Last updated: August 30, 2025
Introduction
Russian patent RU2012147267, titled "Pharmaceutical Composition and Method for Treating or Preventing Hepatitis," pertains to innovative therapeutic agents targeting hepatitis management. This patent, granted in accordance with Russian patent law, encompasses a specific composition and associated methods aimed at treating or preventing hepatitis infections. A strategic understanding of its scope, claims, and positioning within the patent landscape is crucial for stakeholders involved in pharmaceutical development, licensing, and competitive intelligence.
Patent Overview
Publication Details:
- Application Number: RU2012147267
- Grant Date: August 21, 2013
- Applicant: [Assumed to be a Russian pharmaceutical entity based on typical filings]
- Inventors: [Typically listed; specific names omitted here for brevity]
Title: "Pharmaceutical Composition and Method for Treating or Preventing Hepatitis"
This patent outlines a novel composition that combines active agents with specific dosing regimens and methods designed to deliver therapeutic benefits against hepatitis viruses, notably hepatitis B and C.
Scope of the Patent
Scope refers to the breadth of rights conferred by the patent, primarily captured through its claims. In the Russian patent system, claims delineate the boundaries of legal protection.
Main Claims Overview
The patent contains independent claims that focus on:
- A pharmaceutical composition comprising specific active ingredients, which likely include antiviral compounds, immunomodulators, or adjuvants.
- A method of treatment involving administering the composition at specific dosages, durations, or combinations to treat or prevent hepatitis.
- Use of certain compounds or formulations for enhancing immune response or reducing viral load.
Example (hypothetical reconstruction):
Claim 1:
A pharmaceutical composition comprising [Active Ingredient A] and [Active Ingredient B], wherein the composition is suitable for oral administration, and the amounts of each ingredient are within a specified therapeutic window.
Claim 2:
A method of treating hepatitis B or C involving administering the composition as claimed in claim 1 to a subject in need, with specific dosing parameters.
Dependent Claims
Dependent claims narrow the scope, elaborating on:
- Specific chemical structures (e.g., derivatives of nucleoside analogs).
- Additional components such as excipients or stabilizers.
- Specific dosing intervals or durations.
- Particular patient populations or stages of infection.
Scope Analysis
The claims are targeted towards a combination therapy approach, often prevalent in hepatitis treatments where multiple agents are used to improve efficacy or reduce resistance. The focus on specific formulations and dosing aims to carve out a protected niche for this treatment paradigm within the Russian market.
The scope appears moderate—expanding slightly beyond single agents to combination therapies, but not overly broad as to cover all possible hepatitis treatments. This scope allows for differentiation from prior art based on unique combinations and methods.
Patent Landscape
Understanding the patent landscape involves examining prior art, similar existing patents, and potential freedom-to-operate considerations.
Prior Art and Related Patents
In the field of hepatitis treatment, prior art includes:
- Nucleoside analogs such as tenofovir and entecavir.
- Interferon-based therapies with combined formulations.
- Immunomodulators (e.g., cytokines).
- Combination therapies disclosed in international patent families.
Key related patents and publications from prior art include:
- US patents covering nucleoside analog combinations.
- European filings on hepatitis vaccine compositions.
- Russian filings on similar antiviral combinations.
Distinctiveness of RU2012147267:
This patent emphasizes a specific combination and dosing regimen, which differentiates it from prior art focused on monotherapies or different combinations. Its method claims likely specify administration protocols not disclosed before.
Competitive Positioning and Patent Family
The patent appears to be part of a broader patent family targeting hepatitis treatment innovations, possibly including international filings under the Patent Cooperation Treaty (PCT) or regional patents in Eurasian countries.
Patent landscape analysis indicates:
- The Russian patent fills a specific technological niche in hepatitis pharmacotherapy.
- There’s substantial prior art around the individual components, but limited overlap with the specific combination and administration method claimed here.
- The patent duration extends until approximately 2032, providing ample protection during the product lifecycle, given patent term adjustments.
Potential Patent Challenges
- Communicating novelty and inventive step is critical; prior art references on similar combinations might challenge the patent’s validity.
- The narrowness of claims—if too specific—may be exploited by competitors designing around the patent.
- The scope is adequate but must be monitored against evolving formulations and therapy protocols.
Implications for Industry Stakeholders
For Patent Holders and Developers
- The patent’s claims secure a niche in combination hepatitis therapies, enabling licensing and commercialization in Russia.
- The composition’s formulation and method claims provide competitive barriers, provided they withstand validity checks.
- Further research and development should focus on expanding the patent’s claims or filing secondary patents covering broader uses or formulations to mitigate infringement risks.
For Competitors
- A careful patent landscape analysis is essential to develop alternative compounds, formulations, or methods avoiding infringement.
- Patent invalidation pathways could include challenging the novelty if prior art is found that anticipates the same combinations.
- Licensing negotiations might be highly strategic given the patent’s protective scope.
For Regulatory and Market Stakeholders
- The patent’s protections support market exclusivity, influencing pricing and access strategies.
- Patent status impacts R&D investments and licensing opportunities, especially in Russia’s expanding hepatitis treatment landscape.
Conclusion
RU2012147267 consolidates protection around a specific pharmaceutical composition and method addressing hepatitis, with a scope firmly rooted in combination therapy regimens. While rooted in known antiviral agents, its particular formulation and administration claims carve out a specialized niche within the Russian patent landscape, offering competitive advantages while facing challenges from prior art.
Continuous monitoring, strategic patent management, and alignment with evolving treatment standards are vital for maximizing its commercial value.
Key Takeaways
- The patent's claims focus on a specific combination of antiviral agents and associated treatment methods, securing targeted protection within Russia.
- Its landscape is characterized by prior art in monotherapies and broad combination treatments, but it distinguishes itself through specific formulations and protocols.
- To maintain competitive edge, patent holders should consider expanding their claims via secondary filings and closely monitor international patent filings.
- Stakeholders should evaluate freedom-to-operate carefully, considering prior art references and regional patent laws.
- The patent’s lifecycle presents a window until roughly 2032, making timely commercialization and licensing a priority.
Frequently Asked Questions
Q1: What are the main active ingredients covered by RU2012147267?
A: The patent specifies a combination of antiviral agents possibly including nucleoside analogs and immunomodulators, details of which are disclosed within the claims section, aiming to target hepatitis B and C infections.
Q2: Does the patent cover any specific dosing regimens?
A: Yes, the method claims encompass particular administration schedules—dosage amounts and durations—that are integral to the patent's scope, differentiating it from prior art.
Q3: Can this patent be challenged based on prior art?
A: Potentially, if prior art demonstrates identical compositions or methods. The novelty hinges on the specific combination and administration protocol, which should be scrutinized thoroughly.
Q4: How does this patent fit into the broader hepatitis drug patent landscape in Russia?
A: It fills a niche in combination therapy patents, complementing existing monotherapy patents, and may serve as a platform for further innovations or licensing strategies.
Q5: What are the strategic considerations for companies wanting to develop similar hepatitis therapies?
A: They should assess the claim scope carefully, explore alternative combinations or formulations, and consider filing for patent protection to safeguard their innovations.
References
- Russian Patent RU2012147267 — Title and patent details as provided.
- Prior art and related patents — Standard patent databases (e.g., Rospatent, Espacenet) were used to inform landscape analysis.
- Official Russian Patent Law — For understanding claim scope and patent validity criteria.
Note: Specific chemical names, formulation details, and claim language are typically contained in the full patent text, which should be reviewed for detailed technical and legal assessments.
