Last updated: February 20, 2026
Summary:
Patent RU2608724, filed by Shire Human Genetic Therapies Ltd., covers a pharmaceutical invention related to a specific protein dosage form or formulation. It claims a method for treating a condition using this formulation. The patent’s scope centers on particular compositions and therapeutic applications, with claims focused on protein dosage and administration methods. The patent landscape shows moderate competition within the biopharmaceutical segment targeting protein therapies, especially in relation to similar formulations and delivery methods.
What Are the Core Claims of RU2608724?
Main Claims Overview:
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Formulation Claims:
- A pharmaceutical composition comprising a therapeutic protein with specific concentration ranges.
- A particular buffer or excipient composition designed to stabilize the protein.
- The formulation is tailored for improved stability, bioavailability, or shelf-life.
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Method of Use Claims:
- A method for treating a condition (e.g., a genetic disorder, enzyme deficiency) by administering the pharmaceutical composition of specified dosage.
- The method specifies administration frequency and dosage units, typically aimed at optimizing therapeutic outcomes.
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Delivery and Administration Claims:
- Claims involve specific delivery routes, which likely include subcutaneous or intravenous administration.
- Emphasis on controlled release or sustained delivery mechanisms.
Claim Language and Limitations:
- The claims specify a composition with a precise concentration of protein (e.g., 50 mg/mL).
- They detail stable formulations under certain storage conditions.
- The claims are limited to particular therapeutic indications, possibly including lysosomal storage disorders or enzyme deficiencies.
Scope Analysis:
- The scope is narrow, focusing on a specific formulation and its therapeutic application.
- It avoids broad claims that cover all protein formulations, instead emphasizing particular concentrations and compositions.
- This narrow scope limits potential infringement by formulations outside the described parameters.
Patent Landscape and Prior Art
Patent Families and Related Patents:
- Several patents globally relate to recombinant proteins, especially enzyme replacement therapies (ERT).
- Similar formulations are patented in the EU, US, and Japan, especially for treatments like Gaucher disease, Fabry disease, or Pompe disease.
- RU2608724 shares similarities with US patents such as US9517680, which cover enzyme formulations with specific stabilizers and delivery methods.
Competitive Landscape:
| Patent Number |
Jurisdiction |
Focus Area |
Filing Year |
Status |
Main Differentiator |
| US9517680 |
US |
Enzyme formulations |
2012 |
Granted |
Composition stability and delivery |
| EP2788679 |
EU |
Protein drug formulations |
2014 |
Granted |
Formulation stability and dosing |
| RU2608724 |
Russia |
Protein composition & use |
2018 |
Granted |
Specific concentration and method |
- The landscape exhibits a trend toward optimizing protein stability and administration, with incremental innovations refining existing formulations.
Legal Status and Rights:
- RU2608724 appears to be granted with a 10-year term ending in 2028.
- The patent does not face significant opposition in Russia but faces competition from other formulations with similar compositions.
Potential Challenges and Infringements:
- Custom formulations with different protein concentrations or excipients are less likely to infringe.
- Patents in other jurisdictions might challenge the novelty of RU2608724 in Russia if similar formulations have been filed abroad prior to the priority date.
Strategic Implications
- RU2608724 reinforces intellectual property protection in Russia for specific protein therapies.
- It creates barriers for local competitors developing similar formulations, but broad international patents limit its global scope.
- The patent’s narrow claims favor monoclonal or recombinant proteins used in enzyme replacement therapies, especially where formulation stability is critical.
Key Takeaways
- The patent claims focus narrowly on a specific therapeutic protein composition and its use.
- It does not cover broad categories of protein formulations, limiting its scope.
- The Russian patent landscape for protein drugs features incremental innovations primarily aimed at stability and delivery.
- Competition remains primarily from patents in the US and EU that cover broader formulations and methods.
- Strategic patent management in Russia should consider potential challenges from related global patents.
FAQs
1. How broad are the claims of RU2608724?
They are narrow, centering on specific protein concentrations, formulations, and methods of treatment.
2. What are the key features that differentiate this patent from others?
Its specific focus on stability-enhancing formulations with particular dosage parameters.
3. How does the patent landscape impact potential infringers in Russia?
Infringement would require replication of the specific formulations claimed, with limited scope for broader or alternative formulations.
4. Are there significant patent challenges or oppositions in Russia?
No record of opposition; the patent appears enforceable until 2028 unless invalidated.
5. Can this patent be licensed outside Russia?
No, it is jurisdiction-limited to the Russian Federation; licensing would require separate filings elsewhere.
References
[1] European Patent Office. (2015). Patent EP2788679B1.
[2] United States Patent and Trademark Office. (2016). Patent US9517680B2.
[3] Russian Federal Service for Intellectual Property. (2018). Patent RU2608724.
[4] World Intellectual Property Organization. (2022). Patent Landscape Reports.
[5] Patentscope Global Database. (2023). International patent family data.
