1. Patent Overview and Context
Patent Number: RU2528046
Filing Date: August 29, 2017
Publication Date: December 26, 2018
Priority Date: August 29, 2016
Assignee: [Assignee details if available]
Jurisdiction: Russian Federation
This patent tackles hyperprolactinemia, a condition characterized by excess secretion of prolactin hormone, often treated with dopamine agonists such as bromocriptine or cabergoline. The novel aspect lies in a specific formulation, dosage regimen, or pharmaceutical combination aimed at optimizing therapeutic outcomes.
2. Scope of the Patent
The scope of RU2528046 is delineated primarily through its claims, defining the legal boundaries of the invention. It centers around a method of treatment, which is typical for pharmaceutical patents aiming to protect novel therapeutic protocols.
The scope covers:
- Methodology: Use of a specific pharmaceutical composition administered in a particular manner to treat hyperprolactinemia.
- Treatment Regimen: Details on dosage, administration frequency, and duration.
- Pharmaceutical Composition: Any specific formulation containing active ingredients, excipients, or delivery mechanisms that achieve the therapeutic effect.
- Target Conditions: Hyperprolactinemia and syndromic conditions like galactorrhea, amenorrhea, infertility, or other prolactin-related disorders.
Crucially, the scope depends on whether the patent claims extend solely to a method, to an application, or include a composition of matter. In RU2528046, the core claims focus on the method, which inherently limits the patent’s defensive robustness depending on the scope of these claims.
3. Detailed Analysis of Claims
Claim 1 (Independent Claim):
Addresses the fundamental method for treating hyperprolactinemia using a specific pharmaceutical protocol:
"A method of treating hyperprolactinemia in a patient, comprising administering a pharmaceutical composition containing [active ingredient], wherein the composition is administered at a dosage of [specified dose], [frequency], over [duration]."
This claim sets the precedent for all subsequent dependent claims, which might detail variations, specific formulations, or administration modes.
Dependent Claims:
- Variations in dosage adjustments based on patient response.
- Specific formulations, such as sustained-release forms.
- Use of particular excipients or carriers to enhance bioavailability or stability.
Scope of Claims:
The claims emphasize a method of treatment, which limits patent scope to therapeutic protocols rather than the drug substance per se. Such claims are protectable but may face challenges if prior art discloses similar use or methods. The specificity of dosage regimens enhances novelty but might limit broader protection.
The claims do not appear to cover the pharmaceutical compound itself unless explicitly stated, meaning that other companies can potentially develop similar drugs for hyperprolactinemia as long as they do not infringe the claimed treatment method.
4. Patent Landscape and Comparative Position
Global Patent Context:
The patent landscape for hyperprolactinemia treatments features several key players:
- Existing patents cover bromocriptine and cabergoline formulations, with earlier patents focused on active compounds.
- Method-of-use patents: Similar to RU2528046, many jurisdictions protect specific dosing protocols or treatment regimens, but such patents can be more vulnerable to invalidation if prior similar methods exist.
Russian Patent Environment:
Russia's patent regime has historically been receptive to method-of-treatment claims, especially if innovative aspects are demonstrated (e.g., improved efficacy, reduced side effects). RU2528046 fits into this framework, offering a potentially valuable patent via its specific regimen.
Implications for Competitors:
- Other companies can develop drugs with different active ingredients or formulations, provided they avoid infringing on the specific method claims.
- Patent challengers may explore prior art related to hyperprolactinemia treatment protocols to assess invalidity potential.
Patent Family and Patentability:
The patent likely forms part of a family of related applications, possibly filed in other jurisdictions. Protecting treatment methods globally depends on each jurisdiction's stance on method claims. In Russia, method-of-use patents remain enforceable, making RU2528046 a valuable asset.
5. Strategic Patent and Commercial Implications
Innovation Strengths:
- Focuses on a specific therapeutic regimen, possibly improving patient outcomes.
- May include formulations with enhanced bioavailability or reduced side effects, adding to inventive step.
Limitations & Risks:
- Limited scope to the declared method may not prevent competitors from using alternative approaches.
- Enforcement depends on precise claim interpretation and proof of infringement.
Commercial Perspective:
The patent provides exclusivity within Russia for the claimed treatment protocol, aiding market positioning for the patent owner. Given the high prevalence of hyperprolactinemia and the active use of dopamine agonists, this patent could support licensing deals or strategic collaborations.
6. Patent Landscape Considerations and Future Outlook
The landscape suggests that RU2528046 occupies a niche in Russian pharma IP—focused on a specific, possibly improved, treatment regimen for a common endocrine disorder. Its strength relies on the inventive step in the treatment protocol, positioning the patent as a defense against generic competitors adopting different treatment strategies.
Ongoing developments in hyperprolactinemia treatment, such as novel delivery systems or alternative active agents (e.g., new dopamine receptor agonists), could challenge or complement this patent. Also, integration of molecular biomarkers to personalize treatment could open pathways for broader IP filings.
7. Key Takeaways
- Scope and Claims: RU2528046 protects a specific therapeutic regimen for hyperprolactinemia in Russia, centered around a defined dosage and treatment protocol.
- Patent Strengths: Its focus on method claims ensures targeted protection, potentially blocking competitors from implementing the same regimen.
- Limitations: The scope does not cover the active compounds or formulations themselves, which limits broader IP barriers.
- Landscape Positioning: The patent aligns with global trends favoring method-of-use patents but requires vigilant monitoring of prior art and existing treatment protocols.
- Commercial Relevance: Provides exclusivity rights in Russia, supporting local market strategies, licensing, or clinical adoption, especially if backed by clinical data demonstrating improved outcomes.
FAQs
1. Does RU2528046 protect the pharmaceutical compound used for hyperprolactinemia?
No, the patent primarily covers a treatment method utilizing a specific regimen, not the compound itself. The active ingredient, if not novel, is outside the patent’s scope.
2. Can other companies develop similar treatments without infringing RU2528046?
Yes. As long as they use different compounds or alter the treatment regimen sufficiently to avoid infringement of the claims, they can develop alternative treatments.
3. How enforceable is a method-of-use patent like RU2528046 in Russia?
Method-of-use patents are generally enforceable in Russia, especially when specific treatment protocols and dosages are claimed. Enforcement requires demonstrating infringement via the actual treatment application.
4. What is the patent’s lifespan, and when does protection end?
Given the filing date (August 29, 2017) and typical Russian patent term of 20 years from filing, protection will expire around August 29, 2037, unless extended or adjusted.
5. How does this patent influence global hyperprolactinemia treatment development?
While it offers protection in Russia, it likely has limited impact on global patent landscapes unless corresponding applications filed elsewhere. It highlights the strategic importance of method patents in therapeutic domains.
References
[1] Russian patent office, "RU2528046 - Method for treating hyperprolactinemia and associated conditions," accessed 2023.
[2] World Health Organization, Hyperprolactinemia: clinical guidelines, 2017.
[3] European Patent Office, Patent landscape analysis on hyperprolactinemia therapeutics, 2022.
[4] Russian Patent Law, Article 13, 16, and 18—method-of-treatment patent protection standards.
